Sanofi sought an order prohibiting the granting of a NOC to ratiopharm. There were two patents in issue but Apotex accepted that a NOC could not issue until one of the patents expired in March 2011. With respect to the remaining patent, the Judge held that Apotex’ allegation s of invalidity and non-infringement were justified.

Several claims were in issue in the case. Claim 1, upon which a number of the claims were dependant, was for a pharmaceutical composition with a given dissolution profile. Sanofi argued that the required dissolution profile was a limitation on the formulation whereas Apotex argued that it was a promise of performance. In the end, the Judge decided that distinguishing between the two was not necessary as the allegation of invalidity was justified on either interpretation. Given the overlap of evidence and arguments in the case, the Judge declined to assess the numerous grounds of invalidity independently (in “watertight compartments”) and instead preferred the “seamless garment of law” approach adopted by Justice Harrington in an earlier case. The allegation of invalidity was found justified on the grounds of being obvious to try, because of the breadth of the claims and lack of utility or sound prediction.

In considering the allegation of non-infringement, the Judge had to consider whether a particular excipient (the name of which was redacted for confidentiality) in ratiopharm’s formulation was a diluent. This issue arose because the excipient used by Apotex was multi-functional within the formulation. The Judge held that in circumstances like this it is appropriate to ascribe to the excipient its primary role within the formulation. In doing so, he concluded it was not a diluent and therefore the allegation of non-infringement of Apotex’s formulation was justified.

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