Case:

GlaxoSmithKline Inc. et al v. Pharmascience Inc. et al (Federal Court)

DRUG:

Rosiglitazone (AVANDIA®)

Nature of Case:

PM(NOC) Regulations -section 6

Successful Party:

GlaxoSmithKline Inc. et al.

Date of Decision:

March 1, 2011

Summary:

On March 1, 2011, the Federal Court granted GlaxoSmithKline's ("GSK") application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Pharmascience in respect of its generic version of rosiglitazone (AVANDIA) until after the expiry of Canadian Patent No. 1,328,452 ("452 Patent").

In assessing Pharmascience's allegation of obviousness, Justice Hughes considered the expert and inventor evidence before him and concluded that the Pharmascience expert had approached the analysis with hindsight. In the Court's view: "[t]o take several pieces of prior art as Professor Klibanov did, and select certain compounds, reject others, and then endeavour to trace a path for research which is said to be obvious, is a classic example in the application of hindsight. The result was not obvious."

Pharmascience's remaining allegations of insufficiency, inutility and lack of sound prediction were "bound up together". In assessing these allegations, Justice Hughes first construed the specification to determine the promise of the patent. Upon considering the Canadian and U.K. jurisprudence, and having read the 452 Patent in its entirety, Justice Hughes determined that the use of the word "surprising" in the specification would be viewed by a skilled person has language often found in patents and "of little value one way or another in determining what is the real nature of the invention." He went on to find that the use of the phrase "potential use" meant that that promise was not that the compound will treat diabetes but rather that it is of potential use in treating diabetes.

The Court held that GSK had demonstrated by the filing date that rosiglitazone improved blood glucose reducing capability (relying on results from a single mouse test). This evidence met the promise of the patent. Justice Hughes re-iterated that a patentee is not required to demonstrate utility in the specification, so long as the Court finds it to be proven when challenged. He also echoed the Supreme Court of Canada's words from the AZT case that an inventor is not required to prove the safety and efficacy of new compound in order to obtain a patent. Issues such as lack of toxicity are requirements for regulatory approval, not patentability.

Accordingly, Justice Hughes rejected the allegations of insufficiency and inutility and granted the order of prohibition.

LINK TO DECISION:

http://decisions.fct-cf.gc.ca/en/2011/2011fc239/2011fc239.html