December 19, 2022

During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 1 of 2)


More than two years into the COVID-19 pandemic, we have a clearer picture of how the patent community responded to the rush to develop COVID-19 vaccines: patent pledges.  Patent pledges are voluntary, public commitments that a patent holder makes to refrain from exercising some or all of its patent rights, including suing for patent infringement.  Prior examples of patent pledges can be found in the automotive industry (e.g., electric vehicle makers Tesla and Toyota), the software industry (e.g., IBM and Google relating to open-source code), and in the biotechnology industry (e.g., Monsanto relating to genetically modified seeds and Myriad’s pledge not to assert its DNA patents against academic researchers).  In the midst of the COVID-19 pandemic, many patent holders pledged not to enforce patents needed for vaccine development, the frontline immunotherapy for combating COVID-19.  By April 2020, the Open COVID Pledge platform had been formed, allowing for the large-scale pledging not to enforce COVID-19 vaccine-related patents until the end of the pandemic, as declared by WHO, or January 1, 2023 (likely to be extended).

However, these pledges are not permanent.  For instance—on March 7, 2022, Moderna updated its previous COVID-19 pledge not to enforce COVID-19 related patents during the pandemic to instead state that “[i]n non-AMC 92 countries, vaccine supply is no longer a barrier to access. In these countries, the Company expects those using Moderna-patented technologies will respect the Company’s intellectual property. Moderna remains willing to license its technology for COVID-19 vaccines to manufacturers in these countries on commercially reasonable terms.”  Moderna put this revised pledge in action when it filed a patent infringement lawsuit against mRNA vaccine competitors Pfizer and BioNTech, asserting patents it considers foundational to mRNA vaccine development and which predate the COVID-19 pandemic.  In its complaint, Moderna again emphasized that it “would consider a commercially-reasonable license should [Pfizer and BioNTech] request one.”  This dispute will likely be resolved through battling out the merits of the infringement claim in district court or by the parties agreeing to a “commercially-reasonable license.”          

However, perhaps there is an alternative to these patent pledges to facilitate the sharing of foundational patented technology that is needed to develop vaccines in response to a pressing public health emergency.  One such avenue, which has been previously proposed by others, could be to use the model of patent pooling of Standard Essential Patents.  This two-part article will examine what such a Standard Essential Patents regime may look like in the public health emergency vaccine space (Part I), then examine potential effects of such a regime on all parties involved in view of the existing patent pledge regime which helped facilitate the development of a COVID-19 vaccine in under a year (Part II).

Standard Essential Patents (SEPs) are patents claiming technology so essential to an industry’s operation that the technology is considered to be industry standard. For example, when technologies such as LTE and Wi-Fi became standardized, patents covering these technologies became SEPs.  Industry-specific standard setting organizations (SSOs), which are comprised of companies in the industry as well as other industry players, jointly determine which patents are to be categorized as SEPs.  Once the SEPs have been identified, the SSO sets a licensing arrangement so that the SEP holders make their patented technology accessible to other users under Fair, Reasonable, and Non-Discriminatory (FRAND) terms.  FRAND terms ensure that users of SEPs are able to license the patents covering the standardized technology on fair grounds from the SEP holders.  Thus, a SEP system creates a predictable licensing model for entities granting them access to patents necessary to utilize an industry’s standard technology. SEPs and SSOs thus enable others to develop  products that are compatible with the industry-standard technology, such as cell phones that work on LTE networks. 

What would a SEP regime look like for vaccine development during a public health emergency?  The first question to consider is whether in a fast moving public health emergency, could a standard technology for vaccine development emerge?  Looking to the COVID-19 pandemic, two vaccines developed by Pfizer/BioNTech and Moderna utilizing mRNA technology proved to be exceptionally effective and mRNA vaccines came to be viewed as the “gold standards” among COVID-19 vaccines.  Thus, this mRNA vaccine technology could be considered standard for further vaccine development in the current COVID-19 public health emergency.  It is likely in future public health emergencies that another technology could emerge as the standard for vaccine development much as mRNA vaccine technology has in the COVID-19 pandemic. 

With a standard technology identified, the next question to address is the composition of a SSO.  An SSO often includes different types of industry participants such as distributors, producers, suppliers, and inventors.  In the vaccine development space, key players such as vaccine developers, clinicians, and the FDA could comprise the makeup of a SSO.  Once an SSO is created, it would identify patents covering the standard.  Once the standard is agreed upon and SEPs are identified, the SSO will set a licensing arrangement in which SEP holders commit to making their patented technology accessible to other entities under FRAND (Fair, Reasonable, and Non-Discriminatory) terms.  FRAND terms help to ensure that SEP implementers are able to license and use standardized technology on fair grounds.    

Thus, a potential SEP regime for COVID-19 mRNA vaccine technology could allow for a predictable license fee for entities seeking to utilize the technology standard covered by SEPs.  As we are sure to face unknown pandemics in the future, it may be worthwhile to explore these ideas now so as to prepare the most efficient and effective way to develop vaccines that will combat the public health emergency while also properly incentivizing and protecting the efforts of innovators who develop the standard technology.  Stay tuned for Part II of this series which will examine the potential benefits and drawbacks of such a regime being implemented for vaccine development during public health emergencies.

The post During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 1 of 2) appeared first on Immuno-Innovation.

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