SK Bioscience has secured a decisive victory in a long-standing patent dispute with Pfizer, clearing the path for the company to accelerate its global pneumococcal vaccine business, including exports of vaccine ingredients and technology transfers.
The South Korean vaccine manufacturer announced on June 21 that the Supreme Court had ruled in its favor in a lawsuit filed by Pfizer concerning alleged infringement of the multinational firm’s patent on its 13-valent pneumococcal conjugate vaccine (PCV13). The dispute stemmed from SK Bioscience’s supply of individual conjugate substances and investigational pharmaceutical products for PCV13 to a Russian pharmaceutical company.
This is not the first legal encounter between the two companies. In 2016, SK Bioscience obtained regulatory approval in Korea for its own PCV13 vaccine, SKYCellflu. The following year, Pfizer filed a lawsuit alleging that the product infringed on the patent of its own vaccine, Prevnar 13. The case escalated to the Supreme Court, which ruled in Pfizer’s favor. As a result, SK Bioscience was prohibited from producing or selling SKYCellflu in the domestic market until April 2027.
In response to the domestic ban, SK Bioscience pivoted to an international strategy, licensing its technology to a Russian partner and supplying both clinical trial-grade substances and investigational products. Pfizer, however, filed a second lawsuit, contending that these activities also constituted patent infringement. While Pfizer initially won in the lower court, the decision was overturned on appeal and has now been upheld by the Supreme Court.
In its ruling, the court determined that the individual conjugates comprising PCV13 were not covered under Pfizer’s patent claims. Furthermore, it held that manufacturing and supplying investigational PCV13 products for research purposes did not infringe the patent.
SK Bioscience said the ruling is particularly significant as it opens new opportunities to export the individual conjugate substances that comprise PCV13. The company plans to initiate business expansion in regions with high demand for vaccines, such as Southeast Asia and Latin America, and will pursue technology transfer agreements with local partners.
This legal win follows another recent victory by SK Bioscience, which successfully invalidated a Moderna patent related to mRNA COVID-19 vaccines. Observers note that the company is increasingly breaking through global intellectual property barriers, bolstering Korea’s position in the international vaccine market.
“This ruling ensures that a competitive, domestically developed vaccine is not prematurely shelved, but instead leveraged for new global opportunities,” said Ahn Jae-yong, CEO of SK Bioscience. “We are committed to improving access to premium vaccines and contributing to stable global supply chains while achieving sustainable growth.”
