United States: DNA And Genetics Patents: What Impact Will The Myriad Decision Have?

Continuing a trend of narrowing the scope of patentable subject matter, the US Supreme Court's recent Myriad decision held that naturally occurring "isolated DNA" sequences are not patentable subject matter. However, the Court found that cDNA is still patentable and did not address the patentability of method claims involving isolated DNA sequences. In view of this important decision, biotechnology companies and other life sciences organizations should carefully audit their DNA and gene-based patent portfolios and consider new claim drafting strategies to provide maximum protection for new inventions in these areas.

The Court Distinguishes Between "Isolated DNA" and cDNA

On June 13, 2013, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics Inc., et al., and held that an "isolated DNA sequence" is not patentable subject matter because it is a naturally occurring product of nature. Myriad had a number of patents that claimed the entire genetic sequence of BRCA1 and BRCA2, two genes on human chromosomes 17 and 13, respectively, whose mutations have been shown to increase the risk of breast cancer in women from 50-80%. Myriad had claims that covered the entire DNA sequence of these genes and segments thereof, effectively allowing Myriad a monopoly over any use, synthesis and detection methods that involved these two genes. While the Supreme Court recognized that "Myriad found the location of the BRCA1 and BRCA2 genes," it concluded that "discovery, by itself, does not render the BRCA genes 'new . . . composition[s] of matter,' §101, that are patent eligible."

The Court, however, differentiated between DNA sequences that can be found in nature and ones that cannot. DNA that can be found in nature, e.g., a genomic DNA sequence, is not patentable subject matter. In contrast, a cDNA fragment, which lacks non-coding intron sequences, is patentable subject matter as it does not exist in nature. Such cDNA only comes into existence when synthesized in a laboratory, using messenger RNA, or mRNA, as a template. In contrast to genomic DNA, mRNA contains only the nucleotides corresponding to the exons (or amino acid coding segments) of the original DNA strand. Under the Court's reasoning, isolated mRNA itself would be unpatentable because it is exists naturally in the human body. But cDNA, which is created from the mRNA templates, would be patentable because it is not naturally occurring. In sum, if a sequence search demonstrates that a particular DNA sequences matches genomic DNA of any species, the sequence itself is unpatentable naturally occurring DNA when in a native context, even if the DNA sequence was actually synthesized in a laboratory.

What Remains Patentable?

While isolated DNA is no longer patentable, cDNA or fragments thereof remain patentable subject matter as long as the cDNA includes sequences of neighboring introns with the exons removed such that it is not found in nature. The Court also emphasized that the Myriad decision does not address patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Therefore, patent protection may still be obtained for any newly created, altered, or recombined DNA sequence that does not appear as such in nature, as long as all other requirements of patentability are satisfied. Combining naturally occurring DNA sequences with other sequences, e.g., combining a genomic DNA sequence with a heterologous promoter, should therefore be deemed to create patentable subject matter. Accordingly, the Court's decision does not appear to affect patentability of recombinant constructs, transgenic organisms, chemically modified DNA and the like.

Impact on Diagnostic Methods

It is important to note that the Supreme Court decision did not involve method claims. ("Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent."). Similarly, the court found that new applications involving the discovery of DNA sequences were not impacted by this decision. ("[T]his case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.").

While the Supreme Court did not lay out the contours of what types of methods based on naturally occurring DNA sequences might be patentable, the decision nevertheless may impact patentability of genetic-testing inventions in which a naturally occurring mutation is correlated with a disease. The correlation between a mutation and a phenotype may be considered a law of nature just as a correlation between naturally-produced metabolites and therapeutic efficacy and toxicity was in a 2012 Supreme Court Decision. See Mayo v. Prometheus, 132 S. Ct. 1289 (2012). However, diagnostic methods that involve using synthesized mRNA tags, cDNA, or radio labeled DNA or RNA probes to detect for naturally occurring mutations likely remain patentable subject matter.

Conclusion

In order to obtain patent protection for diagnostic inventions, patent applications will need to be crafted precisely, navigating around the legal test and limitations established by the Federal Circuit and the Supreme Court. The danger is that such claims, if not drafted carefully, may not fully protect investments, as it may be possible to either design around the claimed invention or not obtain patent protection at all. Companies with genetic and DNA based inventions should seek counsel and audit their patent portfolios to determine which claims are likely be invalid as claiming naturally occurring DNA sequences. New claim drafting strategies should be employed and companies in litigation or contemplating litigation will need to reevaluate which claims can withstand a patentability challenge. Companies defending against DNA patents should also carefully evaluate whether they now have a viable summary judgment argument under 35 U.S.C. §101 to invalidate patents that fall within the Supreme Court's holding. Finally, companies that have taken licenses to DNA patents may also have an opportunity to renegotiate or challenge their existing licenses if the licensed claims are deemed unpatentable under this decision.

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.

Authors
Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Wolf, Greenfield & Sacks, P.C.
 
In association with
Practice Guides
by Mondaq Advice Centers
Relevancy Powered by MondaqAI
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Wolf, Greenfield & Sacks, P.C.
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.

Disclaimer

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.

General

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