Amgen Seeks Declaratory Judgment Against Genentech in Bevacizumab Suit

Last week, Amgen filed a new lawsuit against Genentech in a California district court. The suit seeks a judgment that Amgen’s newly FDA-approved bevacizumab biosimilar, bevacizumab-awwb (Mvasi) has not infringed and will not infringe on 27 patents for Genentech’s reference bevacizumab treatment, Avastin.

In its complaint, Amgen argues both that it did not infringe on the patents at issue in developing its drug, and also that each of the patents is invalid. In the case of US Patent Number 6,407,213 (the ‘213 patent), which covers a method of making humanized antibodies and which will expire in June 2019, Amgen makes the additional claim that Genentech deliberately misrepresented and omitted information regarding the patent before the US Patent Office. Genentech’s behavior suggested “deceptive intent,” according to Amgen, which it says makes the ‘213 patent unenforceable.

Big Molecule Watch reports that the ‘213 patent is also at issue in several pending inter partes review proceedings, including those filed by drug makers Celltrion (which is developing CT-P16), Boehringer Ingelheim (which is developing BI 695502), Pfizer (which announced positive top-line results from its REFLECTIONS study on PF-06439535 in July), and Samsung Bioepis (which is developing SB8).

Amgen also claims that, during the Biologics Price Competition and Innovation Act (BPCIA) information exchange process concerning the biosimilar bevacizumab, Genentech did not properly comply with the so-called “patent dance” when it failed to make a full response to Amgen in the parties’ negotiations over which patents would be litigated.

Genentech, for its part, has asserted that the 27 identified patents would be infringed upon if Amgen were to produce or market the drug in the United States, and that the rival drug maker has already infringed on the patents by producing bevacizumab.

The FDA granted Amgen and its partner Allergan approval for Mvasi on September 14, 2017, after the agency’s Oncologic Drugs Advisory Committee voted in July to recommend approval of the biosimilar for all of the indications of its reference. Each of the 17 committee members voted in favor of approval based on what committee members called “clean and clear” evidence and “tight confidence intervals.” The September regulatory decision marked the first time that the FDA had approved an anticancer biosimilar.

When Amgen eventually markets Mvasi, the biosimilar will compete for substantial sales in the anticancer market; the reference Avastin earned $6.75 billion in global sales for Genentech in 2016.