SK bioscience, a biotech subsidiary of South Korea's SK Group, has secured a significant legal victory against pharmaceutical giant Pfizer in a patent dispute over pneumococcal vaccine components, according to an announcement made on Wednesday.
The South Korean Supreme Court upheld a lower court's ruling that SK bioscience's 13-valent pneumococcal conjugate vaccine (PCV13) components do not fall within the scope of Pfizer's patent claims. The court further determined that the production and export of PCV13 products for research purposes do not constitute patent infringement.
The legal battle began in 2020 when Pfizer filed a lawsuit alleging that SK bioscience's export of PCV13 components and finished products to Russia for research purposes infringed on the composition patent of Pfizer's Prevnar 13 vaccine.
Background on Pneumococcal Vaccines
Pneumococcal conjugate vaccines are critical in preventing diseases caused by Streptococcus pneumoniae bacteria, including pneumonia, meningitis, and bloodstream infections. These vaccines are particularly important for children and older adults, who face higher risks from pneumococcal infections.
SK bioscience developed SKYPneumo in 2016, marking South Korea's first domestically produced 13-valent pneumococcal conjugate vaccine. However, despite this achievement, the company has been unable to manufacture or sell the vaccine within South Korea due to a separate patent dispute with Pfizer. This restriction will remain in place until 2027 when the relevant patents expire.
Implications of the Court Decision
The recent court decision represents a partial victory for SK bioscience, as it opens new opportunities for the company to export individual PCV13 components to countries with high vaccine demand, particularly in Southeast Asia and Latin America.
"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," said SK bioscience Chief Executive Officer Ahn Jae-yong. "We will leverage this momentum to improve access to premium vaccines, contribute to a stable global vaccine supply, and achieve sustainable growth."
Future Development Plans
While navigating these patent challenges, SK bioscience is simultaneously advancing its vaccine portfolio. The company is developing a more comprehensive 21-valent pneumococcal conjugate vaccine in collaboration with French pharmaceutical company Sanofi. This next-generation vaccine candidate, which targets 21 serotypes of pneumococcal bacteria compared to Prevnar 13's coverage of 13 serotypes, entered global Phase 3 clinical trials in late 2024.
The development of higher-valent pneumococcal vaccines represents an important trend in the field, as manufacturers seek to provide broader protection against pneumococcal disease. Pfizer itself has moved beyond Prevnar 13 with the development of Prevnar 20, which received FDA approval in 2021 for use in adults.
Market and Access Implications
The court's decision could have significant implications for global vaccine access, particularly in regions where pneumococcal disease burden remains high. By allowing SK bioscience to export vaccine components, the ruling may contribute to increased competition and potentially improved vaccine availability in underserved markets.
For SK bioscience, this legal victory provides an opportunity to establish itself more firmly in the global vaccine market while continuing to develop its domestic capabilities despite the ongoing restrictions within South Korea.
