Notice of Compliance Issued Due to Narrow Construction of Listed PatentsBiovail Pharmaceuticals Inc. et al. v. The Minister of National Health and Welfare et al. 2005 FC 9 (Harrington, J.)
January 6, 2005
Deeth/Watts for Biovail Pharmaceuticals Inc. et al. (Applicants)Stainsby/Skokyn for Novopharm (Respondent)Rosenberg for Minister (Respondent)
The applicants (“Biovail”) sought a court order prohibiting the Minister from issuing a Notice of Compliance (“NOC”) to Novopharm Limited (“Novopharm”). Novopharm compared its drug to Wellbutrin®SR tablets, which contained the medicine bupropion hydrochloride, along with hydroxpropyl methylcellulose (“HPMC”), which allow release of the medicine in a controlled or sustained manner. Novopharm’s drug also contained the medicine bupropion hydrochloride, but used hydroxpropyl cellulose (“HPC”), rather than HPMC, to achieve a controlled or sustained release of the medicine. Biovail had two listed patents which were in issue: the ‘754 Patent and the ‘320 Patent. Novopharm took the position that the patents were invalid and not infringed. The court dismissed Biovail’s application on the basis that neither patent was infringed, for the reasons provided below.
‘320 PatentThe ‘320 Patent was directed to a drug containing bupropion hydrochloride and HPMC. The court concluded that Novopharm’s product did not infringe the ‘320 Patent because it contained HPC, rather than HPMC. Expert evidence indicated that a person skilled in the art, at the publication date, would have understood that other hydrogelling polymers, such as HPC, could perform the same function as HPMC. However, applying the test laid out in Improver Corp. v. Remington Consumer Products Limited, [1990] F.S.R. 181, the court concluded that a reader would have nevertheless understood from the language of the claims that the patentee intended that strict compliance with the claim language was an essential requirement of the invention.
The ‘754 PatentThe ‘754 Patent disclosed an osmotic pressure system which affords a controlled release of bupropion hydrochloride. However, the language of the claims appears to cover any composition comprising bupropion hydrochloride together with a solid pharmaceutical carrier which affords continuous release in a controlled manner. Novopharm argued that it did not infringe because it was using a hydrogel process, rather than an osmotic process. Expert evidence indicated that, at the publication date, there were at least nine ways of providing controlled release, including the osmotic pressure system disclosed in the ‘754 Patent and the hydrogel process used by Novopharm. The court construed the claims to be limited to the osmotic pressure system, although the limitation was not expressly made in the claims. Accordingly, the court found Novopharm’s product to be non-infringing. In the alternative, if the claims were not so limited, the court found the patent invalid for overclaiming.
By: Melanie Sharman Rowand
