Global Clinical Trials Gain Momentum, Accelerating Domestic mRNA Technology Acquisition
SK Bioscience, which has entered Phase 1/2 clinical trials for an mRNA (messenger ribonucleic acid) vaccine being developed in collaboration with international organizations, has also broken through the patent barrier of a global corporation.
On April 23, SK Bioscience announced that it had achieved a final victory in a lawsuit to invalidate Moderna's patent for "modified nucleosides, nucleotides, and nucleic acids and their uses," which is related to mRNA COVID-19 vaccine development. In Korea, Moderna's use patent is the only registered mRNA manufacturing technology patent.
A researcher at SK Bioscience is conducting experiments related to mRNA vaccine development. SK Bioscience
In 2023, SK Bioscience filed a lawsuit to invalidate this patent. After approximately two years of deliberation, the Intellectual Property Trial and Appeal Board last month ruled the patent invalid, stating that it did not meet the requirements for correction legitimacy, priority, or inventiveness. Since Moderna did not file an appeal to overturn this decision within the deadline, SK Bioscience's victory has been confirmed as final.
Moderna's patent has been a core technology for manufacturing various mRNA products, including SK Bioscience's Japanese encephalitis vaccine candidate "GBP560." SK Bioscience determined that the patent had been granted undue priority and an excessively broad monopoly, thereby hindering the development of mRNA vaccine technology, and thus proactively initiated the invalidation lawsuit.
This decision is seen as a case where SK Bioscience has secured a significant competitive advantage over global companies. While many companies worldwide are still engaged in patent disputes with Moderna, SK Bioscience has succeeded in breaking down the patent barrier ahead of others. Furthermore, by reducing patent-related risks for domestic companies conducting mRNA research and development, this is expected to greatly contribute to establishing the foundation for vaccine sovereignty.
In February, SK Bioscience began global Phase 1/2 clinical trials for "GBP560," accelerating its leadership in mRNA vaccine development among Korean companies. This clinical trial, currently underway in Australia and New Zealand with 402 healthy adult participants, aims to evaluate the immunogenicity and safety of "GBP560," with interim results expected next year.
SK Bioscience's mRNA vaccine development began in 2022, when it signed an agreement with the international organization CEPI (Coalition for Epidemic Preparedness Innovations) to receive $40 million (approximately 5.72 billion KRW) in initial R&D funding. If the company enters the late-stage development phase after completing Phase 1/2 clinical trials, CEPI will provide up to an additional $100 million (about 14.3 billion KRW) in support.
Through this project, SK Bioscience plans to go beyond pandemic response and secure an mRNA vaccine platform technology that can address various diseases, establish new pipelines, and strengthen its global competitiveness.
The mRNA vaccine platform technology, which was first commercialized with COVID-19 vaccines, enables rapid mass production using genetic sequencing compared to existing platforms. This makes it well-suited for pandemic response, and its potential application to therapeutic development is also increasing, leading to expectations of rapid market expansion.
According to global market research firm Nova One Advisor, the global mRNA pharmaceuticals market is projected to grow at an average annual rate of 17.06%, reaching $58.9 billion (approximately 84 trillion KRW) by 2033.
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