Jan 22

FCA Affirms Section 6(5)(b) is Available to Strike an NOC Application for Lack of Evidence

By: Andrew Moeser Section 6(5)(b) of the NOC Regulations permits a generic company to bring a motion to strike on the basis that the application is “redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process”. This mechanism for early dismissal has predominantly been used to dispose of attempts to re-litigate issues that …

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Dec 16

Federal Court of Appeal dismisses Eli Lilly’s Cialis (948 Patent) Appeal

By: Zarya Cynader Yesterday, the Federal Court of Appeal (Justices Dawson, Near, and Boivin) dismissed Eli Lilly Canada Inc. and ICOS Corporation’s appeal of Justice de Montigny’s decision in Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 178 (tadalafil/CIALIS 948 Patent NOC proceeding). In brief reasons issued from the bench and cited as …

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Oct 19

Update on the Biosimilar “Patent Dance”: Rehearing denied in Amgen v. Sandoz

By: Zarya Cynader On Friday, the U.S. Federal Circuit denied two petitions for rehearing en banc in the Amgen v. Sandoz litigation under the Biologics Price Competition and Innovation Act (BPCIA). This litigation, the first to interpret the biosimilar entry and patent dispute provisions of the BPCIA, was last discussed here in this post. Both …

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Oct 07

Australian High Court Invalidates Myriad BRCA1 Patent

The Australian High Court today released its highly anticipated decision in the Myriad case. From the High Court’s summary of the decision:   “Today the High Court unanimously allowed an appeal from a decision of the Full Court of the Federal Court of Australia. The High Court held that an isolated nucleic acid, coding for a …

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Oct 06

Biologic drugs will be given a minimum of five years of data protection under the TPP

By: Andrea Rico-Wolf More than five years of intense negotiations later, Canada and 11 other Pacific Rim nations have finally reached an agreement on the Trans-Pacific Partnership (“TPP”) pact. TPP negotiations were originally scheduled to end on Friday but were delayed into Monday morning by lingering issues, including a politically charged debate on the protection …

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Oct 05

The Turing-Rodelis-Valeant Drug Pricing Drama

By: Hayley Ossip and Sana Halwani Turing Pharmaceuticals Daraprim, Rodelis Therapeutics’ cycloserine, and Valeant’s Isuprel and Nitropress have all been in the news in the last few weeks for extreme price hikes.  These price hikes, and the resulting public fury, has reached the American presidential race with both Hilary Clinton and Bernie Sanders speaking out …

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Aug 07

CRISPR-CAS9: The Future of Gene Editing Runs Afoul of Ownership Dispute

By: Matt Frontini A new gene editing technique, the CRISPR-CAS9 system, has been hailed as a revolutionary development in the biomedical sciences.  Unlike previous gene editing techniques, the CRISPR-CAS9 system is cheap, efficient and can target multiple gene sequences at once. CRISPRs (short for clustered regularly interspaced short palindromic repeats) are segments of bacterial DNA …

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Jul 29

US Biosimilar Patent Policy is an Unmitigated Mess

By: Nathaniel Lipkus Last week, the U.S. Federal Circuit ruled that biosimilar entrants need not provide copies of their FDA product applications brand companies and negotiate the scope of a patent lawsuit, as contemplated in the Biologics Price Competition and Innovation Act (BPCIA). The majority found that this “patent dance” is optional, with remedies for …

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Jul 24

Newly Leaked Annex Extends Trans Pacific Partnership Agreement to Regulation of Drug Reimbursement

By: Max Morgan The Trans Pacific Partnership (TPP) is a proposed trade agreement between twelve Pacific Rim nations, including Canada, the United States, Japan, Mexico, Australia, Malaysia, Chile, Singapore, Peru, Vietnam, New Zealand, and Brunei.  If ongoing negotiations are successful, the TPP would create the largest trading block in the world, representing approximately 40% of …

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Jun 08

When Will Canada Provide Guidance on Gene Therapies? – An Update

Last week I wrote a post discussing the draft guidance on the quality, non-clinical and clinical aspects of gene therapies published by the European Medicines Agency (“EMA”).  I noted that Health Canada had published a draft guidance on cell therapies, but had not published a guidance on gene therapies, and that it remained unclear whether …

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