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Patents - General. Nova Chemicals Corporation v. Dow Chemicals Company
In Nova Chemicals Corporation v. Dow Chemicals Company (Fed CA, 2020) Stratas JA of the Federal Court of Appeal briefly states the 'patent bargain':[11] Broadly speaking, the Patent Act, R.S.C. 1985, c. P-4 enshrines and regulates a bargain made between inventors and the public: inventors disclose their inventions for the good of all, including the public and later inventors, and, in return, they are given a powerful monopoly for a period of time to exploit their invention. If the Patent Act did not do this, one would expect that many inventors would keep their inventions secret, depriving all of knowledge and know-how that can be built upon. Over time, one would expect fewer discoveries and, thus, fewer benefits for society. The Supreme Court and this Court have repeatedly explained this patent bargain in cases such as Free World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 at para. 13 and Apotex Inc. v. Merck & Co. Inc., 2015 FCA 171,
[2016] 2 F.C.R. 202 at para. 42 (Apotex FCA (2015)). . McCain Foods Limited v. J.R. Simplot Company
In McCain Foods Limited v. J.R. Simplot Company (Fed CA, 2021) the Federal Court of Appeal considers the nature of patent law:[72] Canada’s patent regime is wholly statutory: Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265, at para. 12. While there are aspects of Canadian patent law that are not provided for explicitly in the Patent Act, or any other statute, and have been developed instead through jurisprudence (inducing patent infringement itself being a good example), all such aspects must be based on a statutory text.
[73] As indicated above, inducing patent infringement is simply a form of infringement, not a separate tort. Therefore, the statutory foundation for a claim of inducing infringement is the same as that for direct infringement: subsection 55(1), which is reproduced at paragraph 61 above. . Apotex Inc. v. Eli Lilly Canada Inc.
In Apotex Inc. v. Eli Lilly Canada Inc. (Ont CA, 2022) the Court of Appeal set out some aspects of the statutory patent regime:(i) Patent Regulatory Regime
[7] Before I set out the specific factual background, it is helpful to briefly explain the patent regulatory context in which the relevant events giving rise to these proceedings took place and which informs the issues on this appeal. I refer to only those regulatory provisions[1] that are particularly relevant to the issues on appeal.
[8] Patent law is “wholly statutory” with “no inherent common law right to a patent”, with the result being that “[a]n inventor gets his patent according to the terms of the Patent Act, no more and no less”: Apotex v. Sanofi-Sythelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265, at para. 12; Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, 1963 CanLII 2 (SCC), [1964] S.C.R. 49, at p. 57.
[9] Patents are granted under s. 27 of the Patent Act as an approved new invention for a specific term. In the case of Eli Lilly’s patent, the term was for 20 years from the filing date in accordance with s. 44. Section 43(2) provides that “[a]fter the patent is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the patentee and the legal representatives of the patentee for the term mentioned [in this case] in section 44”. An “early working” exception under s. 55.2(1) of the Patent Act allows a generic drug company to develop copycat drugs before the expiry of a patent. See: AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, at para. 15.
[10] The PM(NOC) Regulations were enacted pursuant to s. 55.2(4) of the Patent Act to prevent patent infringements by persons who take advantage of the “early working” exception set out in s. 52.2(2). The regulatory scheme under the PM(NOC) Regulations creates a Patent Registry within the Ministry of Health (“MOH”) in which an innovator drug company may list its patents. See: AstraZeneca, at paras. 15-17.
[11] Once a competitor’s patent is listed on the Patent Registry, a company may only bring a generic version of the drug to market before the expiration of the patent if that patent is declared invalid. A patent or any claim in a patent may be declared invalid or void by the Federal Court at the request of the Attorney General of Canada or any “interested person”, including a generic drug company: Patent Act, s. 60(1). Under s. 5 of the PM(NOC) Regulations, a generic drug company may also allege that a patent is invalid by filing a submission for a notice of compliance (“NOC”) containing the allegation and serving a notice of allegation (“NOA”) on the patent holder.
[12] The NOA generally triggers the commencement of a proceeding by the patent holder to the Federal Court under the provisions of s. 6 of the PM(NOC) Regulations to prohibit the issuance of an NOC to the generic drug company (the “prohibition proceeding”). The mere initiation by the patent holder of its prohibition proceeding freezes ministerial action for 24 months under s. 7 of the PM(NOC) Regulations, unless the prohibition proceeding instigated by the patent holder is earlier disposed of, which apparently is rare. See: AstraZeneca, at para. 17.
[13] If the allegations of patent invalidity are found to be unjustified and the patent holder is successful in the prohibition proceeding, the issuance of the generic drug company’s NOC is prohibited until the occurrence of the latest of the events listed under s. 7(1) of the PM(NOC) Regulations, including the expiration of the patent.
[14] If a patent, or part of a patent, is declared invalid or void, s. 62 of the Patent Act provides that it shall be held “to have been void and of no effect, unless the judgment is reversed on appeal”. Section 8 of the PM(NOC) Regulations allows a generic drug company to apply for compensation from the patent holder for loss caused by the statutory stay in the event that a patent holder fails in the prohibition proceeding.
[15] The Food and Drugs Act, R.S.C., 1985, c. F-27 governs the safety, efficacy, and approval of drugs for marketing in Canada. A drug cannot be marketed unless and until the MOH issues an NOC under s. C.08.004 of the Food and Drug Regulations, C.R.C., c. 870. Innovator drug companies must submit a New Drug Submission in support of their request for an NOC. Generic drug companies may submit an Abbreviated New Drug Submission (“ANDS”) to the MOH where they seek an NOC for a drug that is the pharmaceutical equivalent of a previously approved drug. . ViiV Healthcare Company v. Gilead Sciences Canada, Inc.
In ViiV Healthcare Company v. Gilead Sciences Canada, Inc. (Fed CA, 2021) the Federal Court of Appeal considers interpretation and standard of review issues in a patent dispute [paras 54-69].
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