Biosimilar litigation and the implications of the BPCIA are continuing to unfold in light of the FDA’s April 5, 2016 approval of Celltrion’s biosimilar of Janssen’s Remicade (infliximab).  This is only the second biosimilar approved by the FDA. The FDA’s approval has set off a series of further interactions between Celltrion and Janssen that impact the litigation between the two companies.

In March 2015, Janssen sued Celltrion in the District of Massachusetts for patent infringement and to enforce dispute resolution portions of the BPCIA.  Among the patents at issue is United States Patent No. 7,598,083 (“the ’083 patent”), related to chemically defined media and relevant to the manufacturing of Remicade.   Remicade is a monoclonal antibody biologic approved for the treatment of several autoimmune diseases, including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and ulcerative colitis.   The media claimed in the ’083 patent—directed at compositions with certain components in certain concentration ranges—is used to culture cells that secrete the relevant antibody.

In light of the FDA’s approval, Celltrion provided Notice of Commercial Marketing under the BPCIA, indicating that it intends to begin commercial sales of its biosimilar on October 2, 2016, with certain reservations.

In response, on April 12, 2016, Janssen sent a letter to the Court requesting an expedited trial.  The Court had previously indicated that it may prefer to consolidate a hearing on a preliminary injunction with a trial on the merits, which would result in a permanent injunction.  Claiming that sales of Celltrion’s biosimilar would cause “irreparable harm,” Janssen’s request signals its hope that a permanent injunction can be decided before Celltrion’s projected October 2, 2016 launch.  In its letter to the Court, Janssen alleges that Celltrion’s cell culture media, used to make its biosimilar, infringes the ’083 patent under the doctrine of equivalents and that it has compiled “powerful evidence” in the form of admissions and recently completed independent scientific testing.  Specifically, a research firm determined that 12 changes to the claimed concentration ranges in Celltrion’s accused media do not result in a significant difference in performance.  Janssen has therefore asked the Court to move the trial date from February 2017 to September 2016.  Janssen indicates that intends to confer with the defendants, and, if necessary, file a formal motion if defendants oppose Janssen’s scheduling proposal.

Janssen’s letter also implies that the dispute regarding Celltron’s Notice of Commercial Marketing is mooted.  Under the BPCIA, Celltrion was required to provide notice 180 days before commercial marketing.  The Federal Circuit in Amgen held that Notice of Commercial Marketing was only effective after FDA approval, and the parties disputed whether this holding was limited to situations in which parties failed to go through the BPCIA’s “patent dance” and, if so, whether Celltrion had followed the “patent dance” procedures.  These issues were in dispute even though another district court (Amgen v. Apotex, S.D. Fla. 15-cv-61631) has already held that notice of commercialization can only be given after FDA approval, even if the applicant complies with the provisions of the patent dance. Now, however, Janssen’s letter indicates that Celltrion provided a second Notice of Commercial Marketing after FDA approval on April 5, 2016, with a target launch date 180 days after FDA approval (October 2, 2016).  Thus, there appears to no longer be a dispute regarding Celltrion’s first Notice of Commercial Marketing.