Amgen advanced further arguments in a November 8, 2016 brief before the Federal Circuit, crystallizing the point of disagreement between it and defendant-appellee Hospira.  The issue before the court is whether, during discovery in a patent-infringement suit arising under the Biologics Price Competition and Innovation Act (BPCIA), a Reference Product Sponsor (RPS) may obtain information that is not relevant to currently asserted claims, but which could be relevant to the RPS’s other patents.  In Amgen’s words, “[t]he issue on appeal is not whether the discovery Amgen seeks is relevant; rather, the issue is whether Amgen is nevertheless entitled to the discovery as a matter of law under the BPCIA, even though it is irrelevant to the pending patent claims.”  (Reply at 15.)  Amgen’s recent filing responds to Hospira’s October brief on the merits, which we summarized here.

We have discussed the procedural history of this case previously (see here).  In short, Amgen appealed to the Federal Circuit in August 2016 to reverse an order given by Judge Andrews of the District of Delaware the same month.  The order denied Amgen discovery of cell-culture manufacturing constituents used by biosimilar applicant Hospira to generate a biosimilar version of Amgen’s Epogen^®.

In its reply brief, Amgen urges the Federal Circuit to reverse the discovery ruling on the grounds that Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015) permits Amgen full access to Hospira’s cell-culture information in order to assess the process by which the proposed biosimilar product is made, specifically, whether those processes are claimed by other patents in Amgen’s estate.  Amgen relies on a passage from Sandoz, where the court stated that after commencing a patent-infringement suit, a Sponsor “can access the required information through discovery,” Sandoz, 794 F.3d at 1356.  Plaintiff-appellant maintains that Hospira cannot shield its manufacturing information from discovery because otherwise a biosimilar Applicant could “unlawfully evade[] the detection of process patent infringement,” Id. at 1355.  In ruling against Amgen, the district court stated it did not believe Sandoz to be “on point” and that Amgen would be engaging in a “fishing expedition” in seeking Hospira’s cell-culture media information to evaluate additional patents.

Amgen contends that this appeal requires an interpretation of the BPCIA, a pure matter of law deserving of de novo review. (Reply at 2.)  But Amgen argues that the result would be the same under the abuse of discretion standard applied by Hospira because the district court based its ruling on an erroneous view of the law. (Reply at 3.)  Amgen argues that the district court erred as a matter of law because “[i]nformation within the scope of subparagraph 262(l)(2)(A) need not be relevant to an asserted patent in order to be discoverable in a patent-infringement lawsuit under the BPCIA.”  (Reply at 5.)  “[W]here the Sponsor brings a patent-infringement lawsuit under the BPCIA, it may access all otherwise-withheld subparagraph 262(l)(2)(A) information,” even if that information is irrelevant to the asserted patent claims in suit. (Reply at 6.)

This reading of the BPCIA necessarily moots Hospira’s argument that the motion to compel discovery was properly denied for seeking information outside Rule 26 of the Federal Rules of Civil Procedure.

Amgen also methodically addresses several other arguments raised in Hospira’s opposition.  In response to Hospira’s argument that it complied with the BPCIA information exchange by providing Amgen with its aBLA comprised of hundreds of thousands of pages, Amgen asserts that there is no difference between a biosimilar applicant who provides a Sponsor with an aBLA and one that does not.  In Amgen v. Apotex, Apotex had argued that it did not need to provide notice of commercial marketing because it, unlike Sandoz, had provided Amgen with an aBLA.  The Federal Circuit rejected this “asserted distinction” and Amgen urges the court to do the same here.

Countering Hospira’s argument that the requested cell culture manufacturing information only relates to commercially-available ingredients sold by third-party vendors, Amgen asserts that the BPCIA does not limit discovery obligations to information about only reagents and components that the biosimilar Applicant itself made.  Amgen claims it has not been able to determine the ingredients from information in the public domain, and that insofar as the materials make up part of the Epogen^® biosimilar manufacturing process, they must be discoverable.  Furthermore, Amgen claims that Hospira is not burdened by this request because Hospira has admitted that the information sought likely amounts to mere “scraps of paper”. (Reply at 10.)

Finally, Amgen revisits the argument, made in its opening brief, that it could potentially be subject to Rule 11 sanctions and antitrust consequences if it were forced to sue first and seek discovery later. (Reply at 11-13.)  Hospira has taken issue with this argument, contending that no Rule 11 sanctions could have possibly attached to mistakenly listing patents on a 3(A) list at the beginning of the patent dance.  Thus, according to Hospira, Amgen had a duty to list any potentially infringed cell culture patents on its section 3(A) list, even it was ultimately determined that they were not infringed.  Amgen maintains that Hospira’s position “misunderstands the law and Amgen’s arguments.”  According to Amgen, by listing a patent on a 3(A) list, the reference product sponsor could either ultimately be forced to bring suit at the conclusion of the patent dance (and potentially risk sanctions) or be permanently limited to a reasonable royalty and forgo all lost profits and injunctions. (Reply at 11-13.)

Briefing in this appeal is now complete.  The Federal Circuit’s resolution of the issue will shed light on the patents an RPS must disclose during the patent dance, the scope of information that must be shared with the RPS during the patent dance, and the extent of discovery available in a first wave of litigation under the BPCIA.

We will continue to monitor this litigation and provide updates.