CASE: Purdue Pharma v. Pharmascience Inc. and the Minister of Health

DRUG: oxycodone hydrochloride (OXYCONTIN®)

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

SUCCESSFUL PARTY: Purdue Pharma

DATE OF DECISION: July 17, 2009 (public reasons released September 2, 2009)

SUMMARY:

On July 17, 2009, the Federal Court (Harrington J) allowed an application by Purdue Pharma ("Purdue") under section 6 of the Patented Medicines (Notice of Compliance) Regulations and prohibited the Minister of Health from issuing a Notice of Compliance to Pharmascience Inc. ("Pharmascience") until after the expiration of Canadian Patent No. 2,098,738 (the "Patent").

The Court held that the inventive concept of the claims at issue was the controlled release of oxycodone according to a particular dissolution and pharmacokinetic profile. The inventive concept was not the mere idea, but rather an appropriate formulation to achieve this profile.

Pharmascience did not make an allegation of non-infringement, but did assert that the Patent was invalid on several grounds. The Court expressly endorsed Justice Hughes's "holistic approach" from Eli Lilly Canada Inc. v. Apotex Inc., 2008 FC 142, and rejected Pharmascience's allegations for the following reasons:

Anticipation – None of the prior art documents cited by Pharmascience disclosed the claimed invention. Confidential in vivo testing does not constitute a public disclosure.

Obviousness – The claimed formulation was not "obvious to try". The Court reached this conclusion on the basis of the fact that devising a formulation involves the consideration of many choices and the inventor required years of work and many trials and errors to reach the solution taught by the Patent.

Sound Prediction of Usefulness – The Patent satisfied the three-part test for sound prediction. It was irrelevant whether narrower dose ranges disclosed within the Patent had been demonstrated to have utility (or could be soundly predicted to be useful), as such language did not form part of the language of the disputed claims and could not be implied by an overall reading of the specification.

Overbreadth and Lack of Disclosure – The particular matrix system disclosed in the examples of the Patent was not an essential element of the disputed claims. A fair "bargain" between the inventor and society cannot be struck if the patent can be easily worked around by using a non-essential variant. Purdue did not claim a "desired result", as it did not claim non-matrix systems such as reservoirs or osmotic systems that could be used to achieve the same result.

LINK TO DECISION:

http://decisions.fct-cf.gc.ca/en/2009/2009fc726/2009fc726.html