United States: Puzzling Out The Patent-Eligibility Of Natural Products

Patent eligibility under Section 101 of the United States Patent Act continues to confound practitioners and create uncertainty as to the value of patents in the life sciences. Recent changes by the Supreme Court and the analyses applied by various tribunals have contributed to this confusion.

The Supreme Court recently upended the law of patent-eligibility in life sciences when it held that isolated segments of DNA were products of nature, not eligible for patent protection (Molecular Pathology v. Myriad Genetics Inc., 133 S. Ct. 2107, 2117 [2013]). This decision reversed the long-standing practice at the United States Patent & Trademark Office (USPTO), which had been issuing patents claiming isolated DNA segments for decades. Yet, the concept that natural products may not be patentable was not new. Seventy years ago, the Supreme Court held in Funk Bros. Seed Co. v. Kalo Inoculant Co. (1948) that a combination of naturally occurring strains of bacteria was not patentable, explaining that the claimed bacteria are "manifestations of laws of nature," and the claimed combination produced "no enlargement of the range of their utility. Each species has the same effect it always had." This case is often cited for the proposition that combinations of natural products are not eligible for patent protection absent a marked change in function or activity.

Despite these setbacks to patent eligibility in the life sciences, patents claiming combinations of natural products have continued to issue from the USPTO. When reviewing such patent applications, the USPTO considers whether such combinations have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. Where the combination itself does not exist in nature, the USPTO considers the combination a product of nature and compares the combination to the individual naturally occurring components. Applying these principles, the USPTO has issued patents claiming naturally occurring components (e.g., strains of bacteria), where the patentee established that the resulting combination exhibited activity not seen in the individual components. The USPTO has also issued patents claiming combinations with added features or functionalities that distinguish them from nature, including natural combinations contained in stabilized formulations, having an added bacterial spore coating, or existing in a different state (e.g., lysed versus live bacterial cells). On the other hand, the USPTO has rejected claims to combinations that do not differ markedly from their natural counterparts, including combinations containing potentially non-natural but arguably conventional ingredients (e.g., liquid carriers, surfactants, diluents, adjuvants and disease control agents). Formulating such combinations to have ratios, amounts or concentrations not found in nature does not typically alter this result.

While the Patent Trials & Appeals Board (PTAB) has generally applied the same analysis as the USPTO, in two notable instances, the PTAB reversed the USPTO's conclusions. In the first, the PTAB determined that combinations of natural products that do not exist as a combination in nature qualified for patent protection, stating that "absent evidence that these constituents co-exist in any naturally occurring composition, any composition combining these constituents must necessarily be an artificially constructed one, and not a natural phenomenon excluded from patentability by Section 101" (Ex parte Calvin, No. 2016-004128; Aug. 31, 2017). In the second case, the PTAB noted that "[w]hile any of these components alone may be naturally occurring, the combination of all the claimed elements does not occur naturally, as transfer factor derived from animal sources would not be found naturally with herb or plant extracts" (Ex parte Hennen, No. 2016-002575; May 10, 2017). These statements may indicate an inclination to analyze these cases outside the rubric of Section 101. This has some logical appeal. If a combination does not exist in nature, how can it constitute a natural phenomenon? Such a result, however, would potentially conflict with the Supreme Court's decision in Funk Bros. Perhaps for this reason, in both cases, the PTAB also relied on evidence that the claimed combinations resulted in "significantly more" than the individual components, thereby distinguishing the claimed combinations from the invention in Funk Bros. and arguably bringing these decisions in-line with precedent.

In contrast to these PTAB decisions, a district court recently determined that a variety of claims relating to non-naturally occurring combinations of natural products did not qualify for patent protection under Section 101. In Natural Alternatives International (NAI) v. Creative Compounds LLC, the court concluded that claims to combinations of creatine, carbohydrate and free amino acid beta-alanine, and (separately) glycine and beta-alanine compounds did not qualify for patent protection. (S.D. Cal. Sept. 5, 2017). The court rejected arguments that these combinations were patentable because they produced unexpected biological results, finding that the resulting biological activities themselves implicated natural phenomena.

The district court decision in NAI is presently on appeal to the United States Court of Appeals for the Federal Circuit. An amicus brief submitted by Biotechnology Innovation Organization (BIO) frames the issues well, arguing that laboratory-created biologically active compositions should be patentable under Section 101, because such combinations and related biological activities do not exist absent human innovation. This case may thus present the court with an opportunity to provide much-needed guidance on the patentability of natural product combinations.

*Amana Abdulwakeel is a law clerk at Finnegan.

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
Events from this Firm
16 Jan 2019, Conference, Washington, DC, United States

Finnegan partner Lionel Lavenue will present “The Technology Accelerates: IP Issues at the Cutting Edge” during the Embry-Riddle Aeronautical University Aviation Law & Insurance Symposium.

17 Jan 2019, Webinar, Washington, DC, United States

As a part of Strafford Publications’ webinar series, Finnegan partners Erika Arner and Michael Flibbert

will discuss best practices for preparing a PTAB case for appeal to the Federal Circuit.

22 Jan 2019, Webinar, Washington, DC, United States

As part of Strafford Publications’ webinar series, Finnegan partners Shana Cyr and Mark Feldstein will provide essential updates on FDA practice and patent law relating to biologics and biosimilars.

Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

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