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Patent Protection for COVID-19-related Innovations

05/04/2022

The two year milestone since the UK’s first lockdown has recently passed. Looking back over this period, the speed and efficacy of vaccines and therapeutics reaching the clinic has been remarkable. But how has innovation in response to the COVID-19 pandemic been reflected in patent filings?

The World Intellectual Property Organization (WIPO) has published a report evaluating the COVID-19-related patent landscape. The report only gives a first indication of patenting activity during the pandemic, containing data on patent applications published before the end of September 2021. Nonetheless, this initial snapshot indicates that COVID-19-related patenting has been a very active area. From January 2020 to September 2021, there were a total of 5293 COVID-19-related patent applications, compared to fewer than 1000 applications relating to SARS during the 2003-2007 SARS outbreak. In addition, COVID-19-related patent applications have been published and granted more quickly than other chemistry and bioscience applications filed during the same period.

Of the 5293 patent applications analysed in the report, 8% are for COVID-19 vaccines, and over a quarter (28%) are for COVID-19 therapeutics.

Novel vaccine technologies have gained momentum  

Nearly two-thirds of COVID-19-related vaccine patent filings refer to conventional vaccine platforms. The remainder use novel vaccine platforms, and include viral vector, DNA and RNA vaccines. However, novel vaccine platforms have greater representation at the clinical trial stage: for example, RNA vaccines account for 12% of vaccine filings, but make up 20% of vaccines in clinical trials. The patent dataset also revealed potential developments in vaccination approaches with published applications for inhalable vaccines, although this technology is not yet approved for use.

It is important to remember that patent applications for the underlying vaccine technologies were mostly filed pre-2020 so are not encompassed in WIPO’s dataset. In the case of mRNA vaccines, these patents are for modified mRNAs that can produce an immune response and for lipid nanoparticle capsules to deliver the mRNA. It has recently been reported that Arbutus Biopharma Corp. has filed a patent infringement lawsuit in the US against mRNA vaccine producer Moderna Inc. relating to six of its US patents for lipid nanoparticles. Moderna Inc. and Pfizer Inc. also face lawsuits filed by Alnylam Pharmaceuticals Inc. for infringement of Alnylam’s patents for a similar technology. It will be interesting to see how these lawsuits unfold and the repercussions this has for COVID-19-related innovation.

Therapeutic innovation ranges from drug repurposing to novel treatment approaches

COVID-19 therapeutics currently in clinical trials are directed to one of four therapeutic targets. However, the patent dataset indicates that other targets are being investigated. 54% of COVID-19-related therapeutic patent applications are for small molecule therapeutics, of which many are repurposed drugs, such as the repurposed anti-cancer drug pazopanib. Furthermore, 36% of therapeutic applications are for biologics, which encompass antibodies and cell therapy. Analysis of the patent dataset revealed developments in innovative treatments including CRISPR-Cas based therapies, drug-loaded exosomes and nucleic acid drugs such as small interfering RNAs (siRNAs).

Where is innovation occurring?

As well as revealing the types of technologies that have emerged from the innovation sparked by the pandemic, WIPO’s report also gives insight into where this innovation is occurring and by whom. Patent Cooperation Treaty (PCT) international applications and filings in China and the US account for the vast majority of vaccine and therapeutic patent applications. COVID-19-related patent applicants are almost equally likely to be companies or universities and research organisations. Interestingly, most patent applications have a single applicant.

WIPO’s report comes at a time when the societal benefits of COVID-19-related patents are being debated, with developments in inter-governmental discussions concerning a patent waiver being reported last month. From the diversity of patent applications detailed in WIPO’s dataset, it is clear that the patent system has not hindered innovation. The finding that most filings have one applicant, in conjunction with the pending vaccine-related lawsuits, emphasise the need for collaboration at later stages of drug and vaccine development in the form of licensing, development and marketing agreements to ensure global access to these innovations.

This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.

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