Earlier this month, Janssen Biotech, Inc., a subsidiary of Johnson and Johnson, (“Janssen” or “Plaintiff”) filed a Complaint in the United States District Court for the District of New Jersey against Samsung Bioepis Co., Ltd. (“Samsung Bioepis” or “Defendant”), a joint venture between Samsung Biologics and Biogen. The patent infringement litigation relates to Samsung Bioepis’s Renflexis® (infliximab-abda), a biosimilar to Janssen’s Remicade®.

Infliximab is an anti-Tumor Necrosis Factor (anti-TNF) monoclonal antibody that was first approved in the United States in 1998. Samsung Bioepis announced in May 2016 that the FDA had accepted its application for SB2, a proposed infliximab biosimilar, for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. In April 2017, Samsung Bioepis announced that the FDA had approved Renflexis® (infliximab-abda) across all eligible indications, as we reported here. The approval of this product marks the fifth biosimilar approval by the FDA and is Samsung Bioepis’s first biosimilar approval in the United States. It was also notable because infliximab is now the only product for which the FDA has approved more than one biosimilar. The FDA previously approved Celltrion’s Inflectra® (infliximab-dyyb) on April 5, 2016, and Inflectra® was launched in the United States in November 2016 under a marketing agreement with Pfizer. Samsung Bioepis has publicly announced that Renflexis® will be marketed in the United States by Merck & Co., Inc. (known as MSD outside of the U.S. and Canada), pursuant to a commercialization agreement entered into in 2013. Samsung Bioepis’s infliximab has been approved previously in the EU, Norway, Lichtenstein, Iceland, Australia, and Korea.

The Complaint filed on May 17, 2017, alleges that Samsung Bioepis’s filing of a biologics license application (“BLA”) for infliximab under the abbreviated section (k) pathway of the BPCIA constitutes an artificial action of patent infringement, pursuant to 35 U.S.C. §271(e)(2)(C), of three patents: U.S. Patent No. 7,598,083 (“the ’083 patent”); Patent No. 6,900,056 (“the ’056 patent”); and Patent No. 6,773,600 (“the ’600 patent”). According to the Complaint, the claims of the ’083 and ’056 patents are directed generally to “cell growth media for use in growing biological products, including infliximab,” and the claims of the ’600 patent cover “methods of purifying biological products such as infliximab.”

The Complaint also contains a separate count seeking a declaratory judgment that Samsung Bioepis violated the requirements of section (l)(2)(A) of the BPCIA by refusing to disclose its abbreviated biologics license application and manufacturing information to Janssen. In a letter to Janssen dated March 26, 2016, a copy of which is attached to the Compliant, Samsung Bioepis advised Janssen that:

On May 20, 2016, the FDA provided notice … that Bioepis BLA No. 761054 has been accepted for review by the FDA. The reference product for Bioepis BLA No. 761054 is Remicade® infliximab … Bioepis will not provide Janssen Biotech, Inc. with a copy of BLA No. 761054 or any information that describes the process or processes used to manufacture the biological product that is the subject of BLA No. 761054. Janssen Biotech, Inc. is hereby notified that Bioepis will forego the exchange of information as described in 42 U.S.C. §§ 262(1)(2)-(1)(6). Thus, pursuant to 35 U.S.C. § 271 (e)(2)(c)(ii) and 42 U.S.C. § 262(1)(9)(C), Janssen Biotech, Inc. may bring an action against Bioepis under 28 U.S.C. § 2201 for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or its use or its manufacture

Janssen acknowledges in the Complaint that under current law, the Federal Circuit has not interpreted the disclosures requirements of section (l)(2)(A) as mandatory; however, Janssen included the Count because the Supreme Court has granted certiorari on this precise issue. We have previously discussed the issues pending before the Supreme Court here, here, and here. The Complaint also includes a separate count alleging violation of the BPCIA related to the notice of commercial marketing provision. According to the Complaint, Samsung Bioepis submitted two letters providing notice of commercial marketing, the first after FDA acceptance of the application, and the second after FDA approval. It appears that Janssen included this Count because Samsung Bioepis refused to withdraw its initial notice of commercial marketing, which is not effective under current law, but could be effective if the Supreme Court were to reverse the Federal Circuit’s interpretation of section (l)(8) of the BPCIA.

This case is not the first litigation involving infliximab. As we previously reported, Janssen and NYU have also filed an infringement suit against Celltrion and Hospira related to their FDA-approved infliximab product Inflectra®, as discussed in detail in this post.

The Janssen v. Samsung Bioepis litigation is Civ. No. 17-cv-03524, in the District of New Jersey, and the case has been assigned to Judge Madeline Cox Arleo and Magistrate Steven C. Mannion. We will continue to keep you apprised as the case develops.