University of Missouri School of Law Scholarship Repository Faculty Publications Faculty Scholarship 2019 The "Evergreening" Metaphor in Intellectual Property Scholarship Erika Lietzan University of Missouri School of Law, [email protected] Follow this and additional works at: https://scholarship.law.missouri.edu/facpubs Part of the Food and Drug Law Commons, Intellectual Property Law Commons, and the Science and Technology Law Commons Recommended Citation Erika Lietzan, The "Evergreening" Metaphor in Intellectual Property Scholarship, 53 Akron Law Review 805 (2019). Available at: https://scholarship.law.missouri.edu/facpubs/984 This Article is brought to you for free and open access by the Faculty Scholarship at University of Missouri School of Law Scholarship Repository. It has been accepted for inclusion in Faculty Publications by an authorized administrator of University of Missouri School of Law Scholarship Repository. For more information, please contact [email protected]. DATE DOWNLOADED: Wed Jan 20 13:42:00 2021 SOURCE: Content Downloaded from HeinOnline Citations: Bluebook 21st ed. Erika Lietzan, The "Evergreening" Metaphor in Intellectual Property Scholarship, 53 AKRON L. REV. 805 (2019). ALWD 6th ed. Lietzan, E. ., The "evergreening" metaphor in intellectual property scholarship, 53(4) Akron L. Rev. 805 (2019). APA 7th ed. Lietzan, E. (2019). The "evergreening" metaphor in intellectual property scholarship. Akron Law Review, 53(4), 805-872. Chicago 7th ed. Erika Lietzan, "The "Evergreening" Metaphor in Intellectual Property Scholarship," Akron Law Review 53, no. 4 (2019): 805-872 McGill Guide 9th ed. Erika Lietzan, "The "Evergreening" Metaphor in Intellectual Property Scholarship" (2019) 53:4 Akron L Rev 805. AGLC 4th ed. Erika Lietzan, 'The "Evergreening" Metaphor in Intellectual Property Scholarship' (2019) 53(4) Akron Law Review 805. MLA 8th ed. Lietzan, Erika. "The "Evergreening" Metaphor in Intellectual Property Scholarship." Akron Law Review, vol. 53, no. 4, 2019, p. 805-872. HeinOnline. OSCOLA 4th ed. Erika Lietzan, 'The "Evergreening" Metaphor in Intellectual Property Scholarship' (2019) 53 Akron L Rev 805 -- Your use of this HeinOnline PDF indicates your acceptance of HeinOnline's Terms and Conditions of the license agreement available at https://heinonline.org/HOL/License -- The search text of this PDF is generated from uncorrected OCR text. -- To obtain permission to use this article beyond the scope of your license, please use: Copyright Information THE "EVERGREENING" METAPHOR IN INTELLECTUAL PROPERTY SCHOLARSHIP Erika Lietzan * Abstract... ................................... 806 I. Introduction ............................ 807 II. The Context for "Evergreening" Allegations ............ 811 A. Approval of Medicines ........... ........ 812 B. Intellectual Property Considerations .... .... 816 1. Statutory Exclusivity .......... ...... 816 2. Patent-Based Statutory Exclusivity ............... 817 3. A Generic Company's Options.... ...... 820 4. Other Statutory Exclusivity ........ ....... 822 C. Marketing, Prescribing, and Dispensing of Medicines ..................... ..... 822 III. Use of "Evergreening" in the Literature .... ..... 826 A. Definitions Offered .............. ...... 828 1. Focus on Actions ............... .... 830 2. Focus on "Extension" of Something ............. 833 3. Focus on the Market ................. 837 B. Examples Offered ..........................840 1. New Products ................ ...... 841 2. Other Examples ......... ............. 845 C. Empirical Studies Offered......... ...... 848 1. Counting Patents and Exclusivities...............848 2. Patent Litigation ............... ..... 851 3. Healthcare Expenditures ......... ..... 853 IV. The Meaning of the Metaphor .......... ..... 853 * Associate Professor of Law, University of Missouri (Columbia). I am grateful to Kristina Acri n6e Lybecker, Krista Carver, (the Hon.) Ryan Holte, Camilla Hrdy, David Korn, Glynn Lunney, Jr., Michael Madison, Liam O'Mellin, Zahr Said, Joshua Sarnoff, and Hans Sauer for comments on drafts of this article, and to Kristina Acri n6e Lybecker, David Lund, and Mark Schultz for the inspiration to write the article. I am also grateful to Henry Adams (University of Missouri School of Law, Class of 2020), Mike Figenshau (Class of 2021), Evan Weidner (Class of 2021), and as always Cynthia Shearrer (Associate Law Librarian), for research assistance. 805 806 AKRON LAW REVIEW [53:805 A. No Extension of Patent or Statutory Exclusivity 855 B. No Extension of "Exclusivity" in the Descriptive Sense .............................. 858 C. An "Extension" Therefore ... of What?.............865 V. Conclusion: A Prelude to Policymaking .... ..... 867 ABSTRACT This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significantpolicymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-morethan 300 articles- discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions taken by the innovative companies that develop and introduce new medicines to market. But they are inconsistent in their descriptions of the circumstances to which the term applies. And though most claim the innovator has "extended" something in these circumstances, they do not agree on the particulars. The literature is similarly in disarray about what has been "evergreened"-an invention, a product, a price, a patent, or something else entirely. All of this makes it hard to know from the literature what exactly scholars are writing about. After sorting through the definitions and examples-and considering the legal framework and practicallandscape in which drug innovators and their generic competitors operate-thisArticle offers an answer and, more importantly, identifies the implicit normative claim. In simple terms, the normative claim in the literature is something like this: "an innovator should not enjoy an exclusive market and supra- competitive pricing for innovations that stem in some fashion from a separate innovationfor which it already enjoyed a 20-year patent term. Or at least, a drug innovatorshould not." This Article does not defend, or reject, this normative claim. Instead, it makes a different claim: that policymaking should be based on descriptive scholarship that is careful and precise about the relevant law andfacts, normative work that is clear and candid about its claim and thorough in its reasoning, and empirical studies that document the actual problem the normative proposals and 2019] THE "EVERGREENING" METAPHOR 807 policymaking proposals are meant to address. Significant policymaking would be premature today, because we have not yet produced this body of work. Constant use of the "evergreening" metaphor may be obscuring this failure. The Article concludes with recommendations for scholars continuing to work on these topics, focusing on ways that we can provide quality work to assistpolicymakers considering the normative claim. I. INTRODUCTION Allegations that drug companies engage in "evergreening" pervade legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing.' English language dictionaries tell us that the primary meaning of "evergreen" is literal; unlike a deciduous tree, an evergreen tree or shrub has green foliage all year round.2 An evergreen leaf lasts from one season to the next.3 Even when the term does not refer to non-deciduous plants, its primary meaning is literal; an evergreen landscape is always green.4 But the term also has a figurative meaning.s Something is "evergreen" if it is "always fresh" or "never failing" or "enduring."' In the literature relating to drug companies, the term "evergreening" is a metaphor. The writer invokes a concrete image familiar to the audience to convey an abstract concept relating to legal and factual circumstances in the real world.' Metaphors are common in legal writing and especially common in intellectual property writing.' They are powerful because they turn the complex and unfamiliar into something simple and familiar, and sometimes they are also powerful because they 1. See infra Part III. 2. Evergreen, MERRIAM-WEBSTER DICTIONARY, at 1, https://www.merniam- webster.com/dictionary/evergreen [https://perma.cc/Z2ST-7HEB]; see also Evergreen, OXFORD ENGLISH DICTIONARY [hereinafter OED], https://www.oed.com/view/Entry/ 65314?redirectedFrom=evergreen#eid [https://perma.cc/JF9T-NYDQ]; Evergreen, THE AMERICAN HERITAGE DICTIONARY OF THE ENGLISH LANGUAGE, https://ahdictionary.com/word/ search.html?q=evergreen [https://perma.cc/YP2T-VJDP]. 3. Evergreen, OED, supra note 2, at lb. 4. Id. at 2a. 5. Evergreen, MERRIAM-WEBSTER, supra note 2, at 2a (defining "figurative" as "expressing one thing in terms normally denoting another with which it may be regarded as analogous"). 6. Evergreen, OED, supra note 2, at 2b; Evergreen, MERRIAM-WEBSTER, supra note 2, at 2a ("retaining freshness or interest"), 2b ("universally and continually relevant"); Evergreen, AMERICAN HERITAGE, supra note 2, at 3 ("automatically renewed or repeatedly made valid").