Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3 in favor of approval. While the FDA is not bound by the Advisory Committee’s decision, it is expected to follow the recommendation and approve the product. However, other requirements of the Biologics Price Competition and Innovation Act (BPCIA) and Janssen’s patents may keep Celltrion’s product off the market for a while longer.

Pending BPCIA Litigation

As summarized in this article, after Celltrion filed its biosimilar application, Janssen sued Celltrion in the U.S. District Court for the District of Massachusetts, alleging violations of the BPCIA and infringement of six patents. One of the BPCIA claims alleged that Celltrion’s “notice of commercial marketing” was premature and ineffective under 42 USC § 262(l)(8) since it was given before the biosimilar product was approved by the FDA.

In Amgen v. Sandoz the Federal Circuit determined that § 262(l)(8) is a “standalone” provision, and that the pre-marketing notice required by that provision cannot be given until the FDA has approved the biosimilar product. However, in Amgen v. Apotex, which is on appeal at the Federal Circuit, Apotex has argued that § 262(l)(8) does not apply when the biosimilar applicant has participated in the patent dance provisions of the BPCIA.

Depending on whether § 262(l)(8) is found to be a true “standalone” provision or to apply only if there are unasserted patents to be litigated, if and when the FDA approves Celltrion’s biosimilar product, Celltrion may have to give Janssen 180 days’ notice before it can market its product.

The Patent Claims

As noted above, Janssen originally asserted six patents against Celltrion. It has since dismissed its claim relating to one patent and sought to stay its claim regarding another patent that is undergoing reexamination. Thus, at least four patents remain in dispute. Janssen may seek a preliminary injunction to prevent Celltrion from entering the market until this patent litigation is resolved, and/or Celltrion may decide against a launch at risk.

Thus, even after the regulatory and pre-marketing notice hurdles of the BPCIA are cleared, Janssen’s patents may keep Celltrion’s biosimilar product off the market.