Rx IP Update - November 2016

by Smart & Biggar

Smart & Biggar

Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting

by Shirley Liang Komosa »

On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA 267 and upheld the Federal Court’s Order of prohibition for tadalafil (Eli Lilly’s CIALIS) regarding Patent No. 2,226,784 (“784 patent”) (previously reported). In doing so, the Federal Court of Appeal chose not to depart from its recent decision in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, 2016 FCA 119 (reported here), holding that Whirlpool Corp v Camco Inc, 2000 SCC 67 (“Whirlpool”) did not settle the question of the relevant date for obviousness-type double-patenting. The Court also found Apotex’s argument with respect to insufficiency to be without merit.

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Supreme Court of Canada News

Supreme Court hears and reserves decision on “promise” of utility. As previously reported, the Supreme Court of Canada heard AstraZeneca’s appeal on the utility of AstraZeneca’s Nexium patent on November 8, 2016 and reserved its decision.

Amgen’s leave to appeal FCA decision re mootness denied: As previously reported, Amgen sought leave to appeal the Federal Court of Appeal’s dismissal of Amgen’s appeal from a decision declining to grant a prohibition order regarding Apotex’s filgrastim product GRASTOFIL (a biosimilar of Amgen’s NEUPOGEN): Amgen v Apotex, 2016 FCA 196. The Federal Court of Appeal had held the appeal was moot. On October 27, 2016, the Supreme Court of Canada dismissed Amgen’s application for leave to appeal.

CETA Approved

As reported in our IP Update, CETA Receives Approval - What IP owners need to know, CETA was approved on October 30, 2016. See our article, Bill C-30 to implement CETA tabled in Canadian Parliament: implications for pharmaceuticals, for more information on implications for pharmaceuticals based on the text of Bill C-30 tabled on October 31, 2016: end to dual litigation, innovator right of appeal, patent-term extension (certificates of supplementary protection).

Patented Medicine Prices Review Board releases November NEWSletter

The Patented Medicine Prices Review Board (PMPRB) released its November 2016 NEWSletter. Highlights include an update on phase 2 of the consultation process regarding the need to reform its Compendium of Policies, Guidelines and Procedures, which allows stakeholders who provided comments on the PMPRB Discussion Paper an opportunity to make oral submissions; updates on the status of proceedings relating to Alexion’s SOLIRIS (eculizumab), Galderma’s DIFFERIN, DIFFERIN XP, TACTUPUMP and TACTUPUMP FORTE, and Baxalta’s ONCASPAR (pegaspargase); and release of the first issue of the National Prescription Drug Utilization Information System’s Market Intelligence Report research series titled Market Intelligence Report: Biologic response modifier agents, 2015.

Health Canada News

Revisions made to Post-NOC Changes: Quality Guidance document. On November 3, 2016, Health Canada announced the release of the revised guidance document entitled Post-Notice of Compliance (NOC) Changes – Quality Guidance, regarding the conditions for the categorization of any post authorization change and recommendations for supporting documentation. Originally published in September 2009, the Guidance document was revised most recently in February 2016 (previously reported). The current revisions are effective immediately, and relate to the addition to Appendix 1 the conditions and supporting data for changes 2a and 2b.

Other Decisions

Glaxo’s claim for breach of good faith by Apotex in contract performance found viable. The Ontario Superior Court dismissed Apotex’s motion to strike portions of the Glaxo plaintiffs’ (“Glaxo’s”) Statement of Claim, including allegations of standing and breach of a duty of good faith in contract performance: GlaxoSmithKline Inc v Apotex Inc, 2016 ONSC 6768. Glaxo alleges that Apotex breached a settlement agreement by selling several years’ worth of valacyclovir hydrochloride (Glaxo’s VALTREX) during an agreed-upon six-month withdrawal from the marketplace. The Court found that it was not plain and obvious that GlaxoSmithKline Intellectual Property (No. 2) Ltd. (“GIP2”) had no standing. Glaxo plead the material facts to establish that Glaxo Group Ltd. had entered into the settlement agreement as an agent for GIP2. The Court also found that it was far from plain and obvious that Glaxo did not have a viable claim for breach of good faith in contract performance. That doctrine is entering into a developmental stage given the Supreme Court’s decision in Bhasin v Hrynew. Where the scope of a legal duty has not been fully settled in the jurisprudence, an allegation that the duty has been breached should not be struck.

Bayer entitled to elect between damages and an accounting of profits. The Federal Court previously found that Apotex and Cobalt infringed Bayer’s valid patent for an oral contraceptive composition combining drospirenone and ethinyl estradiol (Bayer’s YAZ and YASMIN) (2016 FC 1013, as reported here). In that judgment, Justice Fothergill requested written submissions addressing whether Bayer should be entitled to elect between damages and an accounting of the defendants’ profits. On October 27, 2016, the Court held that Bayer is entitled to elect: Bayer Inc v Cobalt Pharmaceuticals Company, 2016 FC 1192.

On behalf of both defendants, Apotex argued that it, not Bayer, should decide Bayer’s remedy. Specifically, Apotex argued that Bayer should not be entitled to damages, but only to an accounting of profits. Apotex relied on the fact that it had complied with the PMNOC Regulations, and successfully alleged non-infringement of Bayer’s patent in the PMNOC application. The Court disagreed, finding a patentee cannot be deprived of its statutory right to damages.

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations


teriparatide (FORTEO)


Eli Lilly Canada Inc and Eli Lilly and Company, US


Teva Canada Limited and the Minister of Health

Date Commenced:

October 21, 2016

Court File No.:



Application for Order of prohibition until expiry of Patents Nos. 2,314,313 and 2,325,371. Teva alleges invalidity and non-infringement.

To check the status of Federal Court cases, please click here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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