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On May 18, the Supreme Court ruled unanimously in favor of Sanofi in its dispute with Amgen over alleged patent infringement. The case involved the application of the statutory enablement requirement of Section 112 of the patent laws to what is referred to as a “genus claim” as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce low-density lipoprotein (“LDL”) cholesterol.
Specifically at issue was “whether enablement is governed by the statutory requirement that the specifications teach those skilled in the art to ‘make and use’ the claimed invention, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort.'”
Robert Rando, an intellectual property attorney who filed an amicus brief in the case, joined us to unpack the decision.
Featuring:
– Robert J. Rando, Partner, Greenspoon Marder LLP
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