BeiGene sues Sandoz and MSN for Brukinsa patent infringement

Sino-American biotech BeiGene (Nasdaq: BGNE) on March 8 disclosed in stock exchange announcement that it has filed patent infringement suits under the Hatch-Waxman Act against the US subsidiary of Swiss firm Sandoz (SIX: SDZ) and separately against Indian-owned companies MSN Pharmaceuticals and MSN Laboratories Private in the US 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 US Food and Drug Administration (FDA), seeking the agency’ 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.

The news came the same day as the US Food and Drug Administration granted accelerated approval for Brukinsa with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The drug generated sales of $1.3 billion for BeiGene last year.