As we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody.  On Tuesday, April 12, counsel for Janssen submitted a letter to Judge Mark L. Wolf of the U.S. District Court for the District of Massachusetts, advising of the FDA's action.  Janssen also reported that Celltrion had notified it "that [defendants] intend to begin commercial sales of their biosimilar in no later than 180 days (on October 2, 2016), subject to certain reservations."  We already knew that Celltrion was not planning on selling its biosimilar before June 30, 2016, the date on which one of the asserted patents will expire.  However, even though this would suggest that Celltrion has now provided the statutory 180-day notice of commercial marketing, the letter was written in such a way as to suggest that Celltrion could launch earlier.  The outcome of the Amgen v. Apotex Federal Circuit appeal could impact this decision.

Nevertheless, counsel for Janssen also informed the Court that Plaintiffs would not seek a preliminary injunction.  This was prompted by comments from the Court during a February 9, 2016 conference, in which "the Court stated its general reluctance to issue a preliminary injunction and then issue a final decision on the merits at a later time".  Instead, Janssen requested that the Court expedite the trial slated for February 2017.  Plaintiffs suggested that the trial on the merits could occur in September 2016, "in order to have their claim for a permanent injunction of the '083 patent [U.S. Patent No. 7,598,083] resolved before defendants' threatened launch date."  They emphasized that if Celltrion launches, Plaintiffs would suffer irreparable harm.

Plaintiffs supported this push for an earlier trial date with information that they had "compiled powerful evidence that the defendants' cell culture media infringe the '083 patent under the doctrine of equivalents ('DOE')."  At Janssen's behest, ExcellGene S.A., a Swiss biotechnology research firm, created precise copies of Celltrion's cell culture medium.  According to the letter, twelve ingredients fell outside the claimed ranges, so ExcellGene modified each of these "one after the other, so that they fell literally within the claimed range."  Plaintiffs reported that the differences between the relevant performance variables in these samples were "not substantial: '[N]one of the variant media tested . . . showed a significant difference in performance' compared to the defendants' cell culture media" (emphasis in original).  As such, according to Janssen, the Celltrion's cell culture media infringes under the DOE.

Interestingly, Janssen suggested that it did not have time in the preceding week to meet and confer with Celltrion.  Therefore, there was no indication as to Celltrion's position regarding an expedited trial.  Nevertheless, Plaintiffs stated that they would submit a formal motion to support their request in the event that Celltrion opposes.  Further action on this matter should forthcoming shortly.