Re Apotex Pty Limited and Commissioner of Patents
[2008] AATA 226
•20 March 2008
Administrative Appeals Tribunal
DECISION AND REASONS FOR DECISION [2008] AATA 226
ADMINISTRATIVE APPEALS TRIBUNAL )
) No 2007/4764
GENERAL ADMINISTRATIVE DIVISION ) Re APOTEX PTY LIMITED
Applicant
And COMMISSIONER OF PATENTS
Respondent
LES LABORATOIRES SERVIER
Joined Party
DECISION
Tribunal Ms N Bell, Senior Member Date 20 March 2008
PlaceSydney
Decision The decision under review is affirmed. ......................SGD........................
Ms N Bell
Senior Member
PATENTS – Expired notice of opposition to patent application - Whether error or omission - Whether failure to file notice of opposition within prescribed period due to error - Whether discretion to grant extension of time should be exercised - Decision under Review Affirmed
Patents Act 1990
Patents Regulations 1991
Kimberly-Clarke Ltd v Commissioner of Patents (No 3) (1988) 13 IPR 569
Vangedal-Nielsen v Smith (Commissioner of Patents) (1980) 33 ALR 144
Lyons v Registrar of Trade Marks (1983) 50 ALR 496
F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283
Les Laboratoires Servier, Servier Laboratories Limited v Apotex Inc, Apotex Pharmachem Inc, Apotex Europe Limited, Apotex UK Limited [2007] EWHC 1538 (Pat)
Vangedal-Nielsen v Smith (Commissioner of Patents) (1980) 33 ALR 144
Re Weir Pumps Ltd and Commissioner of Patents and Stork Pompen BV (1998) 13 IPR 163
Re Imperial Chemical Industries Ltd (Haggis’) Application [1975] RPC 403
REASONS FOR DECISION
Ms N Bell, Senior Member 1. Perindopril is a pharmaceutical compound used in the treatment of hypertension. Apotex Pty Limited (formerly GenRx) launched a generic form of the drug in 2006 for import into and sale in Australia. Les Laboratoires Servier is the applicant for a patent for an alpha crystalline form of perindopril and, among other things, a process for its synthesis. The patent application was filed in July 2001 and advertised as accepted and open to opposition proceedings on 28 July 2005.
2. A person who wants to oppose a grant of patent must file a notice of opposition within three months of publication of the notice of acceptance.[1] The time for filing a notice of opposition to Servier’s patent application expired on 28 October 2005.
[1] Reg 5.3(1) Patents Regulations 1991
3. Apotex purchased the perindopril business concern from Mayne. During a handover period from July to December 2004, Apotex received legal and patent advice from Mayne. In September 2003, Phillips Ormonde & Fitzpatrick carried out a patents search for Mayne and Mayne provided that search to Apotex. The search concerned all patents for perindopril and grouped the patents according to relevance and type. The patent application relevant to this review was categorised in the search report as a process patent (as opposed to a product patent) and was not identified as relevant to Mayne’s, and consequently Apotex’s, concerns as to whether there were any patent applications that would prevent supply of perindopril in Australia. At this point, Apotex had not yet identified a supplier or manufacturer of the compound and was focused on patents concerning product claims, rather than process claims.
4. Apotex did not place the patent application on watch – that is, a regular review of the Patent Office’s databases to keep track of amendments, additions and changes to the status of a patent application. Nor did Apotex lodge a notice of opposition to the patent application by 28 October 2005.
5. Apotex sought to extend the time to file a notice of opposition until 9 March 2007. At that time no patent had been granted on Servier’s patent application. An opposition by another company, Lupin Limited, had been withdrawn in February 2007. The delegate of the Commissioner for Patents decided on 4 September 2007 to refuse Apotex’s application for extension of time within which to oppose the registration of patent applied for by Servier’s patent application. Apotex seeks review of the delegate’s decision.
6. The Commissioner for Patents informed the Tribunal in November 2007 that she did not intend to take an active role in the Tribunal proceedings. Servier was joined as a party in October 2007.
issues
7. Section 223(2) of the Patents Act 1990 provides:
(2) Where, because of:
(a)an error or omission by the person concerned or by his or her agent or attorney; or
(b) circumstances beyond the control of the person concerned;
a relevant act that is required to be done within a certain time is not, or cannot be, done within that time, the Commissioner may, on application made by the person concerned in accordance with the regulations, extend the time for doing the act.
8. The issues that emerge from the requirements of this provision are:
a) whether there was a relevant error or omission;
b) if so, whether Apotex failed to lodge a Notice of Opposition within the prescribed period because of the error; and
c) if so, whether the discretion to allow Apotex’s application for an extension of time should be exercised.
was there a relevant error or omission?
9. In Kimberly-Clarke Ltd v Commissioner of Patents[2], Jenkinson J held that the phrase “error or omission” in an earlier incarnation of section 223(2) should not be restricted to accidents and inadvertences. His Honour noted that “the word ‘error’ is not easily assigned a clear meaning restricted by reference to one or several particular categories of flawed mental function. The attempt is likely to lead to the drawing of fine and often unrealistic distinctions” (at p 579)
[2] Kimberly-Clark Ltd v Commissioner of Patents (No 3) (1988) 13 IPR 569
10. The error relied on by Apotex was the failure of Phillips Ormonde and Fitzpatrick to identify the patent application as including a product claim (in addition to process claims) or to rank it as important in its search report so as to bring it to the attention of Mayne and, by Mayne, of Apotex. Consequently, Apotex submitted, the patent application was not placed on watch. Apotex first became aware of the patent application on 10 August 2006[3]. Ms Keast was not made aware until 9 March 2007 that the circumstances surrounding the identification of the patent application may ground an application for extension of time for the filing of a Notice of Opposition.
[3] Statutory declaration dated 4 May 2007 of Jessica Keast, Regulatory Affairs Manager of Apotex.
11. Servier submitted that it was clear on the face of it that the patent application was in respect of a process patent and properly categorised by the search firm as such. Further, it submitted, that categorisation and relevance ranking of the patent application was appropriate given that until a manufacturer, and therefore the proposed process of manufacture, had been identified by Apotex, a meaningful review of process patents could not occur. In short, until the precondition for watching the patent – the identification of the manufacturing process – had occurred, there was no rationale for placing the patent on watch. For this reason, Servier submitted, the categorisation as simply a process patent was not in error.
12. I note that the patent application specifications Abstract is headed:
NEW a CRYSTALLINE FORM OF PERINDOPRIL TERT-BUTYLAMINE SALT,
A PROCESS FOR ITS PREPARATION
AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT
13. It then sets out the formula for the compound. Similar words are repeated in the first paragraph of the introductory material in the specifications and the application has as its first claim “a crystalline form of the compound of” and the formula follows again. This is a claim as to product rather than process. What follows is a series of claims that concern process, pharmaceutical composition, method of treatment and use. The product claim is not expressed to be dependent on the process or other claims that follow. The first claim, as to product, is amenable to being watched in the absence of a determined process for manufacture. There would be some point to watching the product claim aspect of the patent application before process was considered. To this extent, the patent application was relevant to Apotex’s concerns to commercialise the product and could usefully have been brought to its attention. I accept that the way in which the patent application was categorised may have sat well with the preponderance of process claims contained within it. However, in the context of Apotex’s concern to commercialise perindopril, and given that the first claim was in respect of product, that categorisation amounted to a failure to bring a matter of concern to Mayne’s and Apotex’s attention. I see no reason, in view of Jenkinson J’s decision and comments in Kimberly-Clarke, why this failure should not be classed as an error or omission within the ordinary meaning of those words.
did apotex fail to lodge a notice of opposition within the prescribed period because of the error?
14. In Kimberly-Clarke, Jenkinson J held that it is sufficient that an error or omission contributed to cause the failure to lodge the notice. He quoted with approval from Lyons v Registrar of Trade Marks[4] that the phrase (as it then was) “by reason of” “implies a relationship of cause and effect but it is a relationship which may be indirect” (at p 509).
[4] Lyons v Registrar of Trade Marks (1983) 50 ALR 496
15. Perindopril had commercial significance to Apotex, which had decided, by 2003, to sell it in Australia. It had applied for registration of the product with the Therapeutic Goods Administration on 30 July 2005, two weeks after, unknown to Apotex, the opposition period had begun[5]. By July 2005, it had also arranged for stability and bio-equivalency studies to be undertaken for the product. In February 2007, when it had learned of the patent application but before it had apprehended the grounds for an extension of time to oppose, Apotex sought declaratory relief in relation to the patent application, in the Federal Court. Apotex contends, and Ms Keast declared, that, had it been made aware of the product claim in the patent application, it would have placed it on watch with a view to opposing its grant. Apotex also contended that there were comprehensive grounds on which it could oppose the registration of the patent application.
[5] Keast, 14 December 2007
16. There is no statutory requirement that an opponent seeking an extension of time must have an intention to oppose and that the relevant error intervene to thwart that intention. However, Servier submitted that intention is a logical prerequisite to an error being the cause of a failure to lodge within the limitation period. Of course, in circumstances where the existence of the patent application is not known, a specific intention to oppose the patent application cannot be formed. Servier submitted that in those circumstances there would have to be a habitual practice of watching every Servier patent application and opposing it when the opportunity arises in order to conclude that, had Apotex known about the patent application, it would have opposed it. Not surprisingly, there is no evidence of such a practice on the part of Apotex.
17. Servier also submitted that the heavy onus to be met in order to successfully oppose a patent in the Office of the Commissioner (“clearly invalid” – see F.Hoffman-La Roche AG v New England Biolabs Inc[6]) makes it unlikely that Apotex would have chosen to oppose rather than initiate revocation proceedings in the Court where the hurdle is lower. Mr Hamer, patent attorney of some 25 years experience, declared there are several reasons why a potential opponent might decide not to proceed with a notice of opposition, including the different onuses that apply in opposition proceedings and proceedings for revocation or infringement in the Court, an election to wait to see whether a patentee takes action on the patent and some advantages associated with defending infringement proceedings[7]. However, I note the evidence of Mr Jones, patent attorney[8], that over his 25 or so years as a patent attorney he has never had a client allow a patent to go through to grant and then seek to revoke it in court rather than oppose a patent application.
[6] F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283
[7] Statutory declaration dated 21 December 2007 of Mr Hamer, patent attorney.
[8] Statutory declaration dated 22 January 2008 of Mr Jones, patent attorney.
18. I am mindful that Apotex relies on the decision of the UK High Court of Justice, Les Laboratoires Servier & Anor v Apotex Inc & Ors[9] per Pumfrey J, that the equivalent European patent was invalid. That decision was handed down on 11 July 2007. Apotex submitted that this decision illustrates the availability of substantive grounds on which to oppose the patent application and says that this makes it all the more likely that it would have opposed the application.
[9] Les Laboratoires Servier, Servier Laboratories Limited v Apotex Inc, Apotex Pharmachem Inc, Apotex Europe Limited, Apotex UK Limited [2007] EWHC 1538 (Pat)
19. Both Apotex and Servier rely on the decision in Kimberly-Clarke to support their submissions. I cannot see how the decision supports the proposition that there must be an intention to oppose and the intended opposition be thwarted by the relevant error. Rather, the decision finds the requisite causation to have been established in circumstances where a deliberate decision to not file a notice was made. There was no intention, in the facts of Kimberly-Clarke, to file in the relevant period.
20. Mr Whenman, patent attorney for some 20 years, stated[10] that one of the main purposes of a watching service is to allow a person to assess whether the claims in a patent application remain of concern as an infringement risk. He said the person would usually discuss the scope and validity of the claim with a patent attorney and decide whether or not to file a notice of opposition in respect of the patent application.
[10] Statutory declaration dated 13 December 2007 of Mr Whenman, patent attorney.
21. I consider that, while the majority of cases will disclose a specific intention to oppose, with that intention being thwarted by the relevant error, there will be, as in this case and in Kimberly-Clarke, exceptional circumstances where no specific intention to oppose has been formed. In this case, as in Kimberly-Clarke, the relevant error precluded the forming of the specific intention. In this way, the error contributed to the failure to place the patent application on watch and to form the intention to file the notice of opposition. That, in my view, is sufficient to satisfy the required causal connection described by Jenkinson J in Kimberly-Clarke.
22. I would add that the range of alternative courses of action available to a potential opponent that were described by Mr Harmer in his statutory declaration would remain available to any potential opponent up until the point at which the notice is lodged. They could be availed of at any time until then, despite a clearly formed specific intention to oppose. Their existence as available options does not detract from the probability in this case that, if the error had not occurred, the patent application would have been placed on watch and the opportunity to form an intention to lodge a notice of opposition would have been provided.
should the discretion be exercised?
23. Having concluded that there was a relevant error or omission and Apotex failed to lodge a Notice of Opposition within the prescribed period because of the error, I must consider whether the discretion to extend the time for filing a notice of opposition should be exercised. In Vangedal-Nielsen v Smith (Commissioner of Patents)[11], Bowen CJ noted a number of matters relevant to the exercise of the Commissioner’s discretion: whether there has been full and frank disclosure of all the relevant circumstances; whether a serious opposition has been indicated; the interests of the parties in refusing or granting the extension; and the public interest, including the question of undue delay, in refusing or granting the extension.
[11] Vangedal-Nielsen v Smith (Commissioner of Patents) (1980) 33 ALR 144
delay
24. Seventeen months is a long time. The first 10 months is explained by Apotex’s lack of awareness of the existence of the patent application. I accept that the remainder of the period was due to a combination of Ms Keast’s lack of knowledge of the availability of a ground for an extension of time and the lack of awareness of her advisor, Mr Jones, of the existence of the error that could establish a ground for an extension of time. It was not until 9 March 2007 that both of these absences of awareness were remedied and swift action was taken by Apotex to lodge a notice of opposition.
25. I note there is no statutory limitation on the period for which an extension of time may be granted. However, certainty is desirable. The existence of reasons, even good reasons, or the absence of moral fault, does not detract from the desirability of certainty for patentees and the smooth and predictable operation of the system of patents registration.
full and frank disclosure
26. The statutory declarations of Ms Keast and Mr Jones explain in detail how the error, and the consequent delay in lodging the notice of opposition, came about. Mr Jones, in particular, stated that he is satisfied that all material that could weigh against GenRx and Apotex has been brought to the attention of the Tribunal.
27. Servier submitted that the failure of Apotex to present evidence from Ms Sergi, the Intellectual Property Officer of Mayne to whom Phillips Ormonde and Fitzpatrick provided its search report and who, in turn, provided the report to Mr Aemon, then an officer of GenRx, together with its failure to present evidence from Mr Aemon, meant that full and frank disclosure had not been made. It was said from the Bar table that Ms Sergi, is not, and never was, an officer of GenRx or Apotex and that Apotex knows nothing about Mr Aemon who was simply the person who received Ms Sergi’s letter. Throughout the opposition period, Ms Keast was the Regulatory Affairs Officer of Apotex.
28. I draw no inference, from this absence of evidence from Ms Sergi and Mr Aemon, that either their evidence would not assist in relation to questions of error and causation, or that it’s absence indicates a failure to fully and frankly disclose. Ms Keast was the responsible officer during the relevant notice period and I accept that she has searched for and provided all relevant material found.
serious opposition
29. Apotex pointed to the decision of Pumfrey J in Les Laboratoires Servier & Anor v Apotex Inc & Ors on the equivalent European patent and submitted that its opposition would be based on the same or similar evidence and arguments as were successfully put forward there.
30. Servier submitted, relying on Mr Harmers statutory declaration as to why the UK decision is not persuasive, that, combined with the heavy onus that applies in opposition proceedings, the opposition has little chance of success.
31. Despite the criticisms by Mr Harmer of Pumfrey J’s decision, the existence of a judicial determination on an equivalent patent and orders made by the Court for its revocation suggest grounds for a serious opposition. The UK decision is not binding but it would, at the least, have to be addressed and may be persuasive.
balance of interests of the parties
32. Servier clearly has an interest in minimising delay in the progress of its patent application. I note that the application was made in 2001 and the opposition by Lupin was settled in February 2007. Apotex has a clear interest in ensuring an invalid patent is not granted and it’s exposure to infringement proceedings is minimised.
33. Servier submitted that the current Federal Court proceedings concerning another patent related to perindopril is the appropriate forum in which to test this patent, once granted. Apotex pointed to the comparative swiftness and low cost of opposition proceedings and the intention of Parliament to provide this less elaborate mechanism for the screening of invalid patents.
34. Apotex also submitted that, although the parties, the compound and the alleged infringing activities are identical, this patent raises significantly different issues and evidence to those that are currently before the Federal Court. It also took issue with the suggestion, made originally by the delegate whose decision is under review, that the UK decision drew heavily on evidence given under cross examination – a procedure not available to delegates of the Commissioner of Patents in their consideration of oppositions on the papers.
35. I note that a failure to oppose the grant of a patent does not preclude a person from seeking to have the patent revoked, once granted. Nor does it prevent the defence of an action for infringement. The argument that a failure to grant an extension of time to oppose is not fatal to a person’s ability to establish the invalidity of a patent is commonly raised in relation to applications for extension of time. In Re Weir Pumps Ltd and Commissioner of Patents and Stork Pompen BV[12], Administrative Appeals Tribunal Deputy President Bannon noted that “(l)oss of opportunity to oppose is not disastrous. A patent when granted is often not worth the paper it is written on until tested judicially, in revocation proceedings in a court of competent jurisdiction …” (at p 166). In this matter there are proceedings already on foot in the Federal Court to which issues of validity of this patent, even if they are distinct, might be annexed. This lends force to the argument of further opportunity in the circumstances of this case.
[12] Re Weir Pumps Ltd and Commissioner of Patents and Stork Pompen BV (1998) 13 IPR 163
public interest
36. There is a clear public interest in the efficient and orderly administration of the progression of matters before the Patents Office. Delay goes against this interest. Conversely there is a public interest in preventing registration of patents that are invalid. The test for successful opposition is a tough one (clear invalidity) and opposition proceedings are designed to filter out, by comparatively inexpensive means, those patent applications that are “certain to be revoked” if granted[13].
[13] Re Imperial Chemical Industries Ltd (Haggis’) Application [1975] RPC 403 at 417, quoted by the Full Federal Court in Genetics Institute Inc v Kirin-Amgen Inc (1997) 92 FCR 106
37. It is not appropriate for an application for extension of time to oppose to become a rehearsal of the opposition proceedings sought to be initiated. But some measure of the merits of the substantive application must be taken. While I am satisfied there is a serious opposition to be put by Apotex, I could not say that the patent, if granted, would be “certain to be revoked”. I am grateful to Counsel for their assistance with the complex technical issues canvassed in the UK decision. Their explanations made it plain that there is a vigorous and substantial contest in relation to the equivalent Australian patent. There is some uncertainty as to the outcome, in Australia, of that contest. There is also the need to limit the already considerable delay in the progress of this patent application – a delay that would be increased notwithstanding Apotex’s undertakings to expedite its opposition.
conclusion as to discretion
38. On balance, I consider that the availability of revocation or infringement proceedings, and their possible annexure to proceedings already on foot in the Federal Court, together with the very long period of delay in Apotex’s lodgement of its notice of opposition weighs against the exercise of the discretion to extend the period of time for lodgement. This is so notwithstanding the availability of what appear to be serious and substantial grounds for challenge of the patent and understandable reasons for the delay. I consider that the interests of the public and the parties would be best served by the patent application proceeding to consideration for grant and, if granted, for Apotex to mount its challenge to the patent in another forum.
decision
39. The decision under review is affirmed.
I certify that the 39 preceding paragraphs are a true copy of the reasons for the decision herein of
Signed: .....................................................................................
Associate: Mark DowsettDate/s of Hearing 18 February 2008
Date of Decision 19 March 2008
Counsel for the Applicant Ms Sophie Goddard
Solicitor for the Applicant Ms Kathryn Everett, Freehills
Counsel for the RespondentSolicitor for the Respondent Mr Nick Gouliaditis, AGS
Solicitor for the Joined Party Mr Richard Hamer, Allens Arthur Robinson
Counsel for the Joined Party Mr Adrian Ryan
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