On August 19, 2016, the Federal Court released the public judgment and reasons by Justice Brown in 2016 FC 856. The case was a prohibition proceeding pursuant to s. 6 of the NOC Regulations where the only patent in issue remained Canadian Patent No. 2,512,475, which expires on January 13, 2024. The 475 Patent relates to the use of combinations of tenofovir disoproxil fumarate and emtricitabine in a pharmaceutical composition or formulation for the treatment of HIV infections. A separate companion decision of Justice Brown relating to Canadian Patent No. 2,261,619, listed against Gilead’s VIREAD (tenofovir disoproxil fumarate) product, is reported here (see our summary here).
Asserted claims 15, 16, 24, 25 and 28 of the 475 Patent are generally directed to a pharmaceutical formulation comprising tenofovir and emtricitabine.
Apotex’s allegation of anticipation was based on a transcript of a conference call between Gilead and investment analysts prior to the claim date. During the conference call, Gilead indicated that co-formulation was ongoing and the pathway for the co-formulated products was very straightforward. While Gilead did not contest the content of the contemporaneously transcribed transcript, it sought to exclude it as inadmissible hearsay on the basis that Apotex had not authenticated it or introduced it into evidence by anyone associated with its preparation. Justice Brown, while agreeing the transcript was hearsay, nevertheless admitted the transcript as an exception because Gilead had frustrated Apotex’s attempts to authenticate the transcript by instructing its witness to ignore a direction to attend requiring the witness to produce it:
However, I agree with Apotex that the Conference Call Transcript should be admitted as an exception to the hearsay rule, and do so for the same reasons that led me to admit the Press Release: the exception based on necessity and reliability. Again, Apotex did all it could to prove the Conference Call Transcript including serving a Direction to Attend on Dr. Miller, the only witness in this proceeding who presumably had access to it. Despite being obliged to produce the Conference Call Transcript in full under Rule 94(1) of the Federal Courts Rules or to seek relief under Rule 94(2), Gilead complied with neither component of Rule 94. Gilead’s evidence was that it was instructed by counsel not to look for this or related documents. Perhaps Gilead’s witnesses or employees kept notes, or their own copies of the Conference Call; perhaps they could recall what words were spoken; perhaps they had their own recording. The Court does not know. This state of affairs is brought about because of Gilead’s unilateral conduct. Gilead made it unavailable; the Conference Call Transcript meets the test of necessity.
Having admitted the transcript, Justice Brown concluded that all asserted claims were anticipated.
Justice Brown determined that the inventive concept is the chemically stable co-formulation of tenofovir and emtricitabine for a once-daily oral pill with anti-HIV activity. Justice Brown also held that once the idea of a co-formulation was disclosed during the conference call, a skilled person would only have a finite number of identified predictable solutions for the development of a chemically stable co-formulation of tenofovir and emtricitabine. In his view, it was more or less self-evident that combining the doses of the single products ought to work. The chemical stability could be readily determined through routine tests. He also held that combination therapies represented the state of the art in HIV treatment at the relevant time, and that a co-formulation would assist with patient compliance. Justice Brown held that there was motivation to produce a co-formulation of tenofovir and emtricitabine.
Justice Brown held that the promise of the 475 Patent is a chemically stable co-formulation of tenofovir and emtricitabine which has anti-HIV activity. He concluded that the 475 Patent has utility. He found the chemical stability for the product’s shelf life was soundly predicted through the testing disclosed in the patent.
A copy of Justice Brown’s decision may be found here.