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PATENTS - Criteria for patent protection - Novelty

Thursday, May 13, 2021 @ 6:21 AM  


Lexis Advance® Quicklaw®
Appeals by Apotex from a Federal Court judgment upholding the claims in a patent held by the Shire respondents and refusal of issuance of a Notice of Compliance (NOC). The respondents held the patent for LDX, a sustained release prescription amphetamine used to treat ADHD with reduced potential for abuse. The appellant filed a new drug submission seeking a NOC to sell Apo-LDX. The respondents sought a prohibition order based on infringement. The appellant sought a declaration the respondents’ patent was invalid based on obviousness and anticipation. The Federal Court found in favour of the respondents. Apotex appealed. 

HELD: Appeals dismissed. The trial judge’s failure to formally characterize whether the respondents’ patent was a selection patent was of no import to the validity analysis. On the issue of anticipation, the trial judge adopted the approach required by the jurisprudence. The judge identified differences related to specific asserted claims and found that those specific claims were not anticipated and were novel. That conclusion was amply supported by the evidence. On the issue of obviousness, the trial judge did not err in the determination, analysis and application of the inventive concept. The decision demonstrated the inventive concept could be grasped without difficulty based on analysis of the chemical compound claims as amplified by the specification. The trial judge was aware of the limitation on the use of the inventive concept and its application was not impacted by impermissible redundancy or duplication. The judge considered the state of the art, the gap between the state of the art and the inventive concept, and finally considered whether the differences were obvious based on the enumerated and contextual factors of the obvious to try analysis. No reviewable error was established.

Apotex Inc. v. Shire LLC, [2021] F.C.J. No. 233, Federal Court of Appeal, D.J. Rennie, Y. de Montigny and M.J.L. Gleason JJ.A., March 11, 2021. Digest No. TLD-May102021007