Mylan Prevails in Pegfilgrastim Biosimilar Litigation

On September 17, 2019, the U.S. District Court for the Western District of Pennsylvania endorsed the parties’ stipulation and proposed order of non-infringement of U.S. Patent No. 9,643,997 in favor of Mylan, thereby resolving all pending disputes between the parties in Amgen v. Mylan, Civil Action No. 17-cv-1235, the BPCIA litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb) biosimilar.  Mylan’s product was filed under an aBLA to Amgen’s reference listed product NEULASTA, approved by FDA in June 2018, and launched in the United States in July 2018. Amgen had previously dropped its assertion of the only other patent it was asserting against Mylan.

The district court’s order follows the filing of a joint status report indicating that a recent non-infringement ruling by the Federal Circuit on a related patent in the Amgen v. Sandoz BPCIA litigation effectively resolved the parties’ dispute regarding the ’997 patent in favor of Mylan. In particular, on May 9, 2019, the Federal Circuit affirmed a district court judgment—and an associated claim construction—that Sandoz’s filgrastim biosimilar (ZARXIO) and proposed pegfilgrastim biosimilar did not infringe Amgen’s U.S. Patent No. 8,940,878, directed to a protein refolding method, because the patented method required separate “washing” and “eluting” steps.  Sandoz’s method used a single step.  On September 3, 2019, the Federal Circuit denied Amgen’s petition for rehearing en banc (but granted rehearing to modify certain language in its May 9, 2019 opinion), leaving in place the ruling in Sandoz’s favor.  The ’997 patent asserted against Mylan’s pegfilgrastim biosimilar product is part of the same family of patents as the ’878 patent, and uses similar “washing” and “eluting” claim language.  In submitting their stipulation to the district court, the parties agreed that “under the reasoning of the Federal Circuit’s decision as to the ’878 Patent in the Sandoz appeal, Mylan’s accused process does not meet the claim limitation ‘(d) washing the separation matrix; and (e) eluting the protein from the separation matrix’ in the ’997 Patent, and thus Mylan does not infringe the asserted claims of the ’997 Patent.”

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