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.

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 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).

The 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."

After 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."

The 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