Gilead Sciences, Inc. v. Canada (Health), 2016 FC 856

The Federal Court dismissed Gilead's application for prohibition in respect to the combination drug TUVADA® covered in the '475 Patent. This combination drug is comprised of the drug VIREAD®, which is a medicine patented by the '619 Patent. In the companion case concerning the validity of the ‘619 Patent, the Court granted the prohibition application (see 2016 FC 857; our summary here). In the case at bar, Apotex alleged that the '475 Patent was invalid on the basis of anticipation, obviousness, lack of sound prediction of or demonstrated utility; infringement was conceded by not alleging non-infringement.

On the issue of expert blinding, the Court made the same comments as those in the companion case; the blinding issue is a question of relevance, reliability and weight, and is not a doctrinal matter.

On the ground of anticipation, the parties disagreed on the admissibility of certain documents put forward by Apotex. The Court found that the purported Press Release and the purported Conference Call Transcript were the most relevant documents to this proceeding. The Press Release states there would be a conference call and the Conference Call Transcript confirms the Conference Call took place before the key date for anticipation. The documents were both attached by Apotex to its NOA. Neither document was authenticated or introduced by affidavit or oral testimony of anyone associated with its preparation, nor was the truth of its contents deposed to by anyone associated with its preparation. As a result, Gilead objected to the reliance on both documents on the ground that they both constitute hearsay. The Court agreed that the documents were both hearsay, but held that the documents were admissible. When refusing to produce the documents, Gilead did not argue that the documents were not under its control, nor did it seek relief from production under Rule 94(2) of the Federal Courts Rules. Instead, Gilead unilaterally refused to make the required production under Rule 94(1). The Court found that Gilead's non-compliance with Rule 94(1) resulted in the documents meeting the test of necessity. The documents were also found to be reliable and were admitted.

The Press Release was not found to disclose the invention, and therefore, not anticipate the ‘475 Patent. However, the Conference Call, as reflected in the Conference Call Transcript, was found to both disclose and enable the invention. The Court concluded that the '475 Patent was anticipated. Even though the patent was held to be anticipated, the Court still considered the other allegations of invalidity. Apotex's allegations of obviousness and obvious to try were successful, but its allegation of invalidity based on utility was not justified.