Going Down Swinging: Idenix’s Counterclaim for Infringement and Invalidity Dismissed as Own Patent Held Invalid
On November 2, 2015 Justice Annis released a 326-page decision holding that Canadian Patent No. 2,490,191 invalid (2015 FC 1156; see our blog post here). Gilead sells the antiviral drug sofosbuvir in Canada under the brand name Sovaldi, for use in combatting Hepatitis C virus (HCV). Gilead commenced an action to impeach 191 Patent because the manufacture, use or sale of Sovaldi may have been seen as infringing. The owner of the 191 Patent, Idenix, counterclaimed for a declaration that Gilead infringed the 191 Patent, and that Gilead’s Canadian Patent No. 2,527,657, which claims sofosbuvir, is invalid. Justice Annis dismissed Idenix’s counterclaims, but held the 191 Patent would be infringed by Gilead had it been valid.
Anticipation
The 657 Patent is directed to 2’-C-Me/F compounds containing either cytosine or uracil bases. Gilead argued the 191 Patent is not anticipatory since it discloses bases in general but not specifically cytosine or uracil. In finding the 191 Patent disclosed the subject matter of the 657 Patent, Justice Annis held:
[807] … On the basis of the same careful reading the skilled reader would be aware from the common general knowledge that the nucleoside analogues used as an antiviral drug would be linked to the one of the four natural bases which would include the cytosine or uracil basses. This would be a sufficient direction to disclose the invention.
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[809] I am satisfied therefore, that the same invention of the 657 Patent is disclosed in the ‘191 Patent.
However, having held that the 191 Patent does not sufficiently disclose how to make 2’-C-Me/F compounds, Justice Annis dismissed Idenix’s anticipation argument, holding that the disclosure in the 191 Patent was not enabling:
[810] As I have already found that there is no enabling disclosure of how to synthesize the compounds in the ‘191 Patent, Idenix’s claim of anticipation is rejected.
Section 53 – Failure to name a co-inventor
Idenix argued that the 657 Patent is invalid for knowingly omitting Dr. Stuyver as an inventor. After finding that Idenix failed to demonstrate that Dr. Stuyver contributed to the invention, Justice Annis reviewed the law on whether the failure to name a co-inventor is material, stating:
[923] Idenix has led no evidence to establish any manner by which the alleged failure to name Dr. Stuyver affected the term, substance or ownership of the ‘657 Patent, or the public’s ability to use the invention.
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[929] For all the reasons above, I reject Idenix’s claim that the ‘657 Patent is invalid under section 53(1).
Infringement
Idenix argued that Gilead’s production and sale of sofosbuvir infringed the 191 Patent. Justice Annis framed the infringement issues as follows:
[814] The issues for determination in this matter is whether sofosbuvir and/or Sovaldi and/or the compound identified in paragraph 64A [the “intermediate” compound] of the Amended Statement of Defence and Counterclaim fall within the scope of the ‘191 Patent.
Justice Annis found, based largely on Gilead’s own admission, that the “intermediate” compound falls within the claims of the 191 Patent, stating:
[826] Idenix has pointed out Gilead’s admission that the structure of the compound described in paragraph 64A of the Statement of Defence and Counterclaim as depicted below on the right is the same as Compound 5 in the above scheme. I therefore conclude that Idenix is correct in its determination that the manufacturing intermediate falls within the scope of claims of the ‘191 Patent.
Justice Annis also found that sofosbuvir and/or Sovaldi falls within the claims of the 191 Patent and held the 191 Patent would be infringed had it been valid.
A copy of the Public Judgment and Reasons of Justice Annis can be found here.