In the latest column in their monthly Law360 series on recent noteworthy Federal Circuit decisions, Knobbe Martens partners Jeremiah Helm and Sean Murray explore the court’s opinion in Wyeth LLC. V. AstraZeneca Pharmaceuticals LP, a patent infringement dispute focused on methods of treatment of non-small cell lung cancer.
The case turned on the enablement requirement, which dictates that “a patent’s disclosure must enable a person of ordinary skill in the art to make and use the claimed invention without undue experimentation,” explain the authors. In this instance, Wyeth only included in vitro laboratory testing results for unit dosage amounts of its drug in its patent disclosure, which the court ruled would require undue experimentation to determine the correct dosage amount in human patients.
Helm and Murray discuss how Wyeth illustrates the tension between enablement positions in patent disclosures and obviousness positions, which aim to distinguish a patent’s claim as nonobvious over close prior art. “A nonobviousness argument that downplays a skilled artisan’s ability to move from what was known to what has been invented naturally conflicts with a pro-enablement argument that relies on the ability of a skilled artisan to use routine experimentation to implement a claimed invention based on a cursory disclosure,” they write.
The authors maintain that Wyeth is “likely to lead to more enablement challenges” and “may also cause patentees to weigh their own patent’s disclosure carefully when devising nonobviousness positions, particularly whether to emphasize unpredictability and downplay a skilled artisan’s ability to experiment.”
Read the full article, “Meeting The Enablement Requirement,” in Law360.
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