On February 11, 2026, Formycon AG and Lotus Pharmaceutical announced the execution of an exclusive license agreement directed to Formycon’s pembrolizumab biosimilar candidate, FYB206. Pembrolizumab is currently approved as KEYTRUDA (Merck Sharp & Dohme LLC) and is indicated to treat a variety of tumors. FYB206 is near the end of…
On September 18 and 19, 2025, the Patent Trial and Appeals Board (“PTAB”) issued final written decisions for four inter partes review (“IPR”) challenges brought by Merck Sharp & Dohme LLC (“Merck”) against Johns Hopkins University’s (“Johns Hopkins”) pembrolizumab patents, finding that all claims were unpatentable. The dispute between Merck…
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national pride, and foreign filing license laws encourage such home country first-filings. It is well known that the…
In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins University (“Johns Hopkins”), U.S. Patent No. 11,591,393 (the ’393 patent). The…
On September 20, Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review status to Merck’s supplemental Biologics License Application (sBLA) seeking approval for its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy, as a treatment for newly…