On December 15, 2016 federal jury finds patent infringement of Merck’s US 7,608,597 B2 and awarded $2.54 billion royalty to Merck against Gilead for using patented invention as the basis for its blockbuster drug Sofosbuvir. The jury said that Gilead owed 10 percent royalties on $25.4 billion in total sales for the two drugs.
Sofosbuvir is chemically known as 2′-deoxy-2′-α-fluoro-β-C-methyluridine-5′-triphosphate and structurally represented as
US 7,608,597 B2 (issued to Idenix) claims a method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine β-D-2′-methyl-ribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.
US ‘597 filed as a continuation application from US 6,914,054 which claims priority of May 23, 2000. Sofosbuvir claimed as a product in US 7,964,580 B2 which claims priority of 30 Mar 2007.
The claims of US ‘597 are broad, any pyrimidine β-D-2′-methyl-ribofuranosyl nucleoside or a phosphate compounds for the treatment of HCV infection falls within the scope of US ‘597. US ‘597 neither discloses nor enables Sofosbuvir specifically.
Gilead Arguments for invalidity of US ‘597
Gilead’s argued that Merck patent is invalid as the specification of the US ‘597 patent does not enable the asserted claims (or) as the specification of the US ‘597 patent does not contain an adequate written description of the asserted claims (or) as the for anticipation based on prior invention (or) the claimed subject matter would have been obvious to a person of ordinary skill in the art at the time of the claimed invention. The jury rejected Gilead’s arguments that Merck’s patent is invalid.
The verdict doesn’t affect Gilead to sell its products. The sales of Gilead’s Sovaldi and Harvoni (developed by pharmasset; later acquired by Gilead) accounts for more than half the Gilead’s revenue.
This is the second trial between the two companies. The first, over different patents, ended in a disaster for Merck. A jury in California said that Gilead should pay $200 million in royalties, but that was thrown out because the judge said a key Merck witness lied. In that case, Merck may have to pay Gilead’s legal fees.