In the first half of 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review the following top developments:
- COVID-19: CIPO, Federal Courts, Health Canada
- PMPRB: Amended Regulations to come in force January 1, 2021, revised draft Guidelines released, third party discount/rebate reporting requirements invalid; Board confirms its jurisdiction over Galderma’s DIFFERIN
- Judicial consideration of Health Canada decisions, including SHINGRIX CSP refusal remanded to Health Canada
- Patent decisions on the merits, including first decisions under amended PMNOC Regulations
- Procedural decisions under amended PMNOC Regulations: Order for common trial quashed; action not rendered moot by patent expiry
- Section 8 claims: Infringement not a defence absent real world infringement action
- Damages/Profits references
- Health Canada: Drug sampling laws amended
- Proposed class action alleges generic manufacturers conspired to price-fix and allocate generic market
1. COVID-19: CIPO, Federal Courts, Health Canada
We have seen quick action and flexibility from:
- the Canadian Intellectual Property Office (CIPO) – deadlines through Friday August 7, 2020 are now extended until Monday August 10, 2020;
- the Federal Courts – Federal Court (FC) deadlines were suspended until June 15/June 29 depending on the province, with hearings and at least one patent trial conducted by Zoom. Federal Court of Appeal (FCA) deadlines continue to be suspended for many appeals, but are being lifted for selected files on a weekly basis; and
- Health Canada has taken a number of steps to facilitate availability of COVID-19 health products, to publish information relating to COVID-19 clinical trial applications, approvals and shortages, and to provide guidance on the conduct of ongoing clinical trials in light of COVID-19.
On March 25, the COVID-19 Emergency Response Act was approved, and included an expansion of government powers to use patented inventions and to address drug shortages.
See more and latest here.
2. PMPRB: Amended Regulations to come in force January 1, 2021, revised draft Guidelines released, third party discount/rebate reporting requirements invalid; Board confirms its jurisdiction over Galderma’s DIFFERIN
By way of further June 1 amendments, the amendments to the Patented Medicines Regulations (the Regulations) will now be in force on January 1, 2021 (rather than July 1, 2020), and timelines are also generally pushed back by six months. Revised Guidelines to operationalize the amended Regulations were released on June 19, and are open for consultation until August 4 (see our article here).
On June 29, the FC found s. 3(4) of the amended Regulations invalid as beyond the regulation-making authority of the Patent Act. Section 3(4) would have expanded the reporting requirements for price and revenue information to take into account discounts and rebates provided to third parties. The remaining challenged provisions were found to be valid. Both parties may appeal as of right. The Quebec constitutional challenge to the Regulations is scheduled to be heard September 28 – October 2.
On reconsideration flowing from a FCA judgment, on May 7, the Patented Medicine Prices Review Board (PMPRB) decided that a patent that claims 0.3% adapalene “pertains to” DIFFERIN which contains 0.1% adapalene, as they are two different strengths of the same active ingredient, have the same indication, employ an identical mechanism of action and share a single product monograph. Galderma can seek judicial review.
3. Judicial consideration of Health Canada decisions, including SHINGRIX CSP refusal remanded to Health Canada
In April, GlaxoSmithKline v The Minister of Health was released, and is the first decision considering the eligibility requirements for Certificates of Supplementary Protection (CSPs). The Minister refused to issue a CSP for SHINGRIX on the basis that the patent’s claims pertained to a formulation/use of a formulation. The Court held this was unreasonable and returned the matter to the Minister for redetermination. The Minister has appealed and sought a stay pending appeal.
Beyond CSPs, there were two other judicial review decisions. In Elanco v Canada (Health), the FC declared invalid Health Canada’s decision to disclose portions of Elanco’s regulatory submission regarding FORTEKOR pursuant to an access to information request. In Canada RNA Biochemical v Canada (Health), the FC dismissed Canada RNA Biochemical’s challenge of Health Canada’s refusal of its application for a natural health product licence for lumbrokinase (BOLUOKE).
4. Patent decisions on the merits, including first decisions under amended PMNOC Regulations
In date order, five patent decisions on the merits (all of which have been appealed) and an appeal decision were released in the first half of 2020:
- Seedlings Life Science Ventures v Pfizer (EpiPen) – auto-injector claims anticipated, obvious, overbroad, not infringed.
- Hospira v Kennedy and Janssen (infliximab, INFLECTRA biosimilar, REMICADE) –anticipation and obviousness of new use claims remanded by FCA to trial judge (to consider two further pieces of prior art that had been excluded on basis of reasonably diligent search test and to properly assess all factors required by obvious to try test). Janssen has sought leave to appeal.
- ViiV v Gilead (bictegravir, BIKTARVY) – summary trial on claims construction, compound genus claims not infringed.
These include the first three decisions on the merits under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations):
- Amgen v Pfizer (filgrastim, NIVESTYM biosimilar, NEUPOGEN) – claims to G-CSF made using recombinant genetic technology obvious.
- Janssen v Teva (paliperidone palmitate, INVEGA SUSTENNA) – claims to dosing regimens for long-acting paliperidone palmitate depot formulations for treatment of schizophrenia valid and infringed.
- Biogen v Taro; Biogen v Pharmascience (fampridine, FAMPYRA) – claims to use of fampridine sustained release formulations for improving walking in an MS patient obvious.
5. Procedural decisions under amended PMNOC Regulations: Order for common trial quashed; action not rendered moot by patent expiry
On May 14, in Apotex and Teva v Bayer, the Federal Court of Appeal (FCA) overturned a Federal Court (FC)decision ordering that patent validity issues relating to Bayer’s XARELTO (rivaroxaban) common to four separate actions be heard in a concurrent trial, finding that the decision was inconsistent with the section 6.02 prohibition against joinder of actions. The FCA also stated in obiter that (i) the PMNOC Regulations do not require the FC to render a judgment within 24 months and (ii) following a dismissal of a s. 6(1) action by the FC, “it is not a foregone conclusion” that the pre-amended PMNOC Regulations summary dismissal jurisprudence will apply and later generic challengers would likely have to wait to bring such motions until determination of the appeals.
On May 22, in AstraZeneca v Sandoz, the FC held that an action under the PMNOC Regulations relating to saxagliptin (ONGLYZA) scheduled for trial after patent expiry would not be rendered moot by the patent’s expiry.
6. Section 8 claims: Infringement not a defence absent real world infringement action
On February 25, in Pfizer v Pharmascience, the FCA upheld the FC’s finding that Pfizer’s infringement defence to Pharmascience’s s. 8 claim under the pre-amended PMNOC Regulations related to pregabalin (Pfizer’s LYRICA) was not legally viable as Pfizer did not bring an infringement action against Pharmascience in the real world. Pfizer has sought leave to appeal.
7. Damages/Profits references
In December 2019, the FC publicly released Eli Lilly and Company v Apotex, its reconsideration decision on the quantum of prejudgment interest owed by Apotex for infringement of process patents related to cefaclor (CECLOR). The Court maintained its initial award of over $100M in damages including $75M in prejudgment interest. Apotex has appealed.
On March 11, in Apotex v ADIR, the FCA dismissed Apotex’s appeal of a reconsideration decision ordering Apotex to pay over $61M, its profits from infringement of ADIR’s perindopril patent. The FC rejected Apotex’s non-infringing alternative defence, i.e., that it could and would have obtained non-infringing perindopril from third-party suppliers, and, if so, whether Apotex could and would have sold this material to its U.K. and Australian affiliates. Apotex has sought leave to appeal.
8. Health Canada: Drug sampling laws amended
In April, the Food and Drug Regulations and the Natural Health Products Regulations provisions relating to distribution of drug samples to consumers and health care professionals were amended, providing more flexibility to industry. Health Canada issued related guidance effective July 1.
9. Proposed class action alleges generic manufacturers conspired to price-fix and allocate generic market
On June 3, a proposed class action was commenced against over 50 generic drug manufacturers, alleging they violated the Competition Act by conspiring to allocate the market, fix prices and maintain the supply of generic drugs from 2012 to present, and claiming $2.75 billion in compensation.