The counterplan is the mechanism of waivers
Jerome H. Reichman and Ana Santos Rutschman ’24, Bunyan S. Womble Professor of Law at Duke Law School focusing largely on IP law including comparative and international IP law and former special advisor to the United States National Academies and the International Council for Science (ICSU) on the subject of legal protection for databases, teaches and researches IP law including being a internationally recognized expert on vaccine law and Bio Intellectual Property Scholar in 2017, “A Codified Liability Regime to Stimulate Greater Investment in Subpatentable Innovation,” UC Davis Law Review, February 2024, Vol. 57, Pgs 2033-2034, https://lawreview.law.ucdavis.edu/archives/57/3/codified-liability-regime-stimulate-greater-investment-subpatentable-innovation, Accessed 7-11-2024 by NT-RS through LexisNexis
We note that, already under both international15 and domestic16 patent law, an approach that makes use of liability rules is available in certain circumstances: this happens in the case of compulsory licenses, which may be issued in situations of need for pharmaceuticals and other products without the consent of the patent holder, and which require the licensee to remunerate the patent holder.17 Liability is also a structuring principle in other areas of intellectual property: U.S. copyright law, for example, has codified a compulsory license for making and distributing phonorecords.18 However, in addition to being limited to certain products, current legal embodiments of liability approaches are only available as a last resort.19 By contrast, the regime proposed in this Article would be based on a codified compulsory license from the outset.20 As further discussed below, this would reduce both uncertainty
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15 TRIPS Agreement, supra note 2, art. 31.
16 28 U.S.C. § 1498(a); 35 U.S.C. § 203(a)(2). Compulsory licenses are also available in other areas of intellectual property law.
17 See TRIPS Agreement, supra note 2, art. 31(h) (requiring “adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”). For further discussion of the compulsory licensing regime for pharmaceuticals established through international law, see generally Sapna Kumar, Compulsory Licensing of Patents During Pandemics, 54 CONN. L. REV. 57 (2022) and Jerome H. Reichman, Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options, 37 J.L., MED. & ETHICS 247 (2009) [hereinafter Compulsory Licensing of Patented Pharmaceutical Inventions].
18 17 U.S.C. § 115 (establishing the compulsory licensing regime); see also 17 U.S.C. § 101 (defining phonorecords as “material objects in which sounds, other than those accompanying a motion picture or other audiovisual work, are fixed by any method now known or later developed, and from which the sounds can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device”).
19 For example, in the case of pharmaceuticals, TRIPS imposes several conditions for a compulsory license to be issued, including that efforts be made to obtain a voluntary license or other type of permission from the patent holder and that adequate remuneration be paid to the rightsholder. TRIPS Agreement, supra note 2, art. 31(b)(h). But see id. art. 31(b) (further establishing the possibility of a waiver of the requirement that proposed users seek permission from the patent holder before a compulsory license is issued in cases of “national emergency or other circumstances of extreme urgency”).
20 See infra Part II.
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and transaction costs.21 Moreover, and once again unlike existing approaches, our proposal would apply to any products qualifying as subpatentable innovation, irrespective of the field of technology.22