Supreme Court Sides with SK Bioscience in ‘Sky New Mo’ Patent Case
Export to Southeast Asia, Latin America and Promotion of Technology Transfer
, ‘SK Bioscience’s pneumococcal conjugate vaccine has overcome patent barriers of global companies, allowing for the supply and sale of raw materials and research-finished products.’,
“SK Bioscience announced on the 21st that it had won a final Supreme Court ruling in a patent infringement lawsuit regarding its pneumococcal conjugate vaccine (PCV 13) ‘Sky New Mo’ initiated by global pharmaceutical company Pfizer.”,
No Patent Infringement for Individual Conjugate Raw Materials and Research-Finished Products
, “In 2020, Pfizer filed a lawsuit claiming that SK Bioscience’s PCV 13 individual conjugate raw materials and research-finished products supplied to Russia infringed on the compositional (a new function or characteristic combining various substances) patent of ‘Prevnar 13’.”,
, ‘PCV13 is a vaccine made by conjugating 13 types of pneumococcal serotypes to enhance immune response by separately combining proteins for each serotype. Individual conjugates refer to these 13 protein-bound serotypes kept separate and not mixed.’,
, ‘SK Bioscience argued that the separate individual conjugates of the 13 pneumococcal serotypes do not constitute patent infringement. The Supreme Court accepted this and confirmed the original ruling that each individual conjugate composing PCV13 does not fall within Pfizer’s patent claims. Additionally, it ruled that producing and supplying PCV 13 finished products for research and trial purposes do not infringe on the patents.’,
, “SK Bioscience successfully developed ‘Sky New Mo’, South Korea’s first PCV 13 in 2016, but was prohibited from domestic production and sales of finished products due to losing the patent dispute with Pfizer until all related patents expire in 2027.”,
, New Business Initiatives in Southeast Asia and Latin America
, “Despite being unable to sell ‘Sky New Mo’ finished products, SK Bioscience can now explore new business opportunities for raw materials and clinical trial-use finished products thanks to this ruling.”,
, ‘The export of individual conjugates composing PCV13 has become possible. SK Bioscience plans to officially launch its new business supplying individual conjugate raw materials to vaccine-demanding regions like Southeast Asia and Latin America. They will also pursue technology transfer based on local partnerships.’,
, ‘SK Bioscience intends to expand its influence gradually in the global pneumococcal vaccine market. Once all related patents of Pfizer’s Prevnar 13 expire in 2027, domestic production and sale of Sky New Mo finished products will become possible.’,
, ‘In addition, the release of a 21-valent pneumococcal conjugate vaccine is approaching. At the end of last year, SK Bioscience, in collaboration with global company Sanofi, began a global Phase 3 clinical trial for the 21-valent vaccine.’,
, ‘SK Bioscience and Sanofi are also pursuing the development of a next-generation pneumococcal conjugate vaccine expected to provide broader preventive effects than currently commercialized products.’,
, ‘SK Bioscience CEO Ahn Jae-yong stated, “This ruling is significant as it allows domestically developed competitive vaccines to gain new opportunities instead of going unused.” He added, “We aim to enhance the accessibility of premium vaccines and contribute to the supply stability in the global vaccine market, achieving sustainable growth.”‘
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