The trial judge applied a test of “subjective intent”, namely that the manufacturer must make the product with the intention of targeting the patent-protected market. In contrast, the Court of Appeal applied a test of “objective intent”, holding that direct infringement would be found if the manufacturer knows, or it is reasonably foreseeable, that the drug will intentionally be used for the patented indication. The decision highlights the importance of including in a patent application the technical rationale for why experimental data make an invention plausible in relation to all significant areas of a second medical use patent claim. The decision approves “plausibility” as a non-statutory test for sufficiency of disclosure, and defines its role in establishing validity of a patent claiming a new medical use of a known pharmaceutical compound.
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JR has received honoraria for participation in advisory boards, consulting and lectures from AbbVie, Camurus, Gilead, Hexal, Indivior, and Sanofi-Aventis. JK has received honoraria from Bayer, Janssen, Lundbeck, Neuraxpharm, Otsuka Pharma, Schwabe, and Servier for lecturing at conferences and financial support to travel. He has received financial support for Investigator initiated trials from Medtronic GmbH.
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