Canadian courts issued many life sciences decisions in 2022. This article summarizes a number of the more notable court decisions, as well as other life sciences-related developments from 2022.
- Decisions under the PM(NOC) Regulations
- Dismissal of Statutes of Monopolies claim affirmed on appeal
- Federal Court confirms requirement to market to benefit from patent listing
- Amendments to the Patented Medicines Regulations
- Five years of Certificates of Supplementary Protection
- New rules and procedures for patent applicants
1. Decisions under the PM(NOC) Regulations
Various decisions in respect of infringement and invalidity were released in actions commenced under subsection 6(1) of the PM(NOC) Regulations. We report on four of these below, as well as one interlocutory decision of interest.
The decision of the FCA in Pharmascience v Bristol-Myers Squibb,(2022 FCA 142) relating to a patent covering the anticoagulant medicine apixaban confirmed the validity of two patents against various invalidity attacks. Of particular note was Pharmascience's insufficiency allegation, which contended that the application as filed, rather than the patent as granted, was to be considered for the purpose of insufficiency, and thus that claims that were amended during prosecution to the compound apixaban itself were not to be considered for the purpose of insufficiency. Pharmascience argued that the application as filed, which did not contain specific claims to the compound apixaban, did not disclose an invention as of the patent's filing or publication date. The FCA rejected Pharamscience's argument, distinguishing between the date for determining insufficiency and the document in respect of which insufficiency is to be assessed (namely, the patent as granted).
In Janssen v Apotex, (2022 FCA 184) the FCA addressed an appeal concerning the validity of a patent held by Janssen that related to the treatment of prostate cancer by co-administration of abiraterone acetate and prednisone. The decision is noteworthy in respect of the FCA's willingness to find, in three instances, that the reasons and Judgment of the underlying Federal Court decision contained erroneous statements – all said to constitute "slip[s] of the pen" – and the FCA's willingness to seemingly "correct" these errors under Rule 397(2). Ultimately the appeal was dismissed, with Janssen's patent found to be obvious.
A trial level decision finding infringement and dismissing argument of invalidity in respect of a patent covering Merck's JANUVIA product was released in Merck Sharp Dohme v Pharmascience (2022 FC 417). The patent at issue claimed, inter alia, an enantiomer of a particular salt and crystalline form of the active ingredient sitagliptin. That this subject matter resulted in beneficial properties over sitagliptin in free base form was held to be the patent's inventive concept. As the prior art relied upon by the defendant Pharmascience did not lead to the compound sitagliptin in particular, nor to the specific salt or crystalline form claimed much less its beneficial properties, the claimed subject matter was not obvious to try and Pharmascience's obviousness defence failed.
The decision of Janssen v Apotex, (2022 FC 996) related to infringement via inducement. The patent at issue claimed, generally speaking, the use of the active ingredient macitentan in combination with another medicine, namely a PDE5-inhibitor. The indication in the Product Monograph of both the innovator (Janssen) and the infringer (Apotex) seemingly did not speak of the combination, though Apotex's specific proposed indication is redacted. The case turned primarily on the second prong of the three-part inducement test – whether the acts of direct infringement are influenced by the acts of the inducer to the point that, without the influence, direct infringement would not take place. With the majority of the use of macitentan being in combination with a PDE5-inhibitor, and with Apotex's product monographreferring, inter alia, to a landmark clinical study which established that macitentan is safe and effective in combination with PDE5-inhibitors, the Court found infringement via inducement.
Bayer v Sandoz, (2022 FC 1187) was an interlocutory decision that related to an attempt by the second person to overhaul its invalidity defence late in a proceeding following a change in solicitors. This included the attempted late introduction of an obviousness allegation based on 38 pieces of alleged prior art. Recognizing the prejudice that such an amendment could have on the first person, the Court granted leave to Sandoz to file its proposed amended defence, but held that doing so in respect of many of the proposed defences would result in the trial being adjourned, with a commensurate extension of the 24-month statutory stay.
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2. Dismissal of Statutes of Monopolies claim affirmed on appeal
In Apotex v Eli Lilly Canada, (2022 ONCA 587) the Ontario Court of Appeal affirmed a decision of the Ontario Superior Court which rejected claims by Apotex for: (i) treble damages under the U.K. and Ontario Statutes of Monopolies; (ii) damages or an accounting of profits under the Trademarks Act; and (iii) damages via the tort of conspiracy. The claims sought monetary remedies for time in which Apotex was allegedly kept from marketing a generic version of the medicine olanzapine due to both the operation of the PM(NOC) Regulations, promulgated under the Patent Act, and a court order adverse to Apotex that was issued under the PM(NOC) Regulations.
Each of Apotex's claims were rejected on their individual merits. The claims were also rejected as a collective whole as they were based on alleged harm caused by the operation of law rather than the Defendants, because the Defendants' actions were authorized by law, and because the governing statutory scheme constituted a complete code that did not allow for the remedies sought by the Plaintiffs.
This case represents the first final appellate decision issued in a series of similar cases brought before the Ontario and Quebec Superior Courts.
Please see this article for a summary of the underlying Ontario Superior Court decision.
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3. Federal Court confirms requirement to market to benefit from patent listing
In AbbVie Corporation v Canada (Health), (2022 FC 1209) Justice Justice Fothergill of the Federal Court upheld the Minister of Health's finding that innovator pharmaceutical companies must actively market their drugs in Canada in order to benefit from Canada's patent linkage regime.
The Federal Court agreed with the Minister of Health's interpretation of s. 5(1) of the PM(NOC) Regulations in concluding that the reference to a "drug" must be DIN-specific. Consequently, JAMP was not a "second person," and JAMP was not required to address AbbVie's patents linked to its highly successful biologic drug HUMIRA before JAMP could come to market with its SIMLANDI biosimilar product.
This case establishes that patent enforcement under the PM(NOC) Regulations is available to innovators that market their innovative drugs on a DIN-by-DIN basis in Canada. Both the Federal Court and Health Canada have reiterated that there is an explicit marketing requirement under s. 5(1). Drugs that have not been made available for sale or have been withdrawn from the market such that the DIN is cancelled or dormant will, according to this case, not be considered to be marketed in Canada. An appeal by AbbVie is pending.
Please see this article for a more detailed summary of this decision.
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4. Amendments to the Patented Medicines Regulations
The amendments to the Patented Medicines Regulations came into force on July 1, 2022, after multiple deferrals during the COVID-19 pandemic. However, the government only proceeded with a portion of the previously announced amendments, namely the change to the basket of comparator counties, and reduced reporting requirements for certain medicines.
In April 2022, the Minister of Health announced that, after consultations with stakeholders, the government would not be proceeding with the other previously announce amendments, including the new mandatory factors and the new price calculation for patented medicines. The Minister's announcement also came after the Court of Appeal of Québec's decision, in February 2022, striking down the new mandatory factors and new price calculations, holding those amendments to be ultra vires.
As a result of the amendments coming into force, the basket of comparator countries now includes 11 countries, namely Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, and the United Kingdom. Two countries were removed from the basket of comparator countries, namely Switzerland and the United States.
In Oct. 2022, the Patented Medicines Price Review Board released for consultation the new draft guidelines to give effect to the amendments. The consultation period expired in Dec. 2022. New guidelines are expected to be implemented in 2023.
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5. Five years of Certificates of Supplementary Protection
September 2022 represented five years since Canada's introduction of the Certificate of Supplementary Protection regime. CSPs provide for a maximum two-year term of protection for patents relating to new medicinal ingredients, provided that the regulatory approval is sought in Canada within one year of other major jurisdictions. Coincidentally, 2022 marked the filing of the 100th CSP Application, suggesting a rapid introduction of new medicines into Canada.
Despite an initial uptick in Judicial Review Applications regarding rejected CSP Applications, along with some pushback from the Federal Court in previous years (see here), there was not much judicial commentary on CSPs in 2022. Notably, the Federal Court has not yet been asked to determine the validity of a CSP, though as many of the drugs associated with CSPs exit their six-year "no file" data protection period in the coming years, we expect to see an uptick in challenges to CSP validity.
Overall, CSP applications have exhibited a high approval percentage, and generally benefit from the full two-year period of protection. The vast majority of CSP applications are based upon regulatory submissions for human use, with only five CSP applications filed for veterinary use products. As for subject matter of the CSP, monoclonal antibodies and small molecule inhibitors led the way as the two most common medicinal ingredient types underlying a CSP application.
Some additional "fun facts" on the first five years of CSPs in Canada can be found here.
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6. New rules and procedures for patent applicants
Amendments to Canada's Patent Rules regarding excess claim fees and Requests for Continued Examination (RCE) came into force in 2022. In particular, for applications for which a request for examination was made on or after October 3, 2022:
- The fee for each claim in excess of 20 is $100 CAD or $50 CAD for a small entity. As a multiple dependent claim counts as one claim, applicants may wish to make use of such a type of claim to increase scope of coverage while minimizing costs;
- For an applicant to continue examination after three examination reports (office actions), an applicant must file an RCE and pay a fee of $816 CAD or $408 CAD for a small entity. After the first and any subsequent RCEs, two examination reports may issue before a further RCE must be filed; and
- Where an examiner considers an application allowable subject to the applicant addressing minor defects, a conditional notice of allowance may be issued. The conditional notice of allowance would requisition the applicant to address the defects and pay the final fee, failing which the conditional notice of allowance may be withdrawn and examination may be continued.
For more information regarding these changes, please see this article.
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If you wish to learn more or have any questions, you can contact a member of our Life Sciences Group.