National Emergency Exemption: Patents in the Time of Coronavirus
The recent COVID-19 outbreak has infected millions and disrupted life as we formerly knew it. Hospitals are constantly threatened by an influx of patients and a shortage of equipment available to treat them. One hospital in Italy found themselves facing a shortage of valves needed to hook up a patient to a ventilator. A start-up figured out a way to mass produce the valves through 3-D printing, and donated their valves to the hospital, where patients were immediately treated. [1] But, the rights to the design of the valves belonged to another company, and the start-up faced the threat of lawsuit. Ultimately, the company decided not to sue due to publicity concerns, but the very prospect of the suit highlights a weakness in intellectual property law: patent protections during a global emergency.
What happens when a global emergency confronts intellectual property law? Medical companies obtain patents for innovative technology, which gives these companies legal ground for a lawsuit should another company produce the same good. But in a time of crisis, as we see now with the coronavirus pandemic, there is a need to produce essential equipment on a scale so massive and immediate that it necessitates removing a patent’s protections. [2] Such a situation concerning valve production, of the sort that occurred in Italy, could just as easily unfold in the United States.
Currently, intellectual property law is protected in the US by precedent concerning patentability and grounds for infringement. In order to address the rising threat of the COVID-19 pandemic, the US courts should expand the narrow definition of the research exemption first outlined in the 1813 United States Supreme Court case Whittmore v. Cutter [3] to include medical and pharmaceutical exemption in global emergencies.
Patent law, a subsection of intellectual property law, is intended to exclude others from making, using, or selling a new invention. [4] Patent law originates from Article I, Section 8, Clause 8, of the United States Constitution, which grants Congress the power “to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” [5] This clause is often referred to as the “Patent and Copyright Clause.” Because there exists a constitutional standard of patentability, the Courts, not Congress, hold the supreme power in defining its scope. Constitutional tests for patentability consider public interest in accessibility to new items against the interest of the United States in incentivizing innovation. It is exactly this public interest that comes to issue when the safety of the public is at stake.
There are several existing exemptions from patent infringement, most notably the experimental use defense, or the research exemption. The research exemption originated in Whittmore v. Cutter, a 1813 US Supreme Court case in which the court decided that a patent on a machine could not be infringed by a person who constructed the machine “merely for philosophical experiments or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.” [6] The research exemption was significantly narrowed in the 2002 Court of Appeals for the Federal Circuit case Madey v. Duke University, where the scope of the exemption was restricted by the Court to only exempt activities that “[are] self amusement, satisfy idle curiosity, or strictly philosophical inquiry." [7]
A few years after, in the 2005 case Merck KGaA v. Integra Lifesciences, the Supreme Court asserted the applicability of the research defense. Merck KGaA distributed an Integra Lifesciences patented compound to other companies to use for preclinical research, and Integra Lifesciences sued on grounds of patent infringement. The Court sided unanimously with Merck, agreeing that federal law allowed the use of patented compounds in preclinical studies, as long as it could be reasonably believed that the compound could be the subject of a US Food and Drug Administration submission. [8] The Court’s decision followed from an interpretation of the Drug Price Competition and Patent Term Restoration Act of 1984, which exempts from infringement patented inventions that are used to develop information under a Federal law regarding the regulation of drug manufacture, use, or sale, such as the FDA. [9] These patented inventions are protected from infringement to encourage the development and manufacture of generic drugs by the pharmaceutical industry, as well as to support the role of the federal government as a major drug purchaser. Federal law generally allows use of patented drugs in activities related to the federal regulatory process, and the court reasoned that the federal regulatory process includes preclinical studies. Considering national emergency response is a federal regulatory process, the use of patented compounds as well as patented information relevant to disaster response should be accessible in a national emergency, exempt from the possibility of infringement.
Another way the US can overcome patent barriers is through compulsory licensing. Compulsory licensing, established in the World Trade Organization (WTO) TRIPS Agreement on intellectual property, occurs when a government allows someone to produce a patented product or process without the consent of the patent owner. [10] In Article 31 of the WTO TRIPS Agreement, the justification of compulsory licensing extends to national emergencies and other circumstances of extreme urgency [11], although the specific requirements of what constitutes circumstances of extreme urgency are not detailed and is usually left to the discretion of countries. Compulsory licensing first begins with negotiation for a voluntary license with payment to the patent owner, and government authorities approve the appropriate amount in compensation. However, in certain time-sensitive situations, such as the valves case seen in Italy, compulsory licensing cannot be granted in time. Thus, the Courts need to extend the research exemption to exempt the use of necessary patented information in a national emergency, so innovators are free to pursue solutions. The medical company that owned the patent to the valves refused to share their manufacturing process with the start-up company, yet the start-up company was able to replicate the valves; what would have happened if the start-up was not able to figure out how to print out effective valves in time?
By exempting patented inventions in pursuit of relieving disaster from a national emergency under the research exemption, the United States can effectively allow critical information to be accessible to innovators for the purpose of alleviating a national emergency. In these emergency situations, there are often time-sensitive problems that do not have the luxury of waiting for market solutions or even traditional compulsory licensing. Intellectual property law has many legal mechanisms for rectification of patent infringement, but we as a society cannot count on retrograde solutions, and must ensure that, during a time of crisis, innovators are free to produce solutions and have access to the necessary knowledge without fear of infringement and lawsuit. This is why it is critical that the courts take the existing developments in intellectual property law and extend the research exemption to encompass efforts to alleviate a national emergency. COVID-19 highlighted weaknesses in United States patent law, and the US Courts should learn from COVID and tighten up patent law in national emergencies before the next pandemic hits.
[1] White, Catherine, and Ben Wodecki. “3D Printed Valves Emerge in Italy for Covid-19 Treatment.” Intellectual Property Magazine. Accessed May 2, 2020. https://www.intellectualpropertymagazine.com/patent/3d-printed-valves-emerge-in-italy-for-covid-19-treatment-140190.htm.
[2] “Constitutional Law: Eminent Domain: Taking Private Property for Private Use.” Michigan Law Review 3, no. 2 (1904): 153. https://doi.org/10.2307/1272804.
[3] White, Jonelle. “Patents and Coronavirus – The Research Exemption in the U.S.” S.J. Quinney College of Law, March 24, 2020. https://law.utah.edu/patents-and-coronavirus-the-research-exemption-in-the-u-s/.
[4] “35 U.S. Code § 271 - Infringement of Patent.” Legal Information Institute. Legal Information Institute. Accessed May 2, 2020. https://www.law.cornell.edu/uscode/text/35/271.
[5] “Intellectual Property Clause.” Legal Information Institute. Legal Information Institute. Accessed April 30, 2020. https://www.law.cornell.edu/wex/intellectual_property_clause.
[6] Karp, Jordan P. “Experimental Use as Patent Infringement: The Impropriety of a Broad Exception.” The Yale Law Journal 100, no. 7 (1991): 2169. https://doi.org/10.2307/796819.
[7] Madey v. Duke University, 336 F. Supp. 2d 583 (M.D.N.C. 2004)
[8] Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)
[9] Hatch, and Orrin G. “S.2748 - 98th Congress (1983-1984): Drug Price Competition and Patent Term Restoration Act of 1984.” Congress.gov, August 10, 1984. https://www.congress.gov/bill/98th-congress/senate-bill/2748?s=1&r=5.
[10] “WORLD TRADE ORGANIZATION.” WTO. Accessed May 3, 2020. https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm.
[11] Ibid.