Last month, in a case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) involving Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), Apotex accused Amgen of sham litigation for bringing a patent infringement claim on a patent (the ’138 patent) that the parties agreed to litigate during the immediate litigation phase of the BPCIA.  After the parties completed the BPCIA’s pre-suit information exchanges (the so-called “patent dance”) and agreed on the patents to litigate immediately,Amgen sued Apotex on the two agreed patents within thirty days of the parties’ agreement as statutorily required.  42 U.S.C. § 262(l)(6)(A).  Nonetheless, in its Answer with Counterlcaims Apotex alleged that Amgen engaged in sham litigation by including the ’138 patent in its complaint against Apotex.  Apotex noted that it provided “conclusive and irrefutable proof” that its method of manufacturing its proposed biosimilar “does not and cannot infringe” Amgen’s patent and accused Amgen of patent misuse in seeking to litigate it.  In its Answer to Apotex’s Counterclaims, Amgen pointed out that Apotex had agreed to include the ’138 patent in the infringement action despite having a statutory option to disagree as to which patents should be litigated:

This action was commenced pursuant to 42 U.S.C. § 262(l)(4)(A) and (6)(A), after Apotex—by its own admission—engaged in good-faith negotiations with Amgen and, ultimately, agreed that the ’138 patent shall be the subject of an action for patent infringement. (Apotex’s Answer ¶¶ 12, 51.) Apotex agreed to the inclusion of the ’138 patent despite having a statutorily permitted option not to agree. See 42 U.S.C. § 262(l)(4)(B), (5).

Although Amgen did not move to dismiss Apotex’s claim based on the parties’ agreement to litigate the ’138 patent, the issue will come before the district court soon enough as the case is set for trial in July 2016.  Agreement as to which patents to litigate, when such agreement is not required, should make it difficult for a biosimilar maker to later argue that the inclusion of such a patent in a complaint, as required by the statute, is sham litigation.