The Patent Court of Korea has ruled in favor of SK Bioscience in a significant appeal case against Pfizer's subsidiary Wyeth LLC, overturning a previous decision in a patent infringement lawsuit concerning pneumococcal vaccine components.
The ruling, delivered on December 3rd, determined that SK Bioscience's export of 13-valent pneumococcal conjugate vaccine (PCV13) raw materials to Russia for research purposes did not constitute patent infringement, contrary to Pfizer's claims.
Background of the Patent Dispute
The conflict originated in 2016 when SK Bioscience received approval from South Korea's Ministry of Food and Drug Safety for its PCV13 vaccine, SkyNemo Prefilled Syringe. This prompted Pfizer to file a lawsuit alleging infringement of composition patents related to its own pneumococcal vaccine, Prevnar 13.
In late 2018, South Korea's Supreme Court ruled in favor of Pfizer, resulting in a settlement agreement where SK Bioscience agreed not to manufacture or sell related products domestically until 2027.
The current dispute arose when Pfizer filed an additional patent infringement lawsuit claiming that SK Bioscience's export of pneumococcal vaccine undiluted solution to Russia in 2018 and 2019 violated the settlement agreement. Pfizer argued that these materials could potentially be combined to create a finished product.
Court's Decision and Reasoning
While the first trial ruled in Pfizer's favor, the Patent Court reversed this decision on appeal. The court accepted SK Bioscience's argument that the exported materials were not commercial finished products but rather undiluted solutions intended specifically for research purposes.
This distinction proved crucial in the court's determination that the export activities did not infringe upon Pfizer's patent rights or violate the terms of the previous settlement agreement.
Implications for SK Bioscience and Korean Biotech
The favorable ruling enables SK Bioscience to focus more intently on developing its 21-valent pneumonia vaccine currently in the pipeline. This next-generation vaccine would potentially offer broader protection against pneumococcal strains than existing products.
In a statement following the decision, SK Bioscience welcomed the court's ruling, saying: "We humbly accept the results and adequately check the abuse of patent litigation by global pharmaceutical companies."
The company further expressed hope that the ruling would lead to "policy and institutional supplementation of the patent trial system to actively protect technologies that will be national competitiveness in the vaccine and bio sectors."
Broader Industry Impact
The case highlights growing tensions in the global pharmaceutical landscape as Korean biotech companies continue to advance their technological capabilities and expand internationally.
Industry observers note that the ruling may impact an ongoing investigation by South Korea's Trade Commission, which had previously issued a corrective order against SK Bioscience over alleged unfair trade practices related to the same dispute. SK Bioscience has challenged this order in administrative court.
The pharmaceutical and biotech sectors in South Korea have increasingly called for government support measures to protect domestic innovations against patent litigation from global pharmaceutical companies. This case may serve as a catalyst for enhanced legal frameworks designed to safeguard Korean biotech advancements while maintaining fair competition in the global market.
As Korean biotech companies continue to develop sophisticated vaccines and biologics, navigating the complex international patent landscape remains a critical challenge for their global expansion strategies.
