• Clinical Studies Exempted from Public Use in Allegation of Anticipation
  • June 18, 2014 | Authors: Adrian J. Howard; Beverley Moore; Chantal Saunders; Ryan Steeves
  • Law Firm: Borden Ladner Gervais LLP - Ottawa Office
  • Bayer Inc. v. Apotex Inc., 2014 FC 436
    Drug: YAZ® drospirenone and ethinylestradiol

    This is an application pursuant to the Patented Medicines (Notice of Compliance) Regulations. The Court began by noting that it had issued an Order of prohibition in a proceeding relating to the same patent with a different generic company, Cobalt. The parties agreed not to make submissions with respect to obviousness in light of the Cobalt decision.

    After construing the asserted claims, the Court found that Apotex did not infringe the patent. The Court also considered eligibility for listing on the Patent Register. The Court found that section 6(5) of the Regulationscan allow for the early disposition of this issue, but does not prevent the issue from being raised at the hearing. Accordingly, the Court considered Apotex’ allegation that the patent was not properly listed on the Patent Register because the medicinal ingredient is in the form of a clathrate, which is not claimed in the patent. The Court noted the burden with respect to this allegation lies with Apotex because it is not an allegation that Bayer must demonstrate was not justified as it does with allegations pursuant to section 5(1) or (2) of the Regulations. The Court found that the listing was not improper.

    Apotex also alleged that the asserted claims are invalid for anticipation in light of clinical studies in Europe and the United States. Bayer submitted evidence with respect to the measures taken to ensure confidentiality was maintained. The Court found “that there has been established a “theoretical” possibility that a tablet could have been kept and analyzed, therefore the requirements of subsection 28.2(1)(a) of the PatentAct have been met.” However, the Court then considered that the law allows experimental use in order to bring an invention to perfection, which does not constitute public use. The Court found that Bayer took reasonable steps and it is only a theoretical possibility that some tablets were retained and analyzed. “This theoretical possibility does not preclude the fact that the studies were experimental, and of necessity, conducted by the provision of tablets to members of the public. Thus these clinical studies are exempted from public use.” The claims of anticipation were found not justified.

    The application was dismissed.