Based on the dispute between Celltrion and Genentech over Celltrion’s biosimilar version of Rituxan (rituximab), it should be clear that interpretive disputes relating to the patent dance in the 2010 biosimilar law are far from over. The patent dance is indeed the gift that keeps on giving. And some of the interpretive conundrums lead to ridiculous results, at least, if you’re at all interested in saving litigants money. Look at what Genentech recently found itself doing.
As earlier posts on this blog have noted (here and here), the Supreme Court’s 2017 ruling in Sandoz v. Amgen effectively put an end to arguments that biosimilar applicants can be forced to participate in the “patent dance” with biologics innovators. Even still, there are lots of interesting issues relating to the patent litigation provisions of the 2010 biosimilars law. Here’s one percolating in the courts right now: can a biosimilar company start to dance and then change its mind? Or does it have to finish what it started?
This arises in a dispute between Genentech and Celltrion over a biosimilar copy of Rituxan (rituximab). There’s a second issue in this dispute, which I will describe in another blog post. First some background, and then I’ll unpack the litigation.
I recently wrote a preliminary reaction to the Supreme Court’s Sandoz v. Amgen decision on Health Affairs Blog. This was the Court’s first foray into the Biologics Price Competition and Innovation Act (BPCIA), which created a pathway for licensure of biosimilar biologics. As my essay for Health Affairs notes, the issues presented by this litigation are not entirely resolved. There is fodder for a great deal of further discussion.
Today I am starting with the Court’s ruling that Amgen was not entitled to a federal injunction ordering Sandoz to share its marketing application and manufacturing information with Amgen. The topic here is the origin of the argument that Sandoz made to the Court — the omission of manufacturing process patents from the declaratory judgment provision.