The Federal Court dismissed Gilead’s prohibition application against Apotex for its tenofovir disoproxil fumarate (TDF) and emtricitabine fixed dose combination tablet (Gilead’s TRUVADA):Gilead Sciences, Inc v Apotex Inc2016 FC 856. Gilead sought to prohibit the issuance of a notice of compliance (NOC) until expiry of Patent No. 2,512,475, which claims a formulation comprising TDF and emtricitabine. The Court found Apotex’s allegations of invalidity to be justified on the basis of anticipation and obviousness. Apotex’s anticipation allegation was based on a transcript of an investor conference call held by Gilead prior to the claim date of the patent. The transcript was held admissible as an exception to the hearsay rule; it was found to be necessary as Apotex attempted to prove the document by serving a Direction to Attend and was found to be reliable. The Court held that the asserted claim was in fact disclosed during the conference call and that the disclosure was sufficient to enable a skilled person to make the invention, as development of the actual tablet required only routine tests once the combination was disclosed. Apotex’s obviousness allegation was also found justified, as the Court held that there were only a finite number of predictable solutions to develop a chemically stable co-formulation. On utility, the Court found Apotex’s allegation unjustified, as the invention was useful as a chemically stable co-formulation and was soundly predicted based on the testing disclosed in the patent.