Gilead Sciences, Inc. v. Canada (Health), 2016 FC 857

On August 23, 2016, the Federal Court released its public judgment granting the Order of prohibition for Gilead's ‘619 Patent. The ‘619 Patent covered a prodrug useful in the treatment and prophylaxis of HIV. Apotex had alleged that the ‘619 Patent was invalid on the basis of anticipation, obviousness, invalid selection patent and inutility.

The Court first addressed the issue of "blinding" of experts. Gilead had provided the legal framework to its experts early concerning anticipation, obviousness and utility. In contrast, Apotex stated that it had waited to provide this information until the experts had drawn their own conclusion on various issues, including the promise of the patent, claim construction and prior art. The Court preferred the approaches taken in the recent decisions in Eli Lilly Canada Inc v Apotex Inc, 2015 FC 875, and Shire Canada Inc v Apotex Inc, 2016 FC 382. The Court stated that "the blinding of a witness is a factor, one of perhaps several, that goes to weight, but it is not a matter that goes to admissibility". The Court also noted that “the blinding issue is a question of relevance, reliability and weight, and is not a doctrinal matter".

The Court held that the ‘619 Patent was not anticipated since the EP 214 application did not disclose tenofovir disoproxil (TD). The Court also held that the ‘619 Patent was not an invalid selection patent from the genus disclosed in the EP 214 Application. The evidence and law did not establish that the EP 214 Application encompassed TD. The Court noted that even if the Application did include TD, it would still find that TD presented particular and special advantages over other members of the claimed genus that were not disclosed.

The '619 Patent was also not found to be obvious. The Court noted that there was strong motivation to invent a drug, including financial and medical motivation, as well as motivation to find a nontoxic, stable drug with effective oral delivery. However, the Court concluded that these motivations to invent a drug with TD's properties did not render the invention obvious or obvious to try.

Finally, in respect of utility, the Court found that the goal of the ‘619 Patent was to improve treatment of HIV, whereas the promise was to offer efficient oral delivery of the compound. After defining the promise of the ‘619 Patent, the Court held that utility was demonstrated.