This case dealt with the interpretation of the Canadian Food and Drug Regulations, subsection C.08.004.1(1) concerning data exclusivity protection. The Federal Court of Canada ruled that the five-year data protection to originator manufacturers is not triggered if the subsequent manufacturer, generally a generic manufacturer, can establish the safety and effectiveness of its product on the basis of bioequivalence or bioavailability studies without the Minister having to consult the confidential data filed by the innovator.

In this case Teva Pharmaceutical Industries Ltd challenged the validity of Pfizer Pharmaceuticals Inc’s patent for the drug Viagra. Teva stated that Pfizer had not met the disclosure requirements set out in the Canadian Patent Act. The main issue on appeal was whether Pfizer had failed to properly disclose its invention when it obtained the patent for Viagra.

The Canadian Federal Court granted a limited injunction that prevented the defendant from any further marketing activity for an infringing product but allowed the selling of the same infringing product to patients in the absence of an alternative supplier. The decision is important for the treatment of patent holders that do not use their invention (“non-practicing entities”).