The term “good faith” a sincere belief or motive without any malice or the desire to defraud others. Section 73(1)(a) of the requires that, during the prosecution of a patent, an applicant reply in good faith to any requisition made by a patent examiner in connection with an examination, within six months after the requisition is made. How broadly should the duty of good faith be interpreted? Does it extend to include a duty of candour as exists in the United States, which would suggest a higher, equitable, standard of forthrightness than that arguably provided by s. 73? Is s. 73 to be relegated to administering patent prosecution, or can it be used post patent issue to challenge validity?

An extensive judicial treatment of s. 73 was offered by Justice Hughes in , 2007 FC 81, a case involving an application by an innovator pharmaceutical company to prohibit the Minister of Health from issuing a Notice of Compliance to the respondent, Novopharm. Novopharm had alleged that the patent was abandoned pursuant to s.73(1) because Searle misled the CPO during the course of the prosecution of the application for the ‘576 patent by saying that the EPO had allowed claims identical to claims 1 to 16 to proceed to a patent when in fact only claims 1 to 8 had been allowed to proceed.

While s. 73 was only enacted in October 1996, Justice Hughes opined that there has been a doctrine of good faith in respect of patents in Canada for at least sixty years (citing President Thorson of the Exchequer Court in Noranda Mines Ltd. v. Minerals Separation North American Corp., [1947] Ex. C.R. 306). He also concluded that it is to be expected that there will be full, frank and fair disclosure during communications with the Patent Office.

On the question of whether an after-the-fact finding that a response made during prosecution lacked good faith could invalidate an issued patent, he concluded that “it is not harsh or unreasonable, if after the patent issues, and the disclosure is found to lack good faith, that the Court deems the application, and thus the patent, to have been abandoned.” (G.D. Searle at para. 73)

While conceding that there is no provision in the Patent Act or Rules that directly provides a third party the right to invalidate a patent for lack of good faith during application prosecution, Justice Hughes determined that evidence of prior non-compliance with section 73 could result in a retroactive deemed abandonment of an application, and invalidation of the corresponding issued patent. The trial case was overturned by the Federal Court of Appeal, but on different grounds and with no comment on Hughes J.’s s. 73 dictum.

In ., 2008 FC 744, Justice Shore took a different position than Hughes J. He considered an allegation that a patent was void on the basis that the applicant's agent failed to provide complete particulars of the prior art cited in the corresponding United States and EPO applications resulting in abandonment of the application and a breach of its duty of candour with the Commissioner of Patents. The applicant had only disclosed the identity, and not the particulars, of all prior art references cited in the US application.

Justice Shore concluded that it was sufficient to provide the examiner with citations to the relevant prior art; it was unnecessary to provide the documents themselves. He determined that “it is clear that there is no express duty of candour contained in the Patent Act or the Patent Rules and that the word ‘candour’ does not even appear in this legislation. While a duty of candour and good faith exists during the prosecution of patent applications in the United States Patent Office, a similar duty does not exist in Canada.” (Janssen-Ortho at para. 201)

After reviewing Shore J.’s dictum, Hughes J., in ., 2009 FC 1013, reluctantly conceded that the law as to the duty of candour is currently in a “state of flux and is not so certain.” (at para. 15)

Shortly after Hughes J.’s concession, Mactavish J. delivered a strong judgment in ., 2009 FC 1102, wherein she sided with Hughes J. in G.D. Searle and interpreted s. 73(1)(a) to mean that “it is clear that … there is a duty of candour on the part of applicants in the prosecution of a patent application in Canada.” (Lundbeck at para. 319) In this case, in response to the examiner’s requisitions the patent agents replied by citing various pieces of prior art that taught away from the invention. They had, however, omitted one relevant article that taught otherwise and lent credence to an argument of obviousness. Mactavish J. found that the applicants had failed to reply in good faith to the examiner’s requisition.

The patent agents had written to the examiner that “in light of the prior art available at the time of filing”, it would have been “counter-intuitive and definitely improbable” that a person skilled in the art would have been prompted to undertake the combination used to achieve the claimed composition.�� They insisted that “the prior art clearly teaches away from the combination” and that “the teachings of the prior art as a whole” would not have prompted the skilled person “to elaborate the instant composition”, with the result that the invention claimed was not obvious. (Lundbeck at paras. 336 and 337) Mactavish J. was disturbed by the patent agents’ omission and clearly willful mislead of the examiner: the strong language of the patent agents “was not a fair representation of the teachings of the prior art.” (Lundbeck at para. 345)

In the recent infringement case of ., 2010 FC 602, Phalen J. seemed to side with Shore J. The Defendant had claimed that the patent was invalid on the basis of abandonment by virtue of failure to deal in good faith with the Patent Office during prosecution of the patent. It had not pleaded s. 73 but relied on it by arguing that s. 73(1)(a) gave it a right to challenge the validity of the Patent on the basis of this subsection as if it were a supplement to s. 53 (material misstatement). Phalen J. corrected the Defendant's misapprehension: “… there is no right in a third party to invalidate a patent for fraud or lack of good faith during the prosecution of the application. … [I]t would be stretching the meaning of s. 73 to read in a right to strike down a patent after it is issued on the basis of deemed abandonment during its prosecution unless all the constituent elements of s. 73 are met.” (Weatherford at para. 344) Further, “s. 73 ... is directed at controlling the prosecution of the patent process. The term ‘abandonment’ itself gives an indication that the provision is not directed to post-issuance validity.” (Weatherford at para. 345) He then reminded the court that “the Federal Court of Appeal in . (1999), 86 C.P.R. (3d) 221 (F.C.A.) at paragraphs 26-31 has rejected the notion that a patent can be held to be invalid for alleged breach of the duty of candor, which goes beyond compliance with the provisions of the Act.” (Weatherford at para. 349)

Although Justice Phalen has tried to narrow the application of the s. 73 deemed abandonment provision, the issues of whether the duty of good faith extends to one of candour, as in the U.S., and the extent to which it can be used in litigation are still confusing and being hotly debated. Things are indeed, as admitted by Hughes J. in Mycogen, in a state of flux.

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Since the decision of the Supreme Court in (2000 SCC 66, [2000] 2 S.C.R. 1024) it is supposedly settled law that courts are to construe the claims of a patent in a purposive manner in determining infringement and invalidity. However, courts since have failed to demonstrate consistency in their application of purposive claim construction. What appears from the existing case law is a disparate collection of decisions that fuels litigation and consumes judicial resources. Some courts have kept tightly wed to claims, while others have liberally given more weight to non-claim material, even to the point of disregarding relevant claims and implying promises from the patent’s overall context. Subsequently, stakeholders are subjected to an unpredictable legal landscape with unfortunate consequences.

Firstly, the patentee is no longer confident that his invention will remain protected; a patentee can no longer read his own claims with the belief that the protection he negotiated in prosecution is that which the court will impute. Secondly, the patent system is unreasonably burdened, as competitors are encouraged to infringe patents comforted by knowing they can bring actions for invalidity premised on allegations sourced in the confusion generated by stepping outside the claims. Thirdly, the public policy purposes of maximizing certainty and predictability are compromised since one reading a patent’s claims cannot say for sure that his actions will be infringing on the patentee’s right, and so further innovative efforts are discouraged.

Ludlow and Godbout articulate the importance of accurate claim construction: “…If the boundaries of a patented invention cannot be ascertained 'with some measure of exactness' there is risk that others will stray across the line or be discouraged from seeking new or better inventions.’” (Unilever PLC v. Procter & Gamble Inc. (1995), 61 C.P.R. (3d) 499 (F.C.A.), aff'g (1993) 47 C.P.R. (3d) 479 (F.C.T.D.), cited in Gregory C. Ludlow & Anne M. Godbout, “Survey of Intellectual Property Part IV - Patents” (1998-1999) 30 Ottawa L. Rev. 117 at para. 104). It seems that the court should be more strictly wedded to claims and far less inclined to step outside of these claims to import ‘peripheral meaning’ for the purpose of gleaning the patentee’s intention. I am not advocating a return to literal claim construction, even where a claim is apparently plain and unambiguous; indeed, it is “often unsafe to conclude that a term in a claim [is] plain and unambiguous without having carefully reviewed the specification.” (J.F. Anderson, Patent Law of Canada (Scarborough: Carswell, 1994) at 190, cited in , 2007 FCA 209, [2007] F.C.J. No. 767 at para. 88).

One example of the confusion in the law can be found in the case of (2005 FC 1205). Heneghan J. of the federal trial court examined the utility of claims that covered quinapril. Pfizer argued that a purposive construction would lead to a finding that the '330 patent disclosed an invention relating to ACE inhibition. Conversely, Apotex argued that the invention only encompassed a smaller group of compounds useful in relieving hypertension and not a broader group of ACE inhibitors, some of which did not have sufficient activity to be useful in treating hypertension. Apotex argued that the disclosure limited the invention to those stereoisomers with an "S-configuration", which was known to be especially effective at treating hypertension, but that claims 3 and 5 included all stereoisomers and therefore were overly broad. The trial judge construed claims 3 and 5 of the ‘330 patent, but failed to include claim 1 of the related ‘615 patent in her analysis, pre-determining, in effect, that it was not essential. Yet the issue of infringement “depend[ed] entirely on the construction of claim 1,” (, at para. 43) since it included biochemical configurations that were covered by the ‘330 patent and that a skilled person would consider to include the drug Apotex sought to manufacture.

Heneghan J. concluded that since “claims three (3) and five (5) should be construed so as to include [all] compounds useful for reducing hypertension and [a sub-set of those compounds,] the S-configuration[,] is the optimal configuration for high level ACE inhibition leading to anti-hypertensive results, … the claims … are overly broad” (, ibid. at para. 114). In reversing the trial court’s decision, Nadon J.A. of the Federal Appeal Court insisted that, by failing to thoroughly adhere to the claims in her construction analysis, Heneghan J. did not gain the most accurate understanding of the ambit of protection to be afforded to Pfizer, and would have incorrectly allowed Apotex to infringe Pfizer’s patent. In making reference to the disclosure, which referred to the use of the invention for the treatment of hypertension, Heneghan J. determined that the relevant claims would be read as referring to compounds useful for the relief of hypertension, and not more generally useful in ACE inhibition. Yet claims 3 and 5 claimed “‘all possible stereoisomers’ of the family of claimed compounds,” which were useful in ACE inhibition, and claim 1 included the infringed compound (, ibid. at paras. 120 and 121). Importantly, also, Pfizer had not claimed use for treatment in hypertension. As such, Heneghan J. imported a therapeutic promise from the disclosure, which was not asserted in the claims. This case illustrates the dangers in a more liberal application of purposive claim construction.

By clearly demarcating the boundary of rights afforded by a patent, through stricter adherence to its claims, the court better serves the balanced interests of all stakeholders. With the current state of purposive construction members of the public cannot adequately demark the scope of protection afforded by a patent, and so are discouraged from undertaking related advancements in research. First innovators are also forced to direct more resources into legally defining and protecting those boundaries. Increased costs are then transferred to the consumer. Ultimately, the public – who is supposed to benefit – suffers.

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The US Code: Manual of Patent Exaination Procedure (35 U.S.C. § 101) provides that "any new and useful process, machine, manufacture, or composition of matter" may be patentable subject matter.[3] The business method debate has centred principally around the issue of “…usefull process…”. On May 8, 2008, the Federal Circuit heard en banc oral argument on In re Bilski, which addressed specifically the patent eligibility of business method patents.”[4] Apparently, “courts have traditionally had difficulty in determining whether ‘business methods’ are "processes" within the meaning of the Patent Act.”[5] The contemporary debate on business method patentability re-emerged in 1998 with the precedent setting decision in State Street Bank v. Signature Financial Group, where in the Federal Circuit held that business method claims were not per se unpatentable but instead subject to the same requirements as any other process, and, in particular, patentability was contingent on if the invention produced a “useful, concrete, and tangeable result.”

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The debate is not new however. Business methods have been patented for years. In 1889, the United States granted patents to Herman Hollerith for his method and apparatus that automated the tabulating and compiling of statistical information for businesses and enterprises.[6] Numerous methods have been patented since, though often in ways that creatively avoid the restrictions laid out by the respective patent offices of strict jurisdictions. At the present time, business methods are patentable in the United States, Australia, Japan, and Korea, but not in Europe including the UK, and Canada.[7] However, many BM patent applications filed in Canada are classified as “electrical digital data processing; digital computing or data processing equipment or methods specifically adapted for specific functions” or as “administrative, commercial, managerial, supervisory or forecasting purposes.”[8] According to the TRIPS agreement of the WTO, neither business methods nor software are specifically excludable subject matter for patentability.[9]

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This debate seems, in the end, unnecessary and overly lost in the particulars. There is no express restriction against patenting business methods, despite some patent offices insisting on the contrary. The statutory definition of a patentable invention is that it be novel, non-obvious, and have utility.[10] As long as the invention fulfils these criteria, there is no reason why it should not also be eligible for patent. ��

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While TRIPS is a benefit to Member States with the manufacturing capacity to sustain drug production, it represents a substantial barrier for developing and least developed countries ((L)DCs) in the context of access to medicines. ��By insisting that Member States implement strict patent protection, TRIPS ensures that patentees (largely situated in developed countries) can charge monopoly prices in markets of their choosing, and exclude generic manufacturers from producing cheaper versions for use in markets patentees have conscientiously preferred to avoid. This places a deadlock restriction on access to medicines in poor countries whose consumers substantially cannot pay monopoly prices. Additionally, these countries largely lack the manufacturing infrastructure to support domestic drug production. It is no surprise that patentees argue the impact of TRIPS will be minimal in this regard; many others insist on the contrary. Clearly, strategies need to be implemented to prevent the TRIPS status of (L)DCs from castrating humanitarian drug access regimes.��

Article 31 of TRIPS does permit compulsory licensing on domestic soil. Compulsory licensing occurs when government overrides a patent and allows a generic manufacturer (GM) to produce and sell that drug without patentee approval; it is only sanctioned for acute reasons such as emergencies or crises, is limited to the purpose for which it is authorized and is to be terminated when the motivating circumstances cease. Article 31 only permits manufacturing and distribution domestically however, and so is of no use to (L)DCs, which lack the capacity to produce their own generics. It also fails to address chronic global disease issues faced by these nations.��

Patents arguably have little to no value in poor nations. Since patentees have deliberately avoided these markets, they derive comparatively miniscule revenue from them, if any at all. Flexible patents legislation in these regions would afford little to no economic loss for them. However, Western governments and patentees continue to push for full TRIPS compliance in (L)DCs by 2016 at the latest. This lobby effort is ominous for countries and NGOs working to solve the disease crises in these nations; already anorexic humanitarian efforts will be further impeded, and the aggressive tone of patentees does not suggest that there will be any flexibility or creativity on their part in helping to support a continued global effort. ��

Certainly, the Doha Declaration (November 2001) and subsequent WTO August 2003 Decision have paved the way for Member States to issue compulsory licences for generic manufacturers to make drugs for export to (L)DCs.�� But these “relief valve” provisions, and any Western legislation that has implemented them to date, are onerous, prohibitive and functionally impotent. In fact, no (L)DC has requested the use of these provisions to date, even though the need is glaringly apparent, signaling the failure of these provisions to even closely represent an efficacious solution to the access to medicines problem. On the contrary, the alleged solutions are designed for the full TRIPS intent to remain in force, while providing placating paper promises to “persistent” humanitarian parties. The horizon is bleak for many (L)DCs. Canada must make a concerted effort to fulfill its international humanitarian obligations by amending its “access to medicines” legislation to be more accessible, inviting to (L)DCs and GMs, and able to achieve its objective; it must also press the international community to guard against the impending consequences TRIPS will pose to disadvantaged nations and the collective humanitarian access to medicines effort. ��

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Maxwell R. Morgan, “Medicines for the Developing World: Promoting Access and Innovation in the Post-TRIPS Environment” (2006), 64 U.T. Fac. L. Rev. 45 at para. 19 [Morgan].

Michael J. Trebilcock & Robert Howse, The Regulation of International Trade, 3d ed. (
London: Routledge, 2005) at 413 [Trebilcock].

Morgan, supra note 1 at para. 20.

Ibid., at para. 46.

Trebilcock, supra note 2 at 413.

Morgan, supra note 1 at para. 22.

Ibid., at para. 17.

For example, Canada’s Access to Medicines Regime (CAMR), now implemented as ss. 21.01-21.2 of the Patent Act, R.S.C. 1985, c. P-4.

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