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Unveiling patenting strategies of therapeutics and vaccines: evergreening in the context of COVID-19 pandemic

Bacigalupo et al., Frontiers in Medicine, doi:10.3389/fmed.2023.1287542
Dec 2023  
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Review of the patenting activity and evergreening approaches for three major COVID-19 antiviral medications – remdesivir, molnupiravir, and favipiravir. Authors found extensive primary and secondary patent filing, with 29 applications covering up to 43 years of potential monopoly protections, with an intensification of evergreening efforts during the pandemic, showing attempts to leverage follow-on patents to extend and maintain monopolies. New patents had limited effect for favipiravir where inexpensive generics were available. Expansive patenting creates disincentives for studying or promoting cheaper off-patent treatment alternatives, biases R&D priorities towards patented options, and erects legal barriers to generic competition even after primary patents expire.
Reviews covering molnupiravir for COVID-19 include Anonymous, Bacigalupo, Goldstein, Hadj Hassine, Kosakovsky Pond, Malone, Swanstrom, Waters.
Study covers molnupiravir, remdesivir, and favipiravir.
Bacigalupo et al., 6 Dec 2023, peer-reviewed, 6 authors. Contact: mariaflorenciapignataro@gmail.com.
This PaperMolnupiravirAll
Unveiling patenting strategies of therapeutics and vaccines: evergreening in the context of COVID-19 pandemic
María Lorena Bacigalupo, María Florencia Pignataro, Carolinne Thays Scopel, Sergiy Kondratyuk, Othoman Mellouk, Gabriela Costa Chaves
Frontiers in Medicine, doi:10.3389/fmed.2023.1287542
In the pharmaceutical sector, evergreening is considered a range of practices applied to extend monopoly protection on existing products. Filing several patent applications related to the same active pharmaceutical ingredient (API) is one of the most common manifestations of evergreening. During the COVID-19 pandemic, several health technologies were developed. This study aimed to analyze the extension of evergreening for selected health technologies for SARS-CoV-2 through patent filing strategies. Starting with the selection of three antivirals, one biological and two vaccines, a patent landscape was built based on public and private databases. Regarding these selected technologies, we analyzed some of the evergreening strategies used by different applicants, academic institutions or pharmaceutical companies and found a total of 29 applications (10 after the pandemic) for antivirals, 3 applications for a biological drug (1 after the pandemic), and 41 applications for vaccines (23 after the pandemic). Despite differences among the technologies, a common aspect found in all analyzed cases is the intense patent filing after the pandemic, aligned to the fact that those technologies were moving through the R&D process up to regulatory approval. The evergreening approach pursued has already been found in other diseases, with the risk of monopoly extension and also bringing legal uncertainty due to the lack of transparency of newer patent applications covering specific medical indications. Therefore, efforts to address evergreening should be pursued by countries, including the adoption of a public health approach to the patent examination of those technologies to prevent the granting of undeserved patents.
Author contributions Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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