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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

By Aparajita Lath

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes, creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development.

This issue may be the latest example of the tragedy of the “anticommons” in biomedical research.

Michael A. Heller and Rebecca S. Eisenberg used this phrase in 1998 to explain that proliferation of intellectual property rights in biomedical research could result in under-use of important inventions, due to several owners claiming rights over different / overlapping parts of the invention, and thereby blocking each other and others from use.

This prophesied tragedy is coming to life through patent disputes over mRNA vaccine technology. While this litigation does not seek to block sale of the vaccines, it has the potential to complicate and delay follow-on research efforts. mRNA technology has potential applications beyond COVID, and thus, access to samples is crucial for broader follow-on research. However, some suggest that patents are impeding access to research.

From a strict legal standpoint, since these vaccines are protected by patents, “use” by a third party requires permission from the patent holder. However, obtaining permission or using patented technology for “experimental” purposes is not straightforward.

Obtaining permission becomes complicated and expensive if there is a spiral of patent claims over previous inventions associated with different entities. In the mRNA context, there are several entities claiming patent rights over various aspects of the technology – from RNA modification to delivery.  This problem is not new in the biotechnology sector. For instance, a study conducted in 2005 by the American Association for Advancement of Sciences revealed that 40% of respondents reported problems securing licenses for carrying out research; 58% reported delays due to licensing requirements; and 28% reported abandoning their research due to licensing issues.

Additionally, long delays in resolving biomedical patent infringement disputes increases uncertainty over scope of patent rights. Currently, both Pfizer and Moderna are sparring over rights to their vaccines in at least five lawsuits. When expensive bio-medical inventions are involved, history shows that disputes could drag on in courts for years. This, in turn, delays research and new vaccine development efforts.

Though the common law principle of “experimental use,” which allows for certain “uses” by researchers and scientists as a defense to patent infringement, has long been recognized by courts in the U.S. (Whittemore v. Cutter, 29 F. Cas. 1120, 1121 (C.C.D. Mass. 1813)), it is rather narrow and may not help researchers to the extent desired.

These exceptions are limited to the use of patented material for philosophical experiments, to accomplish non-commercial objectives, or to verify whether the patent has made enabling disclosures. This defense has been applied rarely, since research is usually connected to a commercial objective.

The defense has been narrowed down over the years and “not for profit” status of an entity is not determinative (Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002)). This exception may not apply to broader experimentation that covers testing of patented inventions for the purpose of creating improvements or inventing around patents.

The Drug Price Competition and Patent Term Restoration Act, 1984, also known as the Hatch-Waxman Act, provides a statutory experimental use exception. This exception is also narrow and is applied to small molecule drugs. It allows third parties to use patented material for purposes reasonably related to the development and submission of information to regulatory authorities such as the FDA. However, the act of submitting an application to the FDA based on such research (e.g., to market a generic version prior to the expiration of the patent) is deemed to be an infringement . This “patent linkage” issue can trigger patent litigation.

Additionally, the Biologic Price Competition and Innovation Act prescribes a ‘follow on’ pathway for biologics. However, difficulty in reverse engineering biologics and trade secrecy complications has resulted in few biosimilars and limited uptake of this pathway.

More generally, trade secrecy around manufacturing processes, scientific data, and other process-related information are major obstacles to follow-on research and development.

Other practical challenges to follow-on research include procurement protocols. CDC requirements permit vaccination providers to procure vaccines for the purpose of vaccine administration and not for research use.

Taken together, these U.S. provisions stand in contrast to wider exceptions available in other countries, such as India. Wider exceptions are more conducive for and enable experimentation and research.

Given that the U.S. biotech sector is technologically proficient, and many researchers are interested in and potentially capable of developing mRNA vaccines, research provisions ought to be widened to enable greater levels of innovation. Alternately, research activities may be outsourced to technologically proficient countries with more liberal experimental use provisions.

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