SK Bioscience wins the '8-year Prevenar patent dispute'

The Supreme Court says, "SK Bioscience exporting the PCV13 raw solution to Russia does not infringe on the patent"

SK Bioscience "PCV13 raw solution·finished products for research can be exported…will initiate new global projects on a full scale"

'Domestic sales of SKYPneumo' is not possible until 2027…failed to challenge the conjugate composition patent

In a patent infringement trial against Pfizer involving SK Bioscience's export of 'SKYPneumo' raw solution, SK Bioscience has won after eight years.

 

The latest ruling is expected to enable SK Bioscience's global export of its pneumococcal conjugate vaccine 'SKYPneumo' raw solution.

 

Ruling that 'Exporting SK Bioscience's SKYPneumo raw solution does not infringe on the patent'…an opportunity has been presented to export According to SK Bioscience, on May 21, the Supreme Court of Korea ruled in favor of SK Bioscience in a legal dispute filed by Pfizer for 'Cessation of infringement of Pfizer's Prevenar 13 (PCV13) pneumococcal conjugate vaccine patent.' The Supreme Court recently upheld the second trial ruling, which ruled in favor of SK Bioscience.

 

SK Bioscience and Pfizer long fought over whether the overseas supply of SKYPneumo's raw solution infringes on Pfizer's 'Prevenar 13.' This eight-year legal battle began in 2017 when Pfizer filed a patent infringement lawsuit.

 

The Supreme Court ruled that "Producing and supplying PCV13 finished products for research purposes does not infringe on the patent," adding, "Individual conjugates that make up PCV13 do not fall within the scope of the patent claim." It is analyzed that the Supreme Court's final ruling favoring SK Bioscience is expected to open the door for SK Bioscience to export SKYPneumo raw solution overseas.

 

SK Bioscience says, "While supplying PCV13 finished products is not permitted, the latest ruling presents an opportunity for supplying individual conjugates overseas," and added, "We plan to initiate a new project to supply raw solution of individual conguates to regions with high vaccine demand, such as Southeast Asia and Central and South America.

 

We also intend to pursue technology transfer through local partnerships." SK Bioscience vs.

 

Pfizer: Patent Invalidation·Infringement Lawsuits…3 out of 4 cases transferred to the Supreme Court In addition to this case, the dispute between SK Bioscience and Pfizer surrounding the Prevenar 13 patent has been ongoing for a long time, including 'patent invalidation' lawsuits filed by SK Bioscience and 'cessation of patent infringement' lawsuits counter-filed by Pfizer.

 

First, SK Bioscience challenged two related patents after developing SKYPneumo, a follow-up product to Prevenar 13.

 

SK Bioscience challenged two of Pfizer's Prevenar 13-related patents: ▲Expiring in March 2026, 'a novel formulation that stabilizes immunogenic compositions and prevents precipitation' patent ▲Expiring in April 2027, 'a multivalent pneumococcal polysaccharide-protein conjugate composition' patent.

 

SK Bioscience filed invalidation trials for both patents.

 

Among these, the patent expiring in 2026 was successfully invalidated.

 

The Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of SK Bioscience in January 2020, and the decision was finalized without an appeal from Pfizer.

 

On the other hand, the patent expiring in 2027 ultimately failed to be invalidated.

 

SK Bioscience argued for the invalidation of this patent, but received a dismissal from IPTAB in June 2015.

 

SK Bioscience also lost in the second trial, which proceeded with SK Bioscience's appeal, in November 2017.

 

SK Bioscience decided to appeal to the Supreme Court.

 

However, they again received a losing ruling from the Supreme Court in 2018.

 

In conclusion, the patent expiring in March 2026 was successfully invalidated, while the patent expiring in April 2027 was not.

 

Consequently, domestic sales of SKYPneumo are prohibited until April 2027.

 

Pfizer counter-filed a patent infringement prohibition lawsuit against SK Bioscience during this process.

 

In 2017, Wyeth LLC, the patent holder of Prevenar 13, and Pfizer Korea, the domestic distributor, filed a lawsuit claiming that SKYPneumo infringed on their patent rights.

 

This lawsuit also went to the third trial.

 

Ultimately, the Supreme Court issued a recommendation for settlement in 2019, essentially siding with Pfizer.

 

The Supreme Court ruled that Pfizer's patent was valid and prohibited the production and launch of SK Bioscience's SKYPneumo until 2027.

 

SK Bioscience voluntarily withdrew the product approval for SKYPneumo.

 

However, they re-obtained approval for SKYPneumo in June 2021.

 

The conflict between the two companies continued thereafter.

 

Facing difficulties with the domestic launch, SK Bioscience signed a license agreement to transfer related technology to a Russian pharmaceutical company to develop vaccines in that region.

 

SK Bioscience supplied raw solution for its self-developed pneumococcal vaccine and finished pharmaceutical products for research.

 

Pfizer and Wyeth LLC also interfered with this, filing a cession of patent infringement lawsuit in 2020.

 

SK Bioscience countered, arguing that supplying raw solution for research and testing purposes, not finished products, to overseas markets was outside the scope of patent infringement.

 

In August 2023, Pfizer won in the first trial.

 

SK Bioscience appealed, and ultimately, the Patent Court overturned the first trial ruling and sided with SK Bioscience.

 

This time, Pfizer appealed to the Supreme Court after losing in the second trial.

 

Finally, the Supreme Court upheld the original ruling in the appeal.

 

The two companies engaged in a long-term battle, going to the Supreme Court for three out of four cases, including patent invalidation lawsuits and patent infringement lawsuits.

 

With this, most disputes between the two companies concerning the Prevenar 13 patent have been concluded.

 

However, a trade commission dispute remains.

 

The Korea Trade Commission under the Ministry of Trade, Industry and Energy is investigating SK Bioscience's unfair trade practices.

 

This is because Pfizer and Wyeth LLC have filed a complaint requesting a cessation on exporting SK Bioscience's pneumococcal raw solution.

 

In the pharmaceutical industry, there is an outlook that the trade commission dispute surrounding the export of pneumococcal raw solution will also be concluded soon due to this Supreme Court ruling.