BeiGene Files Patent Infringement Lawsuits Under Hatch-Waxman Act Against Sandoz and MSN Pharmaceuticals

BeiGene, a biotechnology company, has taken legal action by filing patent infringement lawsuits against pharmaceutical companies Sandoz and MSN Pharmaceuticals, along with MSN Laboratories Private Ltd. This move targets the defendants' attempts to market a generic version of the cancer drug BRUKINSA® (zanubrutinib).

The lawsuits, filed in the United States District Court for the District of New Jersey, come in response to Sandoz and MSN's Abbreviated New Drug Applications (ANDAs) submitted to the U.S. Food and Drug Administration (FDA). These applications, which include Paragraph IV certifications, challenge the validity, enforceability, and non-infringement of certain patents listed in the FDA's Orange Book related to BRUKINSA.

Despite these challenges, BeiGene emphasizes that the composition of matter patent for BRUKINSA remains unchallenged and in effect until 2034, protecting it from generic competition. The company's complaints assert that the ANDA filings by Sandoz and MSN constitute infringement of BRUKINSA's Orange Book patents. Seeking a permanent injunction, BeiGene aims to prevent both companies from commercializing their generic versions of BRUKINSA until the expiration of the patents in question.

The outcome of these lawsuits could have significant implications for the availability and pricing of BRUKINSA, a vital treatment for certain types of cancer.