SK bioscience announced on the 23rd that it has won a final victory in the invalidation lawsuit it filed against the patent of the U.S. company Moderna regarding the messenger ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine. With this decision breaking down the patent barrier, the company plans to accelerate its global mRNA clinical trials.
Previously, the company filed an invalidation lawsuit against Moderna's patent on 'modified nucleosides, nucleotides, nucleic acids and their uses' in 2023. After approximately two years of deliberation, last month it received a ruling from the Patent Trial and Appeal Board stating that the amendment's legality, priority, and inventive step were all not recognized.
As Moderna did not file a lawsuit to annul the ruling within the deadline, this lawsuit was confirmed as a final victory for SK bioscience. The only registered mRNA manufacturing technology patent in Korea is Moderna's use patent.
Moderna's patent is being used as a key technology for the manufacture of several mRNA pharmaceuticals, including the Japanese encephalitis vaccine candidate 'GBP560' that SK bioscience is developing. SK bioscience determined that Moderna's patent improperly acknowledged priority and excessively obtained patent monopoly rights, prompting the company to proactively file an invalidation lawsuit.
SK bioscience evaluated that this ruling has secured a competitive advantage in the ongoing patent dispute with global corporations related to Moderna. The company is accelerating mRNA vaccine development following the launch of global Phase 1 and 2 clinical trials for the Japanese encephalitis vaccine in February. This trial, involving 402 healthy adults in Australia and New Zealand, aims to evaluate immunogenicity and safety following vaccination, with interim results expected next year.
SK bioscience noted, 'Through the Japanese encephalitis vaccine development project, we will secure mRNA vaccine platform technology capable of responding to various diseases, beyond pandemic response, and establish a new pipeline of drug candidates to enhance our global competitiveness.'