Reaction to Supreme Court's Decision in AMP v. Myriad

by McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Building #3It has been just over two weeks since the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., holding that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, and determining that cDNA is patent eligible (with one caveat) because it is not naturally occurring (see Patent Docs posts here and here).  Although the Supreme Court has marched on, issuing decisions in Federal Trade Commission v. Actavis, Inc. and Mutual Pharmaceutical Co. v. Bartlett, a review of the initial reaction to the Court's decision in Myriad, given its potential impact, is certainly warranted.

MyriadIn a statement issued by Myriad Genetics, the company noted that the Supreme Court had "upheld its patent claims on complementary DNA, or cDNA," but also "ruled that five of Myriad's claims covering isolated DNA were not patent eligible."  Myriad indicated that despite the Court's decision on isolated DNA, the company still had "more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test," and that "[i]mportantly, the Court noted that many of Myriad's unchallenged claims are method claims applying knowledge about the BRCA 1 and BRCA 2 genes."  Myriad president and CEO Peter D. Meldrum expressed the company's belief that "the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward."

ACLUThe American Civil Liberties Union (ACLU), which along with the Public Patent Foundation (PUBPAT) had filed suit against Myriad, released a statement focusing on the Court's decision regarding isolated DNA.  Noting that the Court had "unanimously invalidated patents on two genes associated with hereditary breast and ovarian cancer," the ACLU contended that the patents had allowed Myriad "to control access to the genes, known as BRCA1 and BRCA2, thereby giving them the right to limit others from doing research or diagnostic testing of the genes," which "made it difficult for women to access alternate tests or get a comprehensive second opinion about their results."  In summarizing the impact of the decision, PUBPAT Executive Director Daniel B. Ravicher stated that "[b]ottom line, diagnostic genetic testing is now free from any patent threat, forever, and the poor can now have their genes tested as freely as the rich."

ACMG The American College of Medical Genetics and Genomics (ACMG), one of the plaintiffs in the suit, applauded the Court's decision in a statement calling the result "a thrilling victory for patients."  The ACMG, however, noted that its "preferred outcome would have gone even further and found that any form of a gene is not patentable because it is the information content that is naturally occurring regardless of whether its genomic or cDNA."  The ACMG expressed "hope that [the decision that human genes are not patentable] will eventually include cDNA also."

Biotechnology Industry Organization (BIO)In a statement issued by the Biotechnology Industry Organization (BIO), the biotech trade group indicated that the Court "summarily ruled that so-called cDNA remains eligible for patenting."  Noting that "cDNA is the commercially most important form of DNA used in biotechnology," BIO suggested that the Court's decision "offers urgently-needed certainty for research-driven companies that rely on cDNA patents for investment in innovation."  However, BIO asserted that the decision "represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences," adding that "the Court's decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions."

The biotechnology trade group also observed that "[t]he United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences."  BIO suggested that patents on isolated DNA molecules have not "stifled research, harmed patients, or interfered with medical care, as numerous independent studies have repeatedly confirmed over the years."  Instead, "[t]he past 25 years have seen an unprecedented explosion of research and scientific publication on the human genome and the genomes of bacterial and viral pathogens."

AIPLA #1The American Intellectual Property Law Association (AIPLA) expressed concern about the impact of the Court's decision in a statement distributed by e-mail.  The AIPLA indicated that "by holding that cDNA molecules are eligible for patent protection but a sequence of DNA molecules isolated from their natural state by known techniques is not," the Court had "continued to cut back on the scope of technologies eligible for patent protection."  While acknowledging that "human genes as they exist in the body are not eligible for patent protection," the group argued in its amicus brief that "the DNA molecules claimed here are compositions of matter that are both structurally and functionally different from human genes, and those differences are man-made."

AIPLA President Jeffrey I. D. Lewis noted that the group was "concerned that, while the Supreme Court has recognized the importance of patent protection to the health industry, [the Myriad decision] may throw into question patent protection for important technology that is critical to improving health for the public, and that has become the cornerstone of the biotech industry."  He also noted that "the opinion in the case is remarkably short given the complex legal and scientific questions that were raised [and] it fails to clarify in any meaningful way the difference needed to change natural material into man-made material that is eligible for patent protection."  While "[i]t remains to be seen how innovation will be affected by this new development," Mr. Lewis suggested that the decision "may even backfire on its proponents, leading to increased secrecy in research and reduced collaboration, so critical in today's research environment."

FierceBiotechFierceBiotech reported that:

Despite the shrill alarms that have been sounded over the case, there's widespread feeling that the ruling itself won't have a dramatic impact on biotechnology.  Myriad has a well established position in the market at this point, and has been improving the quality of its test.  And just because others can use the same sequences without fear of violating patents, it's unlikely that there will be a rush to offer competing tests given the expense and technology required to develop them.

AMAThe American Medical Association (AMA), which joined with other health care organizations to file an amicus brief in the case, indicated in its statement that the group welcomed an end to human gene patents.  Noting that it "has long advocated for a clear prohibition against human gene patents," the AMA called the Court's "unanimous rejection of patenting human genes . . . a clear victory for patients that will expand medical discovery and preserve access to innovative diagnosis and treatment options."  The group said it was "pleased that the [J]ustices saw through the flawed premise that resulted in Myriad's exclusive patent awards and affirmed that human genes are products of nature and not patent eligible."


Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff 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.