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COVID-19 Vaccine IP Catch-up

The world has been in pandemic mode for more than eight months and researchers are working around the clock to find a vaccine against COVID-19. The New York Times reports that there are 38 vaccines in human clinical trials and at least 93 preclinical vaccines under active investigation in animals. Here are some patent updates tied to COVID-19 vaccines.

In China, the National Intellectual Property Administration issued its first COVID-19 vaccine patent to CanSino Biologics Inc. and the Academy of Military Sciences. The issued Patent No. CN111218459 describes Ad5-nCo, a vaccine that is based on human type 5 replication defective adenovirus. Ad5-nCo entered clinical trials in March. In May, Phase 1 safety trials showed promising results. In July, Phase 2 trials showed that the vaccine produced a strong immune response. The abstract of the issued patent reads:

…The vaccine uses the replication-deficient human type 5 adenovirus with combined deletion of E1 and E3 as a carrier, and uses HEK293 cells integrating the adenovirus E1 gene as a packaging cell line, and the protective antigen gene carried is an optimized design of 2019 new coronavirus (SARS‑CoV‑2) S protein gene (Ad5‑nCoV). After optimization of the S protein gene, the expression level in the transfected cells was significantly increased. The vaccine has good immunogenicity in mice and guinea pig models, and can induce the body to produce strong cellular and humoral immune responses in a short time…

In Russia, Gam-Covid-Vac, now renamed Sputnik V, has received a conditional regulatory approval pending positive results from its Phase 3 trials. The vaccine is patent pending and consists of two components, a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector, both carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S).

In the U.S., the U.S. Patent and Trademark Office has implemented a prioritized examination pilot program for certain COVID-19 related patent applications. Recently, a New York-based biotech company called Aquavit Pharmaceuticals, Inc. took advantage of the pilot program and filed a patent application for its self-administrable vaccine delivery method. The Chief Executive Officer, Sobin Chang, said that they are “in talks with multiple global scale pharmaceutical companies, vaccine makers, and major universities for collaborations and partnerships.”

Also in the U.S., an advanced vaccine mRNA-1273 is being developed by Moderna Therapeutics and the National Institutes of Health. The vaccine is based on messenger RNA to produce viral proteins in the body and has progressed to Phase 3 testing. In July, however, Moderna became tied up in some patent disputes over mRNA-1273. First, Moderna unsuccessfully challenged certain claims of an Arbutus Biopharma Corp. patent, which could have cleared out some of Moderna’s infringement concerns. Also, the National Institutes of Health may have filed an earlier patent application tied to mRNA-1273. In an August financial filing, Moderna says that “[they] cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions, including mRNA-1273.”


**This article was originally published by The Lawyer’s Daily (www.thelawyersdaily.ca) a division of LexisNexis Canada Inc.





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