On May 17, 2017, Janssen filed a complaint under the BPCIA in the District of New Jersey against Samsung Bioepis Co., Ltd. regarding Renflexis® (infliximab-abda), Samsung Bioepis’s recently approved biosimilar of Remicade®. The complaint alleges infringement of three patents: U.S. Patent No. 7,598,083, 6,900,056 and 6,773,600. According to the complaint, the ‘083 and ‘056 patents are directed to “cell growth media for use in growing biological products, including infliximab,” whereas the ’600 patent is directed to “methods of purifying biological products such as infliximab so that they are suitable for use in human medicines.” (The ‘083 patent is also at issue in the pending Janssen v. Celltrion BPCIA litigation regarding Celltrion’s Inflectra® (infliximab-dyyb) biosimilar product.)
The complaint also alleges two violations of provisions of the BPCIA, the resolution of both of which Janssen acknowledges may depend on what happens in the BPCIA interpretation dispute presently pending before the Supreme Court. First, Janssen alleges that Samsung Bioepis has refused to produce a copy of its aBLA or to participate in any of the BPCIA’s patent dispute resolution procedures, in violation of 42 U.S.C. § 262(l)(2)(A). Still, Janssen acknowledges that this claim is a protective measure: “Under current law, the Federal Circuit has not interpreted 42 U.S.C. § 262(l)(2)(A) to be mandatory,” but “the Supreme Court may hold that biosimilar makers that make use of the BPCIA’s regulatory procedures also must follow its patent dispute resolution procedures, the first step of which is 42 U.S.C. § 262(l)(2)(A).” According to Janssen, Samsung Bioepis’s refusal to produce its aBLA “made it impossible for Janssen to assess infringement of its patents.”
Second, Janssen alleges that Samsung Bioepis violated 42 U.S.C. § 262(l)(8)(A) by providing a “premature, purported ‘notice of commercial marketing’” on May 26, 2016, well before the FDA had approved the aBLA on April 21, 2017—notice which is ineffective under the Federal Circuit’s interpretation of this provision. The complaint notes, however, that “whether a notice of commercial marketing must be provided after licensing under the BPCIA, as the Court of Appeals for the Federal Circuit has held, is currently before the U.S. Supreme Court.” The complaint indicates that Samsung Bioepis “also served a proper notice of commercial marketing on April 21, 2017, upon FDA approval of its aBLA, in accordance with applicable law,” so the issue in dispute is whether Samsung Bioepis is legally permitted to launch Renflexis® at any time (since more than 180 days have expired since May 26, 2016), or whether Samsung Bioepis is blocked from launching until at least October 18, 2017 (180 days after April 21, 2017).
Stay tuned for further updates here at Big Molecule Watch.