This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221).  The patents are generally directed to processes for producing an antibody or an antibody fragment by transforming a host cell with a first and a second DNA sequence encoding variable domains of the immunoglobulin heavy and light chains, respectively, and independently expressing and producing the heavy and light chains as separate molecules.  Both patents expired on December 18, 2018.  In its two lawsuits, Genentech seeks damages for royalties based on the manufacture of antibody products, using the patented technology, before the patents expired where those products were sold post-patent expiry.

Genentech filed its case against Biogen in the federal District Court for the Northern District of California (No. 2:23-cv-909).  According to the Complaint, Genentech granted Biogen a non-exclusive license to the patents in 2004.  Genentech alleges that “Biogen used the Cabilly method to manufacture the active ingredient in TYSABRI,” and “for many years it paid Genentech substantial quarterly royalties on net sales of that product.”  Genentech states that Biogen stopped paying royalties on net sales that occurred after the patents expired in December 2018.   According to Genentech, Biogen owes royalties for use of the patents in manufacturing a stockpile of TYSABRI (natalizumab) before the patents expired.  Genentech asserts that the “size of that stockpile is unknown to Genentech at this time, but based on industry experience Genentech believes that Biogen owes tens of millions of dollars in unpaid royalties on sales of that product.”

Genentech filed its case against Millennium in the state Superior Court in San Mateo county (23-CIV-00924).  According to the Complaint, Genentech granted Millennium a non-exclusive license to the patents in 2004.  Genentech alleges that Millennium “used the Cabilly method to manufacture the active ingredient in ENTYVIO.”  Like its allegations against Biogen, Genentech alleges that Millennium stopped payment of royalties on sales after the patents expired in 2018, and that Millennium owes royalties, amounting to “tens of millions of dollars” for use of the patents in manufacturing ENTYVIO before December 2018.

Stay tuned to Big Molecule Watch for updates on these cases.

[View source.]