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.

In association with
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.