In Ongoing Adalimumab Litigation With Coherus, Amgen Denies Patent Infringement

In a complaint filed earlier this year, biosimilar developer Coherus BioSciences alleged that Amgen, maker of the EU-authorized and marketed Amgevita, a biosimilar adalimumab, has infringed on a number of Coherus’ patents directed to the stable formulation of adalimumab.

According to Coherus’ original complaint, manufacture of the EU-marketed Amgevita in the United States constitutes infringement on 3 of its US patents, and this infringement warrants an award of damages.

Later, Coherus amended its complaint to include alleged infringement of a fourth patent, also directed to the stable aqueous pharmaceutical composition of adalimumab.

Amgen has now answered Coherus’ complaint, and denies that it has infringed on Coherus’ patents. Amgen also said that the patents are invalid for failure to comply with requirements of the law.

According to Amgen, Coherus “had to deceive the United States Patent and Trademark Office” in order to procure patents that had claims to anticipated and obvious adalimumab formulations. The Amgevita-maker’s response states that the patents’ inventor and Coherus’ attorney together withheld material prior art and other information from the office, and says that these parties misstated material facts with the intention to deceive.

Amgen’s response goes on to say that the inventor and attorney filed multiple petitions for inter partes review (IPR) against claims of patents held by AbbVie (maker of the brand-name adalimumab, Humira), and that these petitions took positions that were directly contrary to those taken in their own applications for patents.

Amgen says these positions were material to the patentability of the claims at issue in Coherus’ complaint, and the existence of these IPR challenges, says Amgen, were not disclosed to the patent office. Disclosure of these issues, says Amgen, could have changed which claims of the asserted patents that the office would have allowed.

Coherus also withheld material prior art references, says Amgen, including the most pertinent prior art from AbbVie’s portfolio of adalimumab patents. However, other, less relevant patents in the same family were submitted. “The single most reasonable inference to be drawn,” says Amgen’s response, is that Coherus’ agents “acted with the intention of deceiving the Patent Office and procuring the Asserted Patents on the basis of an incomplete and/or misleading record.”

Amgen seeks a trial by jury, and has asked the court to deny all forms of relief to Coherus, dismiss Coherus’ complaint, declare that Amgen has not infringed the patents, and declare the patents invalid and unenforceable.