The District Court for the District of Massachusetts (Judge Wolf) yesterday decided two pending motions in Janssen v. Celltrion:
- Plaintiffs’ motion to stay litigation on the ‘471 patent (covering infliximab) pending appeal of the PTAB’s decision invalidating the patent; and
- Plaintiffs’ motion to amend the protective order to permit them to file a new case against the third-party cell culture media supplier for Celltrion’s biosimilar product, based on information produced pursuant to the protective order in this case.
Judge Wolf announced at the outset that he intended to rule on the two motions at the close of the hearing, and that he had informed, tentative views on each motion going into the hearing.
The Court denied Plaintiffs’ motion to stay. Judge Wolf explained that there are three factors the Court considers in ruling on a motion to stay: (1) the stage of the litigation, (2) whether a stay would simplify the issues in the case, and (3) whether a stay would unduly prejudice the non-moving party. Judge Wolf held that while the early stage of the litigation and the potential for the PTAB to simplify issues in the case favored a stay under factors (1) and (2), the third factor outweighed those considerations, and favored Defendants. Quoting Judge Newman’s opinion in Amgen v. Sandoz, Judge Wolf held that the statutory purpose of the BPCIA is to ensure that litigation over relevant patents will “be resolved expeditiously” before the launch of a biosimilar product, and to provide certainty to the biosimilar applicant, the reference product sponsor, and the public. A stay would undermine that statutory purpose, and would create undue prejudice to the Defendants and harm to the public. Judge Wolf further explained that under the BPCIA, the RPS must promptly and faithfully prosecute any infringement claims; otherwise, it is limited to a reasonable royalty in any later attempts to enforce those claims. Granting a stay without limiting the plaintiffs’ available remedies to a reasonable royalty would therefore seem at odds with the BPCIA. In closing, Judge Wolf noted that the ‘471 patent stands invalidated and that a stay could potentially expose the defendants to billions of dollars in damages, which could deter the launch of a cost-saving alternative to Remicade. In light of all these factors, Judge Wolf denied the motion to stay.
The Court granted Plaintiffs’ motion to amend the protective order. In ruling on the motion, Judge Wolf explained that the protective order expressly included a provision allowing the Court to modify the terms of the order, and the protective order was a general “umbrella order” covering a broad scope of issues, and was not particularized to the issues presented by Plaintiffs’ motion. He explained that although Plaintiffs may have had reason to suspect the facts that they now assert as the basis to file a new case, they did not believe they had sufficient information to actually bring a new case until they received information through discovery in this case. Judge Wolf ruled that efficiency and fairness would be better served by amending the protective order and permitting Plaintiffs to use the new information to file a new case.
Other Case Updates
Plaintiffs noted at the outset of the hearing that they plan to file two additional motions this week: (1) a motion for an expedited trial on the merits and (2) a motion for a preliminary injunction to prevent the defendants from launching their approved biosimilar product until October 2, 2016, which, Plaintiffs argue, is the first day the defendants are permitted to begin commercial marketing under the BPCIA’s notice provision, as it is 180 days after the date of FDA’s licensure of the biosimilar product.
Also, Judge Wolf addressed the parties’ recently filed proposed joint stipulation, in which the parties propose a briefing and hearing schedule on any renewed preliminary injunction motion by Plaintiffs following an anticipated decision by the Federal Circuit in Amgen v. Apotex. Although the parties indicated that they expected a decision from the Federal Circuit soon, they do not know when the Federal Circuit will actually rule, or what issues the decision might resolve. Judge Wolf indicated that in any event, he would require full briefing submitted in time for him to consider the arguments before holding an oral argument at which he would likely decide the motion for preliminary injunction.
Stay tuned for further updates here on the Big Molecule Watch.