SK Bioscience, the biopharmaceutical arm of South Korea's SK Group, announced Wednesday it has secured a "final victory" in its patent invalidation case against U.S. biotech giant Moderna, effectively removing a significant barrier to mRNA vaccine development in South Korea.
The Korean company successfully challenged Moderna's patent covering "modified nucleosides, nucleotides, and nucleic acids and their uses" – fundamental components in mRNA-based therapeutics and the only registered patent in South Korea related to mRNA manufacturing technology.
Patent Invalidation Details
SK Bioscience initiated the nullity suit in 2023, arguing that Moderna's patent "unfairly granted priority rights, which hindered the development of mRNA technology." The company specifically contended that the patent lacked legal validity on multiple grounds, including failure to establish an inventive step, issues with patent corrections, and problems identifying proper innovation credit.
The Korean Intellectual Property Trial and Appeal Board ruled in favor of SK Bioscience last month, declaring the patent invalid on all counts. Moderna did not appeal the decision within the legally mandated timeframe, finalizing SK Bioscience's victory.
"This outcome reinforces our ability to expand our development pipeline and enhance global competitiveness," an SK Bioscience official stated. The ruling is expected to accelerate the company's efforts in the increasingly competitive global mRNA landscape.
Strategic Implications for SK Bioscience
The disputed patent was considered critical for mRNA manufacturing and directly relevant to SK Bioscience's ongoing development programs, particularly its Japanese encephalitis vaccine candidate, GBP560.
"Our GBP560 project, which is currently undergoing global phase 1/2 clinical trials, marks a critical step not only in pandemic preparedness but also in establishing a versatile mRNA platform capable of addressing a broad spectrum of diseases," the SK Bioscience official explained.
SK Bioscience has been developing this vaccine in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), a non-governmental organization founded by Bill Gates. CEPI has provided approximately $357 million in funding to South Korean private and academic partners, including SK Bioscience, over the past few years.
Global Market Opportunities
The ruling positions SK Bioscience to potentially expand into international markets where Moderna has not secured patent protection.
"If developed, SK Bioscience's mRNA vaccines could be exported to developing countries in Africa, the Middle East, Latin America and Southeast Asia, regions where Moderna has not yet registered patents for its mRNA vaccines," a company spokesperson noted.
This opportunity comes at a significant time, as the global mRNA therapeutics market is projected to exceed 84 trillion won ($58.9 billion) by 2033, according to market research firm Nova One Advisor.
Broader Industry Context
The legal victory occurs amid ongoing patent disputes involving Moderna and other multinational biopharmaceutical companies in the rapidly evolving mRNA space. The technology gained worldwide prominence during the COVID-19 pandemic but has applications far beyond coronavirus vaccines.
SK Bioscience aims to establish a comprehensive mRNA vaccine platform addressing not only pandemic preparedness but also a broader range of infectious diseases. The company believes the removal of Moderna's patent barrier will allow for more rapid innovation and development in this critical field.
The case highlights the increasing importance of intellectual property in the biopharmaceutical sector, particularly as companies race to establish dominant positions in emerging therapeutic technologies with significant global health implications.
