Who holds the Keytruda patents?
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., is the patentee for Keytruda (pembrolizumab), the leading immunotherapy for cancers like melanoma and lung cancer. The company lists itself as the assignee on key U.S. patents covering the drug's composition, methods of use, and manufacturing.[1]
When do Keytruda's main patents expire?
Core composition-of-matter patents, such as U.S. Patent No. 8,354,509, expire in 2028, with pediatric exclusivity potentially extending to 2029. Later patents on formulations and combinations extend protection into the 2030s, including some listed until 2036.[1][2]
Why are companies challenging these patents?
Generic firms like Viatris, Lupin, and Accord are filing inter partes review (IPR) petitions at the USPTO, arguing obviousness or lack of novelty in Keytruda's PD-1 antibody claims. Merck has defended successfully in several cases, but ongoing litigation could shorten exclusivity.[1][3]
Can biosimilars launch before patent expiry?
No, due to the FDA's Purple Book and 12-year biologic exclusivity from Keytruda's 2014 approval, plus blocking patents. First biosimilar approvals are unlikely before 2028, with launches delayed further by settlements or litigation.[1][2]
How does Keytruda's patent landscape compare to other blockbusters?
Keytruda's portfolio is denser than many small-molecule drugs, with over 100 Orange Book listings versus Opdivo's ~50 from Bristol Myers Squibb. This "patent thicket" deters early entry, similar to Humira's strategy.[1]
[1]: DrugPatentWatch.com - Keytruda Patents
[2]: FDA Orange Book - Pembrolizumab
[3]: USPTO Patent Trial and Appeal Board - Keytruda IPRs