United States: Stakeholders Testify On Patent Subject Matter Eligibility

On May 9, 2014, the USPTO held a public forum on the USPTO's new patent subject matter eligibility guidance (the "Guidance"), previously discussed here. In promoting the forum, the USPTO stated that it wished to "to receive public feedback from organizations and individuals on the Guidance." The USPTO may be regretting it did not request public input prior to the Guidance's release, because the feedback it received at the forum was overwhelmingly critical of both the substantive principles and scope of the Guidance and the procedures by which it was promulgated.

USPTO Opening Remarks

Perhaps anticipating criticism, USPTO officials opened the forum by explaining why the USPTO issued the Guidance without first soliciting public input and the principles behind the Guidance.

Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, emphasized that the USPTO never intended to exclude the public from providing input, but implemented the Guidance as a "stop-gap" measure to direct examination of currently pending cases while it determines what additional guidance is needed. He indicated that further iterations of the Guidance may be issued based on concurrent feedback from the public and patent examiners, including feedback provided at the forum.

Mr. Hirshfeld also explained that the Guidance is necessarily comprehensive and goes beyond nucleic acids, because the Guidance is not based solely on Myriad. Instead, the Guidance is based on Myriad in the context of prior Supreme Court decisions, including American Fruit Growers, Flook, Benson, Funk Brothers, Bilski, J.E.M. Ag Supply, Chakrabarty, Mayo, Diehr, and Morse.

Raul Tamayo, Senior Legal Advisor in the Office of Patent Legal Administration, explained that the "significantly different" standard in the Guidance captures the "marked difference" standard in Chakrabarty and the "significantly more" standard in Mayo. Mr. Tamayo explained that the Guidance requires a "marked difference" to be a structural difference because the "Supreme Court has never held a claim reciting a natural product eligible unless it was structurally different than what exists in nature." Mr. Tamayo also stated that Myriad changed the USPTO's understanding of the law on subject matter eligibility.

Stakeholders Speak Out

Following the USPTO remarks, 10 speakers representing public stakeholders presented their views on the Guidance, relevant Supreme Court precedent, and the likely impact the Guidance will have on investment and innovation. The speakers' presentations can be accessed on the USPTO website here. Members of the audience also spoke during question-and-answer sessions.

Many of the speakers and audience members shared disappointment with the scope of the Guidance and the manner in which it was implemented. The following list highlights top themes raised by the speakers .

  • The USPTO inappropriately issued the Guidance without first providing the public with an opportunity to comment on the Guidance.

The USPTO in the past has published significant guidances for public comment before finalizing them. –Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization.

The USPTO obtained public input before issuing the 2001 Utility Guidelines. –Member of the audience.

In response, USPTO officials confessed to not knowing the facts behind the 2001 Utility Guidelines, but believed that the "stop-gap" implementation of the Guidance followed standard protocol.

  • The Guidance unjustifiably extends beyond nucleic acid molecules and covers subject matter not addressed by the Supreme Court in Mayo or Myriad.

The Supreme Court in Myriad and Mayo cautioned against overly-broad applications of subject matter eligibility exceptions. In Mayo, the Court stated that "The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law." –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP; Duane Marks, Patent Counsel, Roche Diagnostics Operations, Inc.

Pharmaceutical and method of treatment claims should not be included within the scope of the Guidance. The Supreme Court in Mayo and Myriad explicitly stated that it was not addressing "a typical patent on a new drug" or "new applications of knowledge" about genes. –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP.

The USPTO's interpretation of Myriad would render claims directed to formulations comprising purified or isolated Paclitaxel or Baccatin III in therapeutically effective amounts for treating cancer to be patent ineligible in view of the Pacific yew tree (from which these compounds are purified/isolated), even though the tree is not a "formulation" or "composition" comprising therapeutically effective amounts of the compounds. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP.

There is no policy justification for expanding the scope of the Guidance to encompass subject matter not at issue in Myriad. The USPTO's interpretation of Supreme Court cases is not the only permissible one. –Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization.

The Court's decision in Mayo needs to be analyzed in view of the specific claims at issue, and not in the abstract. The Court provided a roadmap of "useful clues" for applying the case to diagnostic claims. –Duane Marks, Patent Counsel, Roche Diagnostics Operations, Inc.

Purified product claims offer the best patent protection and do not run afoul of Myriad, which is limited to "genes and the information they encode." –Kenneth Sonnenfeld, Partner, King & Spalding LLP.

Counsel for Petitioner during oral arguments in Myriad acknowledged that a purified product may be eligible for a patent, stating that "by both changing its nature and by giving it a new function, you may well have patent." –Kenneth Sonnenfeld, Partner, King & Spalding LLP; Warren Woessner, Founding Shareholder, Schwegman Lundberg & Woessner, P.A.

Practical effects are being felt, as Office Actions are now being issued against claims not directed to genetics, including pharmaceutical compositions, industrial enzymes, and methods of treatment. –Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization.

  • The Guidance misinterprets the Supreme Court in Myriad by ignoring function and requiring a "markedly different" structure for product claims.

Chakrabarty discussed the markedly different standard in terms of "markedly different characteristics," which is not limited to structure. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP; Warren Woessner, Founding Shareholder, Schwegman Lundberg & Woessner, P.A.; Barbara Fiacco, Partner, Foley Hoag on behalf of American Intellectual Property Law Association.

The Guidance takes an overly narrow interpretation of Funk Brothers by focusing only on Myriad's statement that the Funk Brothers composition was not patent eligible because "the patent holder did not alter the bacteria in any way." However, Myriad also discussed Chakrabarty's patent eligible bacterium as having "markedly different characteristics." –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP.

The Supreme Court in Myriad focused on genetic information presented by the claim language, not on the chemical structure of DNA. The Court conflates structure with function, as evident by the decision's numerous recitations of "information" and "sequence," but no mention of "function" and only a single mention of "structure." Because the Court considered DNA sequence to be "information," basing a claim's eligibility by considering only structure applies only when structure and function completely collapses. –Leslie Fischer, Senior Patent Attorney, Novartis Pharmaceuticals Corporation.

  • The Guidance's requirement that examiners weigh a number of positive and negative factors to determine subject matter eligibility is inappropriate.

The factor-based approach is similar to the Wands factor-based analysis for enablement under § 112, but is inappropriate for a § 101 analysis. Supreme Court decisions on subject matter eligibility never weighed positive factors against negative factors. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP.

Claims should be considered as a whole and not parsed apart into claim elements such that only those elements that are not a judicial exception can support patent eligibility. –Courtenay Brinckerhoff, Partner, Foley & Lardner LLP.

The claims must be read as a whole. –Barbara Fiacco, Partner, Foley Hoag, speaking on behalf of American Intellectual Property Law Association; Gregory Cox, Assistant General Patent Counsel, Eli Lilly and Company, speaking on behalf of American Bar Association Section of Intellectual Property Law.

The Guidance factors should be simplified. There is a concern that more factors are likely to be generated by the USPTO or caselaw. –Anthony D. Sabatelli, Partner, Dilworth IP LLC.

  • The Guidance examples do not provide a good roadmap for examiners or patent practitioners.

The USPTO should provide real examples to guide § 101 analysis. –Suzannah Sundby, Partner, Smith, Gambrell & Russell, LLP; Kenneth Sonnenfeld, Partner, King & Spalding LLP.

The Guidance's amazonic acid method claim example is limited to a single indication and contains multiple limiting elements (e.g., 10 to 20 days and 0.75 to 1.25 teaspoons) that a potential infringer could avoid by making "immaterial changes." –Kenneth Sonnenfeld, Partner, King & Spalding LLP.

The Guidance examples are not useful due to oversimplification or a scope that is too narrow. –Member of the audience.

Practical effects are being felt through Office Actions rejecting method claims that do not contain as much detail as the examples in the Guidance. —Member of the audience.

What's Next?

USPTO officials acknowledged suggestions that the Guidance be withdrawn, but were skeptical that a wholesale suspension of the Guidance would occur. Instead, the USPTO officials renewed their request for comments offering different interpretations of the case law and additional examples of eligible and ineligible subject matter that could be used to supplement the Guidance. In the meantime, applicants were advised to respond to new § 101 rejections as they would to any other rejections.

You can find the USPTO patent eligibility guidelines, related information, and instructions for submitting comments on the USPTO's Myriad-Mayo Guidance webpage.

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
 
In association with
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
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 you may opt out by clicking here

    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.

    Disclaimer

    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.

    Registration

    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.

    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.

    Cookies

    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.

    Links

    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.

    Mail-A-Friend

    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.

    Emails

    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 .

    Security

    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.

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