The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court rejected the Defendant’s attempt to avoid infringement based on the scope of its abbreviated new drug submission and product monograph (PM). … Continue reading
The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal Court (FC) properly considered the evidence and that it did not err in finding that the decision … Continue reading
The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic version of VYVANSE® (lisdexamfetamine). Shire’s counterclaim for infringement in the action was dismissed but the Court … Continue reading
As we reported, on September 21, 2017 the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act and accompanying regulations came into force. The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations … Continue reading
Following the Federal Court’s decision that Bayer’s patent relating to YAZ and YASMIN (both containing drospirenone and ethinyl estradiol) was valid and infringed by Apotex and Cobalt, Apotex argued that it, rather than Bayer, should be entitled to elect between damages and an accounting of profits. As we reported, the court disagreed, and ordered that … Continue reading
The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s withdrawal of a notice of compliance (NOC) granted to Apotex Inc. for Apo-omeprazole. Health Canada withdrew the NOC because Apotex had not demonstrated bioequivalence. Health Canada also rejected Apotex’s request for reconsideration. The court found Apotex did not have legitimate expectations … Continue reading
As we reported, Apotex Inc. applied for judicial review of the Minister’s decisions to disclose information from Apotex’s abbreviated new drug submission in response to an access to information request. The Federal Court of Appeal upheld an order adding the Commissioner of Information as a respondent, holding that the test was whether the Commissioner’s participation … Continue reading
On June 2, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that AstraZeneca’s Canadian Patent No. 1,292,693 was valid and infringed by Apotex’s manufacture, sale, and promotion of Apo-Omeprazole capsules. Case: Apotex Inc v AstraZeneca Canada Inc, et al (SCC Docket: 37478) Drug: LOSEC® (omeprazole) Nature of case: Appeal … Continue reading