Explainer: Pharma Giant Moderna's Allegations Against Pfizer And BioNTech For Copyright Infringement

The pharmaceutical giants Pfizer and BioNTech are embroiled in a high-stakes lawsuit filed by their rival, Moderna, over the intellectual property rights central to the development of COVID-19 vaccines. The London High Court is set to hear the complaint filed by Moderna against Pfizer and BioNTech for infringement of its patent to manufacturing of mRNA vaccines. What is the lawsuit? Moderna alleges that Pfizer and BioNTech infringed on its patents in the development and distribution of their 'Comirnaty' vaccine. Specifically, Moderna claims that Pfizer and BioNTech violated two of its mRNA patents, which it asserts are foundational to the innovative approach used in COVID-19 vaccination. Conversely, Pfizer and BioNTech challenge the validity of Moderna's patents and refute allegations of infringement. They argue that Moderna's developments in mRNA technology were merely obvious improvements on previous work and, therefore, do not warrant patent protection. What is mRNA technology? Messenger RNA (mRNA) technology is an approach in vaccine development that harnesses the body's natural mechanisms to stimulate an immune response against specific pathogens, such as viruses like SARS-CoV-2, which causes COVID-19. mRNA technology represents a departure from traditional vaccine approaches, offering several advantages in speed, versatility, and efficacy. Patent Moderna argues that it holds patents for mRNA technology dating back to 2010-2016, well before the emergence of COVID-19. These patents are crucial as they protect Moderna's intellectual property rights in its mRNA platform, which forms the basis of its COVID-19 vaccine. Moderna alleges that Pfizer and BioNTech utilized its patented mRNA technology without authorization, thereby infringing upon its intellectual property rights. Patent litigation is a common recourse in cases where companies believe their patents have been infringed upon. In October 2020, amid the global health crisis, Moderna made a significant commitment by pledging not to enforce its IP rights for vaccines intended to combat the pandemic. However, in March 2022, Moderna shifted its stance by amending its IP pledge, signalling a more assertive approach to protecting its intellectual property. The company stated that it expected rivals like Pfizer and BioNTech to respect its IP rights and indicated its willingness to license the technology on commercially reasonable terms. Other Cases One prominent example is the legal battle between pharmaceutical giants Amgen and Regeneron over patents related to monoclonal antibody drugs. In this case, Amgen alleged that Regeneron's drug, marketed as Praluent, infringed upon its patents for a class of cholesterol-lowering drugs known as PCSK9 inhibitors. The litigation involved multiple lawsuits and appeals, with both companies seeking injunctions and damages for patent infringement. Another notable case involves the patent dispute between Gilead Sciences and Merck over hepatitis C virus (HCV) drugs. Gilead's drug, Sovaldi, and its successor, Harvoni, revolutionized HCV treatment but sparked legal challenges from Merck, which alleged that Gilead infringed upon its patents for HCV drugs.

Explainer: Pharma Giant Moderna's Allegations Against Pfizer And BioNTech For Copyright Infringement

rajesh kumar

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