In a rare case where drug samples were given under consent in an NOC proceeding Novartis sought, but was denied, to use these samples in a related litigation in Portugal (2016 FC 1091).
Samples are rarely provided in NOC proceedings. Nevertheless, production may be compelled if samples were provided to the Minister as part of the drug submission (Patented Medicines (Notice of Compliance) Regulations (SOR/93-133), s. 6(7)). This was not the situation in this case where Mylan consented to producing the samples, subject to the existing protective order.… Continue Reading
Changes are coming swiftly, as the federal government moves to implement the Comprehensive Economic and Trade Agreement (“CETA”) just days after it was signed by Prime Minister Trudeau in Brussels at the end of October 2016.
These changes will significantly impact biologic/pharma patents in two major ways. First, they will implement, for the first time, a Canadianized version of patent-term restoration. Second, they will revamp the current framework for linkage between patents and the approval of biosimilar/generic drugs in Canada by giving innovators the right of appeal, by changing the nature of the PM(NOC) proceedings to a more U.S.-style approach, … Continue Reading
In Teva Canada v. Novartis Canada 2016 FCA 230, the Federal Court of Appeal confirms that in assessing the utility of a patented invention, different patent claims can have different promised utilities.
This decision was made in Teva’s appeal from the Federal Court’s judgment (2015 FC 770) in which the Minister of Health was prohibited from granting an NOC to Teva in respect of its generic version of Novartis’ EXJADE® (deferasirox).
The only issue on appeal was whether the lower court erred in law in its construction of the so-called “promise of the patent”.… Continue Reading