荷兰法院禁止Keytruda SC在欧洲八国销售，韩国合作方已在当日盘中重定价

Dutch Court Bans Keytruda SC Sales in Eight European Countries - Seoul Economic Daily
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MSD's Keytruda Qlex (Keytruda SC). Photo courtesy of MSD
A subcutaneous (SC) formulation of Keytruda, the immuno-oncology drug from U.S. drugmaker Merck & Co., known as MSD outside the United States, has been barred from sale in eight European countries. The ruling is expected to affect Alteogen (196170), which supplied core technology for Keytruda SC, and Samsung Biologics (207940), which manufactures the antibody used in the SC formulation.
The Hague District Court in the Netherlands recently ruled in favor of Halozyme in a patent infringement suit against Merck, according to pharmaceutical and biotech industry sources. The court barred the manufacture, sale and storage of Keytruda SC, including contract manufacturing, in eight countries: the Netherlands, Belgium, Denmark, France, Ireland, Italy, Sweden and Switzerland.
At issue was whether Alteogen's ALT-B4, used in Keytruda SC, infringed a European patent (EP 622) tied to Halozyme's MDASE technology. The patent covers a hyaluronidase (PH20) modified to improve stability in the presence of phenolic preservatives, and expires in December 2032.
The litigation began last year when MSD moved first, arguing that Halozyme's patent was invalid. Halozyme filed a countersuit in February of this year, expanding its claims to eight countries beyond the Netherlands. Responding to the ruling, MSD said it strongly disagreed with the Dutch court issuing a cross-border injunction and that it was reviewing its options.
The decision is expected to have repercussions for Korean companies. Samsung Biologics produces the high-concentration antibody used in Keytruda SC at facilities including its third plant, and a substantial share of that output is reportedly bound for Europe. Alteogen, which supplies ALT-B4 to MSD and receives sales royalties, could also take a hit to earnings. An Alteogen official said the company's own estimates put Keytruda sales in the eight countries at roughly 6% to 8% of the global total, and that Keytruda SC accounts for a smaller share than that.
MSD also lost a preliminary injunction case brought by Halozyme in Germany in December of last year. Halozyme submitted test results to the court showing that ALT-B4 was more stable than unmodified hyaluronidase in the presence of phenolic preservatives. Hana Securities has estimated that Germany accounts for about 2% of total Keytruda sales. An appeal hearing is scheduled for next month.
If the injunction is upheld on appeal, some observers expect Halozyme's advantage in Europe to harden. Eom Min-yong, a research fellow at Shinhan Securities (008670), said the Dutch and German decisions were cases in which Halozyme prevailed without specific grounds, and that MSD would seek to steer future litigation toward an outcome like the one in the United Kingdom.
Outside Europe, by contrast, MSD has the upper hand in English-speaking jurisdictions. The company has filed invalidation petitions against more than 10 Halozyme patents with the U.S. Patent and Trademark Office and has won every case decided so far. In the United Kingdom, Halozyme abandoned the EP 622 patent on which it won in Germany and the Netherlands, handing MSD the advantage. A trial over EP 347, a divisional patent, is set to open in the United Kingdom next month.
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Original reporting by
Han Min-gu
for Seoul Economic Daily.
AI-translated from Korean. Quotes from foreign sources are based on Korean-language reports and may not reflect exact original wording.
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