The pharmaceutical patent disputes between domestic biosimilar companies and original pharmaceutical firms are escalating.
According to industry sources on Jan. 31, Samsung Bioepis and Celltrion are embroiled in patent disputes with original pharmaceutical companies.
Alexion Pharmaceuticals, a subsidiary of AstraZeneca, has filed a patent infringement lawsuit against Samsung Bioepis in the U.S. District Court for the District of Delaware. Alexion alleges that Samsung Bioepis has violated patents associated with Soliris, including material patents, through its developed biosimilar, “SB12.”
Alexion has filed the lawsuit against Samsung Bioepis due to its anticipation of a significant impact on revenue if Samsung Bioepis releases SB12 in the United States. Soliris is a blockbuster drug that achieved a whopping 5 trillion won (US$3.75 billion) in global sales in 2022 alone.
The aftermath of the patent dispute raises concerns that the release of Samsung Bioepis' biosimilar products could face obstacles. Despite receiving approval for domestic clinical field treatment purposes for SB12 from the Ministry of Food and Drug Safety in August of last year, it is expected that there may be delays in the domestic launch as well.
Regeneron Pharmaceuticals, a U.S. pharmaceutical company, has initiated a patent infringement lawsuit against Celltrion and Samsung Bioepis. If the lawsuit favor Regeneron to some extent, there is a potential for an extension in the patent protection period, enabling the collection of royalties from latecomers. Analysts suggest that this lawsuit could result in a somewhat delayed market entry for domestic companies.