Amgen has been sued by Genentech, a Roche company, for withholding information on its biosimilar to Genentech’s bevacizumab (Avastin), thereby creating a barrier for filing a potential patent infringement lawsuit.
In its complaint, Genentech states that Amgen has violated the Biologics Price Competition and Innovation Act (BPCIA) as it develops the biosimilar to bevacizumab. Genentech expected access to Amgen’s manufacturing information of the biosimilar to determine whether the manufacture or sale of the product would infringe on Genentech’s patents. The company also wants sufficient time for a legal intervention, if need be, before the biosimilar is launched in the market.
The lawsuit, filed in a US District Court in Delaware, claims that Amgen is refusing to share relevant “confidential information” with Genentech’s consultants, beyond the Abbreviated Biologics License Application (aBLA), which would allow an infringement analysis. Per the BPCIA statute, Genentech expected to have not just the copy of the aBLA for review, but additional information that describes the steps used to manufacture the biosimilar product—in this case, bevacizumab—within 20 days of filing the aBLA on January 4, 2017. This would allow Genentech to provide Amgen with a list of patents within 2 months of receiving information from the company.
The complaint also accuses Amgen of improperly withholding consent for 4 experts to review their aBLA, which “violates subsection (l)(1)(C) of the BPCIA.”
Genentech would like its 60-day window for providing its list of patents to Amgen to begin only after Amgen provides all the required information. The company also seeks to prevent marketing of Amgen’s biosimilar till it meets all obligations per the BPCIA.
Amgen has witnessed this “patent dance” before, with one of its own products, epoetin alfa (Epogen). Amgen had then sued the biosimilar manufacturer, Hospira, for noncompliance with the BPCIA.
The competition for the high stakes involved with this multi-billion dollar industry has resulted in companies tapping into loopholes left by the fairly new rules around biosimilars. Amgen is already involved in a case with Sandoz that will decide whether a biosimilar applicant can completely opt out of the BPCIA information exchanges, and if so, what information would the originator company end up with. Another argument is over the 6-month obligatory waiting period for biosimilar manufacturers after they have informed the originator about its biosimilar product.