On Monday, Celltrion filed a response to the letter Janssen submitted to the Court on April 12 requesting an expedited trial schedule.  Celltrion maintains that Janssen improperly argues the merits of Janssen’s claim of infringement of the ’083 patent based on the doctrine of equivalents and requests an expedited case schedule based on inaccurate statements regarding defendants’ commitments regarding its launch date.

Celltrion first points out that Janssen should not have offered evidence, including expert evidence regarding its infringement theory through a letter.  Celltrion points out that Janssen is not asserting literal infringement, but rather infringement through the doctrine of equivalents based on an “unprecedented theory, where [Janssen] admits that the accused cell culture media avoids literal infringement twelve different ways” (emphasis in the original). Celltion asserts it is not aware of any court finding infringement under the doctrine of equivalents where there was more than one missing limitation, let alone twelve.  Celltrion continues that if Janssen’s theory were correct, the patent could cover an infinite variety of cell culture media, disregarding the requirement of definiteness and the public notice function of patents.

Next, Celltrion states they have not agreed to withhold the launch of their product until October 2, 2016. Rather, they have “repeatedly and expressly reserved their right to market as early as June 30, 2016.”  According to Celltrion, it will only delay launch if required by the anticipated decision in Amgen Inc. v. Apotex Inc., No. 16-1308 (Fed. Cir.).  As such, Celltrion argues, there is no reason to expedite the trial schedule.    In Celltrion’s opinion, expediting the trial schedule for just one patent (the ’083 patent) when the Court has not yet ruled on Janssen’s motion to stay the case on the ’471 patent, is highly prejudicial to Celltrion.

Celltrion’s clarifying statements regarding its launch date also mean that the dispute is still alive over whether its first Notice of Commercial Marketing, given before FDA approval of its biosimilar, was effective.  Celltrion’s position would be advanced if the Federal Circuit in Amgen. v. Apotex disagrees with the district court and holds that its previous decision (in Amgen v. Sandoz) requiring Notice of Commercial Marketing after FDA approval is limited to situations in which none of the BCPIA’s “patent dance” procedures are followed.  The parties also dispute whether Celltrion followed the “patent dance” procedures, bringing it outside the scope of the narrower interpretation ofAmgen v. Sandoz.

Celltrion closes its letter stating it would be open to an earlier dispositive hearing on both patents, but opposes the proposal set out in Janssen’s opening letter to the Court.