The Ethical Considerations of Patent Protections for Societal Benefit
Patents are an inventor’s best friend, as they confer on them exclusive rights to their projects, ideas, and inventions for a period of time.[1] Without patents, society would not be able to progress technologically or advance ideas that make people’s lives easier.[2]
But because patents, in theory, confer monopolies to their inventors, it can be ethically dangerous to allow an inventor full autonomy to the use of a particular invention.[3]
Ethically, we must consider balancing between innovation incentives and ethical responsibility, regarding patent protections, challenging the traditional balance between intellectual property protection and the greater good.[4] While patents are designed, in theory, to reward inventors and harness technological progression, there are legal mechanisms, both in common law and statutory frameworks, that allow for exceptions in extraordinary circumstances.[5] From compulsory licensing under federal law to state emergency powers and the doctrine of eminent domain, the legal system has occasionally permitted the overriding of patent rights for public benefit.[6] This blog explores whether, when, and how patents can—or should—be disregarded in the interest of society’s health and welfare, analyzing the legal, ethical, and practical implications of such actions.
Claimed inventions can only be patented if they are considered a process, method, machine, apparatus, manufacture, or composition of matter.[7] And the inventions must fall outside of the three exceptions–laws of nature, physical phenomena, and abstract ideas.[8] The Supreme Court has noted that these exceptions must be excused from the purview of patentability because they are concepts of knowledge free to all “men” and “reserved exclusively to none.”[9] The holding in Bilski illustrated that some societal benefit derived from inventions should outweigh protection from patents.[10] But even if the invention qualifies–in order to be protected under the Patent Act’s protection–the invention must also be novel, nonobvious, and fully and particularly described.[11] Specifically, courts have generally required that patentable inventions be more than bare concepts.[12] Inventions applying abstract ideas or deriving from the law of nature must have an “inventive concept” beyond the abstract idea or natural law or satisfy the machine-or-transformation test.[13]
But with the recent event of COVID-19, U.S. law began to consider waiving intellectual property (IP) rights–specifically patent rights for public health benefits.[14] Among the many legal mechanisms against patent protection, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows, under certain circumstances, exceptions to patent protection.[15] One of the exceptions is the compulsory licenses provision, where a competitor is allowed to use a patented license without the patent owner’s consent under specific conditions.[16] For example, during the formation of TRIPS, the U.S. opposed the compulsory license provisions, only allowing it to protect the public interest or stop anti-competitive behavior.[17] Even so, the U.S. seems to be waiver-averse, meaning they rarely–if at all–waive patent protection for the public’s interest.[18] But since the Bayer incident, the U.S. has softened its stance by working with medical manufacturers or institutions to push out medical items.[19] Additionally, the United States Patent Act protects patent owners by allowing them to have infringement claims despite not even using or licensing the patent.[20]
But European countries and Canada seem to be more waiver-friendly, following more so in line with the views of the World Health Organization.[21] Nonetheless, Congress still confers on the government the authority to use a patent without the owner’s permission to protect public health, national security, or prevent anti-competitive practices.[22] It is important to note that legal mechanisms to bypass patent protections for medical products are rarely practiced because countries like the US and some European countries contend that bypassing patent protections would harm the necessary medical advancement, which, in the long run, would be more beneficial for the world’s health.[23] Further arguing bypass of patent protections would harm the integrity of the intellectual property system, which is meant to reward innovation through means of exclusivity and control of one’s own invention.[24]
There are also legal mechanisms within Article 30 of TRIPS, where research and experimental use of the patented item can be justified without the patent owner’s consent.[25] This legal mechanism is one of the most commonly used exceptions for products and technology patents.[26] Under this exception rule, researchers may conduct research using a patented product or technology without fear of infringement. [27]
During 2020, there was pending legislation–called the Fight Coronavirus Act–which would have allowed medical professionals to conduct or modify patented medical equipment to help combat the pandemic without obtaining the patent owner’s consent.[28] But the Pharmaceutical Research and Manufacturers of America (PhRMA), a political advocacy group consisting of 30 pharmaceutical companies, took a stance against this legislation enacted by the Biden administration.[29]
The debate over whether the government has the right to waive patent protection contains many nuances and ethical considerations.[30] On one hand, waiver opponents want to protect patent protections to safeguard inventors’ integrity and confidence for the patent system. On the other hand, waiver proponents are willing to harm such integrity and confidence to give access to the benefits of certain patented items.[31] Waiver opponents believe in maximizing the demand and supply of the patent system–allowing for as much innovation–while addressing the issues of accessibility through international and governance policies.[32] For example, a country can maximize its patents but pledge to donate the patented vaccines to countries that need them.[33] In other words, waiver opponents believe the burden should not be upon the innovators or patent owners but rather the government and international leaders to facilitate accessibility.[34]
Though legal mechanisms of bypassing patent protections exist, applications are far and few between. Governments understand the importance of protecting the integrity of patents. Yet ethical considerations force governments to consider when patents should be bypassed for the health and safety of people.
Footnotes
