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PTAB Invalidates Johns Hopkins’ US Pembrolizumab MOT Patent in MSD’s IPR

Jun 9, 2025

On 9 June 2025, the US Patent Trial and Appeal Board issued a written decision invalidating all claims of Johns Hopkins University’s US Patent No. 11,591,393 on the basis of anticipation and obviousness.  US Patent No. 11,591,393 is directed to treating patients with microsatellite instable (MSI) or DNA mismatch repair deficient (dMMR) colorectal cancer with pembrolizumab.  The decision was issued in proceedings for inter partes review (IPR) filed by MSD on 20 November 2021 (IPR2024-240).

The following IPRs commenced by MSD in relation to Johns Hopkins University (JHU) patents relating to pembrolizumab remain pending:

In November 2022, MSD filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel.  Based on the complaint, the dispute arose out of a contract between MSD and the University to design and conduct a clinical trial on administration regimes for Keytruda® (pembrolizumab) in cancer patients with certain genetic biomarkers.  JHU filed a counter-claim on 12 April 2023, including alleging infringement of each of the patents subject to the IPR proceedings referred to above.  The US Court proceeding has been stayed pending the outcome of the IPRs.  No trial date has been scheduled.