[1] The accommodation of methods of medical treatment within Australian and
United Kingdom (‘UK’) patents law has been
controversial since the
first patent applications in respect of such methods were filed in the early
20
th century. For the last 30 years that controversy has been
accepted as having a moral
[1] basis,
the issue being whether the public interest in encouraging research and
innovation in the medical arena through the provision
of patent-related
incentives for creators of new and useful therapeutic methods on the one hand is
outweighed, on the other, by the
various public policy objections to permitting
the monopolisation of such methods. Those objections include fears that the
monopolisation
of medical methods would:
(a) hinder medical research by
restricting the free availability of knowledge;
(b) be inconsistent with the teaching of medical students and practitioners;
(c) expose medical practitioners and patients who use and accept the use of a patented method
without a licence to liability for patent
infringement; and
(d) enable patentees to exact unreasonable payments for life-saving or potentially
life-saving techniques.[2]
[2] The controversy regarding the patentability of methods of medical
treatment has not always been understood as an ethical one.
Prior to 1971 the
inherent patentability of methods of medical treatment was expressly regarded by
both Australian and UK decision
makers as turning on the essentially black
letter law question of the nature of an ‘invention’, a question that
only
arose in those jurisdictions after the introduction of
modern
[3] patents
legislation.
[4]
Reconception of the issue from 1971 in moral terms can be attributed to a number
of possible causes, including the recovery by decision
makers from the initial
shock caused by the prospect of allowing patents for potentially life-saving
treatment, and the general increase
in community (and judicial) interest in the
morality of science and its implications for patents law. However, it can also
be viewed
as a recognition by the judiciary of the questions that have always
laid at the heart of the issue concerning methods of medical
treatment and
patents law – namely, whether methods of medical treatment
should
be patentable and, as a precursor to that question, to what extent (if any)
legal constructions of the term ‘invention’
and patent eligibility
generally can legitimately and openly accommodate ethical and other public
policy considerations.
[3] There is a great deal of literature concerning the
specific public policy arguments for and against the patenting of methods of
medical treatment,[5] and it is not
the purpose of this article to review such arguments nor to argue for their
resolution along particular lines. Rather,
the purpose of the article is to
consider by historical analysis the relationship between decision makers’
responses to medical
method patents and their conceptions of inherent
patentability generally. The thesis advanced in the course of such consideration
can be summarised as follows. First, for the last 100 years much of the
important jurisprudence relating to inherent patentability
in the UK and
Australia has derived from cases involving methods of medical treatment.
Secondly, those cases are distinguished by
the failure of decision makers to
resolve convincingly or consistently: (a) the basis for the exclusion from
patentability of methods
of medical treatment; and (b) the extent (if any) to
which legal constructions of inherent patentability can legitimately accommodate
ethical and other (non-commercial) public policy considerations. And thirdly,
this failure is largely responsible for the unduly
restrictive legal principles
that governed inherent patentability in Australia and the UK until 1959 and
methods of medical treatment
until the 1970s. It is also responsible for the
ongoing uncertainty on the part of Australian decision makers concerning the
relevance
of morality and public policy generally to inherent
patentability.
[4] Central to this thesis are the issues noted above
concerning what an ‘invention’ is and whether patents law, in its
various 20th century guises, permits decision makers to consider
moral issues when determining a subject matter’s prima facie eligibility
for patent protection. At a time of increasing public and legal debate regarding
both the ability of certain new technologies to
be treated as inventions and the
moral implications of such
treatment,[6]
an historical account of the development of decision makers’ responses to
these issues has never been more important. That
account serves, among other
things, as a reminder of the potential consequences for law of dressing public
policy decisions in black
letter principle, or of otherwise assuming inherent
(un)patentability without proper consideration of the foundations for that
assumption.
II THE PATENTABILITY OF METHODS OF MEDICAL TREATMENT
IN AUSTRALIA AND THE UK TO 1959
[5] Inherent patentability under Australian and UK law has been the subject
of legislation since 1623. Analysis of the development
of inherent patentability
must therefore begin with a description of its contemporary and historical
legislative basis.
A Legislative Definitions of Inherent Patentability
1 Australia
[6] Inherent patentability under Australian law depends on the existence of
an inherently patentable subject matter or, as such subject
matter has
traditionally been denoted, on the existence of an ‘invention’
within the meaning of contemporary patents
legislation. The current legislative
definition of ‘invention’ is contained in sch 1 of the
Patents Act 1990
(Cth) (‘1990 Act’) and remains essentially unchanged since the
introduction of the first federal Australian patents legislation
in
1903.
[7]
Pursuant to that definition, an ‘invention’ is ‘any manner of
new manufacture ... within section six of the
Statute of Monopolies
[including] an alleged
invention’.
[8]
Section 6
of the
Statute of Monopolies 1623 (Eng) (‘
Statute of
Monopolies’)
[9] in turn
provides as follows:
Provided also, and be it declared and enacted, that any declaration,
before-mentioned, shall not extend to any letters patent and
grants of privilege
for the term of fourteen years, or under, hereafter to be made, of the sole
working or making of any manner of
new manufactures within this realm, to the
true and first inventor and inventors of such manufactures, which others at the
time of
making such letters patent and grants shall not use, so as also they be
not contrary to the law, nor mischievous to the state, by
raising prices of
commodities at home, or hurt of trade, or generally inconvenient. The said
fourteen years to be accounted from
the date of the first letters patent of
grants of such privilege hereafter to be made, but that the same shall be of
such force as
they should be, if this act had never been
made, and of none other.
[7] Thus an invention for the purposes
of Australian law is ‘any manner of new manufactures ... not contrary to
the law, nor
mischievous to the state, by raising prices of commodities at home,
or hurt of trade, or generally inconvenient’ within the
meaning of the
1623
Statute of
Monopolies.
[10]
2 The UK
[8] Before the introduction of the current patents legislation in
1977,
[11] inherent patentability had
the same statutory form in the UK as in Australia and thus depended on the
existence of a ‘manner
of new manufacture’ within the meaning of s 6
of the
Statute of Monopolies. This common legislative basis makes it
appropriate to view the jurisprudence of Australia to date and the UK prior to
1977 as forming
one ‘Anglo-Australian’ jurisprudence; a view that is
supported by the historical reliance of Australian decision makers
in this area
on UK decisions. Despite this, differences in the interpretation of the
Statute of Monopolies and of patentability generally by decision makers
in both jurisdictions do exist, and are reflected in the case law involving
methods
of medical treatment. In the following historical analysis of
Anglo-Australian jurisprudence those differences are highlighted as
they arise
and in so far as they relate to inherent patentability. The effect of the
changes to the legislative definition of inherent
patentability introduced in
the UK in 1977 is also discussed, both for the sake of completeness and as a
point of comparison with
contemporary Australian law.
[9] Before considering
the patentability of medical methods under Anglo-Australian law
some description of the legal
background to that issue is necessary. This is
particularly so given the central thesis of the article regarding the inadequacy
of
decision makers’ responses to medical method patents and its
consequences for inherent patentability generally. Hence the purpose
of the
following section, which is to give an overview of inherent patentability prior
to the emergence of medical methods as an
issue for Anglo-Australian law in the
early 20th century.
B Inherent Patentability in Anglo-Australian Law
Prior to the Emergence of Methods of Medical Treatment as a Patents Law
Issue
[10] Before the introduction of the first modern patents legislation in the
UK in 1883 there was very little detailed consideration
by Anglo-Australian
decision makers of the concept or requirements of inherent patentability. This
is perhaps not surprising given
the general confusion that resulted from the
first attempt at such consideration in the late 18
th century case of
Boulton v Bull,
[12] and is
likely a reflection of the courts’ reticence to revisit the issues at the
centre of that confusion. Those issues and
their resolution in
Boulton v
Bull are a recurring theme in the 20
th century debates concerning
inherent patentability generally, and medical methods specifically.
1 Inherent Patentability Before the
Enactment of Modern Patents Legislation: Boulton v Bull and
Beyond
(a) Background to Boulton v Bull
[11] In 1795 the law of inherent patentability was still in its infancy.
Whilst legislation codifying the common law principles of
patentability had
existed for over 150 years (in the form of s 6 of the
Statute of
Monopolies), for a variety of mainly political reasons the patents system
saw little use from the introduction of that legislation in 1623 to
the
mid-18
th
century.
[13]
The result was that in 1795, such principles and the
Statute of
Monopolies itself had still not received the sustained attention of the
courts.
[14]
It is largely for this reason that
Boulton v Bull has acquired so much
significance, as it is the first case in which inherent patentability under UK
law was considered in detail.
(b) The Decision in Boulton v Bull
[12] Boulton v Bull involved a challenge to a patent for a new
method of using an old steam engine in a more beneficial way that was described
in the
specification
[15] as
consisting of certain principles applied in a particular mode to the purposes of
the invention.
[16] The question for
the Court was whether the alleged invention so described was a method or
principle and, if so, whether this rendered
the patent invalid for lack of
patentable subject matter. The Judges’ decisions differed greatly in
method and conception,
ultimately producing a split of 2:2 on the question of
the patent’s validity. The implications of those decisions for inherent
patentability can be considered in terms of three related points.
[13] The
first point concerns methodology. Three of the Judges – Eyre CJ, and
Buller and Heath JJ – treated the inherent
patentability of the alleged
invention as depending upon its classification as a ‘manufacture’
within the meaning of
s 6 of the Statute of
Monopolies.[17] The fourth
Judge, Rooke J, also relied on the Statute of Monopolies but for its
‘spirit’ and not its concept of
manufacture.[18] According to his
Honour, the spirit of s 6 supported the patent – there being a new and
useful improvement in fire engines
sufficiently described in the
specification[19] – and
arguments of invalidity moving from classification of its subject matter as a
method or principle not within the scope
of ‘manufacture’ were
merely verbal.[20] Implicit in this
approach was a view of inherent patentability as encompassing any new and useful
technological advance adequately
represented in the specification.
[14] The
second point concerns the widely divergent results of the other three
Judges’ reliance on the concept of manufacture
for the purposes of
determining the alleged invention’s inherent patentability. According to
Heath J, ‘manufacture’
meant vendible machine or
substance,[21]
with the result that an invention for patentability purposes required a definite
physical form.[22] Excluding the
requirement of vendibility Buller J
agreed,[23]
confirming the restriction of inherent patentability to mechanical and chemical
objects.[24]
This view of the invention was, however, not shared by Eyre CJ, who considered
judicial exposition of the Statute of Monopolies to have bestowed a much
wider meaning on ‘manufacture’ than ordinary language would
support.[25] Whilst not quite
conceding its co-extensiveness with the phrase ‘any thing’ in s 1 of
that statute, the Chief Justice
did consider ‘manufacture’ to be of
extensive signification, applying not only to things made but also to practices
of
making, ways of operating, and principles carried into practice in a new
manner or to produce new (including non-physical)
results.[26]
Ultimately for the Chief Justice, an invention for patentability purposes
included any specific human action producing effects of
use or benefit to the
public. This understanding of the invention was sympathetic to the view of
inherent patentability supported
by Rooke J.
[15] The third point about
Boulton v Bull of present relevance concerns the limitations recognised
by each Judge as to the scope of inherent patentability. All agreed that
principles were inherently unpatentable and, with the exception of Heath J,
understood ‘principle’ in this context to
mean an abstract
notion[27] or elementary truth of
the arts and
sciences.[28]
For Heath J principles extended beyond such elementary principles to encompass
methods of production, which were therefore also inherently
unpatentable in his
view.[29]
Buller J agreed with this conclusion regarding methods of production, but
rationalised it by reference to the nature of a method
as a ‘double
use’ rather than a principle per
se.[30]
Thus, uses constituted a third category of subject matter identified in
Boulton v Bull as inherently unpatentable.
[16] The overall conclusion
to be drawn from Boulton v Bull is that in 1795 the common law principles
concerning inherent patentability were in a state of confusion. Such confusion
centred
on two central issues: first, how subject matter for which a patent had
been granted was to be construed and defined; and second,
how the inherent
patentability of subject matter so defined was to be determined. Central to this
second issue was the importance
of the initial classification of the subject
matter itself. In particular, was the inherent patentability of an alleged
invention
to depend upon its classification as a ‘manufacture’ and,
if so, what did ‘manufacture’
mean?[31] The polarised responses to
these issues in Boulton v Bull define to a large extent the
post-18th century debates regarding inherent patentability, including
those in respect of methods of medical treatment.
(c) Inherent Patentability Post-Boulton v
Bull
[17] The innate difficulty of the issues raised in
Boulton v Bull is
reflected in the case law of the following 100 years. This case law contains
virtually no express judicial consideration of inherent
patentability,
[32] reflecting
instead a struggle on the part of the courts and other decision makers to
understand that concept sufficiently to deal
with the individual subject matter
before them. Despite this, some conclusions can be drawn from the decisions of
this period in
relation to the nature and scope of inherent patentability.
Principal amongst them is that decision makers overwhelmingly supported
the
approach of Eyre CJ and Rooke J in
Boulton v Bull by acknowledging that
any product or method could support a patent, subject only to its inherent
ability to satisfy each of the secondary
patentability requirements of novelty,
utility, and sufficient description in the
specification.
[33]
The only subject matter incapable of doing so (and therefore incapable of
supporting a patent) were statements of abstract principle
having no specified
practical utility
[34] and, for
innate lack of novelty (and later
inventiveness),
[35] uses and
collocations of known objects, the working or underlying principle of which was
identical to that of an existing
invention.
[36] With the exception of
these three subject matter,
[37] no
other exclusions from inherent patentability were recognised during the
19
th century. In addition, patented inventions during this period
were routinely construed in liberal and abstract terms, as practical
manifestations of an underlying or working principle, the novelty of which
derived either from such principle itself or its particular
manifestation.
[38] It was against
the background of this very liberal understanding of inherent patentability that
modern patents law and the question
regarding the position of medical methods
within it emerged.
2 The Modern Law of Inherent
Patentability
(a) Legislative Reform
[18] As has been noted, the modern era of Anglo-Australian patents law
began with the introduction of the
Patents, Designs and Trade Marks Act
1883 (UK) (‘1883
Act’),
[39] which was reflected
in Australian colonial legislation soon after. The principal significance of
that Act for inherent patentability
derived from its effect in focusing the
attention of decision makers on the literal terms of patents legislation,
including s 6 of
the
Statute of Monopolies by reference to which inherent
patentability was now expressly
defined.
[40]
This identification of inherent patentability as a discrete concept and issue
was facilitated by the Act’s recognition of a
distinction between the
existence of an invention on the one hand and its novelty on the
other.
[41] An equivalent distinction
between an invention and the need for inventiveness and utility was introduced
in the second quarter of
the 20
th century, when each of the threshold
and secondary criteria of patent protection was given explicit statutory
expression as a ground
for opposing a patent application or seeking revocation
of a patent grant.
[42] The effect of
such expression was to require decision makers from the mid 20
th
century, and earlier in the case of novelty, to treat inherent patentability as
a discrete concept independent of inventiveness,
utility and novelty in order to
distinguish between the various grounds for statutory action.
[19] In
addition to the entrenchment by modern patents legislation of the need for an
‘invention’ as a discrete and threshold
requirement of
patentability, two other turn-of-the-century developments of significance for
inherent patentability should be noted.
The first is the centralisation of the
patents system in Australia following
federation[43] and, in particular,
the conferral of original jurisdiction in respect of patents matters on the
newly established High Court.[44]
Such conferral created an additional source of patents decisions to supplement
those of the UK and Australian Attorneys- and Solicitors-General,
the State
Supreme Courts and the High Court of England. This development was of particular
significance given the seniority of the
High Court within Australia’s
judicial hierarchy compared with that of the UK decision makers having
equivalent patents law
jurisdiction.
[20] The second significant development
around 1900 was a change in the types of technologies for which patents were
sought and, in
particular, the emergence of a range of new subject matter and
their demand for accommodation within traditional patents jurisprudence.
Two
such subject matter to be considered in the UK and Australia were abstract
schemes and methods of facilitating a natural
process.[45] The early response of
decision makers to those subject matter can be viewed in hindsight as precursory
to the reception of methods
of medical treatment.
(b) Signs of Judicial Reform: The Exclusion from
Patentability of Abstract Schemes and Methods of Facilitating a Natural
Process
[21] The first case to consider in detail the inherent patentability of
abstract schemes,
[46] and one of the
earliest cases to consider in detail the scope of inherent patentability under
modern legislation was
Re Cooper’s Application for a Patent
(‘
Cooper’s
Application’),
[47] decided
in 1901. That case involved a patent application in respect of an improved form
of newspaper page featuring a blank space
along which the page could be folded
without disrupting the line of its
text.
[48] Allowing an appeal from a
decision of the Comptroller-General, Sir Robert Finlay A-G affirmed the inherent
patentability of the subject
matter on the ground that it involved
‘invention with reference to a manufacture’ resulting in a material
artificial
product.
[49] The
requirement advanced by the Attorney-General for production of a material
artificial product was not justified by reference to
any authorities and,
indeed, was advanced primarily to support the ‘tolerably obvious’
proposition that ‘[y]ou
cannot have a Patent for a mere scheme or
plan’.
[50] Regardless of the
correctness of that proposition itself, the need for a material artificial
product had no evident basis in contemporary
UK patents law. In addition, it
went against the 19
th century view of inherent patentability as
encompassing any practical manifestation of an idea regardless of physical form,
conforming
instead to the more restrictive principles of Heath and Buller JJ in
Boulton v Bull. The same trend was signaled nine years later in the first
reported case to consider the patentability of a method of facilitating
a
natural process. That case was
Rogers v
Commonwealth,
[51]
and was a decision of the High Court of Australia.
[22] Rogers v
Commonwealth involved an opposition to a patent application in respect of a
method of burning timber that involved causing a self feeding slow
fire to act
continuously against the side of a tree. The main contention of the opponent was
that the method was not an invention
within the meaning of the statutory
definition. That contention was accepted by the two-Judge
majority
, albeit for different reasons. For
Griffiths CJ, the alleged invention was ‘a [mere] direction how best to
use materials in
everyday use to achieve an everyday
object’
[52] equivalent to an
inherently unpatentable analogous use. For O’Connor J, in contrast, the
alleged invention was unsuited to
patent protection because it involved neither
the production of any vendible article nor the inventive application of any
mechanical
contrivance or chemical
substa
nce.
[53]
His Honour stated:
The proposition [articulated by Tindal CJ in Crane v
Price[54]]
that a patent may be granted for a new method of producing an old result in a
more efficient and more economical manner must be
qualified by the condition
that the new method must either produce some vendible article or must be
carried out by some mechanical contrivance or some substance the use or
adaptation of which for the purpose of working the new method is part of the
invention.[55]
[23] Whilst
not expressly supported by reference to
Cooper’s Application
– or for that matter any other decision – this requirement for the
production of a vendible article or use of a mechanical
or chemical object was
reminiscent of that case with two qualifications. First, the requirement for
production of a physical article
was expressed by O’Connor J as applying
only in respect of methods not involving the use or adaptation of a mechanical
contrivance
or substance, and was thus not absolute. But second, to the extent
that production of a physical article was required the article
had to be
‘vendible’, consistent with the judgment of Heath J in
Boulton v
Bull.
[24] The ultimate significance of Justice O’Connor’s
decision lies in its reflection (with Cooper’s Application) of an
emerging trend during the early 20th century of restrictively
interpreting the scope and requirements of inherent patentability in order to
exclude subject matter not
involving the production or treatment of vendible
and/or artificial products. Whilst it is difficult to view the decision of
Griffiths
CJ in Rogers v Commonwealth as having supported or undermined
this trend, the minority view of Isaacs J in the same case was clearly against
it. In a judgment
reminiscent of the decisions of Eyre CJ and Rooke J in
Boulton v Bull, his Honour rejected both the contention of law proposed
by O’Connor J and the interpretation of the subject matter suggested
by
Griffiths CJ, arguing in respect of the former that any subject matter could on
current authority support a patent if it involved
a new and useful combination
of idea and modus
operandi.[56] As has been seen,
this conception of the invention as ‘applied idea’ was consistent
with the approach of UK decision
makers throughout the 19th
century.
[25] Despite their lack of supporting authority, the judgments of
O’Connor J in Rogers v Commonwealth and the Attorney-General in
Cooper’s Application were largely vindicated in 1914 by the
recognition, in the UK, of a general requirement that a subject matter to be
patentable must
involve the production or treatment of a commercial product. The
case in which this requirement was formulated is Re C & W’s
Application for a Patent (‘C & W’s
Application’),[57]
which is the first reported case in the history of Anglo-Australian law to
consider the inherent patentability of methods of medical
treatment.
C The Emergence of Medical Methods as an Issue for
Anglo-Australian Patents Law
1 C & W’s
Application
[26] In
C &
W’s Application a method of extracting lead from human bodies was held
ineligible for patent protection because of its lack of association with the
manufacture or sale of a ‘commercial product’, and consequential
inability to be regarded as an ‘invention’
within the meaning of the
applicable patents legislation.
[58]
In reaching his conclusion, the Solicitor-General relied on the original
statutory context of the phrase ‘manner of new
manufacture’
[59]
– including, in particular, the exclusion from patentability by s 6 of the
Statute of Monopolies of subject matter ‘contrary to the law []or
mischievous to the state, by raising prices of commodities at home, or hurt of
trade, or generally inconvenient’ – to support a conception of the
invention as a new or improved thing or substance,
or ‘a machine or a
process that can be used in making something that is, or may be, of commercial
value’.
[60]
Whilst a human being could be considered a working organism that would be
improved by the method in question, this was not sufficient
in the
Solicitor-General’s opinion to make that method one of relevance to
‘manufacture or
trade’.
[61] The result was the
acceptance by the Solicitor-General of a general exclusion from patentability
covering methods of medical treatment.
[27] Three comments can be made in
relation to that exclusion and its rationalisation by the Solicitor-General. The
first concerns
the Solicitor-General’s reliance on the proviso in s 6 of
the Statute of Monopolies. Such reliance was consistent with the emphasis
of decision makers during the late 19th and early 20th
centuries on the literal language of modern patents legislation, and with their
related concern to justify in terms of that language
the historical exclusions
from patentability. One consequence of this trend was a practice during this
period of invoking the s 6
proviso to support a particular conclusion regarding
a subject matter’s inherent
patentability.[62] To the extent
that it reflected this trend C & W’s Application was not
unusual. Reliance on the proviso in the context of methods of medical treatment
was, however, significant in establishing
a doctrinal link that would become
important later in the 20th century.
[28] The second comment in
respect of C & W’s Application is that no authorities were
cited by the Solicitor-General in support of his decision generally or the
exclusion of medical methods
from patentability specifically. This is partly
explicable by reference to the absence of reported decisions involving methods
of
medical treatment, but also reflects the lack of precedential support for the
vendible product requirement itself. Indeed, the only
reported decision
expressly in favour of a vendible product requirement was that of Heath J in
Boulton v Bull – which, as has been seen, was discredited by the
approach of decision makers during the 19th century. Whilst the
decisions of Buller J in the same case, the Attorney-General in
Cooper’s Application and O’Connor J in Rogers v
Commonwealth[63] all came close,
they ultimately fell short of stipulating that all inherently patentable methods
must involve the production or treatment
of a vendible object and remained, in
any case, anomalous reflections of a very restrictive understanding of inherent
patentability.[64]
For these reasons C & W’s Application is best explained as the
third in a line of early 20th century Anglo-Australian cases to
support an increasingly narrow interpretation of inherent patentability.
Similarly the commercial
product requirement articulated in C & W’s
Application – which manifested the trend represented by those cases
– is best explained as a useful expedient to support the exclusion
from
patentability of methods of medical treatment.
[29] This raises the third
point concerning C & W’s Application, which is that if as
contended the commercial product requirement was a means of justifying ex post
facto the denial of patents for
methods of medical treatment, the question
remains as to the reason for that denial. Put differently, why were methods of
treating
humans considered by the Solicitor-General to be ineligible for patent
protection? Whilst the express reason offered by the Solicitor-General
was that
such methods have no relevance to ‘manufacture and trade’, exactly
how or on what basis that reason was reached
is unclear. Consideration of his
decision as a whole suggests as its likely basis an unwillingness to treat
humans as objects of
commercial exploitation. In addition, it appears from the
Solicitor-General’s judgment that such unwillingness was fuelled
by his
view that doctors should not, on moral grounds, seek commercial monopolies in
respect of their professional skills. This is
despite the
Solicitor-General’s express statement that morality was not a
consideration in his finding of unpatentability:
It has been urged, and I think quite rightly, that the question of humanity
ought not to affect the decision in such a case as this
... Of course, it is
well known that the medical profession do all in their power to discourage
members of their body from obtaining
protection for any discovery that has for
its object the alleviation of human suffering, and it is impossible to speak too
highly
of such conduct, but it cannot affect my judgment in arriving at a
conclusion upon the terms of the Section of the Act of Parliament,
and I have
altogether excluded such consideration from my
mind.[65]
[30] Ultimately,
the Solicitor-General’s success in not allowing his views regarding the
morality of monopolizing medical methods
affect his legal judgment must be
doubted given the absence of any convincing alternative justification for his
decision. In addition
the Solicitor-General’s assertion that morality was
not relevant to inherent patentability, apart from being gratuitous, was
inconsistent with the thrust of contemporary UK patents legislation which
implicitly acknowledged such relevance in its conferral
of power on the
Comptroller to ‘refuse to grant a patent for an invention ... of which the
use would, in his opinion, be contrary
to law or
morality’.
[66]
It was also arguably inconsistent with the historical prohibition, reflected in
s 6 of the
Statute of Monopolies (and thus incorporated into modern
Anglo-Australian legislative definitions of ‘invention’), against
the monopolisation
of subject matter considered ‘generally
inconvenient’
[67] which, at
least in theory,
[68] provided the
Crown and Privy Council with an unfettered discretion to deny patentability on
any public policy
ground.
[69]
[31] The
overall impression created by C & W’s Application is that the
Solicitor-General’s eschewal of the relevance of morality to inherent
patentability, and his recognition of a commercial
product requirement as the
basis for a general exclusion from patentability in respect of methods of
medical treatment, were the
combined result of his refusal: (a) to engage openly
with the moral issues purportedly raised by the patenting of medical methods;
and (b) to concede that, morality or other public policy aside, there was no
sound legal basis for denying patentability to such
methods. This impression is
borne out by the subsequent history of the medical methods exclusion.
Interestingly, it is also consistent
with the only other case during the early
20th century in which the relevance of morality to inherent
patentability was expressly considered. That case, A & H’s
Application,[70] involved an
appeal from a decision by the Assistant-Comptroller to refuse a patent
application in respect of a contraceptive device
on the ground that use of such
device was ‘contrary to ... morality’ within the meaning of the
applicable patents
legislation.[71]
On appeal, the patentee disputed this finding by contending that use of a
contraceptive device was contrary neither to law nor to
morality, and that the
application should therefore be permitted to proceed as relating to an
‘invention’. Interestingly
given his first instance decision, the
Assistant-Comptroller when responding to this contention avoided the
‘morality’
issue and urged the Solicitor-General instead to
‘refuse the Grant of a Patent for articles which it would not be fitting
to
sell as being protected by Royal Letters
Patent’.[72] The
Solicitor-General complied, thereby also avoiding discussion of the
device’s morality. He said:
The question ... arises whether, quite apart from Section
75,[[73]] the Crown in the exercise
of its prerogative could possibly be expected to exercise its discretion to
grant a patent for an article
designed as an apparatus for the prevention of
contraception ... I decline to be any part to the grant of a patent for this
class
of article ... Even if, as to which I express no opinion, its use as a
contraceptive is consistent with morality, I am not prepared
to exercise on
behalf of the Crown the Crown’s discretion in favour of the grant of a
patent in respect of it ... I express
no opinion as to whether the use of these
articles is consistent with morality, because I am not aware that the law has
laid down
what the exact standards of morality are. I am a Court of Law, and not
a Court of Morality. All I say is I think these are not articles
for which,
whether the specification be amended or not, the Crown can be expected to
exercise its discretion by way of granting a
patent. I therefore dismiss the
Appeal.[74]
[32] Thus,
and as in C & W’s Application, the Solicitor-General’s
suggestion that morality could not be considered when determining inherent
patentability left him
with the task of finding another legal basis on which to
justify rejection of the patent application before him. The fact that the
device
was a physical object and not a method meant that the ‘commercial
product’ requirement of C & W’s Application was not
available to this end. Rather than deriving an equivalent restriction based on
the necessary characteristics of an invention,
the Solicitor-General relied
instead on his role as delegate of the Crown, and on the
‘inappropriateness’ of exercising
the Crown’s prerogative in
respect of articles of dubious moral status. In so doing he avoided the need to
engage openly with
the moral issues concerning the patenting of a contraceptive
device, whilst also avoiding the admission and conclusion that, morality
aside,
there was no obstacle to allowing the device to be patented. In method this
decision was very similar to that of C & W’s Application, and
supports the conclusions reached in respect of that case above. In both cases a
new principle of black letter law masqueraded
as public policy.
2 C & W’s Application Before the
High Court of Australia: Maeder v Busch
[33] The instability of the legal foundation of
C & W’s
Application was acknowledged in the only other Anglo-Australian decision
prior to 1959 to consider methods of medical treatment in detail, which
was the
decision of the High Court of Australia in
Maeder v
Busch.
[75][34] Maeder v
Busch concerned a patent application for a method of forming permanent waves
in human hair that was opposed, among other things, for its
alleged failure to
involve an ‘invention’ on the principles of
C & W’s
Application. Of the four Judges to hear the opposition, two offered
tentative support for
C & W’s
Application[76] and two
expressed reservations about its
correctness.
[77] None however was
prepared to decide the matter finally, and only Dixon J was prepared to consider
it in any detail. In the course
of such consideration his Honour cast doubt on
the limits of the exclusion recognised in
C & W’s Application,
articulating the problem as follows:
To be patentable an invention must relate to an art. Perhaps the widest
statement is one of the earliest [referring to the statement
of Eyre CJ in
Boulton v Bull]. But the ultimate end in view is the production or
treatment of, or effect upon, some entity. Applications of old things to a new
use, accompanied by the exercise of inventive power, are often patentable though
there be no production of a new thing. But in every
case the invention must
refer to and be applicable to a tangible thing.
In the present case there is nothing to be affected but the hair. The chemical
compounds already exist. The use of them, the application
of heat and the method
of treatment constitute nothing but method, procedure, treatment or process. Can
the hair growing upon the
human head be regarded as satisfying the condition
that the process shall in some way relate to the productive
arts?[78]
[35] His
Honour’s answer to this question was ambivalent. On the one hand a method
of treating hair was not, he suggested, aimed
at producing or helping to produce
any article of commerce; no substance or thing forming a possible subject of
commerce or contribution
to the productive arts being brought into existence by
it or with its aid.
[79] On the other
hand, however, the method could be considered to be ‘embodied in a manual
art or craft’ on the ground that
its purpose was the treatment of an
object of purely mechanical
utility.
[80] Thus the patentability
of the method depended in his Honour’s view on whether a process to be an
invention had to involve the
production or treatment of a commercial product (as
had been held in
C & W’s Application), or merely the production
or treatment of some object of mechanical utility so as to reflect a manual art
or
craft.
[81]
According to Dixon J, however, even the latter view would not save from
unpatentability methods of treating or manipulating a vital
part of the human
body which, he held, would always lack the artificial or mechanical element of
an invention.
[82]
[36] The effect
of Justice Dixon’s reasoning was two-fold. First, it challenged the
breadth of the existing scope of the medical
methods exclusion beyond methods
having a therapeutic purpose. But second, it added new weight to the exclusion
so restricted by
identifying as its underlying justification the inherent
inability of methods of treating a vital part of the human body to possess
the
artificiality required of an invention. That justification was not affected by
the question raised by Dixon J concerning the
correctness of the commercial
product requirement, and suggested as the critical distinction for methods of
medical treatment the
distinction between ‘natural’ and
‘artificial’ subject matter. Exactly why a method of treating a
living
thing such as a human being should not be considered
‘artificial’ was not explicated by Dixon J and is difficult to
understand.
Specifically, it is difficult to see how the
‘naturalness’ of the object of a method can be viewed as affecting
the artificiality
or otherwise of the method itself; a point implicitly
acknowledged by Evatt J in the following passage from the same case:
[I]t was suggested that, under the Patents Act, assuming that every other
element necessary to establish a valid patent is present, the mere fact that the
curls are to be produced
on the head of a living person precludes a valid grant.
The question whether this one fact – that curls are to be made on the
head
of a living person – prevents the issue of a grant need not here be
decided; but I am inclined to the opinion that providing
all the other elements
of patentability are present, it cannot be laid down as an absolute rule that
although the making of artificial
curls for subsequent use on the human head can
be protected by a patentable process, doing very much the same thing with the
hair
that is already on the head cannot be
protected.[83]
[37] Ultimately,
the justification offered by Dixon J for a continued medical methods exclusion
independent of any vendible product
requirement is unconvincing, and reflects
the same concern as in
C & W’s Application to entrench that
exclusion without proper consideration of its underlying basis. Unlike the
Solicitor-General in
C & W’s Application, however, Justice
Dixon’s decision appears genuinely not to have been motivated by any moral
concerns regarding the patenting
of medical methods; his Honour having expressly
(and convincingly) stated that the purpose for or vocation in which the alleged
invention
was to be used could not in logic be relevant to its
patentability.
[84] Exactly why Dixon
J was so adamant in affirming the exclusion, despite his otherwise cautious and
well-reasoned decision, is unclear.
The fact remains, however, that his decision
in this regard reflected for the second time in as many decisions the adaptation
of
first principles of patents law to support an unconvincing view of medical
methods as lacking the characteristics required of inventions.
3 The Commercial Product Requirement and
Medical Methods Exclusion After Maeder v Busch
[38] Justice Dixon’s questioning of the commercial product
requirement and reformulation of the legal basis for the medical
methods
exclusion had no effect on the approach of UK decision makers for the two
decades following
Maeder v Busch. Indeed, four years after that case the
commercial product requirement was approved and entrenched in the UK by the
decision of the
Patents Appeal Tribunal (‘PAT’) in
G E C’s
Application.
[85] The alleged
invention in
G E C’s Application was somewhat similar to that of
Rogers v Commonwealth[86]
and, in a judgment reminiscent of the judgment of O’Connor J therein, was
denied a patent for its failure to involve the production,
improvement,
restoration or preservation of a vendible
product.
[87]
In support of the requirement for such involvement the PAT in
G E C’s
Application confirmed the inherent unpatentability of ‘processes or
methods of treating diseases in human
beings’;
[88] its reasoning in
this regard being somewhat ironic given the original justification of the
medical methods exclusion by reference
to the vendible product requirement
itself.
[89] Put differently, it is
ironic that the medical methods exclusion was now being relied on to support the
restrictive conception of
inherent patentability from which that exclusion was
itself originally said to derive.
[39] The circularity of the reasoning in
G E C’s Application belied the ongoing instability of the legal
foundation on which the vendible product requirement and the (purportedly
related) rule
against patenting medical methods rested, even in the UK. Some
acknowledgement of that instability was reflected almost immediately
during the
1940s, when Evershed LJ attempted to relax the vendible product requirement in
order, his Lordship held, that it not restrict
the common language meaning of
‘manner of new
manufacture’[90]
and through it the statutory definition of ‘invention’ per
se.[91] The initial focus of
Evershed LJ in this regard was on the word ‘product’ which he stated
could only be reconciled with
‘manner of new manufacture’ if it was
understood as having been used by Morton LJ as
a convenient and compendious term to indicate the article or material resulting
from the activity, and [not as] intending to limit
by reference to what may be
the common acceptation to-day of the word ‘product’ that which
results from a
manufacture.[92]
[40] The
immediate effect of this clarification was to concede as inherently patentable
methods involving the treatment of any (vendible)
tangible matter regardless of
its physicality or
artificiality.
[93]
Whilst a human body is clearly a ‘tangible matter’, the problem
remained of the more restrictive aspect of Lord Justice
Morton’s rules
which required that the product of a patentable process be
‘vendible’. That requirement was also
elucidated by Evershed LJ
during the 1940s, when his Lordship held in
Re an Application for a Patent by
Rantzen[94] that a
‘vendible product’ was not confined to something that could be
passed from one man to another upon a transaction
of purchase or sale, but
rather encompassed anything that might ‘fairly be regarded as the outcome
of a process of
manufacture’.
[95]
Even had this liberal interpretation of the vendible product requirement been
supported by his Honour’s contemporaries (which
it was
not),
[96] it would still have
precluded the patenting of methods of medical treatment. Thus, by 1959, methods
of treating the human body remained
inherently unpatentable both in the UK (by
operation of the vendible product requirement) and in Australia (by operation of
the same
requirement and/or the need for production or treatment of an
artificial product). In that year the rift between UK and Australian
law,
already evident in
Maeder v Busch, widened with the
important
[97] decision of the High
Court of Australia in
National Research Development Corporation v
Commissioner of Patents
(‘
NRDC’).
[98]
The effect of this decision was to demolish both the vendible product
requirement and the requirement recognised by Dixon J for the
production or
treatment of an artificial product. Amazingly, however, the exclusion from
patentability of methods of medical treatment
that had previously rested on
those requirements continued intact.
III THE PATENTABILITY OF METHODS OF MEDICAL TREATMENT IN AUSTRALIA AND THE UK FROM 1959
A Revision of the Vendible Product Requirement and
its Implications for Methods of Medical Treatment
[41] NRDC involved a method of using a known chemical substance to
treat soil in order to eradicate and control weeds from crop areas without
affecting the crops
themselves.
[99] The issue it
raised was whether such a method was precluded from patentability because, among
other things, of its failure to result
in any new or improved vendible product.
In a unanimous decision the High Court held that it was not so precluded on the
ground that
it was a proper subject of letters patent according to the
historically developed principles governing application of
s 6 of the
Statute
of Monopolies; its purpose being to create a ‘vendible product’
in the sense of an artificially created end of practical
utility.
[100]
[42] There are
two aspects, to the High Court’s finding on this point. The first concerns
the question to be posed by decision
makers in determining the existence of an
‘invention’ within the meaning of modern patents legislation, and
the second
concerns the essential attributes of an invention so defined. In
respect of the first of these aspects the Court held that the right
question is
not ‘“Is this a manner (or kind) of manufacture?”’, but
rather ‘“Is this a proper
subject of letters patent according to the
principles which have been developed for the application of s. 6 of the
Statute of
Monopolies?”’.[101]
By emphasizing the spirit of the Statute of Monopolies over its literal
terms, the Court vindicated the approach of Rooke J in Boulton v Bull
more than 150 years earlier.
[43] In respect of the second aspect of the
NRDC decision concerning the essential attributes of an invention, the
Court’s reasoning proceeded as follows. First, the Court
noted the comment
by the Chief Justice in Maeder v Busch that a widening conception of the
invention had been a characteristic of the growth of patents
law,[102] and cited as examples of
the accuracy of that statement the conceptions of the invention articulated by
Eyre CJ in Boulton v
Bull[103] and Tindal CJ in
Crane v
Price.[104]
It then described, as the central unresolved issue concerning such conception,
‘whether it is enough that a process [to be
patentable] produces a useful
result or whether it is necessary that some physical thing is either brought
into existence or so affected
as the better to serve man’s
purposes’,[105] before
reviewing the early 20th century Anglo-Australian case law in respect
of that issue including, in particular, G E C’s Application and the
line of cases in which the rules there articulated were subsequently
applied.[106] Such review was
concluded by the Court with the statement that the rules of G E C’s
Application could only be upheld as ‘wide enough to convey the broad
idea which the long line of decisions on the subject has shown to
be
comprehended by the
Statute’[107] if the word
‘product’ in those rules was understood ‘as covering every end
produced’,[108] and the word
‘“vendible” as pointing only to the requirement of utility in
practical affairs’.[109] The
effect of this conclusion was to bring NRDC’s method within
the scope of those rules, as a method ‘[having] as its end result an
artificial effect falling squarely within
the true concept of what must be
produced by a process if it is to be held
patentable’.[110] The Court
extrapolated:
This view is, we think, required by a sound understanding of the lines along
which patents law has developed and necessarily must
develop in a modern
society. The effect produced by the appellant’s method exhibits the two
essential qualities upon which
‘product’ and ‘vendible’
seem designed to insist. It is a ‘product’ because it consists in an
artificially created state of affairs, discernible by observing over a period
the growth of weeds and crops respectively on sown
land on which the method has
been put into practice. And the significance of the product is economic; for it
provides a remarkable
advantage, indeed to the lay mind a sensational advantage,
for one of the most elemental activities by which man has served his material
needs, the cultivation of the soil for the production of its
fruits.[111]
[44] Thus,
in the view of the High Court, any method resulting in an objectively
discernible and artificially created state of affairs
of economic significance
would be a proper subject of letters patent within the meaning of the
Statute
of Monopolies; a subject matter of this type being a method producing an end
of utility in practical affairs. The effect of this view was to bring
inherent
patentability back into line with 19
th century authorities, and to
undermine the two historical reasons expressed for denying patents to medical
methods. Such effect was
not however recognised by the High Court – or at
least was not recognised as being sufficient to permit the patenting of methods
of medical treatment. Hence the Court’s rather
tentative
[112] suggestion
that
[t]he exclusion of methods of surgery and other processes for treating the human
body may well lie outside the concept of invention
because the whole subject is
conceived as essentially
non-economic.[113]
[45] This suggestion that the exclusion from patentability of
methods of medical treatment could be justified on the basis of their
non-economic value is unconvincing. Indeed, it is difficult to see how medical
methods could be devoid of ‘economic significance’
in the broad
sense in which that phrase was understood in
NRDC when they are routinely
performed for commercial profit. As with the decision of Dixon J in
Maeder v
Busch, the High Court’s apparent refusal to concede the implications
for methods of medical treatment of its own principles of inherent
patentability
reflects an unchallenged assumption that such methods were an inappropriate
subject matter for patent protection. The
result in
NRDC, as for Dixon J
in
Maeder v Busch, was the dubious adaptation of first principles of
inherent patentability to justify perpetuation of the medical methods
exclusion.
[46] During the 1960s, the High Court’s continued
recognition of an exclusion in respect of methods of medical treatment was
welcomed in the UK as vindicating the result of C & W’s
Application. The High Court’s justification of that exclusion by
reference to the ‘essentially non-economic’ nature of such
methods
was, however, largely ignored. This left decision makers in the (no longer
novel) position of having a recognised exclusion
that they were keen to
perpetuate but no recognised legal basis on which to do so. Their response was
to borrow from the emerging
jurisprudence regarding another subject matter
involving living matter – biotechnology – and in so doing to revert
to
the reasoning of Dixon J in Maeder v Busch.
B 1960-70: Methods of Medical Treatment as Insufficiently Artificial
[47] The only reported cases to involve a patent application in respect of
a method of medical treatment in the decade following
NRDC were decided
in the UK. Each of those cases upheld the historical exclusion of medical
methods
[114] and many relied in
doing so on
NRDC.
[115] The
central reason offered for that exclusion was not however that such methods
lacked commercial value as had been held in
NRDC, but rather that they
lacked the artificiality required of inventions. In addition to supporting the
approach of Dixon J in
Maeder v Busch, this reason reflected contemporary
decisions in which agricultural and biotechnological subject matter had been
denied patentability
on the basis of their dependence upon the physiological
functions of a higher life form, and consequential inability to be regarded
as
controllably responsive to human
operation.
[116]
That reason was first articulated in
Swift & Company’s
Application[117]
in respect of a method of treating live animals, and was adapted during the
1960s to support the exclusion from patentability of
methods of treating
humans.
[118] Thus in
Neva
Corporation’s Application
(‘
Neva’)
[119] a
method of inducing a state of reduced awareness in humans (and animals) by means
of sounds generated by a known apparatus was held
to be an unpatentable method
of medical treatment on the ground that its utility depended upon the reception
and interaction of the
sounds with the human brain. This was consistent with
London Rubber Industries Ltd’s Patent (‘
London
Rubber’),
[120] where a
method of controlling female ovulation through the prescribed oral
administration of known hormones was refused a patent
on the ground, implicitly,
that the utility of such method depended upon the physiological response of the
person treated and for
this reason fell outside the realm of useful arts in
which inventions exist.
[121] In
one of the very few early decisions that expressly considered the reason for the
exclusion of methods of medical treatment from
inherent patentability, the PAT
in
London Rubber reconciled its decision with
NRDC as
follows:
[In NRDC i]t was suggested that the justification for excluding from the
concept of invention methods of surgery or other processes for the
treatment of
the human body might well rest upon the fact that they are essentially
non-economic and the reference in the judgment
to Maeder v Busch [1938] HCA 8; (1938)
59
C.L.R. 684 at 706 shows that by this is meant that: (a) the object is
not to produce or aid in the production of any article of commerce; (b)
no
substance or thing forming a possible subject of commerce or a contribution to
the productive arts is to be brought into existence
by means of or with the aid
of the process ...
[T]he improvisation of a method of treating a human being cannot in reason be
regarded as affording proper subject matter for letters
patent. If for the
purposes of argument the oral administration of specific pills in a controlled
manner be taken to be a method
or constitute a process, it still cannot be
asserted with any reality that the human response to the ingredients so
administered
falls within any category of the useful
arts.[122]
[48] In
this passage the Swift & Company’s Application emphasis on
human control is reconciled with the NRDC emphasis on results of
commercial significance by positing as the results of medical methods, the human
response to them which, in
NRDC terms, was considered ‘essentially
non-economic’. It was not long however before this rather tortuous
explication of
the two decisions was rejected, and the reconception of
the medical methods exclusion on public policy grounds began.
C Developments in Australia and the UK Since 1970
1 The Reconception of the Medical Methods Exclusion in the UK and Australia From 1970-77
(a) Cracks in the Façade of London Rubber
[49] Cracks in the façade of
London Rubber were already
evident in the 1970 case of
Palmer’s
Application.
[123] In that
case, a Superintending Examiner’s finding of inherent unpatentability in
respect of a method of treatment that depended
for its efficacy upon the
physiological response of the persons treated was overruled on appeal, on the
basis that a method so depending
could still involve the practical employment of
a person’s art and skill so as to constitute an
invention.
[124] The effect of such
recognition was to remove yet again the primary legal obstacle to the inherent
patentability of surgical and therapeutic
methods. Whilst that effect was
acknowledged the following year in
Schering AG’s Application
(‘
Schering’),
[125]
its acknowledgement was still not sufficient to secure a reversal of the
historical rule against the patenting of such methods, with
the PAT in
Schering once again finding a new justification for that rule’s
perpetuation. While consistent with the trend of past cases in this respect,
in
another respect the PAT’s judgment represented a radical departure from
those cases. Such departure came with its concession
that morality both
should and
could provide a basis for denying patents to medical
methods; a concession that constituted an important step in the reconception of
the
medical methods exclusion.
(b) The First Step in Reconceiving the Medical
Methods Exclusion: Schering
[50] The subject matter in
Schering was a method of female
contraception almost identical to that in
London Rubber but, contrary to
the decision in
London Rubber, was allowed to proceed to grant in the
face of opposition for patent ineligibility. At first
instance,
[126] the Superintending
Examiner (‘SE’) focused on distinguishing
Palmer’s
Application in order to preserve the historical position regarding methods
of medical treatment, the correctness of which, he noted, was confirmed
in
NRDC.
[127] On appeal, in
contrast,
[128] the PAT avoided
discussion of
Palmer’s Application opting instead for a first
principles analysis that led it to the following four central observations:
‘The method in question
was the result of considerable research effort,
and represented a novel and important contribution to the techniques of
contraception’.
[129]
[51] Whilst
it was plainly arguable upon ethical grounds that there should be no patent
protection in the medical field at all, the
patentability under UK law of
pharmaceutical substances and curative devices had long been recognised, and had
resulted in an enormous
investment in the field of medical
research.[130]
Such patentability was subject to certain legislative safeguards against
unwarrantable
exploitation.[131]
[52] If the
practice of awarding patents for medical substances and devices in order to
encourage further investment in medical research
was approved – and if the
object of the patent system was in truth to give hope of a reward to people
whose research and industry
resulted in valuable products or processes –
there could be no logical basis for not extending that practice to medical
methods,
subject to extension also of the legislative safeguards applicable in
respect of medical substances and
devices.[132]
[53] Whilst the
denial of patents to methods of medical treatment had historically been
considered axiomatic, the demise of the need
for any treatment or production of
a commercial object made the logic of such denial
unclear.[133]
[54] Despite
these observations, the PAT concluded that the absence in contemporary patents
legislation of safeguards against the
unwarranted exploitation of processes for
medical treatment, as existed for medical substances and
devices,[134]
reflected a clear assumption by Parliament that methods of medical treatment
could not be patented.[135] This
raised the question as to the meaning of ‘method of medical
treatment’ in this context and as to whether that meaning
included methods
of contraception such as that in
issue.[136] The PAT held it did
not, ‘medical treatment’ denoting treatments to cure or prevent
disease.[137]
[55] The
overall significance of the decision in Schering is four-fold. First, it
confirmed as the primary justification for the conferring of patents the
rewarding of inventors for their
introduction within the jurisdiction of new and
useful objects through the expenditure of skill, effort and
expense.[138] Secondly, it
confirmed the applicability of this justification in respect of methods of
medical treatment, thereby removing any first
principle policy objections to the
patenting of such methods and affirming generally the non-discriminatory bias of
inherent patentability
central to the decision in
NRDC.[139] Thirdly, it
confirmed the absence of any relevant distinction for patentability purposes
between methods of medical treatment on
the one hand and medical substances and
devices on the other, and conceded the absence of any logical basis for treating
the former
as a ‘fine art’ and the latter as an invention or
‘useful art’. The effect of this concession was to confirm
the
inherent patentability of methods of medical treatment pursuant to the
principles of NRDC and emphasise – for the second
time[140] – the illogicality
of intuitive objections to the patenting of such methods given the absence of
similar objections in respect
of medical products.
[56] This raises the
fourth point regarding Schering, which concerns the PAT’s
suggestion that, express legislative provision aside, the only legitimate ground
on which methods
of medical treatment could be denied inherent patentability was
that of ethics. This reconception of the medical methods exclusion
in moral
terms reflected two things. First, it reflected yet another attempt by an
Anglo-Australian decision maker to find a legitimate
basis for perpetuating that
exclusion. And secondly – in a radical departure from existing
jurisprudence – it reflected
an admission that the only such basis that
existed was morality. The foundation for that admission, however, remained
unclear. Specifically,
the PAT in Schering offered no legal justification
to support its view of morality as relevant to inherent patentability, let alone
any policy justification
to support its view of morality as requiring the
exclusion from patentability of methods of medical treatment. In respect of the
first of these points there remained the historical principle against the
relevance of morality to inherent patentability; a principle
that, as has been
seen, was established in the context of medical methods
themselves.[141] In respect of the
second, the PAT merely accepted without critical discussion that moral
objections to the patenting of medical methods
not only existed, but were such
as to require prima facie the exclusion from patentability of all medical
subject matter, whether
method or
product.[142]
[57] One final
point of interest about Schering should be noted, and that is the absence
of any suggestion by the SE or PAT that the alleged invention should be denied
patentability
on the basis of the immorality of its contraceptive purpose, which
was the approach in A & H’s Application nearly 50 years
earlier. It is clear from such absence that whatever the view regarding the
ethics of patenting methods of medical
treatment generally, societal prejudices
regarding the morality of contraceptive devices and processes had changed by the
1970s.
(c) Reconception of the Medical Methods
Exclusion in Moral Terms by the High Court of Australia in 1972: Joos v
Commissioner of Patents
[58] It took only two years and two
cases
[143] for the import of
Schering to be taken up at a higher judicial level. Thus, in the 1972
High Court of Australia case of
Joos v Commissioner of Patents
(‘
Joos’)
[144]
Barwick CJ held that a method of cosmetic treatment was inherently patentable by
reason of its commercial significance (consistent
with
NRDC), and
suggested that any general exclusion from inherent patentability of methods of
medical treatment – which his Honour defined
narrowly as methods
‘for medical treatment of human disease, malfunction, disability or
incapacity of the human body or any
other part of
it’
[145] not including
methods of cosmetic treatment such as that in
issue
[146] – could only be
justified at common law on ‘public policy [grounds] as being, in the
language of the
Statute of Monopolies, “generally
inconvenient”’.
[147]
The implication of this suggestion was that the only legitimate basis on which
the inherent patentability of medical methods could
be denied was public policy
and that, public policy aside, medical methods were ‘inventions’
within the meaning of
NRDC and the
Statute of
Monopolies.
[148]
[59] Two
points were central to the decision in Joos. The first concerns the
effect of NRDC which, his Honour held, was to establish as inherently
patentable any process having economic value, whether or not ‘directly
supplied by the nature of the activity which would utilise the
process’;[149] a finding
that directly undermined the treatment of medical methods in that case as
‘essentially non-economic’. And the
second concerns the phrase
‘general inconvenience’ in s 6 of the Statute of Monopolies
which, the Chief Justice suggested, could provide a general public policy basis
for the exclusion of subject matter from inherent
patentability.[150] This
suggestion recognised for the first time a legal basis for opposing inherent
patentability on moral grounds. The Chief Justice’s
reliance to this end
on general inconvenience was consistent with two (then) recent decisions of the
UK PAT and
SE.[151]
Whilst his Honour referred to neither of those decisions, the effect of his
judgment was to support their interpretation of ‘general
inconvenience’ and to confirm the existence under Australian patents law
of a general discretion permitting decision makers
to deny patentability to any
subject matter on public policy
grounds.[152] It is interesting
that the source of this discretion – the proviso to s 6 of the Statute
of Monopolies – was the same as that relied on by the
Solicitor-General in C & W’s Application to support the
vendible product requirement from which the medical methods exclusion was (then)
said to derive.[153]
(d) The Acceptance of Joos in the UK to
1977
[60] After
Joos it was generally accepted by UK decision makers that
any historical reason in principle or logic for the denial of patent protection
to methods of medical treatment was removed by the test of inherent
patentability articulated in
NRDC, despite the apparent confirmation in
that case that medical methods could not support a
patent.
[154]
It was also accepted however that methods of medical treatment could, in theory,
still be legitimately regarded as beyond the scope
of
s 6 of the
Statute of
Monopolies – and therefore beyond the definition of
‘invention’ in contemporary patents legislation – on ethical
grounds
which, it was assumed, were accommodated within the concept of
‘general inconvenience’ contained in that
section.
[155]
This had the effect of reducing the question of the inherent patentability of
methods of medical treatment to a question of public
policy and, more
specifically, to the question of whether allowing patents for such methods would
be unethical or otherwise ‘generally
inconvenient’ within the
principles developed in respect of that concept under the
Statute of
Monopolies.
[61] Despite this, the issue of the ethics of permitting
patents for methods of medical treatment continued to elude the direct attention
of UK decision makers. This is notwithstanding the shift reflected in
post-Joos cases in the intuitive response of decision makers to that
issue, as evidenced by the following statement of the PAT in Eli Lilly &
Company’s Application (‘Eli
Lilly’):[156]
The reasons for such exclusion [of methods of medical treatment from
patentability] appears to us to be based in ethics rather than
logic but if
there is to be a change of policy, which would appear to us to be sensible, this
ought in our view to be effected by
legislation rather than by
interpretation.[157]
[62] Two
things are interesting about this statement. The first is the PAT’s
suggestion that the policy against allowing patents
for medical methods on
ethical grounds should be changed, and the second is its suggestion that
effecting such change is a matter
for the legislature and not the courts. Thus,
whilst recognizing the ethical basis of the medical methods exclusion, the PAT
questioned
the courts’ competency to reconsider that basis in order to
displace the exclusion and permit patents for methods of medical
treatment.
[158] In addition to
vindicating the view of the Solicitors-General in
C & W’s
Application and
A & H’s Application 50 years earlier
regarding the inappropriateness of considering morality when determining
inherent patentability, the PAT’s
approach in
Eli Lilly showed the
ongoing intransigence of the medical methods exclusion even after judicial
support for its perpetuation had declined.
2 Methods of Medical Treatment in the UK
from 1977: Explication of Section 4(2) of the Patents Act 1977
(UK)
(a) Statutory Reform
[63] The PAT’s call for legislative action in respect of medical
methods was answered in 1977 with the introduction of a new
patents system in
the UK mirroring that of the
Convention on the Grant of European Patents
(‘
EPC’).
[159]
Amongst other things, the
Patents Act 1977 (UK) (‘1977 Act’)
replaces the express definition of ‘invention’ by reference to s 6
of the
Statute of Monopolies with a list of specific exclusions from
patentability including, by s 4(2), the exclusion of ‘method[s] of
treatment of the
human or animal body by surgery or therapy or of diagnosis
practised on the human or animal
body’.
[160] The express
legislative basis of this exclusion is not public policy or inherent
patentability per se, but rather the inability of
medical (and veterinarian)
methods to satisfy the secondary patentability requirement of industrial
applicability.
[161] That the
exclusion has a public policy justification is, however, recognised by the
courts, although – and consistent with
the stirrings of the PAT in
Eli
Lilly – that justification is no longer accorded the respect shown by
the Solicitor-General in
C & W’s Application and the PAT in
Schering. This is reflected in the following passage from the judgment of
Jacob J in the 1998 case of
Bristol-Myers Squibb Co v Baker Norton Inc
(‘
Bristol-Myers v Baker
Norton’):
[162]
[T]he limited purpose of the [s 4(2)] exception ... is not so broad as to stop
doctors using whatever they feel they need to treat
patients. If that were the
purpose then one would not allow patents for medicines or medical implements at
all. The purpose of the
limitation is much narrower, merely to keep patent law
from interfering directly with what the doctor actually does to the patient.
Patent monopolies are permitted to control what he administers to, or the
implements he uses on, the patient. The thinking behind
the exception is not
particularly rational: if one accepts that a patent monopoly is a fair price to
pay for the extra research incentive,
then there is no reason to suppose that
that would not apply also to methods of treatment. It is noteworthy that in the
U.S. any
such exception has gone, and yet no-one, so far as I know, suggests
that its removal has caused any
trouble.[163]
[64] The
irony of the UK legislature’s entrenchment of the medical methods
exclusion – which for the first time removes
any doubt as to the legal
basis for that exclusion – at precisely the time when decision makers were
starting to question its
public policy basis cannot be ignored. Not
surprisingly, the shift away from viewing the patenting of methods of medical
treatment
as contrary to public policy has not been confined to the UK, but
rather is reflected amongst decision makers in most jurisdictions
around the
world.
[164] In the following
section the impact of that global shift on the scope of s 4(2) to date will be
considered. The conclusion from such
consideration is that the loss of judicial
support for the medical methods exclusion entrenched by that section is unlikely
to have
the same impact in the UK as in other countries faced with the same
exclusion and shifting judicial perspectives regarding the ethics
of medical
method patents.
(b) The Liberalisation of the UK Approach to
Medical Method Patents
[65] The relaxation of judicial attitudes to methods of medical treatment
discernible in
the 1970s is also reflected in the earliest cases
involving s 4(2) of the 1977 Act, which go some way to limiting the impact of
that
section on the availability of patent protection for medical methods in the
UK. For example, in the 1980 case of
Blendax-Werke’s Application
(‘
Blendax’),
[165]
Graham J of the Patents Court approved the principle – which he himself
had articulated 10 years earlier in
Organon Laboratories Limited’s
Application
(‘
Organon’)
[166]
– that the inventor of a method of medical treatment involving a novel and
inventive means of administering known drugs could
obtain
‘back-door’ protection for such method by patenting the form in
which the drugs are packaged. The reason offered
in
Organon for this
principle was that there would be ‘no reason why [anyone] should want to
[use the packaging] except for the new
treatment’;
[167] a fact that
also precluded the argument that permitting the patent would cause
‘general
inconvenience’.
[168]
[66] Both
the conclusion and reasoning of Organon were upheld in Blendax as
a legitimate means of circumventing s 4(2) of the 1977 Act. In the words of
Graham J,
I do not ... see why the applicant, who has invented a valuable process which,
owing to the law as it stands at present, he cannot
claim as a process, should
not be able, as far as he can, to get a monopoly for packs or other articles
which are useful in that
process, so that he can in effect rely on the value of
his discovery in claiming something which otherwise people might think had
no
subject
matter.[169]
[67]
A similarly liberal approach to s 4(2) is reflected in the second of the
post-1977 Act cases to involve a method of medical
treatment, which is
Stafford-Miller Ltd’s Applications
(‘
Stafford-Miller’).
[170]
The patent in that case was for a method of controlling extoparasites or their
ova on humans,
[171] and the issue
turned on whether such method fell within the scope of s 4(2) as a ‘method
of treatment of the human ... body
by ... therapy’. Overruling a decision
of the SE that it did so fall, the Patents Court upheld the Court of
Appeal’s
decision in
Upjohn, restricting operation of the medical
methods exclusion to ‘method[s] of treatment of a human
ailment’.
[172] The Patents
Court concluded that ‘a treatment involving the destruction of parasites
which are to be found on the body or in
the hair’ was not such a
method.
[173] The reason given by
Whitford J for this conclusion was that the object of the treatment was outside
the body, and that whilst the
distinction for s 4(2) purposes between treating
organisms outside and inside the body
may well be somewhat strange ... a line has to be drawn somewhere and I am not
sufficiently satisfied that these claims fall on the
wrong side of the line as
to justify saying at this stage in their life that these patents are incapable
of providing a good basis
for a sound
claim.[174]
[68] Overall,
the decisions in Blendax and Stafford-Miller go some way to
limiting the impact of s 4(2) on the scope of patentability by means of
principles formulated in the 1970s. The liberal
approach reflected in those
decisions reached its limit, however, in the 1980s, when a new genre of patent
claims aimed at defeating
that section emerged.
(c) Limits to the Liberalisation of the UK
Approach to Medical Method Patents: Swiss Style Claims
[69] So-called ‘Swiss style’ claims are claims for the
‘use of substance or composition X for the manufacture of
a medicament for
a specified new and inventive therapeutic
application’.
[175] Whilst
claims described in this manner do not on their face involve methods of medical
treatment, they do involve uses of a known
substance and are thus prima facie
unpatentable for lack of novelty under s 2 of the 1977 Act. An issue arises
however by virtue
of s 2(6) of that Act, which provides an express exemption
from the novelty requirement for certain uses of known substances in methods
of
medical treatment, as follows:
In the case of an invention consisting of a substance or composition for use in
a method [excluded from patentability by s 4(2)],
the fact that the substance or
composition forms part of the state of the art shall not prevent the invention
from being taken to
be new if the use of the substance or composition in any
such method does not form part of the state of the art.
[70]
When initially considered, this provision was held in the UK not to cover Swiss
style claims on the ground that its application
was limited to the
first
use of a known substance in any method of medical
treatment.
[176] This
interpretation was supported by the legislative intent underlying that provision
and, it was said, by the intent underlying
the equivalently worded art 54(5) of
the
EPC.
[177] A problem
arose, however, when the Enlarged Board of the European Patent Office
(‘EPO’) disagreed with this construction
of art
54(5).
[178] According to the
Board, the novelty of any second or subsequent medical use of a known substance
derived, for the purposes of art
54(5), from that second or subsequent use
itself; the claims envisaged by article 54(5) being purpose-limited product
claims to a
known substance or composition when used in a particular medical
method.
[179] This finding formed
the basis of a second decision by the Enlarged Board in
Mobil/Friction
Reducing Additive
(‘
Mobil’).
[180]
In that case it was held that the use of a known compound in a known method to
achieve a new technical effect would only be invalid
for lack of novelty if such
effect had previously been made available to the public. In considering whether
an effect had ‘previously
been made available’, the Board emphasised
the need to draw ‘a line ... between what is in fact made available, and
what
remains hidden or otherwise has not been made
available’;
[181] noting that
the mere fact of an effect having ‘inherently taken place in the course of
carrying out what [had] previously been
made available’ was not sufficient
to destroy the use’s
novelty.
[182] The effect of this
reasoning is to emasculate the medical methods exclusion contained in art 52(4)
by enabling any method of medical
treatment involving the use of a known
substance to be protected as a ‘second medical indication’ or
‘purpose-limited
product’, provided only that such substance has not
previously and knowingly been used for the same purpose in the same medical
treatment.
[183] The result is that
medical methods involving the use of a substance can support a patent under the
EPC if described in Swiss style form.
[71] The impact of the
EPO’s acceptance of Swiss style claims on UK law has been decisive. Having
had their patents system pegged
to that of the
EPC,[184] UK decision
makers have been forced to adopt the EPO position in relation to those claims in
the interests of doctrinal
conformity[185] and despite their
clear rejection of its
correctness.[186] Since this
adoption, however, the same decision makers have been working to find paths
around the EPO principles. To date two such
paths have been identified. The
first involves recognition of a more rigorous ‘supporting
description’ standard in respect
of Swiss style claims, under which full
disclosure is required not only of the substance, but also of the means by which
that substance
is to be used in the medical treatment (including dosage amounts
and forms of administration).[187]
This requirement for detailed supporting description has been relied on several
times already to strike down a second medical use
patent,[188] despite objections by
some applicants that it cannot reasonably be satisfied until full and proper
testing has been undertaken, which
itself cannot occur until after a patent has
been granted.[189]
[72] The
second means by which UK decision makers have avoided the effect of EPO
authorities regarding Swiss style claims has been
to distinguish them on the
facts of individual cases. This was the approach adopted more recently by the
Patents Court in Bristol-Myers v Baker
Norton,[190] where Jacob J
– after almost lamenting his inability to declare such authorities
‘bad law’[191] –
proceeded to strike down a second medical use patent on the ground that it was
not a case of a second or other medical use
at all, but rather ‘a case of
a mere discovery about an old
use’.[192] The effect of his
Honour’s decision is to undermine Mobil by providing a means for
excluding from patentability uses of a known compound previously used in the
same manner but for the purpose
of achieving a different technical
effect.[193]
(d) Conclusion
[73] It is tempting to view contemporary UK law regarding methods of
medical treatment as vindicating the decision of the Solicitor-General
in C
& W’s Application nearly 90 years ago, in which the exclusion from
patentability in respect of such methods was first recognised. However, whilst
the
existence of that exclusion has never been doubted, the fact of such
existence remains the only consistent and reliable theme in
the history of
medical method patents in the UK to date. Indeed, so intransigent has the
exclusion been that it has survived the
discrediting of its various legal bases
and the shift in judicial attitude to the public policy issues underlying them.
Whilst such
intransigence has not been shown in Australia, the development of
the principles governing medical methods since 1977 continues to
chart the same
general course there as in the UK. The purpose of the following and concluding
section is to consider this development.
3 Methods of Medical Treatment in
Australia Since 1977
[74] It is a remarkable fact, given the length of time that had passed
since the PAT’s initial suggestion in
Schering that morality was a
legitimate basis for the exclusion of medical methods from patentability, that
the nature and force of the moral
issues raised by the patenting of such methods
were not considered in detail until 1992. Less surprising, given the historical
trend
of decision making in this area, is that when they were so considered it
was by an Australian and not a UK court. Also unsurprising
in light of this
trend – and in light of the shift in judicial attitudes to the patenting
of medical methods generally –
is that when considered, morality was
deemed insufficient to justify the denial of patentability to such methods at
all. The case
in which that consideration was undertaken is
Rescare.
[194]
(a) Analysis of the Public Policy Considerations
Relating to Medical Method Patents: the Rescare Litigation of the
1990s
[75] Rescare involved methods for treating obstructive sleep apnoea,
more commonly known as snoring. In a strong judgment, Gummow J confirmed
the
inherent patentability of the methods on the test set by Barwick CJ in
Joos, resolving the public policy question at the heart of that test as
follows:
Counsel for the respondent ... submitted that [the method claims were]
‘generally inconvenient’ within the Statute of Monopolies
because: (i) modern medicine depends on technological innovation and it is in
the public interest that this should be published and
freely available; (ii) to
grant a monopoly in respect of methods of treatment of disease would be
‘inconsistent’ with
the teaching of medical students and
practitioners of such methods; (iii) if such grants were permitted the medical
practitioner
who applied the treatment without a licence and the patient who
authorised the treatment would be infringers; and (iv) the dissemination
of the
description of the method by a teacher or medical writer might amount to
exploitation of the invention within the meaning
of the definition of
‘exploit’ in Sch 1 of the 1990 Act and thus to infringement; and (v)
the patentee would be able
to refuse to license the invention or to charge
substantial licensing fees, subject only to the operation of the compulsory
licence
and Crown use provisions in chs 12 and 17 of the 1990 Act.
Counsel for the applicant responded to point (v) that the position was no
different with patents for pharmaceutical products. As
to the other points, it
was most unlikely that the patient who authorised the use of the process upon
his or her person would be
held to infringe or that a medical teacher or writer
would either exploit the invention or authorise such exploitation within the
meaning of the 1990
Act.[195]
[76] By
this reasoning, his Honour rejected the respondent’s argument that the
methods of treatment should be denied a patent
for general inconvenience,
thereby overruling the medical methods exclusion for the purposes of Australian
law.
[196] That decision was upheld
on appeal by a divided Full
Court.
[197] Whilst the three
Judges constituting the Court agreed with Justice Gummow’s conception and
resolution of the issue in terms
of ‘general inconvenience’ and
public policy, only two – Lockhart and Wilcox JJ – held the public
interest
to favour patentability. In the principal judgment of the Court,
Lockhart J relied heavily on a 1979 decision of Davison CJ of the
Supreme Court
of New Zealand
[198] to reason as
follows:
The statement by the court in [Eli Lilly] that in dealing with the
exclusion of a process for medical treatment from patent protection ‘the
reasons for such an exclusion
appear to us to be based in ethics rather than
logic’ was criticised, correctly in my respectful opinion, by Davison CJ
...
The original basis which was reaffirmed in the C and W case in 1914
was not ethics, but that a process for medical treatment was not ‘an art
of manufacture’ or was not a form
of manufacture or trade. As Davison CJ
observed ... now that the foundation for the decision in the C and W case
has been removed by subsequent decisions, the courts have been grasping for some
other ground on which to base a refusal to exclude
processes for medical
treatment from patent protection. The Chief Justice found no warrant in the law
for grounding such refusal
on ethical considerations. He said that the law
permits the granting of a patent for a drug, the inventor has rights to it, and
it
can be employed in medical treatments only if made available to the medical
profession by reason of licensing or compulsory licensing.
If a process for
medical treatment is invented, it can be licensed it the same way ... As members
of the public are not currently
deprived of the use of drugs under the existing
law, Davison CJ saw no reason why the public would be deprived of the use of
patented
methods of medical treatment ...
Davison CJ said that on the other hand there were sound grounds for granting
patent protection for processes of medical treatment
which by research result
from discovery of the fact that new properties and new uses exist for known
chemicals. There would be reduced
incentive to expend time, effort and money,
often necessary to make such discoveries, if no financial return was to be
available.
Drugs have long been recognised as patentable subject matter. I
respectfully adopt the Chief Justice’s comments. Once the notion
of the
necessity for a ‘vendible product’ is eliminated there is no
distinction in principle between a product for treating
the human body and a
method of treating the human
body.[199]
[77] Two
points are implicit in this reasoning. The first is that the reliance by UK
decision makers on ethics to support a medical
methods exclusion following the
abolition of the vendible product requirement was a reflection of ex post facto
justification rather
than sound legal reasoning. And the second is that any
ethical arguments against the patenting of medical methods were outweighed
by
the need to encourage medical research and by the long-standing acceptance of
the patentability of medical
products.
[200] Justice Wilcox
agreed. In addition, his Honour distinguished the line of UK authorities in
favour of the medical methods exclusion
as ‘not so deeply embedded in
Australian law as to preclude an appellate court departing from
it’.
[201] Indeed, according
to Wilcox J, it was obvious that the High Court of Australia had, in each of the
three cases in which the issue
was raised (
Maeder v Busch,
NRDC
and
Joos), assumed rather than decided the existence of a medical methods
exclusion.
[202] The result, his
Honour suggested, was that methods of medical treatment were not only inherently
patentable under Australian law,
but had never been declared by an Australian
Court to be otherwise.
[203] In
this way, Wilcox J relied on the dubiousness of the High Court’s reasons
for affirming the medical methods exclusion as
evidence of its lack of genuine
support for that exclusion. Whilst this view is arguable in relation to Chief
Justice Barwick’s
decision in
Joos, and even in relation to
NRDC, it is a less convincing explanation of Justice Dixon’s
decision in
Maeder v Busch, in which the unpatentability of medical
methods was more clearly asserted.
[78] Challenging the view of the majority
in the Rescare appeal was Sheppard J, who delivered a strong dissent
against patentability. Central to his Honour’s decision was the view
that
the need not to impede the work of those engaged in the alleviation of human
suffering outweighed the need to encourage medical
research and, more
specifically, that permitting the monopolisation of means of treating
potentially life-threatening illness would
be ‘generally
inconvenient’ within the meaning of the Statute of
Monopolies.[204] In his
Honour’s words:
It is not going too far, I think, to say that the Court should not contemplate
the grant of letters patent which would give to one
medical practitioner, or
perhaps a group of medical practitioners, a monopoly over, for example, a
surgical procedure which might
be greatly beneficial to mankind. Its denial
might mean the death or unnecessary suffering of countless people. I cannot
think that
this is really what the medical profession as a whole would seek to
achieve. Its whole history is a denial of the
proposition.[205]
[79] Although
in dissent, the decision of Sheppard J was upheld and applied by Heerey J of the
Federal Court at first instance in
Bristol-Myers, the next (and most
recent) case to consider the medical methods issue in
Australia.
[206] Not surprisingly,
however, given the weight of authority against that decision, Justice
Heerey’s judgment in
Bristol-Myers did not survive on appeal to the
Full Court, which unanimously affirmed the inherent patentability of methods of
medical treatment
on the principles expressed by Lockhart and Wilcox JJ in the
Rescare appeal.
[207] Whilst
the Full Court’s decision in
Bristol-Myers offers no new insight to
the public policy issues on which the division of opinion in the
Rescare
litigation turned, it does reignite the historical issue concerning the legal
basis for denying patentability on moral grounds and,
in so doing, casts doubt
over the ability and willingness of Australian judges to engage with moral
issues when determining inherent
patentability.
(b) Bristol-Myers and the Relevance of Morality
to Inherent Unpatentability
[80] Bristol-Myers involved a patent for a method of administering
the drug taxol in the treatment of cancer. Two judgments were delivered on
appeal;
the first by Black CJ and Lehane J, and the second by Finkelstein J. The
question of inherent patentability was resolved swiftly
in the first judgment by
reference to the weight of past judicial
opinion.
[208] More detailed
consideration of the issue was offered in the decision of Finkelstein
J.
[209]
[81] Justice
Finkelstein began by affirming the general approach of Anglo-Australian decision
makers since Rescare, viewing the exclusion of methods of medical
treatment from patentability under Australian law as supportable on public
policy grounds
only and, in particular, on the ground that permitting patents
for such methods would be ‘generally inconvenient’ within
the
meaning of the Statute of
Monopolies.[210] He then
proceeded to consider the public policy arguments for and against the patenting
of methods of medical treatment, concluding
as follows:
How is a court able to resolve these competing contentions? None of them is
supported by evidence. Some may not even be capable of
proof. Even if evidence
was called to make good the unsubstantiated assertions, on what basis is the
court to decide how the public
interest will best be served? .... I do not
believe that in a controversial issue such as is raised by the present argument,
I would
be abandoning my responsibility as a judge to follow this approach and
to hold that if public policy demands that a medical or surgical
process should
be excluded from patentability, then that is a matter that should be resolved by
the parliament.
It is likely that few of the arguments admit of a definitive answer. The area of
controversy is great. Public interest groups, medical
and professional
associations, medical scientists and the pharmaceutical industry, among others,
would need to be approached and
their views ascertained before a court could
ever hope to arrive at a reasoned conclusion, if it could ever do so. Indeed a
court
might well be asked to take account of ethical and moral considerations to
arrive at a decision. This is not the function of a court
on an issue such as
this. In my opinion, medical treatment and surgical process [sic] are
patentable under the legislation and, if public policy requires a different
result, it is for the parliament to amend the 1990
Act.[211]
[82] Thus,
in Justice Finkelstein’s view, the fact that resolving the public policy
question raised by medical method patents
might require the consideration of
moral or ethical issues made that question an inappropriate one for the
courts;
[212] the result being that
medical methods should remain inherently patentable unless and until Parliament
legislates to the contrary.
This view receives some support from the decision of
Wilcox J in
Rescare[213]
and reflects also the approach of the UK PAT in the 1970s’ cases of
Eli
Lilly and
Upjohn.
[214]
Ultimately, however, it goes beyond those decisions in its suggestion that any
public policy question having a moral or ethical dimension
is beyond the
competency of the courts. Exactly how the line between public policy and
morality is to be drawn is unclear, with Finkelstein
J himself having implicitly
conceded that the very nature of a public policy exception is, in some cases at
least, synonymous with
an exception based on
ethics.
[215]
[83] In addition, whilst historically very few patented subject matter have
raised ethical issues, this is rapidly changing with the
biotechnological
revolution of the last 20 years. This revolution has given rise to a range of
new and developing subject matter
that are seeking accommodation within
traditional patents jurisprudence in exactly the same way as occurred with
methods of medical
treatment in the early 20th century. The
difference in respect of such subject matter, however, is that the legal and
ethical issues raised by their patenting
is the subject of a wide-ranging public
debate. Whilst much of this debate concerns the logic and morality of treating
biotechnology
as ‘inventions’ capable of
monopolisation,[216] it also
raises questions regarding the rights of patients versus those of pharmaceutical
companies which increasingly represent the
primary source of ownership of
patents for recombinant and other medicinal
products.[217] However the ethical
issues concerning individual biotechnological subject matter are ultimately
resolved, it is clear that if they
are to be resolved judicially and on a
case by case basis, the courts will first need to answer the question raised by
Finkelstein J regarding
the extent to which decision makers are competent to
consider ethical issues when determining a particular subject matter’s
eligibility for patent protection. Interestingly, in casting doubt over such
competency, Finkelstein J undermined the distinction
drawn by Sheppard J in the
Rescare appeal between the approaches of Australian and New Zealand
judges to the medical methods question (as, indeed, did the other Full
Court
Judges in Bristol-Myers). According to Sheppard J, whilst the Judges of
the New Zealand Court of Appeal in the (then) leading case in that
jurisdiction[218] had felt bound
or led by existing authority to conclude that medical methods were not
patentable and had viewed any decision to the
contrary as the responsibility of
the legislature and not the courts, the Judges of the High Court of Australia in
NRDC had ‘regarded the matter as one which the Court was free to
decide’ – the reason it had not been conclusively decided
in that
case being that the matter had not been raised for
decision.[219]
[84] Whether
the High Court of Australia will regard the inherent patentability of methods of
medical treatment as one it is ‘free
to decide’ when the issue next
comes before it remains to be seen, although Justice Gummow’s first
instance decision
in Rescare suggests that he, at least, is likely to do
so. In the meantime, however, the Judges of the Full Federal Court in
Bristol-Myers have each opted for the approach ascribed by Sheppard J to
the New Zealand Court of Appeal in Wellcome, albeit with the opposite
result. Thus Black CJ and Lehane J were led by existing authority to conclude
that methods of medical treatment
were patentable, and Finkelstein J renounced
the competency of courts to decide to the contrary. Ultimately this approach is
a further
reflection of the historical unwillingness of Anglo-Australian
decision makers to deal substantively with the relationship between
inherent
patentability and morality. In addition, however, it demonstrates that such
unwillingness is not of itself conclusive of
a particular result, the Federal
Court having obtained the opposite result in Bristol-Myers to that
obtained by the New Zealand Court of Appeal in Wellcome, and the UK PAT
in Eli Lilly and Upjohn, even though it adopted the same
approach.
IV CONCLUSION
[85] As has been noted, the existence of an exclusion from patentability in
respect of methods of medical treatment has been the only
consistent and
reliable theme in the history of medical method patents in the UK to date.
Whilst the same cannot be said of Australia
(where such methods are now accepted
to be inherently patentable), what can be said is that Australian judicial
thinking has charted
and continues to chart the same general course as judicial
thinking in the UK. This is reflected not only in the shifting judicial
perspectives regarding the public policy issues raised by medical method
patents, but also in the changing views regarding the relevance
of such issues
to conceptions of inherent patentability per se. Hence the assumption by
decision makers in both jurisdictions until
the 1970s that any exclusion from
patentability in respect of medical methods could only be justified by reference
to their failure
to possess the essential tangible characteristics of an
invention. Hence also the (continued) instability of the medical methods
exclusion following its reconception in ethical terms after the 1970s, caused in
the UK by the unwillingness of decision makers to
consider ethical issues and
(more recently) in Australia by the same emerging unwillingness. The
exclusion’s entrenchment by
Parliament has not stabilised it in the UK,
even though such entrenchment relies on grounds other than inherent
patentability and
public policy. Perhaps ironically however, particularly given
the general lack of support for a medical methods exclusion amongst
contemporary
decision makers, courts in the UK have resisted the recent trend in Europe of
supporting clever drafting techniques
aimed at allowing such methods to be
patented. Whether the legislature will enter the fray in Australia remains to be
seen. If it
does, it will be interesting to see how Australian judges interpret
any future legislative exclusion of methods of medical treatment
from
patentability.
[86] The overall conclusion to be drawn from the history of
medical methods in Australian and UK law is that the rudderless nature
of
decision makers’ responses to medical method patents has been to the
detriment of 20th century patents law in its precipitation of at best
unclear, and at worst unconvincing, legal principles. Whilst historically the
main focus of such principles has been inherent patentability, and the role
therein of morality and other public policy considerations,
the secondary
requirement of novelty has also more recently been implicated in the UK.
Inevitably such principles have had –
and in Australia particularly look
set to continue to have – implications for a wide range of subject matter
beyond methods
of medical treatment.
[*] Law School, The
University of Melbourne, Parkville, Victoria 3010, Australia. Email:
j.pila@law.unimelb.edu.au. The author wishes
to thank David Brennan and Jonathan
Pila for their detailed comments in relation to this
article.[1] Throughout
this article the terms ‘morality’ and ‘ethics’ are used
interchangeably in accordance with their
common language meanings (see The
Macquarie Dictionary (3rd ed, 1997)). Note however the changing
pattern of usage of those terms within patents law from ‘morality’
to ‘ethics’
without any apparent change in intended meaning (see,
eg, below ns 66,
74, 130,
155 and accompanying text). The most recent
view of the courts has been that references to ‘morality’ and
‘ethics’
in the context of patents law are misplaced and should be
replaced by references to ‘public policy’ (see below n
215).[2] See
further Anna Feros, ‘Patentability of Methods of Medical Treatment’
[2001] European Intellectual Property Review 79, 84-5; below n
195 and accompanying
text.[3] Whilst the
patents legislation of 1883 (Patents, Designs & Trade Marks Act 1883
(UK) 46 & 47 Vict, c57 (‘1883 Act’)) was preceded by two other
19th century statutes (An Act to Amend the Law Touching Letters
Patent for Inventions 1835 (UK) 5 & 6 Wm IV, c83 (‘1835
Act’); Patents Law Amendment Act 1852 (UK) 15 & 16 Vict, c83
(‘1852 Act’)), it is the 1883 Act that is generally considered to
have ushered in the era
of modern patents law, principally by reason of its
extensive procedural reforms: see generally Neil Davenport, The UK Patent
System: A Brief History With Bibliography (1979)
20-1.[4] Whilst the
word ‘invention’ has been used to denote inherently patentable
subject matter in patents legislation since
1835, it was not expressly defined
until 1883.[5] See, eg,
Joel J Garris, ‘The Case for Patenting Medical Procedures’ [1996]
American Journal of Law and Medicine 85, 90-100; Beata Gocyk-Farber,
‘Patenting Medical Procedures: A Search for a Compromise Between Ethics
and Economics’
[1997] Cardozo Law Review
1527.[6] The new
technologies that have attracted the most attention in this regard are
biotechnological subject matter such as recombinant
DNA technology and its
various applications and products. The literature relating to the legal and
moral implications raised by the
patenting of such subject matter is vast, but
includes: Rebecca S Eisenberg, ‘Re-examining the Role of Patents in
Appropriating
the Value of DNA Sequences’ (2000) 49 Emory Law
Journal 783; David Keays, ‘Patenting DNA and Amino Acid Sequences
– An Australian Perspective’ (1999) 7 Health Law Journal 69;
Karinne Ludlow, ‘Genetically Modified Organisms and their Products as
Patentable Subject-matter in Australia’ [1999] European Intellectual
Property Review
298.[7] Patents Act
1903 (Cth) (‘1903 Act’). Note that the same definition was
contained in the colonial patents legislation of the late 19th
century, which replicated the provisions of the UK 1883 Act. Throughout this
article references to Australian statutory law are confined
to federal
legislation.[8] Patents,
Designs & Trade Marks Act 1883 (UK) 46 & 47 Vict, c57 s 46;
Patents and Designs Act 1907 (UK) 7 Edw 7, c29 (‘1907 Act’) s
93; Patents Act 1949 (UK) 12, 13 & 14 Geo 6, c87 (‘1949
Act’) s 101; Patents Act 1903 (Cth) s 4; Patents Act 1952 (Cth)
(‘1952 Act’) s 6; Patents Act 1990
(Cth) sch 1.[9] 21
Jac I, c3.[10] For a
detailed discussion of the nature of an invention within the meaning of the
Statute of Monopolies, see Justine Pila, ‘The Common Law Invention
In Its Original Form’ [2001] Intellectual Property Quarterly
209.[11] Patents
Act 1977 (UK) (‘1977
Act’).[12] [1795] EngR 4114; (1795)
126 ER 651.[13] See
generally Christine MacLeod, Inventing the Industrial Revolution: The English
Patent System, 1600-1800 (1988) 34; Edward C Walterscheid, ‘The Early
Evolution of the United States Patent Law: Antecedents’ (Pt 4) (1996) 78
Journal of the Patent and Trademark Office Society 77,
80.[14] The only
reported case from 1623-1794 in which inherent patentability was considered in
any detail was R v Arkwright (1785) 1 Web Pat Cas 64, in which additions
to existing machinery were held to be inherently patentable, reversing the
earlier authority of Bircot’s case (1573) Co 3rd Inst
181. For an account of the law of inherent patentability prior to 1623, see
generally Pila, above n
10.[15] For
a detailed account of the patent in issue in Boulton v Bull in its social
and economic context, see generally E Robinson and A E Musson, James Watt and
the Steam Revolution (1969); J P Muirhead, The Origin and Progress of the
Mechanical Inventions of James Watt
(1854).[16] The
principles of the invention concerned the nature of steam, the particular mode
involved keeping the steam vessel in the engine
as hot as the steam during the
time the engine was at work, and the purposes were to lessen the engine’s
consumption of fuel:
Boulton v Bull [1795] EngR 4114; (1795) 126 ER 651,
651.[17] Boulton v
Bull [1795] EngR 4114; (1795) 126 ER 651, 660-1 (Heath J), 663 (Buller J), 665-7 (Eyre
CJ).[18] Ibid 658:
Rooke J was inclined to support the patent on the basis of its conformance to
the ‘spirit’ of the Statute of Monopolies ‘provided it
may be supported without violating any rule of law’. In considering
whether the patent did violate any rule
of law his Honour did not refer to s 6
of the Statute of
Monopolies.[19] Ibid.[20] Ibid
659.[21] Ibid
660-1.[22] Interestingly,
the view of the invention as requiring some physical form was inconsistent with
the nature of the post-specification
invention as an abstract conception and of
the pre-specification invention as a working device or trade, which had a
tangible existence
but (in the case of trades at least) no necessary physical
form (see generally Pila, above n
10).[23] Boulton
v Bull [1795] EngR 4114; (1795) 126 ER 651,
662-3.[24] Note,
however, the inconsistency of Justice Buller’s conception of the invention
as physical object with his statement that
additions were inherently patentable
provided the relevant patent ‘be for the addition only, and not for the
old machine too’:
ibid
664.[25] Boulton v
Bull [1795] EngR 4114; (1795) 126 ER 651,
666.[26] The Chief
Justice also noted that a patent for a method involving no new mechanism and
producing no new result would necessarily
be for the method itself; ie, for the
‘method detached from all physical existence whatever’: ibid
667.[27] Boulton v
Bull [1795] EngR 4114; (1795) 126 ER 651, 667 (Eyre
CJ).[28] Ibid 659
(Rooke J), 662 (Buller
J).[29] Ibid 661.
Despite the argument of Heath J to the contrary, it is clear that his
Honour’s conclusion that methods of production
were inherently
unpatentable contradicted the position established by pre-1795 authorities,
which overwhelmingly supported the ability
of such methods to support a patent.
This was recognised by Eyre CJ, who commented (ibid 667) that
we should well consider what we do in this case, that we
may not shake the foundation upon which these patents stand. Probably I
do not
over-rate it when I state that two-thirds, I believe I might say three-fourths,
of all patents granted since the [Statute of Monopolies] passed, are for
a method of operating and of manufacturing, producing no new stances and
employing no new machinery. If the list
were examined, I dare say there might be
found fifty patents for methods of producing all the known salts, either the
simple salt,
or the old compounds.
[30] Boulton v Bull
[1795] EngR 4114; (1795) 126 ER 651,
663.[31] The
confusion surrounding the construction of patented subject matter and the
determination of its inherent patentability was further
reflected four years
later in the decision in Hornblower v Boulton [1799] EngR 585; (1799) 101 ER 1285, in
which the issue in Boulton v Bull was re-litigated. All four judges in
that case affirmed the validity of the patent, two without substantive reasoning
and two adopting
the reasoning of Buller J in Boulton v Bull by focusing
on the need for some physical ‘manufacture’ accurately described in
the
specification.[32] Cf
R v Wheeler (1819) 106 ER
392.[33] See
generally Cartwright v Eamer (1800) G 112; Bainbridge v Wigley
(1810) 1 Carp Pat Cas 270; Manton v Parker (1814) 1 Carp Pat Cas 274;
Bovill v Moore [1846] EngR 23; (1815) 47 ER 1048; Wood v Zimmer [1815] EngR 921; (1815) 171 ER 161;
Cochrane v Smethurst [1816] EngR 349; (1816) 171 ER 448; Macfarlane v Price [1816] EngR 343; (1816)
171 ER 446; R v Cutler [1814] EngR 134; (1816) 171 ER 495; Hill v Thompson [1817] EngR 834; (1817)
36 ER 239; R v Wheeler (1819) 106 ER 392; R v Fussell (1826) 1
Carp Pat Cas 449; Sturtz v De la Rue [1828] EngR 938; (1828) 38 ER 1048; Lewis v
Davis (1829) 1 Web Pat Cas 488; Lewis v Marling (1829) 1 Web Pat Cas
490; aff’d (1829) 1 Web Pat Cas 493; Jupe v Pratt (1837) 1 Web Pat
Cas 145; Househill Iron Co v Neilson (1843) 1 Web Pat Cas 673. Note that
the same exclusive concern with novelty, utility and adequacy of specification
is also reflected in the pre-1795
case
law.[34] The rule
that abstract principles lacked the practical utility necessary for inherent
patentability was implicit in the judgment
of Eyre CJ in Boulton v Bull
[1795] EngR 4114; 126 ER 651, 667, and was not revisited during the 19th
century.[35] In
respect of the emergence of inventiveness as a requirement distinct from
novelty, see generally Brook v Aston [1857] EngR 879; (1857) 120 ER 178; aff’d
(1857) 28 LJ QB 175; The Patent Bottle Envelope Company v Seymour (1858)
141 ER 65, 69; Harwood v Great Northern Railway Co (1862) 9 ER 1488;
Calvert v Ashburn (1862) JPM 84; Horton v Mabon [1862] EngR 623; (1862) 142 ER
1213; Thompson v James [1863] EngR 377; (1863) 55 ER 224; Willis v Davison (1863) 1
NR 234; Ralston v Smith [1865] EngR 268; (1865) 11 ER 1318; Jordan v Moore [1866] UKLawRpCP 43; (1866)
LR 1 CP 624; Parkes v Stevens (1869) LR 5 Ch 36; Tatham v Dania
(1869) 1 Gr 213; Rushton v Crawley [1870] UKLawRpEq 157; (1870) LR 10 Eq 522; Bamlett v
Picksley (1875) 1 Gr 40; Hill v Tombs (1881) JPM
82.[36] See generally
Losh v Hague (1838) 1 Web Pat Cas 202; Kay v Marshall (1839) 2 Web
Pat Cas 71; aff’d (1841) 2 Web Pat Cas 79; R v Cutler (1847) Macr
124; Bush v Fox (1852) Macr 140; aff’d [1856] EngR 709; (1856) 10 ER 1080;
ibid.[37] A fourth
subject matter denied inherent patentability during the 19th century
was working directions or instructions concerning the use of a known product or
process: see, eg, Patterson v The Gas Light and Coke Company [1876] UKLawRpCh 191; (1875) 2 Ch
D 812, 834; aff’d (1875) 3 App Cas 239. That subject matter can, however,
be viewed as an instance of analogous
use.[38] See
generally Jones v Pearce (1832) 1 Web Pat Cas 123; Morgan v
Seaward (1836) 1 Web Pat Cas 170 (rule nisi subsequently obtained on
unrelated point: (1837) 150 ER 874); Jupe v Pratt (1837) 1 Web Pat Cas
145; Kay v Marshall [1839] EngR 687; (1839) 132 ER 1189; aff’d [1841] EngR 831; (1841) 8 ER 96;
Neilson v Harford (1841) 1 Web Pat Cas 331; Walton v Bateman
(1841) 1 Web Pat Cas 613; Walton v Potter (1841) 1 Web Pat Cas 585;
aff’d (1842) 1 Web Pat Cas 597; Househill Iron Co v Neilson (1843)
1 Web Pat Cas 673; Muntz’s Patent (1846) 2 Web Pat Cas 113 and
accompanying commentary; Newton v Vaucher [1851] EngR 654; (1851) 155 ER
794.
[40] The effect of the
insertion of an express definition of the term ‘invention’ into
Anglo-Australian legislation in focusing
attention on the literal terms of s 6
of the Statute of Monopolies is also reflected in the contemporary
academic writings of the time regarding inherent patentability: see, eg,
Courtney Terrell,
Thomas Terrell, The Law and Practice Relating to Letters
Patent for Inventions (4th ed, 1906) 39; H Fletcher Moulton,
The Present Law and Practice Relating to Letters Patent for Inventions
(1913) 15; T M Stevens, Lewis Edmunds, The Law and Practice of Letters Patent
for Inventions (2nd ed, 1897)
18-19.[41] Patents,
Designs & Trade Marks Act 1883 (UK) 46 & 47 Vict, c57 s
11.[42] Before 1883,
a patent was revocable by writ of scire facias for failure to satisfy the
common law requirements of patentability (An Act to Amend the Law Touching
Letters Patent for Inventions 1835 (UK) 5 & 6 Wm IV, c83 s 3; Patents
law Amendment Act 1852 (UK) 15 & 16 Vict, c83 s xv). In 1883 the
scire facias action was abolished in the UK and replaced with a statutory
revocation procedure, which could be instituted on any of the grounds
of the
original action: Patents, Designs & Trade Marks Act 1883 (UK) 46
& 47 Vict, c57 s 26. The same change was effected in Australia by s 86 of
the Patents Act 1903 (Cth). In the UK, the grounds for revoking a patent
were first given explicit legislative form in 1907 (Patents and Designs Act
1907 (UK) 7 Edw 7, c29 ss 25, 26), and were expanded to include lack of an
‘invention’ within the meaning of the statutory
definition in 1932
(Patents and Designs Act, 1932 22 & 23 Geo 5, c32 (‘1932
Act’) s 3(d), amending Patents and Designs Act 1907 (UK) 7
Edw 7, c29 s 25). In Australia, the grounds for revoking a patent were
individually explicated by s 100 of the
Patents Act 1952 (Cth), and included by
s 100(1)(d) ‘lack of an invention’ within the meaning of the
statutory definition. In the UK, an
action for opposing the grant of a patent
was first introduced in 1883, and was limited to the ground of lack of novelty
(Patents, Designs & Trade Marks Act 1883 (UK) 46 & 47 Vict, c57 s
11). In Australia the same action was introduced by s 56 of the Patents Act
1903 (Cth) (see generally the decisions of the High Court of Australia in
respect of this section in Dunlop v Cooper [1908] HCA 67; (1908) 7 CLR
146; Gum v Stevens [1923] HCA 48; (1923) 33 CLR
267). In the UK the grounds for opposition were extended in 1907 to
include insufficient description of the invention in the specification
(Patents and Designs Act 1907 (UK) 7 Edw 7, c29 s 11) and again in
1949 to include (among other things) lack of inventiveness and lack of an
‘invention’ within the statutory
definition: Patents &
Designs Act 1949 (UK) 12, 13 & 14 Geo 6, c 62, s 7; Patents Act 1949
(UK) 12, 13 & 14 Geo 6, c87 s 14. In Australia they were extended in
1952 to include (among other things) the same grounds (Patents Act 1952 (Cth)
s 59).
Inherent patentability remains both a threshold requirement for patentability
and a ground for opposition and revocation
of a patent in current Australian
legislation: Patents Act
1990 (Cth) s 18(1), s 59(b), s 138(3)(b).
Note, finally, that in both the UK and Australia the Comptroller and
Commissioner of Patents respectively have always had the power
to refuse an
application and specification for a patent for failure to claim and disclose an
‘invention’ within the meaning
of the statutory definition. In
respect of the UK, see Re an Application for a Patent by Compagnies Reunies
des Glaces et Verres Speciaux Du Nord De La France (1930) 48 RPC 185
(‘Compagnies’ Application’) (in respect of the 1907 Act
and, by inference based on the relevant equivalence of its provisions, the 1883
and 1949 Acts).
In respect of Australia, see Patents Act 1903 (Cth) ss
4, 33, 47; Patents Act
1952 (Cth) ss 6, 35 (particularly
after the insertion of s 35(1)(aa) by Patents Act 1969 (Cth) No 34, s 7),
52; Patents Act
1990 (Cth) ss 18, 29, 49, 50, sch
1.[43] The Federal
Parliament’s power to legislate with respect to patents derives from s 51(xviii),
(xxix), (xxxi) of the Australian Constitution.
Note that the right to apply for a patent under the State Patent Acts was not
revoked until 1952: Patents
Act 1952 (Cth) s
9.[44] Patents
Act 1903 (Cth), ss 47(1), 59, 86(2). Whilst the Supreme Courts of the States
also had original jurisdiction under these provisions, such jurisdiction
was
rarely exercised. Note that the Federal Court of Australia has been the
principal Court for patent matters in Australia since
1976 when it was created
and Part XVII was inserted into the Patents Act 1952
(Cth).[45] The
subject matter most alike abstract schemes and methods of facilitating a natural
process, the inherent patentability of which
was considered before the
20th century, were methods of producing a negative or non-physical
result: see, eg, Hartley’s Patent (1777) 1 Web Pat Cas 54 (method
of securing buildings and ships against the calamities of fire, described by
Eyre CJ in Boulton v Bull [1795] EngR 4114; (1795) 126 ER 651, 666 as having as its purpose
the production of ‘a mere negative quality, the absence of fire’ as
distinct from any ‘stance
or composition of things’); see further
Boulton v Bull [1795] EngR 4114; 126 ER 651, 661 (Heath J), 663 (Buller J); Electric
Telegraph Company v Brett [1851] EngR 372; (1851) 138 ER 331 (improvements in giving signals
and sounding alarms in distant places by means of electric currents); Newton
v Vaucher [1851] EngR 654; (1851) 155 ER 794 (improvements in method of packaging machines to
render them air and fluid
tight).[46] See also
Re Brown [1899] ArgusLawRp 39; (1899) 5 ALR
81.[47] (1901) 19 RPC
53.[48] Ibid 54.
[49] Ibid.[50] Ibid.[51] [1910] HCA 19; (1910)
10
CLR
701.[52] Ibid
709.[53] Ibid
712.[54] [1842] EngR 766; (1842) 134
ER 239, 248. Note the subsequent reliance by the High Court of Australia on the
decision of Tindal CJ in Crane v Price to justify a broad conception of
inherent patentability: see below n 104 and
accompanying
text.[55] Rogers v
Commonwealth [1910] HCA 19; (1910) 10 CLR
701, 712 (emphasis
added).[56] Ibid
718.[57] (1914) 31
RPC
235.[58] Patents
and Designs Act 1907 (UK) 7 Edw 7, c29 s 93; see below n
8 and accompanying
text.[59] C &
W’s Application (1914) 31 RPC 235,
235.[60] Ibid
235-6.[61] Ibid
236.[62] See, eg,
Morgan v Windover (1890) 7 RPC 131; Thierry v Riekmann (1895) 12
RPC 412; Wood v Raphael (1896) 13 RPC 730; Schwer v Fulham [1910] HCA 37; (1910)
11
CLR
249.[63] Note
however that even Justice O’Connor’s test of inherent patentability
would have encompassed methods of medical treatment
to the extent that they
involved the use of a physical object: see above n
55 and accompanying
text.[64] Cf
Cornish v Keene [1837] EngR 455; (1837) 132 ER 530, 536; Hornblower v Boulton
[1799] EngR 585; (1799) 101 ER 1285, 1287-8 (Lord Kenyon
CJ).[65] C &
W’s Application (1914) 31 RPC 235,
236.[66] Patents,
Designs & Trade Marks Act 1883 (UK) 46 & 47 Vict, c57 s 86. This
provision was replicated in the Patents and Designs Act 1907 (UK)
7 Edw 7, c29 s 75 (sequently expanded by s 11 of the Patents and Designs Act,
1932 22 & 23 Geo 5, c32), but was removed from UK patents legislation in
1949. No equivalent provision was ever introduced in
Australia.[67] The
historical prohibition against the monopolisation of ‘generally
inconvenient’ subject matter derived from the 16th century
Crown practice of including in letters patent clauses enabling their revocation
for ‘inconveniency’: see D Seaborne
Davies, ‘The Early History
of the Patent Specification’ (1934) 50 Law Quarterly Review 86,
102.[68] Note however
that in practice the ‘general inconvenience’ provision had
historically been invoked for the exclusive purpose
of protecting local
employment: see Davies, above n 67, 102-4. The main way a patent would threaten
the interests of local workers
was by encouraging their replacement with
machines: see Re an Application for a Patent by T S [1924] 41 RPC 530,
538.[69] See MacLeod,
above n 13,
13.[70] A &
H’s Application (1927) 44 RPC
298.[71] Patents
and Designs Act 1907 (UK) 7 Edw 7, c29 s 75 (see above n
66).[72] A
& H’s Application (1927) 44 RPC 298,
298.[73] See above n
71.[74] A
& H’s Application (1927) 44 RPC 298,
298.[75] [1938] HCA 8; (1938) 59 CLR
684.[76] Ibid
699 (Latham CJ), 708 (McTiernan
J).[77] Ibid 706-7
(Dixon J), 707 (Evatt
J).[78] Ibid
706.[79] Ibid.[80] Ibid.[81] Ibid.
[82] Ibid.[83] Ibid
707.[84] Ibid 706
(Dixon J):
It is difficult to base any legal distinction on the
motive or purpose of the operator or manipulator or on the vocation he pursues.
It can hardly matter whether he acts in the exercise of a profession or art or
trade or business. The purpose of the patentee and
those intended to employ the
process may be entirely commercial. The process may be intended for use in
ordinary trade or business
such as that of hairdressing, manicure, pedicure. The
purpose, on the other hand, may be the relief of suffering by surgical or
manipulative
means.
[85] (1942) 60 RPC
1.[86] The subject
matter in G E C’s Application was a method of extinguishing fires
using a known chemical
stance.[87] G E
C’s Application (1942) 60 RPC 1,
4.[88] Ibid
6.[89] See above n
60 and accompanying
text.[90] Re Two
Applications for Patents by The Cementation Company Ltd (1945) 62 RPC 151,
153 (‘The Cementation Company’s Application’), where
Evershed LJ construed the common language of ‘manufacture’ as
embracing ‘(a) the action or process
of making by hand (b) the making of
articles or material ... by physical labour or mechanical power and (c) a branch
of productive
industry’.[91] Ibid
153-4.[92] Ibid
154.[93] See, eg,
The Cementation Company’s Application (1945) 62 RPC 151; Re an
Application for a Patent by Rantzen (1946) 64 RPC 63; Re Philips
Electrical Industries Ltd’s Application for a Patent [1959] RPC 341;
compare
Re an Application for a Patent by Bovingdon (1946)
64 RPC 20, 21. See further Re the Dow Chemical Company’s Application
for a Patent [1956] RPC 247; Re American Chemical Paint Company’s
Application [1958] RPC 47; British Petroleum Coy Ld’s Application
for a Patent [1958] RPC
253.[94] (1946) 64
RPC 63.[95] Ibid
66.[96] With the
exception of Lloyd-Jacob J (as illustrated by the decisions in Re an
Application for a Patent by Lenard (1954) 71 RPC 190 and Elton and Leda
Chemical Ld’s Application for a Patent [1957] RPC 267), Lord Justice
Evershed’s contemporaries applied Lord Justice Morton’s rules to
justify the exclusion from patentability
of two main types of process from
1942-1959. The first involved the production or treatment of ephemeral matter
(see, eg,
Re an Application for a Patent by C M (1944) 61 RPC
63; Re F’s Application for a Patent (1954) 72 RPC 127; Re
Huber’s Application for a Patent [1956] RPC 50; Re Philips
Electrical Industries Ltd’s Application for a Patent [1959] RPC 341;
British Petroleum Co Ltd’s Application for a Patent [1958] RPC
253), and the second involved the treatment of soil to improve its crop-bearing
capacity (see, eg, Standard Oil Development Company’s Application
(1951) 68 RPC 114; Re the Dow Chemical Company’s Application for a
Patent [1956] RPC 247; Re American Chemical Paint Company’s
Application [1958] RPC 47).
[97] The importance
of the decision in NRDC has frequently been acknowledged by Australian
and overseas courts (see, eg, Joos v Commissioner of Patents [1972] HCA 38; (1972) 126 CLR
611, 616 (Barwick CJ); Swift and Company v Commissioner of
Patents [1960] NZLR 775, 779 (Barrowclough
CJ)).[98] [1959] HCA 67; (1959)
102 CLR
252.[99] The
claims in issue in NRDC are extracted at ibid
260-1.[100] NDRC
[1959] HCA 67; (1959) 102 CLR
252,
276-7.[101] Ibid
269.[102] Ibid
270.[103] [1795] EngR 4114; 126 ER
651, 666; see above n 26 and accompanying
text.[104] [1842] EngR 766; 134 ER
239, 248; see above n 54 and accompanying
text.[105] NDRC
[1959] HCA 67; (1959) 102 CLR
252,
270.[106] Ibid
271-6.[107] Ibid
276.[108] Ibid.[109] Ibid.[110] Ibid
277.[111] Ibid.[112] The
tentative nature of the Court’s finding in respect of methods of medical
treatment is reflected not only in the language
in which it is expressed but
also in its appearance in
parentheses.[113] NDRC
[1959] HCA 67; (1959) 102 CLR
252, 275 (footnotes
omitted).[114] Cf
Swift & Company’s Application [1962] RPC 37, discussed below n
117.[115] See,
eg, United States Rubber Company’s Application [1964] RPC 104;
London Rubber Industries Ltd’s Patent [1968] RPC 31
(‘London
Rubber’).[116] Biotechnological
subject matter was treated after NRDC as inherently patentable, subject
only to the requirement that it manifest a sufficient level of human involvement
to take it out
of the realm of nature and into the realm of (artificial)
invention; the difficult question in such cases being the construction
and
application of the nature-artifice divide itself. See generally General
Electric Co Ltd’s Application (Patent) [1961] RPC 21; American
Cyanamid Company (Dann’s) Patent [1971] RPC 425; Ranks Hovis
McDougall Limited (1976) 46 AOJP 3915; American Cyanamid Company v Berk
Pharmaceuticals Limited [1976] RPC 231; Kiren-Amgen Inc v Board of
Regents of University of Washington [1995] APO 61; (1995) 33 IPR 557. For a general
discussion of this issue see Ludlow, above n
6. Note the similarity of the legal
justification for the medical methods exclusion during this period with the
legal justification
for the same exclusion recognised under 19th
century US law: Morton v New York Eye Infirmary 17 Fed Cas 879, 884
(1862).[117] [1961]
RPC 129. Whilst the decision in Swift & Company’s Application
was overruled on appeal by the High Court of Justice on the basis of the
Court’s ‘reasonable doubt’ as to its correctness
(Swift
& Company’s Application [1962] RPC 37), UK decision makers
throughout the 1960s supported in stance the approach of the SE and PAT over
that of the High Court of Justice:
see, eg, Neva Corporation’s
Application [1968] RPC 481 (‘Neva’); London Rubber
[1968] RPC
31.[118] See in
this context Puharich and Lawrence’s Application [1965] RPC 395.
Note that detailed reasons were not always provided for the exclusion of methods
of medical treatment from patentability during the
1960s (see, eg, United
States Rubber Company’s Application [1964] RPC
104).[119] [1968]
RPC
481.[120] [1968]
RPC 31.[121] Ibid
35.[122] Ibid
34-5.[123] [1970]
RPC 597. But note the decision of the High Court of Justice in Swift &
Company’s Application discussed above n
117, and the New Zealand case (Swift and
Company v Commissioner of Patents [1960] NZLR 775) on which that decision
was
based.[124] Palmer’s
Application [1970] RPC 597,
601.[125] [1971]
RPC 337.[126] Ibid
338.[127] Ibid.[128] Ibid
339.[129] Ibid.[130] Ibid
340.[131] Ibid.[132] Ibid
341.[133] Ibid
342.[134] The
relevant legislative safeguards against unwarranted exploitation of medical
stances and devices were contained in s 41 of the
Patents Act 1949 (UK)
12, 13 & 14 Geo 6, c87, which provided for compulsory licences in respect of
such stances and devices consistent with s 38A
of the Patents and Designs Act
1907 (UK) 7 Edw 7, c29 (inserted by Patents and Designs Act 1919 (UK)
9 & 10 Geo 5, c80, s
11(1)).[135] Schering
[1971] RPC 337,
343.[136] Ibid.[137] Ibid
344. Note the similarity between the definition of ‘methods of medical
treatment’ adopted in Schering and that supported by Dixon J in
Maeder v Busch, focusing on methods of treating or manipulating vital
parts of the human body (see above n 81 and
accompanying
text).[138] The
justification for patents offered by the PAT in Schering was consistent
with the emphasis of 19th century decision makers on novelty, utility
and sufficient description as the only real restrictions on the scope of
patentability:
see above n 33 and
accompanying
text.[139] In
NRDC the High Court expressly rejected an argument that
‘agricultural’ or ‘horticultural’ processes should prima
facie be excluded from patentability (NRDC [1959] HCA 67; (1959) 102 CLR
252, 279), and supported a conception of inherent patentability as not
discriminating between different kinds of subject matter or fields
of
technology.[140] See
above n 83 and accompanying
text.[141] See
above n 65 and accompanying text. Note the
irony of the fact that the PAT’s apparent departure from this principle
came only after the
removal from UK legislation of the very provision that had
originally undermined it (see above n 66 and
accompanying
text).[142] The
PAT’s acceptance that the ethical issues relating to the patenting of
medical methods applied equally in respect of medical
products undermined the
illogicality of the differential treatment of medical methods and products
within patents law; the reason
being that, unlike those to the patenting of
medical methods, the moral objections to the patenting of medical products were
rebutted
by the existence of compulsory licencing provisions: see above n
134 and accompanying
text.[143] The
intervening cases involving methods of medical treatment are Bio-Digital
Sciences Incorporated’s Application [1973] RPC 668 and Calmic
Engineering Company Limited’s Application [1973] RPC
684.[144] [1972] HCA 38; (1972)
126 CLR
611.[145] Ibid
622.[146] The
definition of ‘methods of medical treatment’ supported by Barwick CJ
in Joos was consistent with that of the PAT in Schering (see above
n 137 and accompanying
text).[147] Joos
[1972] HCA 38; (1972) 126 CLR
611,
622.[148] Ibid
623-624.[149] Ibid
624. The implications of this test for the cosmetic method in issue in
Joos were stated as follows:
In this case, the processes are to be used in what cannot
be described otherwise than as a commercial activity of hairdressing,
a sector
of activity that accounts, I imagine, for a great deal of employment. I could
not assign the skill of the hairdresser to
the area of the fine arts and have
little difficulty placing it in the area of the useful arts. In my opinion, it
is an activity
in the field of economic endeavour and has commercial
significance as those expressions ought to be understood in relation to the
grants of patents. Therefore, it could not be said, in my opinion, that the
application should not be allowed to proceed because
clearly it had no
commercial significance in the relevant aspect.
[150] Joos [1972] HCA 38; (1972)
126 CLR
611,
623.[151] See
Rolls-Royce Ltd’s
Application [1963] RPC 231
(‘Rolls-Royce’) and Hiller’s
Application [1969] RPC 267 concerning, respectively, a method of operating a
known engine to improve its performance and an improved plan for subterranean
utility
distribution schemes. The effect of those cases was to permit an
opposition to a patent application on the basis of the ‘general
inconvenience’ that permitting the patent would in each case have caused
to the public. (See further Application by Fluid Energy Systems Pty Ltd
[1991] APO 40.) In Rolls-Royce, the source of the ‘general
inconvenience’ was the additional burden that would be imposed on pilots
– whose responsibility
in carrying passengers was held to be sufficiently
onerous already – should they be required to ‘[avoid] infringement
of a statutory monopoly in the operation of [their] standard engine
controls’: Rolls-Royce [1963] RPC 231, 256. The same reasoning was
adopted in Hiller’s Application in respect of those responsible for
providing utility services: see Hiller’s Application [1969] RPC
267, 268. Whilst leaving the question open, the PAT on appeal in
Hiller’s Application indicated that objection to the patent on the
ground of general inconvenience ‘may well be ... fatal’:
Hiller’s Application [1969] RPC 267, 270. Interestingly, the
decisions in Rolls-Royce and Hiller’s Application were
inconsistent with the only other case since the Statute of Monopolies to
have considered expressly the phrase ‘generally
inconvenient’:
Re an Application for a Patent by T S [1924] 41 RPC
530.[152] See above
n 69 and accompanying
text.[153] See
above n 60 and accompanying
text.[154] See, eg,
Eli Lilly & Company’s Application [1975] RPC 438; The Upjohn
Company (Robert’s) Application [1977] RPC 94
(‘Upjohn’); Rescare Ltd v Anaesthetic Supplies Pty Ltd
(1992) 25 IPR 119 (‘Rescare’); Anaesthetic Supplies
Pty Ltd v Rescare Ltd [1994] FCA 1065; (1994) 50 FCR 1 (‘Rescare appeal’);
Laboratories Prographarm v F H Faulding & Co Ltd [1988] APO 63;
Bristol-Myers Squibb Company v F H Faulding & Co Ltd (1998) 41 IPR
467 (‘Bristol-Myers’); Bristol-Myers Squibb Company v F H
Faulding & Co Ltd [2000] FCA 316; (2000) 46 IPR 553 (‘Bristol-Myers v FH
Faulding’); cf Application for a Patent by N V Organon (1974)
44 AOJP
4503.[155] Ibid.[156] [1975]
RPC 438.[157] Ibid
445.[158] See also
Upjohn [1977] RPC 94,
98.[159] Opened for
signature 5 October 1973, 13 ILM 268 (entered into force 7 October
1977).[160] Patents
Act 1977 (UK) s 4(2). The EPC provision corresponding to s 4(2) is art
52(4).[161] The
requirement for industrial applicability under the Patents Act 1977 (UK)
(ss 1(1)(c), 4) and the EPC (arts 52(1), 57, 52(4)) is equivalent to the
requirement for utility under Australian
law.[162] [1999]
RPC 253.[163] Ibid
274.[164] See
generally Bristol-Myers v FH Faulding [2000] FCA 316; (2000) 46 IPR 553, 594 (Finkelstein
J).[165] [1980] RPC
491.[166] [1970]
RPC 574.[167] Ibid
579.[168] Ibid.[169] [1980]
RPC 491,
506.[170] [1984]
FSR
258.[171] Whilst
the principal claim of the Stafford-Miller patent application was
directed to the method when used in respect of any substrate, it was conceded by
the applicants to have as
its particular focus human
beings.[172] [1977]
RPC 94,
98.[173] [1984] FSR
258,
261.[174] Ibid.[175] Claims
directed to a second medical use of a known stance or composition are referred
to as being of ‘Swiss form’ in
recognition of their original
allowance by the Swiss Patent Office: see ‘Statement of practice regarding
“use claims”
issued by the Swiss Federal Intellectual Property
Office’ [1984] EPOR
581.[176] Sopharma
S A’s Application [1983] RPC 195, 197-8; applied Bayer A G
(Meyer’s) Application [1984] RPC 11,
12.[177] [1983] RPC
195,
198-9.[178] See
generally Re Eisai Co Ltd (Decision G 5/83 (1985)) [1985] EPOR
241(‘Eisai’).[179] Ibid
248-9.[180] (Decision
G02/88) [1990] EPOR 73. In relation to the connection between Mobil and
Eisai see generally Bristol-Myers v Baker Norton [1999] RPC 253,
277, where Jacob J held it ‘arguable that there is no logical or
reasonable distinction between [the decision in Mobil] and the decision
in Eisai’, and stated that ‘to try and ... steer a course
between accepting Eisai and yet holding Mobil wrong’ would
‘at best ... involve more Byzantine logic’; cf Mobil [1990]
EPOR 73,
84-5.[181] [1990]
EPOR 73,
88.[182] Ibid 89.
The implications of the reasoning in Mobil for the subject matter in
issue was to establish as novel the addition of a known compound to lubricating
oil for the purpose of
reducing friction, even though the same compound had
previously been added to lubricating oil for the purpose of preventing rust.
See
also Plant Genetic Systems/Glutamine Sythetase Inhibitors (T356/93)
[1995] EPOR
545.[183] See above
n
180.[184] Patents
Act 1977 (UK) s 130(7); John Wyeth & Brothers Ltd’s
Application; Schering A G’s Application [1985] RPC 545, 565
(‘Wyeth; Schering’); Merrell Dow Pharmaceuticals Inc v H N
Norton & Co Ltd [1995] UKHL 14; [1996] RPC 76, 82 (‘Merrell Dow’);
Bristol-Myers v Baker Norton [1999] RPC 253,
272-3.[185] Wyeth;
Schering [1985] RPC 545, 567; Bristol-Myers v Baker Norton [1999] RPC
253, 272, 276-7. Note also the extra-curial views expressed by Jacob J of the
Patents Court in relation to the EPO’s application
of novelty principles
to Swiss form claims in Sir Robin Jacob, ‘Novelty of Use Claims’
(1996) 27 International Review of Industrial Property and Copyright Law
170.[186] See, eg,
ibid.[187] A
rigorous supporting description standard for Swiss style claims was first
recognised in Hoermann’s Application [1996] RPC 341,
345.[188] See, eg,
ibid; McManus’s Application [1993] FSR 558; Consultants
Suppliers Ltd’s Application [1996] RPC
348.[189] See, eg,
Hoermann’s Application [1996] RPC 341,
347.[190] [1999]
RPC 253.[191] Ibid
277. Aside from the persuasiveness of decisions of the Enlarged Board of the
EPO, there remained the UK case of Merrell Dow [1995] UKHL 14; [1996] RPC 76 in which
‘the House of Lords ... given the opportunity to say that Mobil was
bad law, clearly declined to take it’ (ibid
277).[192] Ibid.[193] Ibid
278-9.[194] (1992)
25 IPR
119.[195] Ibid
150-1.[196] Note
that the decision of Gummow J that methods of medical treatment were inherently
patentable put Australia in conflict with almost
every other jurisdiction to
have considered the patentability of medical methods, including Europe, Japan,
the UK and New Zealand.
See EPC art 52(4) (Europe); Patents Act
1977 (UK) s 4(2) (UK); Pharmaceutical Management Agency Ltd v
Commissioner of Patents (1999) 46 IPR 655 – in respect of surgery and
methods of preventing or treating disease only (New Zealand); cf Ex parte
Scherer 103 USPQ 107, 110
(1954).[197] Rescare
appeal [1994] FCA 1065; (1994) 50 FCR
1.[198] Wellcome
Foundation Ltd v Commissioner of Patents (1979) 2 NZLR 591
(‘Wellcome’); overruled on appeal by unanimous decision of
the New Zealand Court of Appeal in Commissioner of Patents v The Wellcome
Foundation Limited (1983) 2 IPR 156 (‘Wellcome appeal’).
Note also the decision of the New Zealand Court of Appeal in respect of methods
of medical treatment in Pharmaceutical Management Agency Ltd v Commissioner
of Patents (1999) 46 IPR
655.[199] Rescare
appeal [1994] FCA 1065; (1994) 50 FCR 1,
18.[200] As
Lockhart J noted in his reasons (ibid), the arguments raised in Schering
in relation to the limited availability of compulsory licences for medical
subject matter under UK legislation were inapplicable
in Australia by reason of
its different licensing system (see Patents Act 1990
(Cth) s
133).[201] Rescare
appeal [1994] FCA 1065; (1994) 50 FCR 1,
44.[202] Ibid.[203] Ibid.[204] Ibid
41.[205] Ibid.[206] Bristol-Myers
(1998) 41 IPR 467. In Bristol-Myers Heerey J held a patent for
administering the drug taxol in the treatment of cancer to be invalid on the
ground among others that
it claimed a method of medical treatment which, his
Honour held, was not a proper subject matter for a patent. His Honour’s
reasoning emphasized three main points. First, such obiter as existed tended
against the patentability of methods of medical treatment
of the human body
(Bristol-Myers (1998) 41 IPR 467, 479). Secondly, the New Zealand Court
of Appeal had decided against patentability (Wellcome appeal
(1983) 2 IPR 156, overruling the decision of Davison CJ affirmed by Lockhart
J in the Rescare appeal), and it was desirable that Australian and New
Zealand commercial laws be consistent (Bristol-Myers (1998) 41 IPR 467,
479). And thirdly, the exclusion of methods of medical treatment was required by
the same public policy considerations outlined
by Sheppard J in the Rescare
appeal, including the nature and objectives of the medical profession
(Bristol-Myers (1998) 41 IPR 467, 480). Finally, Heerey J noted that any
illogicality in the distinction created by his decision between medical products
(which his
Honour conceded were patentable) and medical processes was explicable
by the nature of the life of the law which, he noted, had been
experience and
not logic (Bristol-Myers (1998) 41 IPR 467,
481).[207] Bristol-Myers
v FH Faulding [2000] FCA 316; (2000) 46 IPR
553.[208] In their
joint judgment, Black CJ and Lehane J deferred expressly to the preponderance of
Australian appellate opinion which, they
held, was represented by the
majority’s decision in the Rescare appeal. In so doing they noted
two additional considerations as providing additional support for the position
represented by that
opinion. The first of those considerations was the public
policy problem of distinguishing between products and methods of treating
the
human body, and the second was the failure of Parliament to exclude such methods
from patentability ten years earlier, when the 1990 Act was introduced.
See generally ibid
558.[209] Note that
Finkelstein J ultimately decided the question of inherent patentability on
another basis (not relevant to the present discussion),
with the result that the
aspect of his Honour’s decision herein discussed is strictly obiter
dictum.[210] Rescare
(1992) 25 IPR 119, 148-9; affirmed by Finkelstein J after considering
the history of the proviso to s 6 of the Statute of Monopolies
(Bristol-Myers v FH Faulding [2000] FCA 316; (2000) 46 IPR 553,
589).[211] Ibid
595-6.[212] In
respect of the inappropriateness of courts determining moral or ethical issues
see further ibid
586.[213] Rescare
appeal [1994] FCA 1065; (1994) 50 FCR 1,
42-3.[214] See
above n 156 and accompanying
text.[215] Justice
Finkelstein noted that the references by Graham and Whitford JJ in Schering
[1971] RPC 337 and Eli Lilly [1975] RPC 438 to the ‘ethical
grounds’ justifying the exclusion of medical processes from patent
protection should be understood as
references to ‘public policy
grounds’: Bristol-Myers [2000] FCA 316; (1998) 46 IPR 553,
591.[216] See above
n
6.[217] See
generally Ray Moynihan, ‘Saving patients or protecting patents?’,
The Australian Financial Review Weekend (Sydney), 7-8 April 2001,
30.[218] Wellcome
appeal (1983) 2 IPR
156.[219] Rescare
appeal [1994] FCA 1065; (1994) 50 FCR 1, 40.
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