Biotech Values

[DewDiligence]

Apropos to NVS’ Enbrel FoB—(from your post):

Sandoz's alleged refusal to hand over its filgrastim application isn't the company's first attempt to bypass the patent dance. In 2013 the company filed a lawsuit against Amgen and Hoffman-LaRoche over another drug, a generic version of Amgen's Enbrel (etanercept).

Although Sandoz hadn't yet filed an application with the FDA and was still testing its version of etanercept in a phase 3 trial, the company asked the California Northern District Court to issue a declaratory judgment that its biosimilar will not infringe on two of Amgen's patents, and that those patents were invalid and unenforceable, in part, because they had been issued more than a decade and a half after they were first filed.

In November 2013, the judge dismissed the case as premature as Sandoz had not yet engaged in the BPCIA's patent information exchange process.

The Court may now consider this case ripe for adjudication.