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July 25, 2014

Section 101 Fells Dolly: What Organism Is Next? Adult Cell Cloning.

On Thursday May 8th  a panel of the Fed. Cir. affirmed a board decision refusing a patent claim to an animal prepared by adult cell cloning (a copy is available at the end of this post). Specifically, the patent claims covering “Dolly” the cloned sheep were held invalid on the basis that Dolly is a “product of nature” that, although man-made, does not exhibit “markedly different characteristics” over its DNA donor sheep.

adult cell cloningWhile this was a predictable outcome, Roslin Institute might have developed a factual record that would have supported their arguments that there were genetic differences between the two animals. More disturbing is the emphasis on the need for “markedly different characteristics from any found in nature.” This is dictum from Chakrabarty that seems reasonable enough when dealing with biofactories like Chakrabarty’s bioengineered bacteria. However, language in this opinion gives me the uneasy feeling that the Fed. Cir. is poised to repudiate In re Bergy II. This decision, vacated by the S. Ct., held that pure cultures of microorganisms that excrete lincomycin, are patent-eligible due to the beneficial results of removing the bacteria from the jungle of nature and taming them into useful organisms.

At pages 6-7 of the Slip Op., Judge Dyk writes: “Accordingly, discoveries that possess ‘markedly different characteristics from any found in nature’…are eligible for patent protection. In contrast, any existing organism or newly discovered plant found in the wild is not patentable [citing In re Beinke for the proposition that a plant discovered in the wild is not patent-eligible, "in part because such a plant was not in any way the result of the [applicant's] creative efforts or indeed anyone’s creative efforts.”

Well now, were the pure cultures in Bergy II the result of “creative efforts”? Was vitamin B12 or adrenalin? (And why is Judge Dyk using language usually reserved for poets and painters?) I am speaking on “markedly different” at the PTO 101 Forum on May 9th. This storm front is about to become even more threatening. Take cover!

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To see part 2 of Analysis:  

© 2014 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

About the Author

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Warren Woessner is a registered patent attorney and a founding shareholder of Schwegman, Lundberg & Woessner. His practice focuses on chemical patent law, including biotechnology, pharmaceuticals, vaccines, medical treatments, diagnostics, and biofuels and agricultural chemistry, including related opinion and licensing matters.

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