Steven Zuccarelli is a JD Candidate at Osgoode Hall Law School.
Balancing pharmaceutical patent rights with public health needs is a contentious issue that poses enormous challenges to lawmakers. The conflict between innovators of therapeutics and generic manufacturers is fought from divergent perspectives on the battlefield formed by patent laws. At stake is the balance in legislation between protecting an owner’s Intellectual Property (IP) rights and providing sufficient access to life saving drugs for individuals.
Professor Cynthia Ho, in her paper Unveiling Competing Patent Perspectives, attempts to provide insights into what factors influence that balance by investigating the compulsory licensing by the Thailand government of patents relating to HIV-treating antiretrovirals. The practice, which allows a government to force the licensing of a patent held by an owner, has been met with significant resistance and criticism from big Pharma, as it represents a subversion of owner rights in the pursuit of greater public health.
In approaching the issue, Ho attempts to dissect the rationale behind each party, demonstrating that each side is prescribing to either a rights maximizing or rights minimizing theory of patent law. Ho’s argument is that neither of these theories is on its own correct. Instead, it is paramount to understand how these different perspectives impact the interpretation and understanding of international laws that pertain to patents, including the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that in part governs international IP. Given that there is widespread discord not only on the appropriateness of compulsory licenses, but on the broader question of the balance between patent rights and public health, a better understanding of the impact of these competing perspectives could have implications for an improved understanding of current patent-related controversies.
Ho first distinguishes between the divergent perspectives. Those that view patents as a government granted privilege see innovation as only one goal amongst other competing societal goals. This perspective would sympathize with Thailand’s position of prioritizing the health of HIV positive individuals by offering forcibly obtained generic versions of effective therapeutics. This group would not see patents as property in the traditional sense, but rather as government granted rights that are intended to balance the interests of innovators and the public, and are therefore subject to conditions. Conversely, the rights maximizers, or the Uber-right prescribers as Ho brands them, believe in a privileged property right. This right is subject only to minimal conditions, with innovation and the maintenance of respect for owner IP rights being of primary importance.
The Thailand case study is used to demonstrate these underlying perspectives. On one hand, the Thai government utilized contentious provisions in TRIPS to force the licensing of established antiretroviral patents to the state, effectively facilitating generic production of these drugs at affordable prices. According to the privilege perspective, this values the health of citizens to a greater extent than the profits of multinational pharmaceutical corporations. These same individuals would submit that the small size of Thailand’s drug market would not threaten the profits of the patent holders. However, the successful implementation of these statutes by Thailand may lead to other nations implementing similar provisions. This may serve to compromise profits of innovative pharmaceuticals by reducing the size of their market to the point that entering those markets, or even developing certain drugs, may be avoided.
Conversely, those who prescribe to the Uber-right view would argue that the patent has effectively been stolen, as the IP is being used against the wishes of the owner. They too would point to provisions in TRIPS that seemingly conflict with those put forth by the opposing side, also claiming that the use of compulsory licenses goes against the spirit of TRIPS. In addition, they would posit that Thailand is threatening innovation by compromising intellectual property protection. However, Ho is quick to point out the flaws in this argument, claiming that there is little evidence in demonstrating the connection between innovation and the strict enforcement of patent rights.
While the above outlines the relevant perspectives, it is how these parties interpret the relevant legislation that is particularly interesting, according to Ho. While Ho argues that Article 31 of TRIPS permits the use of compulsory licensing at the will of the nation, it is made clear that the confusion concerning compulsory licensing’s legality is due in part to ambiguity in the definitions of terms contained in TRIPS. This includes any requirements prior to a state obtaining compulsory licensing. In explaining these ambiguities, Ho points to the pressure on lawmakers to make concessions to both perspectives during the drafting of legislation in order to have a large enough consensus on legislation to enact it.
Ho advocates that to solve the issues underlying the debate on public health versus patent rights, we must be cognizant of the perspectives involved. These perspectives help explain the current difficulties that face compulsory licensing, but can also be extrapolated to broader policy issues facing patent law.
While Ho may be correct in suggesting that these perspectives underlie patent issues as a whole, it is an altogether different challenge to accommodate both viewpoints. Ultimately, little insight is provided on how to achieve this, but nonetheless ambiguity in drafting legislation is not an appropriate solution. Satisfying both the patent owners, who underwent enormous cost and risk to bring therapeutics to market, and the general public, who require inexpensive treatments to disease, will be a significant challenge.
As is often said, certainty is paramount in property law. With IP’s pervasiveness and impact on society only growing, it will be critical to establish laws that appropriately balance the needs of the public with the interests of owners. Cynthia Ho’s analysis serves to shed light on the hidden perspectives that impact how that balance is expressed.