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22 February 2017
Apotex's infringement of AstraZeneca's omeprazole formulation patent upheld
Supreme Court denies Teva leave to appeal venlafaxine Section 8 hearsay decision
Apotex seeks leave on obviousness-type double patenting decision
CETA implementation act completes second reading
CIPO revises antibody sections of Manual of Patent Office Practice
PMPRB finds it has jurisdiction over Galderma's Differin
Competition Bureau approves Abbott's acquisition of St Jude Medical
Reports on Canada's health and prescribed drug spending
Application regarding Pharmascience's zolpidem tartrate dismissed
Federal Court prohibits issuance of notice of compliance for Actavis's methylphenidate
The Federal Court of Appeal has affirmed the validity of AstraZeneca's Patent 1,292,693 in a unanimous decision released on January 12 2017 (2017 FCA 9).(1) The patent covers AstraZeneca's successful product, Losec, for inhibiting gastric acid secretion and treating gastrointestinal diseases such as stomach ulcer.
Teva filed leave to appeal a decision of the Federal Court of Appeal setting aside the Federal Court's award of damages under Section 8 of the Patented Medicines (Notice of Compliance) Regulations to Teva for its venlafaxine hydrochloride product (Pfizer's Effexor XR) (for further details please see "Federal Court of Appeal overturns Teva's award for improper reliance on hearsay evidence").(2) The Federal Court of Appeal found that the Federal Court had improperly admitted and relied on hearsay evidence. The matter was remitted to the Federal Court for redetermination, excluding that evidence. On January 19 2017 the Supreme Court dismissed Teva's application for leave to appeal (Docket 37162).
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) (for further details please see "Federal Court of Appeal opines on framework for analysing obviousness-type double patenting").(3) In doing so, the Federal Court of Appeal did not depart from its decision in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc (2016 FCA 119), holding that the relevant date for obviousness-type double-patenting is an open question (for further details please see "Canadian Federal Court of Appeal clarifies test for double patenting"). On December 28 2016 Apotex applied to the Supreme Court for leave to appeal (Docket 37368).
On October 31 2016, the day following the signing of the Comprehensive Economic and Trade Agreement (CETA), Bill C-30 was tabled in Parliament (for further details please see "Bill C-30 to implement CETA: implications for pharmaceuticals").(4) On December 13 2016 Bill C-30 completed its second reading and was referred to the Standing Committee on International Trade for consideration. Bill C-30 includes provisions for restoration of patent term to account for marketing delays resulting from the time required to obtain regulatory approval in the form of supplementary protection certificates.
On January 9 2017 the Canadian Intellectual Property Office (CIPO) announced that it has revised Sections 17.07 and 17.08 concerning antibodies in Chapter 17 of the Manual of Patent Office Practice.(5)
On December 21 2016 the Patented Medicine Prices Review Board (PMPRB) issued its reasons relating to allegations that Galderma had failed to report pricing and sales information in relation to its acne medicines Differin and Differin XP. Although the hearing panel dismissed the application with respect to two of the three patents at issue, it found the third patent pertained to Differin and therefore ordered Galderma to provide the PMPRB with pricing and sales information regarding Differin. Galderma has sought judicial review.
On December 28 2016 the Competition Bureau announced the signing of a consent agreement with Abbott Laboratories relating to its proposed US$25 billion acquisition of St Jude Medical. The board found that the majority of medical devices offered in Canada by Abbott and St Jude are largely complementary. However, Abbott and St Jude are the largest suppliers in Canada of vessel closure devices (VCDs). Under the terms of the consent agreement, St Jude's VCDs business will be sold to Terumo Corporation. The Competition Bureau cooperated with the US Federal Trade Commission to reach a coordinated resolution in both jurisdictions.
On December 9 2016 the Federal Court dismissed Valeant and Meda's Patented Medicines (Notice of Compliance) Regulations proceeding regarding Pharmascience's zolpidem tartrate tablets (Valeant and Meda's Sublinox) and Patent 2,629,988. The court held that Pharmascience's allegation of non-infringement was justified and its allegation of invalidity on the basis of overbreadth was justified only with respect to Claim 1. Pharmascience's remaining allegations of invalidity (ie, anticipation, obviousness and utility) were not justified.(6) The court found that Claim 1 was overbroad as the positioning of the bioadhesive/mucoadhesive agent was an essential feature of the invention, and while this limitation was present in Claim 2 and all subsequent claims, it was not a limitation in Claim 1.
On January 9 2017 the Federal Court granted Janssen's application for an order prohibiting the minister of health from issuing a notice of compliance to Actavis for its methylphenidate product (Janssen's Concerta).(7) Janssen had previously been unsuccessful on the same patent (2,264,852), when the court found that Novopharm's allegations of non-infringement were justified.(8) In the present case, Justice O'Reilly followed the prior court's construction of the claims, but found that Janssen established that most tablets tested showed the release methylphenidate at a sustained ascending rate for the claimed period. He also held that Actavis's allegations of obviousness, lack of soundly predicted or demonstrated utility, overbreadth and inutility were unjustified.
For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) Previously reported here.
(2) Previously reported here.
(3) Previously reported here.
(5) A list of the changes is available here.
(6) Meda AB v Canada (Health), 2016 FC 1362.
(7) Janssen Inc v Actavis Pharma, Canada (Health), 2016 FC 1361.
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