“Beyond the Scope of Ordinary Training and Knowledge”: The Argument for Droit Moral, U.S. Research Science Intellectual Property Moral Rights

Research science intellectual property law has undergone tremendous change within the past two decades.1 In particular, * Joan Jackson has a J.D. from the University of MassachusettsDartmouth School of Law; B.S. and M.S. in Biology from Tulane University; and Ph.D. in Zoology from the University of Nebraska-Lincoln. She spent twenty-seven years as a senior research scientist/laboratory director/program manager/inventor, identifying new drugs and diagnostics for orphan diseases, and designingand conducting preclinical new drug efficacy studies; twenty years as Deputy Tropical Medicine Course Director/Adjunct faculty, teaching M.D., and medical students. Acknowledgments: This Article would not exist but for years of kind mentorship and patient correction of numerous drafts by Ralph D. Clifford, Esq., Professor of Law and Former Associate Dean, University of Massachusetts-Dartmouth School of Law; and Frances Howell Rudko, Esq., Professor of Law, University of Massachusetts-Dartmouth School of Law. Any mistakes or errors are to be solely attributed to the Author. Contact: Joan E. Jackson, email: researchsciencelaw@aol.com; cell: 301-661-9002; or joanjacksonlaw.com. The phrase, “Beyond the Scope of Ordinary Training and Knowledge,” borrowed from 35 U.S.C. § 103 (2006), refers herein to novel research science achievement, arguably qualifying its natural creator for moral rights under international standards. 1. “Research science” and “scientific research” are used interchangeably. “Science” is defined herein broadly to include traditional laboratory sciences and social sciences. “Research” has been defined by the National Institutes of Health (NIH) as: A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements. Glossary & Acronym List, U.S. DEP’T HEALTH AND HUM. SERVICES, http://grants.nih.gov/grants/glossary.htm#S (last visited July 14, 2012). David L. Faigman et al. distinguished “applied research” from “basic research” as follows: “Basic research” is performed in order to provide a theoretical understanding of a phenomenon of interest. . . . [I]n science [a theory] means an explanation for a set of observed facts. Theory is not contrary to fact, it is the abstract or conceptual account [composed of hypotheses] for why the observed facts exist as they do. These [conceptual explanations] may or may not lead to a practical application. The steps in the process of theory development 4 http://digitalcommons.pace.edu/plr/vol32/iss3/3 JACKSONMACRO 99 PAGES 11/13/2012 9:03 AM 680 PACE LAW REVIEW [Vol. 32:3 research science procedure and focus has shifted dramatically and testing – hypothetico-deductive research [include] . . . . 1. Observations of some phenomenon are made. . . . 2. Possible explanations [theories] are proposed for what is observed. . . . 3. Hypotheses [conceptual propositions] are logically derived from the theories. 4. Studies are designed to test [the validity] of the hypotheses. In essence, the [research] study makes news observations that might disconfirm the hypothesis and thereby falsify the theory. 5. The results of such empirical tests lead to the revision or abandonment of older theories or the creation of still newer and hopefully better [more accurate] theories. 6. The process repeats itself as more empirical tests are conducted and theories undergo continued re-evaluation. DAVID L. FAIGMAN ET AL., SCIENCE IN THE LAW: STANDARDS, STATISTICS AND RESEARCH ISSUES 120-21 (2002). “‘Applied research’ is aimed at answering immediate, practical questions. . . . Some [applied] research [e.g., a research survey] is conducted to provide a thorough description of something,” to “try to explain patterns or similarity and variation that had been found.” Id. at 120. To be disclosed or published, most research science must be subject to peer review. The NIH defines “peer review” as: The process that involves the consistent application of standards and procedures that produce fair, equitable, and objective examinations of [research funding] applications [and research findings submitted for publication or disclosure] based on an evaluation of scientific or technical merit or other relevant aspects of the application [or research manuscript submitted for publication]. The review is performed by experts (Peer Reviewers) in the field of endeavor for which support [or professional journal publication] is requested. Peer review is intended to provide guidance and recommendations [e.g. commentary on research to prospective research scientist authors] . . . . NIH Grants Policy Statement, U.S. DEP’T HEALTH AND HUM. SERVICES, http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch1.htm#definitions_o f_terms (last visited July 14, 2012); see also Peter W. B. Phillips & Camille D. Ryan, The Role of Clusters in Driving Innovation, in 1 INTELLECTUAL PROPERTY IN HEALTH AND AGRICULTURAL INNOVATION: A HANDBOOK OF BEST PRACTICES 281, 281-94 (Anatole Krattiger et al. eds., 2006). See generally AM. LAW INST., Introduction to PRINCIPLES OF THE LAW: INTELLECTUAL PROPERTY PRINCIPLES GOVERNING JURISDICTION, CHOICE OF LAW, AND JUDGMENTS IN TRANSNATIONAL DISPUTES 3-7, §§ 101-103 (2008) [hereinafter ALI] (ALI’s model principles regarding current global intellectual property law and law practice).