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Hakki, Murat Metin --- "European Directive on the Legal Protection of Biotechnological Inventions: Scope, Status and Controversies in a Nutshell" [2004] MurdochUeJlLaw 4; (2004) 11(1) Murdoch University Electronic Journal of Law

European Directive on the Legal Protection of Biotechnological Inventions: Scope, Status and Controversies in a Nutshell

Author: Murat Metin Hakki LLM
LLM Candidate, Cornell University
Issue: Volume 11, Number 1 (March 2004)

Contents

    Background

  1. The European Parliament as well as the EU Council and Commission struggled for over ten years with a Directive on the legal protection of biotechnological inventions that would achieve both harmonization and clarification whilst ensuring that strict ethical rules are respected. Finally, on May 12, 1998, the Parliament voted in favour of the latest draft of a Directive. The text was later on formally accepted by the Council and published in the Official Journal of the Communities on July 30, 1998 (see ANNEX 1).

  2. The Directive was supposed to have been written into the national laws of the Member States by July 30, 2000. Nevertheless, to date only seven countries put the Directive into practice (see ANNEX 2). Despite its noble objectives, since the date of its publication in the official European Community journal, the Directive has come under a significant level of criticism. For example, The Netherlands finds the requirement that that patents be granted over plants and animals to be morally objectionable.[1] They have sought to annul the legislation through an action brought before the European Court of Justice (ECJ), but their attempt was unsuccessful.[2] On the other hand, the French, Belgians, Austrians and Italians are concerned about the appropriation of the human genome by the private sector and fear negative effects that DNA sequence patents may have over healthcare.[3]

  3. On July 10 of this year, the European Commission referred the eight non-implementing states to the ECJ for their breach of obligations under the Community law.[4] The industry expects the court decision to end a period of uncertainty in which the investors feared that biotech patents would not be protected if they were challenged in one of the eight non-compliant countries.

  4. In view of what has been said above, the aim of this paper would be to examine the extent to which the objections levelled at the Directive can be justified. In this respect, I will endeavour first to describe what the main provisions and goals of the Directive are, and secondly to have regard to the opinions of the leading scholars in this field in order to assess whether the legislation adequately fulfilled its purposes overall. Given time and space constraints, more attention will be devoted to the first seven articles that have provoked the most discussion over the past few years.

  5. The thrust of my opinion is that whilst the acceptance of the Biotech Directive constitutes a major step forward for Europe in the field of biotechnology, there are uncertainties regarding the scope of many of its provisions and the reasoning enshrined in some of the articles, notably Arts 3 and [5] are flawed.

    General Structure of the Directive

  6. The Biotech Directive has two components: recitals and articles. Articles are directly binding on states whereas the recitals merely serve to set out moral obligations and are unenforceable unless also contained in an article.5 The Directive can be split into five main groups:[6]

    Patentability

  7. Article 1 requires Member States to protect biotechnological inventions under national patent law and to adjust their national patent law to achieve this. However, this obligation is without prejudice to their obligations under international agreements, particularly TRIPs and the Convention on Biological Diversity. This arguably has the effect of making the other treaties to prevail over the Directive in cases, if any, of conflict. The ECJ has rejected the Dutch arguments and has held that there is no incompatibility between the Directive and the other major multinational treaties involving the Union (Case C-377/98).

    Definitions (Art.2)

  8. This provision provides definitions of 'biological material ', 'microbiological processes, 'essentially biological process for the production of plants or animals' and 'plant variety'. As will be seen below, apart from removing uncertainty, these definitions remove many other things from the realm of patentability to the realm of patentability.

  9. 'Biological material' is defined in Art. 2 (1) (a) as 'any material containing genetic information and capable of reproducing itself or being reproduced in a biological system'.

  10. Art. 2(1) (b) defines a 'microbiological process': 'any process involving or performed upon or resulting in microbiological material'.

  11. 'An essentially biological process for the production of plants or animals' is defined in Art. 2 (2) as a process that 'consists entirely of natural phenomena such as crossing or selection'.

    Patentability of Biological material (Art.3)

  12. Pursuant to Art.3 (1), a product consisting of or containing biological material, or a process by means of which biological material is produced, processed or used, is patentable if it meets the basic patentability requirements ( novelty, inventive step and susceptibility of industrial application). So the Directive makes it perfectly clear that the member states are not allowed to have any extra hurdles in their patent laws for inventions relating to biological material. Art. 3(2) lay down that:

    Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.

  13. The provision means that, so long as the biological material is in its natural environment (e.g. a DNA), it is not patentable. Nevertheless, once the material has been isolated from that environment or otherwise produced by means of a technical process, it becomes patentable. Dr. Wibbelmann[7] cites this section as an example of emphasis being placed upon the distinction between discoveries v inventions. Yet, scholars like Sigrid Sterckx[8] are not quite convinced in this respect, saying that even if a natural element has been isolated from the body by technical means, this does not change the 'naturalness' of the element. Is Wibbelmann's comment analytically weak?

  14. The European Commission has sought to clarify and justify their stance in relation to Article 3. Whilst the Commission agreed that the mere sequencing of a genome belongs to the area of discovery, they have attempted to distinguish certain events by holding that: 'it is different however if a DNA sequence is released from its natural surroundings by means of a technical procedure and is made available for the first time to a commercial application. Here there is a 'step taken from knowing to being able'. Such a gene is new in the patent sense and therefore patentable, if it was not previously accessible to public as such, and thus technically was not available'.[9]

  15. With respect, I think such an argument is flawed. In my opinion, pointing to the technical character of the process of isolation can only constitute an argument in support of the patentability of the processes themselves but not of the elements that were isolated during these processes.

    Exception of plant and animal varieties from patentability (Art. 4)

  16. The Directive clearly sets out that plant and animal varieties (as such) shall not be patentable. However, inventions which concern plants or animals shall be patentable, if the technical feasibility of the invention is not confined to a particular plant or animal variety.

  17. For the definition of the concept of 'plant variety' reference can be made to Art. 5 (2) of Regulation (EC) No 2100/94. Regrettably, the Directive does not define the meaning of 'variety' in relation to animals. This is highly problematic for more and more patent applications are being filed in the field of animal biotechnology.[10]

  18. Recitals (29) to (32) can also be resorted to for further elaboration on some of the technical terms referred to above. They employ a fundamental distinction between the concept of 'plant variety' and 'plant groupings' which are characterized by a particular gene. In the former case, the variety is defined by its whole genome and therefore possesses individuality, thus being clearly distinguishable from other varieties. Still, plant groupings (which are not characterised by the whole genome of each member) are not excluded from patentability, even if they comprise new varieties of plants. The Directive clarifies that in the case of an invention which solely genetically modifies a particular plant variety, any claim to such a plant (variety) shall not be granted.[11]

  19. Finally, the Directive excludes 'essentially biological processes for the production of plants and animals from patentability'. In this regard, it defines that a process is essentially biological if it consists entirely of natural phenomena such as crossing or selection (Art. 4 (1) (b)).

    The human body and its elements (Art. 5)

  20. It is submitted that this section of the legislation is one of few that have attracted the most controversy. There are a substantial number of opinions to the effect that Article 5 violates the fundamental distinction between a 'discovery' and an 'invention' as well as the ethical principle of not making 'commercial' use of the human body. Besides, there are those who say that its wording conveys ambiguity:

    ''whilst it is clear from the first paragraph that the simple discovery of the sequence or partial sequence of a gene does not constitute an invention, the following paragraph goes on to say that 'an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element'. This wording in fact says that any gene or sequence would be patentable, on the condition of it being cloned. It gives a determining role to cloning techniques which do not meet any criteria of novelty, thereby almost totally canceling the point made by the previous paragraph''.[12]

  21. At this point, I would like to repeat the conclusion that I reached above in relation to the interpretation of Article 3 of the Directive and assert that isolation of a particular gene from its natural surroundings by a technical process does not result in an invention. For example, if you were to peel the skin of an apple, the pips or the juicy bits that you get following that process are not pears or oranges but still an apple! Seen in that light, I cannot say anything apart from submitting my support to those who complain about the reasoning and ambiguity of the said article.

  22. Furthermore, four respected societies from the United Kingdom -the Clinical Genetics Society, the Clinical Molecular Genetics Society, the Association of Clinical Cytogeneticists and the Genetic Nurses and Social Workers Association- have presented a joint statement that tends to adopt an approach similar to mine:

    The suggestion that such sequence might be patentable if it is ''isolated in a pure form'' or ''isolated outside of the body'' seems to us a sophistry, and should not be allowed.[13]
    This brings us to the second limb of the discussion: the question of whether patenting genes in one form of another is indeed objectionable. It is submitted that this can only be answered by weighing the benefits that the patenting process generally may bring to or take away from the humanity.[14]

  23. It is said that patentability is justified because:

    * researchers would be rewarded for their work as a result of patents and could invest the proceeds generated by exploitation of their patents in their future research;
    * investment in research would consequently be encouraged if a right of commercial exploitation were granted to an inventor, who, subject to given conditions, would be entitled to enjoy a monopoly over a period not exceeding 20 years, assuming that the right has not lapsed beforehand. Having obtained the right, the inventor would undertake to describe his innovation in exhaustive detail. Only those elements of the innovation that could legitimately be so covered would be covered by the right, that is to say, competitors would be forbidden to produce, use, or sell the patented invention without the inventor's consent or a license to use it;
    * as regards biotechnological products in the health sector, the patent right would serve to encourage medical research and development;
    * it would be possible to avoid expensive and useless overlapping of efforts seeking to achieve the same results;
    * research would be directed into unexplored new areas;
    * It would be less necessary to resort to industrial secrecy, and all researchers would have access to the new invention (without infringing the patent right).

  24. However, many arguments have been put forward in support of the idea that human genes should be unpatentable:

    * Owing to the high cost of using the information to which they relate, the award of patents could impede diagnostic and therapeutic research (gene therapy and predictive medicine), creating a system in which genes would be exploited on a monopoly basis. Some developing countries consider that as a threat to their development;
    * even if the industries interested in the research were willing to pay them, the high royalties accorded to the holders of patents for gene sequences would eventually be passed on to consumers, thus making the products resulting from the research more expensive and difficult to obtain;
    * The only kind of medical development which patents would accelerate would be that linked to research into diagnostic and therapeutic tools offering the prospect of substantial profit. By contrast, all research activity would cease in fields that did not hold out the promise of the desired profit margins, in which nobody would want to invest;
    * if patents were awarded for genes, future generations would come to perceive life as an invention pure and simple, in which the boundaries between the sacred and the profane, intrinsic value and utilitarian value, would be erased, reducing life itself to the rank of an object without any unique or essential quality to distinguish it from a basically mechanical system;
    * genomic data should be brought rapidly into the public domain, since only in that way will research be able to proceed normally at international level;
    * if new data on genomic sequences could be patented before there were an opportunity to ascertain what products or clearly defined applications might result from them, a wealth of information would be 'confiscated' by a minority of dominant companies, which would consolidate their position by applying for patents;
    * Some people certainly believe that the patentability of genes might induce medicine, spurred by the pharmaceutical laboratories, to adopt an exclusively genetic approach to diseases. The important work in the field of genomics must not cause physiology to be regarded as wholly linked to genes and the appreciable effects due to the environment to be underestimated.

  25. Considering both views, I tend to favour the argument that patentability in this area is necessary. I believe that without patentability, information will be kept secret and prevent other researchers from sharing the knowledge. Without such safeguard, industry and other investors would be unwilling to invest their time and money in research and development. All this will slow down even hamper research and destroy academic freedom. I do not agree that biotechnological patentability would be in any way harmful to the developing nations. On the contrary, research in biotechnology may help save many African countries presently crippled by AIDS and other epidemics (see ANNEX 3).

  26. But none of the above should detract from the sensible position that discoveries are not patentable. My argument in the last paragraph is in relation to the processes leading to the aforementioned forms of biotechnological discovery. That would achieve the best of both worlds by providing the requisite safeguard for research, while at the same time dispensing with the arguments about 'commercialisation of the human body or other natural things'.

    Ethics (Art.6)

  27. Directive 98/44/EC avoids patentability of inventions whose industrial applications are contrary to 'ordre public or morality' (Art.6 (1)). This is not the case in US patent laws.[15] Paragraph 2 cites the examples where certain 'inventions' may be caught by this prohibition:

  28. The main weakness of Article 6 is the uncertainty about its scope, i.e. the issue of whether the list mentioned in the second paragraph is exhaustive or not. That the processes for modifying the germ-line genetic identity of human beings are excluded may be considered as regrettable. On the other hand, Article 6(d) is welcome as limiting the balancing of incommensurables (animal pain against human benefit), the approach currently favoured by the European Patent Office (EPO). The limitation of benefit to "medical" is disturbing, since this may not allow alleviation of human hunger. The International Chamber of Commerce thinks it should allow this. Few citizens of the European Union go hungry, but hunger is a major issue for the global community.[16]

    Ethical Review

  29. Following Article 7, an expert group of ethicists- the European Group on Ethics in Science and New Technologies (EGE)- has been set up to ensure that the Biotech Directive conforms, in practice, with ethical considerations relating to biotechnological innovations. This group of ethicists has only advisory power.[17] To the best of my knowledge, given the widespread non-implementation of the Directive, this body has largely remained inactive over the past few years.

    Issues relating to the 'consent requirement' under Paragraphs 26-27 of the Preamble

  30. No analysis of the Directive requirements governing patentability would be complete without touching briefly on the principles relating to 'consent'. As will be explained below, there are too many questions on this ethically important issue to which the answers are not clear.

  31. The new disclosure requirements in the Preamble cause concern. They have not been thought through and it is not clear how they will work in practice. Suppose it is not known where (or whom) the material came from? Is a potentially valuable invention to go unprotected and perhaps undeveloped in consequence? What is meant by the "place of origin" of a plant or animal sample? Is this the historic geographical origin of the species (which may be diverse, or unknown), or the place where the patentee acquired the sample (which may be irrelevant for purposes of the CBD)? The penalty of loss of rights for not meeting these requirements is severe.[18]

  32. As if these weaknesses are not enough, scholars like Beyleveld and Brownsword[19] submit that the moral of the ECJ decision in Case C-377/98 is not simply that patent law offers no succor to those donors of tissue whose consent is not properly obtained, but also that patent law offers no encouragement to those biotechnological companies who adhere to respect for fundamental values in their research and development practice. Like many other areas, this one is in need of urgent clarification too.

    Brief commentary on the other parts of the Directive that are less controversial[20]

    Scope of protection

  33. By virtue of Article 8, the protection given by biological patents for products and processes is specifically extended to include material derived by propagation or multiplication. Claims extending to material so produced have long been familiar in patents under the EPC, but the author is not aware that they have ever been tested in the courts. While, strictly, the Biotechnology Directive does not extend to patents granted under the EPC, one can hope and expect that such claims would be upheld; and certainly Article 8 will be prayed in aid by anyone seeking to sustain such a claim.

  34. Similarly, Article 9 specifically provides that protection given by a patent to a product containing or consisting of genetic information shall extend to all material in which the product is incorporated and in which the genetic information is contained and performs its function (subject to the exclusions of the human body under Art. 5 (1)). This provision, of course, does of itself effectively overrule any exclusion of patents on plant or animal varieties. Varieties which include the patented gene will infringe patent claims to the gene alone, whether or not the claims to plants or animals are upheld.

    Derogations

    Seed for sowing

  35. Not surprisingly, if unnecessarily, Article 10 excludes from protection biological material resulting from multiplication or propagation of biological material marketed for that purpose, provided the material obtained is not subsequently used for further propagation or multiplication. This protects a farmer from patent infringement proceedings if he sows seeds that he has bought from the patentee (or more probably a merchant licensed by the patentee). It is hard to imagine that there could ever be any doubt that the sale of seed carries with it the licence to sow the seed and harvest the crop and sell it as a commodity product, wheat for flour for example (but obviously not to re-use the crop as seed). This appears to be another example of the political need to make clear to the European Parliament that farmers' normal activities would not be hampered by the grant of patents on biotechnological inventions.

    'Farm saved seed and animal reproductive material' (Article 11)

  36. the extended right given to farmers to dispose of patented seed for "agricultural purposes" apparently allows farmers to multiply and sell patented seed for replanting. This makes a patent on a plant much weaker than a similar plant variety right. This will discourage plant research. Questions also arise as to what rights the buyer of the patented seed has (given that the patentee has not consented to the resale). It would be better and clearer to return to the previous arrangements, where the two rights had similar effects.[21]

    Compulsory cross-licensing of patent and plant variety rights

  37. According to Article 12 (1), a breeder who cannot acquire or exploit a plant variety right without infringing a prior patent may apply for a compulsory licence under that patent to exploit the plant variety right, subject to payment of an appropriate royalty and subject to the patent holder being entitled to a cross- licence to use the protected variety.

  38. Under Article 12 (2), where a holder of a patent for a biotechnological invention cannot exploit it without infringing a prior plant variety right, he may apply for a compulsory licence under the plant variety right, similarly subject to payment of a royalty and grant of a cross-licence under the patent.

  39. In order to succeed, applicants for these compulsory licences must show they have applied unsuccessfully to the rights holder for a contractual licence and, more importantly, that the plant variety or the invention for which the licence is required "constitutes significant technical progress of considerable economical interest" compared with the invention claimed in the patent or the protected plant variety under which licences are to be sought.

    Deposit and supply of samples of biological material

  40. Articles 13 and 14 provide for the deposit of biological material, for example under the Budapest Treaty, and the supply of samples under it. Such samples are only to be supplied under the usual terms of such deposits:

    (1) before first publication of the patent application to persons authorised under national patent law;
    (2) between first publication of the patent application and grant of the patent, if the patentee so requires, only to an independent expert (the so- called "expert solution"); and
    (3) after grant to anyone requesting it.

    Samples will only be supplied to those who undertake, while the patent is in force, not to make the sample or any materials derived from it available to third parties, nor to use it or any material derived from it save for experimental purposes, without the patentee's consent.

    Reports to the Parliament and Council

  41. By Article 16 the Commission is required:

    (1) every five years, starting in July 2000, to report on any problems encountered in the relationship between the Directive and international agreements on the protection of human rights to which the Member States have acceded;
    (2) within two years of July 30, 1998 to report on the implications for genetic engineering research of failure to publish or late publication of, papers on subjects which could be patentable; [that is on the effects and consequences of delay on publication of papers while waiting for patent applications to be filed;] and
    (3) annually from July 30, 2000 to report on the developments and implications of patent law in the field of biotechnology and genetic engineering. No doubt these reports will include comments supplied by the Commission's Ethical Group (Art. 7; see above). Indeed, they may rely heavily on that Group's reports, because one of the areas which was, and no doubt will continue to be, of concern to the Parliament was the ethical aspects of the Directive, and particularly the problem of consents from patients, questions of geographic origin, and questions of morality and ordre public.

    Final Considerations

    The Commission [22] claims that by 2005 the European biotechnology market could be worth over Euro 100 billion. By 2010, global markets, including sectors where life sciences and biotechnology constitute a major portion of new technology applied, could amount to over Euro 2,000 billion, excluding agriculture.

  42. All these signify overall how important it is to maintain harmony between the EU member states over certain key aspects of patents law. The Directive that we have discussed goes an important way towards achieving this objective. Yet, some fundamental problems relating to the substance of the legislation still remain. The precise meaning of 'animal variety' in Article 4 is not known. There are questions relating to the scope of Article 6 as well as the scope of the 'consent requirement' referred to in the articles. Agreeing with Sterckx, I believe that rejection of the Parliamentary Amendment No.76 is unfortunate in this respect. Article 11 is also problematic as it may inhibit research. Yet the biggest controversy arises from the reasoning in Arts 3 and 5 which is not only flawed but partially justifies the Dutch objections too.

  43. The way forward is for the non-implementing member states to implement the Directive as soon as possible. It is only in this way that the weaknesses of the legislation may be identified through the case law that will thereby arise. That will lead the way to the EGE or other bodies to propose amendments for the renegotiation and the gradual amendment of the Biotech Directive by mutual consensus. What the future will bring to this area remains to be seen.

ANNEX

The text of Directive 44/98/EC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article

100a thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social Committee (2),

Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),

(1) Whereas biotechnology and genetic engineering are playing an increasingly important role in

a broad range of industries and the protection of biotechnological inventions will certainly be of

fundamental importance for the Community's industrial development;

(2) Whereas, in particular in the field of genetic engineering, research and development require

a considerable amount of high-risk investment and therefore only adequate legal protection can

make them profitable;

(3) Whereas effective and harmonised protection throughout the Member States is essential in

order to maintain and encourage investment in the field of biotechnology;

(4) Whereas following the European Parliament's rejection of the joint text, approved by the

Conciliation Committee, for a European Parliament and Council Directive on the legal

protection of biotechnological inventions (4), the European Parliament and the Council have

determined that the legal protection of biotechnological inventions requires clarification;

(5) Whereas differences exist in the legal protection of biotechnological inventions offered by

the laws and practices of the different Member States; whereas such differences could create

barriers to trade and hence impede the proper functioning of the internal market;

(6) Whereas such differences could well become greater as Member States adopt new and

different legislation and administrative practices, or whereas national case-law interpreting such

legislation develops differently;

(7) Whereas uncoordinated development of national laws on the legal protection of

biotechnological inventions in the Community could lead to further disincentives to trade, to the

detriment of the industrial development of such inventions and of the smooth operation of the

internal market;

(8) Whereas legal protection of biotechnological inventions does not necessitate the creation of

a separate body of law in place of the rules of national patent law; whereas the rules of national

patent law remain the essential basis for the legal protection of biotechnological inventions

given that they must be adapted or added to in certain specific respects in order to take adequate

account of technological developments involving biological material which also fulfil the

requirements for patentability;

(9) Whereas in certain cases, such as the exclusion from patentability of plant and animal

varieties and of essentially biological processes for the production of plants and animals, certain

concepts in national laws based upon international patent and plant variety conventions have

created uncertainty regarding the protection of biotechnological and certain microbiological

inventions; whereas harmonisation is necessary to clarify the said uncertainty;

(10) Whereas regard should be had to the potential of the development of biotechnology for the

environment and in particular the utility of this technology for the development of methods of

cultivation which are less polluting and more economical in their use of ground; whereas the

patent system should be used to encourage research into, and the application of, such processes;

(11) Whereas the development of biotechnology is important to developing countries, both in

the field of health and combating major epidemics and endemic diseases and in that of

combating hunger in the world; whereas the patent system should likewise be used to encourage

research in these fields; whereas international procedures for the dissemination of such

technology in the Third World and to the benefit of the population groups concerned should be

promoted;

(12) Whereas the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs)

(5) signed by the European Community and the MemberStates, has entered into force and

provides that patent protection must be guaranteed for products and processes in all areas of

technology;

(13) Whereas the Community's legal framework for the protection of biotechnological

inventions can be limited to laying down certain principles as they apply to the patentability of

biological material as such, such principles being intended in particular to determine the

difference between inventions and discoveries with regard to the patentability of certain

elements of human origin, to the scope of protection conferred by a patent on a biotechnological

invention, to the right to use a deposit mechanism in addition to written descriptions and lastly

to the option of obtaining non-exclusive compulsory licences in respect of interdependence

between plant varieties and inventions, and conversely;

(14) Whereas a patent for invention does not authorise the holder to implement that invention,

but merely entitles him to prohibit third parties from exploiting it for industrial and commercial

purposes; whereas, consequently, substantive patent law cannot serve to replace or render

superfluous national, European or international law which may impose restrictions or

prohibitions or which concerns the monitoring of research and of the use or commercialisation

of its results, notably from the point of view of the requirements of public health, safety,

environmental protection, animal welfare, the preservation of genetic diversity and compliance

with certain ethical standards;

(15) Whereas no prohibition or exclusion exists in national or European patent law (Munich

Convention) which precludes a priori the patentability of biological matter;

(16) Whereas patent law must be applied so as to respect the fundamental principles

safeguarding the dignity and integrity of the person; whereas it is important to assert the

principle that the human body, at any stage in its formation or development, including germ

cells, and the simple discovery of one of its elements or one of its products, including the

sequence or partial sequence of a human gene, cannot be patented; whereas these principles are

in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot

be patented;

(17) Whereas significant progress in the treatment of diseases has already been made thanks to

the existence of medicinal products derived from elements isolated from the human body and/or

otherwise produced, such medicinal products resulting from technical processes aimed at

obtaining elements similar in structure to those existing naturally in the human body and

whereas, consequently, research aimed at obtaining and isolating such elements valuable to

medicinal production should be encouraged by means of the patent system;

(18) Whereas, since the patent system provides insufficient incentive for encouraging research

into and production of biotechnological medicines which are needed to combat rare or 'orphan`

diseases, the Community and the MemberStates have a duty to respond adequately to this

problem;

(19) Whereas account has been taken of Opinion No 8 of the Group of Advisers on the Ethical

Implications of Biotechnology to the European Commission;

(20) Whereas, therefore, it should be made clear that an invention based on an element isolated

from the human body or otherwise produced by means of a technical process, which is

susceptible of industrial application, is not excluded from patentability, even where the structure

of that element is identical to that of a natural element, given that the rights conferred by the

patent do not extend to the human body and its elements in their natural environment;

(21) Whereas such an element isolated from the human body or otherwise produced is not

excluded from patentability since it is, for example, the result of technical processes used to

identify, purify and classify it and to reproduce it outside the human body, techniques which

human beings alone are capable of putting into practice and which nature is incapable of

accomplishing by itself;

(22) Whereas the discussion on the patentability of sequences or partial sequences of genes is

controversial; whereas, according to this Directive, the granting of a patent for inventions which

concern such sequences or partial sequences should be subject to the same criteria of

patentability as in all other areas of technology: novelty, inventive step and industrial

application; whereas the industrial application of a sequence or partial sequence must be

disclosed in the patent application as filed;

(23) Whereas a mere DNA sequence without indication of a function does not contain any

technical information and is therefore not a patentable invention;

(24) Whereas, in order to comply with the industrial application criterion it is necessary in cases

where a sequence or partial sequence of a gene is used to produce a protein or part of a protein,

to specify which protein or part of a protein is produced or what function it performs;

(25) Whereas, for the purposes of interpreting rights conferred by a patent, when sequences

overlap only in parts which are not essential to the invention, each sequence will be considered

as an independent sequence in patent law terms;

(26) Whereas if an invention is based on biological material of human origin or if it uses such

material, where a patent application is filed, the person from whose body the material is taken

must have had an opportunity of expressing free and informed consent thereto, in accordance

with national law;

(27) Whereas if an invention is based on biological material of plant or animal origin or if it uses

such material, the patent application should, where appropriate, include information on the

geographical origin of such material, if known; whereas this is without prejudice to the

processing of patent applications or the validity of rights arising from granted patents;

(28) Whereas this Directive does not in any way affect the basis of current patent law, according

to which a patent may be granted for any new application of a patented product;

(29) Whereas this Directive is without prejudice to the exclusion of plant and animal varieties

from patentability; whereas on the other hand inventions which concern plants or animals are

patentable provided that the application of the invention is not technically confined to a single

plant or animal variety;

(30) Whereas the concept 'plant variety` is defined by the legislation protecting new varieties,

pursuant to which a variety is defined by its whole genome and therefore possesses individuality

and is clearly distinguishable from other varieties;

(31) Whereas a plant grouping which is characterised by a particular gene (and not its whole

genome) is not covered by the protection of new varieties and is therefore not excluded from

patentability even if it comprises new varieties of plants;

(32) Whereas, however, if an invention consists only in genetically modifying a particular plant

variety, and if a new plant variety is bred, it will still be excluded from patentability even if the

genetic modification is the result not of an essentially biological process but of a

biotechnological process;

(33) Whereas it is necessary to define for the purposes of this Directive when a process for the

breeding of plants and animals is essentially biological;

(34) Whereas this Directive shall be without prejudice to concepts of invention and discovery,

as developed by national, European or international patent law;

(35) Whereas this Directive shall be without prejudice to the provisions of national patent law

whereby processes for treatment of the human or animal body by surgery or therapy and

diagnostic methods practised on the human or animal body are excluded from patentability;

(36) Whereas the TRIPs Agreement provides for the possibility that members of the World

Trade Organisation may exclude from patentability inventions, the prevention within their

territory of the commercial exploitation of which is necessary to protect ordre public or

morality, including to protect human, animal or plant life or health or to avoid serious prejudice

to the environment, provided that such exclusion is not made merely because the exploitation is

prohibited by their law;

(37) Whereas the principle whereby inventions must be excluded from patentability where their

commercial exploitation offends against ordre public or morality must also be stressed in this

Directive;

(38) Whereas the operative part of this Directive should also include an illustrative list of

inventions excluded from patentability so as to provide national courts and patent offices with a

general guide to interpreting the reference to ordre public and morality; whereas this list

obviously cannot presume to be exhaustive; whereas processes, the use of which offend against

human dignity, such as processes to produce chimeras from germ cells or totipotent cells of

humans and animals, are obviously also excluded from patentability;

(39) Whereas ordre public and morality correspond in particular to ethical or moral principles

recognised in a MemberState, respect for which is particularly important in the field of

biotechnology in view of the potential scope of inventions in this field and their inherent

relationship to living matter; whereas such ethical or moral principles supplement the standard

legal examinations under patent law regardless of the technical field of the invention;

(40) Whereas there is a consensus within the Community that interventions in the human germ

line and the cloning of human beings offends against ordre public and morality; whereas it is

therefore important to exclude unequivocally from patentability processes for modifying the

germ line genetic identity of human beings and processes for cloning human beings;

(41) Whereas a process for cloning human beings may be defined as any process, including

techniques of embryo splitting, designed to create a human being with the same nuclear genetic

information as another living or deceased human being;

(42) Whereas, moreover, uses of human embryos for industrial or commercial purposes must

also be excluded from patentability; whereas in any case such exclusion does not affect

inventions for therapeutic or diagnostic purposes which are applied to the human embryo and

are useful to it;

(43) Whereas pursuant to Article F(2) of the Treaty on European Union, the Union is to respect

fundamental rights, as guaranteed by the European Convention for the Protection of Human

Rights and Fundamental Freedoms signed in Rome on 4 November 1950 and as they result from

the constitutional traditions common to the Member States, as general principles of Community

law;

(44) Whereas the Commission's European Group on Ethics in Science and New Technologies

evaluates all ethical aspects of biotechnology; whereas it should be pointed out in this

connection that that Group may be consulted only where biotechnology is to be evaluated at the

level of basic ethical principles, including where it is consulted on patent law;

(45) Whereas processes for modifying the genetic identity of animals which are likely to cause

them suffering without any substantial medical benefit in terms of research, prevention,

diagnosis or therapy to man or animal, and also animals resulting from such processes, must be

excluded from patentability;

(46) Whereas, in view of the fact that the function of a patent is to reward the inventor for his

creative efforts by granting an exclusive but time-bound right, and thereby encourage inventive

activities, the holder of the patent should be entitled to prohibit the use of patented selfreproducing

material in situations analogous to those where it would be permitted to prohibit the

use of patented, non-self-reproducing products, that is to say the production of the patented

product itself;

(47) Whereas it is necessary to provide for a first derogation from the rights of the holder of the

patent when the propagating material incorporating the protected invention is sold to a farmer

for farming purposes by the holder of the patent or with his consent; whereas that initial

derogation must authorise the farmer to use the product of his harvest for further multiplication

or propagation on his own farm; whereas the extent and the conditions of that derogation must

be limited in accordance with the extent and conditions set out in Council Regulation (EC) No

2100/94 of 27 July 1994 on Community plant variety rights (6);

(48) Whereas only the fee envisaged under Community law relating to plant variety rights as a

condition for applying the derogation from Community plant variety rights can be required of

the farmer;

(49) Whereas, however, the holder of the patent may defend his rights against a farmer abusing

the derogation or against a breeder who has developed a plant variety incorporating the

protected invention if the latter fails to adhere to his commitments;

(50) Whereas a second derogation from the rights of the holder of the patent must authorise the

farmer to use protected livestock for agricultural purposes;

(51) Whereas the extent and the conditions of that second derogation must be determined by

national laws, regulations and practices, since there is no Community legislation on animal

variety rights;

(52) Whereas, in the field of exploitation of new plant characteristics resulting from genetic

engineering, guaranteed access must, on payment of a fee, be granted in the form of a

compulsory licence where, in relation to the genus or species concerned, the plant variety

represents significant technical progress of considerable economic interest compared to the

invention claimed in the patent;

(53) Whereas, in the field of the use of new plant characteristics resulting from new plant

varieties in genetic engineering, guaranteed access must, on payment of a fee, be granted in the

form of a compulsory licence where the invention represents significant technical progress of

considerable economic interest;

(54) Whereas Article 34 of the TRIPs Agreement contains detailed provisions on the burden of

proof which is binding on all Member States; whereas, therefore, a provision in this Directive is

not necessary;

(55) Whereas following Decision 93/626/EEC (7) the Community is party to the Convention on

Biological Diversity of 5 June 1992; whereas, in this regard, Member States must give particular

weight to Article 3 and Article 8(j), the second sentence of Article 16(2) and Article 16(5) of the

Convention when bringing into force the laws, regulations and administrative provisions

necessary to comply with this Directive;

(56) Whereas the Third Conference of the Parties to the Biodiversity Convention, which took

place in November 1996, noted in Decision III/17 that 'further work is required to help develop

a common appreciation of the relationship between intellectual property rights and the relevant

provisions of the TRIPs Agreement and the Convention on Biological Diversity, in particular on

issues relating to technology transfer and conservation and sustainable use of biological

diversity and the fair and equitable sharing of benefits arising out of the use of genetic

resources, including the protection of knowledge, innovations and practices of indigenous and

local communities embodying traditional lifestyles relevant for the conservation and sustainable

use of biological diversity`,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I Patentability

Article 1

1. Member States shall protect biotechnological inventions under national patent law. They

shall, if necessary, adjust their national patent law to take account of the provisions of this

Directive.

2. This Directive shall be without prejudice to the obligations of the Member States pursuant to

international agreements, and in particular the TRIPs Agreement and the Convention on

Biological Diversity.

Article 2

1. For the purposes of this Directive,

(a) 'biological material` means any material containing genetic information and capable of

reproducing itself or being reproduced in a biological system;

(b) 'microbiological process` means any process involving or performed upon or resulting in

microbiological material.

2. A process for the production of plants or animals is essentially biological if it consists entirely

of natural phenomena such as crossing or selection.

3. The concept of 'plant variety` is defined by Article 5 of Regulation (EC) No 2100/94.

Article 3

1. For the purposes of this Directive, inventions which are new, which involve an inventive step

and which are susceptible of industrial application shall be patentable even if they concern a

product consisting of or containing biological material or a process by means of which

biological material is produced, processed or used.

2. Biological material which is isolated from its natural environment or produced by means of a

technical process may be the subject of an invention even if it previously occurred in nature.

Article 4

1. The following shall not be patentable:

(a) plant and animal varieties;

(b) essentially biological processes for the production of plants or animals.

2. Inventions which concern plants or animals shall be patentable if the technical feasibility of

the invention is not confined to a particular plant or animal variety.

3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a

microbiological or other technical process or a product obtained by means of such a process.

Article 5

1. The human body, at the various stages of its formation and development, and the simple

discovery of one of its elements, including the sequence or partial sequence of a gene, cannot

constitute patentable inventions.

2. An element isolated from the human body or otherwise produced by means of a technical

process, including the sequence or partial sequence of a gene, may constitute a patentable

invention, even if the structure of that element is identical to that of a natural element.

3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in

the patent application.

Article 6

1. Inventions shall be considered unpatentable where their commercial exploitation would be

contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary

merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them

suffering without any substantial medical benefit to man or animal, and also animals resulting

from such processes.

Article 7

The Commission's European Group on Ethics in Science and New Technologies evaluates all

ethical aspects of biotechnology.

CHAPTER II Scope of protection

Article 8

1. The protection conferred by a patent on a biological material possessing specific

characteristics as a result of the invention shall extend to any biological material derived from

that biological material through propagation or multiplication in an identical or divergent form

and possessing those same characteristics.

2. The protection conferred by a patent on a process that enables a biological material to be

produced possessing specific characteristics as a result of the invention shall extend to

biological material directly obtained through that process and to any other biological material

derived from the directly obtained biological material through propagation or multiplication in

an identical or divergent form and possessing those same characteristics.

Article 9

The protection conferred by a patent on a product containing or consisting of genetic

information shall extend to all material, save as provided in Article 5(1), in which the product in

incorporated and in which the genetic information is contained and performs its function.

Article 10

The protection referred to in Articles 8 and 9 shall not extend to biological material obtained

from the propagation or multiplication of biological material placed on the market in the

territory of a MemberState by the holder of the patent or with his consent, where the

multiplication or propagation necessarily results from the application for which the biological

material was marketed, provided that the material obtained is not subsequently used for other

propagation or multiplication.

Article 11

1. By way of derogation from Articles 8 and 9, the sale or other form of commercialisation of

plant propagating material to a farmer by the holder of the patent or with his consent for

agricultural use implies authorisation for the farmer to use the product of his harvest for

propagation or multiplication by him on his own farm, the extent and conditions of this

derogation corresponding to those under Article 14 of Regulation (EC) No 2100/94.

2. By way of derogation from Articles 8 and 9, the sale or any other form of commercialisation

of breeding stock or other animal reproductive material to a farmer by the holder of the patent or

with his consent implies authorisation for the farmer to use the protected livestock for an

agricultural purpose. This includes making the animal or other animal reproductive material

available for the purposes of pursuing his agricultural activity but not sale within the framework

or for the purpose of a commercial reproduction activity.

3. The extent and the conditions of the derogation provided for in paragraph 2 shall be

determined by national laws, regulations and practices.

CHAPTER III Compulsory cross-licensing

Article 12

1. Where a breeder cannot acquire or exploit a plant variety right without infringing a prior

patent, he may apply for a compulsory licence for non-exclusive use of the invention protected

by the patent inasmuch as the licence is necessary for the exploitation of the plant variety to be

protected, subject to payment of an appropriate royalty. Member States shall provide that, where

such a licence is granted, the holder of the patent will be entitled to a cross-licence on

reasonable terms to use the protected variety.

2. Where the holder of a patent concerning a biotechnological invention cannot exploit it

without infringing a prior plant variety right, he may apply for a compulsory licence for nonexclusiveuse of the plant variety protected by that right, subject to payment of an appropriate

royalty. Member States shall provide that, where such a licence is granted, the holder of the

variety right will be entitled to a cross-licence on reasonable terms to use the protectedinvention.

3. Applicants for the licences referred to in paragraphs 1 and 2 must demonstrate that:

(a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to

obtain a contractual licence;

(b) the plant variety or the invention constitutes significant technical progress of considerable

economic interest compared with the invention claimed in the patent or the protected plant

variety.

4. Each Member State shall designate the authority or authorities responsible for granting the

licence. Where a licence for a plant variety can be granted only by the Community Plant Variety

Office, Article 29 of Regulation (EC) No 2100/94 shall apply.

CHAPTER IV Deposit, access and re-deposit of a biological material

Article 13

1. Where an invention involves the use of or concerns biological material which is not available

to the public and which cannot be described in a patent application in such a manner as to enable

the invention to be reproduced by a person skilled in the art, the description shall be considered

inadequate for the purposes of patent law unless:

(a) the biological material has been deposited no later than the date on which the patent

application was filed with a recognised depositary institution. At least the international

depositary authorities which acquired this status by virtue of Article 7 of the Budapest Treaty of

28 April 1977 on the international recognition of the deposit of micro-organisms for the

purposes of patent procedure, hereinafter referred to as the 'Budapest Treaty`, shall be

recognised;

(b) the application as filed contains such relevant information as is available to the applicant on

the characteristics of the biological material deposited;

(c) the patent application states the name of the depository institution and the accession number.

2. Access to the deposited biological material shall be provided through the supply of a sample:

(a) up to the first publication of the patent application, only to those persons who are authorised

under national patent law;

(b) between the first publication of the application and the granting of the patent, to anyone

requesting it or, if the applicant so requests, only to an independent expert;

(c) after the patent has been granted, and notwithstanding revocation or cancellation of the

patent, to anyone requesting it.

3. The sample shall be supplied only if the person requesting it undertakes, for the term during

which the patent is in force:

(a) not to make it or any material derived from it available to third parties; and

(b) not to use it or any material derived from it except for experimental purposes, unless the

applicant for or proprietor of the patent, as applicable, expressly waives such an undertaking.

4. At the applicant's request, where an application is refused or withdrawn, access to the

deposited material shall be limited to an independent expert for 20 years from the date on which

the patent application was filed. In that case, paragraph 3 shall apply.

5. The applicant's requests referred to in point (b) of paragraph 2 and in paragraph 4 may only

be made up to the date on which the technical preparations for publishing the patent application

are deemed to have been completed.

Article 14

1. If the biological material deposited in accordance with Article 13 ceases to be available from

the recognised depositary institution, a new deposit of the material shall be permitted on the

same terms as those laid down in the Budapest Treaty.

2. Any new deposit shall be accompanied by a statement signed by the depositor certifying that

the newly deposited biological material is the same as that originally deposited.

CHAPTER V Final provisions

Article 15

1. Member States shall bring into force the laws, regulations and administrative provisions

necessary to comply with this Directive not later than 30 July 2000. They shall forthwith inform

the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or

shall be accompanied by such reference on the occasion of their official publication. The

methods of making such reference shall be laid down by Member States.

2. Member States shall communicate to the Commission the text of the provisions of national

law which they adopt in the field covered by this Directive.

Article 16

The Commission shall send the European Parliament and the Council:

(a) every five years as from the date specified in Article 15(1) a report on any problems

encountered with regard to the relationship between this Directive and international agreements

on the protection of human rights to which the Member States have acceded;

(b) within two years of entry into force of this Directive, a report assessing the implications for

basic genetic engineering research of failure to publish, or late publication of, papers on subjects

which could be patentable;

(c) annually as from the date specified in Article 15(1), a report on the development and

implications of patent law in the field of biotechnology and genetic engineering.

Article 17

This Directive shall enter into force on the day of its publication in the Official Journal of the

European Communities.

Article 18

This Directive is addressed to the Member States.

Done at Brussels, 6 July 1998.

For the European Parliament

The President

J. M. GIL-ROBLES

For the Council

The President

R. EDLINGER

(1) OJ C 296, 8.10.1996, p. 4 and OJ C 311, 11.10.1997, p. 12.

(2) OJ C 295, 7.10.1996, p. 11.

(3) Opinion of the European Parliament of 16 July 1997 (OJ C 286, 22.9.1997, p. 87). Council

Common Position of 26 February 1998 (OJ C 110, 8.4.1998, p. 17) and Decision of the

European Parliament of 12 May 1998 (OJ C 167, 1.6.1998). Council Decision of 16 June 1998.

(4) OJ C 68, 20.3.1995, p. 26.

(5) OJ L 336, 23.12.1994, p. 213.

(6) OJ L 227, 1.9.1994, p. 1. Regulation as amended by Regulation (EC) No 2506/95 (OJ L 258,

28.10.1995, p. 3).

(7) OJ L 309, 31.12.1993, p. 1.

Member States implementing the Directive

  • Member State
    a) Implementation: State of play as per 12/09/03 b) Implementation Date

  • Denmark
    a) -
    b) May 2000

  • Spain
    a) -
    b) 30 April 2002

  • Finland
    a) -
    b) 30 June 2000

  • Greece
    a) Decree on 15-10-2001
    b) 22 October 2001: Communication to the Commission

  • Ireland
    a) -
    b) 30 July 2000 : Regulations; Notification to the Commission done

  • Portugal
    a) Draft law has been adopted by Parliament. The Minister Council has definitively adopted the law. It will enter into force 6 months after this adoption b) 1 July 2003

  • United Kingdom
    a) -
    b) 28 July 2000: Implementation on time for articles 1-11

  • 6 July 2001: Implementation of Articles 13 and 14 1 March 2002: implementation of Article 12

    Danish Cystic Fibrosis Association Statement ot the European Parliament

  • Patents are important to patients!

    - 6 points in patients' support of Biotech Patenting.

    * For many people suffering from severe disorders and diseases like heart and lung diseases, HIV and AIDS, cancer and sclerosis etc. the biotechnology contains so much hope and so many possibilities for research and development into causal treatment either via gene therapy or traditional pharmacological approaches.
    * Patent protection on pharmaceutical products is not a new development, but very familiar to e.g. patients with cystic fibrosis and HIV/AIDS. The only treatment until now available to these patients have been antibiotics - all of which are patented. Actually no novel drug have been promoted in Europe without being protected.
    * It must be remembered that in respect of patenting human genes the Directive does not change patent law as it has been applied for decades. The Directive does not generate a new situation. The Directive will simply harmonize national patent law and will point out guidelines for what is patentable and what is not in the field of biotechnological inventions.
    * Patents safeguard the free flow of information among scientists. Without a patent an inventor can not be protected against others commercializing his inventions. Without patentability information will be kept secret and prevent other researchers from sharing the knowledge. It will slow down even hamper research and destroy academic freedom.
    * We see patents on biotechnological inventions as PATENTS FOR LIFE and not as patents on life. We do NOT perceive a synthetic copy of a gene sequence as LIFE, but as knowledge obtained by the help of human efforts - by human intelligence - which nature is not capable of generating. We do all consist of DNA - a substance of 4 letters A T C and G - but for us life is more than 4 letters.
    * What is paramount for us is that patents on gene-technological inventions for the development of innovative medicines, cell lines, proteins, antibodies, hormones and other products for the treatment of disorders can be granted. Recent years' milestones within this area have raised hopes among many of us that we may obtain new treatments and hope for better chances of survival and quality of life.

    11 May 1998
    Danish Cystic Fibrosis Association

    Notes

    [1] Letter from Y.C. van Drimmelen, Public Relations Officer, Dutch IP office to L. Iding, student to E.R. Gold (29 June 2000).

    [2] (Case C-377/98).

    [3] See P. Lemaitre and J-Y Nau, '' La directive europeenne sur le genome humain est incompatible avec le droit francais, selon Mme Guigou'', Le Monde (9 June).

    [4] http://www.nature.com/cgi-taf/DynaPage.taf?file=/nbt/journal/v21/n9/full/nbt0903-960.html

    [5] Gold and Gallochat, 'The European Directive on the Legal Protection of Biotechnological Inventions: History, Implementation and Lessons For Canada', at p.2

    [6] see http://www.patent.gov.uk

    [7] Dr. Jobst Wibbelmann, 'Protection of Biotechnological Inventions in Europe', at p.3

    [8] Sigrid Sterckx, 'Some Ethically Problematic Aspects of the Proposal for a Directive on the Legal Protection of Biotechnological Inventions', [1998] E.I.P.R. 123, at p.124.

    [9] http://europa.eu.int/rapid/start/cgi/guestan.ksh?p_action.gettxt=gt&doc=MEMO/00/39%7

    [10] Sterckx, 'Biotechnology, Patents and Morality', Ashgate Publ. (2000), at p.42

    [11] http://wuesthoff.de/protecti.htm, at p.3

    [12] See the Opinion No. 64 on a preliminary draft law incorporating transposition into the Code of intellectual property, of a European Parliament and Council Directive 98/44/EC on the legal protection of biotechnological inventions, given to the French Secretary of State for Industry by a group of experts (CCNE) upon his request on June 8, 2000.

    [13] Sterckx, 'Biotechnology, Patents and Morality', Ashgate Publ. (2000), at p.62

    [14] http://europa.eu.int/comm/research/biosociety/pdf/pe_genetics.pdf

    [15] As an example of the more liberal American approach, the granting of a US patent 6,211,429 to the University of Missouri for a method of creating human and other mammal clones can be cited. (Taken from: http://www.osborneclarke.com/publications/text/cloning.htm ).

    [16] http://www.iccwbo.org/home/statements_rules/statements/1997/biotechnology.asp

    [17] Gold and Gallochat, 'The European Directive on the Legal Protection of Biotechnological Inventions: History, Implementation and Lessons For Canada', at p.4

    [18] See: Tim Roberts, "Biotechnology: Revised Draft Directive on Legal Protection of Biological Inventions." European Intellectual Property Review 19 (10): D 269-270.

    [19] ''Is Patent Law Part of the EC Legal Order? A Critical Commentary on the Interpretation of Art. 6 (1) of Directive 98/44/EC in Case C-377/98?'', [2002] IPQ No1, pp 97-110, at p.110

    [20] The following two articles have been relied on while wrting this section:
    Robin Nott, 'You Did It!': The European Biotechnology Directive At Last.", European Intellectual Property Review 20 (9): 347(351.
    Tim Roberts, "Biotechnology: Revised Draft Directive on Legal Protection of Biological Inventions." European Intellectual Property Review 19 (10): D 269-270.

    [21] ibid.

    [22] http://www.europa.eu.int/

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