Genentech Sues Pfizer Over Proposed Bevacizumab Biosimilar, PF-06439535

Genentech, together with City of Hope, has filed a new complaint for patent infringement against Pfizer over PF-06439535, Pfizer’s proposed bevacizumab biosimilar referencing Genentech’s Avastin.

The complaint, filed in the United States District Court for the District of Delaware, claims that Pfizer has infringed on 22 patents related to bevacizumab and comes after Pfizer submitted an abbreviated Biologics License Application (aBLA) for the product to the FDA.

According to the complaint, Pfizer had 20 days to provide Genentech with its aBLA after regulatory submission, and the biosimilar developer was also required to provide “other information” related to manufacturing of the proposed product. This early disclosure under the terms of the Biologics Price Competition and Innovation Act (BPCIA), says Genentech, is important for the undertaking of preliminary injunction proceedings.

However, according to the complaint, Pfizer “ignored this targeted request” for information and “took the position that producing only portions of its aBLA alone was sufficient under the statute.” In September of last year, Pfizer produced “only portions” of the aBLA and did not give Genentech the other information that it sought.

Despite Genentech’s protests, Pfizer has indicated that its production satisfied statutory obligations, leading to an exchange of correspondence between the drug makers over the following months.

In March 2019, Pfizer accepted and agreed on the patents, for which Genentech provided infringement contentions, that would be the subject of a patent infringement action under the BPCIA.

Some of the patents listed in the complaint have already expired, but Genentech contends that, prior to expiry, Pfizer infringed these patents by making its proposed biosimilar in the United States in a manner not covered by safe harbor.

Genentech has requested a trial by jury. It has asked that the court find that Pfizer has infringed on its asserted patents and will infringe on those patents by making, using, or selling its product, and it also asks that the court find that Pfizer failed to provide adequate information as required under law. Genentech seeks damages, including a preliminary and a permanent injunction against infringement of the patents in question.