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Amgen Appeals Ruling on Requirement to Produce Manufacturing Information for a Biosimilar Product under Amgen v. Sandoz

Amgen has appealed a partial denial of its motion to compel in Amgen v. Hospira, No. 15-cv-839, currently pending in the District of Delaware.  The case, filed last September, concerns Hospira’s proposed biosimilar of Amgen’s Epogen (epoetin alfa), and has been assigned to Judge Andrews.  Amgen asserted patent infringement claims as well as claims for Hospira’s alleged failure to comply with the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  Though Hospira has moved to dismiss Amgen’s BPCIA claims, Judge Andrews has put off a decision on the motion pending the Federal Circuit’s guidance in Amgen v. Apotex (No. 2016-1308), which will further address how to properly interpret the BPCIA and will be the first Federal Circuit appeal applying its only decision interpreting the BPCIA to date, Amgen v. Sandoz.  As to Amgen’s patent infringement claims for its two asserted patents, discovery is proceeding.

In early May, the parties became embroiled in a discovery dispute, filing dueling letters to the court. Amgen sought discovery of the formula for the cell culture media that Hospira uses for its biosimilar, making two arguments – one narrow, one broad:

First, and more narrowly, Amgen argued that the formulation was relevant to one of its two patents-in-suit.  Though neither patent is directed to cell culture media, one of the patents calls for cells to be cultured under suitable nutrient conditions.  Thus, Amgen asserts that Hospira must produce the formula for its cell culture media so that infringement of this patent can be assessed.

Second, Amgen contended that Hospira did not disclose its manufacturing information under the BPCIA in accordance with 42 U.S.C. § 262 (l)(2)(A) and that when the biosimilar maker refuses to provide this required information during the BPCIA’s pre-suit information exchange (the so-called “patent dance”) the Federal Circuit’s Amgen v. Sandoz decision holds that the reference product sponsor, here Amgen, can commence suit and “access the required information through discovery.”  According to Amgen, if Hospira has no obligation to provide its manufacturing information either during the BPCIA’s patent dance or in a subsequent lawsuit, then it could “evade detection of patent infringement and thereby deny Amgen access to the courts to protect its patent rights.”  Amgen argued further that the “very purpose of § 262 (l) is the identification and resolution of patent disputes through the exchange of information, negotiation, and only if necessary, litigation” and that manufacturing patents are “especially important in protecting innovation in the area of biologics.”  If the required manufacturing information is not disclosed, the reference product sponsor might not be able to determine which of its manufacturing patents are infringed.

Hospira responded that because neither of Amgen’s asserted patents is directed to cell culture media, the requests are beyond the scope of Rule 26 of the Federal Rules of Civil Procedure.  Further, it argued that unlike the biosimilar maker in Amgen v. Sandoz, Hospira had disclosed its aBLA to Amgen, which includes certain manufacturing information.  Hospira did not dispute that its aBLA did not include information on the cell culture media that it uses to make its proposed biosimilar but argued that it had no obligation under the BPCIA or otherwise to provide any information beyond the aBLA.  Hospira did not address that 42 U.S.C. § 262 (l)(2)(A) states that the biosimilar maker shall provide the reference product sponsor with a copy of its aBLA “and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.”

Hospira argued that the Federal Circuit’s decision in Amgen v. Sandoz, just as the Federal Rules of Civil Procedure, did not “permit a party to obtain discovery of information that is not to the claims at issue in the litigation.”  Thus, according to Hospira, because Amgen did not sue Hospira on its cell culture media patents without knowing if they were infringed or not, it could not obtain the discovery in the current litigation to assess infringement of those unasserted patents.

Delivering his decision orally at a hearing on May 4, Judge Andrews ruled in favor of Amgen on the narrower of its two arguments, agreeing that Hospira’s cell culture media are relevant to infringement of the asserted patent that calls for culturing cells under suitable conditions.  Judge Andrews disagreed, however, with Amgen’s broader argument under Amgen v. Sandoz.  He stated that he was “inclined to give [Amgen] an alternate ruling one way or the other on the broader ground, too, so that [Amgen] can make whatever decisions are appropriate.”

Amgen then proceeded to file an appeal on the broader ground.  In a Notice of Appeal filed on June 3, Amgen indicated that it was appealing from the court’s May 4 order “denying Amgen’s request to compel [Hospira] to produce certain manufacturing information that Hospira refused to provide to Amgen under 42 U.S.C. § 262(l)(2)(A).”  Amgen therefore is appealing Judge Andrews’s holding that it is only entitled to Hospira’s manufacturing information because one of its patents calls for suitable nutrient conditions, not because Hospira must produce such information under Amgen v. Sandoz.  Amgen’s appeal has been docketed at the Federal Circuit as No. 16-2179 and its appeal brief is due on August 8.

It is unclear whether the appeal will proceed since parties may not appeal interlocutory discovery rulings unless the district court certifies the issue, at which point the Federal Circuit has discretion to hear the case or not.   A certification does not appear on the public docket but Judge Andrews seemingly reached the alternate ruling on Amgen’s broader ground to make it possible for Amgen to appeal the issue.

Whether or not the appeal goes forward, the case raises an important lesson in the aftermath of Amgen v. Sandoz.  An innovator that asserts only a subset of its patents, as Amgen did, could open itself up to the types of relevance arguments that Hospira made and Judge Andrews accepted, thus limiting discovery to only the asserted patents.  Innovator companies may choose to assert all of their manufacturing patents in order to obtain manufacturing information that biosimilar makers fail to provide under the BPCIA.

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