Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

by McDonnell Boehnen Hulbert & Berghoff LLP
Contact

USPTO SealOn 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 begun to focus on selected comments in a series of posts.

The 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 International Bioindustry Associations, a coalition of twelve associations and organizations representing "thousands of biotech businesses, academic and nonprofit research centers, technology transfer organizations and other entities dedicated to biotechnological innovation throughout the world."  The twelve signatories to the comments include:  ASEBIO -- The Spanish Bioindustry Association; AusBiotech, Australia's Biotechnology Organisation; Belgian Biotechnology Industry Organisation; BIA, The UK BioIndustry Association; BIO Deutschland; BIOTECanada; Biotechnology Industry Organization; CropLife International; EuropaBio; HollandBIO; Japan Bioindustry Association; and P-BIO, Portugal's Biotechnology Industry Organization.

The coalition begins its comments letter by expressing "concern over the recent judicial and administrative expansion of nonstatutory patent law governing the patent-eligibility of certain classes of biotechnology inventions in the United States, as manifested in the PTO's March 4 Guidance."  The group also "note[s] with concern the significant departure from internationally accepted norms of patentability that would be established by the Guidance, particularly with regard to industrial, agricultural, and pharmaceutical preparations of naturally-derived substances, compositions, and processes."  Among the many examples of inventive preparations based on naturally-occurring substances, the letter points to a number of vaccine antigens, crop protection products, plant biotechnology and breeding, industrial enzymes, immunosuppressive drugs, anticancer compounds, and antibiotic drugs (in several footnotes, the coalition lists an array of specific naturally-occurring substances, many of which have been patented).

With respect to drug discovery, the letter states that "preparations of novel and unobvious naturally occurring molecules continue to be an important source for drug discovery," citing Swinney & How, 2011, Nat. Rev. Drug Discov. 10: 507-19, for the proposition that "naturally-occurring molecules and their close derivatives have contributed an estimated 36% of all first-in-class small molecules approved by the FDA between 1999 and 2008."  Pointing to the costs associated with drug discovery (the letter indicates that the average drug requires an investment of $1.2 billion with clinical testing taking eight years), the coalition explains that:

For every successful biopharmaceutical product, thousands of candidates are designed, screened, and rejected after large investments have been made.  Only a small minority of drugs even advance to human clinical trials and most of those fail to obtain regulatory approval.  Investment therefore is predicated on the availability of patent protection that enables biotechnology businesses to attract capital and commercial partners in order to advance basic inventions -- including those based on naturally-occurring substances and processes -- from the laboratory to the marketplace and ultimately to generate an expected return on investment in the form of patent-protected products or services.

While suggesting that "[t]he use of naturally-occurring substances and the practical application of newly discovered biomarkers is playing out with equal importance in the area of diagnostics and personalized therapy," the group contends that:

The proposed Guidance, by its unfavorable treatment of these inventions, has the potential to seriously impair the scientific advances of U.S. universities over universities in e.g. Europe and Japan, which provide broader patent protection to inventors.  In the end, this could lead to the United States falling behind in this extremely important area of research, one that has significant implications on drug discovery and development.

Arguing that "it is extremely important that investment in biotechnological innovation is not discouraged by systematically erecting special hurdles to patent protection for all inventions that relate to naturally-derived substances and processes," the coalition expresses concern for the "investment-hostile extrapolation and expansion of nonstatutory U.S. patent law that was not required by the U.S. Supreme Court's decisions" as manifested in the Guidance.  The group explains that "[t]he Court's multiple cautionary statements about the narrowness of its holding and of all the questions it was explicitly not deciding, signal a narrow, incremental decision that should not compel broad changes in examination practice."  The group specifically takes issue with the way the Guidance handles combinations of naturally-occurring products, methods of treatment, and purified naturally-occurring substances, asserting that:

[T]he Supreme Court's decisions do not require the application of a heightened patent-eligibility test to inventions such as combination products (especially in instances where the claimed combination occurs neither in a natural state nor in the prior art); methods of drug administration or the use of medicinal molecules for the treatment of disease; or purified naturally-occurring substances (such as antibiotics or vaccine antigens) which, in the claimed purified state, are for the first time provided for real-world practical uses and having industrial applicability not possessed in their natural, impure state.

The group concludes its comments letter by noting the absence of "a policy justification for why the USPTO adopted such a far-reaching interpretation of judicial decisions and departed so profoundly from its own past policies and from internationally accepted practices."  The letter argues that "what is . . . needed is a public dialogue not just over what the law 'is,' but over what the right policies ought to be," adding that "there is a real risk of 'getting it wrong' when trying to extract generalizations and uniformly applicable principles from an unstable jurisprudence and from judicial decisions that stand in tension with each other," particularly "in light of consistent reminders by the U.S. Supreme Court that the statute is inclusive and the exceptions to it are narrow -- not the other way round."

Patent Docs will examine other Guidance comments in subsequent posts.

For additional information regarding this topic, please see:

• "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
Contact
more
less

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):
hide

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.

Security

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.
Feedback? Tell us what you think of the new jdsupra.com!