"They Called It a 'Routine Process'... Sam Chun Dang Pharm-Regeneron, Eylea Patent Dispute Drags On"

U.S. Court Issues Discovery Order
Sam Chun Dang Pharm Files Motions to Quash and Dismiss

The patent dispute between Samchundang Pharm and Regeneron Pharmaceuticals (Regeneron) over the Eylea biosimilar is entering a protracted phase. It has been confirmed that the legal battle between the two parties shows no sign of abating, particularly over the "discovery" process that Regeneron initiated in a U.S. court.

According to the decision obtained by The Asia Business Daily from the United States District Court for the District of Delaware on the 27th, the court ordered on the 23rd (local time) that Samchundang Pharm’s U.S. subsidiary (SCD Biotech, SCD US) must have its "motion to quash and vacate a discovery order and to dismiss the subpoena" separated from the original case and processed as an independent new case. Discovery refers to a legal process by which parties involved in lawsuits abroad can legitimately seek evidence from entities in the United States. As Samchundang Pharm has filed to quash this process and the court now proceeds with a full legal review and additional briefing, there is a strong likelihood that it will take several months before a final decision is reached. In April, The Asia Business Daily reported that the dispute over the Eylea biosimilar was ongoing. At the time, Samchundang Pharm maintained that it was merely following “a standard process pursuant to agreement”; however, contrary to this explanation, legal uncertainties have not been resolved—in fact, it has now entered a more drawn-out legal phase.

Eylea is an ophthalmic treatment developed by Regeneron. It is used to treat wet age-related macular degeneration and diabetic macular edema, and is considered a blockbuster original drug with annual sales reaching approximately 14 trillion won. From 2024, patents in Korea, the United States, Europe, and other regions have been expiring one after another. Samchundang Pharm developed the Eylea biosimilar "Bevacfrey (SCD411)," but has been in ongoing legal conflict with Regeneron over patent infringement issues. Although it was announced in February that a settlement with its U.S. partner had resolved the local patent dispute and secured sales rights, since April, Regeneron has sought to obtain key materials—including the Biologics License Application (BLA) and manufacturing process records—from Samchundang Pharm’s U.S. subsidiary through discovery at the U.S. District Court in Delaware. The acquired materials are expected to serve as crucial evidence in an ongoing patent infringement lawsuit in Korea.

Samchundang Pharm’s U.S. subsidiary did not comply immediately with the discovery order, instead obtaining an extension, and then applied to quash and dismiss the previous court order on the deadline of the 1st of this month. This was on the grounds that "the U.S. subsidiary was not involved in work related to Eylea, and that activities in the U.S. pertained solely to non-infringing areas already covered by a license agreement with Regeneron."

In response, on the 15th of this month, Regeneron submitted an opposition brief and a declaration by its counsel, strongly contesting the motion. Regeneron argued that the Samchundang Pharm subsidiaries had not even conducted a basic search to determine whether responsive materials exist and insisted on pursuing the discovery process to secure evidence for ongoing litigation in Korea and other jurisdictions.

This content was produced with the assistance of AI translation services.