Gilead Science Inc. v Idenix Pharmaceuticals Inc., 2015 FC 1156 (Annis, J.)
November 2, 2015
Jason Markwell, Jordana Sanft, Amy Grenon and Adam Haller for Gilead Sciences
Patrick Smith, Alex Gloor, Viktor Haramina, Ivy Tsui, Melissa Binns and Chris VanBarr for Idenix Pharmaceuticals
Gilead commenced a proceeding for a declaration that Idenix’s ‘191 Patent was invalid on the grounds of insufficient disclosure, lack of demonstrated utility/sound prediction and overbreadth. By way of counterclaim, Idenix alleged that Gilead’s ‘657 Patent was invalid and that Gilead has infringed certain claims of its ‘191 patent. The Federal Court (FC) allowed Gilead’s claim and declared the ‘191 Patent invalid due to insufficient disclosure and lack of demonstrated utility/sound prediction.
Lack of demonstrated utility/sound prediction
Idenix admitted that it had not tested any of the compounds falling within the scope of the claims prior to filing its patent application. Therefore, utility was assessed using the doctrine of sound prediction. The FC started the utility analysis by looking at the promise of the ‘191 Patent. The FC was of the view that the skilled person would interpret treatment for Hepatitis C infections “as requiring effectiveness in combination with low toxicity as measured in accordance with the therapeutic index”. The FC also noted that the promise did not include any specific result or level of treatment. Thus, Gilead had to prove that Idenix had not soundly predicted a scintilla of utility in the compounds for the treatment of Flaviviridae. The FC held that Gilead was successful on this issue, as Idenix could not demonstrate, nor soundly predict as an inferred fact or prima facie reasonable inference, the utility of the 2’-C-Me/F compound as an effective treatment of Hepatitis C.
The FC also considered whether there was a requirement to disclose the factual basis and line of reasoning for the sound prediction in the patent. The FC adopted Rennie J.’s reasoning in Astrazeneca Canada Inc. v Apotex Inc., 2014 FC 638, which limits the disclosure requirement of soundly predicted utility to “new use” inventions. Since the ‘191 Patent relates to a sound prediction of a new composition, the FC concluded that there was no utility disclosure requirement. Further, the FC assumed that this exemption from disclosure applied both to the factual basis and the line of reasoning. The FC cautioned that the disclosure requirement is still a matter of contention in the case law at large, and if Idenix had been required to disclose, it would have failed in this respect.
Insufficient disclosure
Gilead’s allegation of invalidity due to insufficient disclosure was also successful. The FC’s sufficiency analysis focused on whether there was sufficient disclosure of the synthesis of the 2’-C-Me/F compound in the ‘191 Patent. The FC held that the ‘191 Patent discloses neither the synthesis of the 2’-C-Me/F compound, nor its precursor compounds. Further, the FC concluded that the evidence did not support Idenix’s claim that common general knowledge and permissible experimentation provided enabling disclosure of how to synthesize the 2’-C’-Me/F compound.
Overbreadth
The FC rejected Gilead’s novel invalidity argument with respect to overbreadth, which the FC summarized as follows:
- At the time the patent application was filed and published, Idenix had been unsuccessful in making a compound within the scope of the claims; as they did not have a way of making the claimed compounds, they cannot be said to have completed the act of invention; and
- Not having invented the compounds, any claim to any such compounds is by definition overbroad.
The FC noted that Gilead was, in effect, adding a new condition that the inventor must have a way of making the invention to the requirement of being able to describe how to make it. The FC disagreed and affirmed that if the claims are soundly predicted and there has been sufficient disclosure of how to make the invention, then there can be no overbreadth of claims.
Counterclaim
The FC dismissed Idenix’s counterclaim that Gilead’s patent was invalid on the basis of anticipation and pursuant to s. 53 of the Patent Act for wilful misrepresentation of the inventor. While there was disclosure of the same invention in Gilead’s ‘657 Patent, there was no enabling disclosure of how to synthesize the compounds in the ‘191 Patent. Therefore, Idenix’s claim of anticipation was rejected.
With respect to Idenix’s s. 53 claim, the FC found that Idenix was unable to establish that Dr. Stuyver was a co-inventor of the compound. Further, his omission as an inventor would not have satisfied the materiality requirement under s. 53, since Idenix could not show that the omission would have affected the term, substance or ownership of the patent, or the public’s ability to use the invention.
Finally, on Idenix’s counterclaim of infringement, the FC concluded that, had the ‘191 Patent been found valid, Gilead’s product fell within the scope of claims at issue, and therefore, the ‘191 Patent would have been infringed.
By: Jillian Brenner, Borden Ladner Gervais LLP