Addressing for the first time the issue of whether a sponsor has the right to obtain discovery related to infringement of non-asserted patents in a biosimilar litigation, the US Court of Appeals for the Federal Circuit concluded that there is no right to discovery not otherwise permitted by the Federal Rules of Civil Procedure. Amgen, Inc. v. Hospira, Inc., Case No. 16-2179 (Fed. Cir., Aug. 10, 2017) (Dyk, J).

Hospira filed an application seeking approval for a biosimilar of Amgen’s EPOGEN product. Pursuant to the requirements of the Biologics Price Competition and Innovation Act (BPCIA), Hospira produced its biosimilar application. Amgen, the listed patent owner, requested that Hospira provide additional information regarding the specific composition of components used in its manufacturing process in order to evaluate whether it could reasonably assert infringement of additional patents. Hospira refused to provide the requested information. Amgen sued Hospira and asserted patents directed to the EPOGEN product and method of manufacture, but did not assert or otherwise identify any additional patents. 

During the ensuing litigation, Amgen again sought information regarding the composition of specific components used in manufacturing. Hospira again refused, and Amgen moved to compel. The district court denied the motion because the requested discovery had “essentially, no relevance to the patents that are asserted.” Amgen appealed the decision, and in the alternative, requested a writ of mandamus compelling the district court to order production of the requested discovery.

As a threshold matter, the Federal Circuit addressed whether jurisdiction was proper since Amgen did not appeal a “final judgment.” Amgen argued that jurisdiction was appropriate under the collateral order doctrine, which allows for appeal of an order that “conclusively determine[s] the disputed question, resolve[s] an important issue completely separate from the merits of the action, and [is] effectively unreviewable on appeal from a final judgment.” Amgen argued that the order was “effectively unreviewable” because forcing Amgen to wait until final judgment would “defeat . . . the purpose of [the BPCIA’s] disclosure requirements—to enable the sponsor [] to commence infringement litigation immediately.” The Court disagreed, explaining that “there is no clear-cut statutory purpose that would be undermined by denying immediate appeal,” and concluded that the present dispute was no different from other “run-of-the-mill discovery disputes.” 

The Federal Circuit next turned to Amgen’s petition for a writ of mandamus and focused on whether Amgen established that it had a “‘clear and indisputable right’ to the relief it seeks”—a prerequisite to issuing a writ. The Court concluded that Amgen did not have any such clear and indisputable right to the requested discovery, since that discovery was admittedly not relevant to the instant patent litigation. Amgen argued that discovery was necessary for it to exercise its rights under the BPCIA and that asserting a patent for which it did not possess sufficient information to evaluate infringement would put it at risk for potential sanctions under Rule 11 and/or antitrust liability. The Court rejected Amgen’s concerns, explaining the proper mechanism to obtain the information Amgen sought. 

Specifically, the Court explained that, based on the applicant’s initial disclosure, the BPCIA “requires the sponsor to list patents that it ‘believes . . . could reasonably be asserted.’” The “reasonableness” requirement of the BPCIA does “not preclude a sponsor from listing a patent for which an applicant has not provided information” as part of its initial statutory disclosure. Then, “once a patent is listed by the sponsor, the BPCIA’s information exchange further requires the applicant to ‘provide to the . . . sponsor, with respect to each patent listed . . . a detailed statement that describes, on a claim by claim basis, the factual and legal basis’ for the applicant’s assertion that ‘such patent is invalid, unenforceable, or will not be infringed.’” At that point, if the applicant “fails to comply” with its disclosure obligations, the “sponsor would have a reasonable basis for asserting a claim of patent infringement.”

The Federal Circuit found that these considerations dispelled any notion that Amgen would need to bring suit simply based on its unsupported belief of potential infringement. Since Amgen could have listed the unasserted patents, the denial of discovery did not undermine the purpose of the BPCIA. Accordingly, the Court dismissed the appeal for lack of jurisdiction and denied Amgen’s petition for a writ of mandamus.