On March 22, 2022, WIPO published the Patent Landscape Report on COVID-19 Related Vaccines and Therapeutics, which was compiled from patent applications filed before the end of September 2021. As the average timeframe for a patent application to be published takes roughly 18 months from initial filing, the report should be considered as an examination of global patent activities during the beginning of the COVID-19 pandemic. A summary of the key findings presented within the report are as follows:

1. Filing activity related to the pandemic has been extraordinarily active so far.

Between the start of 2020 until the end of September 2021, there were a total of 5,293 patent filings on technologies related to COVID-19 in general, including 1,465 (27.68%) on therapeutics and 417 (7.88%) pertaining to vaccine development.

In comparison, there were only around 500 patent filings related to active ingredients within influenza vaccines between 1941 and 2011. Even during the SARS outbreak in early the 2000s, fewer than 1,000 related patents were published and no candidates emerged.

2. Patenting filing activity has been concentrated in three patent offices.

As COVID-19 vaccines and therapeutics have become a global concern, patents for therapeutics have been filed and published across 31 patent offices. Patents for vaccines have been filed and published across 19 patent offices. The numbers are expected to increase as more patent information becomes available. According to the existing dataset, most of the patent filings are concentrated at the China National Intellectual Property Administration (CNIPA), World Intellectual Property Organization (WIPO), and the United States Patent and Trademark Office (USPTO). Filings for therapeutics exceed those for vaccines across patent offices in India and the Republic of Korea.

3. Both the business and research community have contributed significantly to the patent landscape.

Patent applicants are distributed almost evenly between companies and universities/research organizations, with companies taking a slight lead. Within the therapeutics dataset, 44% of filings are by companies, and 41% are by academic research organizations. Within the vaccine dataset, 49% of filings are by companies, and 44% are by academic research organizations.

4. Different innovators played an important role in developing patented technologies

As the patent application period explored at this stage is fairly short, no single patent applicant stands out amongst the rest at the time. An analysis of patent applicants reveals that different innovators are making contributions to the development of new patented technologies. Different innovators include pharmaceutical companies, biotechnology startups, universities, research organizations, and independent inventors.

5. Filing strategies are already focused on international protection through the PCT system

As per the existing data at the time of the patent search, patent filing strategy patterns vary. Applicants in certain regions are focused exclusively on protecting their domestic IPs. Other applicants have attempted seek patent protection in multiple jurisdictions and related markets by filing European Patent (EP) and PCT applications. So far, the PCT system has received the second highest number of filings of any office.

6. China is currently the lead origin of patent filings related to vaccines

The top five patent applicant locations in the field of vaccines are China, the U.S., Russia, the U.K., and India. The top five patent applicant locations in the field of therapeutics are China, the U.S., India, the Republic of Korea, and Russia.

7. Development of COVID-19 vaccines has been across both conventional and novel platforms

COVID-19 vaccine development is occurring across multiple vaccine platforms spanning conventional to novel technologies. Conventional vaccine technology includes live attenuated viruses, inactivated viruses, protein subunits, and virus-like particles (VLP). Novel technology includes adenovirus vectors, DNA and mRNA vaccines. Overall, protein subunit vaccines are dominating patent application filings for conventional vaccine technologies at 46%. Novel vaccine technologies account for 35% of patent application filings, with viral vectors accounting for 23% and mRNA vaccines accounting for 12%.

8. Filings related to innovative viral vector and mRNA vaccines are the second biggest categories in patent data and mRNA second biggest in clinical trial data

35% of patent filings refer to novel vaccine platforms like viral vector and mRNA vaccines, ranking second overall. Although mRNA vaccines account for 12%, they account of 20% in clinical trial data, indicated that novel vaccine platforms are gaining momentum in clinical studies and that their contribution to patenting efforts in the future may be expected to grow.

9. COVID-19 therapeutics have developed on multiple fronts

As of the end of September 2021, combined analysis of data from the World Health Organization (WHO), the Milken Institute, the Regulatory Affairs Professionals Society (RAPS), and U.S. clinical trial data showed that 63 drug candidates have entered Phase 3 (or Phase 2/3) clinical trials, with several having already received conditional approval.

10. Most COVID-19 drug candidates are repurposed

Repurposed drugs means those that have been approved for treatment of a different disease but are now approved for a new use in treating COVID-19. The mechanism of action of new treatments include disrupting virus replication, modulating immune functions, reducing inflammation-associated tissue damage due to over-production and release of pro-inflammatory molecules (i.e., pro-inflammatory cytokines). Among these approaches are newly developed small-molecule antiviral drugs that can be taken at home.

11. Small molecule and biologic drugs are the main types of therapeutics

COVID-19 therapeutics are predominantly small molecules and biologics. Small molecule drugs include synthetic compounds and natural compounds extracted from plants; and biologic drugs include antibodies, non-antibody peptides/proteins, cell therapy, and nucleic-acid therapy. Patent filings related to COVID-19 therapeutics reveal that 54% are small molecule drugs and 36% are biologics, but clinical trial data reveals a roughly equal distribution of therapeutic candidates between small molecules and biologics. However, there is a significantly higher percentage of de novo synthesized drugs in biologics than in small molecules. As such, it may reflect an increasing interest among drug developers in the more sophisticated biologics and transforming them into clinical drugs.

12. Antibodies account for nearly half of the biologics, and their newly developed virus-neutralizing form introduces a new class of antivirals

Antibodies account for 42% of patent applications in biologics. COVID-19 therapeutic antibodies include the newly developed neutralizing antibodies directed against the SARS-CoV-2 spike (S) protein and previously developed antibodies that modulate the host’s immune/inflammatory response to the virus. Patent and clinical trial data reveals that virus-neutralizing antibodies are capable of binding to various regions of a crucial segment in the SARS-CoV-2 S protein to effectively block interaction with the corresponding human cell receptors, representing a new class of antivirals.

13. Innovative treatment approaches have been disclosed in the patent dataset

Novel treatment methods for COVID-19 include: targeting viral genes with CRISPER-Cas technology to disrupt the ability of the virus to infect host cells; attacking the virus and/or modulate host dependency factors by designing nucleic-acid based drugs (e.g., small interfering RNA, short hairpin RNA, microRNA, antisense oligonucleotides, aptamers); and novel delivery vehicles such as engineered exosomes (i.e., membrane-bound extracellular vesicles). However, the potential application of these innovative COVID-19 treatments has yet to be determined.

14. Cooperation is higher in drug development, clinical trials and manufacturing

Despite moderate levels of joint patent filings, higher levels of cooperation are happening upstream in the drug development lifecycle, and the phenomenon is more visible at the clinical trial stage. Vaccine data analysis by the Milken Institute, the Regulatory Affairs Professionals Society (RAPS), and the World Health Organization (WHO) reveals cooperation in the form of licensing, development, and marketing agreements to facilitate the development and distribution of both vaccines and therapeutics.

15. Collaborations comprise of pharmaceutical companies, biotech startups and universities

Collaborations exist between large pharmaceutical companies and smaller biotech startups, as well as between universities and commercial organizations. Examples include the development of oral antiviral therapeutic Molnupiravir, which is a joint effort between Emory University, Merck, and Ridgeback Biotherapeutics.

16. A combination of pandemic preparedness and response allowed for unprecedented accelerated vaccine and drug development

While the COVID-19 outbreak undoubtedly accelerated research and innovation, the record-breaking speeds by which vaccines and therapeutics were developed and approved would not have been possible without the scientific breakthroughs and related patenting activities over the past decades.

• Publish Date : 2022-11-09
• Update : 2022-11-09
• Organization : International Legal Affairs Office
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