"The U. S. Supreme Court's decision in Amgen Inc. v. Sanofi reiterated that patentees cannot claim a wide functional class of inventions without providing sufficient guidance or examples to enable others to use the full range of what is claimed ( Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)). The Supreme Court did recognize in some cases that disclosing a general property common to a class or genus of embodiments may be enough to satisfy the enablement requirement."
"For example, in Wood v. Underhill, the Supreme Court upheld a patent for making bricks using coal dust and clay, accepting general guidance on proportions with allowances for natural variation (46 U.S. 1 (1847)). Similarly, in Minerals Separation, Ltd. v. Hyde, the Supreme Court found that preliminary testing to adapt a metal separation process to different ores did not render the patent invalid (242 U.S. 261, 270 (1916))."
Amgen Inc. v. Sanofi reaffirmed that patentees cannot claim broad functional classes without providing sufficient guidance or examples to enable use of the full claimed range. The Supreme Court acknowledged that disclosing a general property common to a genus may sometimes satisfy enablement, but that approach has been more effective in fields with predictable physical properties. Historical precedents such as Wood v. Underhill and Minerals Separation show acceptance of general guidance where properties were predictable. Enablement remains more complex in biotechnology and life sciences, especially for antibodies, because small structural changes can yield unpredictable functional outcomes.
Read at IPWatchdog.com | Patents & Intellectual Property Law
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