Bristol-myers Squibb Canada Co v. Teva Canada Limited, 2016 FC 580 

Drug: atazanavir

This is an application under the Patented Medicines (Notice of Compliance) Regulations related to two patents. The first patent (the '840 Patent) claims the commercial compound, atazanavir, and the second patent (the '736 Patent) claims a particular salt. The Court found that the allegations in respect of the '840 Patent were not justified, but the allegations in respect of the '736 Patent were justified.

With respect to the '840 Patent, two allegations were pursued at the hearing, namely obviousness and anticipation. For the purposes of obviousness, the parties disagreed about whether a portion of an Australian patent application was publically available as of the relevant date. The Court found that Teva had not demonstrated that the particular pages that it relied on were available and were not added at a later date. The parties also disagreed as to whether a letter to the European Patent Office was available to the public as of the relevant date. The Court noted that there was little evidence that the letter was available to the public, the letter was written in German and no translation was provided, and it was not cited in the Notice of Allegation (NOA). The Court construed the inventive concept of the ‘840 Patent and noted that it can be different to the construction of the claims. The Court preferred the evidence of BMS' expert and found that Teva's expert conducted a results-driven, hindsight analysis. After considering the evidence, the Court found that this allegation was not justified. With respect to anticipation, the Court rejected Teva's interpretation of the term "arylakly", and concluded that atazanavir does not fall within the genus of the compounds claimed in another patent. The Court determined that even if the genus patent did include atazanavir, following the patent would not inevitably result in atazanavir. An Order of prohibition was granted.

With respect to the '736 Patent, this patent claims the bisulfate salt of atazanavir. The Court considered an issue of construction and preferred BMS' construction. Teva alleged that the '736 Patent was obvious in light of the '840 Patent. The Court accepted that it would have been more or less self-evident to a person skilled in the art that improving the solubility of atazanavir ought to improve its bioavailability. Further, it was not inventive  to make salts to try to improve the solubility of atazanavir. The Court distinguished the Court of Appeal decision relating to PLAVIX where "in light of the lack of information regarding the properties of the enantiomers of the PCR 4099 racemate, the POSITA would have no motivation to single out and try to resolve the racemate. In contrast, when confronted with the limited bioavailability of the free base of atazanavir in this case, the skilled person would have had every reason to try making salts of atazanavir in order to improve its solubility and bioavailability. It was therefore obvious to try." The Court therefore found the allegation of obviousness to be justified and the application relating to the '736 Patent was dismissed.