United States: Petitioners File Supreme Court "Gene Patenting" Brief

Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or "Petitioner" or "ACLU") filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit's decision and the USPTO's decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior briefings, the Petitioners argue that the patents issued to Respondent Myriad Genetics, Inc. et al. ("Myriad") were erroneously issued because they claims products of nature. Petitioner also applied the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)("Mayo"). A copy of the brief is attached [MyriadPetitionersMeritsBrief].

Petitioner's Framing of the Facts

Petitioners start simply – "Human genes are, of course, products of nature." They argue that Myriad did not invent any genes or variants or cause their significance. The ACLU also contends that because it is not possible to study or use the genes unless they are isolated, the patents preempt medical research and diagnostic testing. Petitioners contend that "even more disturbingly," because the claims reach all possible uses of the claimed genes, Myriad is arguably authorized to block avenues of scientific inquiry.

Although the patent claims are directed to "isolated DNA" the ACLU frames the issue (as does the Supreme Court) as whether human genes are patentable. Petitioners attempt to equate the "isolated DNA" of the claims with "human genes" by focusing on the similarities in the coding content of DNA and genes – the linear sequence of nucleotides that are converted to the amino acids that in combination, create proteins.

The ACLU also allege that Myriad's patents have prevented others from sequencing and studying the isolated DNA of the claims and the clinical use of the information, and go one step further by claiming that women and their families are prevented from obtaining second opinions.

Petitioners further argue that the fact that the DNA is "isolated" is of no importance because isolated DNA is not markedly different in either structure or function from a gene in the body because the nucleotides that make up the DNA is the same. Isolation by separating the gene from other parts of the body to which it is normally attached does not distinguish the DNA from genes in the human body, according to petitioners. The claims are alleged by the ACLU to reach any "isolated DNA" that will create the proteins naturally created by the BRCA1 and BRAC2 genes and other forms of genetic material. Although the claims recite a specific limitation to stated sequences, the ACLU argues that the claims are defined by function given to the genes in nature and not limited to any molecular structure or any particular use.

Petitioner's Arguments

Briefly, the ACLU urged reversal on the following grounds:

1. "Isolated DNA" is not patentable subject matter under Section 101, because isolated DNA does not have markedly different characteristics from any found in nature. As noted previously, Petitioners focused on the functional, informational nature of DNA, not the biochemical nature of genes as they occur in nature.

2. The challenged claims are not based on an "inventive concept" but instead claim products and laws of nature. Petitioners applied Mayo and prior Supreme Court precedent because nothing of significance was added to the law of nature (the isolated DNA).

3. The challenged claims are alleged to preempt uses of products and laws of nature. The Petitioners argue that because isolation (an element of the claims and the focus of the Federal Circuit's opinion) is a necessary step in any serious study, research, or clinical or commercial use of the native DNA, the patents preempt research and development.

4. cDNA is not patentable subject matter because cDNA is, at its simplest level, identical to DNA except the non-coding regions have been removed. cDNA and DNA allegedly are not "markedly different" in function. Petitioners allege that nature, not the inventors, determined which non-coding regions to remove.

5. Petitioners also urge the Supreme Court to disregard the USPTO's decades long practice of granting patents on isolated DNA because the PTO's practice is "largely irrelevant."

6. Patent claims on isolated DNA violate the First Amendment because they amount to a grant of exclusive control over a body of knowledge. The First Amendment is alleged to limit the reach of intellectual property laws because granting patents gives control over an entire body of knowledge.

What do the Patents Cover and Protect?

The legal and lay press is replete with opinions and analysis of the legal issue that will soon be addressed by the Supreme Court in this case. Many have opined on the issue and, following the ACLU's lead, have framed the legal issue in terms of the allegedly broad scope of the claims and their possible impact on research and the delivery of health care. There is no doubt that there are likely issued patents that are overreaching and provide a monopoly that exceed the contribution that the patented invention provides to society. Whether or not the Myriad patents are within this class of patents is difficult to determine. The patent claims were never construed by the courts thus allowing the ACLU (and Myriad too) to interpret and opine on what the claims do and do not cover. Are the patent claims without limit ? Are the claims limited by structure ? Do they unnecessarily preempt innovation? It is difficult to assess and therefore allows arguments based on "factual" premises that are, at this time, mere conjecture.

Next step-Myriad's response.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Foley & Lardner
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Foley & Lardner
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions