2022 Year in Review: Life Sciences
February 15, 2023
By Luba Naiberger, Jessica Sudbury, Nyrie Israelian, Noel Courage
The Canadian life sciences patent news was diverse and non-stop the past year. Here is our update on all that you need to know.
Patentable Subject Matter - Dosage Regimen Claims
The issue of what constitutes a patent-ineligible method of medical treatment in the dosing area remained a hot topic in 2022, and there was some good news for patent applicants. Progress was made in several Patent Appeal Board (PAB) and Federal Court cases. In general, medical use claims containing a dosage or dosing regimen are not patentable subject-matter if the exercise of professional skill and judgment of a medical professional is part of the claimed invention.
The PAB allowed medical use claims reciting a dosage range (for treating osteoporosis or stimulating bone growth). The PAB held that there was nothing in the description that indicated that the claimed doses within the range would not all work for all subjects falling within the patient group. The dosage was also not selected based on any patient-specific features. This decision reinforces that a dosage range is patent eligible.
The Federal Court upheld as patentable the claims directed fixed dose amounts, fixed intervals and fixed injection sites with elements involving choices such as dosing windows and injection sites for the maintenance dose. Fixed dose amounts are typically patent-eligible. It is helpful for applicants that this court case addressed a claim with additional choices.
In another case, the PAB initially concluded that claims directed to treating a variety of conditions, containing a range of doses and time intervals were not patent-eligible subject matter. The PAB held that the claims encompassed the exercise of skill and judgment of a medical professional. The only claims allowed by the PAB were claims directed to specific conditions with fixed dosage regimens and timing.
The PAB allowed medical use claims including a fixed dosage regimen and a treatment period of either “at least 6 months” or “at least 12 months”. The PAB concluded that the decision by a physician to stop treatment would be outside the scope of the claims. It is helpful to applicants that dosage regimens involving a time limitation were confirmed to be patent-eligible.
In a positive decision for patent owners, the FCA declared Canadian Patent Nos. 2,461,202 and 2,791,171 valid. Both patents are directed to Factor Xa inhibitors and apixaban compounds marketed as ELIQUIS. Pharmascience appealed on the basis that the ‘202 patent was not a proper selection patent over Canadian Patent No. 2,349,330 because it failed to disclose any special advantage compared to the ‘330 patent. This argument was rejected because “[t]here is no requirement for a selection patent to discuss the special advantages of the selection over the genus in any particular way”. At any rate, a special advantage could be disclosed by inference in the ‘202 patent. Pharmascience filed an application for leave to appeal to the Supreme Court on October 21, 2022.
In another case upholding a patent, it was found that simultaneous, independent invention by another person does not necessarily indicate obviousness. A key feature of the patented invention was present but not made available to the public prior to the claim date in a competitor’s modules. The fact of another skilled person making the invention as of the claim date, albeit not publicly, did not indicate obviousness. The conception of a simultaneous invention can in some cases require the exercise of inventive ingenuity.
In a welcome decision, the Federal Court of Appeal provided a clear statement that recourse to the disclosure is always permissible in a purposive claim construction. The Court found that “the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims”.
Prior Use Defence to Patent Infringement
The Federal Court provided the first interpretation of the recently amended Patent Act provisions relating to the prior use defence to claims of patent infringement. The amended section 56(1) grants a person who, in good faith, committed an “act” that would otherwise infringe a patent claim (or made serious and effective preparations to commit such an act), the right to commit “the same” act without being liable for patent infringement. In this decision, the Court laid out the process to be followed in considering whether the subsection 56(1) defence applies:
- First, if the acts being performed pre- and post-claim date are identical (other than wholly non-functional changes), then subsection 56(1) applies.
- If the acts are not identical, the analysis gets complex. The Court must determine whether the acts infringe the patent, and if they do, which claims. If the post-claim date acts do not infringe the patent, then there are no “otherwise infringing acts” and therefore no need to rely on subsection 56(1). If the pre-claim date acts do not infringe the patent, subsection 56(1) cannot apply. If the post-claim date acts infringe a particular patent claim that the pre-claim acts do not, subsection 56(1) cannot apply.
- Finally, if the pre- and post-claim date acts are not identical but only infringe the same claims, the Court must determine whether the changes relate to the inventive concept of the patent. If they do not, then subsection 56(1) will apply.
PMNOC Litigation / Patent Register
Canada has linkage regulations, called PMNOC regulations, which can require generic and biosimilar companies to address certain innovator company patents for a medicine as part of the regulatory approval process. The goal of these regulations is to prevent patent infringement. A generic or biosimilar company cannot get its marketing authorization until after the patent issues have been cleared.
It is important for patent owners to list patents with Health Canada on its Patent Register in order to take advantage of the PMNOC Regulations. A recent case showed that the listing timelines are very strict and non-extendable. Merck’s patent list was submitted to Health Canada after the expiry of the 30-day listing deadline. Merck’s application for leave to appeal the Federal Court of Appeal’s decision refusing listing was dismissed without reasons.
Competition Law and Pharma Patents
In an unusual case, an Ontario court considered competition law remedies under the Statute of Monopolies. The Court dismissed Apotex’s appeal of a rejected claim for treble damages under the Statute of Monopolies and disgorgement of Eli Lilly’s profits. Apotex had also sought damages for false or misleading claims under the Trademarks Act and damages for the common law tort of civil conspiracy. The basis of the issue was that Eli Lilly had listed Canadian Patent No. 2,041,113 on the Patent Register and prevented Apotex from marketing generic versions of its olanzapine products under the PM(NOC) Regulations. Apotex had lost its PMNOC case to get marketing authorization. However, Novopharm subsequently invalidated the ‘113 patent in its own, separate proceeding. In light of that outcome, Apotex brought an unsuccessful motion for reconsideration of the judgment against it. After that did not succeed, Apotex then headed to the Ontario court. The case did not work out for Apotex because the Ontario Court of Appeal held that the PM(NOC) Regulations provide a single remedy for successful challenges to patent registration by a generic manufacturer.
Patented Medicine Prices Review Board (PMPRB)
The contentious amended Patented Medicines Regulations (the Regulations) came into force on July 1, 2022. The Regulations now include a new basket of comparator countries, omitting the United States and Switzerland, and reduced reporting requirements for medicines at lower risk of excessive pricing.
In other PMPRB news, the Supreme Court of Canada declined to hear the PMPRB’s appeal of a case that reined in the scope of PMPRB’s jurisdiction. The Federal Court of Appeal held that the Canadian Patented Medicines Prices Review Board must stay within its mandate of preventing excessive pricing. The Board does not have the power to pursue a more general mandate of ensuring reasonable pricing, price regulation, or consumer protection at large.
Data Protection (Exclusivity)
The data protection rules aim to protect and reward innovator drug makers by preventing unfair competitor use of innovator data generated for regulatory approval. The Federal Court clarified that the data protection rules contain two clear and distinct prohibitions. The first is the “approval prohibition”: if a manufacturer seeks a NOC for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug, using the innovative drug’s data, that submission will not be approved before the end of six years after the day on which the first NOC was issued in respect of the innovative drug. The second is the “issuance prohibition”: an NOC will not be issued in respect of the new drug before the end of a period of eight years after the day on which the first NOC was issued in respect of the innovative drug. The FC also clarified that the issuance prohibition is not dependent on the approval prohibition for its application and that the evaluation of a possible comparison which an innovative drug is assessed continuously until the NOC is issued.
 Ipsen Pharma S.A.S. 2022 CACP 11.
 Janssen Inc. v. Pharmascience Inc.,  FC 1218.
 Merz Pharma GMBH & Co. KGAA, 2022 CACP 3.
 Biogen MA Inc. 2022 CACP 2.
 Kobold Corporation v NCS Multistage Inc., 2021 FC 1437.
 Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden and the United Kingdom.
 Catalyst Pharmaceuticals, Inc. v. Canada (Attorney General), 2022 FC 929
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