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!


To see part 2 of Analysis:  

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

About the Author


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.


Boost: AJAX core statistics

Legal Disclaimer

You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's  Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on are intended for general information purposes only. Any legal analysis, legislative updates or other content and links should not be construed as legal or professional advice or a substitute for such advice. No attorney-client or confidential relationship is formed by the transmission of information between you and the National Law Review website or any of the law firms, attorneys or other professionals or organizations who include content on the National Law Review website. If you require legal or professional advice, kindly contact an attorney or other suitable professional advisor.  

Some states have laws and ethical rules regarding solicitation and advertisement practices by attorneys and/or other professionals. The National Law Review is not a law firm nor is  intended to be  a referral service for attorneys and/or other professionals. The NLR does not wish, nor does it intend, to solicit the business of anyone or to refer anyone to an attorney or other professional.  NLR does not answer legal questions nor will we refer you to an attorney or other professional if you request such information from us. 

Under certain state laws the following statements may be required on this website and we have included them in order to be in full compliance with these rules. The choice of a lawyer or other professional is an important decision and should not be based solely upon advertisements. Attorney Advertising Notice: Prior results do not guarantee a similar outcome. Statement in compliance with Texas Rules of Professional Conduct. Unless otherwise noted, attorneys are not certified by the Texas Board of Legal Specialization, nor can NLR attest to the accuracy of any notation of Legal Specialization or other Professional Credentials.

The National Law Review - National Law Forum LLC 4700 Gilbert Ave. Suite 47 #230 Western Springs, IL 60558  Telephone  (708) 357-3317 If you would ike to contact us via email please click here.