GENE PATENTS, DRUG PRICES, AND SCIENTIFIC RESEARCH: UNEXPECTED EFFECTS OF RECENTLY PROPOSED PATENT ELIGIBILITY LEGISLATION.

• Author: Duan, Charles

1. INTRODUCTION II. PATENT ELIGIBILITY OF HUMAN GENES, SCIENTIFIC DISCOVERIES, AND OTHER NATURAL LAWS AND PHENOMENA III. EFFECTS FOR SCIENTIFIC RESEARCH A. Early-1900s "Scientific Property" Proposals B. Deterrence of Downstream Research C. Do Patents Motivate Research Scientists? IV. EFFECTS FOR DRUG PRICES AND HEALTH CARE A. A Tool for Drug Patent Evergreening B. Development of Diagnostic Tests and Treatments C. Ability to Obtain Second Opinions D. Safety and Efficacy of Medical Tests V. EFFECTS FOR INNOVATION A. Development of Genetic Testing Services B. Can Patent Ineligibility Encourage Innovation? VI. EFFECTS FOR SCIENTIFIC NORMS, MEDICAL ETHICS, AND HUMAN RIGHTS VII. ALTERNATIVES TO THE DRAFT LEGISLATION VIII. CONCLUSION . I. INTRODUCTION

   It was 1923, and Francesco Ruffini was going to rescue science. The Italian senator's plan was simple: Give scientists an ownership stake in their discoveries--a sort of patent on the laws of nature they discovered. He had written a compelling and widely praised report and proposal, he had the backing of the newly formed League of Nations, and he had the support of prominent scientific and legal experts. But within a few years, Ruffini's grand plan would fall apart. Scientists around the world rejected the plan, and lawmakers shelved it. Ruffini's committee on the League of Nations, the Committee on Intellectual Cooperation, would come to be remembered by one member, Albert Einstein, as "the most ineffectual enterprise with which I have been associated." (1)

   Now, Ruffini may have the last laugh. Despite decades--arguably centuries--of law prohibiting patents on "laws of nature, physical phenomena, and abstract ideas," (2) there has been recent interest in expanding the realm of patents in ways that may allow for patents on the scientific discoveries that Ruffini hoped to protect. In particular, in response to several recent Supreme Court decisions on patentable subject matter eligibility, (3) there have been numerous calls for Congress to revise 35 U.S.C. [section] 101, the statutory basis for these limits on patent eligibility. (4) Congress has listened: Across the first half of 2019, the Intellectual Property Subcommittee of the Senate Judiciary Committee first held a series of private roundtables to discuss potential legislation, (5) then produced "draft bill text" to amend [section] 101, (6) and then held three days of hearings in June with forty-five witnesses testifying on the state of patent eligibility law. (7)

   By rendering an entire body of Supreme Court and other judicial precedent "hereby abrogated" (8) among other things, the proposed legislation will undoubtedly have widespread and unexpected implications. This article identifies several, specifically directed to concerns about patents and scientific discoveries.

   Section II reviews the draft legislation and considers its effects with respect to the perspectives of medicines and science. (9) In particular, by abrogating precedent that conclusively rejected patenting of laws of nature and natural phenomena, the draft legislation reopens the door to patenting of scientific discoveries and human genes among other things. In other words, the legislation would reach much the same result that Ruffini's proposal in the 1920s had hoped to accomplish.

   The remainder of the article considers the effects of opening up the possibility of patenting scientific discoveries, human genes, and other analogous laws and products of nature. Section III discusses how the draft legislation could inhibit scientific research by enabling patents that essentially cover those laws of nature that are the foundation of scientific progress. (10) After reviewing the historical parallels between the present legislative proposal and Senator Ruffini's proposal of the 1920s, the section will consider contemporary perspectives of scientists in the genetic research and similar fields, who generally find that patents on scientific discoveries would interfere with downstream research while failing to provide any concomitant incentive to scientific research.

   Section IV discusses the likelihood that the draft legislation will raise drug prices at a time when soaring costs of health care are a top priority for American voters. (11) More concerningly, there is historical reason to believe that expanding patent eligibility in this way may reduce access to lifesaving medical treatments, thereby resulting in American health care being lower in quality and diminished in safety compared to that of other nations.

   Section V extends the previous two arguments by considering the effect of draft legislation on innovation, particularly in the health care and life science industries. (12) An important lesson from the last few decades is that the inventors of genetic testing and medical diagnostic technologies have recognized that patents on laws and products of nature frequently stymie their work. Those same inventors have further said that patents are not a necessary incentive for their work, and economic data supports their claims. Indeed, several past experiences show that expansive patents on products of nature actually discouraged further innovation even by the patent owner, instead leading to destructive races that soured collaboration and progress in science.

   Finally, Section VI discusses ways in which the draft legislation may clash with scientific norms, medical ethics, and human rights. (13) Patents on scientific discoveries draw scientists away from contributing to the public store of knowledge. Patents on diagnostic test results force medical professionals to choose between infringing patents and giving their patients potentially lifesaving information. And patents on human genes distort notions of bodily integrity and rights of self-determination.

   Though the draft legislation on the table exhibits the many issues discussed above, it is not the only possible alternative. Section VII reviews a number of other pathways forward with regard to legislative or policy solutions. (14) Some involve amendment to [section] 101, while others involve changes to other aspects of the patent laws in tandem. These alternatives, drawn from academic research and recent case law, ought to inform any process for going forward with reconsideration of patent subject matter eligibility.

2. PATENT ELIGIBILITY OF HUMAN GENES, SCIENTIFIC DISCOVERIES, AND OTHER NATURAL LAWS AND PHENOMENA

   The draft legislation leaves little room for doubt as to its effect: It will allow for the patenting of human genes, diagnostic test results, and a wide range of scientific discoveries of the laws of nature. (15)

   The legislative proposal explicitly eliminates the three historic categories of ineligible subject matter for patenting, notably including laws of nature and natural phenomena. (16) It further abrogates all existing judicial precedent pertaining thereto, including Ass 'n for Molecular Pathology v. Myriad Genetics, Inc., (17) which prohibited the patenting of human or other naturally occurring gene sequences; Mayo Collaborative Services v. Prometheus Laboratories, Inc. , (18) which prohibited the patenting of natural correlations between diagnostic tests and treatment adjustments; Funk Bros. Seed Co. v. Kalo Inoculant Co., (19) which prohibited the patenting of naturally occurring bacteria; and Diamond v.

   Chakrabarty, (20) which recognized the "relevant distinction" for patent eligibility purposes "between products of nature, whether living or not, and human-made inventions." (21)

   Furthermore, the draft legislation enshrines into law the primary argument that the Supreme Court considered and rejected in Myriad when considering the patent eligibility of human gene sequences. Myriad Genetics, the patent owner, contended that the BRCA1 and BRCA2 genes at issue in the case were not products of nature because they had been isolated from the rest of the genome, and thus were the product of human intervention rather than nature; the Supreme Court rejected this argument. (22) By contrast, the draft legislation provides that patent eligibility inheres in any "invention or discovery" that arises "through human intervention." (23) The draft legislation thus, by its plain language, undoes the exact argument that the Supreme Court relied on to reject the patenting of human genes.

   The draft legislation further eliminates barriers to patenting scientific discoveries of principles of nature. Besides explicitly abrogating the "laws of nature" exception to patent eligibility, the draft provides that patent eligibility is to be determined "without discounting or disregarding any claim limitation." (24) Any competent patent attorney can include a conventional step of receiving information or a test sample prior to reciting a natural law to which the information or test sample is to be applied. (25) That would apparently render the natural law patent-eligible, despite the fact that there would be no practical change to who would infringe the patent.

   Accordingly, the draft legislation evinces no limits that would prevent the patenting of human genes or scientific discoveries. If this legislation were enacted, it must be assumed that such patents would issue in due course.

3. EFFECTS FOR SCIENTIFIC RESEARCH

   It has long been recognized that patents on the laws and products of nature can stifle important scientific research. As the Supreme Court explained in Funk Bros., natural laws and phenomena, "like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge" and as such are "free to all men [and women] and reserved exclusively to none." (26) By abrogating this decision among others, the draft legislation is thus to the detriment of the storehouse of knowledge and to the detriment of the progress of science that the storehouse of knowledge may beget.

   History and experience prove what theory suggests: Patents on human genes--products of nature--have...