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Timestamp: 2019-04-19 21:02:08+00:00

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Where Will It Arise Next?
By Barbara Murchie and Christopher Heer, Bennett Jones LLP1 Under the Patent Act, an applicant for a Canadian patent has two statutory obligations to act in good faith. Section 53 requires the applicant to be honest and complete in the description of the invention in the specification; section 73 requires the applicant to respond in good faith to the The Federal Court has also suggested there may be a more general duty to act in good faith beyond that specifically set out in the Patent Act. This general duty can be framed in terms of the bargain theory. In return for full, frank and fair disclosure of its invention, an applicant will be granted a twenty year monopoly to that invention. If the applicant's disclosure and/or dealings with the Patent Office are misleading, then the patent has been granted on a false premise and/or the applicant's bargain with the public has not been honoured. Those arguing against a more general duty will note that the Patent Act specifically sets out and limits the good faith obligations to the circumstances described in the legislation. In the context of discussing the requirements for the patent specification, Dr. Fox explains that because a patent represents a bargain between the inventor and the public with some consideration flowing in both directions, "the utmost good faith must be observed by the applicant in disclosing his invention and in framing his specification, which must not contain any false representation or be willfully misdescriptive or misleading in any material part"2. Section 1 Barbara Murchie is a partner in the intellectual property litigation group of the Toronto office of Bennett Jones LLP, practicing primarily in the area of pharmaceutical patent litigation. Christopher Heer is an associate lawyer and registered patent agent in the intellectual property litigation group of the Toronto office of Bennett Jones LLP, practicing primarily in the area of patent litigation. 2 Harold G. Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions, 4th ed. (Toronto: Carswell, 1969) at 178. 53 has codified this good faith requirement and provides a penalty for failing to honour it; if any material allegation in the specification is found to be intentionally misleading, the patent is void. In a more general statement, Dr. Fox goes on to say that good faith is "a necessary incident. The inventor must act uberrima fide and and there must be no false suggestion".3 Under section 35 of the Patent Act, every patent application filed with the Canadian Patent Office must be examined by a competent examiner for compliance with the Patent Act and Patent Rules. During this examination, the patent applicant is given the opportunity to address areas of alleged non-compliance by responding to requisitions from the examiner to which the applicant may either amend its application so that it does comply or make arguments as to why the application already complies. Pursuant to section 73(1)(a) of the Patent Act, these responses by the applicant must be made in good faith, failing which the patent application goes There are two Canadian court decisions (Lundbeck v. Ratiopharm, 2009 FC 1102 and G.D. Searle v. Novopharm Limited, 2007 FC 81) that find a breach of the duty of good faith under section 73(1)(a) of the Patent Act in the PMNOC context. This paper reviews those decisions and sections of the Patent Act and Patent Rules to comment on the extent of the duty of good faith under section 73(1)(a) in Canada. We then examine other decisions which have found or rejected a more general duty of good faith in dealing with the Patent Office in Canada. Next, we provide a summary of the U.S. inequitable conduct doctrine and the statutory differences which make reference to U.S. inequitable conduct jurisprudence in Canada problematic. Finally, the article concludes with suggested best practices relating to the duty of good faith for both patent prosecutors and patent litigators.
The duty of good faith in patent prosecution in Canada arises by statute in section 73(1)(a) of the post-1996 Patent Act. Section 73(1)(a) prescribes "[a]n application for a patent in Canada shall be deemed to be abandoned if the applicant does not reply in good faith to any requisition made by an examiner in connection with an examination, within six months after the requisition is made or within any shorter period established by the Commissioner." The language of the section defines both who owes the duty of good faith and under what Who Owes a Duty of Good Faith in Patent Prosecution?
The duty of good faith according to section 73(1)(a) is owed by the applicant. Unlike in the United States, the applicant's patent agent (or associate patent agent) in Canada does not owe a duty of good faith independent of that of the applicant. While Rule 22 of the Patent Rules provides "any act by or in relation to a patent agent or an associate patent agent shall have the effect of an act by or in relation to the applicant", there is no court decision that extends the s. 73 duty of good faith to the patent agent to disclose anything known to him that does not relate to the activities of the applicant. Since the duty of good faith is owed by the applicant, the applicant's knowledge may be presumed to include, for example, prior art references cited in prosecution of related and corresponding foreign patent applications. This imputed knowledge can be considerable in cases where the applicant has, for instance, submitted a long list of prior art in an information disclosure statement before the U.S. Patent Office in a corresponding U.S. application. Under What Circumstances Is the Duty of Good Faith Owed?
The duty of good faith under section 73(1)(a) of the Patent Act is owed in replying to any requisition made by an examiner in connection with an examination. Consequently, not every communication with the Patent Office is subject to the duty of good faith under section of Requisitions may be made under the following sections of the Patent Rules:  Rule 23 – appointment of patent agents  Rule 29(1) – corresponding examination information and related documents  Rule 29(2) – identification of first publication  Rule 30(2) – non-compliance with Act or Rules - amend or argue against defects  Rule 30(4) – final action for non-compliance with Act or Rules - amend or argue against  Rule 30(5) – payment of final fee after final action rejection withdrawn  Rule 58(4) – translations of international applications  Rule 58(5) – evidence that applicant is the legal representative  Rule 71 – translations of documents  Rule 89 – certified copies of priority documents  Rule 94 – application completion requirements  Rule 104.1 – date of deposit of biological material  Rule 136 (sandwich Patent Act) – translations of documents  Rule 143 (sandwich Patent Act) – certified copies of priority documents  Rule 172 (old Patent Act) – translations of documents  Rule 180 (old Patent Act) – certified copies of priority documents When is the Duty of Good Faith Breached?
In Lundbeck Canada v. Ratiopharm, 2009 FC 1102, two patents were at issue. Lack of good faith was alleged against only one of the patents, the '492 patent. The '492 patent was also alleged to be invalid for lack of utility and invalid as anticipated and obvious in view of two references: the Justice Mactavish did not find the allegations of anticipation or obviousness justified. However, she did find that the allegation that the '492 patent was invalid for lack of utility was justified. In respect of the duty of good faith, ratiopharm asserted that the applicant failed to make full, frank and fair disclosure of the import of the Wenk article. In particular, ratiopharm alleged that in responding to a requisition from the examiner, the applicant misrepresented that the prior art "taught away" from using a combination of memantine and an acetylcholinesterase inhibitor in 4 G. D. Searle v. Novopharm Limited, 2007 FC 81 at para. 72. 5 G. D. Searle v. Novopharm Limited, 2007 FCA 173 the treatment of Alzheimer's disease and that this constituted a failure to communicate with the In the prosecution of the application leading to the '492 patent, the examiner had noted that the claims were directed to an aggregation of two known types of compounds and remarked that there was no invention in combining two known compounds unless there was a new use or unless the combination of the two compounds to perform the old use provided "a new and unexpected result". The examiner further commented that there was no evidence that a synergistic effect occurs between the two compounds in the treatment of mild cognitive impairment or dementia. In addition, the examiner made a requisition, pursuant to Rule 29 of the Patent Rules, that the applicant identify any prior art cited in respect of the United States and In response to the Rule 29 requisition, the applicant responded that there were no corresponding United States or European Patent Office applications pending. The applicant then went further and indentified two documents cited in the International Search Report, one of which was the Wenk article. The response did not discuss the Wenk article or provide a copy of the article to the examiner, nor was either action required. Subsequent to the applicant's identification of Wenk, a requisition was sent by the examiner which reiterated the obviousness rejection. The examiner stated that "the applicant has failed to show that their combination results in a unitary result, and not a mere addition of the effects of the two known drugs". It was the applicant's response to this rejection that ratiopharm took issue with. The applicant's response included the following statement: … In order to evaluate the inventiveness of the present invention, it is important to appreciate the understanding a person skilled in the art would have had at the time of filing of the present application. It is therefore of prime importance to note that, at that time, there were numerous articles in the prior art which warned against the combination of NMDA antagonists and AchE [or acetylcholinesterase] inhibitors because NMDA antagonists attenuated the effect of AchE inhibitors, i.e. NMDA antagonists rendered AchE inhibitors ineffective… The applicant then went on to discuss four such articles and concluded as follows: [I]t would thus have been counter-intuitive and definitely improbable that, in view of the prior art available at the time of filing, one skilled in the art would have been prompted to combine a NMDA antagonist with an AchE inhibitor to achieve the claimed composition. In fact, in view of the prior art, which showed that NMDA antagonists attenuate the effect of AchE, it was not obvious for a skilled person to arrive at the present invention. Indeed, the prior art clearly teaches away from the combination of a NMDA antagonist with an AchE inhibitor as claimed in the instant application. It is therefore the Applicant's opinion that the teachings of the prior art as a whole would not have prompted the skilled person faced with the problem of formulating a composition for the treatment of mild cognitive impairment or dementia, to elaborate the instant composition and that consequently the claims on file are not obvious in view of the prior art. Therefore, withdrawal of this objection is respectfully requested. [emphasis added] Ratiopharm argued that in this response the applicant breached its duty of good faith in failing to alert the examiner to the importance of the Wenk article, which taught that while some acetylcholinesterase inhibitors do lose their therapeutic effect when used in conjunction with memantine, others do not. In particular, Wenk found that memantine's inhibitory effect was restricted to "irreversible" acetlycholinesterase inhibitors such as DFP, and that other "reversible" acetylcholinesterase inhibitors such as donepezil, THA (or tacrine hydrochloride) and galantamine did not lose their therapeutic effect when used in conjunction with memantine. In her review of the duty of good faith, Justice Mactavish found that paragraph 73(1)(a) of the Patent Act explicitly imposes a duty on patent applicants to "reply in good faith to any requisition made by an examiner in connection with an examination" and that the only cases considering the scope of paragraph 73(1)(a) are the Federal Court decision in G.D. Searle v. Novopharm (discussed above) and the decision of the Federal Court of Appeal reversing it. After discussing the G.D. Searle decisions, Justice Mactavish remarked that it is noteworthy that the Federal Court of Appeal did not take issue with Justice Hughes' review of the law with respect to the duty of good faith in the prosecution of patent applications. From this, she accepted Justice Hughes' review as an accurate overview of the obligations on an applicant and expressly agreed with the analogy drawn between an application for a patent and an ex parte court proceeding.6 Justice Mactavish found that the examiner was concerned about the fact that the use of both memantine and acetylcholinesterase inhibitors was already known in the prior art for the 6 The analogy to an ex parte proceeding appears to relate to the general duty of good faith in patent prosecution. There is no statutory requirement to disclose information material to patentability, as there is in the United States. treatment of mild cognitive impairment or dementia. She further found the applicant had in response discussed four articles referencing acetylcholinesterase inhibitors which were not referenced in the patent whereas the one study that was relevant to the combination of the acetylcholinesterase inhibitors discussed in the patent and memantine was Wenk, which was not discussed. In other words, the applicant provided the examiner with four less relevant items of prior art which "taught away" from pursuing the invention, yet failed to mention the one directly relevant study that came to the opposite conclusion. In view of those findings, Justice Mactavish concluded that it was not a fair representation of the prior art to say "the prior art clearly teaches away" from combining an NMDA antagonist with an acetylcholinesterase inhibitor while also saying the four less relevant studies were "of prime importance" to the issue of obviousness. She remarked that surely Wenk was even more important given that it was far more relevant than any of the four studies cited in the response. Justice Mactavish therefore found ratiopharm's allegation of abandonment based on a breach of the duty of faith justified. She further commented that "[a] proper understanding of the prior art is clearly critical to patent examination. The duty of good faith imposed by paragraph 73(1)(a) of the post-1996 Patent Act requires that this prior art be fully and fairly described by applicants and their agents when answering requisitions from the Patent Office." In considering Justice Mactavish's reasons as a whole, it is unclear whether anything in her analysis turns on the applicant having identified the Wenk reference in response to the Rule 29 requisition. If Wenk had not been voluntarily identified to the Canadian examiner, Wenk still have been known to the applicant and the applicant's response could still be said to lack good faith. But, on the other hand, the identification of the Wenk reference to the examiner may have made it easier for the Court to infer the applicant lacked a good faith intent in omitting discussion of Wenk from its response, as opposed to doing so by inadvertence or mistake. Is There a Duty of Good Faith Outside of the Circumstances of Sections 53 and 73?
The law on the duty of good faith in patent prosecution is still in its infancy in Canada. While it is clear that a duty of good faith exists in disclosing the invention in the specification (s. 53(1)) and in responding to a requisition by an examiner in the examination of a patent application (s. 73(1)(a)), it is not yet settled whether a duty of good faith or a duty of candour arises in other circumstances. In view of this uncertainty, patent litigators may choose to allege a breach of the duty of good faith in wide-ranging circumstances until the jurisprudence becomes better-defined.

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