In a corrected brief filed October 25, 2016, defendant-appellee Hospira responded to Amgen’s opening brief on the merits seeking to overturn a discovery ruling that kept Hospira’s cell culture media information secret.  Hospira argues that the Federal Circuit lacks jurisdiction to hear Amgen’s appeal and that Hospira is not required to produce any further information regarding its cell culture media.

This case began with Hospira’s application to the FDA in December 2014 for a biosimilar version of Amgen’s Epogen^® (human erythropoietin). Originally approved by the FDA in 1989, human erthyropoietin is now also marketed as Procrit^® by Janssen, a subsidiary of Johnson & Johnson, via a license with Amgen.  (See Pollack, A., “Johnson & Johnson to Pay $150 Million in Amgen Suit,” New York Times, October 19, 2002.)  The therapeutic agent treats anemia by increasing red blood cells, thereby assisting patients receiving cancer chemotherapy and dialysis.  Human erythropoietin is produced in mammalian cell culture using recombinant DNA technology.

Hospira’s description of the events leading to the appeal do not differ significantly from those described by Amgen, reported here.  In short, Hospira notified Amgen in February 2015 that its aBLA had been accepted by the FDA and disclosed more than 700,000 pages of information on its product and manufacturing processes.  Amgen alleged that certain information was missing regarding Hospira’s cell culture media ingredients, but never listed a cell culture patent in its patent lists.  After several information exchanges regarding other patents, Amgen filed suit in Delaware in September 2015, initiating the first stage of litigation under paragraph (6) of the Biologics Price Competition and Innovation Act (BPCIA).  The complaint alleged patent infringement and BPCIA violations due to Hospira only sharing its aBLA and not particular details about raw materials and trace elements in Hospira’s cell culture media.  When Amgen sought further information about the cell culture ingredients during discovery, Hospira again refused.  This led to a discovery dispute decided in Hospira’s favor and the current appeal. At this point, the parties seem to be in agreement that the information sought by Amgen is not directly relevant to contested limitations in the currently asserted patents.

Although the parties agree on the timeline of events, Amgen and Hospira differ significantly in how they characterize the current dispute.  Whereas Amgen claims that the denial of its motion to compel discovery upsets the “entire balance of the BPCIA”, Hospira maintains that this is a simple discovery dispute and that Amgen’s motion to compel was properly denied for seeking information outside Rule 26 of the Federal Rules of Civil Procedure.

First, Hospira notes that the current dispute is a discovery dispute that should be reviewed for abuse of discretion, not an issue of law to be reviewed de novo.  In particular, Hospira asserts that there is no issue of statutory interpretation of the BPCIA.

Second, Hospira agrees with the district court that the Federal Circuit decision in Amgen v. Sandoz is not “really on point” and does not alter the traditional rules of discovery.  Amgen has cited Sandoz, which states that once a reference product sponsor brings an infringement suit, “it can access the required information through discovery.”  Hospira argues that Amgen cannot rely on this statement from Sandoz to sue on some patents, and then seek discovery on different patents not in-suit—that is, the Federal Circuit was not undermining the applicability of Federal Rule of Civil Procedure 26(b)(1) to BPCIA litigations.  According to Hospira, Sandoz is limited to its particular facts where the aBLA applicant (Sandoz) failed to disclose its aBLA to the reference product sponsor (Amgen).  Here, in contrast, Hospira disclosed its entire aBLA pursuant to paragraph (2)(A).

Hospira also takes issue with Amgen’s doomsday scenario in which Amgen would never be able to sue on cell culture patents.  Amgen has taken the position that it could not list its cell culture patents in its initial 3(A) list at the start of the patent dance because the statute instructs reference product sponsors to only list those patents that could “reasonably be asserted.” 42 § 262(l)(3)(A). Amgen has contended that, without Hospira’s cell culture information, Amgen would not know if its cell culture patents could “reasonably be asserted.”  Amgen has also argued that it would be exposed to Rule 11 sanctions for bringing suit without the proper basis.  In response, Hospira contends that the goal of the BPCIA is to resolve patent disputes “expeditiously” and Amgen had a duty to list all of its potentially infringed patents.  Hospira also argues that the basis for filing a complaint is different than that for listing patents on a 3(A) list.  In addition, according to Hospira, Amgen would not expose itself to Rule 11 sanctions for including a patent on its 3(A) list because Rule 11 in the Third Circuit only applies to pleadings or papers made before the court, not including a patent on a 3(A) list.  Had Amgen disclosed its cell culture media patents in its paragraph (3)(A) list, Hospira would have had the opportunity to refute the claims via paragraph (3)(B), prior to litigation.

Finally, Hospira argues that all of the information sought by Amgen is outside the scope of discovery allowed under Federal Rule of Civil Procedure 26.  Hospira emphasizes that Amgen seeks the specifics of media components that are commercially available products purchased from third-party suppliers.  Although these cell media components could potentially be relevant to additional Amgen patents, Amgen has yet to identify any such patents, they were not listed on Amgen’s “patent dance” lists, and they are not the subject of the underlying district court litigation.  Hospira notes that decisions construing the Hatch-Waxman Act, which is similar in concept to the BPCIA, have readily applied Rule 26 as a limit on discovery in situations such as the current dispute, where the discovery request is overbroad and disproportionate or unrelated to the needs of the case.

Hospira’s opening brief also asserts that the Federal Circuit does not have jurisdiction to hear the merits of the appeal in the first instance.  Hospira argues that the Federal Circuit lacks jurisdiction because the discovery order is neither a final judgment nor a collateral order.  Hospira also contends that the Federal Circuit lacks jurisdiction under the All Writs Act because “Amgen has failed to establish a ‘clear and indisputable right’ to the extraordinary remedy of mandamus.”

We will continue to monitor this litigation and provide updates.