SK Bioscience wins over Moderna in mRNA patent suit

A researcher at SK Bioscience conducts tests related to messenger ribonucleic acid technology in this undated handout photo released, Wednesday. Courtesy of SK Bioscience

Korean biotech firm SK Bioscience won a domestic legal battle over vaccine giant Moderna’s patent on messenger ribonucleic acid (mRNA) technology, effectively nullifying the U.S. pharmaceutical company’s monopoly over the technology that is crucial for developing next-generation vaccines.

SK Bioscience said Wednesday it clinched a final victory in a lawsuit to invalidate Moderna’s patent titled “Modified Nucleosides, Nucleotides, and Nucleic Acids and Uses Thereof.” Moderna is known for its mRNA COVID-19 vaccine, and the patent is the only use patent related to manufacturing mRNA platforms registered in Korea.

SK Bioscience filed the lawsuit in 2023 in a preemptive move to prevent the patent from hampering the development of mRNA-based vaccines, including the company’s GBP560 Japanese encephalitis virus vaccine.

After nearly two years of deliberation, Korea’s Intellectual Property Trial and Appeal Board ruled last month that the patent lacked validity in terms of priority rights and inventiveness. As Moderna did not file an appeal within the legal time frame, the ruling became final, confirming SK Bioscience’s victory.

The disputed patent is a critical technology in manufacturing mRNA, which instructs cells to produce specific proteins to stimulate the immune system, thus enabling faster development of vaccines. SK Bioscience argued that the patent was unfairly granted priority rights, hindering the development of mRNA technology.

Along with SK Bioscience, other drug makers here are developing vaccines based on mRNA technology. GC Biopharma is developing influenza vaccine GC3117A, and ST Pharm is conducting clinical trials on its STP2104 COVID-19 vaccine.

As the technology is widely used among mRNA vaccine developers, the ruling is expected to ease patent-related risks for not only SK Bioscience but also other Korean biotech companies, helping Korea secure vaccine sovereignty.

The ruling also came as a milestone for SK Bioscience, as many biopharmaceuticals around the world are still entangled in patent disputes with Moderna. With the ruling, SK Bioscience has gained a competitive edge by breaking through the patent barrier, allowing it to accelerate its efforts to secure proprietary mRNA technology.

In February, SK Bioscience initiated clinical trials of GBP560 in Australia and New Zealand. The trials will involve 402 adult patients to evaluate the immunogenicity and safety of GBP560. Interim results are expected next year.

The GBP560 project is based on an R&D agreement with the Coalition for Epidemic Preparedness Innovations (CEPI), which pledged $40 million in initial funding in 2022.

If the project advances into late-stage trials and other validating stages, the CEPI will finance additional $100 million.

The mRNA platform, which gained global attention in the wake of COVID-19, enables rapid and mass production, making it a powerful tool in pandemic responses.

Due to its potential in therapeutic applications, the mRNA therapeutics market is viewed as one of the most promising sectors. According to global market research firm Nova One Advisor, the global mRNA therapeutics market is expected to surpass $58.90 billion by 2033, with an average annual growth rate of 17 percent.

“SK Bioscience seeks to go beyond pandemic response and establish an mRNA vaccine platform capable of targeting a wide range of diseases, which will build a pipeline competitive in the global market,” an official at SK Bioscience said.