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.
References
Banerjee, Banerjee, Singh, Kumar, Pooja et al., A clinical insight on new discovered molecules and repurposed drugs for the treatment of COVID-19, Vaccines,
doi:10.3390/vaccines11020332Benenato, Kumarasinghe, Cornebise, Inventors, Modernatx, Inc, applicant. Compounds and compositions for intracellular delivery of therapeutic agents, WO
Chaves, Vieira, Rdfda, Vianna, Medicines under exclusivity situation funded by the Ministry of Health: analysis of the patent situation and public 10
Correa, Guidelines for the examination of patent applications relating to pharmaceuticals
Cross, Rho, Reddy, Pepperrell, Rodgers et al., Who funded the research behind the Oxford-AstraZeneca COVID-19 vaccine?, BMJ Glob Health,
doi:10.1136/bmjgh-2021-007321Daerden, Moderna's profits show why big pharma can't meet our health needs
Forbes, The global 2000
Garrison, How the 'Oxford' Covid-19 vaccine became the ' AstraZeneca' Covid-19 vaccine
Hatchett, Saville, Downham, Cueni, Bigger et al., Towards vaccinating the world: landscape of current COVID-19 supply chain manufacturing capacity, potential challenges, initial responses, and possible "solution space
Holy, Rosenberg, Inventors
Kondratyuk, Access to Oxford-AstraZeneca, Johnson and Johnson, Moderna and Pfizer-BioNTech COVID-19 vaccines in 17 middle-income countries in 2021
Krishnamurthy, Grimshaw, Axson, Choe, Miller, Drug repurposing: a systematic review on root causes, barriers and facilitators, BMC Health Serv Res,
doi:10.1186/s12913-022-08272-zLabban, The case of remdesivir: how do you calculate the cost of a pandemic drug? Pharmaceutical technology
Lalani, Nagar, Sarpatwari, Barenie, Avorn et al., US public investment in development of mRNA covid-19 vaccines: retrospective cohort study, BMJ,
doi:10.1136/bmj-2022-073747Lamontagne, Agarwal, Rochwerg, Siemieniuk, Agoritsas et al., A living WHO guideline on drugs for covid-19, BMJ,
doi:10.1136/bmj.m3379Lo, Jordan, Arvey, Sudhamsu, Shrivastava-Ranjan et al., GS-5734 and its parent nucleoside analog inhibit filo-, Pneumo-, and paramyxoviruses, Sci Rep,
doi:10.1038/srep43395Lurie, Keusch, Dzau, Urgent lessons from COVID 19: why the world needs a standing, coordinated system and sustainable financing for global research and development, Lancet,
doi:10.1016/S0140-6736(21)00503-1Medicines, COVID-19: another of Gilead's five patent applications on remdesivir is opposed in Argentina
Medicines, Pool, Medspal, None
Medicines, Pool, None
Medicines, Pool, Vaxpal, None
Medicines, Thai civil society opposes patent on an influenza drug, now used for COVID-19
Oliyai, Fardis, 05 -Viread
Pilkington, Keestra, Hill, Global COVID-19 vaccine inequity: failures in the first year of distribution and potential solutions for the future, Front Public Health,
doi:10.3389/fpubh.2022.821117Pollack, High cost of Sovaldi hepatitis C drug prompts a call to void its patents, The New York Times
Reynolds, US gets almost all of the world's supply of key Covid-19 drug
Rubin, Chan-Tack, Farley, Sherwat, FDA approval of remdesivir: a step in the right direction, N Engl J Med,
doi:10.1056/NEJMp2032369Scopel, Estratégias de acumulação de capital das big pharma: estudo de empresas selecionadas entre 2008 e 2019
Sheahan, Sims, Graham, Menachery, Gralinski et al., Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses, Sci Transl Med,
doi:10.1126/scitranslmed.aal3653Shores, The mRNA patent and competitive landscape: pioneers, litigation outlook and big pharma's next moves (part III). IPWatchdogcom Patents & Intellectual Property Law
Singla, Goyal, Antiviral activity of molnupiravir against COVID-19: a schematic review of evidences, Bull Natl Res Cent,
doi:10.1186/s42269-022-00753-9Thambisetty, Mcmahon, Mcdonagh, Kang, Dutfield, Addressing vaccine inequity during the COVID-19 pandemic: the trips intellectual property waiver proposal and beyond, Camb Law J,
doi:10.1017/S0008197322000241Warry, Coronavirus: US buys nearly all of Gilead's Covid-19 drug remdesivir
