Alteogen announced on the 12th that it has secured registration with the United States Patent and Trademark Office (USPTO) for a formulation patent related to its subcutaneous (SC) Keytruda product.
Keytruda SC (brand name: Keytruda Qurex) combines Keytruda (generic name: pembrolizumab) with Alteogen’s Hybrozyme platform-based recombinant human hyaluronidase, ALT-B4 (ingredient name: berahyaluronidase alfa).
With this registration, Keytruda Qurex will be protected by patent in the United States for about 17 years, through early 2043. Keytruda Qurex received approval from the U.S. Food and Drug Administration (FDA) in September last year and is currently being marketed in the United States. Alteogen may receive sales-based milestone payments totaling $1 billion (approximately KRW 1.48 trillion), based on annual and cumulative sales. After all milestone payments are received, the company will receive royalties based on sales.
Alteogen said that, despite intellectual property issues raised regarding ALT-B4, the USPTO has once again reaffirmed the novelty of ALT-B4 and its status as an independent invention. The company also described the patent as part of the portfolio it has been building to provide multilayered protection for the Hybrozyme platform.
Alteogen CEO Tae-yeon Jeon, a U.S. patent attorney, said, “It is highly meaningful that ALT-B4, a hyaluronidase developed as an independent invention, has secured intellectual property protection not only for the substance itself but also for the formulation combined with pembrolizumab,” adding, “This will support the exclusivity of Keytruda Qurex, the first product to use Hybrozyme.”
