Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022):
- Patent decisions on the merits
- PMNOC Regulations: Fifth-year anniversary of major amendments, marketing requirement
- PMNOC Regulations: First amended section 8 cases scheduled for 2023 trials
- Dismissal of Apotex’s olanzapine Statute of Monopolies case upheld on appeal
- Patent Rules amendments largely in force October 3, 2022
- PMPRB: Amendments came into force on July 1, 2022, amended guidelines delayed; SOLIRIS redetermination resolved; PROCYSBI pricing excessive
- Final report from pan-Canadian formulary advisory panel released
- Health Canada’s regulatory initiatives for 2022-2024, including pathway for adaptive machine learning-enabled medical devices, approvability of different salt forms of generic drugs
- Biosimilars update
- Federal Court issues decision on application of data protection when submissions are co-pending
- Competition Bureau updates
- Supreme Court of Canada affirms $645M patent infringement profits award in Dow v Nova
1. Patent decisions on the merits
The Federal Courts released the following patent decisions in 2022, all relating to s. 6(1) actions under the Patented Medicines (Notice of Compliance) Regulations. Federal Court (FC) decisions:
- Janssen v Pharmascience, Janssen v Apotex (paliperidone palmitate, INVEGA SUSTENNA) – Following the first summary trials under the PMNOC Regulations, the FC concluded Pharmascience and Apotex would induce infringement of claims for a dosing regimen. Appeals by both are pending. Subsequent to the summary trial, Pharmascience’s invalidity defence was unsuccessful at trial; Pharmascience’s appeal is pending.
- Allergan v Apotex (risedronate sodium, ACTONEL DR) – Formulation claims “for use with or without food or beverage intake” held valid (not anticipated, not obvious, useful, not insufficient, not overbroad), but not infringed (product monograph stated should be taken with food). Allergan’s appeal was dismissed on consent.
- Merck Sharp & Dohme Corp v Pharmascience (sitagliptin phosphate monohydrate, JANUVIA) – Claim to R-enantiomer of the dihydrogen phosphate salt of sitagliptin in crystalline monohydrate form held valid (not obvious in view of Merck’s prior genus application which included sitagliptin and its hydrochloride salt, not insufficient). Pharmascience’s appeal was discontinued.
- Janssen v Sandoz, Janssen v Apotex (macitentan, OPSUMIT) – In the Sandoz case, claims to macitentan in combination with a phosphodiesterase type-5 inhibitor to treat diseases where vasoconstriction is involved, including pulmonary arterial hypertension, were held valid (not obvious, utility soundly predicted, not overbroad, not insufficient). In the Apotex case, validity was not challenged, and the FC held Apotex would induce infringement. Appeals by Sandoz and Apotex are pending.
Federal Court of Appeal (FCA) decisions:
- Pharmascience v Teva (glatiramer acetate, COPAXONE, GLATECT) – The FCA upheld the finding that claims to use of 40 mg glatiramer acetate administered by subcutaneous injection three times weekly for treatment of relapsing-remitting multiple sclerosis (802 patent) were valid (utility soundly predicted, not obvious). Infringement finding not challenged on appeal. Pharmascience’s SCC leave application was dismissed.
- Pharmascience v Bristol-Myers Squibb (apixaban, ELIQUIS) – The FCA upheld the finding that the two patents were valid: (1) the 202 patent, which claims apixaban, an anticoagulant, and the use of apixaban in the treatment of thromboembolic disorders (novel, not obvious in view of BMS’ prior genus patent, no double patenting and sufficient); and (2) the 171 patent, which claims tablet formulations of apixaban (not obvious, not ambiguous/overbroad). Pharmascience’s SCC leave application is pending.
- Biogen v Pharmascience, Taro (fampridine, FAMPYRA) – The FCA upheld the finding that the patent relating to uses of fampridine sustained release compositions to treat multiple sclerosis was invalid as obvious.
- Janssen v Apotex, Pharmascience, Dr. Reddy’s (abiraterone acetate, ZYTIGA) – The FCA upheld the finding that the patent relating to treatment of prostate cancer in humans by co-administration of abiraterone acetate and prednisone was invalid as obvious.
2. PMNOC Regulations: Fifth-year anniversary of major amendments, marketing requirement
In September, we provided a fifth anniversary update on cases under the significant amendments to the PMNOC Regulations, which includes statistics on actions commenced, pending, decided, and appealed. In the fifth year post-amendments, Apotex was the most active patent challenger, followed by a tie for second between JAMP Pharma and Sandoz.
As of December 23, 2022, of the approximately 234 actions started since the 2017 amendments came into force, only 26 actions have been pursued to a decision on the merits (a total of 15 decisions, as some of the actions were tried together and decided in a single set of reasons), though a number of actions remain pending. The innovator was successful in 12 actions. There have been five appeal decisions, all of which have affirmed the trial decisions, with six appeals pending.
The Federal Court found the Minister of Health was reasonable in his interpretation of s. 5(1) of the PMNOC Regulations as applying only to the drug identification number (DIN) specific version of the innovator’s drug. As a result, as some strengths of AbbVie’s high-concentration HUMIRA (adalimumab) were not marketed when JAMP filed its regulatory submission for those strengths, JAMP was not a “second person” under the PMNOC Regulations for its high-concentration product, SIMLANDI, a biosimilar of AbbVie’s HUMIRA. AbbVie’s appeal is pending. Patent trials were completed in December 2022.
All s. 6(1) trials will be presumptively held in-person as of January 2023.
3. PMNOC Regulations: First amended section 8 cases scheduled for 2023 trials
Section 8 damage cases brought by Dr. Reddy’s and Apotex against Janssen regarding their abiraterone acetate products (Janssen’s ZYTIGA) are scheduled for consecutive trials in June 2023. These would be the
first trials under section 8, as amended in 2017. The trial relating to Pharmascience’s section 8 claim has not yet been scheduled.
Various pre-trial motion decisions illustrate some of the issues raised in these cases:
- Janssen’s motion to have evidence in the three cases on common issues heard together was dismissed as a common hearing “would not achieve the most efficient resolution of the matters in issue in the section 8 actions.” The Court noted that each case requires the construction of separate “but-for worlds” with different parameters, and evidence may differ between the separate but-for worlds as to what third-party generic manufacturers would have done.
- The Court granted Janssen’s motion to particularize its pleading that Apotex did not have the ability and/or capacity to supply the market by adding reference to supply disruptions in the U.S. and Canadian markets experienced by Apotex in the real world.
- The Court dismissed Dr. Reddy’s motion for a pre-trial determination of the following question of law:
Under the [PMNOC Regulations], when a patentee has exercised its right to a section 7 statutory stay against generic entry, and never resolved or renounced that right in relation to certain generics in the real world, does that same obstacle to entry by those generics prevail in the section 8 but-for world (other than the section 8 claimant)?
4. Dismissal of Apotex’s olanzapine Statute of Monopolies case upheld on appeal
In 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims for damages against Eli Lilly under the Statute of Monopolies, Trademarks Act, and common law conspiracy relating to a patent for olanzapine. While Eli Lilly was successful in the PMNOC proceeding against Apotex (and therefore Apotex could not claim section 8 damages), the patent was later found invalid in a separate case against Novopharm. In August, the Ontario Court of Appeal dismissed Apotex’s appeal, based in part on its finding that the Patent Act and PMNOC Regulations form a complete code. Apotex’s SCC leave application is pending.
5. Patent Rules amendments in force October 3, 2022Significant changes to Canadian patent practice and procedure came into effect on October 3, 2022, with the coming into force of amendments to the Patent Rules. A government fee of CAD $100 ($50 for a small entity) is payable for each claim over 20 in applications in which examination was requested on or after October 3, 2022. Fees are calculated based on the greatest number of claims pending at any time from when the examination is requested to when the issue fee is paid. A request for continued examination and a government fee of CAD $816 ($408 for a small entity) are required in order to reopen prosecution after a notice of allowance or conditional notice of allowance or to respond to a third Examiner’s Report and every second subsequent Examiner’s Report. Read more articles on this issue .
6. PMPRB: Amendments came into force on July 1, 2022, amended guidelines delayed; SOLIRIS redetermination resolved; PROCYSBI pricing excessive
Amendments: In February, the Quebec Court of Appeal declared the confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations invalid. The Minister of Health did not seek to appeal that decision and instead decided not to proceed with those amendments. The narrowed amended Patented Medicines Regulations, originally scheduled for July 1, 2020, came into force on July 1, 2022. The amendments:
(i) amended the basket of foreign reference countries for price benchmarking and
(ii) reduced reporting obligations for veterinary, over-the-counter (apart from non-prescription schedule D drugs such as vaccines and insulin) and generic medicines.
The FCA upheld the FC decision which had rejected
a validity challenge to the amended basket. In August, the PMPRB announced an interim “status quo approach” to price reviews from July 1 until the publication of its revised Guidelines. The revised draft Guidelines were released for comment in October; proposed changes include a waiver of filing requirements for vaccines and biosimilars. Release of revised Guidelines has been delayed.
SOLIRIS redetermination proceeding resolved – In 2017, the Board decided that Alexion’s SOLIRIS (eculizumab) was sold at an excessive price. In doing so, the Board departed from the Guidelines, in finding the appropriate benchmark was the lowest international price. The FCA – criticizing the Board for its lack of transparency in departing from the Guidelines and finding the Board had misunderstood its mandate, which is directed at controlling patent abuse – remitted the matter to the Board for redetermination. In August, the redetermination was discontinued following issuance of a consent Order regarding payment by Alexion and setting the ex-factory list price until patent expiry.
PROCYSBI found excessively priced – In September,
a Panel held that the price of PROCYSBI (cysteamine delayed release
capsules), used to treat an ultra-rare genetic disorder, is excessive and required Horizon to pay excess revenues. The Panel declined to depart from the Guidelines as proposed by Board Staff, disagreed with Horizon that PROCYSBI satisfied breakthrough
status, and instead applied the Moderate Improvement Test.
Annual Report – The 2021 Annual Report was released in November.
7. Final report from pan-Canadian formulary advisory panel released
In June, the advisory panel released its Final Report: Building Toward a Potential Pan-Canadian Formulary,together with summary highlights.
8. Health Canada’s regulatory initiatives for 2022-2024, including pathway for adaptive machine learning-enabled medical devices, approvability of different salt forms of generic drugs
In June, we reported on Health Canada’s Forward Regulatory Plan: 2022-2024 which included:
(i) reference to an Advanced Therapeutic Products Pathway for Adaptive Machine Learning-enabled Medical Devices and
(ii) notice that in fall 2022 (later updated to spring 2023), we may see final amendments to the Food and Drug Regulations pre-published in 2019 (see our previous article from 2019), which would permit a generic manufacturer to file an abbreviated new drug submission for a drug having a different salt form of the medicinal ingredient in the Canadian reference product.
Health Canada released a new guidance document on clinical evidence requirements for medical devices in November.
9. Biosimilars update
Our most-read article of 2022 was Urszula Wojtyra’s latest biosimilars update on approvals, pending regulatory submissions, and litigation, regulatory, and market access developments. In October, Saskatchewan launched a biosimilars initiative and in December, Ontario announced a biosimilars transitions policy which will be fully effective on December 29, 2023.
10. Federal Court issues decision on application of data protection when submissions are co-pending
Catalyst received a notice of compliance (NOC) for FIRDAPSE (amifampridine). Médunik later received an NOC for RUZURGI (also containing amifampridine) based on a new drug submission filed about one month after FIRDAPSE, referencing FIRDAPSE data, and on the same day, FIRDAPSE was found to be eligible for data protection. Data protection precludes the filing of a submission based on a direct or indirect comparison to FIRDAPSE for six years after issuance of the NOC. In 2021, the Court quashed the RUZURGI NOC and returned the matter to the Minister for redetermination. On redetermination, Health Canada issued a new NOC for RUZURGI and in March, the Court quashed the RUZURGI NOC for a second time, sending the matter back again for redetermination. The Minister of Health’s appeal is pending.
11. Competition Bureau updates
In January, Alice Tseng provided an update on the Competition Bureau’s continued interest in the health sector. In May, the Competition Bureau announced it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered in the two investigations suggested the agreements did not contravene the Competition Act. In June, the Competition Bureau announced it completed a preliminary investigation into potential anti-competitive harm from “relabelled” biologic drugs.
12. Supreme Court of Canada affirms $645M patent infringement profits award in Dow v Nova
In November, the Supreme Court of Canada affirmed a CAD $645 M award granted to The Dow Chemical Company as a result of Nova’s infringement of Dow’s patent on novel polyethylene blends. While the decision is outside the life sciences area, it is a good reminder of the availability of this discretionary remedy for patent infringement in Canada.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.