Amgen has filed patent infringement claims against Mylan and its subsidiaries over Mylan’s proposed biosimilar version of Neulasta (pegfilgrastim). Neulasta, a long-acting version of Amgen’s Neupogen (filgrastim), is a blockbuster biologic medicine used by cancer patients on chemotherapy to fight off infections. Amgen alleges that Mylan infringes two of its patents, U.S. Patent Nos. 8,273,707 and 9,643,997, which claim methods of purifying proteins.
Neulasta is the subject of other ongoing litigation, including patent infringement claims against both Sandoz and Coherus. In its lawsuit against Coherus, Amgen alleges infringement of the ‘707 patent, one of the patents asserted against Mylan. Amgen’s lawsuit against Sandoz involves another protein purification patent, U.S. Patent No. 8,940,878. Amgen identified this patent to Mylan in its pre-suit disclosures under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but it was not selected for immediate litigation. Apotex is yet another developer of a proposed biosimilar version of Neulasta. Apotex was the first to submit an application to FDA; it prevailed at the district court level over Amgen’s infringement claims for a different Neulasta manufacturing patent last year. Oral argument on Amgen’s appeal of the district court’s decision is set for October 3.
Although many biosimilar makers have tried to obtain approval for proposed biosimilar versions of Neulasta, approval has been hard to come by so far. No biosimilar applicant has been approved to market a proposed biosimilar version of Neulasta in the United States or Europe. Last month, Mylan withdrew its submission for approval of its proposed Neulasta biosimilar in Europe. EMA raised a number of manufacturing concerns for the proposed product, including the lack of a certificate of good manufacturing practice for the product’s manufacturing site.
Amgen’s lawsuit against Mylan was filed after the parties completed the pre-suit procedures set out in the BPCIA. FDA accepted Mylan’s abbreviated Biologics License Application (aBLA) in February, and it remains under review. In its complaint, Amgen points to FDA’s goal of acting on most applications within 10 months of the 60-day-filing review period as indicating that FDA may act upon Mylan’s application imminently. Mylan also had previously announced that the FDA goal date is early next month, October 9, 2017. Amgen claims it will be irreparably harmed by Mylan’s manufacture and sale of the biosimilar if approved by FDA.
The case is Amgen Inc. v. Mylan Inc., 2:17-cv-01235-MRH (W.D. Pa.).