SK Bioscience wins 2nd trial on pneumococcal patent dispute

Court rules in favor of SK Bioscience after 7 years of dispute

Patent Court overturns 1st trial and rules in favor of SK Bioscience… ‘exporting the undiluted solution to Russia does not infringe upon the rights’

SK Bioscience in a long-term legal battle over the pneumococcal vaccine ‘Skypheumo’ with Pfizer·Wyeth

  SK Bioscience has won the second trial of its patent infringement lawsuit against Pfizer over its pneumococcal vaccine, overturning the ruling made in the first trial.  The two companies have been engaged in a long-running lawsuit over SK Bioscience's 13-valent pneumococcal vaccine, ‘Skypheumo Prefilled Syringe (Skypheumo).’ According to the pharmaceutical industry on the 3rd, the patent court recently ruled in favor of the plaintiffs in the appeal of SK Bioscience's patent infringement lawsuit against Pfizer and Wyeth LLC.  The two companies' conflict over Skypheumo dates back to 2017.

 

Wyeth, the Korean patent holder for the pneumococcal vaccine Prevenar 13, and its Korean distributor, Pfizer, filed a lawsuit alleging that SK Bioscience's Skypheumo infringed on their patent rights.  The case went to the 3rd court, and the Supreme Court sided with Pfizer in 2019 with a settlement recommendation.

 

The Supreme Court ruled that Pfizer's patent was valid and banned SK Bioscience from producing and launching Skypheumo until 2027.

 

SK Bioscience voluntarily withdrew the marketing authorization for Skypheumo, then in June 2021, and again received marketing authorization for Skypheumo.

 

The conflict between the two companies persisted since then.

 

Faced with difficulties in launching the vaccine in Korea, SK Bioscience signed a license agreement to transfer the technology to Russian pharmaceutical companies to develop the vaccine in the region and supply the undiluted solution of the pneumococcal vaccine.  SK Bioscience believed that the supply of an undiluted solution for research trials, not the finished product, was outside the scope of patent infringement.  However, Pfizer and Wyeth put the brakes on the act as well.

 

In 2020, the companies filed a patent infringement lawsuit and won the first trial in August last year.

 

SK Bioscience appealed, and eventually, the patent court overturned the first ruling and ruled in favor of SK Bioscience.  The ruling is expected to have a significant impact on other disputes between the two companies.  The Korea Trade Commission under the Ministry of Trade, Industry, and Energy has been investigating SK Bioscience for unfair trade practices.

 

Pfizer and Wyeth have sued to sanction SK Bioscience's export of its undiluted solution.  Pfizer and Wyeth sued SK Bioscience in 2019, and the KTC sided with Pfizer in February this year and issued a correction order.

 

SK Bioscience responded by filing an appeal with the Seoul Administrative Court.

 

In October of this year, Pfizer-Wyeth filed another suit against SK Bioscience with the same allegations.  The industry’s analysis is that the KTC sided with Pfizer because of the first patent infringement ruling.

 

It is analyzed that the KTC issued a correction order to SK Bioscience based on Pfizer’s win in the first patent infringement trial.

 

However, as the second trial of the patent infringement lawsuit resulted in a ruling that was opposite to the first trial, there is the prospect that the KTC’s judgment may also change regarding SK Bioscience's unfair trade practices.