Michelle Mao is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.
Moderna and Pfizer battle’s over the inventive process of their respective mRNA COVID-19 vaccines revisit the negative associations of profit, monopolies, and optics in patent litigation. On August 26, 2022, Moderna released a press statement that they will pursue a patent infringement lawsuit against Pfizer/BioNTech for their use of Moderna’s registered mRNA patents in creating the Pfizer COVID-19 mRNA vaccine. Moderna claimed that they had registered foundational mRNA patents between 2010 and 2016. Most interestingly, however, is that while Moderna is pursuing an infringement claim, they clarified that they will not prevent future sale of Pfizer vaccines, will not seek damages from sales of Pfizer’s vaccines in certain circumstances, will not seek a cut of Pfizer’s sales from the US government or from the 92 low and middle-income countries that had trouble accessing COVID-19 vaccines. While the specific remedy sought by Moderna is not defined in the press statement, experts think Moderna wants a chunk of Pfizer’s profits, such as through royalties.
The strategic choice of Moderna’s press statement to detail remedies they will not pursue without revealing the precise remedies they will pursue has led critics to call Moderna out for using “optics” and the quasi-sacrosanctity of intellectual property to further profits and strengthen their position in the mRNA pharmaceutical business. The balance that patent law seeks to achieve is well known, with Article I, Section 8, Clause 8, of the United States Constitution defining the purpose “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.” Moderna sought to protect themselves from the feeling of “unfairness” that arises when another appropriates your labour (in this case, Moderna’s labour of researching mRNA-based vaccines). Appealing to deeply engrained values of ownership, investment of resources and labour, and protecting themselves against misappropriation of their invested resources Moderna can protect its brand image while seeking billions of dollars from Pfizer in royalties or other types of remedies by, for example, appealing to deeply engrained values of ownership, investment of resrources and labour, and protecting themselves against misappropriation of their invested resources.
The values at issue in this lawsuit speak to the current flaws of patent laws around the world, and the lawsuit’s impacts will be especially prominent as it relates to the COVID-19 vaccine that has saved almost 20 million lives in just one year. Currently, the Moderna versus Pfizer patent litigation is only being restricted to high-income countries solely on Moderna’s promise not to seek money from sales in low-income countries. However, reliance on this promise may be flimsy as Moderna has already modified its promise to not enforce patents through litigation during the pandemic to enforcement in high-income countries (as seen now). This exposes some concerns about our patent laws. For example, this lawsuit may have a chilling effect on future mRNA vaccine development. Another concern is how low- and middle-income countries (LMICs) may suffer from future patent lawsuits where promises not to seek sales from LMICs are not made and in the context of . Balancing the need to encourage rapid responses to global emergencies that require new technologies and access to these technologies all while discouraging monopolies will need to be scrutinized as we head out of the COVID-19 pandemic.
So what solutions are available to prevent slowdowns in innovation and concerns for access in LMICs? What solution could be to make amendments to a country’s patent act, such as Canada’s COVID-19 Emergency Response Act which included such amendments. However, the impacts to the patentee could be significant, especially in terms of profits in a national or global emergency. While the amended Patent Act ensures payment of remuneration which the Commissioner of Patents deems adequate in section 19(4) of the Patent Act, this provision may not be feasible in countries with weaker economic power. A statutory defense to patent enforcement could be another solution, as seen in the American approach in 28 U.S. Code § 1498 (a). This section allows patent “infringement” if the manufacturers are manufacturing goods for the use of the government in difficult times. Interestingly, we are already seeing this defense being used by Moderna themselves against the patent infringement claims made against them. While these are two approaches available, the countries implementing these adjustments to patent protections are high-income countries with economic power to guarantee patentees are adequately recompensated, leaving the issue for LMIC concerns unaddressed. Additionally, these solutions also may not adequately address the chilling effect on innovation as the statutory defense is limited and the consequences of patent litigation are expensive.
Currently, no court decisions have been rendered regarding Moderna’s patent infringement claim against Pfizer. However, given the novelty and scale of the COVID-19 pandemic, there is no doubt that whatever decision is made, it will become a new precedent for future patent infringement claims of this scale.