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…
On Sept. 1, 2020, NeuClone Pharmaceuticals announced that they are developing biosimilar candidates referencing OPDIVO and KEYTRUDA. According to NeuClone, the two biosimilar candidates “are in the advanced states of pre-clinical development.” This brings the number of NeuClone’s biosimilar pipeline to 8 announced products with another 12 in development that…
As we previously reported, Bristol-Myers Squibb Co. and Ono Pharmaceutical Company sued Merck & Co. in 2015 alleging that Merck’s sale of Keytruda® infringes a patent directed to the use of anti-PD-1 antibody to treat metastatic melanoma. Last week, the parties announced that they settled the litigation. According to the…
At yesterday’s European Society for Medical Oncology (ESMO) meeting, Merck Sharp & Dohme Corp. announced positive data from two studies regarding its Keytruda ® (pembrolizumab) biologic. According to Merck’s press release, Keytruda performed better than the standard of care chemotherapy as a first line therapy for patients with metastatic non-small…
Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody products. Merck received FDA approval to market Keytruda® (pembrolizumab) for treating certain melanomas and lung cancers, and…
On Tuesday, July 7, 2015, the USPTO granted U.S. Patent No. 9,073,994, directed to a method of treating metastatic melanoma using an anti-PD-1 antibody to Ono Pharmaceuticals, a partner of Bristol-Myers Squibb Co. BMS makes Opdivo (nivolumab), an anti-PD-1 antibody, approved to treat metastatic melanoma and non-small cell lung cancer. …