Amgen Seeks Discovery Regarding AbbVie’s Patent Dance with Other Biosimilar Applicants

In the ongoing litigation between AbbVie and Amgen regarding Amgen’s proposed biosimilar for Humira® (adalimumab), Amgen is seeking discovery from AbbVie regarding its exchanges with other adalimumab biosimilar applicants under the BPCIA, commonly known as the “patent dance.”

The parties were before the Court on May 9 for a discovery conference, during which the Court considered Amgen’s motion to compel such discovery.  The Court expressed concern that the discovery in question would implicate non-parties’ highly confidential information, and requested further briefing on the issue.

Yesterday, Amgen filed a letter providing additional briefing in support of its motion.  In the letter, Amgen states that while it originally sought “the patent exchange contentions that AbbVie has exchanged or will exchange with other Humira biosimilar applicants,” it now only seeks those “portions that concern the invalidity and validity of (i) the patents-in-suit and (ii) any patents that share a common priority with the patents-in-suit.”  Amgen emphasized that it “does not want the infringement contentions or any confidential information of the other applicants,” which should be redacted prior to production.  Amgen argues, among other things, that similar discovery regarding “the invalidity of asserted and related patents from other proceedings are routinely produced in discovery” in federal court.  Amgen further argues that the mere fact that an aBLA has been submitted to FDA is not in itself confidential, as evidenced by the public statements of other biosimilar applicants about their aBLAs.

A full copy of the letter and supporting exhibits can be seen here.