As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar pegfilgrastim. Mylan’s motion argued that under the claims of the patent, the salts and protein used to produce pegfilgrastim must be mixed before being loaded into the column to undergo chromatography. Construed this way, Mylan reasoned, the claims of the patent would not cover its process because the salt concentration of Mylan’s mixture is lower than what is claimed.
On November 15th, the district court denied Mylan’s motion without prejudice. The court reasoned that several of Mylan’s arguments “depend on the Court’s construction of at least two terms in dispute in the ’707 Patent: ‘mixing a preparation containing the protein with a combination of a first salt and a second salt’ and ‘between about 0.1 M and 1.0.’” Although the court recognized that courts may engage in claim construction at the pleading stage, and claim construction had been briefed and argued, the court decided that it should not issue an order on the pleadings before its claim construction order because the arguments of the parties could change depending on its construction.
Stay tuned for updates from Big Molecule Watch as this case continues to unfold.