The courtroom battles and the future of the vaccine technology
The Covid-19 pandemic may be officially over, but the battle surrounding the technologies developed in response to the pandemic continues in courtrooms and patent offices worldwide. As the technology is adapted to address divergent diseases, the demand for new vaccines persists, leading to an ongoing surge in patent filings and legal disputes.
Remembering How it All Started
It’s a date of which not everyone will be aware, but some say it was the official start of the Covid-19 pandemic in Australia. The date was 19 January 2020, when four travellers from Wuhan, China were confirmed as having brought the novel coronavirus to New South Wales and Victoria. What followed was a race to close schools, ban gatherings, stop unnecessary travel, impose visiting restrictions to keep those in aged-care safe, lockdown all but essential workers, impose hotel quarantine for returning travellers and put-up barriers (in some cases literally) to enforce border closures. On 30 January 2020, the World Health Organisation (WHO) declared a public health emergency of international concern over the global outbreak of Covid-19 and the word “pandemic” entered everyone’s vocabulary.
The Race for Patent Protection
While the governments battled to keep their citizens safe, the pharmaceutical companies fought against time to be the first to find a vaccine to prevent the spread of Covid-19, and to file for patent protection of their invention. The first step was the sequencing of the Covid-19 (originally called SARS-CoV-2) genome, which was uploaded to GenBank on 12 January 2020. GenBank is an open access, annotated database of all publicly available nucleotide sequences and their protein translations. It took only 15 days after this for US company Novovax to file a patent application for its vaccine. Moderna, and Janssen Pharmaceuticals (wholly owned by Johnson & Johnson), filed their own patent applications before the end of that month.
An article published by the World Intellectual Property Organisation (WIPO) revealed that from January 2020 to September 2022, there were 7,758 patent filings on technologies related to COVID-19, including 1,298 patent filings related to vaccine development. The majority of filings came from China and the US, with Germany, the Republic of Korea and the Russian Federation next in line but with far less filings. Not surprisingly, corporations were the biggest filers.
It was 12 months before a Covid-19 vaccine was available in Australia. 22 February 2021 saw the start of a roll out of both the Pfizer/BioNTech (commonly referred to as just Pfizer) and Moderna mRNA vaccines, with the government paying the bill.
However, in third world countries the battle wasn’t about being the first company to have a vaccine approved, it was the availability of vaccines. Wealthier countries and the pharmaceutical companies said they would help by sending vaccines over to developing countries, but an article in The Guardian published on 21 October 2021 drew attention to the fact that only 14% of vaccines promised to these countries had reached them. Furthermore, according to the Our World in Data website, on 7 April 2022 the percentage of fully vaccinated people in high-income countries reached 74.1%. In contrast, the percentage of fully vaccinated people in low-income countries was only 11.51%.
With the fear and frustration surrounding Covid-19, and the huge amounts of money spent on not only developing suitable vaccines but also the cost of filing patent applications around the world, it’s not surprising that in mid-2022, the pharmaceutical companies began to turn on one another and the lengthy war of patent infringement and invalidity proceedings began.
Taking the Battle to the Courtrooms
On 26 August 2022, Moderna commenced proceedings against Pfizer and BioNTech in the US and Germany, claiming infringement of three of its patents relating to mRNA advances it had pioneered and patented well before the COVID-19 pandemic began in late 2019. The latter companies counterclaimed that the patents in suit were invalid. Fast forward to April 2024, when the US proceeding was put on hold while the US Patents Office decides whether two of the three Moderna patents are valid. Meanwhile in November 2023 the European Patent Office revoked one of the Moderna patents, but in May 2024 it decided that another patent was valid.
2022 found Moderna itself coming under attack, with proceedings started against it in the US by Arbutus Biopharma and Genevant Sciences Corporation, companies that claimed intellectual property rights in the nanoparticle lipids used by Moderna for its vaccines. Alynlam Pharmaceuticals also started US proceedings against both Moderna and Pfizer in 2022, alleging infringement of a number of of its patents directed to nanoparticle lipid delivery technology.
The list of companies engaged in patent proceedings keeps growing and crossing into multiple jurisdictions.
The Future of Vaccine Technology
Many of the technologies developed for Covid-19 vaccines, including the use of mRNA and nanoparticle lipids, have been repurposed to achieve vaccines effective against diseases that were previously challenging.
For example, recent publications have discussed mRNA vaccines against malaria, HIV, influenza and H5N1 bird flu. The mRNA and nanoparticle lipid platform technologies, which provide fast developments and productions times, are supremely suitable for the development of vaccines against a range of historical and emerging diseases.
As the Covid-19-stimulated vaccine race is now a race for the treatment of different diseases, it is likely that the war being fought inside court rooms and before patent offices around the world in relation to the patents discussed above will continue. As long as diseases exist, new vaccines will be needed, more patents will be filed, and more proceedings will be fought.
If you have any questions about patent protection for your pharmaceutical, biotech or life science product please do not hesitate to get in touch. Wrays would be happy to help.