Supreme Court Decides Landmark Gene Patent Case

by Quinn Emanuel Urquhart & Sullivan, LLP

Actress Angelina Jolie recently spent around $3200 to take one of Myriad Genetics’ many breast cancer screening tests. When the test revealed that a mutation existed somewhere in a sequence of 81,000 nucleotides found on her seventeenth chromosome, Jolie made an aggressive decision. She opted for a double mastectomy to remove the entirety of her breast tissue. In doing so, she drastically reduced the 50-80% chance that women with mutations in the BRCA1/BRCA2 sequence will develop breast or ovarian cancer.

The Supreme Court recently issued its unanimous decision in the closely-watched case of Association for Molecular Pathology v. Myriad Genetics, in which it held that an isolated segment of human DNA is not eligible for patent protection. The Court held that Myriad Genetics did not have the right to be the sole user and analyst of two genes critical to the detection and diagnosis of breast cancer. Because the genetics company “did not create anything,” but rather only isolated a segment of naturally-occurring DNA, the Court ruled that Myriad’s claims were invalid based on the subject matter requirements of 35 U.S.C. § 101.

The Court found the mere act of isolating certain gene segments insufficient to receive patent protection. The Court affirmed the patentability of synthetic, man-made genes, and left open the possibility of providing patent protection for natural gene sequences that have been subject to some alteration. The ruling also provides guidance for drafting patents that claim other biomolecules, such as carbohydrates and lipids.

By invalidating Myriad’s patents, other genetic companies may be able to offer screening tests at competitive pricing. Whether the Court provided a definitive answer to the question, “are human genes patentable?” may not be known until these issues are further tested by the lower courts.

Isolating the BRCA1 and BRCA2 Genes
In 1994, researchers at Salt Lake City-based Myriad Genetics identified and obtained a patent on the precise genetic sequences that may harbor a mutation that corresponds to a significantly increased risk for breast cancer. By studying the genetic sequences of thousands of women, Myriad was able to pinpoint the mutation-carrying genes—a distinct sequence of 81,000 nucleotides designated BRCA1 and BRCA2. With this knowledge, Myriad has been able to offer a number of predictive breast cancer tests, albeit at a cost reflecting the $500 million that was spent in research and development.

The human genome is composed of DNA, the well-known double-helix chain. DNA is found in all known forms of life and functions as a blueprint for the various proteins that help to build cells. Although it is comprised of both coding and non-coding segments, only the coding segments of DNA are relevant to the creation of new compounds. By splitting DNA into two strands and excising the non-coding portion, the body is able to use the resulting genetic code to generate different amino acids, the building blocks of proteins. In this manner, the human body constantly produces a vast number of different proteins based on the discrete segments of DNA known as genes.

This same replication process can be performed in the laboratory. Moreover, lab technicians can create synthetic DNA that includes only the coding portions of the genetic sequence. By utilizing these well-known procedures, Myriad isolated and recreated the precise mutation-carrying gene its researchers had already identified. By comparing patients’ BRCA gene with normal BRCA genes to identify any discrepancies—known as mutations—Myriad’s test can inform individuals if they are genetically predisposed to a severely increased risk of developing breast cancer.

Myriad obtained a composition patent on BRCA1 and BRCA2, thereby preventing any other company from reproducing the genes for the purposes of screening tests. When the University of Pennsylvania’s Genetic Diagnostic Laboratory (GDL) began offering genetic testing services to women, Myriad filed suit to enforce its patent. The case settled when GDL agreed to stop testing and otherwise cease all allegedly infringing activity. In similar fashion, Myriad prevented a number of other entities from providing BRCA1 and BRCA2 genetic testing.

In 2009, Dr. Ostrer, a researcher at New York University School of Medicine who routinely sent his patients’ DNA samples to GDL for testing, sought declaratory relief to obtain a judgment of patent invalidity.

Affirmed in Part, Reversed in Part
Myriad presented the Court with a profoundly fundamental question to resolve, especially in the face of very complex science: where to draw the line between natural and man-made. The Supreme Court and the Federal Circuit have interpreted patent laws to allow protection for “anything under the sun made by man,” while also denying the grant of a patent monopoly to laws of nature, natural phenomenon, or discoveries of such laws of nature, no matter how ground breaking, innovative or brilliant.

On March 29, 2010, Judge Sweet of the Southern District of New York issued a 152-page opinion determining that isolated DNA molecules were not patent eligible subject matter. The Court of Appeals for the Federal Circuit reversed, explaining that the claimed isolated strands did not exist independently in nature, but only as part of a longer DNA chain. The Federal Circuit upheld the claims on both the DNA and synthetic DNA compositions, as well as the method claims for screening of cancer-causing mutations.

Writing for the Supreme Court, Justice Thomas reversed the Federal Circuit on the DNA claims, but affirmed the portion of the ruling pertaining to the synthetic DNA. Myriad’s discovery and isolation of the naturally-occurring genetic sequences were not sufficiently transformative for patent protection, Justice Thomas explained. Conversely, the synthetic DNA—a copy of DNA, only without the coding segments—was unlikely to ever be naturally occurring and therefore was eligible for patent protection.

The decision comports with the Supreme Court’s previous jurisprudence relating to bioengineering inventions. In Diamond v. Chakrabarti, the Court gave the nod to a patent claiming an engineered bacterium that had never before existed in nature. 447 U.S. 303 (1980). In Funk Brothers Seed Co. v. Kalo Inoculant Co., however, the Court ruled that discovering compatible combinations of bacteria without altering them in any way was not enough for patent protection. 333 U.S. 127 (1948).

The impact of the Supreme Court’s decision may be felt most by women who soon might be able to purchase more affordable screening tests for the BRCA1 and BRCA2 genes. More than 1 in 10 women develop breast cancer, and it is not unreasonable to assume that the social importance of this technology weighed on the minds of the Court’s members.

However, Myriad is not ready to give up its monopoly on BRCA gene testing without a fight. When Ambry Genetics publicly announced that it had begun offering cheaper breast cancer testing as a result of the Court’s ruling, Myriad filed a patent infringement suit asserting a number of patent claims that were left intact by the Court. Myriad argues that the Supreme Court affirmed the validity of its claims directed to synthetic DNA and methods of testing. Ambry Genetics disputes that its tests utilize synthetic DNA or Myriad’s testing methods. Only time will tell whether competitors will be able to offer genetic screening tests while successfully steering clear of Myriad’s surviving patent claims.

Finally, it is unclear how the Court’s ruling—which addresses only DNA—will affect the rest of the biotech industry, especially with respect to the practice of patenting other isolated organic compounds, such as lipids and carbohydrates. The same day the Court issued its ruling, the PTO released a memorandum instructing patent examiners to “reject product claims drawn solely to naturally occurring nucleic acid, or fragments thereof, whether isolated or not.” The decision may encourage the biotech industry to draft patents regarding the human genome differently, emphasizing the method of creation and the dissimilarity with the naturally-occurring version of the biomolecule.

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.

© Quinn Emanuel Urquhart & Sullivan, LLP | Attorney Advertising

Written by:

Quinn Emanuel Urquhart & Sullivan, LLP

Quinn Emanuel Urquhart & Sullivan, LLP 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.