Patent Landscape ReportCOVID-19-related vaccines and therapeuticsPreliminary insights on related patenting activity during the pandemicPatent Landscape ReportCOVID-19-related vaccines and therapeuticsPreliminary insights on related patenting activity during the pandemicThis work is licensed under Creative Commons Attribution 4.0 International. 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Box 18CH-1211 Geneva 20, SwitzerlandDOI: 10.34667/tind.45030ISBN: 978-92-805-3359-0 (PDF)ISBN: 978-92-805-3360-6 (online)ISSN: 2790-7007 (print)ISSN: 2790-7015 (online)Attribution 4.0 International (CC BY 4.0)Cover: Getty Images / Jonathan Filskov Drazen ZigicContents Acknowledgements 4Key findings 5Introduction 9Background biology of COVID-19 10Overview of patenting activity related to COVID-19 12Patent filings during 20202021 12Filing and publication of COVID-19- related patent applications over time 13COVID-19-related vaccine and therapeutic patent applicant profiles 16Research collaboration and IP strategies related to technologies important to COVID-19 vaccines and therapeutics 16Disclosure of sequences within patent documents 17COVID-19 vaccines 18Background vaccine platforms 18Conventional vaccine platforms 19Novel vaccine platforms 19Patent and vaccine distribution by vaccine platform and published applicant location 22Speed of vaccine development 23COVID-19 vaccine patent landscape 24Core vaccine technologies, collaboration and licensing 28Analysis of WHO data on COVID-19 vaccines 29Timelines on key technologies for COVID-19 vaccine development 31Technologies relevant to mRNA vaccine 31Timeline details for adenovirus vaccine development 33Timeline details for vaccine adjuvant development 34COVID-19 therapeutics 36Background 36Analysis of COVID-19 therapeutics- related patent applications by substances type 37Top locations of patent applicants for COVID-19 therapeutics and their filing strategies 38Highlights of patent filings related to COVID-19 therapeutic development 42Patent filings related to development of small-molecule drugs for COVID-19 42Patent filings related to the development of biologics for COVID-19 43Patents related to antibodies for COVID-19 treatment 43Peptide and protein therapies 43Nucleic-acid-based therapies 44Aptamer-mediated therapy 45Cell-based therapies 45Other biologic-based therapies 45Analysis of COVID-19 therapeutics in clinical trials 46Analysis of COVID-19 therapeutics data in the Milken Institute and Regulatory Affairs Professionals Society (RAPS) tracker data 46Distribution of COVID-19 drug candidates across small molecules and biologics, repurposed drugs and de novo synthesized drugs 47Classification of COVID-19 drug candidates in clinical trials by molecular nature and function 47Feature summary of examples of anti-COVID-19 drug candidates in clinical trials 48Perspectives 51Annex 54Data sources and methods 54Tables of vaccine types and candidates currently in clinical trials 56Examples of partial, early disclosure observed at the Israeli, U.K. and Singapore patent offices 67Glossary 69References 72Further reading 8134AcknowledgementsThis Patent Landscape Report on COVID-19 related vaccines and therapeutics is part of the WIPO COVID-19 response package launched by Director General Daren Tang to assist member states in addressing the COVID-19 pandemic and building back better as part of their sustainable post-COVID economic recovery efforts. This publication was prepared with the stewardship of Marco Alemn (Assistant Director General, IP and Innovation Ecosystems Sector), under the direction of Alejandro Roca Campa (Senior Director, IP for Innovators Department) and Andrew Czajkowski (Director, Technology and Innovation Support Division), and led by Irene Kitsara (IP Information Officer, Technology and Innovation Support Division).The report was prepared by the project team led by Irene Kitsara, including Catherine Saveson, Adam Miller, Cynthia Liu, Dmitrii Polshakov, Qiongqiong (Angela) Zhou, Jeffrey Smoot, Rumiana Tenchov, Yingzhu Li, Anne Gregg, Linda Garner, Natalie Ciancetta, Tiffany Beskid, Cinda Harrold (all from CAS, a division of the American Chemical Society), with inputs from Luca Falciola (Scibilis) on patent search methodology. Examples of partial, early disclosure, observed at the Israeli, U.K. and Singapore patent offices, as well as examples of accelerated patent publication and grant, were provided by Luca Falciola. The report also draws on helpful input received during the conceptualization phase from Martin Friede (WHO), Amina Maillard (Medicines Patent Pool MPP) and Hans Georg Bartels (Global Challenges Division), and benefited greatly from reviews by Amina Maillard (MPP) and a number of WIPO colleagues, including Carsten Fink (Economics and Data Analytics Department); Amy Dietterich and Hans Georg Bartels (Global Challenges Division); and Lakshmi Supriya and Craig Dsouza (Access to Information and Knowledge Division) during the validation proofreading phase. Figures were prepared by Lakshmi Supriya (Technology and Innovation Support Division) with the support of Vipin Saroha (Partnerships, Platforms and Tools Section). Thanks also go to Charlotte Beauchamp (Head, Publications and Design Section) for her invaluable support and advice, Vanessa Harwood for her editorial oversight and Sheyda Navab for the report design.Further informationOnline resources: The electronic version of this report can be accessed at wipo.int/publications/en/details.jsp?id=4589. This webpage also includes COVID-19, COVID-19 vaccines and therapeutics datasets.Contact: patent.informationwipo.int5Since the start of the COVID-19 pandemic there have been remarkable research and innovation efforts to fight the SARS-CoV-2 virus and the COVID-19 disease. This report provides early observations on the patenting activity which took place in the field of COVID-19 vaccines and therapeutics, and compares these results with clinical trial data for related candidate vaccines and drugs.Filing activity related to the pandemic has been extraordinarily active so far The patent search looked at related patent filings from the beginning of 2020 through the end of September 2021. It revealed 5,293 patent filings on technologies related to COVID-19 in general, including 1,465 patent filings about therapeutics and 417 about vaccine development.By comparison, from 1941 to 2011 there were just over 500 patent filings related to active ingredients about the influenza vaccines (WIPO, 2012). Even during the SARS outbreak of the early 2000s, fewer than 1,000 related patents were published, with no vaccine candidate emerging.Early numbers are only a snapshot of actual patent activityOn average, there is an 18-month period between filing a patent application and the time this application becomes published and thus publicly available and known. For this reason, at the time of the data collection (end of September 2021), the information publicly available was not yet complete. The current study should therefore be viewed as a first indication of patenting activity during the pandemic.Patenting filing activity has been concentrated in three patent officesAs COVID-19 vaccines and therapeutics concern a global market, it is no surprise that already at this stage related applications were filed and published across 31 (therapeutics) and 19 (vaccines) patent offices; numbers which are expected to increase as more patent information becomes available.In the current dataset the China National Intellectual Property Administration (CNIPA), the World Intellectual Property Organization (WIPO), administering the Patent Cooperation Treaty (PCT) system, and the United States Patent and Trademark Office (USPTO) received most of the patent applications in both these fields.According to the data available so far, India and the Republic of Korea are offices that have received more filings in the field of therapeutics than vaccines.Both business and the research community have contributed significantly to the patent landscapePatent applicants are distributed almost evenly between companies (49 percent of the vaccines and 44 percent of the therapeutics dataset) and universities and research organizations (44 percent of the vaccines and 41 percent of the therapeutics dataset), with companies accounting for a slightly higher proportion of the two datasets.Key findings6Patent Landscape Report COVID-19-related vaccines and therapeuticsThe research community has played an important role in developing patented technologiesWhile corporates are typically the producers of final products and hold more patents, universities and research organizations play a significant role in developing patented technologies in this area, as shown by their high contribution to the patent dataset. This is further exemplified by the role of Oxford University in the development of an adenovirus vector COVID-19 vaccine by AstraZeneca, and the number of universities and research organizations which feature among the vaccines and therapeutics developers and manufacturers in the related clinical trial data.Full information on patent applicants is not yet available, but we see innovators representing different profilesThe present patent analysis does not systematically highlight top patent applicants as the patenting period in question is very short and the full patent data for this period is not yet available. Nevertheless, we already see patenting activity from key innovators and developers of candidate vaccines and therapeutics which feature in the clinical trial data and the news. There are different innovator profiles contributing to patented technologies: pharmaceutical companies, biotechnology startups, universities, research organizations and independent inventors.China is currently the lead origin of patent filings related to vaccinesThe patent applicants location can provide an indication about the profile and origin of key players in patenting activity.The top five patent applicant locations in the field of vaccines are China, the United States of America (U.S.), the Russian Federation, the United Kingdom (U.K.) and India. In the field of therapeutics, China, the U.S., India, the Republic of Korea and the Russian Federation are the top applicant locations.Filing strategies are already focused on international protection through the PCT systemAs per the existing data at the time of the patent search, patent filing strategy patterns vary. Applicants in some locations have focused exclusively on protecting their intellectual property (IP) domestically. Others have already expressed an intention to seek patent protection in multiple jurisdictions and related markets, by filing European Patent (EP) and PCT applications: the PCT system has received the second highest number of filings of any office so far, both in the fields of vaccines and therapeutics.Bearing in mind the increasing availability of patent data over time, the filing strategy picture may change in the coming months, as patent applicants may exercise their right to file for patent protection in additional jurisdictions beyond their national offices, and as PCT applications enter national phase in different jurisdictions.Development of COVID-19 vaccines has been across both conventional and novel platformsMultiple vaccine platforms have been explored for COVID-19 vaccine development. These platforms range from the conventional ones, such as live attenuated and inactivated/killed whole virus vaccines, protein subunit vaccines and virus-like particles (VLP), to the novel ones, including adenovirus-vector-based, DNA-based and mRNA vaccines.While a patent document may claim different vaccine platforms, there are more patent filings referring to conventional vaccine platforms (protein-based, live attenuated, inactivated, VLP) than to novel vaccine technologies.The conventional vaccine category of protein subunit vaccines is the largest category in the dataset, with 46 percent of the overall vaccine patent filings referring to it. Novel vaccine technologies have a lower yet notable contribution to the dataset, with 35 percent of the patent filings referring to either viral vector (23 percent) or RNA (12 percent) vaccine technologies.Looking at the clinical trial data, while protein subunit vaccines are again the biggest category (accounting for 34 percent of vaccines in clinical 7Key Findingstrials and preclinical studies), there are nearly double as many RNA vaccines in clinical trials (20 percent) compared to their contribution to the patent dataset (12 percent). This would indicate that the novel platforms are gaining momentum, especially in clinical studies.Filings related to innovative viral vector and mRNA vaccines ar