By Rivka Monheit and Patrea Pabst
The U.S. Court of Appeals for the Federal Circuit recently issued a decision that modifies and clarifies previous case law regarding the Patent Act’s written description and enablement requirements, making it significantly easier to obtain patents on genetically engineered materials. Amgen, Inc. v. Hoechst Marion Roussel, Inc. and Transkaryotic Therapies, Inc., 314 F.3d 1313 (Fed. Cir. 2003).
The Enablement and Written Description Requirements
The enablement and written description requirements are found in 35 U.S.C. § 112, first paragraph, which states that the patent specification must contain "a written description of the invention, and of the manner and process of making and using it…[such] as to enable any person of ordinary skill in the art to which it pertains … to make and use the same … " The enablement requirement is part of the fundamental trade-off struck by the Patent Act. In exchange for the grant of a patent, an inventor must
