Rx IP Update — November 2015 | Smart & Biggar/Fetherstonhaugh

IN THIS ISSUE:

Federal Court invalidates Idenix patent, dismisses attacks on Gilead patent for SOVALDI »

Federal Court quashes Import Ban against Apotex companies »

Text of Trans-Pacific Partnership free trade agreement released »

Federal Court overturns decision on motion to strike, allows Pharmascience’s claim for other products to remain in Statement of Claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations »

Decision striking Statement of Claim challenging constitutionality of natural drug product regulations upheld »

New Court proceedings »

Federal Court invalidates Idenix patent, dismisses attacks on Gilead patent for SOVALDI

by Kevin Siu »

On October 9, 2015, the Federal Court ruled on the validity of two patents relating to Gilead’s SOVALDI (sofosbuvir) in Gilead Sciences, Inc v Idenix Pharmaceuticals, Inc, 2015 FC 1156 (public judgment and reasons were issued on November 2, 2015). The Court declared Idenix’s Patent No. 2,490,191 (‘191) invalid and dismissed Idenix’s counterclaims for infringement of the ‘191 patent and a declaration of invalidity of Gilead’s Patent No. 2,527,657 (‘657).

Federal Court quashes Import Ban against Apotex companies

by Andrew Mandlsohn »

On October 14, 2015, the Federal Court quashed the Minister of Health (“Minister”)’s Import Ban against Apotex and certain related companies (collectively “Apotex”) on the basis that the Minister issued it for an improper purpose and denied Apotex procedural fairness: Apotex Inc v Minister of Health, 2015 FC 1161.

Text of Trans-Pacific Partnership free trade agreement released

As reported previously, on October 5, 2015, the Government of Canada announced that the members of the Trans-Pacific Partnership (TPP) had successfully concluded negotiations on a free trade agreement. The text of the agreement was released on November 5, 2015. See our IP Update: Canada concludes negotiations on free trade agreement with Trans-Pacific Partners, which provides an overview of the intellectual property provisions, including specifically as they relate to pharmaceuticals.

Recent Court decisions

Federal Court overturns decision on motion to strike, allows Pharmascience’s claim for other products to remain in Statement of Claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations. In an appeal of a Prothonotary’s order striking two paragraphs of Pharmascience’s Statement of Claim in a section 8 action under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) relating to pregabalin (Pfizer’s LYRICA), Justice Zinn of the Federal Court held that the two paragraphs in question, which included claims to lost sales of non-pregabalin products and lost opportunity for increased sales and market share for non-pregabalin products, should not have been struck. Pfizer could not meet the burden of showing that it was “plain and obvious that the claim sought to be struck disclose[d] no reasonable cause of action.” Justice Zinn noted that this threshold was different from a motion to amend pleadings, thereby distinguishing this case from Eli Lilly Canada Inc v Novopharm Ltd, 2013 FC 677, where the Court refused to allow Teva to amend its pleadings to add lost sales and market share of other products. Justice Zinn also pointed out that Pfizer’s pleadings in defence of similar claims in other cases could “stand as evidence that it was able to respond to a general pleading of a loss of sales on other products.”

Pharmascience Inc v Pfizer Canada Inc, 2015 FC 1134

Decision striking Statement of Claim challenging constitutionality of natural drug product regulations upheld. In a decision issued October 27, 2015, the Federal Court of Appeal unanimously upheld the July 16, 2014, decision of Justice Russell of the Federal Court striking a Statement of Claim relating to the regulation of natural drug products with leave to amend. The plaintiffs challenged Parliament’s constitutional authority to regulate natural health products, pleading in the alternative that the regime violates various Charter provisions. The plaintiffs further accused the government of tortious conduct in its administration and enforcement of the regime. As a preliminary matter, the Court of Appeal rejected the appellants’ submission that Justice Russell had not struck the claim in its entirety and that what remained could stand. It was clear that Justice Russell had struck the entire Statement of Claim. With respect to the sufficiency of the pleadings, the Court of Appeal found that the appellants had failed to plead material facts in support of their various allegations. The Court further found that certain Charter claims and remedies were not available to the corporate plaintiffs. While the Court agreed with the appellants that Justice Russell erred in striking their claim under section 8 of the Charter on the basis of collateral attack, he had correctly identified it as an abuse of process. As there was no need to deal with the cross-appeal, it was also dismissed.

Mancuso v Canada (National Health and Welfare), 2015 FCA 227

Federal Court decision – 2014 FC 708

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

Medicine:	filgrastim (NEUPOGEN)
Applicants:	Amgen Canada Inc and Amgen Inc
Respondents:	Apotex Inc and Minister of Health
Date Commenced:	October 9, 2015
Court File No.:	T-1710-15
Comment:	Application for Order of prohibition until expiry of Patent No. 1,341,537 (‘537 patent). Apotex alleges lack of consent of the owner of the ‘537 patent for inclusion on the Patent Register, non-infringement, and invalidity. Amgen asserts Apotex’s letter is an abuse of process, Apotex having previously served a notice of allegation regarding the ‘537 patent for filgrastim, resulting in the proceedings in Court File No. T-2072-12. That application was heard from October 26 to 30, 2015, and a decision was taken under reserve.

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

RANKINGS AND RECOGNITIONS

Smart & Biggar honoured as the Canadian Patent Contentious Firm of the Year and Gunars Gaikis named Canadian Patent Litigation Attorney of the Year by LMG Life Sciences
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Smart & Biggar named Canada’s Intellectual Property Litigation Firm of the Year and Mark Evans named Canada’s Trademark Litigator of the Year by Benchmark Canada
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Smart & Biggar honoured as one of only two Canadian firms selected as a ‘Band One’ firm in Canadian intellectual property law in the 2016 edition of Chambers Canada
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Smart & Biggar once again leads in Canadian IP law as the only firm chosen at the top of the rankings in Ottawa, Toronto, Montreal and Vancouver in the 2015 edition of The Canadian Legal Lexpert® Directory
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Smart & Biggar lauded as a “Canadian IP titan” in the 2015 edition of IAM Patent 1000 — The World’s Leading Patent Practitioners
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Smart & Biggar lauded as one of only two Canadian firms to receive the highest ranking in the areas of patent prosecution and patent contentious and praised with more ‘IP Stars’ than any other firm in Canada in Managing Intellectual Property’s 2015 IP Stars Handbook: Patents
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Smart & Biggar/Fetherstonhaugh is once again recognized as 'the biggest and deepest IP shop in Canada' by Benchmark Canada 2015
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Smart & Biggar repeats as Managing Intellectual Property’s 2015 Canadian Trademark Contentious Firm of the Year, and wins Canadian Trademark Milestone Case of the Year Award
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David Schwartz named the 2016 Biotechnology Law "Lawyer of the Year" in Ottawa by Best Lawyers
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The future is bright: Smart & Biggar dominates Canadian IP in LMG Rising Stars rankings
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26 Smart & Biggar lawyers recognized in the 2016 edition of The Best Lawyers in Canada
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For more information or to request a copy of any decision, pleading or legislation, please contact:

Nancy Pei (Editor)
CASE-LAW BRIEFS BY: Andrew Mandlsohn Kevin Siu	Urszula Wojtyra	Paul Jorgensen	Abigail Smith
LITIGATION CONTACTS Gunars Gaikis Nancy Pei	Steven Garland Mark Biernacki	Sheldon Hamilton Jeremy Want	Yoon Kang Colin Ingram
PROSECUTION CONTACTS Christopher Robinson David Schwartz	Yoon Kang	Daphne Lainson	Thuy Nguyen
REGULATORY CONTACTS Nancy Pei	Daphne Lainson

DISCLAIMER

The preceding is intended as a timely update on Canadian intellectual property and regulatory law of interest to the pharmaceutical industry. The contents of this newsletter are informational only and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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