Patentability Standards for Follow-On Pharmaceutical Innovation

37 BIOTECHNOLOGY LAW REPORT 131 (2018)

31 Pages Posted: 31 Jul 2018 Last revised: 6 May 2020

See all articles by Christopher M. Holman

Christopher M. Holman

University of Missouri - Kansas City School of Law

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

Eric M. Solovy

Sidley Austin LLP

Abstract

Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays a very important, but at times under-appreciated, role in providing innovative solutions to compelling medical needs. Examples of follow-on innovation include new forms of a drug with improved safety-efficacy profiles, new formulations and dosages providing improved patient outcomes, and new methods of using an established drug more safely or to treat new indications. Patents play a critical role in incentivizing the research, development, testing, and ultimately commercialization of follow-on pharmaceutical innovation, and in doing so provide substantial benefits for public health and patients’ quality of life. There is, however, a body of literature characterizing patents directed towards follow-on innovations as “secondary pharmaceutical patents”. Some have even gone so far as to propose that the criteria for patentability should be enforced more stringently with respect to follow-on pharmaceutical inventions as compared to other inventions. The underlying assumption of such proposals is that follow-on pharmaceutical innovations are somehow secondary to other pharmaceutical innovation, and thus less deserving of patent protection. In this article, we refute the notion that follow-on pharmaceutical innovation should be categorically singled out for unfavorable treatment under the patent laws, and provide numerous examples of the value that follow-on innovation brings to medicine, and ultimately to patients. We also propose, in view of the minimum standards of patentability required by international treaties including the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), standards and best practices for assessing the patentability of inventions arising out of follow-on pharmaceutical innovation. These are essentially the same stringent standards applicable to “primary” pharmaceutical innovation, and inventions in general. This article provides numerous examples from jurisdictions around the world in which patent offices and courts have applied the well-recognized requirements of patentability, including patent eligibility, novelty, inventive step and industrial application, to follow-on pharmaceutical inventions, and in so doing have advanced innovation in public health and ultimately the lives of patients.

Keywords: UNDP, Patentability Guidelines, Patent Examination, Pharmaceutical Patents, TRIPS Agreement

Suggested Citation

Holman, Christopher M. and Minssen, Timo and Solovy, Eric M., Patentability Standards for Follow-On Pharmaceutical Innovation. 37 BIOTECHNOLOGY LAW REPORT 131 (2018), Available at SSRN: https://ssrn.com/abstract=3197925

Christopher M. Holman (Contact Author)

University of Missouri - Kansas City School of Law ( email )

5100 Rockhill Road
Kansas City, MO 64110-2499
United States

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law ( email )

Karen Blixens Plads 16
Copenhagen, 2300
Denmark
+46 708 607517 (Phone)

HOME PAGE: http://jura.ku.dk/cebil/staff/profile/?pure=en/persons/381631

Eric M. Solovy

Sidley Austin LLP ( email )

1501 K Street, N.W.
Washington, DC 20005
United States
2027368296 (Phone)

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