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Federal Court requires patent to disclose the factual basis and sound line of reasoning to support a sound prediction of utility of a compound claim
by Urszula Wojtyra »
On January 15, 2016, the Federal Court dismissed Eli Lilly Canada Inc’s (Lilly) application for an order prohibiting the issuance of a notice of compliance (NOC) to Hospira Health Care Corporation (Hospira) for its generic version of pemetrexed disodium (Lilly’s ALIMTA): Eli Lilly Canada Inc v Hospira Health Care Corporation, 2016 FC 47. Pemetrexed is an antifolate drug useful in the treatment of certain cancers.
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Supreme Court of Canada news
Sandoz seeks leave regarding PMPRB jurisdiction over generic manufacturers. As previously reported, the Federal Court of Appeal overturned the Federal Court’s decision and held that the Patented Medicine Prices Review Board (PMPRB) had not erred in finding that Sandoz Canada Inc. and ratiopharm Inc. are “patentees” within the meaning of subsection 79(1) of the Patent Act and are therefore subject to the PMPRB’s jurisdiction. On January 5, 2016, Sandoz filed for leave to appeal to the Supreme Court of Canada. Alexion Pharmaceuticals has sought leave to intervene. As previously reported, Alexion has separately challenged the constitutionality of the PMPRB provisions in the Federal Court.
Sandoz Canada Inc, et al v Attorney General of Canada, et al (SCC Case No. 36798)
Court of Appeal decision — 2015 FCA 249
Federal Court decision — 2014 FC 501
PMPRB decision — PMPRB-10-D2-SANDOZ
CIPO: Updated practice notice on biological sequence listings, Manual of Patent Office Practice Updates
As reported previously in an IP Update, on January 12, 2016, the Canadian Intellectual Property Office (CIPO) released an updated practice notice on biological sequence listings.
Further, on January 28, 2016, CIPO updated Chapter 15 (Anticipation, Obviousness, and Double-Patenting) and Chapter 19 (Amendments to Patent Applications) of the Manual of Patent Office Practice (MOPOP).
Federal Court of Appeal reaffirms appropriate standard of review for appeals of prothonotary appeals
On January 19, 2016, the Federal Court of Appeal dismissed Bayer’s appeal of a decision of the Federal Court that dismissed its appeal from the decision of a Prothonotary granting Fresenius’s motion to strike. In doing so, the Court reaffirmed that the standard of review applicable to appeals of prothonotary appeals is the standard set out in Z.I. Pompey Industrie v ECU-Line NV, 2003 SCC 27: the Federal Court of Appeal may interfere with a decision of the Federal Court reviewing a Prothonotary’s order where the Federal Court had no grounds to interfere with the Prothonotary’s decision, or in the event such grounds existed, if the decision of the Federal Court was arrived at on a wrong basis or was plainly wrong.
The proceeding relates to Bayer’s ongoing application for an order prohibiting the Minister of Health from issuing a notice of compliance to Fresenius Kabi Canada Ltd. in relation to its proposed moxifloxacin hydrochloride product. Prothonotary Lafrenière struck all portions of the application that related to one of the three patents at issue, finding it plain and obvious that Fresenius was neither infringing nor inducing the infringement of that patent. The Federal Court upheld the Prothonotary’s decision, applying a de novo review pursuant to Canada v Aqua-Gem Investments Ltd, [1993] 2 FCR 425.
Both parties asserted that the proper standard of review was the normal appellate standard, as set out in Housen v Nikolaisen, 2002 SCC 33. The Court acknowledged its previous finding that Housen had overtaken other arcane appellate standards of review, but given that the decision in Z.I. Pompey post-dates Housen and having not received full argument on the point it applied the Z.I. Pompey standard. However, the Court noted that the Supreme Court’s more recent call for procedural simplification in Hryniak v Mauldin, 2014 SCC 7 may have overtaken Z.I. Pompey.
The Court concluded that whether reviewed on the basis of Housen or Z.I. Pompey, the appeal would fail.
Bayer Inc v Fresenius Kabi Canada Ltd — 2016 FCA 13
Federal Court decision — 2015 FC 797
Prothonotary’s decision — 2015 FC 388
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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dabigatran etexilate (PRADAXA)
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Applicants:
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Boehringer Ingelheim (Canada) Ltd and Boehringer Ingelheim International GmbH
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Respondents:
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Actavis Pharma Company and The Minister of Health
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Date Commenced:
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January 15, 2016
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Court File No.:
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T-88-16
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Comment:
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Application for order of prohibition until expiry of Patents Nos. 2,476,054 and 2,537,054. Actavis alleges non-infringement and invalidity.
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Other proceedings
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Medicine:
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olopatadine (PATANOL, ACT Olopatadine)
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Plaintiff:
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Actavis Pharma Company
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Defendants:
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Alcon Canada Inc, Alcon Research Ltd, and Kyowa Hakko Kirin Co, Ltd
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Date Commenced:
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December 4, 2015
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Court File No.:
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CV-15-542062
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Comment:
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Action seeking damages pursuant to section 8 of the PMNOC Regulations, treble damages pursuant to the Ontario Statute of Monopolies, and/or the UK Statute of Monopolies based on the discontinuance of Alcon’s prohibition application in respect of Patent No. 2,195,094.
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Medicine:
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valacyclovir hydrochloride (VALTREX, Apo-Valacyclovir)
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Plaintiffs:
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GlaxoSmithKline Inc, Glaxo Group Limited and GlaxoSmithKline Intellectual Property (No. 2) Limited
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Defendant:
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Apotex Inc
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Date Commenced:
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January 4, 2016
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Court File No.:
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CV-16-543789
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Comment:
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Action seeking damages equal to lost revenues suffered by GSK due to lost sales of VALTREX. GSK alleges that it and Apotex entered into a settlement agreement during a trial relating to Apotex’s claim for damages pursuant to section 8 of the PMNOC Regulations and GSK’s counterclaim for infringement and that in breach of its duty of good faith, Apotex issued invoices to wholesalers for an extraordinary volume of Apo-Valacyclovir between February 6 and 13, 2014, and continued to sell Apo-Valacyclovir after February 14, 2014, in breach of the agreement.
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Medicine:
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pantoprazole magnesium (TECTA)
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Plaintiff:
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Mylan Pharmaceuticals ULC
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Defendants:
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Takeda Canada Inc and Takeda GmbH
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Date Commenced:
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January 15, 2016
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Court File No.:
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T-85-16
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Comment:
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Action seeking damages pursuant to section 8 of the PMNOC Regulations based on the dismissal of Takeda’s prohibition application in respect of Patent No. 2,341,031: 2015 FC 751.
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Medicine:
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tramadol (TRIDURAL, Taro-Tramadol)
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Applicant:
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Paladin Labs Inc
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Respondents:
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The Minister of Health, Attorney General of Canada and Taro Pharmaceuticals Inc
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Date Commenced:
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January 25, 2016
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Court File No.:
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T-157-16
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Comment:
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Application seeking to quash notice of compliance for Taro-Tramadol. Paladin had acquired Labopharm in October 2011, which included TRIDURAL, against which a patent was listed. Taro allegedly served a notice of allegation (NOA) on the prior Labopharm address. Paladin alleges that it advised Health Canada of the address and name change such that service of the NOA on the old address was invalid.
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