BeiGene (BGNE) Files Parent Infringement Suit Against MSN Pharmaceuticals

On March 8, 2024, BeiGene (NASDAQ: BGNE) filed patent infringement suits under the Hatch-Waxman Act against Sandoz Inc. (“Sandoz”) and separately against MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. (collectively “MSN”) in the United States District Court for the District of New Jersey. The patent infringement suits are in response to Sandoz’s and MSN’s notices to BeiGene concerning the filings of Abbreviated New Drug Applications (“ANDAs”) with the U.S. Food and Drug Administration (“FDA”), seeking FDA approval to market a generic version of BRUKINSA® (zanubrutinib) along with “Paragraph IV certifications” challenging certain BRUKINSA Orange Book patents for invalidity, unenforceability and/or non-infringement. According to the notices, neither Sandoz nor MSN have challenged BRUKINSA’s composition of matter patent, which remains intact and protects BRUKINSA® from generic competition until its expiration in 2034.
BeiGene’s complaints allege that by filing the ANDAs, each of Sandoz and MSN has infringed BRUKISNA’s Orange Book patents included in their respective Paragraph IV certifications, and seek a permanent injunction to prevent Sandoz and MSN from commercializing a generic version of BRUKINSA until the expiration of the asserted patents.
ANDA litigation is common in the U.S. pharmaceutical industry. We may receive additional notices from other generic drug companies and may file additional ANDA lawsuits in the future.

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