[Exclusive] Did Samchundang Pharmaceutical Disclose Only Favorable Information?... 'Eylea Patent Dispute' Not Over Yet

U.S. pharmaceutical giant Regeneron Pharmaceuticals (Regeneron) has secured the ability to obtain key information about Samchundang Pharm's eye disease treatment (Eylea biosimilar) through a local court decision. This move strengthens Regeneron's offensive in the ongoing global patent dispute against Samchundang Pharm. The reality is markedly different from Samchundang Pharm's announcement last month that the U.S. patent dispute had been resolved, and the repercussions are likely to be significant.

The United States District Court for the District of Delaware issued an order on the 20th (local time) granting Regeneron's discovery motion against SCD Biotech LLC and SCD US, Inc., the U.S. subsidiaries of Samchundang Pharm. Accordingly, Regeneron can now issue subpoenas for the production of documents to Samchundang Pharm's U.S. subsidiaries that carry legal obligations. Photo by Donghoon Jung

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According to documents obtained by The Asia Business Daily from the United States District Court for the District of Delaware on the 24th, the court granted Regeneron's discovery motion against Samchundang Pharm's U.S. subsidiaries, SCD Biotech and SCD US, on the 20th (local time). This decision was made pursuant to Section 1782 of Title 28 of the U.S. Code, which allows a person involved in foreign litigation to lawfully request evidence from a company located in the United States. As a result, Regeneron has obtained the authority, with court approval, to issue subpoenas requiring Samchundang Pharm's U.S. subsidiaries to submit relevant documents. The key materials Regeneron is targeting include the full drug application submitted by Samchundang Pharm to the U.S. Food and Drug Administration (FDA), detailed manufacturing records, product samples, and contracts with overseas sales partners.

Eylea is a leading ophthalmic disease treatment jointly developed by Regeneron in the U.S. and Bayer in Germany. It is a blockbuster original drug, generating annual sales of around 14 trillion won, used to treat wet age-related macular degeneration and diabetic macular edema. Patents in Korea, the U.S., Europe, and elsewhere have begun expiring sequentially from 2024. Samchundang Pharm began developing the Eylea biosimilar “Bevacfree (SCD411)” in 2014 and has since obtained marketing approval in Korea, Europe, Canada, and other regions. Regeneron, which holds the original drug's patent, filed a lawsuit in a Korean court in 2024 alleging that Samchundang Pharm infringed its patent.

Last month, Samchundang Pharm announced that it had concluded the U.S. patent dispute over its Eylea biosimilar and secured local marketing rights. The company explained that its U.S. partner Fresenius Kabi had finalized a patent dispute settlement with Regeneron, thus resolving the dispute. While the specific terms of the settlement were not disclosed due to confidentiality clauses, Samchundang Pharm stated that it had secured the right to sell the Eylea biosimilar in the U.S. market as a result of this agreement.

Jeon In-seok, CEO of Samchundang Pharm, is attending a press conference held at the Samchundang Pharm headquarters in Seocho-gu, Seoul, on the 6th of this month. Photo by Yonhap News Agency

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Contrary to Samchundang Pharm's previous announcement, the recent U.S. court decision confirms that Regeneron is continuing litigation over global patents. While Samchundang Pharm published a shareholder notice stating that it had reached a settlement to end the patent dispute, it did not disclose whether directly or indirectly related lawsuits would continue or any specific details regarding remaining legal risks. Although the company is not legally required to disclose all litigation information, it is open to criticism for selectively providing only favorable information to shareholders who have limited access to company data.

The documents obtained are expected to become key evidence in the ongoing patent infringement lawsuit in Korea. Regeneron is pursuing a patent infringement suit at the Seoul Central District Court against Samchundang Pharm and its subsidiary Optus Pharm, seeking to prohibit manufacturing and sales, and is also engaged in a separate lawsuit at the Patent Court over product composition. The Seoul Central District Court previously dismissed Regeneron's request for Samchundang Pharm to provide related documents, prompting Regeneron to obtain a discovery order from the U.S. court to overcome this obstacle.

The legal pressure Regeneron is exerting on Samchundang Pharm is also expanding to Taiwan. In February, Regeneron filed a patent infringement lawsuit with a Taiwanese court against Samchundang Pharm's local manufacturing company. This action took place around the same time Samchundang Pharm announced that it had resolved the U.S. patent dispute through settlement. While Regeneron may have reached "some form of settlement" with Samchundang Pharm in the U.S., it is simultaneously pursuing lawsuits and evidence-gathering measures in other countries where Samchundang Pharm's manufacturing facilities and headquarters are located as part of its ongoing patent defense efforts.

Legal experts believe this procedure could become a variable that determines the direction of the litigation in Korea. Attorney Kim Junrae of Kim Junrae Law Office commented, "It is a situation where Regeneron has forcibly obtained manufacturing process documents that could not be secured in the Korean courts, using the authority of the U.S. judiciary," and added, "Regeneron will now present these in Korean court to assert patent infringement."

Attorney Ko Hankyung of Brighton Law Office stated, "If CMC data, manufacturing process records, and product samples are obtained and submitted to the Korean courts, they will become important evidence for determining infringement and calculating damages." However, he also noted, "If the U.S. court issues a protective order over highly confidential business information, the practical scope of use could be limited."

In response to these developments, Samchundang Pharm told The Asia Business Daily, "It is difficult to provide a specific answer," adding, "The settlements in the U.S. and Canada have already been completed, and the procedures in other regions are part of the ordinary process as settlements progress."

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