CaseTeva Canada Innovation and Teva Pharmaceutical Industries Ltd. v. Apotex Inc., 2014 FC 1070

Drug: AZILECT® (rasagiline)

Nature of case: Section 6 prohibition proceedings under the PM(NOC) Regulations

Successful party: Apotex Inc.

Date of decision: December 19, 2014 (Public Judgment and Reasons); November 12, 2014 (Confidential Judgment)

Summary

In a recently published Public Judgment and Reasons, Justice Gleason dismissed Teva Canada Innovation and Teva Pharmaceutical Industries Ltd.’s (Teva) application for a prohibition order under s. 6 of thePatented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) on December 19, 2014, in respect of rasagiline (AZILECT®), a drug used in the treatment of Parkinson’s disease. She found that Apotex’s non-infringement allegation was justified, and given her decision on infringement, did not address the allegations of invalidity.

Construction

The claims at issue claimed compositions that include a “pentahydric” or “hexahydric” alcohol. Apotex’s products contained a particular alcohol, and Justice Gleason’s decision turned on whether the alcohol in Apotex’s products was a pentahydric or hexahydric alcohol.

The parties agreed that alcohols are organic compounds that have at least one hydroxyl group, but did not agree on the meaning of “pentahydric” and “hexahydric” alcohol. Although they both accepted that “pentahydric” and “hexahydric” refer to alcohols with five and six hydroxyl groups, respectively, the parties differed in how the hydroxyl groups in a given molecule should be counted. Teva asserted that “pentahydric” and “hexahydric” include any alcohol with five or six hydroxyl groups or any alcohol containing an alcohol moiety with five or six hydroxyl groups. Therefore, according to Teva, to classify an alcohol as either “pentahydric” or “hexahydric”, the skilled person would only count the hydroxyl groups on the alcohol moiety. Justice Gleason rejected Teva’s construction, and instead accepted Apotex’s assertion that “pentahydric” and “hexahydric” alcohols contain a total of five or six hydroxyl groups, and to classify an alcohol the skilled person would count all of the hydroxyl groups in the molecule.

Despite striking some of Apotex’s evidence because it relied on documents that were not disclosed in Apotex’s Notice of Allegation (NOA), Justice Gleason preferred Apotex’s evidence on construction. She noted that at the construction stage, Apotex’s experts were unaware of the alcohol Apotex used in its product. Their analysis was therefore “in accordance with the direction from the Supreme Court of Canada, requiring that the construction exercise be uninfluenced by concerns over infringement or invalidity.” She criticized Teva’s experts’ knowledge of Apotex’s NOA and products before they formulated their opinions on construction, stating that Teva’s experts “conducted their construction of the terms with a view to the potentially infringing substance.” She also pointed to errors in Teva’s experts’ reports and Teva’s refusal to allow one of its experts to answer questions on cross-examination as additional reasons to afford the opinions of Teva’s experts’ less weight.

Justice Gleason also held that Apotex’s construction was supported by the language of the patent at issue.

Infringement

Justice Gleason held that Apotex’s products do not infringe the claims at issue – the claimed compositions include a pentahydric or hexahydric alcohol and Apotex’s products do not contain a pentahydric or hexahydric alcohol.

Link to decision:

2014 FC 1070 may be found here