In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below:
Table of Contents
- COVID-19: CIPO, Federal Courts, Health Canada
- PMPRB: Amended Regulations with revised Guidelines not yet in force, third party discount and rebate reporting requirements invalid
- Judicial reviews of Health Canada decisions: certificates of supplementary protection, data protection
- Patent trial decisions, 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
- Biologics, biosimilars
- Proposed class action alleges generic manufacturers conspired to price-fix and allocate generic market
1. COVID-19: CIPO, Federal Courts, Health Canada
In response to the pandemic, we saw quick action and flexibility from:
- the Canadian Intellectual Property Office (CIPO) – deadlines from March 16 to August 28 were extended until August 31. On December 14, the Trademarks Office began accepting requests for expedited examination of trademark applications associated with medical goods or services related to COVID-19;
- the Federal Courts – Federal Court (FC) deadlines were suspended until June 29 or July 13, depending on the province, and a number of hearings and patent trials were conducted by Zoom. Federal Court of Appeal (FCA) deadlines continue to be suspended for some appeals, but are being lifted for selected files on a weekly basis. The FC held that the 45-day time limit for commencing a s. 6(1) action under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) was suspended under the Time Limits and Other Periods Act (COVID-19) from March 13 to July 30; and
- Health Canada – Health Canada facilitated availability of COVID-19 health products (including an Interim Order that resulted in the authorization of the Pfizer-BioNTech and Moderna vaccines), published information relating to COVID-19 clinical trial applications, approvals and shortages, and provided guidance on the conduct of ongoing clinical trials in light of COVID-19.
Health Canada also approved a number of Interim Orders to address drug shortages related to COVID-19. Not restricted to COVID-19, in response to a new U.S. rule permitting import of certain drugs from Canada, on November 27, Health Canada issued a further Interim Order prohibiting bulk exportation of drugs which may risk drug shortages.
See our most recent updates here.
2. PMPRB: Amended Regulations with revised Guidelines not yet in force, third party discount and rebate reporting requirements invalid
While scheduled to come into force on January 1, 2021, in recognition of the fact that the COVID-19 pandemic continues to challenge all stakeholders, the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) will now come into force on July 1, 2021. However, new s. 4(4) (s. 3(4) of the Amending Regulations), which would have required price and revenue reporting to take into account confidential rebates provided to provincial payers, is to come into force on a day to be fixed by a separate amendment. This provision has been found invalid by the FC (appeals pending) and unconstitutional by the Quebec Superior Court on June 29 and December 18, respectively. Section 4(4) would have expanded price and revenue reporting requirements to take into account third party discounts and rebates. On October 23, the PMPRB’s final Guidelines were released. The Guidelines are being studied by the House of Commons Standing Committee on Health. On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the Guidelines.
On reconsideration flowing from an FCA judgment, on May 7, the PMPRB decided that a patent that claims 0.3% adapalene “pertains to” Galderma’s 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 has sought judicial review.
3. Judicial reviews of Health Canada decisions: certificates of supplementary protection, data protection
The FC issued its first decisions assessing the eligibility requirements for Certificates of Supplementary protection (CSPs), remitting both decisions back to the Minister of Health for reconsideration, as being unreasonable:
- In GlaxoSmithKline v The Minister of Health, the Minister had rejected a CSP application for SHINGRIX on the basis that the patent’s claims pertained to a formulation/use of a formulation. The Minister has appealed; a stay was denied.
- In ViiV Healthcare v The Minister of Health, the Minister had rejected a CSP application for JULUCA, which contains a combination of dolutegravir and rilpivirine, as the patent while claiming dolutegravir does not claim the combination. The Minister did not appeal.
The FC also dismissed a pair of decisions relating to data protection, finding both reasonable:
- In Natco v Minister of Health and Gilead, the Minister had refused to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir alafenamide hemifurate (TAF) / emtricitabine product, as its indirect comparison to an innovative drug (GENVOYA, containing TAF) was precluded by data protection. Natco did not appeal.
- In Janssen v Canada (Attorney General), the Minister had found that SPRAVATO was not eligible for data protection as it contains esketamine hydrochloride, an enantiomer of ketamine hydrochloride which had been approved as KETALAR. Janssen has appealed.
4. Patent trial decisions, including first decisions under amended PMNOC Regulations
Nine patent decisions on the merits (all of which were or still may be appealed) and two appeal decisions were released in 2020. These include the first decisions on the merits and the first appeal decision under the amended PMNOC Regulations (items 4-9 below). Ordered by date, the decisions were:
1. Seedlings Life Science Ventures v Pfizer (EpiPen) – auto-injector claims anticipated, obvious, overbroad, not infringed.
2. Hospira v Kennedy and Janssen (infliximab, INFLECTRA biosimilar, REMICADE) – FCA remanded anticipation and obviousness of new use claims 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’s leave application was dismissed. The reconsideration decision is pending.
3. ViiV v Gilead (bictegravir, BIKTARVY) – based on summary trial claims construction, compound genus claims not infringed.
4. Amgen v Pfizer (filgrastim, NIVESTYM biosimilar, NEUPOGEN) – claims to G-CSF made using recombinant genetic technology obvious; appeal dismissed.
5. 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.
6. Biogen v Taro; Biogen v Pharmascience (fampridine, FAMPYRA) – claims to use of fampridine sustained release formulations for improving walking in a multiple sclerosis patient obvious.
7. & 8. Eli Lilly v Mylan; Eli Lilly v Teva; Eli Lilly v Pharmascience and Riva; Eli Lilly v Apotex and Eli Lilly v Apotex (tadalafil, CIALIS) – claims to use of dosage forms for treatment of erectile dysfunction processes anticipated and obvious; claims to processes anticipated and obvious.
9. Allergan v Sandoz (silodosin, RAPAFLO) – claims to a capsule of silodosin that achieves a defined rapid dissolution profile valid but not infringed.
5. Procedural decisions under amended PMNOC Regulations: Order for common trial quashed; action not rendered moot by patent expiry
There were a number of developments regarding procedure and practice under the PMNOC Regulations including:
- In Apotex and Teva v Bayer, the FCA overturned a 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 it inconsistent with the s. 6.02 prohibition against joinder. 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.
- 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.
- In September, Urszula Wojtyra and Katie Lee prepared an update on the third anniversary of the coming into force of the amended PMNOC Regulations, reporting that “significantly more actions under the Regulations were commenced compared to the prior year, the first decisions on the merits issued, and inescapably, COVID-19 had an effect on actions under the Regulations”.
- In Fresenius Kabi v Minister of Health, the FC ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA. AbbVie had filed a s. 7(2) letter with the Minister, consenting to the making and constructing of IDACIO by Fresenius Kabi and providing consent to the using and selling as of February 15, 2021. The FC, noting inter alia that AbbVie did not object to immediate issuance of an NOC, held that the Minister’s finding that the consent was effective only as of February 15, 2021 was unreasonable.
- In November, the Federal Court released a new consolidated practice direction, Case and Trial Management Guidelines for Complex Proceedings. The Guidelines apply to complex proceedings or those expected to require five or more trial days, with additional rules for actions under the PMNOC Regulations.
- In Apotex v Allergan; Pharmascience v Bayer, the FCA held that the threshold for obtaining leave to appeal interlocutory decisions under s. 6.11(1) requires: (i) a fairly arguable case taking into account the standard of review and (ii) that the issue raised is capable of having a direct impact on the overall success or failure of the case.
6. Section 8 claims: infringement not a defence absent real world infringement action
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’s leave application was dismissed.
The first action under amended s. 8(1) was brought by Pfizer against Amgen in July, following the dismissal in Amgen v Pfizer (filgrastim, NIVESTYM biosimilar, NEUPOGEN).
7. Damages/profits references
In Eli Lilly and Company v Apotex, the FC maintained its reconsideration decision on the quantum of prejudgment interest ($75M) owed by Apotex for infringement of process patents related to cefaclor (CECLOR). Apotex has appealed. Apotex’s appeal is pending.
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 was denied leave to appeal.
8. Biologics, biosimilars
Our most-read article in 2020 was Urszula Wojtyra’s latest update on biosimilars which provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access).
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.