BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has initiated patent infringement proceedings against two generics manufacturers: Switzerland’s Sandoz Inc. (OTCMKTS: SDZNY) and U.S.-based MSN Pharmaceuticals. This legal action follows notifications received from both companies regarding their Abbreviated New Drug Applications (ANDAs) submitted to the U.S. Food and Drug Administration (FDA), which target BeiGene’s Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib).
According to BeiGene’s filing with the SEC, the patents listed in the FDA’s Orange Book provide protection for Brukinsa against generic competition until 2034. However, both ANDA submissions include Paragraph IV certifications, directly contesting the validity of these existing patents. Importantly, neither Sandoz nor MSN is challenging the composition of matter patent for Brukinsa. BeiGene is seeking an injunction to prevent the commercial launch of any generics until the expiration of the asserted patents. The company noted that “the ANDA litigation process is common in the U.S. pharmaceutical industry,” suggesting that more such lawsuits may arise as additional generic firms pursue the drug.
Brukinsa recently secured its fifth indication approval in the U.S. for follicular lymphoma, adding to its existing approvals for Waldenström’s macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia. The best-in-class BTK inhibitor achieved global sales of $1.3 billion in 2023, reflecting a remarkable year-on-year growth of 129%.- Flcube.com
