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In the on-going battle between Moderna and BioNTech/Pfizer over mRNA patents, the European Patent Office (EPO) has revoked one of Moderna’s patents involved in the dispute.
What happened between Moderna and rival pharmaceuticals?
Moderna had previously filed the patent in question, EP3718565 titled “Respiratory Virus Vaccines”, with the European Patent Office in October 2016. The patent was prosecuted and subsequently granted in April 2022 in the midst of the COVID-19 pandemic. Following the grant of the European patent, Moderna sued both BioNTech and Pfizer in several countries, including Germany, UK, the Netherlands, Belgium, and Ireland for infringement of this patent and another, EP3590949 directed to “Ribonucleic Acids containing n1-Methyl-Pseudouracils”. The litigation revolved around the COVID-19 vaccines produced and sold by BioNTech and Pfizer, and if Moderna were to win this litigation, they would recoup millions of pounds in damages relating to COVID-19 vaccine sales.
Moderna, BioNTech and Pfizer all started selling COVID-19 vaccines in 2020 but Moderna claim that the COVID-19 vaccines being sold by BioNTech and Pfizer make use of Moderna’s patented technology. In particular, Moderna claim that neither Pfizer nor BioNTech were at the same level of mRNA vaccine development as Moderna at the time of the COVID-19 pandemic.
How BioNTech and others responded to patent claims
In response to the litigation, BioNTech and others filed an opposition against EP3718565 on the grounds that the claimed subject matter extended beyond the content of the application as originally filed. They also claimed the subject matter was neither novel nor inventive, and that the invention was not disclosed in a matter sufficiently clear and complete for it to be carried out by a person skilled in the art. These are all grounds for rejection of a patent application under the European Patent Convention and may be raised by an opponent of a granted patent during the opposition period. The opposition procedure in this case involved over one hundred citations provided by the parties involved as evidence for their respective positions and dozens of auxiliary amended applications submitted by the patent proprietor before the proceedings were brought to a close.
Patent appeal and moving forward
Following oral proceedings, the EPO revoked the patent based on added subject matter and the EPO’s Decision was published on 21st November 2023. Moderna have confirmed that they intend to appeal the decision. It therefore looks like the dispute between the big pharmaceutical companies over the COVID-19 vaccine will rumble on for years to come.
If not for the revocation of the patent following the opposition proceedings, Moderna would have been able to protect their patented invention for up to 20 years from the date of filing of the application. Under European law, the term of pharmaceutical patents may be further extended under a supplementary protection certificate by up to five years, potentially worth millions to the company.
The patents cited by Moderna’s infringement actions brought against BioNTech and Pfizer relate specifically to the Covid-19 vaccines, however pharmaceutical and chemical patents and applications may relate more broadly to various technologies and sectors; from pharmaceutical formulations, bulk chemicals, aviation fuels, mixed fuel systems, cosmetic formulations, sun protection formulations, domestic cleaning product formulations, soluble sachets, drug delivery systems, through to industrial chemicals, agrochemicals and industrial scaling and polishing systems.
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