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Alphapharm Pty Ltd, Apotex Pty Ltd, Aspen Pharma Pty Ltd, Sandoz Pty Ltd v H Lundbeck A/S [2014] APO 41 (25 June 2014)

Last Updated: 25 June 2014

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Alphapharm Pty Ltd v H Lundbeck A/S

Apotex Pty Ltd v H Lundbeck A/S

Aspen Pharma Pty Ltd v H Lundbeck A/S

Sandoz Pty Ltd v H Lundbeck A/S

[2014] APO 41

Patent: 623144

Title: (+)-Enantiomer of citalopram and process for the preparation thereof

Patentee: H Lundbeck A/S

Opponents: (1) Alphapharm Pty Ltd
(2) Apotex Pty Ltd
(3) Aspen Pharma Pty Ltd
(4) Sandoz Pty Ltd

Delegate: Dr S.D. Barker

Decision Date: 25 June 2014

Hearing Date: 7 May 2014, in Canberra

Catchwords: PATENTS – oppositions to an extension of term of a pharmaceutical patent – previous extension of term removed from the Register – application for extension based on the goods CIPRAMIL – oppositions fail – extension of term granted

Representation: Patentee: Katrina Howard SC and Richard Niall SC, and Matthew Swinn of Corrs Chambers Westgarth

Opponents: David Catterns QC, Christian Dimitriadis of counsel, and Kim O’Connell and James Ellsmore of King & Wood Mallesons

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent: 623144

Title: (+)-Enantiomer of citalopram and process for the preparation thereof

Patentee: H Lundbeck A/S

Date of Decision: 25 June 2014

DECISION

The oppositions fail on all grounds.

I grant an extension of the term of patent 623144. According to section 77, the term of the patent is extended to 9 December 2012. I direct that notice of the grant be published in the Official Journal.

I direct that the Register is not updated to reflect the extended term until 28 days from the date of this decision or, in the event that the Commissioner is served in that period with a copy of a notice of appeal and an application for a stay, until the stay application is determined by the court.

I award costs according to Schedule 8 against each of the opponents: Alphapharm Pty Ltd, Apotex Pty Ltd, Aspen Pharma Pty Ltd and Sandoz Pty Ltd.

REASONS FOR DECISION

1. Patent application number 623144 (the patent) was filed on 13 June 1989, and granted on 31 August 1992. The patentee is H Lundbeck A/S (Lundbeck). Lundbeck has sought an extension of the term of the patent. Oppositions to the extension of term were filed by four different opponents: Alphapharm Pty Ltd (Alphapharm), Apotex Pty Ltd (Apotex), Aspen Pharma Pty Ltd (Aspen) and Sandoz Pty Ltd (Sandoz) (together, the Opponents). The four oppositions are identical, and were run as a single action on behalf of the Opponents jointly. A hearing was held on 7 May 2014 in Canberra to decide the oppositions. Lundbeck was represented by Katrina Howard SC and Richard Niall SC, and Matthew Swinn of Corrs Chambers Westgarth. The Opponents were represented by David Catterns QC, Christian Dimitriadis of counsel and Kim O’Connell and James Ellsmore of King & Wood Mallesons.

The history of the present matter

2. Citalopram is a compound belonging to the therapeutic category of selective serotonin re-uptake inhibitors. Citalopram is a racemate, meaning that the molecule exists as two mirror-image forms in equal amounts.

3. The racemate of citalopram is covered by patent 509445 which ceased on 5 January 1993. The racemate is marketed as CIPRAMIL, which was registered on the ARTG on 9 December 1997.

4. The (+)-enantiomer of citalopram, also known as escitalopram, is the active enantiomer. Escitalopram is covered by patent 623144, which was filed on 13 June 1989. The normal 20 year term of the patent expired on 13 June 2009.

5. Escitalopram is marketed under the brand name LEXAPRO. LEXAPRO received ARTG registration on 16 September 2003.

6. An extension of the term of the patent based on the registration of LEXAPRO was granted on 27 May 2004.

7. Alphapharm requested rectification of the Register on the basis that the extension of term was wrongly calculated. The Commissioner found that the extension of term should have been based on CIPRAMIL rather than LEXAPRO and recalculated the extension accordingly (Alphapharm Pty Ltd v H Lundbeck A/S [2006] APO 18, 69 IPR 629).

8. On appeal, Lindgren J held that the extension of term should be removed from the Register (Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559, 76 IPR 618; the Lundbeck case). The Full Court upheld this decision (H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228; the Lundbeck appeal). The High Court refused special leave to appeal (Alphapharm Pty Ltd v H Lundbeck A/S [2009] HCATrans 324).

9. On 12 June 2009 (the day after the decision of the Full Court of the Federal Court) Lundbeck filed a new application for an extension of term based on the CIPRAMIL registration, and an application under section 223 for an extension of time to make the application for an extension of term.

10. The extension of time was opposed by Alphapharm, Apotex, Sandoz and Sigma Pharmaceuticals (Australia) Pty Limited. The extension of time was granted by the Commissioner on 1 June 2011 (Alphapharm Pty Limited v H Lundbeck A/S [2011] APO 36, 92 IPR 628). On appeal, the Administrative Appeals Tribunal (AAT) upheld the decision of the Commissioner (Aspen Pharma Pty Ltd and Commissioner of Patents [2012] AATA 851). The decision of the AAT was upheld by the Full Court of the Federal Court (Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCAFC 129). The High Court has granted special leave to appeal that decision (Alphapharm Pty Ltd v H Lundbeck A/S [ 2014] HCATrans 79  (11 April 2014).

11. Currently, the extension of time to make the application for extension of term has been granted, and that decision has not been overturned. The Federal Court refused to grant a stay of that decision (Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCA 324).

12. The application for an extension of term based on CIPRAMIL is currently before the Commissioner. Four oppositions have been filed, and the present decision deals with those matters.

The specification

13. The present patent relates to the (+)-enantiomer of citalopram, commonly known as escitalopram. Claim 1 of the patent reads:

(+)-1-(3-dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof.

14. It is not in dispute that escitalopram is an alternative name for the compound named in full in claim 1. The specification provides a list of “exemplary” acids that form addition salts in the passage bridging page 1a and page 2. The list includes oxalic acid, hydrochloric acid and hydrobromic acid.

The law

15. Extensions of term of patents are dealt with in Part 3 of Chapter 6 of the Patents Act (the Act). Extensions under these provisions are limited to standard patents relating to pharmaceutical substances. Pharmaceutical substance is defined in Schedule 1 of the Act:

pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

a chemical interaction, or physico-chemical interaction, with a human physiological system; or action on an infectious agent, or on a toxin or other poison, in a human body; but does not include a substance that is solely for use in in vitro diagnosis or in in vitro testing

16. Importantly, a pharmaceutical substance can be either a single substance or a mixture of substances. The relationship between the pharmaceutical substance and the patent is specified in section 70(2)(a):

Either or both of the following conditions must be satisfied:

one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification; ...

17. Thus, the pharmaceutical substance must be both described and claimed in the specification.

18. The meaning of “in substance be disclosed” was considered by Bennett J in Pfizer Inc v Commissioner of Patents [2005] FCA 137; 64 IPR 547. For present purposes, it is not necessary to consider that decision. There is no doubt that (+)-citalopram is in substance disclosed in the specification and is the subject of the claim.

19. The relationship between the pharmaceutical substance and the ARTG is specified in section 70(3):

Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:

goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;

the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.

20. It is also a requirement in section 70(4) that there has not been a previous extension of the term:

The term of the patent must not have been previously extended under this Part.

21. The manner in which an application for an extension of term is made is found in section 71(1):

An application for an extension of the term of a standard patent must:

(a) be in the approved form; and
(b) be accompanied by such documents (if any) as are ascertained in accordance with the regulations; and
(c) be accompanied by such information (if any) as is ascertained in accordance with the regulations.

22. Finally, the time for making an application for extension of term is found in section 71(2). Relevantly for the present case, pursuant to paragraph (b) of that subsection the period is 6 months from

the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substance referred to in subsection 70(3)

23. The relevant regulations on the information to accompany the application are found in regulation 6.8:

(2) For paragraph 71(1)(c) of the Act, the application must be accompanied by information showing that goods containing, or consisting of, the substance are currently included in the Australian Register of Therapeutic Goods.

(3) The application must also be accompanied by information identifying the substance, as it occurs in those goods, in the same way (as far as possible) as the substance is identified in the complete specification of the patent.

The oppositions

24. The grounds of opposition relied on by each opponent are identical, and the particulars are identical. Each opposition alleges that there is a failure to comply with the requirements of

• section 70(2)(a),
• section 70(3)(a),
• section 70(4), and
• section 71(1).

25. The Opponents filed declarations by Richard Charles Oppenheim and James Edward Ellsmore. Lundbeck did not file evidence in answer.

26. Lundbeck has made the submission that the opposition under s 70(2)(a) and 70(3)(a) is relitigating an issue already decided and that the roles have simply reversed and that Lundbeck lost in court by running the opponent’s current argument. Lundbeck are merely pursuing the extension they are entitled to. They also stated that two of the parties, Aspen (formerly Arrow) and Alphapharm, are approbating and reprobating here having taken one side of the argument to suit them previously and now they are running the other. They further submit that Alphapharm and Aspen are estopped from contesting this ground.

27. Issue estoppel was described by Dixon J in Blair v Curran [1939] HCA 23; (1939) 62 CLR 464 at 532:

"A judicial determination directly involving an issue of fact or of law disposes once for all of the issue, so that it cannot afterwards be raised between the same parties or their privies."

28. It is unclear whether an estoppel can apply to proceedings before the Commissioner. However, even if it can, there cannot be an estoppel between Lundbeck and all of the parties. Consequently, it is necessary for me to consider the substance of the oppositions as a whole. However, the fact that the Federal Court has already considered these issues in a slightly different context in the Lundbeck case and the Lundbeck appeal means that I should pay particular attention to what has already been decided.

What was previously decided?

29. The Full Court of the Federal Court in the Lundbeck appeal found that the patent was not entitled to an extension of term based on the goods LEXAPRO, because the extension should have been based on CIPRAMIL. Bennett J stated at [224]:

"The primary judge upheld the decision of the delegate of the Commissioner of Patents to the effect that Lundbeck was not entitled to an extension of the term of the Patent as from the date of the registration of Lexapro on the ARTG but only to an extension by reference to the registration of Cipramil."

30. Her Honour came to the same conclusion, stating at [247]:

"the term of any extension of the Patent is limited by the date of registration of Cipramil"

31. Emmett J did not need to decide the point, but noted at [111]:

"If I did, I would be disposed to accept his Honour's conclusions as correct."

32. It seems clear that the Court considered that the patent was entitled to an extension of term based on CIPRAMIL. It would then follow that the present application for an extension of term based on CIPRAMIL is valid, and the oppositions must fail. However, I do not believe that I can simply dispose of the oppositions in this way. I am required to consider each of the grounds of opposition, and form my own view as to whether any of the grounds succeed. In doing this I will have careful regard to the comments in the Lundbeck case and the Lundbeck appeal.

33. In relation to the issue of whether the Opponents behaviour was approbatory and then reprobatory, I asked the representative of Lundbeck what course of action I should follow if I were to agree with that characterisation. Counsel stated that they were happy not to have the Commissioner decide on this specific issue and instead to decide the opposition on its merits. That is the course of action I will adopt.

Section 70(2)(a): Is claim 1 directed to a pharmaceutical substance per se?

34. The Opponents argued that claim 1 is not a claim to a pharmaceutical substance per se. This argument needs some explanation.

35. Section 70(2) requires that a pharmaceutical substance per se must in substance fall within the scope of the claim or claims of the specification. The Full Court in Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647, 52 IPR 529 (the Boehringer case) said (at [37]) that the expression "fall within the scope of the claim or claims of that specification" means that it must be "included amongst the things claimed" (at [42]). Consequently, to obtain an extension a pharmaceutical substance per se must be the subject of one or more claims.

36. The "per se" requirement has been considered several times by the Federal Court, and it has been held that the claim must be to a substance alone. In the Boehringer case the Federal Court considered a patent that claimed an active agent in a container for nasal administration. At first instance, Heerey J held that section 70(2)(a) was not satisfied because the expression per se showed that an extension of term is to be available only where the claim is for a pharmaceutical substance as such, not a substance forming part of a new delivery method or process. The Full Court agreed (at [37]).

37. In Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77, 57 IPR 424 all of the claims were method claims, not product claims. Wilcox and Cooper JJ (Allsop J concurring) held that a substance that is mentioned in the context of a method claim does not per se fall within the scope of a method claim (at [24]):

"for a substance to fall within s 70(2)(a) it must itself be the subject of a claim in the relevant patent. It is not enough that the substance appears in a claim in combination with other integers or as part of the description of a method (or process) that is the subject of a claim."

38. The question is whether a claim contains "other integers" in addition to the pharmaceutical substance per se.

39. In the present case the pharmaceutical substance is escitalopram. This is clear from the application form filed by Lundbeck, and the parties are in agreement on this point. In order to be clear, the pharmaceutical substance is escitalopram on its own, without the mirror image ()enantiomer.

40. As stated by Bennett J in the Lundbeck appeal at [231]:

"There is no dispute that the pharmaceutical substance for the purposes of s 70(2)(a) is (+)-citalopram"

41. The dispute is about whether or not claim 1 is directed to a pharmaceutical substance "per se".

42. Turning to claim 1 it is directed to escitalopram (and its acid addition salts, but this does not detract from the fact that it explicitly claims escitalopram). Claim 1 was interpreted by the Full Court as the (+)-enantiomer in pure form. This is clear from the comments of Bennett J at [160]:

"in my view, claim 1 is to the pure or isolated or separated (+)-enantiomer"

and Middleton J at [252]:

"The mere reference to (+)-enantiomer in claim 1 without more indicates that it is the separated or the isolated enantiomer that is claimed."

43. The Opponents sought to characterise the purity of the compound as a limitation on the substance, such that it is another integer of the claim, with the result that the claim is no longer directed to a substance per se.

44. The opponents cited the Manual of Practice and Procedure which has examples stating that claims directed to a specified quanta of a substance or a substance when produced by a method are not claims to the pharmaceutical substance per se. This portion of the Manual has been quoted by Heerey J in Boehringer Ingelheim International v Commissioner of Patents [2000] FCA 1918 at [18], who said at [19] that he found it "of assistance". However, the Manual does not address the issue of claims to a substance in pure form. In this regard, the Manual does not assist the Opponents.

45. Approaching the question from first principles, I note that "per se" means "taken alone; essentially; without reference to anything else", Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305, 69 IPR 1 at [94]. By definition, a pure compound is a substance "alone". Indeed, if a pure compound is not a pharmaceutical substance per se, what could ever come within the scope of the term? I have no doubt that claim 1 is directed to a pharmaceutical substance per se.

46. Another way to consider this issue is to view the pharmaceutical substance in this case as the pure escitalopram (i.e. free of the (-)-enantiomer). The presence in the claim of the same requirement of purity ensures that the claim is directed to the pharmaceutical substance, and nothing more than the pharmaceutical substance.

Section 70(3): Do the goods CIPRAMIL contain escitalopram?

47. The Opponents argue that the goods CIPRAMIL do not contain or consist of the pharmaceutical substance escitalopram. This argument is based on the fact that CIPRAMIL contains the active ingredient citalopram (i.e. a mixture of the (+) and (-) enantiomers) in the form of the hydrobromide salt, instead of escitalopram.

48. It is true that escitalopram in pure form is not used in the preparation of CIPRAMIL. In this sense, CIPRAMIL does not contain escitalopram. However, it is also true that CIPRAMIL has within it molecules of escitalopram, and in this sense CIPRAMIL does contain escitalopram. Which approach should be followed?

49. In Merck & Co Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344, 59 IPR 226 the goods included on the ARTG were MEVACOR. The active compound in MEVACOR was lovastatin. Lovastatin contained a small amount of lovastatin beta-hydroxy acid (LHA). LHA was present as a minor, unknown impurity in lovastatin. Wilcox J was satisfied that MEVACOR contained LHA, despite the fact that LHA was not used in the preparation of MEVACOR. This is consistent with the second approach above: a substance is contained in goods if molecules of the compound are present in the goods.

50. In the Lundbeck appeal Bennett J said at [239]:

"The level of inquiry required by s 70(3) does not look to the therapeutic effect of the pharmaceutical substance. Rather, it is a simple comparison of the pharmaceutical substance with the 'ingredients' of the goods on the ARTG. The question is whether Cipramil contains or consists of the (+)-enantiomer molecule. Given the racemic mixture includes both the (-)-enantiomer and the (+)-enantiomer in equal parts, Cipramil must 'contain' the (+)-enantiomer."

51. I conclude that the second approach is the correct way to interpret section 70(3), and that the goods CIPRAMIL contain escitalopram. This ground of opposition is unsuccessful.

52. I note that CIPRAMIL contains escitalopram in the form of the hydrobromide salt. While the salt can be viewed as a different compound to the native compound, the Opponents did not suggest that this represented a basis for opposition

Section 70(4): Has the term of the patent been previously extended?

53. The Opponents rely upon the fact that an extension of term based upon Lexapro was previously granted. It is true that an extension of term based on LEXAPRO was previously granted. The Full Federal Court decision was handed down on 11 June 2009 (and ordered the extension based on LEXAPRO be removed). The present application for an extension of term was filed on 12 June 2009. The Register was not corrected until after 12 June 2009.

54. On the day that the application for extension of term was filed, the extension that appeared on the Register was invalid. It follows that as a matter of fact the term of the patent had not been extended, and an entry wrongly existing in the Register cannot override this fact. This is sufficient to dispose of this ground of opposition.

55. I note that the AAT has previously come to the same conclusion in Aspen Pharma Pty Ltd and Commissioner of Patents [2012] AATA 851 at [50]:

"the extension referred to was subsequently found to be invalid and was removed by the Federal Court"

and consequently:

"The original extension, being invalid or void ad initio, could therefore have no operative effect to prevent the present application for extension."

56. Finally, the critical date for assessing compliance with section 70(4) is the day on which I make my decision. Looking at the Register today, there is no previous extension of term of the patent. This ground of opposition fails.

Section 71(1): Was the application for extension of term defective?

57. The Opponents stated that the application form filed for the extension of term did not comply with section 71(1) and failed to comply with the regulations 6.8(2), (3) as well as regulation 6.10. They claim that the application failed to make a statement as to how (+)-citalopram is contained in citalopram.

58. The application states:

“(+)-citalopram is contained, together with (-)-citalopram, in goods marketed in Australia under the trade mark CIPRAMIL.”

59. The Certificate of Registration of CIPRAMIL and the public summary which accompanies the application refer to:

“CIPRAMIL citalopram hydrobromide ...”

60. I consider this is a clear assertion that the goods CIPRAMIL contain a racemic mixture of the (+) and (-) enantiomers of citalopram. I do not consider that anything more was required in this case.

61. The Opponents further argue that the application does not reference the relevant proceedings, and does not provide details of the decision of the Federal Court. However, the application clearly gives the court references, and I do not consider it necessary to repeat the entire reasons for the decision in the application. The Commissioner has had no difficulty understanding the relevant background to the extension of term. I do not believe this ground has been made out.

62. The application complies with section 71(1) and the regulations and this ground of opposition fails.

The implementation of the decision

63. At the hearing the parties questioned whether this decision would have immediate effect, or whether the Commissioner would defer implementation until the end of the period allowed for appeal. Unsurprisingly, the parties had different views on whether the decision should be implemented immediately. I allowed both parties a short period to file written submissions on this point.

64. The Opponents said that section 75(2), which reads:

"If the grant of an extension of the term of a standard patent is opposed, the Commissioner must decide the case in accordance with the regulations."

is affected by section 75(4):

"The applicant, and any opponent, may appeal to the Federal Court against a decision of the Commissioner under this section"

so that the final grant of an extension of term must be after the appeal period of 21 days.

65. Lundbeck referred to section 76(1) which says that the Commissioner "must" grant the extension where the decision in the opposition is that the extension should be granted.

66. Since the opposition is unsuccessful, I must grant the extension of term. I do not believe that section 76 envisages a situation where I find that an extension should be granted but that I delay doing so. I believe that I must grant the extension of term immediately.

67. There is a separate question as to whether the Register should be updated immediately. I note the comments of the Deputy Commissioner in Re Pfizer Corporation [2005] APO 38:

"While the principle is that decisions of the Commissioner have immediate effect, it is also the case that an order of the Court can be sought staying the execution of a decision under appeal or review. The Commissioner in my view should not act in a way to circumvent a party’s right to seek such an order before implementing a decision and for that reason I believe it would be inappropriate in this case to immediately implement an adverse decision by amending the Register. However, considering the public interest in maintaining certainty in the Register, it seems to me that the stay on implementing the decision should only extend for a time sufficient for the patentee to seek and, if the Court finds it appropriate, obtain a stay on the implementation of the decision."

68. While those comments were made in a different context, it seems to me that this is a sensible approach that I should follow in this case. Although the extension of term is effective from the date of this decision, I will direct that the Register is not updated to reflect the extended term until 28 days from the date of this decision or, in the event that the Commissioner is served in that period with a copy of a notice of appeal and an application for a stay, until the stay application is determined by the court.

Conclusion

69. The oppositions fail on all grounds and the term of patent 623144 should be extended based on the ARTG registration of CIPRAMIL. According to section 77, the term of the patent is to be extended to 9 December 2012.

70. Finally, section 76(2) states that the Commissioner must notify the applicant for the extension of term in writing. This decision represents such notification.

Costs

71. The parties submitted that costs should follow the event. I see no reason to depart from that result. Costs should be awarded against the Opponents.

Dr S.D. Barker
Delegate of the Commissioner of Patents