Happy New Year from Pharma in Brief!
Reflecting back on 2017, the only constant over the last year was change, with the implementation of CETA, the rejection of the Promise Doctrine and proposals for reform of various regulatory regimes. We have compiled our list of top headlines below.
- Major changes to regulatory framework for pharmaceutical industry. The implementation of the Comprehensive Economic and Trade Agreement Act on September 21, 2017 brought two major changes to industry: a single-track pharmaceutical patent litigation regime under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC)) and up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations (CSP). Both regimes are in their infancy and the full extent of the impact remains to be seen. However, the first court action under the newly amended PM(NOC) Regulations was commenced on December 11, 2017 and CSP applications are being posted to the CSP Register.
- Changes coming to PMPRB oversight. Proposed amendments to the Patented Medicines Regulations and a scoping document have been released. Potential changes include empowering the PMPRB to consider pharmacoeconomic information when determining excessive pricing, require broader disclosure of price adjustments and rely on a revised group of international comparators. Amended Regulations and Guidelines are expected in January 1, 2019.
- End of the Promise Doctrine. In a landmark decision and a significant win for patentees and pharmaceutical innovation in Canada, the Supreme Court rejected the “promise doctrine” as a basis for invalidating patents for lack of utility. In its first application of the decision, the Federal Court of Appeal rejected an overarching promise for enzyme inhibition and therapeutic use, refused to expand the subject matter beyond what the claim states and held that enzyme inhibition is “doubtlessly a useful discovery.
- Obviousness. The Federal Court of Appeal commented on the framework for analyzing obviousness twice in 2017, first by stating that the “inventive concept” is not materially different from “the solution taught by the patent,” which has often been treated as synonymous with “what is claimed” or simply “the invention” and second, by characterizing the search for an “inventive concept” in the obviousness analysis as an “unnecessary satellite debate”.
- Health Sector Payment Transparency Act. Bill 160, which includes the Health Sector Payment Transparency Act, has received Royal Assent in Ontario. Although the Act is not yet in force and many details will be released in yet to be published regulations, the Act will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations.
- Section 8 damages. For the first time, in 2017 the Federal Court disentitled compensation under s. 8 on the basis of infringement of a patent. The Court rejected the argument that, as liability for section 8 damages had already been established, it was not open to the court to redetermine the issue and maintained it has a broad discretion under subsection 8(5) to consider all circumstances bearing on the section 8 claim and the ability to craft an appropriate remedy.
- Proposal for abbreviated ANDS pathway. In July, Health Canada sought input on potential changes to the Food and Drug Regulations that would allow different salts, esters and complexes of the medicinal ingredient and generic drug products with different but comparable dosage forms to be approvable by way of an abbreviated new drug submission.
Pharma in Brief would also like to acknowledge the unexpected passing of Barry Sherman, the founder and visionary behind Apotex, in December, 2017. The impact of Dr. Sherman’s death on Apotex and the generic industry in Canada remains to be seen.