Despite continued COVID-19 lockdowns and restrictions, 2021 has seen no shortage of Canadian judicial and patent appeal board decisions affecting the pharmaceutical industry. This article provides a recap of the “top 10” year to date decisions, which span issues relating to Canada’s Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC Regulations”), patentable subject matter (i.e., dosage regimes), obviousness and claims construction.
Scope of the Notice of Allegation (NOA)
- In Sunovion Pharmaceuticals Canada Inc. v. Taro Pharmaceuticals Inc., 2021 FC 37, the Federal Court allowed amendments to a Statement of Defence in a PM(NOC) action that went beyond the grounds of invalidity set out in the Defendant’s Notice of Allegation (“NOA”). The Court held that the purpose of the delivery of the NOA is to facilitate an early consideration of issues and arguments that may be raised in a proceeding under the PM(NOC) Regulations. The Court also considered several factors in finding that the amendments should be allowed, most of which related to the timeliness and relevance of the litigation. The decision was recently affirmed on appeal (Sunovion Pharmaceuticals Canada Inc. v. Taro Pharmaceuticals Inc., 2021 FCA 113).This represents a significant shift from the practice under the previous PM(NOC) regime in place until 2017, under which the second person was strictly limited to the allegations contained in its NOA. See our article from January 18, 2021 for more information.
- In Teva Canada Innovation v. Pharmascience Inc., 2021 FC 367, the Court stayed an ongoing patent re-examination proceeding before Canadian Patent Office until a final judgment in a related patent infringement action. To be granted the stay, Teva was required to show: (1) a serious issue to be tried, (2) that it would suffer irreparable harm if the stay were not granted; and (3) that the balance of convenience favours the stay. Notably, the Court held that this particular re-examination was akin to duplicative litigation with the risk of inconsistent results, which amounted to a non-speculative form of irreparable harm. While the decision is largely fact driven, it suggests that in the context of a stay, irreparable harm may be established where facts demonstrate the “risk” of an inconsistent result. See our article from June 2, 2021 for more information.
Certificate of Supplementary Protection (CSP) Regulations
- In Canada (Health) v Glaxosmithkline Biologicals S.A., 2021 FCA 71, the Court of Appeal considered for the first time, the Minister of Health’s (the “Minister”) interpretation of the terms “medicinal ingredients” and “a claim for the medicinal ingredient or combination of all the medical ingredients” under s. 3(2) of Canada’s Certificate of Supplementary Protection Regulations (the “CSP Regulations”). Canada’s CSP regime permits patent holders to receive up to two years of additional patent protection for approved medicines. The Minister determined that GSK’s patent relating to its shingles vaccine SHINGRIX, did not meet CSP eligibility because its claims were directed to a formulation, and not to “the medicinal ingredient or combination of all the medicinal ingredients” contained in SHINGRIX. While the Minister’s decision was set aside by the lower court (2020 FC 397), that decision was overturned on appeal, which found the Minister’s interpretation reasonable. Although the Court of Appeal was prepared to accept more than one possible interpretation of “medicinal ingredient”, the reasonableness standard did not call for an assessment of the most logical interpretation. See our article from May 4, 2021 for more information.
- In Allergan Inc. v. Sandoz Canada Inc., 2020 FC 1190, Allergan brought an action for infringement of Canadian Patent No. 2,507,002 (the “002 Patent”) against Sandoz under the PM(NOC) Regulations. At issue was Sandoz’ proposed generic of Allergan’s RAPAFLO (silodosin) product used to treat benign prostatic hyperplasia. The patent claims, inter alia, a formulation comprising “a granule prepared by wet granulation…”. Central to the case was whether “wet granulation” was an essential element of the claims as Sandoz’s product was not prepared using a wet granulation process. The Court construed the term as essential, and found Sandoz not infringing. In doing so, the Court also considered s. 53.1 of the Patent Act, only in force since 2019, that permits file prosecution history evidence to be admitted to rebut a patentee’s argued patent construction in a subsequent action. As Allergan in this instance was only a “licensee”, the Court held it was not a “patentee” within the meaning of Act, precluding the application of s. 53.1. See our article from January 12, 2021 for more information.
- In Merck Sharp & Dohme Corp and Merck Canada Inc v Wyeth LLC, 2021 FC 317, Merck sought to impeach three Canadian patents relating to Wyeth’s PREVNAR®13 pneumococcal vaccine. The central claim at issue referred to an immunogenic composition “comprising 13 distinct polysaccharide-protein conjugates…”. Merck argued that the claim was limited to exactly 13 serotypes. The Court agreed and rejected Wyeth’s argument that the claim disclosed a “platform” for making a vaccine with greater coverage. The Court held that the term “comprising” could not be given an open-ended interpretation without some other justification found in the patent. Notwithstanding, the Court rejected Merck’s obviousness allegation, finding that the skilled person would not have arrived at the invention without prolonged and arduous experimentation. See our article from June 1, 2021 for more information.
- In Janssen Inc. et al v. Apotex Inc. et al, 2021 FC 7, the Court invalidated the asserted claims of Janssen’s Canadian patent relating its cancer drug ZYTIGA (combination of abiraterone acetate and prednisone). The Court held that the claims were obvious, despite the patent previously being upheld in an earlier case under the old version of the PM(NOC) Regulations. The Court applied a restrictive interpretation of the asserted claims in part, based on definitions provided in the patent’s disclosure particularly with respect to “treatment of prostate cancer”. Based on this limited scope (which excluded palliative effects, survival benefits, mitigation of side effects, or reversal of resistance), the invention was held to be obvious in light of the prior art and common general knowledge. The decision serves as a reminder to patent applicants to be cautious when using explicit definitions in a patent description, as it may unduly limit the claim scope. See our article from January 20, 2021 for more information.
- In Janssen et al. v. The Minister of Health, 2021 FCA 25, also relating to Janssen’s drug ZYTIGA, the Court of Appeal provided clarity on the obvious to try test. While the appeal was moot (since the impugned patent had since been invalidated – see the discussion under topic 3 above), it proceeded as it could have had an impact on section 8 damages. Apotex argued that the lower court erred when applying the obvious to try test by considering “more or less self evident that it ought to work” as the overarching requirement, and leaving other factors such as extent, nature, and amount of effort required, motive to find the solution, and actual course of conduct, as mere considerations. The Federal Court of Appeal disagreed, and found that the lower court considered all the other factors as relevant for the obvious to try analysis.See our article from March 16, 2021 for more information.
Patentable Subject Matter: Dosage Regimen Claims
- In Re Amgen Research (Munich) GmbH (2021 CACP 2), the Patent Appeal Board allowed medical use claims reciting a dosage range in Amgen’s Canadian Patent Application directed to an antibody for use in the treatment of B cell non-Hodgkin lymphoma or B cell leukemia. Past decisions of the Federal Court have found that claims which require the exercise of professional skill or judgement, for example a claim containing a dosage rage, are not patentable subject matter. Notwithstanding, the Board held that the dosage regimen in this instance was patentable as there was no evidence to suggest that the claimed dosage range required the skill and judgment of a physician to administer. See our article from January 25, 2021 for more information.
- In Re Genentech, Inc. (2021 CACP 8), the Patent Appeal Board allowed medical use claims reciting a mg/kg dosage regimen. The decision follows clarification of patentable subject matter in CIPO’s guidance document (PN2020-04), which notes that in determining the patentability of medical use claims, it is necessary to consider whether professional skill and judgment is part of the actual invention. The claims at issue were directed to an antibody for treatment in breast cancer, wherein the antibody was administered pursuant to a dosage regime. The Examiner refused the claims, finding that a physician’s skill and judgment was required to exercise the full scope of the claims. The Patent Appeal Board overturned the Examiner’s decision, finding instead that the calculation of the dose at issue did not require professional judgment. The Board noted that there was no evidence that monitoring of a patient’s weight would be required, and therefore the doses were fixed. See our article from June 2, 2021 for more information.
Section 8 Damages
- In Apotex Inc. v. Eli Lily Canada In., 2021 ONSC 1588, the Ontario Superior Court considered whether a 400 year-old English Statute of Monopolies was applicable in the determination of damages under Canada’s PM(NOC) drug regime. The Court determined that the English Statute (along with an analogous Ontario statute and the common law) were not applicable. The Court held that Canada’s Patent Act and the PM(NOC) Regulations constitute a “complete code” which precludes causes of action arising from the operation of that code. Effectively, the decision limits a generic company’s recoverable damages caused by operation of the PM(NOC) Regulations to those pursuant to section 8 of those regulations. See our article from March 24, 2021 for more information.