Examination of Myriad-Mayo Guidance Comments -- AUTM, COGR, AAU, and APLU

by McDonnell Boehnen Hulbert & Berghoff LLP

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance"), to implement a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).  At a biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting in April, the Office announced that it would be hosting a public forum on the Guidance in May to receive public feedback on the Guidance, and at that forum encouraged shareholders to submit written comments on the Guidance.  The original "end of June" deadline for submitting comments on the Guidance was subsequently extended to July 31.  With that extended deadline now passed, Patent Docs has summarizing selected comments in a series of posts.

AUTMThe Office has posted the comments that were submitted on the USPTO website.  The comments are divided into five groups (with the number of submissions in each group also provided):  Intellectual property organizations and other associations (18), academic and research institutions (7), law firms (6), companies (9), and individuals (42).  Today, we examine the comments submitted by the Association of University Technology Managers (AUTM), Council on Governmental Relations (COGR), Association of American Universities (AAU), and Association of Public and Land-Grant Universities (APLU).

COGRThe comments letter submitted by the four academic groups begins by noting that AUTM is a nonprofit organization with more than 3,000 members from more than 300 universities, research institutions, and teaching hospitals as well as numerous businesses and government organizations; COGR is an association of 190 U.S. research universities and their affiliated academic medical centers and research institutes; AAU is an association of 60 U.S. and two Canadian research universities; and APLU is a research, policy, and advocacy organization representing 234 public research universities, land-grant institutions, state university systems, and affiliated organizations.  The comments letter indicates that "[t]he majority of AUTM members and the entire COGR, AAU and APLU memberships represent nonprofit research institutions that do not directly commercialize their discoveries and intellectual property but are dependent on the private sector to invest in, develop and market products and services based on university-created technology."  According to the four academic organizations, "[w]ith over $36 billion in net sales of products based on inventions made at institutions represented by our associations, it has been estimated that academic technology transfer generates $80 billion dollars in economic activity annually in the U.S."

AAUAfter describing the contribution of the organizations' members to the economy and innovation in the U.S., the groups state that they are "deeply concerned about the PTO Guidance Memorandum and its unwarranted, as well as legally inconsistent broad changes in examination practice."  In particular, the letter asserts that "[t]he Guidance adversely and unnecessarily impacts our ability not only to license and commercialize future discoveries and inventions, but also the validity of many existing patents for products, particularly in life science areas which make up the majority of university patents."

APLUThe academic organizations identify one primary concern and two major flaws with the Guidance.  With respect to the former, the groups suggest that "the Guidance is overly broad and contravenes the Supreme Court's own warning in Mayo against over-interpreting its holdings in a way that might stifle innovation, the very kinds of innovation to which U.S. universities contribute," and support opponents of the Guidance "who have criticized the emphasis on structure rather than the functional characteristics of a product."  As for the major flaws, the groups argue that the Guidance provides "[a]n inappropriate and legally questionable interpretation of Myriad," and as a result "[t]o patent a product (e.g., a drug) purified from a natural source under the new Guidance, the claimed product must be both structurally and functionally different from its natural state, a position not supported by case law."  The letter contends that "earlier cases emphasized functionality rather than the need for a significant modification from their natural form."

The letter indicates that the second flaw is the Guidance's "[m]isinterpretation of Mayo [that] could seriously harm the diagnostics industry and patients relying on its products."  According to the academic organizations, "[t]he examples provided in the Guidance [relating to diagnostic methods] are unclear, ambiguous, and raise more questions than they answer."

The letter argues that "[b]y drafting and releasing this Guidance, the PTO is assuming a judicial authority that is not properly PTO's to assume by erroneously re-interpreting Supreme Court case law, with no opportunity for public comment."  The comments letter concludes by stating that:

Numerous AUTM, COGR, AAU, and APLU members . . . find the Guidance unsettling because it could improperly prevent universities from patenting valuable and potentially life-saving technology and effectively block these technologies from ever reaching the public.  It could also create grave uncertainty about pending and issued university patents and remove the incentive for companies to license them and create innovative products and services that will benefit society.

The groups urge the USPTO revise the Guidance, arguing that "[f]ailing to do so will eviscerate the benefits of that research by unnecessarily denying patent protection to promising technologies, stifle innovation in academia, seriously harm the ability of companies to develop products that will help the American public, and significantly, adversely impact job growth in America."

Patent Docs will examine other Guidance comments in subsequent posts.

For additional information regarding this topic, please see:

• "Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations," August 11, 2014
• "Examination of Myriad-Mayo Guidance Comments -- ACLU," August 5, 2014
• "Guest Post: Overview of First Published Comments on Myriad-Mayo Patent Eligibility Guidance," July 13, 2014
• "Guest Post: USPTO Public Forum on Patent Guidance: My Thoughts as a Speaker and Attendee," June 11, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part IV," May 22, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part III," May 15, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part II," May 14, 2014
• "Guest Post: How to Patent Grapefruit Juice -- The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
• "USPTO Holds Forum on Subject Matter Eligibility -- Part I," May 12, 2014
• "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
• "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014



Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.