Enablement is one of the requirements a patent application must satisfy in order for the patent to be granted. Enablement means that the specification (the written text and drawings) teaches a person skilled in the art how to make and use the invention. 35 U.S.C. §112, ¶1. The enablement requirement is satisfied if a person, after reading the specification, could make and use the invention without undue experimentation.
In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., 707 F.3d 1330, 2013 U.S.App. LEXIS 3203 (Fed. Cir., February 14, 2013), the Federal Circuit Court of Appeals held that experimentation is not “undue” even if it is “complicated and difficult.”
Cephalon owned two patents covering a method of drug delivery, which used effervescent agents to increase the absorption of the drug. Cephalon sold the brand-name drug Fentora to treat breakthrough cancer pain, which utilized the patented method.
Continue Reading Patent Enablement: Undue Experimentation Does Not Mean No Experimentation
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