Federal Court

Intellectual Property


Validity of patent

Opinion was tainted by hindsight and presupposition that skilled person already understood role of dosage shape in affecting retention

Applicant pharmaceutical company held patent rights under 624 patent, now expired, and 671 patent for its drug product. Applicant applied for order prohibiting Minister of Health from issuing Notice of Compliance to respondent G Inc. for its generic version of product until 671 patent expired. Application granted. There were three elements to inventive concept of 671 patent, with size element specifications including minimum swollen length for shorter axis, time element requiring swelling to take one hour, and shape element specifying that dosage form have planar projection of oval or parallelogram. Prior art might have disclosed size and time elements of inventive concept, but shape element and combination of all three elements were missing. There was no teaching or discussion of potential correlation between shape of dosage form and gastric retention in prior art. Fact that swelled dosage form was depicted as oval in one article’s figure was happenstance as nothing in that article suggested that shape was relevant factor in improving gastric retention. Wide range of options to enhance gastric retention disclosed in prior art would not have led skilled person inexorably to invention of combining three elements without inventive ingenuity. Opinion by G Inc.’s expert that determining interplay between sizes and shapes useful to enhance gastric retention was matter of routine testing was tainted by hindsight and by presupposition that skilled person already understood role of dosage shape in affecting retention. Invention could not be obvious to try without insight that dosage shapes would affect gastric retention. Nothing in prior art suggested correlation between dosage shapes and gastric retention and so there was no motive in prior art to try solution addressed by 671 patent.

Valeant Canada LP/Valeant Canada S.E.C. v. Generic Partners Canada Inc. (2019), 2019 CarswellNat 650, 2019 FC 253, Fothergill J. (F.C.).

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