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Healthcare & Life Sciences

20 November 2019
Urszula Wojtyra Update on biosimilars

Canada - Smart & Biggar

Since June 2018 a number of biosimilar developments – including with regard to approvals, pending submissions, regulatory matters, litigation and market access – have taken place in Canada. For example, Health Canada recently published an updated Biosimilar Biological Drugs in Canada: Fact Sheet, which provides an overview of the regulatory framework for biosimilar drugs in Canada.

Author: Urszula Wojtyra
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Abigail Smith Amgen not precluded from litigating same patent under amended PMNOC regulations

Canada - Smart & Biggar

The Federal Court of Appeal recently dismissed Pfizer's appeal of its failed motion to dismiss Amgen's action regarding an infringing patent under Section 6 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Pfizer argued that Amgen's action ought to be dismissed as an abuse of process on the basis that Amgen had unsuccessfully litigated the same patent under the pre-amended PMNOC Regulations.

Author: Abigail Smith
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Scott D Stein Ninth Circuit invited to weigh in on public disclosure bar falsity

USA - Sidley Austin LLP

A US District Court for the Central District of California judge recently granted a stay and certified two questions for interlocutory appeal in a relator's False Claims Act suit. The case involved allegations that one of the defendants had perpetrated an upcoding scheme whereby it trained its doctors to describe medical conditions with language that would support increasing the severity levels of diagnosis-related groups that the defendant reported to Medicare, leading to inflated Medicare reimbursements.

Authors: Scott D Stein, Joseph LoCascio
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