Regulatory & Marketplace
The Patent Landscape Behind COVID-19 Vaccines
Development of vaccines to prevent COVID-19 has become a fascinating story, especially for those with any interest in life sciences. The speed in development and diversity of strategies that have arisen all around the world involve a vast patchwork of private companies, public institutions, and private-public partnerships such as CEPI (the Coalition for Epidemic Preparedness Innovations) and Gavi, a Geneva-based vaccine procurement organisation. However, most of the novel vaccines are being built using previously developed vaccine platform technologies. By vaccine platform technologies we refer to those techniques or methods that typically comprise multiple components or a common “recipe” and are used or have been proposed to be useful for producing more than one different vaccine1. Some platform technologies are older than others. For example, viral vectors carrying an antigen of choice have been used for longer and are more established than nucleic acidbased vaccines. In the development of Covid-19 vaccines, there has been a surprising uptake in the use of relatively new vaccine platforms. The choice of the less-tested platforms likely stems from the fact that the more traditional vaccine platforms have not been particularly successful in attempts to develop vaccines against coronaviruses, and also because many of the novel strategies promise a faster development timeline compared to the traditional platforms.
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Given that most of the newer vaccine platforms, or at least some components of them, will have been developed within the past 20 years, many of them are likely to be still covered by patent protection. In this article, we took a look at the patent landscape covering some of the platform technologies that are being exploited by researchers in the race to develop an effective COVID-19 vaccine. The WHO reported that as of July 14, 2020, there were 23 vaccines in clinical development and 140 vaccines in preclinical research2. Of this total of 163 vaccine candidates, 51 are reported as being developed using previously used platforms for vaccines against non-coronavirus targets. That leaves 112 vaccines that use a platform that has not previously been used for any approved vaccine. For the vaccines in clinical development, the number of vaccines that have been developed using a completely novel approach is surprisingly high, at roughly 50% (11/23). It is worth noting that vaccines that have been in development based on recent next-generation vaccine platform technology against other coronaviruses, such as SARS or MERS, have not yet resulted in clinically successful vaccines. On the topic of platform technologies, the EPO has recently published a variety of search statements to help in identifying the most relevant documents in various technical fields3. This is fairly similar to the WIPO coronavirus search tool that we described in our previous article 4, however the EPO tool includes a specific section that is focussed only on vaccines. The vaccine platform categories listed
are fairly broad, but include some of the specific platforms we will look at here, such as virus-like particles, nucleic acid based vaccines, nanoparticles and adjuvants used in formulating the vaccines. New Patent Coverage? Based on prior experience in patent filings for vaccines at the time of epidemics, it is clear many patents have been and will be filed for the new COVID-19 vaccines. We cannot yet evaluate most of the claims that have been filed to cover the novel vaccines themselves or see by whom they have been filed, because patent applications are typically published no earlier than 18 months from the filing. Having said that, the first patent application that specifically covers a COVID-19 vaccine was reportedly published on June 2nd, 2020 by China National Intellectual Property Administration5. The application No. CN202010193587.8 was only filed on March 18th by the Institute of Military Medicine, Chinese Academy of Military Sciences in conjunction with CanSino Biologics, a Chinese vaccine manufacturer. The patent application seems to describe the use of a human replication-deficient adenovirus as a vector encoding a specific S-protein sequence antigen. The description set forth that the claimed S-protein encoding nucleic acid sequence was optimised by reducing the content of rare codons to 3%, increasing the content of high-frequency codons to 81%, and increasing the GC content to 58%. The description further notes that the homology of the engineered S-protein antigen coding nucleic acid sequence with the original S-protein gene sequence was
Autumn 2020 Volume 12 Issue 3
