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Last week I wrote a post discussing the draft guidance on the quality, non-clinical and clinical aspects of gene therapies published by the European Medicines Agency (“EMA”).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...
View ArticleNewly Leaked Annex Extends Trans Pacific Partnership Agreement to Regulation...
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,...
View ArticleUS 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...
View ArticleCRISPR-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...
View ArticleThe 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...
View ArticleBiologic drugs will be given a minimum of five years of data protection under...
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...
View ArticleAustralian 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...
View ArticleUpdate 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...
View ArticleFederal 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...
View ArticleFCA Affirms Section 6(5)(b) is Available to Strike an NOC Application for...
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...
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