THE SCOPE OF GENUS CLAIMS The Supreme Court's recent ruling in Amgen v. Sanofi reinforced the difficulty of securing broad genus claims in biotech patents. The case centered on Amgen's patents covering monoclonal antibodies that inhibit PCSK9, a target for lowering cholesterol. The Court found that Amgen's patent did not provide sufficient guidance for how to make and use all claimed antibodies, highlighting that merely describing a few examples is often insufficient for the written description and enablement; thus, the patent was held invalid.
GUIDING CASE LAW
AMGEN V. SANOFI (2023)
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