Categories & Search

Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue

The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that biosimilar makers could opt out of the first step of the BPCIA pre-litigation procedures, the provision requiring biosimilar makers to provide their abbreviated Biologics License Application (aBLA) and other manufacturing information describing the processes used to make the biosimilar twenty days after the FDA accepts the aBLA for review.  The court held that the innovator company could sue under the BPCIA in such circumstances and “access the required information through discovery.”  In its second decision, Amgen v. Apotex, the court further buttressed its reasoning as to why the first step of the BPCIA patent-dispute resolution provisions was optional.

Amgen now appeals a discovery ruling in its biosimilar litigation with Hospira holding that Amgen v. Sandoz does not require Hospira to produce manufacturing information for its proposed biosimilar of Amgen’s Epogen (epoetin alfa).   Hospira moved to dismiss the appeal on the ground that district court has not yet issued a final judgment in the case.  The Federal Circuit denied the motion and is allowing the appeal to proceed on the merits while at the same time requiring the parties to further address jurisdictional issues.

The parties’ dispute centers on whether and when the first step of the BPCIA’s pre-litigation procedures, 42 U.S.C. §262(l)(2)(A), as interpreted by the Federal Circuit in Amgen v. Sandoz, requires a biosimilar maker to produce manufacturing information.  Prior to the lawsuit, Hospira produced its aBLA to Amgen but not its manufacturing information.  Amgen sued Hospira on a subset of its patents and sought discovery of Hospira’s processes for making its proposed biosimilar product in the litigation before Judge Andrews in the District of Delaware.  After denial of en banc review in Amgen v. Sandoz, Amgen filed an amended complaint stating that it intended to “seek to assert additional patents following eventual receipt of Hospira’s manufacturing information to be produced in discovery.”

After Hospira refused to provide the information in discovery, Amgen moved to compel its production.  Amgen focused on the composition of the cell culture media used in the manufacture of Hospira’s proposed biosimilar product, arguing first that it was relevant to whether one of the patents Amgen asserted was infringed, and second that the BPCIA and the Federal Circuit’s decision in Amgen v. Sandoz required production of such information in any event.  Amgen had not asserted a number of its cell culture media patents in the litigation in order to first assess whether they were infringed.

Judge Andrews held for Amgen on the first ground, but did not agree that there was any freestanding requirement in the BPCIA or under Amgen v. Sandoz to produce manufacturing information during litigation.  Judge Andrews held that the Amgen v. Sandoz was simply “not on point” and that Amgen could not discover manufacturing information without first having filed an infringement action on a patent that would make the manufacturing information relevant under Federal Rule of Civil Procedure 26.

Following the ruling, Hospira notified Amgen that it would not contest that the limitations in the asserted patent relating to cell culture media were met and that it therefore would not be producing any discovery relating to cell culture media in the litigation.  As such, Hospira effectively mooted Judge Andrews’s order on the first ground and Amgen is unlikely to obtain the discovery that it needs absent a Federal Circuit ruling in its favor on the second ground.  Amgen appealed the district court’s denial of its motion to compel.

Hospira moved to dismiss Amgen’s appeal for lack of jurisdiction since there was no final judgment in the case.  Hospira also argued that the district court’s ruling did not qualify as a collateral order since it did not resolve an important issue separate from the merits of the action, and therefore was not appealable.  Amgen responded that the discoverability of manufacturing information under the BPCIA presented an important issue for the Federal Circuit to decide on the merits, and that if Hospira’s refusal to produce information were to be upheld, “the purposes of the BPCIA will unravel” as biosimilar applicants “surgically carv[e] out information from disclosure.”

In a short order, Judge Newman denied Hospira’s motion to dismiss.  The order stated that “Amgen sued for infringement of two of its patents and, pursuant to [Amgen v. Sandoz], sought discovery to obtain the information that Hospira had previously declined to provide—information that Amgen requested for the purpose of evaluating whether Hospira infringes patent claims not currently asserted in the litigation.”  The order also noted Amgen’s argument that “the litigation is unlikely to end before Hospira is able to launch the biosimilar and that the district court’s ruling is tantamount to denying Amgen its sole remedy under paragraph (l)(2)(A) [of the BPCIA].”

The court “deem[ed] it the proper course” for the appeal to proceed on the merits and for the parties to also brief whether the court has jurisdiction under collateral order doctrine, briefed as part of Hospira’s motion to dismiss, or the All Writs Act, 28 U.S.C. § 1651(a), which Amgen did not raise.  The All Writs Act authorizes federal courts to “issue all writs necessary or appropriate in aid of their respective jurisdictions” and can provide an alternative basis for jurisdiction.

Amgen’s appeal provides an opportunity for the Federal Circuit to clarify Amgen v. Sandoz and its interpretation of (l)(2)(A) in view of a discovery order reflecting that innovators may not be able to “access the required information through discovery” without having to assert patents that may not be infringed.

Case Tags: