The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the third biosimilar maker to file an application for approval of a biosimilar product with FDA, chose a different course. Apotex participated in and completed the BPCIA’s pre-suit information exchanges (also known as the “patent dance”) for its proposed biosimilar of Amgen’s Neulasta (pegfilgrastim). As Amgen’s recent lawsuit shows, Apotex followed the patent dance again for its proposed biosimilar of Amgen’s Neupogen (filgrastim).
FDA approved Neupogen to prevent infections in cancer patients in 1991 and approved Neulasta, a longer-lasting version, in 2002. Apotex is seeking FDA approval for its proposed biosimilar versions of both products. In August 2015, Amgen sued Apotex in connection with its proposed biosimilar of Neulasta. In October 2015, Amgen sued Apotex in connection with its proposed biosimilar of Neupogen. Both of these cases are pending in the Southern District of Florida and have been assigned to Judge James Cohn. Judge Cohn has now consolidated both cases for all purposes, including trial.
The two cases present similar issues. In the new case involving a biosimilar of Neupogen, as in the one involving Neulasta, Apotex followed the BPCIA’s patent dance. After FDA accepted Apotex’s regulatory application for review in February 2015, Apotex provided its abbreviated Biologics License Application (aBLA) to Amgen. 42 U.S.C. § 262(l)(2)(A). Amgen then provided its list of patents that could be asserted against Apotex. 42 U.S.C. § 262(l)(3)(A). Apotex in turn provided its noninfringement and/or validity contentions to Amgen as set forth under the BPCIA. 42 U.S.C. § 262(l)(3)(B). Amgen then provided Apotex with its infringement contentions and any responsive validity contentions. 42 U.S.C. § 262(l)(3)(C). According to Amgen’s complaint, the day after Amgen provided its contentions, the parties proceeded to determine which of the listed patents should be the subject of the first phase of BPCIA litigation (the so-called “immediate litigation phase”). 42 U.S.C. § 262(l)(4). The good faith negotiations lasted a week. On September 4, 2015, Amgen and Apotex agreed that two patents should be the subject of the BPCIA’s immediate litigation phase. Amgen then sued Apotex within thirty days, on October 2, 2015, as required under the BPCIA. 42 U.S.C. § 262(l)(6)(A).
As agreed by the parties, Amgen sued Apotex on a manufacturing patent and a method of use patent. The manufacturing patent issued just this year. It is also at issue in Amgen’s case against Apotex involving the proposed biosimilar of Neulasta. The method of use patent is not at issue in the Neulasta case. In addition to patent infringement, Amgen sued Apotex for violating the BPCIA’s notice of commercial marketing provision. 42 U.S.C. § 262(l)(8)(A). Apotex provided its 180-day notice of commercial marketing in April 2015, long before any FDA approval of its proposed biosimilar of Amgen’s Neupogen. On July 21, 2015, the Federal Circuit held in Amgen v. Sandoz that a biosimilar maker can only provide an effective notice of commercial marketing after FDA approval. Later that month, Amgen requested Apotex to provide a notice of commercial marketing after the Apotex product is approved by FDA. According to the complaint, Apotex responded that “because Apotex followed the pathway and provided Amgen with its application and manufacturing information, providing a notice of commercial marketing is not mandatory.” In its complaint, Amgen seeks an injunction preventing Apotex from marketing its product until at least 180 days after FDA approval.
The exact same issue is before the court in Amgen’s case against Apotex involving the proposed biosimilar of Neulasta. Amgen has moved for a preliminary injunction to prevent Apotex from marketing its proposed biosimilar of Neulasta until at least 180 days after it provides valid notice. With the two actions now consolidated, the briefing will apply to Apotex’s proposed biosimilar of Neupogen as well.
Amgen’s consolidated suits against Apotex are set for trial in July 2016. But it is unclear when Apotex’s proposed biosimilar products will be approved and what the scope of any approval will be. FDA accepted Apotex’s application for a biosimilar of Neulasta in December 2014 but has not yet announced plans for an advisory committee meeting. FDA’s targeted 10-month decision date for the application has passed. The timing of any FDA approval for Apotex’s proposed biosimilar of Amgen’s Neupogen, a simpler product than Neulasta, is also uncertain.