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October 7, 2024

PTAB Institutes Eight More IPRs Filed by Merck on Johns Hopkins Pembrolizumab Patents

In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab.  The eight patents are generally directed to methods for treating cancer in a patient having a tumor that exhibits a high microsatellite instability (MSI-high) or a mismatch repair (MMR) deficiency status.

On September 23, 2024, the PTAB granted institution of four IPRs:  IPR2024-00622 (U.S. Patent No. 10,934,356); IPR2024-00623 (U.S. Patent No. 11,325,974); IPR2024-00624 (U.S. Patent No. 11,325,975); and IPR2024-00625 (U.S. Patent No. 11,339,219).  On September 27, 2024, the PTAB granted institution three more IPRs on patents in the same patent family: IPR2024-00647 (U.S. Patent No. 11,649,287); IPR2024-00649 (U.S. Patent No. 11,629,187); and IPR2024-00650 (U.S. Patent No.  11,634,491.  Finally, on October 3, 2024, the PTAB granted institution of an IPR on additional patent in the same family: IPR2024-00648 (U.S. Patent No. 11,643,462).  Based on the arguments and assertions in the petition, the PTAB concluded that Merck had shown a reasonable likelihood that it would prevail and therefore instituted IPR on all challenged claims and on all asserted grounds (anticipation and obviousness) for each of the nine patents.

Relatedly, Merck’s petition for IPR on U.S. Patent No. 11,591,393, which belongs to the same patent family, was instituted on June 13, 2024.

All of the patents are involved in a district court litigation filed by Merck against Johns Hopkins, alleging breach of contract, promissory estoppel, and declaratory judgement of noninfringement.  The case, Merck Sharp & Dohme LLC v. The Johns Hopkins University, 1:22-cv-03059-JRR (D. Md.), was stayed in June 2024, pending resolution of the IPR on the ʼ393 patent.

Stay tuned to Big Molecule Watch for updates on these IPRs and the district court litigation.

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