As we previously reported, Amgen is appealing the District Court’s decision to dismiss, with prejudice, Amgen’s patent infringement complaint against Coherus regarding its (recently approved) biosimilar of Neulasta® (pegfilgrastim). Amgen filed its opening brief on August 20, challenging the district court’s dismissal of the suit.
On October 31, 2018, Coherus filed its responsive appellate brief, which became available on the public docket on November 7. Coherus argues:
- The District Court correctly held that Amgen’s infringement claim is barred because the asserted claims do not cover Coherus’ accused method. Coherus argues that during patent prosecution, Amgen distinguished the claim in suit from the prior art on the grounds that the claim did not encompass a “particular combination” of salts, but is now trying to expand their claim to include “any” combination of salts. Coherus further argues that if Amgen had pursued this claim in a straightforward manner, the USPTO would likely have rejected it on the grounds of obviousness, lack of written description, and lack of enablement.
- Amgen’s claim under the doctrine of equivalents fails because of the disclosure-dedication doctrine. The disclosure-dedication doctrine applies when material is disclosed in the patent application but is not claimed. The unclaimed material is said to be dedicated to the public. Therefore, Coherus argues that Amgen’s infringement claim fails because the doctrine prevents reading the claims to cover the unclaimed material.
Amgen’s reply is due December 12, 2018.