Much ado about genes: untangling the evolving law of subject matter eligibility.

AuthorLeney, Sardiaa
PositionI. Introduction through IV. Analysis A. Criticism of the March 2014 Guidance, p. 522-556
  1. INTRODUCTION

    Recent claims from the biomedical industry, the patent bar and the United States Patent and Trademark Office (USPTO), that the Courts have radically reshaped the law of subject matter eligibility for patents are overstated. A more measured reading of these cases indicates that, while these rulings have not resolved every future issue, they have given clarity to patent eligibility questions concerning genes, genetically engineered product and methods that address the biological and genetic states of patients. In its attempt to provide clarification to examiners while the courts continued to work through the issues, the USPTO's published "Guidances" have unfortunately contributed to the uncertainty. It is suggested that USPTO's Guidance practice would be improved by a narrower focus on the meaning of key precedents, while still being free to highlight and discuss issues that remain incompletely defined that are relevant to currently developing technologies.

    Recent litigation concerning diagnostic methods and gene patenting, particularly the BRCA (breast cancer) genes, has led to an evolution of the standards for patent subject matter eligibility. (1) This note examines the efforts by the USPTO to clarify the implications of the rulings. (2) The Supreme Court decisions occasioning the reshaping of subject matter eligibility are also analyzed. This note contends that the patent system is best served by the Court's concise clarification of the underlying principles, and further illustrates that such a clarification has now emerged. A solid understanding of the uncertainties along the road to this new clarity will assist inventors and patent counsel in framing claims consistent with the new eligibility synthesis. The Supreme Court's newly enunciated criteria can be framed with remarkable simplicity after a careful reading of the cases that shape and conclude the BRCA litigation.

    Biotechnology employs over 1.4 million Americans, and remains one of the most reliable growth areas in our economy, even in the face of the adverse global economic situation over the last decade. (3) In 2014, seven of the top ten grossing drugs were biotechnology products. (4) While the patent system has enabled the first few generations of synthetic-biotechnology-derived drugs to flourish, (5) the therapies earning big dollars have relied on patent protection for novel recombinant molecules that are synthesized as drugs to modify biological activity in patients. (6) To date, only a few (and notably in smaller markets) have provided a replacement for something that a healthy patient would naturally have. (7) Increasingly, however, it seems likely that medicine will be able to solve some problems by replacing, repairing, adding or subtracting, activating or deactivating patient genes, cells, and tissues directly. (8) This next generation of therapies, so-called "Advanced Therapy Medicinal Products" (ATMPs), may not be individual blockbuster drugs in the mold of the earlier generation, but will likely have major impacts on health through increasingly specialized drugs, each tailored for and applied to smaller and more specific patient populations--perhaps as small as a single patient, and perhaps developed and made by entities other than major pharmaceutical corporations. (9) Many such products will be genes themselves, will contain genes or gene-modifying components, and as with many more conventional therapies, will increasingly be dosed to patients on the basis of analyses of their individual genetic makeup. (10) Although ATMPs have been slow to come to market in the United States, (11) the commercialization of gene therapies began in Europe several years ago. (12) In addition, diagnostic tests for genes and gene variants are already important to identifying which patients are candidates for modified interventions or therapies with both ATMPs and conventional drugs. (13)

    Americans now have a statutory commitment to universal healthcare, a system that, at least rhetorically, seeks to keep people healthy rather than treating them after they get sick. (14) How health care technologies are developed, commercialized, and paid for will remain an important focus of debate in our society, while the underlying details will inevitably become more and more intricate and complex. (15) An economically and scientifically vibrant biotech sector will serve this need, but to flourish it requires stability and certainty in the patent system to secure adequate investment. (16)

    While the USPTO must apply legal precedent, it should also seek to do so in a patent-specific manner, rather than pursuing the practice of generalizing and extending guidance to hypothetical situations that somewhat overstep the boundaries of what the courts have actually said. (17) Where possible, the courts also need to frame the principles of the system as clearly and unambiguously as possible to avoid confusion or unintended consequence. If both the USPTO and the courts stay in their respective lanes, then innovative, biotechnology-derived therapeutics will likely flourish in the U.S. (18)

  2. HISTORY

    Patent-issuing authorities fulfill a balancing function within the scope of the patent law, and, in the inevitably changing landscape of technology, courts assist in guiding this balance. (19) In the United States, the inventors or improvers of a new and useful process, machine, manufacture, or composition of matter are allowed to patent it, subject to the other provisions of Title 35 of the United States Code. (20) Consumers, payers, users, and the general public have direct interests in accessing the fruits of invention, and indirect interests in the fostering of a healthy and progressive, knowledge-based economy. (21) The broader interests of the United States and her citizens in the management of transnational economic policy are also relevant, particularly the perceived benefits of an internationally-harmonized approach to intellectual property as exemplified by the TRIPS Agreement. (22) Uncertainty in the intellectual property regime, and differences between the approach to subject matter eligibility in the U.S. and that operating in other major markets including Australia, Canada, China, the European Union, India, and Japan, can only serve as a brake on American innovation and the American economy. (23)

    In seeking to balance these interests, the courts of the United States have refined their interpretation of 35 U.S.C. [section]101, containing the statutory criteria for patent subject matter eligibility. (24) While the [section]101 inquiry is a formality for most inventions, the courts have generally recognized that natural phenomena, including the unmodified products of nature such as physical and...

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