Big Molecule Watch
May 1, 2019

Samsung Bioepis Sued Regarding Its Recently-Approved Etanercept Biosimilar

Yesterday, Immunex, Amgen, and Hoffmann-LaRoche (collectively, “Plaintiffs”) filed a complaint in the District of New Jersey against Samsung Bioepis alleging patent infringement under the BPCIA based on Samsung Bioepis’ submission of an aBLA for a biosimilar of ENBREL® (etanercept).  As we reported yesterday, Samsung Bioepis recently received FDA-approval for that product, ETICOVO (etanercept-ykro).  According to the complaint, Samsung Bioepis did not provide Plaintiffs with a copy of its aBLA under 42 U.S.C. § 262(l)(2) and has not provided notice of commercial marketing under § 262(l)(8)(A).

Plaintiffs allege that Samsung Bioepis’ product infringes or will infringe five asserted patents, two that are owned by Hoffmann-LaRoche and exclusively licensed to Immunex (U.S. Patent Nos. 8,063,182 and 8,163,522) and three that are owned by Immunex (U.S. Patent Nos. 7,915,225, 8,119,605, and 8,722,631).  According to Plaintiffs, the patents generally relate to fusion proteins that bind to human TNF, materials and processes for making and isolating the proteins, and methods of using etanercept to treat psoriasis and/or psoriatic arthritis.  Amgen is allegedly an exclusive licensee, or exclusive sublicensee, to each of the asserted patents.

In addition to asserting claims for patent infringement and seeking related declaratory judgments, Plaintiffs also seek an injunction “preventing [Samsung] Bioepis from commercial marketing consistent with the notice period provided by the statute” based on Plaintiffs’ alleged “infer[ence] that Bioepis might not provide [180 days’] notice to Immunex in accordance with § 262(l)(8)(A).”

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