November 2017

Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman

The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for pharmaceutical patent linkage litigation in Canada. That scheme is now much closer to the US Hatch-Waxman scheme, but with remaining key differences, as shown in the chart below. A special thank you to Brian Coggio of Fish & Richardson for contributing the Hatch-Waxman details.

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Federal Court finds PMPRB unreasonable in finding Galderma patent 'pertains to' medicine in DIFFERIN

In a November 9, 2017 decision, Justice Phelan of the Federal Court found that the Patented Medicine Prices Review Board Panel (Board) was unreasonable in its assessment that a patent ‘pertained’ to Galderma Canada’s DIFFERIN (0.1% adapalene), as the Board failed to consider the entire patent: Galderma v Attorney General of Canada, 2017 FC 1023. As a result, the Court quashed the Board’s decision requiring Galderma to file pricing information for DIFFERIN.

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PMPRB releases 2016 annual report

On October 26, 2017, the Federal Minister of Health tabled the 2016 Annual Report of the PMPRB with the Clerks of the House of Commons and the Senate. The report indicates that Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the PMPRB reviewed prices, behind Switzerland, Germany and the United States. Sales of patented drug products in 2016 totaled $15.5 billion and accounted for 60.8% of total drug sales in Canada. Research and development spending in 2016 remained unchanged from 2015 and was reported as 4.4% of sales revenues. As of March 31, 2017, 101 investigations into possible excessive patented drug pricing were ongoing.

Health Canada publishes final guidance documents on quality requirements for regulatory filings

On October 30, 2017, Health Canada published the final version of the following guidance documents and template:

• Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

• Addendum - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers

• Glossary of Quality Terms

• Guidance Document: Certified Product Information Document – Chemical Entities

• Certified Product Information Document – Chemical Entities (CPID-CE) Template

According to the announcement, the Guidance Documents implement new requirements for New Drug Submissions and Abbreviated New Drug Submissions, including requirements for stability studies on three batches of product for existing drugs, commercial scale batches and pilot batch sizes for certain products. The changes will be implemented in a phased-in approach, with the General Quality Guidance requirements being implemented on January 30, 2018, and the new stability requirements and requirements for commercial scale and pilot scale batches becoming fully implemented on October 30, 2019. After October 30, 2019, a submission must contain at least 6 months of stability data on at least 3 primary batches of the drug substance and drug product.

Federal Court declines to assess litigation funding arrangement

Seedling Life Science Ventures (“Seedlings”) is the plaintiff in a patent infringement action against Pfizer relating to Patent No. 2,486,935 and auto injectors. Seedlings brought a motion seeking approval of a litigation funding agreement (LFA) with a third party (Bentham IMF Capital Limited, the Canadian subsidiary of IMF Bentham Ltd, a professional litigation funding enterprise from Australia), as required by the terms of the agreement: Seedling Life Science Ventures LLC v Pfizer Canada Inc, 2017 FC 826.

The LFA, to which Seedlings’ counsel are also parties, provides that Bentham will fund Seedlings’ legal fees and disbursements, and that each of Seedlings, Bentham and counsel for Seedlings will be entitled to financial returns from a successful outcome. Seedlings remains in control of the litigation but Bentham has the right to be consulted on settlement. Bentham will have access to all documents in the litigation, but will be subject to the same confidentiality or implied undertaking obligations as Seedlings.

The Prothonotary dismissed the motion on the basis that such approval is not required beyond class proceedings. Moreover, the Federal Court does not have jurisdiction to make any determination as to the validity of the LFA. Seedlings is asserting its own rights in the within action, thus the question of whether the LFA constitutes champerty or maintenance does not affect the validity of Seedlings’ rights, and therefore champerty or maintenance is not a basis to bring the issue within the Court’s jurisdiction.

The Prothonotary also found it was not necessary to determine this issue for the purpose of allowing information to be shared with the financing entity over the course of the litigation, or to give effect to its agreement to be bound by confidentiality and the implied undertaking. No confidentiality order was yet in place, and in any event, previous examples have addressed disclosure to third parties. The implied undertaking will allow such sharing of information when it is for the purpose of conducting the litigation, and can be enforced by the Court without any determination on this motion.

New Court Proceedings

For complete details about these pharmaceutical proceedings, click here.

PM(NOC) Proceedings

darunavir ethanolate (PREZISTA): Janssen v Apotex and Minister of Health 

aripiprazole (ABILIFY): Bristol-Myers Squibb and Otsuka v Mint and Minister of Health

abiraterone acetate (ZYTIGA): Janssen v Apotex and Minister of Health

lenalidomide (REVLIMID): Celgene v Dr. Reddy’s and Minister of Health

ticagrelor (BRILINTA): AstraZeneca v Apotex and Minister of Health

travoprost ophthalmic solution (IZBA): Novartis v Apotex and Minister of Health

bevacizumab (AVASTIN): Genentech, F Hoffmann-La Roche v Amgen and Minister of Health

acetaminophen intravenous solution (OFIRMEV): Mallinckrodt v Avir and Minister of Health 

Other Proceedings

cinacalcet (SENSIPAR): Mylan v Amgen

eculizumab (SOLIRIS): Alexion v Attorney General of Canada

GHR, GHR-15: BIE Health Products and Richard Beemer v Minister of Health

desvenlafaxine (PRISTIQ, Apo-desvenlafaxine): Wyeth and Pfizer v Apotex

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