pharm edaily

[Yu Jin-hee, Edaily Reporter] SEOUL, South Korea-SK Bioscience has secured a decisive legal victory that may pave the way for its pneumococcal conjugate vaccine to reenter the global market. On May 21, the South Korean vaccine developer announced that the Supreme Court had ruled in its favor in a patent infringement lawsuit filed by global pharmaceutical giant Pfizer over the 13-valent pneumococcal conjugate vaccine (PCV13), marketed by Pfizer as Prevnar 13.



Pfizer originally filed the suit in 2020, alleging that SK’s export of individual serotype bulk substances and investigational finished products of PCV13 to Russia infringed on its composition patent for Prevnar 13. However, the court concluded that SK’s actions did not fall within the scope of Pfizer’s patent claims, confirming earlier rulings in SK’s favor. The court also determined that producing and supplying PCV13 for research and testing purposes did not constitute patent infringement.

The ruling marks a potential turning point for SK Bioscience, which had been barred from manufacturing or selling its domestic 13-valent pneumococcal conjugate vaccine, SKYNeumo, following an earlier loss in the patent dispute. Although final marketing of PCV13 finished products remains prohibited until Pfizer’s patents expire in 2027, the decision now allows SK to export individual serotype bulk substances used in PCV13 formulations.

The company plans to target emerging markets in Southeast Asia and Latin America, where demand for pneumococcal vaccines is high. It will also pursue technology transfers in partnership with local companies to facilitate supply.

SK Bioscience is aiming to expand its global footprint, particularly as its next-generation pneumococcal vaccine pipeline advances. SKYNeumo, the first Korean-developed PCV13, was launched in 2016 but stalled due to the patent dispute. With Pfizer’s composition patents set to expire in 2027, SK will be able to resume production and domestic sales of the finished vaccine.

Meanwhile, a 21-valent pneumococcal conjugate vaccine under co-development with Sanofi entered Phase 3 global trials late last year. The two companies are also working on a next-generation candidate expected to offer broader protection than currently available products.

The global pneumococcal vaccine market is projected to grow steadily, supported by widespread immunization efforts and government initiatives. According to Global Market Insights, the market is expected to expand at a CAGR of 5.6% through 2034, reaching approximately $15.1 billion.

With public-sector procurement playing a key role in market access;especially in low- and middle-income countries;SK Bioscience, known for its active role in public vaccine supply, is positioned to capitalize on growing international demand.

“This ruling ensures that a competitive, domestically developed vaccine will not go to waste and instead gains a new opportunity,” said Ahn Jae-yong, CEO of SK Bioscience. “We will leverage this momentum to improve access to premium vaccines and contribute to global supply security, driving sustainable growth.”