CASE: Schering-Plough Canada et al. v. Pharmascience Inc. et al. (Federal Court)     

DRUG: Desloratadine (AERIUS®)

NATURE OF CASE: NOC Regulations: Prohibition proceeding – Section 6

SUCCESSFUL PARTY: Pharmascience Inc. et al.

DATE OF DECISION: December 22, 2009 (confidential reasons issued November 4, 2009)

SUMMARY:  

On December 22, 2009, the Federal Court dismissed an application for an Order preventing the Minister of Health from issuing a notice of compliance to Pharmascience Inc. ("PMS") in respect of a generic version of Schering-Plough’s ("Schering") desloratidine drug until the expiry of Canadian Patent Nos. 2,325,014 ("'014 patent") and 2,267,136 ("'136 patent"). PMS had alleged that its product would not infringe either patent and, in any event, the impugned claims of the '014 and '136 patents were invalid on various grounds, including anticipation, obviousness, overbreadth, and inutility.

Claim construction was a significant issue in respect of both patents, which were directed to formulations of desloratidine. Based on the construction adopted, Snider J. held that the PMS product: (1) infringed claims 1, 6 and 9 of the '136 patent, but not claim 23 (which was dependent on claim 16); and (2) did not infringe any of the claims in issue of the '014 patent.

The Court, in the alternative, considered the validity of claims 1, 6 and 9 of the '136 patent. Claim 9, which was directed to either the tablet or capsule form of the pharmaceutical composition, was found to be anticipated on the basis that a previously taught example using a capsule dosage form fell within the scope of the claim. Schering unsuccessfully argued that s.27(5) of the Patent Act could save claim 9 by treating the alternate tablet formulation as a separate claim. The Court adopted Justice Phelan's analysis in Abbott Laboratories v. Canada (Minister of Health), 2005 FC 1332 and concluded that, for the purposes of a NOC proceeding, the entire claim will fail if even one alternative of the claim is anticipated.

For obviousness, Justice Snider applied the obvious-to-try test for claims 1, 6, 9 and 23 of the '136 patent. Upon identifying the inventive concept of the patent to be the attainment of a stable formulation of the pharmaceutical composition, Justice Snider concluded that pre-formulation experiments are routine and that it is more or less self-evident that companies would want to obtain a stable formulation. Claims 1, 6, 9 and 23 were therefore found obvious.

The Court also discussed functional claims in evaluating the non-infringement and invalidity allegations of claim 23 of the '136 patent. Snider J. stated that functional claims, which were described as claims expressed in a way that leads to a desired result, were legally permissible as long as the skilled person is able to come to the desired result directly. The Court concluded that claim 23, as construed, was not an acceptable functional claim as it was overbroad.

The Court finally considered the validity of the impugned claims of the '014 patent, in the alternative (having already found the non-infringement allegation justified). Snider J. rejected PMS's allegations of lack of utility, obviousness and overbreadth.

LINK TO DECISION:

Schering-Plough v. Pharmascience 2009 FC 1128