Hard to believe, but we are halfway through 2017 already! It has been a busy six months, with major developments, including Canada preparing to implement CETA and the Supreme Court of Canada abolishing the “Promise Doctrine.” Below, Pharma in Brief has compiled the top headlines so far this year.
The Big Three:
Utility and the promise of the patent. In a landmark ruling, the Supreme Court of Canada has rejected the “Promise Doctrine” as a basis for invalidating patents for lack of utility.
Canada awaits CETA implementation. Bill C-30 – the act intended to implement the Comprehensive Economic and Trade Agreement (CETA) into Canadian law – will bring significant change to the pharmaceutical industry as it provides for certificates of supplementary protection for patents relating to pharmaceutical products and for proceedings under the Patented Medicines (Notice of Compliance) Regulations (Regulations) to proceed as full actions that will result in final determinations of patent infringement and validity. Draft regulations for both have been released, but are not yet in force. The Federal Court is also preparing for the upcoming changes to the Regulations, and has released new practice guidelines for the trial management of actions. The reforms were originally scheduled to come into force on July 1, 2017; however, the government is now reporting a provisional application date of September 21, 2017.
PMPRB – jurisdiction and proposed amendments. In December 2016, the Federal Court issued a decision on the regulation of excessive pricing in relation to Alexion’s SOLIRIS® (eculizumab). In dismissing Alexion’s two appeals, the court upheld the constitutionality of the Patent Act’s price control provisions and the PMPRB’s powers to amend excessive pricing allegations shortly before a PMPRB hearing. In May 2017, Health Canada published a consultation paper titled “Protecting Canadians from Excessive Drug Prices,” in which a number of amendments to the Patented Medicines Regulations were proposed. The proposal outlined new tools and information that would assist the PMPRB in exercising its power to regulate excessive drug pricing, including new pricing factors, new price comparator countries, a complaints-based system for generic drugs, and new disclosure requirements for patentees.
In April, the FCA provided guidance on obviousness and “inventive concept” in Bristol-Myers Squibb Canada Co v Teva Canada Limited, a case relating to REYATAZ® (atazanavir bisulfate). The FCA held that there is no one mandatory approach to assessing obviousness and “obvious to try” is not an appropriate test in every case. Furthermore, “inventive concept” is not materially different from the “solution taught by the patent,” which, in turn, is often treated as synonymous with “what is claimed” or “the invention.”
The FCA has released two decisions on damages so far this year, one relating to section 8 and one to apportionment of profits. In July, in an appeal relating to AstraZeneca’s LOSEC® (omeprazole), the FCA considered the impact of a successful infringement judgement on a prior order for section 8 damages, and affirmed it is for the judge hearing the infringement action to ensure that overall, taking the proceedings together, a party is not under- or overcompensated. In an appeal relating to Servier Canada’s COVERSYL® (perindopril), the FCA held that Apotex was not entitled to apportion its export profits when paying damages to Servier Canada for patent infringement. The indemnity revenues included in the price of Apotex’s export profits were part of the damage calculation because, had perindopril not been patented, there would have been no need for Apotex to provide such a clause. Profits resulting from the sale of perindopril were thus entirely causally attributable to the invention.
Update on Health Canada:
Continued litigation with Apotex. Apotex was unsuccessful in overturning two Health Canada decisions this year. In February, the Federal Court dismissed Apotex’s application for judicial review of Health Canada’s dismissal of its abbreviated new drug submission for Apo-Progesterone. Despite Apotex’s allegations that “suggested that it was somehow led on” by Health Canada and Health Canada was “somehow antagonistic” to Apotex, the court held that Apotex was afforded a fair and impartial procedure, with sufficient opportunity to respond, and that the decision was reasonable. The Federal Court also upheld Health Canada’s decision to require additional information on certain Apotex drugs (varenicline and sitagliptin) manufactured in India prior to the issuance of a notice of compliance. Health Canada pointed to real data integrity concerns associated with Apotex’s Indian affiliates, including evidence of Apotex’s own dealings with regulatory authorities. The additional information was required pursuant to Health Canada’s general policy requiring additional information for any drug for which there exists concerns about data integrity. Health Canada’s decision was found to be legitimate and reasonable.
Future reforms. Health Canada has made several proposals for regulatory reform this year, most notably proposals regarding changes to regulation of non-prescription drugs, natural health products and cosmetics, public release of clinical information contained in drug and medical device submission, and changes to broaden access to generic drug equivalence. Health Canada also released a revised guidance document on data protection, which reflects judicial consideration of the term “innovative drug” and includes new guidelines for submissions relying on third-party data, drugs containing the same medicinal ingredient as an innovative drug, biosimilars, and pediatric population extensions. Draft regulations under Vanessa’s Law have also been published that elaborate on the Minister of Health’s powers to require tests, assessments and studies of a drug post-market authorization and set out additional reporting requirements for manufacturers based on the actions of foreign regulators and eliminate the need for individual clinical case reports filed with a new drug submission.
New procedures in effect. Health Canada has also released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPP Guide) in June as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use). The GLPP Guide offers direction in terms of compliance with the new Plain Language Labelling Regulations and the Canadian Drug Facts Table’s requirements, as well as general information on label and packaging design and contents.