A Patent-ly Bad Idea

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Issue 15, Volume 111

By Rania Zaki 

Cover Image

When I first heard about the COVID-vaccine, I sighed with relief. Metaphorically, I had mistaken it for a holy cure, a solution to ailment and alienation. However, the outcome of the pandemic is as reliant on social structures as protein structures. A vaccine ready for injection comes to nothing without the social structures that lead to its development, production, and distribution. A major factor is pharmaceutical policies, which can impede or support effective measures toward a shift to a pre-COVID society. Thus, there is an urgent need to scrutinize the role of the law in one of the major problems: vaccine inaccessibility.

So far, it’s not a pretty outlook. Over half of all doses administered have been in Europe and North America, while many developing countries have vaccinated less than one percent of their populations. In India, a second wave has paralyzed the nation. Some areas have 0.1 vaccines per 100 people while the U.S. has over 78 per 100. Over 80 percent of developing countries are lacking in vaccine supplies. To say it’s grim, at least for poor countries, would be an understatement.

There has been recent scrutiny surrounding intellectual property (IP) rights, which not only provide the right to possess material through protections, such as copyrights, but also allow the material’s usage to be controlled by the owner. In the biomedical sector, this protection is granted through a short-term monopoly given to innovative firms through patents. Patents protect inventions for a designated time frame, usually 20 years, while at the same time allowing firms to set the invention’s price and decide if, when, and where it can be produced. Economically, IP rights are needed because companies invest heavily in research and development with a high risk of failure. If other companies could freely replicate a newly discovered innovation, the new invention’s price would quickly fall to the marginal cost of production, leaving the innovator unable to recuperate the costs of development. The existence of this monopoly ensures that generic medication, like those found in local pharmacies, are produced after the reimbursed period expires.

There are two ways that patents disincentive widespread production. First, patent law discourages the disclosure of unpatentable information that might lead to a patentable development. This follows from patenting being the first-takes-all framework. Regardless of how many research teams close in on a patentable discovery, the first group to the patent office gets all the rights in the development. This deters researchers from sharing unpatentable insights, such as the genetic makeup of a virus, that could lead to patentable treatments with further development. Secondly, patent laws are unique to each country, meaning that many enforce their production in only the country of origin. Agreements like the Trade-Related Aspects of Intellectual Property Rights (TRIPS) can prevent data-sharing in countries due to the nature of policies implemented under sovereignty. As the rights under another country might be difficult to implement, many research teams do not patent under other jurisdictions.

Many have sounded the alarm: a proposal has been circulating for months to waive IP protections for COVID-19 vaccines. Though the U.S. holds most of the IP protections regarding vaccines, the Biden administration voiced support for this waiver, which would allow the production of generic vaccinations domestically and internationally. The waiver is vague but emphasizes that “negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved."

However, this is not as simple as waiving all patents and vaccinating the unprivileged. The accessibility of COVID-19 vaccines is dependent on both affordability and manufacturing capabilities. Such a waiver would increase manufacturing capability while reducing manufacturing effectiveness, risking an expensive failure. Vaccines are not drugs: while drugs tend to have a strict chemical makeup and are easy to synthesize through generic replication, vaccines are often created through proprietary recipes and specific cell lines. That means that even if a vaccine is developed, a specific process as well as the materials are required for production. Though other manufacturers will be able to produce the vaccine, they will encounter a barrier of knowledge in doing so efficiently. As companies are not required to disclose such insights, we run the risk of companies dismissing any requests for information. Pouring money into other firms, who may not have the right equipment or tools to create these vaccines, would entail more time and effort in securing these specifications than using the patented manufacturer.

Many opposing the waiver have questioned the chain-effect of patents. A vaccine is made up of many components, from its biofillers to the machinery made to produce the vaccine; waiving ne IP right will not dismantle the many other protected processes used to produce the vaccine.

However, many in support of the waiver prioritize urgency over that of IP rights for two reasons. First, COVID variants put an expiration date on vaccines: the more we limit vaccinations to increase long-term innovation, the more likely we are to allow the spread of variants that may become resistant to vaccines, such as the ones in India and California. As vaccines are specific to one or a few types of variants, over-enforcing these IP rights would obliterate the profits these companies seek and result in an obsolete product.

Second, many argue that a global pandemic was never a situation in which the patent system was supposed to function. IP rights are meant to prevent unfair competition that could limit reimbursement for research, such as otherwise unprofitable research into rare diseases that have small patient pools. However, due to the widespread effect of COVID-19, this is not a factor to consider. Also, many vaccines received public funding directly or indirectly through previous phase trials under the SARS-research grants, meaning that sales have already recouped many development costs. Sales of Gilead’s Sofosbuvir, a hepatitis C drug used to treat COVID-19, have reached $58.6 billion, having received $880 million in funding from U.S. public agencies. Many technological sectors, much less one innovation, have never received so much money in such a short time.

The IP waiver isn’t the only option. A newly launched global COVID-19 IP Pool, under the control of the World Health Organization, allows organizations to voluntarily share their IP rights, technology transfers, and other know-how relevant to vaccines and diagnostic developments. This will then be available for free or licensed “on reasonable and affordable terms,” thus improving the advancement, accessibility, and affordability of treatment measures.

As miscommunication and medicinal exclusivity curtail international access, we need to ensure that information sharing is done in a way that facilitates access for developed countries as well as developing countries. Though the bedrock of moving with the IP waiver is on heavy waters, the predominance of medical inaccessibility requires us to re-analyze the frameworks that led to this. For once, there needs to be a shift from nationalism to internationalism and from exclusivity to inclusivity.