by April Breyer Menon | Aug 11, 2017
One of the primary incentives provided in the BPCIA to engage in the “patent dance” is that if the applicant completes the dance and the reference product sponsor does not sue that 30-day period, as required by statue, infringement damages for patents that...
by April Breyer Menon | Aug 9, 2017
Inter partes review (or IPR for short, which people tend to use in the industry) has become an important process for patents throughout the life science industry, but interestingly, so far we haven’t seen as many in the biosimilars space as one might expect. We...
by April Breyer Menon | Aug 7, 2017
Sandoz v. Amgen concerned the interpretation of two procedural provisions of the BPCIA setting the framework for biosimilar patent litigation. Essentially, the BPCIA (codified at 42 USC s. 262(l)(2)(A)) states that once the FDA accepts an application for a...
by April Breyer Menon | Jul 26, 2017
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by April Breyer Menon | Jul 6, 2017
On June 12, 2017 the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted: 1) whether a...
