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British ship EP622 canceled, patents related to US ships invalidated one after another… Netherlands recognizes validity and infringement
MSD refutes that the patent is invalid worldwide... Merck stock price rises 0.6% despite the ruling
In the global patent battle surrounding Alteogen's (196170) subcutaneous injection (SC) formulation platform ALT-B4, conflicting rulings were reached with the US and UK. The Dutch court ruled that the patent that Halozyme had voluntarily agreed to cancel in the UK was valid, and acknowledged that Keytruda SC, which applied ALT-B4, had infringed on it.
In the United States, MSD is successively winning invalidity trials filed against Halozyme's MDASE-related patents. In Europe, the results of patent litigation by country were clearly mixed, with the UK and the Netherlands reaching different conclusions regarding the same EP622 patent.
According to Halozyme and foreign media on the 8th, the District Court of The Hague, Netherlands, ruled that MSD infringed on Halozyme's MDASE-related European patent EP 2,797,622 (EP622). The patent invalidity claim filed by MSD was also not accepted.
Accordingly, MSD BV, the corporation holding MSD's European licensing rights, was ordered to stop manufacturing, selling, importing, and maintaining inventory of Keytruda SC in eight countries, including the Netherlands, Belgium, Denmark, France, Ireland, Italy, Sweden, and Switzerland.
EP622 canceled UK route… Netherlands recognizes validity and infringement
What is noteworthy about this ruling is that the EP622 in question is a patent that has already been canceled in the UK. According to the British High Court decision, MSD filed a lawsuit claiming that the UK patent for EP622 was invalid, and Halozyme countered, claiming patent infringement. However, as Halozyme agreed to cancel the UK patent for EP622 last May, the dispute in the UK surrounding the patent no longer continued.
On the other hand, the Dutch court recognized the validity of the Dutch designated patent EP622, which is the same European patent, and determined that Keytruda SC, which applied ALT-B4, infringed on it. Regarding one European patent, Halozyme agreed to its cancellation in the UK, while in the Netherlands, conflicting results were obtained, with both validity and infringement recognized.
The background to the differences in judgments by country is also the difference in the issues and proof processes addressed in each lawsuit. In the UK, as EP622 was canceled, the validity and infringement judgment on the patent did not continue until the end, while the Dutch court judged the validity of the patent and whether ALT-B4 was infringed on the merits.
Since European patents lead to designated patents that are effective in each country, the court's judgment in each country may vary even for the same patent. However, this ruling differed significantly from the results of recent patent battles in that the Netherlands recognized both validity and infringement while the related patent was invalidated in the United States and EP622 was canceled in the United Kingdom.
In the US, MSD continues to win... Halozyme patents invalidated one after another
At the U.S. Patent and Trial Board (PTAB), MSD is winning successive invalidity trials filed against Halozyme's MDASE-related patents. PTAB successively denied the patentability of the claims subject to trial on the grounds that Halozyme's related patents did not meet the written description requirements and enforceability requirements.
Also this month, in the PGR2025-00052 case, a final decision was made that all claims 1 to 17 of Halozyme's US Patent No. 12,264,345 were not patentable. As other PGRs have previously made decisions in the same direction, Halozyme-related patents are being judged invalid one after another in the United States.
The Dutch ruling is in the opposite direction to the results followed in the US and UK. In particular, it is an unfavorable result for MSD and Alteogen in that not only the validity of the patent but also the infringement of Keytruda SC using ALT-B4 was acknowledged and an injunction was issued targeting eight countries.
MSD immediately refuted... Merck stock price rises 0.6% despite the ruling
MSD immediately protested against this ruling. The company stated that it strongly disagrees with the Dutch court's decision to issue a cross-border injunction, stating that the Halozyme patent is invalid worldwide and that the infringement claim is groundless. We are currently reviewing response procedures, including appeals.
Merck's stock price did not shake significantly despite the ruling. On the New York Stock Exchange on the 7th (local time), Merck closed at $142.79, up 0.60% from the previous trading day. Halozyme's stock price, which won the case, also rose by about 2%. Although an injunction was issued targeting eight European markets, the movement of the two companies' stock prices that day was limited.
Patent disputes in Europe also continue. MSD has been contesting the validity of EP622 in several European countries, and related proceedings are also underway in major markets, including Germany. The Dutch ruling also requires follow-up legal procedures.
Although this Dutch ruling is unfavorable to Alteogen and MSD, it is too early to extend it to the conclusion of the entire global patent battle. In the US, Halozyme's MDASE-related patents are being invalidated, and in the UK, the same EP622 has already been cancelled. On the day of the ruling, Merck's stock price also rose 0.6%, showing limited market reaction. As the judgments surrounding the same patent differ from country to country, it is necessary to check the follow-up procedures in the Netherlands and the judgments that will follow in each European country.
