Patents: Isolated DNA Held Not to be a “Product of Nature”

by Dentons

[author: Kirsten Anderson]

Start-up biotechnology companies often seek patent protection for inventions related to their genetic discoveries and genetic testing methods. A recent United States patent case, The Association for Molecular Pathology v. United States Patent and Trademark Office (“AMP v. USPTO”),1 illustrates two issues facing biotechnology companies in showing that their claims are patentable: demonstrating that the invention is not a “product of nature” and demonstrating that a patent method claim for genetic testing is based on more than mere abstract thought processes.


In AMP v. PTO, several medical organizations, researchers, genetic counselors and patients (the “Plaintiffs”) sued Myriad Genetics, Inc. as well as other defendants for declaratory relief related to Myriad’s patent composition claims and patent method claims concerning two human genes known as BRCA1 and BRCA2. Myriad had filed patent composition claims claiming to identify and isolate the BRCA1/BRCA2 genes and patent methods for genetic testing to look for the mutations associated with a higher risk of breast cancer. The Plaintiffs asserted that the isolated DNA created by Myriad was not an invention but a “product of nature” already existing in nature and therefore ineligible for patent protection. On summary judgment, the trial court (the court of first instance) agreed with the Plaintiffs, finding that the subject of each of Myriad’s patent composition claims was a “product of nature”. It also found that Myriad’s patent method claims did not demonstrate anything more than abstract thought processes for which a patent cannot be granted.

Court of Appeals Decision

In Myriad’s appeal, the United States Court of Appeals for the Federal Circuit reversed the trial court’s ruling that Myriad’s patent composition claims were invalid. The Court of Appeals affirmed the trial court’s ruling regarding Myriad’s patent method claims concerning comparing or analyzing sequences but reversed the trial court’s ruling regarding Myriad’s method claim directed to screening potential cancer therapeutics. Demonstrating the complexity of the issues involved, in addition to the majority opinion, a concurring opinion and a dissenting opinion were issued on the issue of the patent composition claims.

In the majority opinion, the Court of Appeals held that the isolated DNA molecules that were the subject of Myriad BRCA1/BRCA2 patent composition claims, were “markedly different” from the natural DNA because the isolated DNA molecules have a different chemical structure than native DNA molecules and were the isolated DNA for the BRCA1/BRCA2 were the result of human intervention and not a “product of nature”. The majority opinion held that the chemical composition of the isolated DNA was different from that of the natural DNA and that the isolated DNA did not exist independently in nature because it had to be cleaved. The concurring opinion further relied on the differing chemical composition of the isolated DNA to the native DNA.

The majority opinion also rejected the U.S. government’s argument that the isolated DNA was a product of nature because if an extremely powerful imaginary microscope existed, it would be possible to see the molecules in question. In rejecting the argument, the majority opinion reiterated that the isolated DNA did not exist independently and therefore it could not be seen even if such an imaginary microscope existed.2

The Court of Appeals affirmed the trial court with regard to Myriad’s patent method claims comparing or analyzing sequences because the court found that they claimed only abstract mental processes rather than transformative steps as Myriad would essentially compare one genetic sequence to another genetic sequence. However, the Court of Appeals reversed the trial court with regard to Myriad’s patent claim for a method to screen potential cancer therapeutics. The Court found that the claim included transformative steps such as growing transformed cells in the absence or presence of potential cancer therapeutics and measuring growth rate and thus did not involve solely abstract mental processes.


As some of the parties in AMP v. USPTO have indicated an intention to petition the United States Supreme Court for review, the case serves as a reminder for start-up biotechnology companies to keep these issues in mind when considering patent composition and patent method claims related to human genes.

1 2011 U.S. App. LEXIS 15649; 99 U.S.P.Q.2D (BNA) 1398
2 The United States government appeared as amicus curiae in support of the Plaintiffs’ position that the subject of the patent claims involved products of nature.

Kirsten Anderson is an associate in FMC's Vancouver office. She advises clients in general corporate and commercial transactions and also acts for clients in venture capital transactions.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Dentons | Attorney Advertising

Written by:


Dentons on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.