Blog Big Molecule Watch August 15, 2019

Amgen Drops Assertion of One Patent Against Mylan in Pegfilgrastim Biosimilar Litigation; One Patent Remains

As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen has asserted that Mylan infringes two protein purification process patents: U.S. Patent Nos. 8,273,707 and 9,643,997. Early this month, the district court requested the parties’ positions with regard to the ’707 patent, in light of last month’s Federal Circuit ruling in Amgen v. Coherus that held that the protein purification process that Coherus uses to make its pegfilgrastim biosimilar could not be found to infringe the ’707 patent under the doctrine of equivalents in view of Amgen’s clear and unmistakable disclaimer of claim scope during prosecution.

Last week, Amgen and Mylan filed a Joint Status Report in which the parties stipulated that Mylan does not infringe the asserted claims of the ’707 patent under Amgen v. Coherus in light of the district court’s claim construction ruling. The parties stipulated, however, that Amgen retained its right to appeal the district court’s judgment with respect to the ’707 patent, including the underlying claim construction ruling. The stipulation further clarified that it had no impact on the ’997 patent, which Amgen continues to assert.

Finally, Mylan requested that the district court extend the stay of discovery (which was set to expire on August 14, 2019) for an additional 30 days, in view of, among other things, Amgen’s pending petition for rehearing en banc in the Amgen v. Sandoz appeal concerning a protein purification process patent that is related to the ’997 patent. Amgen stated that it did not oppose Mylan’s request so long as the extension does not delay the anticipated trial date.

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