Pneumococcal polysaccharide conjugate vaccine

No patent infringement found in exports of individual conjugate bulk substances and research-use finished products of PCV13 to Russia Company plans to export PCV13 vaccine components "We aim for the global PCV market with our 21-valent and next-generation pneumococcal vaccines currently under development." SEONGNAM, South Korea, May 21, 2025 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it the Supreme Court of Korea has ruled in its favor in a patent infringement lawsuit filed by large global pharmaceutical giant Pfizer over its 13-valent pneumococcal conjugate vaccine (PCV13). In 2020, Pfizer claimed that SK bioscience's export of PCV13 individual conjugate bulk substances and research-use finished products to Russia infringed on the composition patent of its vaccine, Prevnar 13. Continue Reading SK bioscience L HOUSE manufacturing plant However, the Supreme Court ruled that the individual conjugates comprising PCV13 do not fall within the scope of Pfizer's patent claims, thereby upholding the lower court's ruling in favor of SK bioscience. The Court also confirmed that the production and supply of PCV13 finished products for research purposes did not constitute patent infringement. SK bioscience successfully developed Korea's first 13-valent pneumococcal conjugate vaccine, SKYPneumo, in 2016. However, due to the ongoing patent dispute with Pfizer, the company has been prohibited from manufacturing and selling the vaccine in Korea until 2027, when the related patents set to expire. Following the ruling, SK bioscience now plans to initiate new business in pneumococcal conjugate vaccines by exporting individual components of PCV13 to countries with high vaccine demand, such as those in Southeast Asia and Latin America. Technology transfers through local partnerships are also being pursued in parallel. Looking ahead, SK bioscience aims to expand its presence in the global pneumococcal vaccine market. From 2027, the company will be able to manufacture and sell SKYPneumo domestically. In addition, the company is developing a 21-valent pneumococcal conjugate vaccine with global pharmaceutical company Sanofi, which entered Phase 3 global clinical in late 2024. Simultaneously, the two companies are also working on a next-generation pneumococcal vaccine that is expected to offer broader protection than current options. The global pneumococcal vaccine market continues to grow. According to Global Market Insights, the market is projected to grow at a compound annual rate of approximately 5.6% to reach USD 15.1 billion (approximately KRW 21.55 trillion) by 2034. This growth is driven by expanded vaccination programs and support from governments and international organizations like WHO and Gavi. SK bioscience's strong track record in public vaccine supply and cooperation with global health organizations positions it well for future expansion. Jaeyong Ahn, CEO of SK bioscience, said, "This latest court decision is meaningful in that it ensures a competitively developed vaccine in Korea does not go to waste but instead finds new opportunity. We will leverage this momentum to improve access to premium vaccines, contribute to a stable global vaccine supply, and achieve sustainable growth." Meanwhile, SK bioscience recently secured a definitive legal victory in a patent invalidation suit against Moderna, successfully challenging the biotech giant's Korean patent related to messenger RNA (mRNA) vaccine technology. The contested patent covers 'modified nucleosides, nucleotides, and nucleic acids and their uses.' This case, which invalidated the only registered mRNA manufacturing patent in Korea, regarded as a major step in reducing patent-related risks and removing barriers to innovation for domestic companies engaged in mRNA research and development. About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin ([email protected]) Jeannie S. Pak ([email protected]) SOURCE SK bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SK bioscience has emerged victorious in a long-running patent suit filed by Pfizer in 2020, with South Korea's Supreme Court ruling that the Korean company did not infringe on Pfizer's patent for its Prevnar 13 pneumococcal vaccine.The case centred on SK's export of individual conjugate bulk substances and research-use finished products for its own 13-valent pneumococcal conjugate vaccine (PCV13) to Russia. The court sided with SK, affirming an earlier lower court ruling that the specific components SK exported were outside the scope of Pfizer's patent. The Supreme Court also ruled that the production and supply of finished products for research purposes don't constitute infringement.Although SK remains barred from selling its own PCV13 vaccine — SKYPneumo, which it developed in 2016 — within South Korea until related Pfizer patents expire in 2027, the company says it now plans to export individual PCV13 components to markets with "high vaccine demand" such as those in Southeast Asia and Latin America, while at the same time pursuing technology transfer agreements with local partners.The company is simultaneously advancing a 21-valent pneumococcal conjugate vaccine with Sanofi, which entered Phase III testing last year, and developing next-generation pneumococcal vaccines offering broader protection.The victory follows another recent legal win against Moderna. In a patent invalidation case finalised last month, SK successfully nullified Moderna's Korean patent related to mRNA vaccine technology covering modified nucleosides, nucleotides and nucleic acids and their uses — reportedly the only such patent registered in the country. After nearly two years of review, the Korean Intellectual Property Trial and Appeal Board found the patent lacked legitimacy in terms of validity, priority and inventiveness. Moderna did not appeal the decision, which finalised the outcome in SK's favour.SK had argued that the patent was an unfair barrier to innovation, one that could have stifled the development of homegrown mRNA technologies. With that legal obstacle now out of the way, the company said last month that it was pushing ahead with its own mRNA vaccine pipeline, including GBP560, an mRNA-based Japanese encephalitis vaccine candidate in Phase I/II testing since February in Australia and New Zealand.