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 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