GUEST BLOGGER Joshua D. Sarnoff

The U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) has decided an important case regarding the application of the obviousness requirement to gene patents.  In re Kubin, No.2008-1184 (Fed. Cir. Apr. 3, 2009).  That case upheld the rejection by the U.S. Patent and Trademark Office (USPTO) of typical claims to gene sequences as unpatentable because they were obvious.

The recent U.S. Supreme Court case KSR International, Inc. v. Teleflex Corp., “calls into serious question the validity of many of the genetic sequence and other natural products or phenomena claims issued by the PTO.”  This is because the Federal Circuit and the USPTO for decades had been applying a much more limited test of obviousness than was authorized by the law and binding precedents.  The Federal Circuit consequently allowed patents on purported inventions that would have been rejected previously.  In Kubin, though, the Federal Circuit recognized that KSR had “unambiguously discredited” the Federal Circuit’s earlier holdings that had rejected an “obvious to try” approach to finding gene patents obvious.  See, e.g., In re Deuel, 51 F.3d 1552, 1559 (Fed. Cir. 1995).  Given the correct approach, the Federal Circuit held the claims invalid; there was sufficient motivation for skilled persons to isolate the cDNA sequences, given prior art knowledge of the importance of the protein and a reasonable expectation of success in doing so given that the methods of DNA isolation were conventional.  The Federal Circuit, referring to Supreme Court language in KSR, said, “Therefore, the claimed invention is ‘the product not of innovation but of ordinary skill and common sense.'”  Similar motivations should exist for isolating the sequences claimed by many issued patents, and the reasoning of Kubin (known methods, a reason to apply them, and expected success makes the result obvious) also should extend to other reasons for isolating genetic sequences than a known important protein.  Thus, many if not most issued gene patents are likely invalid for obviousness.

Joshua D. Sarnoff is a Professor of the Practice of Law at Washington College of Law, American University, where he supervises law students in the practice of intellectual property law. He is a registered patent attorney, teaches patent law, and has been involved in a wide range of intellectual property legal and policy disputes.