Patent Rights in a Pandemic: Does the Race for a Covid-19 Vaccine Mean Inequitable Access?
The coronavirus pandemic has changed life as we know it. The world has come a long way since the initial outbreak, but the uncertainty surrounding a potential Covid-19 vaccine persists. Even with mounting uncertainty, the demand for a safe and effective vaccine continues to increase. The Food and Drug Administration’s approvals and authorizations for the Covid-19 vaccine are only some of the obstacles in this respect. Even if these approvals come through and a vaccine becomes marketable, there is no guarantee that the vaccine will be widely accessible. This is where intellectual property starts playing a crucial role in the distribution and affordability of a potentially successful vaccine. If this vaccine is patented, it would grant exclusive rights to the patent holder to exclude others from making, using, importing, and selling the patented innovation for the duration of the patent grant, within the boundaries of the United States.
In the pharmaceutical industry, it is necessary to strike a balance between innovation and the ethical implications of patents for human health. Patent protection is required to stimulate innovation and incentivize pharma companies given the extensive time and resources needed for the development of a new drug. This incentive is crucial for the creation of new drugs and treatments, which benefits patients and society at large. However, these patent rights often restrict access to these medicines and this has negative implications for human health. There have been legitimate concerns that the current patent framework prioritizes profit over access to medical technologies, especially lifesaving Covid-19 treatments. For instance, when the drug remdesivir, produced by American pharma giant Gilead, was being considered as a potential treatment option for Covid-19, Gilead started signing confidential licensing agreements with very few pharmaceutical manufacturers. This meant that several countries would not able to produce or distribute generic versions of the drug, allowing Gilead to control global supply and access of its patented drug. Gilead said that they would make a cheaper, generic version of the drug available for distribution in many countries, including almost all the poorest countries. However, this excluded some of the countries that are worst-hit by coronavirus including the United States, Brazil, Russia, Britain and Peru. Brook Baker, a professor of law at Northeastern University, posited that these countries have been excluded because they “have commercial potential and because Gilead wants to reserve the right to prevent competition and charge higher prices.” While Gilead’s initial statements may have seemed altruistic, Gilead was, in effect, exploiting these wealthier and middle-income countries who were frantic for a cure. Activists and civil society organizations, including the medical charity Doctors Without Borders, drafted an open letter to Gilead condemning Gilead’s actions and urging them to take prompt action to make remdesivir readily available and affordable during the coronavirus pandemic.
Like Gilead, Labrador Diagnostics LLC (“Labrador”) has also attempted to capitalize on the pandemic tragedy. SoftBank, a major investor in Labrador, has the rights to patents it bought from a blood-testing start-up company, Theranos. Emphasizing its exclusive rights under these Theranos patents, Labrador sued a health start -up company, BioFire. In the lawsuit, Labrador alleged that testing technologies used by BioFire infringed on two patents that Labrador owns, and they also sought an injunction to stop BioFire from using its technologies. BioFire had announced that it was planning to launch Covid-19 tests using the technologies that were the subject of the lawsuit. BioFire’s development of these Covid-19 tests would come to a halt if Labrador’s injunction was granted. This resulted in public backlash, after which Labrador claimed that they were not aware that BioFire was working on Covid-19 tests when they filed the lawsuit. Thereafter, Labrador backpedaled and released a press statement announcing that it would permit third parties to use its patented technologies for development of Covid-19 tests.
While the situation is far from ideal, there is a silver lining. The aforementioned instances do demonstrate the frequently observed strife between patents and healthcare, but in some cases, this strife can be mitigated. For example, some patent holders give into public pressure (as evidenced by the Labrador example) and some, conscientiously, could make it easier and less expensive to access their patented technologies. To this extent, during the coronavirus pandemic, there have been some encouraging developments. The World Health Organization (“WHO”) has put together a Covid-19 Technology Access Pool that will be a storehouse of “Covid-19 health technology related knowledge, intellectual property, and data” to be of assistance globally in the development of vaccines and drugs. The Open-Covid Pledge has been advocating free access to patents in light of the serious nature of the pandemic. In the early stages of the pandemic, when HIV medication Kaletra was being assessed as a potential treatment for Covid-19, AbbVie Pharmaceuticals rose to the occasion and declared that it would not enforce its global patents rights on Kaletra. Whether AbbVie’s move was motivated by publicity, increasing public pressure, or simply goodwill on their part is up for debate; what is important is that they catered to general societal welfare by preventing a potential shortage of drug supply.
Despite these positive developments, the concerns surrounding inequitable access to a potential Covid-19 vaccine are valid. In anticipation of unfair access and distribution, some countries have already implemented compulsory licensing protocols. This allows governments to “authorize themselves, or third parties, to make use of a patent without the permission of the patent owner” subject to “protecting the legitimate interests of the right holder.” The use of compulsory licensing is particularly justifiable in light of the public’s interest during a pandemic. Compulsory licensing in the United States is called “march-in rights.” These rights give the U.S. government the right to grant licenses to applicants irrespective of the patent holder’s exclusive right, if the government determines that the patent holder has “(1) not taken effective steps to achieve practical application of the invention; (2) not reasonably satisfied health and safety needs; (3) not reasonably met requirements for public use specified by federal regulation; or (4) granted an exclusive right to use the patented invention to somebody without obtaining a required promise, or where the licensee in that case breaches a required promise, that the invention will be manufactured substantially in the United States.” Notably, the U.S. government’s use of march-in rights is only limited to federally-funded patents, which is not the case with compulsory licensing in other countries. As of now, it is unclear whether the U.S. government will resort to enforcing its powerful march-in rights. However, it seems unlikely because the government has previously never invoked its march-in rights. If the U.S. government decides to do so, alleviating “health or safety needs” is a compelling reason for the exercise of such rights in the middle of a pandemic.
Patent holders can choose to step up and provide easier access to Covid-19 technologies. Especially during the coronavirus pandemic, given the pressing need for equal and inexpensive access to a Covid-19 vaccine, they can and should responsibly utilize the wide discretion that they enjoy over their patents. If these patent holders choose to grant free access to their patents during the pandemic, then maybe the U.S. government will not have to intervene and resort to its march-in rights. At a larger level, perhaps the focus has been too much on the lucrative economic value of patents, rather than its ethical implications on human health. A re-evaluation of the role ethics play in the world of patents is imperative, and, if anything, the Covid-19 predicament is an ideal foundation to use to re-visit the conflict between patents and healthcare.
About the Author: Madhura Banerjee is a 2L at Cornell Law School. She grew up in Kolkata, India and has a law degree from Jindal Global Law School, India. This summer, Madhura worked at a corporate law firm and is interested in eventually pursuing a career in Intellectual Property.
Suggested Citation: Madhura Banerjee, Patent Rights in a Pandemic: Does the Race for a Covid-19 Vaccine Mean Inequitable Access?, Cornell J.L. & Pub. Pol’y: The Issue Spotter (Nov. 6, 2020), http://jlpp.org/blogzine/patent-rights-in-a-pandemic-does-the-race-for-a-covid-19-vaccine-mean-inequitable-access/.