Gene Patents, Drug Prices, and Scientific Research: Unexpected Effects of Recently Proposed Patent Eligibility Legislation

Marquette Intellectual Property Law Review Volume 24 Issue 2 Article 3 Summer 2020 Gene Patents, Drug Prices, and Scientific Research: Unexpected Effects of Recently Proposed Patent Eligibility Legislation Charles Duan Follow this and additional works at: https://scholarship.law.marquette.edu/iplr Part of the Constitutional Law Commons, Intellectual Property Law Commons, and the Science and Technology Law Commons Recommended Citation Charles Duan, Gene Patents, Drug Prices, and Scientific Research: Unexpected Effects of Recently Proposed Patent Eligibility Legislation , 24 Marq. Intellectual Property L. Rev. 139 (2020). This Article is brought to you for free and open access by the Journals at Marquette Law Scholarly Commons. It has been accepted for inclusion in Marquette Intellectual Property Law Review by an authorized editor of Marquette Law Scholarly Commons. For more information, please contact . DUAN_MACRO.DOCX (DO NOT DELETE) 2/12/21 12:34 PM GENE PATENTS, DRUG PRICES, AND SCIENTIFIC RESEARCH: UNEXPECTED EFFECTS OF RECENTLY PROPOSED PATENT ELIGIBILITY LEGISLATION CHARLES DUAN* ABSTRACT Recently, Congress has considered legislation to amend § 101, a section of the Patent Act that the Supreme Court has held to prohibit patenting of laws of nature, natural phenomena, and abstract ideas. This draft legislation would expand the realm of patent-eligible subject matter, overturning the Court’s precedents along the way. The draft legislation, and movement to change this doctrine of patent law, made substantial headway with a subcommittee of the Senate holding numerous roundtables and hearings on the subject. This article considers some less-discussed consequences of that draft legislative proposal. The legislation likely opens the door to patenting of subject matter such as human genes and scientific discoveries, given its broad language and abrogation of precedent. Allowing such patents would have consequential effects such as potentially raising drug prices, decreasing quality of health care, deterring scientific research, slowing the development of innovative technologies, and conflicting with scientific and ethical norms. *(c) 2019–2021 Charles Duan. Senior Fellow, Technology and Innovation Policy, R Street Institute, Washington, D.C. The views expressed in this article are the author’s own and should not be attributed to the R Street Institute or its other scholars. The author would like to thank Luis Gil Abinader, Tahir Amin, Torie Bosch, Michael Carrier, Robert Cook-Deegan, David Jones, Burcu Kilic, Steven Knievel, Priti Krishtel, Joshua Landau, Matthew Lane, Jennifer Leib, James Love, Alexandra Moss, Sasha Moss, Joe Mullin, Sandra Park, Christina Pesavento, Abigail Phillips, Arti Rai, Lauren Rollins, Kathleen Ruane, Joshua Sarnoff, Daniel Takash, and many others who have provided me with valuable thoughts and information. I would also like to thank the staff of the Library of Congress, the Harold Washington Library Center of the Chicago Public Library, and the Rinn Law Library of DePaul University College of Law for their research assistance, as well as the editors of the Marquette Intellectual Property Law Review. This article is based on the author’s testimony before the Intellectual Property Subcommittee of the Senate Committee on the Judiciary on June 4, 2019, and also an article originally published in Slate: Future Tense. See The State of Patent Eligibility in America: Hearing Before the Subcomm. on Intellectual Property of the S. Comm. on the Judiciary, 116th Cong. (June 4, 2019) (testimony of Charles Duan), https://www.judiciary.senate.gov/imo/media/doc/Duan%20Testimony.pdf; Charles Duan, A Century-Old Debate over Science Patents Is Repeating Itself Today, SLATE (Feb. 25, 2019), https://slate.com/technology/2019/02/patenting-nature-francesco-ruffini-history-tillis-coons. html. DUAN_MACRO.DOCX (DO NOT DELETE) 140 2/12/21 12:34 PM MARQ. INTELL. PROP. L. REV. [Vol. 24:2 Considerations such as these ought to be top-of-mind for legislators intending to change the law of patentable subject matter eligibility. I. INTRODUCTION .......................................................................................... 140 II. PATENT ELIGIBILITY OF HUMAN GENES, SCIENTIFIC DISCOVERIES, AND OTHER NATURAL LAWS AND PHENOMENA ....................................... 143 III. EFFECTS FOR SCIENTIFIC RESEARCH ...................................................... 144 A. Early-1900s “Scientific Property” Proposals ............................... 145 B. Deterrence of Downstream Research ........................................... 149 C. Do Patents Motivate Research Scientists? .................................... 152 IV. EFFECTS FOR DRUG PRICES AND HEALTH CARE.................................... 153 A. A Tool for Drug Patent Evergreening ........................................... 154 B. Development of Diagnostic Tests and Treatments ....................... 156 C. Ability to Obtain Second Opinions............................................... 157 D. Safety and Efficacy of Medical Tests ........................................... 158 V. EFFECTS FOR INNOVATION ...................................................................... 159 A. Development of Genetic Testing Services ................................... 159 B. Can Patent Ineligibility Encourage Innovation? ........................... 160 VI. EFFECTS FOR SCIENTIFIC NORMS, MEDICAL ETHICS, AND HUMAN RIGHTS ................................................................................................ 163 VII. ALTERNATIVES TO THE DRAFT LEGISLATION....................................... 165 VIII. CONCLUSION ........................................................................................ 167 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 1. Stanley W. Pycior, Marie Skłodowska Curie and Albert Einstein: A Professional and Personal Relationship, 44 POLISH REV. 131, 141 (1999). For references and authorities for this paragraph, see Section III.A infra notes 27–60. DUAN_MACRO.DOCX (DO NOT DELETE) 2020] PATENT ELIGIBILITY LEGISLATION (...truncated)