Confidentiality in BPCIA Cases


The Biologics Price Competition and Innovation Act ("BPCIA") contemplates the exchange of highly sensitive information from the pre-suit "patent dance" (see, e.g., 42 U.S.C. 262 (l)(2)(A)) throughout litigation, bringing confidentiality concerns to the fore. An emerging concern for biosimilar applicants proceeding under the BPCIA framework is whether in-house counsel for a competing reference product sponsor can access (and, if so, with what restrictions) highly confidential information belonging to the biosimilar applicant. The BPCIA expressly provides that at least one in-house attorney for the reference product sponsor may access the confidential information exchanged in subsection 2(A) (including the abbreviated Biosimilar License Application ("aBLA") and manufacturing information) as well as any other information the applicant deems confidential, as long as that person does not engage in patent prosecution of the reference product. (See 42 USC 262(l)(1)(B)). But the BPCIA is silent with respect to the confidentiality provisions governing other information, such as non-public communications between the FDA and the biosimilar applicant.

The BPCIA parties are free to negotiate a confidentiality agreement governing the pre-suit document exchanges set forth by the BPCIA, and such an agreement can cover additional individuals, additional information, and/or additional contingencies. For example, in the patent dance between Sandoz and Immunex Corporation and two other companies with patent rights to ENBREL®, the parties agreed that three Immunex in-house attorneys could access Sandoz's confidential information, which was defined as 1) Sandoz's aBLA; 2) documents describing Sandoz's processes for manufacturing the biosimilar; and 3) additional information related to the first two categories requested by Immunex and provided by Sandoz at Sandoz's sole discretion. Sandoz Letter Brief, Immunex Corp. v. Sandoz Inc., No. 2:16-CV-01118-CCC-JBC (D.N.J. July 11, 2016) ECF No. 17, Ex. B. The agreement further provided that the Immunex in-house attorneys could not participate in any regulatory submissions. Id.

Yet after Immunex filed suit for patent infringement, the parties disagreed about how to structure the protective order. Immunex Corp. v. Sandoz Inc., ECF No. 79. Sandoz requested a two-tier system in which Sandoz could designate a small set of documents as HIGHLY-CONFIDENTIAL-OUTSIDE COUNSEL'S EYES ONLY (OCO). Id. at 1. In particular, Sandoz intended to use the OCO designation for FDA communications related to Sandoz's pending aBLA.  Id. In support of its position, Sandoz cited case law recognizing the appropriateness of excluding in-house counsel engaged in competitive decision making. Id. at 2-3. Sandoz argued that in-house counsel in a position to file a Citizen's Petition or mastermind other regulatory maneuvers were engaged in competitive decision making and should be barred from accessing the FDA communications. Id. In July, the court sided with Sandoz, granting it permission to temporarily designate communications with the FDA relating to the aBLA as OCO. ECF No. 82. If the FDA approved the aBLA, the OCO tier would disappear. ECF No. 113 at 2. A few months later, the parties submitted a Stipulated Discovery Confidentiality Order that would allow Sandoz to indefinitely designate future FDA communications relating to the aBLA as OCO. ECF No. 115 at ¶¶ 4, 19.

Perhaps emboldened by this small victory in the District of New Jersey, Sandoz made almost identical arguments only months later in the Northern District of California, where it sought to impose a two-tier confidentiality system in a patent fight with Amgen involving a biosimilar version of Amgen's NEULASTA®. Joint Letter Brief, Amgen Inc. v. Sandoz Inc., No. 3:16-CV-02581-RS (N.D. Cal. Dec. 23, 2016) ECF No. 64. The Court, however, was not persuaded, reasoning that though it may be appropriate to exclude in-house counsel who were in fact competitive decision makers, it was premature to make that determination as Amgen had not yet designated the in-house counsel who would have access to Sandoz's confidential information. ECF No. 66. The court did leave the door open for Sandoz to move for an OCO designation at a later date: "Sandoz may move to modify the protective order once Amgen identifies its designated in-house counsel, provided Sandoz can point to factual circumstances of each counsel that suggest the risk of inadvertent disclosure of confidential information." Id.

In other BPCIA cases, parties have agreed to protective orders that do not employ a two-tier confidentiality designation. The agreements grant in-house attorneys access to aBLA-related information and provide provisions designed to mitigate the risk of inadvertent disclosure that could harm the biosimilar applicant. The protective order in Amgen v. Hospira proscribed the designation of in-house counsel involved in preparing FDA submissions. Amgen, Inc. v. Hospira, Inc., Case No. 15-839 (RGA) (D. Del.) The protective order in Janssen Biotech v. Celltrion Healthcare Co. Ltd. did not preclude in-house counsel involved in FDA regulatory matters, but the agreement proscribed using confidential information as supporting material in any regulatory matter, including a Citizen's Petition. Janssen Biotech v. Celltrion Healthcare Co. Ltd., Case No. 15-CV-10698 (D. MA).

Sales for the most successful biologics total in the billions annually. Biosimilar applicants wanting to carve out some of those sales face fierce competition, a new regulatory framework, and a dearth of case law. Counsel for the reference product sponsor can expect that biosimilar applicants, wary of disclosure to their competitors in this high stakes field, will fight for strict safeguards in confidentiality agreements and protective orders.

Authors: Jenny Shmuel, Karrie Wheatley, Tasha Francis