The Federal Court has dismissed Gilead's prohibition application against Apotex for its tenofovir disoproxil fumarate (TDF) and emtricitabine fixed-dose combination tablet – Gilead's Truvada.(1) Gilead sought to prohibit the issuance of a notice of compliance until the expiry of Patent 2,512,475, which claims a formulation comprising TDF and emtricitabine. However, the court found that Apotex's allegations of invalidity were 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 before 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 to the combination was disclosed during the conference call and that the disclosure was sufficient to enable a skilled person to make the invention, as development of the tablet required only routine tests once the combination was disclosed.

Apotex's obviousness allegation was also found justified, as the court held that there was 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 soundly predicted based on the testing disclosed in the patent.

For further information on this topic please contact Kevin Siu at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at


(1) Gilead Sciences, Inc v Apotex Inc, 2016 FC 856.