Big Molecule Watch
September 23, 2015

Janssen v. Celltrion: Motion to Modify Protective Order

In addition to the pending cross-motions for partial summary judgment on which we’ve previously reported, the parties in the Janssen v. Celltrion BPCIA litigation recently completed briefing on the issue of whether the district court should permit Janssen to use confidential information obtained through discovery as a basis for a new complaint for patent infringement—outside the scope of the BPCIA—against Celltrion and the (yet unnamed) third-party supplier of the cell culture media that Celltrion uses to manufacture its product.

On August 12, 2015, Janssen filed a motion to modify the protective order to permit Janssen to use Celltrion’s and its supplier’s confidential information in preparing a new complaint alleging infringement against Celltrion and its supplier of U.S. Patent No. 7,598,083, a patent which Janssen is already asserting against Celltrion in the pending BPCIA litigation. In its opening brief, Janssen describes this patent as covering a 61-ingredient cell culture media that “is optimal for the production of antibodies, such as Remicade.” Janssen alleges that Celltrion has sold a biosimilar of Remicade, made using the patented cell culture media, outside the United States since at least 2012—activity that typically is outside the jurisdiction of U.S. patent law. According to Janssen, however, it recently learned through confidential materials disclosed by Celltrion and its supplier under the protective order that Celltrion’s supplier has been manufacturing the patented cell media, upon Celltrion’s custom orders, in the United States. Janssen asserts that good cause exists to modify the protective order to allow Janssen to use that information to file, under seal, a new patent infringement suit against Celltrion and its cell culture media supplier.

Celltrion opposes the motion on multiple grounds, and has filed a cross-motion to stay Janssen’s motion pending resolution of the BPCIA litigation. In addition to characterizing Janssen’s infringement position as meritless, Celltrion asks the court to deny Janssen’s motion because Janssen is trying “to circumvent the BPCIA, which contains strict confidentiality restrictions, and the stipulated (but not yet entered) protective order.” Citing 42 U.S.C. §§ 262(l)(1)(C), (D) and (H), Celltrion asserts that the BPCIA “prohibit[s] not only the public disclosure of confidential information, but also the ‘use[]’ of any confidential information for purposes other than asserting patent infringement under the BPCIA,” and that “any violation ‘shall be deemed to cause the [biosimilar] applicant to suffer irreparable harm….’” Celltrion also argues that Janssen has failed to show good cause to modify the protective order.

In reply, Janssen argues that the BPCIA provisions on which Celltrion relies are inapplicable because they ceased to apply as soon as the parties agreed to a protective order. Citing 42 U.S.C. §§ 262(l)(1)(F) (“In the event that the reference product sponsor files a patent infringement suit, the use of confidential information shall continue to be governed by the terms of this paragraph until such time as a court enters a protective order regarding the information….”), 262(l)(1)(A) (“Unless otherwise agreed to by [the parties], the provisions of this paragraph shall apply to the exchange of information described in this subsection.”).

None of the cases on which the parties are relying come from BPCIA or Hatch-Waxman litigations, so it will be interesting to see how the court deals with the parties’ respective motions. The motions in Janssen v. Celltrion appear to be the first to deal with the interpretation and applicability of the confidentiality provisions of the BPCIA and modification of a protective order in a BPCIA litigation to permit use of confidential information outside of a BPCIA litigation. Check back here on Big Molecule Watch for updates on this case. We expect this type of motion practice to become relatively commonplace in BPCIA litigations, where a huge array of patents could be implicated, particularly in situations (unlike in Janssen v. Celltrion) in which the applicant opts out of the patent dance.