Patenting antibodies has long been challenging. Although most inventions can be patented based on their functionality, assuming the functionality is new and non-obvious, for antibodies and other biomolecules there is a higher standard. Although the antibody standard was recently challenged, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided to uphold it.
Nearly five years ago the U.S. Court of Appeals for the Federal Circuit (CAFC) decided the controversial case of Ariosa v. Sequenom. In Sequenom the invention was a radically new method of fetal genetic testing by amplifying free paternal DNA from the mother’s blood. This test has today largely replaced the previous method of
The legal meaning of the transition language “consisting essentially of” is well-established in Federal Circuit case law and is generally construed to mean that the composition or formulation (a) necessarily includes the listed ingredients and (b) is open to unlisted ingredients that do not materially affect the basic and novel properties of the composition. Similarly,