Federal Court of Canada Declares Idenix’s Hepatitis C Drug Patent Invalid and Upholds Gilead’s Sofosbuvir Compound Patent

On November 2, 2015, Annis J of the Federal Court of Canada issued his public judgment in Gilead Sciences, Inc v Idenix Pharmaceuticals, Inc, 2015 FC 1156, declaring Canadian Patent No 2,490,191 (191 Patent), co-owned by Idenix Pharmaceuticals, Inc (Idenix), invalid.  Annis J dismissed Idenix’s counterclaims for infringement of the 191 Patent by Gilead Pharmasset, Inc, Gilead Sciences, Inc, and Gilead Sciences Canada, Inc (together, Gilead) and seeking a declaration of invalidity of Gilead’s Canadian Patent No 2,527,657 (657 Patent).

The 191 and 657 Patents both relate to the compound sofosbuvir (Gilead’s SOVALDI®) for the treatment of Hepatitis C viral (HCV) infections.  Annis J found that sofosbuvir, including its metabolites, and a manufacturing intermediate, fell within the scope of the 191 Patent claims.

Gilead initiated this action to invalidate the 191 Patent on the grounds of (i) inutility (lack of demonstrated utility/sound prediction), (ii) insufficient disclosure, and (iii) overbreadth.  Annis J concluded that all claims of the 191 Patent were invalid for inutility and insufficiency.

Idenix counterclaimed to invalidate Gilead’s 657 Patent on the grounds of (i) anticipation by Idenix’s (earlier) 191 Patent and (ii) under section 53 of the Patent Act for wilful misrepresentation by knowingly omitting a co-inventor.  Annis J dismissed Idenix’s counterclaim.

Idenix has appealed to the Canadian Federal Court of Appeal.

For a more detailed review of this case, click here.