UPDATE in Janssen v. Celltrion: Stipulation of Voluntary Dismissal Narrows Issues to be Litigated

Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News  •  U.S. District Court Decisions

The parties in Janssen v. Celltrion have filed a stipulation of voluntary dismissal narrowing the issues in the litigation.  While it does not dispose of all patent infringement claims in suit, the stipulation narrows the case as follows:

  1. Defendants will not launch any biosimilar infliximab product in the United States until after September 15, 2015, the date the ‘715 patent expired.
  1. All claims and defenses pending between the parties related to alleged infringement of the ‘715 patent under 35 U.S.C. § 271(e)(2)(C)(i) are dismissed as moot, and that dismissal is with prejudice only with respect to all claims and defenses related to the ‘715 patent and Defendants’ proposed infliximab biosimilar products the subject of aBLA No. 125544.
  1. All claims and defenses pending between the parties related to alleged infringement of the ‘056 patent under 35 U.S.C. § 271(e)(2)(C)(ii) are dismissed, and that dismissal is with prejudice only with respect to all claims and defenses related to the cell growth media described in the Cell Growth Media Spreadsheet.

Counts 1-4, 6, and 8 of Janssen’s Complaint, alleging violation of the BPCIA patent dance disclosure provisions, violation of the BPCIA’s notice-of-commercial-marketing provision, and infringement of the ‘471, ‘396, ‘083, and ‘600 patents, remain in dispute.

We’ll post any further developments in this case here on the Big Molecule Watch.

 

 

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