Treating Diagnostics: Protecting in Vitro Diagnostic Testing in an Uncertain § 101 Landscape

Akron Law Review Volume 54 Issue 3 Intellectual Property Issue Article 6 2021 Treating Diagnostics: Protecting in Vitro Diagnostic Testing in an Uncertain § 101 Landscape Emily Iroz Rich Follow this and additional works at: https://ideaexchange.uakron.edu/akronlawreview Part of the Intellectual Property Law Commons Please take a moment to share how this work helps you through this survey. Your feedback will be important as we plan further development of our repository. Recommended Citation Iroz Rich, Emily (2021) "Treating Diagnostics: Protecting in Vitro Diagnostic Testing in an Uncertain § 101 Landscape," Akron Law Review: Vol. 54 : Iss. 3 , Article 6. Available at: https://ideaexchange.uakron.edu/akronlawreview/vol54/iss3/6 This Notes is brought to you for free and open access by Akron Law Journals at IdeaExchange@UAkron, the institutional repository of The University of Akron in Akron, Ohio, USA. It has been accepted for inclusion in Akron Law Review by an authorized administrator of IdeaExchange@UAkron. For more information, please contact , . Iroz Rich: Treating Diagnostics TREATING DIAGNOSTICS: PROTECTING IN VITRO DIAGNOSTIC TESTING IN AN UNCERTAIN § 101 LANDSCAPE By: Emily Iroz Rich* Abstract ................................................................................ 690 I. Introduction ............................................................... 691 II. The Importance of Diagnostic Testing ...................... 694 III. The Development of Subject-Matter Eligibility for Diagnostic Testing ..................................................... 697 A. Early Supreme Court Jurisprudence ................... 699 B. Refinements of the 20th Century ........................ 701 C. Recent Supreme Court Decisions ....................... 703 IV. The Current State of Chaos ....................................... 707 A. The Aftermath of the Mayo ................................ 707 B. USPTO Efforts .................................................... 710 C. A Split Federal Circuit ........................................ 713 D. A Sleeping Supreme Court ................................. 714 E. The Proposed Congressional Fix: Eliminate Everything ........................................................... 715 V. Carving Out Middle Ground: A Diagnostic Test Patent Act .................................................................. 716 A. Creating special eligibility standards for diagnostic testing ................................................ 717 B. Creating infringement limitations on the owner’s monopoly to promote further medical research and advancements ................................. 718 1. The Bolar Exception ...................................... 720 2. Experimental Use Exceptions ........................ 721 * J.D., University of Akron School of Law, 2021. I am grateful to Aurelie and Alison Pahnke who inspired my research; to Patrick Gaughan for his mentorship throughout the writing process; and to my husband, Matthew Rich for his continued support and encouragement. Thank you also to the editors of the Akron Law Review for their thoughtful suggestions and editing. All errors and opinions are my own. 689 Published by IdeaExchange@UAkron, 2021 1 Akron Law Review, Vol. 54 [2021], Iss. 3, Art. 6 690 IV. AKRON LAW REVIEW [54:689 C. Protecting Return on Investment and Granting Access through Compulsory Licensing .............. 723 1. Compulsory licensing for diagnostic testing . 725 2. Conditions for Granting Compulsory Licensing ....................................................... 727 a. Anti-competitive practices ....................... 727 b. Refusal to deal ......................................... 728 c. Failure to work and inadequate supply .... 729 d. Dependent patents.................................... 730 e. Governmental Use or Public Health Interests .................................................... 731 Conclusion ................................................................. 732 ABSTRACT Beyond question, medical diagnostic tests, they save lives. The diagnostic tests also contribute to the overall health of the U.S. economy. However, the current state of subject-matter eligibility for patent protection does not incentivize the research and development of these lifesaving tools. Previous legislative and judicial efforts to fix subject-matter eligibility have failed. This article proposes a diagnostic patent act to allow the protection of in vitro diagnostic tests. The proposed diagnostic patent act would include safeguards to allow adequate access to fundamental research while incentivizing the return of investment to the patent holder. Safeguards would include exceptions to patent infringement claims and compulsory licensing requirements under certain conditions. Exceptions, which limit infringement liability to third parties in specific situations, would be used for narrow experimental use and mandatory processes required to comply with federal regulations. Compulsory licensing, which requires patent holders to allow third parties to use a patent in certain circumstances in exchange for a determined fee, would be permitted when the patent holder acts in an anticompetitive way and for governmental or public health uses. The combination of these limitations on a patent holder’s exclusive monopoly will ensure that access to research is available while patent holders are adequately incentivized to develop innovative diagnostic tests. https://ideaexchange.uakron.edu/akronlawreview/vol54/iss3/6 2 Iroz Rich: Treating Diagnostics 2020] TREATING DIAGNOSTICS 691 I. INTRODUCTION In the Fall of 2009, Alison, a four-year old girl, was diagnosed with myasthenia gravis. 1 Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disorder that causes varying degrees of weakness in the voluntary skeletal muscles.2 In hindsight, Alison’s symptoms were typical of MG, but at the time, Alison’s symptoms weren’t anything out of ordinary by themselves. 3 Alison stopped drinking from her sippy cup. She couldn’t blow out her birthday candles. Sometimes she and her twin brother would laugh when milk came out of her nose. Her voice was quieter and her smile seemed wrong. When Alison couldn’t drink her favorite treat, a Slurpee, out of a straw in light of her other symptoms, Alison’s mom knew something was wrong and sought medical advice. 4 At first, Alison’s condition puzzled many doctors. Diagnosing MG is a difficult task and is often delayed months, or even years because MG has multiple mechanism types that exhibit an array of symptoms that can be confused with other diseases. 5 Diagnosing MG generally requires multiple tests to eliminate similar diseases that manifest similar symptoms. 6 After ruling out numerous conditions through various diagnostic testing, a neurologist hypothesized that Alison had MG. 7 In Alison’s case, she underwent a variety of tests and treatments to confirm the MG hypothesis. The next task was to dete (...truncated)