Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative
PMPRB News
PMPRB issues a Notice of Hearing for allegations of excessive pricing of PROCYSBI
Under reserve: Appeal from judicial review quashing PMPRB decision on jurisdiction over DIFFERIN
Health Canada News
Health Canada releases Medical Devices Action Plan
Health Canada requests feedback if company names were added to the Generic Submissions Under Review List
Apotex seeks leave to appeal ramipril pleadings amendment decision
New Court Proceedings
Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative
By Urszula Wojtyra
On the eve of a section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex’s purported non-infringing alternative (NIA) was unlawful as it would have infringed a third party’s patent: Apotex Inc v Abbott Laboratories Limited, 2018 ONSC 7736.
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PMPRB News
By Lynn Ing
PMPRB issues a Notice of Hearing for allegations of excessive pricing of PROCYSBI
The Board will hold a public hearing (on a date to be determined no later than February 27, 2019) to determine whether Horizon Therapeutics Canada is selling or has sold PROCYSBI (cysteamine bitartrate) in any market in Canada at a price that, in the Board's opinion, is or was excessive; and if so, what order, if any, should be made to remedy the excessive pricing.
News Release; Notice of Hearing; Statement of Allegations of Board Staff
Under reserve: Appeal from judicial review quashing PMPRB decision on jurisdiction over DIFFERIN
On January 17, 2019, the Federal Court of Appeal heard the Attorney General of Canada’s appeal from a judicial review that quashed a Board decision that it has jurisdiction over Galderma’s DIFFERIN (0.1% adapalene). Our report on the Federal Court decision, 2017 FC 1023, is found here. Innovative Medicines Canada intervened in the appeal. The Federal Court of Appeal reserved judgment.
Health Canada News
By Katie Lee
Health Canada releases Medical Devices Action Plan
On December 20, 2018, Health Canada published an Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality. The Action Plan states that despite existing regulations, more can be done to improve the safety and effectiveness of medical devices, and optimize health outcomes. The Action Plan is set out through a three-part strategy, all with 2019 milestones for at least initial steps towards implementation:
1. Part I: Improving how devices get on the market, including by:
a. increasing research by allowing health professionals and researchers to file an application for authorization to conduct investigational tests, and
b. reviewing evidence requirements related to higher-risk medical devices to strengthen evidence requirements for devices based on previously authorized versions and expanding scientific expertise, including by creating a new expert advisory committee on women’s health issues for drug and medical devices;
2. Part II: Strengthening monitoring and follow-up of devices, including through:
a. proposed regulations under Vanessa’s Law introducing mandatory reporting by Canadian hospitals (see here for our previously published article on the June 2018 proposed amendments),
b. proposed regulations under Vanessa’s Law to compel manufacturers to conduct assessments, tests and studies and improved reporting from healthcare facilities besides hospitals (e.g., long-term care facilities), and
c. enhancing capacity in inspection and enforcement; and
3. Part III: Providing more information to Canadians about the medical devices they use, including through:
a. implementing regulations governing the release of clinical trial data for medical devices (see here for our previously published article on the December 2017 proposed amendments), and
b. increasing information published on approvals (expanding to Class III, in addition to Class IV approvals) and medical device incident data through launch of a searchable database.
Health Canada requests feedback if company names were added to the Generic Submissions Under Review List
By Tierney GB Deluzio
The Generic Submissions Under Review (GSUR) list (previously reported) is a list of Abbreviated New Drug Submissions (generic submissions) that were accepted into review on or after October 1, 2018 and is intended to be updated on a monthly basis. The list currently includes the medicinal ingredient(s), therapeutic area and number of submissions under review. On January 7, 2019, Health Canada published a Notice soliciting feedback on possible impacts and uses to stakeholders if the GSUR list is updated to include sponsor names (i.e., the company that filed the generic submission). As previously reported, sponsors are included in the Submissions Under Review List for new drug submissions (which includes biosimilars) accepted into review on or after October 1, 2018. Stakeholder feedback should be submitted by email to Health Canada by February 8, 2019.
Apotex seeks leave to appeal ramipril pleadings amendment decision
By Brandon Heard
As previously reported, the Ontario Court of Appeal (ONCA) granted Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada’s decision in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (“AstraZeneca”). In the underlying action, Apotex relies on Sanofi-Aventis Canada v Apotex Inc., 2009 FC 676 (“invalidity decision”) as a central element of its novel claims under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and Trade-Marks Act. The invalidity decision found certain claims of Canadian Patent No. 1,341,206 invalid on the basis of the “promise doctrine”, which was subsequently rejected as “unsound” in AstraZeneca. The ONCA concluded that depriving Sanofi and Schering of the opportunity to argue that the invalidity decision is suspect would be “fundamentally unfair”. On January 7, 2019, Apotex applied for leave to appeal to the Supreme Court of Canada (docket No. 38471).
New Court Proceedings
For complete details about these proceedings, click here.
PMNOC Actions
glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes (COPAXONE): Teva v Pharmascience
glatiramer acetate 40 mg/mL prefilled syringes (COPAXONE): Teva v Pharmascience
liraglutide 6 mg/mL prefilled pens (VICTOZA): Novo Nordisk v Teva
abiraterone acetate (ZYTIGA): Janssen and BTG v Apotex
apixaban (ELIQUIS): Bristol-Myers Squibb v Pharmascience
apixaban (ELIQUIS): Bristol-Myers Squibb and Pfizer v Pharmascience
apixaban (ELIQUIS): Bristol-Myers Squibb and Pfizer v Natco Pharma
Selected Rankings
Canadian IP Impact Case of the Year
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences
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Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada
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