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Patent extensions are the most effective and desirable incentive for producing bioterrorism countermeasures and to prevent dual-use technology to fall into the hands of bad-actor engineering.

Million-Perez 16 Helena Rachael Million-Perez is a senior associate in the Denver office of WilmerHale, New York Bar Admission 6/6/16, United States Court of Appeals for the Sixth Circuit Admission 7/19/2018, United States Disrict Court for the Western District of Tennessee 7/18/2018, Colorado State Bar Admission 6/3/2019, United States Court of Appeals for the Federal Curcuit 9/7/2023, Attended Washington University Law School, expert on patent and trade secret litigation for life sciences and technology companies. (Helena Rachael, Summer 2016, “Addressing Dual-Use technology in an Age of Bioterrorism: Patent Extensions to Inspire Companies Making Dual Use Technology to Create Accompanying Countermeasures,” AIPLA Quarterly Journal, Volume 44, Number 3, Pg. 428-430, https://heinonline.org/HOL/Page?collection=journals&handle=hein.journals/aiplaqj44&id=404&men_tab=srchresults)

Traditional avenues of regulation of dual-use technology are not adequate to address bioterrorism because of globalization and the unique qualities of dual-use technology. As a result, one may assume that the materials necessary to create a dual-use technology will reach the hands of malfeasors. For this reason, countermeasures to this type of technology are paramount. Past, current, and proposed legislation concerning dual-use technology, however, has been inadequate in incentivizing private industry to create countermeasures. The following suggests a patent-term extension for dual-use technologies in exchange for an accompanying countermeasure, arguing this incentive will be practical and effective.

III. ANALYSIS

Although previous congressional proposals, Acts, and committees aimed to fund and incentivize countermeasures, each failed to target dual-use technology countermeasure development. This article proposes, therefore, that the USPTO offer a patent-term extension for patents directed to dual-use technology on the condition that the patent owner creates an accompanying countermeasure. This article argues for an extension of three years 251 for patent owners who meet this condition in addition to any patent-term adjustments afforded to the patent owner pursuant to Title 35 of the U.S. Code or legislative acts.

A. Patent Extension for Dual-Use Technologies in Exchange for an Accompanying Countermeasure is an Appropriate and Realistic Incentive that Could Yield Significant Benefit

The conditional patent-term extension proposed here provides an incentive that will: (1) reduce unbridled accessibility to dual-use technologies, (2) make countermeasure development an attractive and cost-effective business investment, and (3) take advantage of companies and individuals who currently specialize in the dual-use technology field, and who possess the necessary resources to create accompanying countermeasures.

The conditional patent-term extension proposed here provides an incentive that will reduce unbridled accessibility to dual-use technologies. Although accessibility to dual-use technology is essentially ungovernable in the Internet age, providing a three-year patent-term extension to a dual-use technology will motivate companies to collaborate with the U.S. Government to identify and enjoin individuals infringing their patented dual-use technology. 252

As a result, biohackers and terrorist organizations will have diminished access to these technologies.

Dissimilar to previous and current countermeasure incentives, the conditional patent-term extension proposed here will make countermeasure development an attractive and cost-effective business investment, because it will be easily applicable, lower the financial risk of countermeasure development, and potentially lead to profits. Unlike previous incentives, a patent-term extension on a dual-use technology in exchange for creating a countermeasure to that technology presents a simple and easily applicable business model. Private companies need not contort themselves to meet the demands of legislation, like Project BioShield. Rather, a patent-term extension on the dual-use technology will be granted when the company identifies a dual-use quality of one of its innovations and opts to develop a countermeasure to the dual use of that specific innovation. Upon successful development of a countermeasure, the USPTO will then extend the company's dual use technology patent. Because the company likely has already received approval of the dual-use technology, it need not worry about whether the extension is affected by the countermeasure's approval time. The simplicity of this proposed regime would attract companies and individuals frustrated with other complicated or inapplicable incentives.

In addition, the length and specificity of this proposed extension renders it a strong incentive that will lower the financial risk of countermeasure investment. The length of patent-term extension incentive must be able to generate participation by virtually guaranteeing a return on the company's investment in countermeasure production. As discussed above, the risk of countermeasure development is incredibly high, and thus the promise that a company may recoup or even profit from developing a countermeasure will entice companies who had previously avoided countermeasure investment. 253 For these reasons, this article proposes a three-year patent term extension.

Recent studies showed an increase in domestic R&D investment and new pharmaceutical product development when the patent-term extension changed from seventeen years to twenty years in both the United States and Canada. 254 A similar surge may occur for dual-use technology countermeasure investment under the proposed extension. Over the additional three years of the patent term, companies are likely to receive the benefit of extending their monopoly on a profitable dual-use technology such that the company will likely recoup countermeasure development costs and, potentially, profit. As a result, dual-use technology countermeasure production is likely to increase. Additionally, proponents of patent extension, like Dr. Josh Bloom, Director of Chemical and Pharmaceutical Sciences at the American Council on Science and Health, contend that three-year patent extensions are likely appropriate for patents related to the company's portfolio.255

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