Categories & Search

Apotex Drops Sham Litigation Counterclaims in Neupogen and Neulasta Biosimilar Litigation

In a consolidated litigation in the Southern District of Florida involving Apotex’s proposed biosimilars of Amgen’s Neupogen, an anti-infection drug for cancer patients, and of Amgen’s Neulasta, a long-acting version of Neupogen, Apotex participated in the pre-suit information exchanges of the BPCIA (the so-called “patent dance”), negotiated and agreed with Amgen as to what patents should be asserted in the BPCIA’s immediate litigation phase but then counterclaimed that Amgen engaged in sham litigation by bringing suit on one of the agreed patents.  According to Apotex, it provided Amgen with “conclusive and irrefutable proof” during the pre-suit information exchanges that it would not infringe this patent.  As a result, Apotex argued that it was a sham for Amgen to assert it.  Amgen argued, on the other hand, that Apotex was precluded from asserting such claims since Apotex agreed to include this patent in the immediate litigation phase, requiring Amgen to assert it within 30 days of that agreement or lose its right to lost profits and injunctive relief for infringement of the patent.  In addition, Apotex had the statutory right under the BPCIA to disagree as to which patents should be litigated immediately.  See 42 U.S.C. § 262(l)(4)(B), (5).  Apotex recently stipulated to dismissal of its sham litigation counterclaims and the infringement of the patent will be tried starting on July 11, 2016 without those claims at issue.  With the claims dropped, this case will not answer the question of whether a biosimilar maker can both agree as to which patents to litigate immediately and sustain a claim of sham litigation against the reference product sponsor, here Amgen, for asserting the agreed patent.