SK bioscience announced on the 21st that it has received a final Supreme Court ruling in favor of its case against Pfizer, which had filed a patent infringement injunction regarding the '13-valent pneumococcal conjugate vaccine (PCV 13)'. The ruling opened up business opportunities for the PCV 13, which had been unable to be launched due to patent barriers posed by large pharmaceutical companies.
Previously, Pfizer had sued SK bioscience in 2020, claiming that the individual conjugate concentrate and research-grade finished goods supplied by SK bioscience to Russia infringed on Pfizer's patent for the 'Prevnar 13' vaccine formulation. In response, the Supreme Court ruled that each individual conjugate making up PCV 13 does not fall within the patent's claims, thereby affirming the lower court's ruling that favored the defendant, SK bioscience. The court also ruled that producing and supplying PCV 13 finished goods for research purposes did not constitute patent infringement.
Accordingly, SK bioscience has found new business opportunities for the pneumococcal conjugate vaccine, which had struggled to identify business prospects due to patent barriers. Although SK bioscience succeeded in developing Korea's first 13-valent pneumococcal conjugate vaccine 'Skyneumo' in 2016, it faced restrictions on domestic production and sales until the relevant patents expire in 2027 after losing a patent dispute with Pfizer.
This ruling is significant as it has opened the export paths for the individual conjugates that make up PCV 13, despite the fact that sales of PCV 13 finished goods remain prohibited. SK bioscience plans to begin its pneumococcal conjugate vaccine business in earnest, focusing on supplying individual conjugate concentrates to regions with high vaccine demand, such as Southeast Asia and Latin America. They also plan to promote technology transfer locally.
SK bioscience aims to expand its influence in the global pneumococcal vaccine market. Starting from 2027, when all related patents, including Pfizer's Prevnar 13 formulation, expire, SK bioscience will be able to produce and sell Skyneumo finished goods domestically.
A 21-valent pneumococcal conjugate vaccine jointly developed with France's Sanofi has entered Phase 3 global clinical trials since late last year. The two companies are also developing a next-generation pneumococcal conjugate vaccine, which is expected to show broader preventive effects than currently commercialized products.
According to market research firm Global Market Insights, the global pneumococcal vaccine market is projected to grow at an average annual rate of about 5.6% until 2034, reaching around $15.1 billion (approximately 21.6 trillion won), supported by expanded vaccination and government and international organization support policies. The role of SK bioscience, which has been active in public vaccine supply, is expected to be vital, especially as procurement expands through key health organizations like the World Health Organization (WHO) and Gavi, the Vaccine Alliance, to enable entry into low- and middle-income markets.
An Jae-yong, CEO of SK bioscience, noted, "This ruling is a meaningful outcome that allows competitive vaccines developed domestically to gain new opportunities rather than being sidelined," and added, "We will use this as a chance to enhance access to premium vaccines, contribute to the supply stability of the global vaccine market, and achieve sustainable growth."