WYETH LLC V. ASTRAZENECA PHARMA. LP
Before Lourie, Linn, and Hughes. Appeal from District Court for the District of Delaware.
Summary: Patent claims were not enabled because the specification failed to provide sufficient guidance for determining “unit dosages” across the full scope of claimed compounds without undue experimentation.
Wyeth sued AstraZeneca, alleging induced infringement of the ’314 and ’162 patents through the marketing, distribution, and sale of its irreversible EGFR inhibitor. At trial, AstraZeneca requested JMOL that the claims were not enabled, arguing that the patents failed to teach how to determine the claimed “unit dosage” without undue experimentation. The district court granted JMOL, holding that the claimed “unit dosage” needed to be calculated to produce the claimed “desired therapeutic effect” in a patient, and the patents provided only a starting point for further research and required undue experimentation to identify workable dosages
On appeal, Wyeth argued that the district court improperly altered its construction of “unit dosage” by adding clinical safety and efficacy requirements. The court disagreed. Because the claims require a “unit dosage” that is “administer[ed] daily” to a human patient to achieve the desired therapeutic effect, the claims require a therapeutically calculated daily dosage. Here, identifying workable dosages would require additional testing and screening beyond what the patent taught. Accordingly, the Federal Circuit affirmed the district court’s ruling that the patents failed to enable the claimed invention.
Editor: Sean Murray
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