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Canadian Federal Court Clarifies Good Faith Requirement in Patent Prosecution

In a proceeding under the Patented Medicines (Notice of Compliance) Regulations, the Federal Court recently held that there is a duty of candour on applicants in how they represent prior art during the prosecution of their patent applications.

In Lundbeck Canada Inc v ratiopharm Inc, 2009 FC 1102, the plaintiff (Lundbeck) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to ratiopharm Inc (Ratiopharm) regarding the drug mematime sold under the brand name EBIXA until the expiry of Canadian Patent No 2,426,492 (the ‘492 Patent) and 2,014,453 (the ‘453 Patent). Both prohibition applications were dismissed.

Ratiopharm alleged that the ‘492 Patent should be deemed to have been abandoned because the applicant breached its duty of good faith by misrepresenting the prior art. The ‘492 Patent claimed a combination of two drugs. During prosecution, Lundbeck was requisitioned to identify prior art cited in respect of related foreign patent applications, and it identified a prior art reference, Wenk.

In a subsequent requisition, the Examiner objected to the pending claims as being obvious because they claimed an aggregation of known compounds. In response, Lundbeck argued that the prior art “taught away” from the pending claims, discussing four such prior references, and that the combination was not obvious. Significantly, however, Lundbeck did not discuss Wenk in response to this requisition.

The Court found that the prior art discussed by Lundbeck was not directly relevant to the ‘492 Patent but that the Wenk reference was directly relevant and coming, as it did, to the opposite conclusion, the Court held that Ratiopharm’s allegation of deemed abandonment was justified.

Additionally, the Court found that Ratiopharm’s allegations of anticipation and obviousness with respect to the ‘453 Patent were justified.

For the 114-page reasons for judgment in Lundbeck Canada Inc v ratiopharm Inc, 2009 FC 1102, see:

http://decisions.fct-cf.gc.ca/en/2009/2009fc1102/2009fc1102.html

Summary by: Lauren Lodenquai

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