2023 Year in Review: Life Sciences
Once again, 2023 saw much action in Canadian life sciences patent news. Here we provide a summary of some of the key updates and decisions that you should know.
Federal Court (FC) and Federal Court of Appeal (FCA) Decisions
Test for Inducing Infringement for Pharmaceutical Medicines
In overturning a decision made by the FC, the FCA in Teva Canada Limited v Janssen Inc[i] clarified the three-pronged test for inducing infringement particularly in regard to generic/biosimilar drugs. The three-pronged test for inducing infringement of a patent is as set out in Corlac Inc v Weatherford Canada Inc, (Corlac)[ii] where the patentee is required to establish that:
i. the act(s) of infringement must have been completed by the direct infringer;
ii. the completion of the act(s) of infringement were influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place; and
iii. the influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement.
Focusing on the second prong of the test, the FC found that the decision in Corlac set out a more stringent test than had previously been required in that a defendant will now not be found to induce infringement of a patent unless the patentee establishes that, “but for” the acts of the defendant, the infringement did not occur. In its review of this decision, the FCA found that the FC’s interpretation of the test for inducement applied an unduly onerous requirement at the second step. The FCA clarified that the decision in Corlac did not change the law regarding the requisite element for inducing infringement and, at the second step of the analysis, what is required is proof that the putative infringer influenced the party that directly infringes to the point that, without such encouragement, infringement would not occur. In the case of a generic drug (such as Teva’s product), “inclusion as one of the recommended uses within the product monograph for the drug of the alleged infringing use, among others, has been found to be sufficient to constitute the requisite encouragement to satisfy the second prong of the test for inducement”. It does not matter that physicians use their own skill and judgment in dispensing the drug, nor that they must make an active choice to perform the infringing use.
Obviousness of Dosage Regimens
The FCA in Eli Lilly v Apotex [iii] dismissed Eli Lilly’s appeals of judgements that held their patent covering the use of oral pharmaceutical unit dosage forms containing tadalafil (marketed as “Cialis™”) for the treatment of erectile dysfunction invalid. Eli Lilly had brought four infringement actions against Apotex, Pharmascience/Riva, Mylan, and Teva, all of whom counterclaimed for invalidity of the patent. The Trial Judge found that infringement had been established if the claims had been found valid, but the patent was deemed invalid on grounds of anticipation and obviousness.
On appeal, Eli Lilly argued that the Trial Judge erred in the construction of the inventive concept in their obviousness analysis and proposed their own. The FCA concluded that even if Eli Lilly’s proposed inventive concept was accepted, the finding on obviousness still stands. As a part of the obviousness analysis, the Trial Judge found that drug dosage testing of tadalafil for the treatment of erectile dysfunction was routine work with respect to the prior art. Fortunately, the FCA made it clear that although this finding was true in the case at hand, the statement should not be endorsed at large and that “there may be cases where dosage selection is not routine.”
Enantiomers are not eligible for Data Protection
In January 2023 the FC dismissed a judicial review application from Janssen[iv] concerning data protection for the drug Spravato™ for the treatment of Major Depressive Disorder. Spravato™ contains esketamine hydrochloride, an enantiomer of ketamine hydrochloride, which had been previously approved by the Minister of Health. According to the Food and Drug Regulations, enantiomers do not qualify as an innovative drug and are thus not eligible for data protection.
Janssen was unsuccessful in arguing that the implementation of the Canada-United States-Mexico Agreement (CUSMA) changed the language for conferring data protection from “utilize new chemical entities” to “do not contain a chemical entity that has been previously approved”. Ultimately, the FC concluded this did not change the definition of “innovative drug” which, under the previous treaty (NAFTA) intentionally excluded enantiomers.
This case serves as an important reminder that legislative definitions such as “innovative drugs” which intentionally exclude entities such as enantiomers trump any arguments based on legislative intent. As it stands, enantiomers continue to be ineligible for data protection.
Patented Medicines (Notice of Compliance) (PM(NOC)) Regulations
Canada has linkage regulations, called PM(NOC) 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.
No Section 8 Liability When Generic’s Allegations are Unsuccessful
Section 8 of the PM(NOC) regulations outlines the financial remedy available to generic or biosimilar drug companies for being wrongly held off the Canadian market as a result of regulatory proceedings initiated by the innovator drug companies.
In Apotex v Eli Lilly [v], the Ontario Superior Court held that Apotex was not entitled to claim damages under section 8 of the PM(NOC) Regulations with respect to Eli Lilly’s patent for atomoxetine. Moreover, the Court ruled Apotex had not sustained any damages because it would not have entered into the market any sooner in the hypothetical damages world than it did in the real world.
Apotex served Eli -Lilly with a Notice of Allegation with respect to Eli Lilly’s patent for atomoxetine after Teva had already commenced an impeachment action against the same patent. In response, Eli Lilly commenced a prohibition application against Apotex. In the impeachment action, which was heard before the prohibition application, the Federal Court found the patent to be invalid. Consequently, the Federal Court then dismissed the prohibition action against Apotex for mootness, but not before expressly stating that allegations of invalidity made by Apotex in its NOA were not justified and that the prohibition application would have been successful.
The Ontario Superior Court found that because prohibition application against Apotex would have been successful, Apotex was not entitled to claim section 8 damages and that permitting Apotex to seek damages in these circumstances would allow it to be a “free rider” on Teva’s accomplishment in the impeachment action. The Ontario Superior Court further found that Apotex did not suffer any damages during the time period for which it made its claim.
Transfer Of Ownership of New Drug Submission Does Not Require Service of a New Notice Of Allegation
In Bayer Inc. v BGP Pharma ULC (Viatris Canada),[vi] Bayer and Regeneron submitted to the Federal Court, an application for judicial review of a decision of the Minister of Health which upheld the Minister’s decision that a new owner of a New Drug Submission (NDS) could adopt the steps previously taken by the previous owner (Viatris) to comply with the PM(NOC) Regulations, including service of the Notice of Allegation (NOA).
Viatris transferred ownership of their NDS to a third party after an action against Viatris had been already commenced by Bayer and Regeneron under the PM(NOC) Regulations. Bayer and Regeneron argued that the new owner was required to serve a new NOA. The Minister disagreed and advised that new owner can adopt an NOA served by the previous owner under the Regulations and requested that the new owner be added as defendant to the action.
The Federal Court upheld the Minister’s decision as reasonable and found the transfer of the NOA aligns within the scheme and objectives of the PM(NOC) Regulations.
Certificates of Supplementary Protection (CSP) – “Authorization for sale”
The CSP regime provides up to 2 years of additional patent protection for new pharmaceutical products protected by an eligible patent in certain circumstances where there has been a delay in obtaining marketing approval. Since its implementation in 2017, 122 CSP application have been filed with Health Canada (101 issued, 14 refused, 2 pending and 5 withdrawn).
This past year Health Canada released three updated versions of the Guidance Document: Certificates of Supplementary Protection. Notably, in the May 12, 2023 update,[vii] changes to the definition of “authorization for sale” were made to reflect changes to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations.
To be eligible for a CSP, certain conditions must be met including that an “authorization for sale” issued in respect of a medicinal ingredient or combination of medicinal ingredients in a drug is the first “authorization for sale” for that drug. The definition of “authorization for sale” in the CSP regulations was amended exclude certain limited purpose drug authorizations, including, for example, authorizations to sell a drug for emergency treatment, authorization of a COVID-19 drug for the purposes of a clinical trial, and the sale of a drug imported into Canada to address an urgent public health need, including a drug shortage.
PMPRB Adopts Amended Interim Guidelines to Expedite New Patented Medicine Price Reviews
Due to a backlog in review of new medicine pricing, the Patented Medicine’s Pricing Review Board (PMPRB) proposed and ultimately adopted an Amended Interim Guidance to expedite the assessment of price filings for new medicines and to aid in providing some predictability and consistency until a full guideline is released. The Amended Interim Guideline[viii] indicates that unreviewed new medicines in the backlog will be considered as “reviewed” if their list price is below the median international price for the “PMPRB11” basket of comparator countries (i.e. Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom). New medicines that do not meet this criterion would continue to be “under review” until the new guidelines are in place. The Amended Interim Guidance took effect in September 2023 and the PMPRB intends to finalize the new guidelines in 2024.
Antibody Claim Construction
While this is a review of Canadian patent law, we would be remiss if we did not mention perhaps the most talked about decisions in Life Sciences patent law that came out of the United States and Japan last year and their potential impact on Canadian law.
The Supreme Court of the United States (SCOTUS)[ix] and the Japanese IP High Court both issued decisions which require functional claims to a broad group of antibodies need to include support for members across the full scope of the group.
The decisions both relate to patents held by Amgen which broadly claimed a genus of antibodies that bind PCSK9. The U.S. patents concerned “the entire genus” of antibodies that bind to specific amino acids on PCSK9 while the Japanese patent was directed to any monoclonal antibody capable of neutralizing the binding of PCSK9 to LDL receptors and which competes with the 21B12 antibody.
In both instances the patents were declared invalid for a lack of support. In the U.S. the claims were deemed to be much broader than the 26 antibodies described by Amgen and that scientists would be forced to engage in painstaking experimentation to find antibodies that work. In the Japanese decision the IP High Court found that the specification did not disclose how any antibody could neutralize binding of PCSK9 to LDL receptors and thus did not support a claim to “any” antibody. The Court commented that the inclusion of a mechanism may have been enough to save the patent.
Functional claims to antibodies, which are preferable for strong patent rights as they are more difficult to design around, are allowable in other major jurisdictions such as Europe, South Korea and Australia. In Canada, the enablement requirement is fulfilled for antibody claims if the skilled person would be enabled to produce an antibody according to the claims without displaying inventive ingenuity or undertaking undue experimentation. It remains to be seen whether the U.S. and Japanese Amgen decisions will influence how life science patent enablement is assessed before Canadian courts.
[i] Teva Canada Limited v Janssen Inc, 2023 FCA 68
[ii] Corlac Inc v Weatherford Canada Inc, 2011 FCA 228
[iii] Eli Lilly v Apotex, 2023 FCA 125
[iv] Janssen Inc. v Canada, 2023 FC 7
[v] Apotex v Eli Lilly, 2023 ONSC 1968,
[vi] Bayer Inc. v BGP Pharma ULC (Viatris Canada), 2023 FC 1325
[vii] https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates/certificate-supplementary-protection-regulations.html#a2271
[viii] https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/interim-guidance.html
[ix] Amgen Inc. et al. v. Sanofi et al. 598 U.S.____ (2023)
