A panel of the Court of Appeals for the Federal Circuit (CAFC) rendered a decision today, in the Myriad case, regarding patent eligibility of “isolated” DNA molecules. See Association for Molecular Pathology v. PTO, posted at http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf. The CAFC panel reversed the District court’s decision that had held Myraid’s claims to “isolated” DNA patent ineligible. In doing so, the CAFC panel gave weight to the word “isolated,” distinguishing “isolated DNA” from “purified DNA”. More specifically, the Court indicated that the claimed “isolated DNA” defined a distinct chemical entity, one lacking covalent bonds to other genetic material present in DNA molecules existing in nature. Relevant excerpts from the decision follow.
On the merits, we reverse the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. We, however, affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.*** As set forth below, we conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101. ***
In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. *** The dissent disparages the significance of a “chemical bond,” presumably meaning a covalent bond, in distinguishing structurally between one molecular species and another. But a covalent bond is the defining boundary between one molecule and another. The dissent’s citation of Linus Pauling’s comment that covalent bonds “make it convenient for the chemist to consider [the aggregate] as an independent molecular species” underlines the point. The covalent bonds in this case separate one chemical species from another.
One of the three panel members dissented, concluding that “Yet there is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken….” Consequently, there is a significant chance that this case will continue via a request for en banc CAFC rehearing or a petition for review by the Supreme Court.
Regardless of outcome, at least one practice point is obvious. To claim “isolated” DNA in pending patent applications.
Rick Neifeld, Ph.D. Patent Attorney
President, Neifeld IP Law, PC
4813-B Eisenhower Avenue
Alexandria Virginia 22304
Tel: 703-415-0012
Fax: 703-415-0013
Home Page: http://www.Neifeld.com/
