As American Merck (MSD) accelerates its plan to launch the cancer drug Keytruda in a subcutaneous injection (SC) formulation instead of an intravenous injection (IV), a patent dispute has erupted over the related technology. Changing from an intravenous injection to a subcutaneous injection can create new demand even after the patent period ends, but it has now encountered a new obstacle in the form of patent disputes.
American Halozyme Therapeutics announced on the 24th (local time) that it has filed a patent infringement lawsuit against MSD in the U.S. District Court for New Jersey, claiming that MSD infringed on its patent for the high-dose subcutaneous injection technology known as 'MDASE.'
Keytruda, which recorded sales of $29.482 billion (42.27 trillion won) last year, is the world’s top-selling drug. The patent for Keytruda expires in 2028. Many global pharmaceutical companies, including MSD, have adopted formulation changes as a strategy to maintain market competitiveness. Switching from an intravenous injection to a subcutaneous injection shortens the time for drug administration and allows patients to self-administer without going to a hospital. It not only increases patient convenience and creates new demand but also extends the pharmaceutical patent.
MSD has completed the Phase 3 clinical trial for the Keytruda subcutaneous injection and is undergoing approval review by the U.S. Food and Drug Administration (FDA). MSD plans to launch the Keytruda subcutaneous injection after receiving FDA approval in September this year.
However, Halozyme stated that 'MSD is infringing on its patent without a legitimate technology license negotiation.' The company is also seeking an injunction to prevent the commercialization of the Keytruda subcutaneous injection formulation along with damages. Earlier, Halozyme warned that it could file a lawsuit if negotiations on the licensing contract with MSD fell through, which it has now executed.
MSD stated that it has applied the subcutaneous injection technology of Korean company Alteogen to the intravenous formulation of Keytruda. Alteogen possesses independent technology (ATL-B4) that can transform intravenous therapies into subcutaneous injections.
On the other hand, Halozyme claims that MSD has infringed on 15 broad patents for modified human hyaluronidases. The hyaluronidase proteins enable drugs that were previously only possible to administer via intravenous injection to be given in a subcutaneous form.
MSD claims that the technology for the subcutaneous injection formulation change was independently developed by Alteogen and that the amino acid sequences making up that protein are not disclosed in any of Halozyme’s patents.
On the same day that Halozyme filed the lawsuit, MSD announced its first-quarter results for this year. During a conference call (earnings announcement), MSD revealed that the Keytruda subcutaneous injection formulation has confirmed equivalent efficacy and safety in Phase 3 trials compared to the existing intravenous formulation.
MSD reported first-quarter sales of $15.5 billion (approximately 22.24 trillion won), an increase of about 8% compared to the same period last year. Sales of Keytruda increased by 6% year-on-year to $7.2 billion (approximately 10.33 trillion won) on a constant currency basis. Its newly launched pulmonary arterial hypertension drug Winrevair also recorded first-quarter sales of $280 million (approximately 400 billion won).