Big Molecule Watch
June 21, 2024

Update on John Hopkins and Merck Pembrolizumab Litigation

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 ’393 patent issued on February 28, 2023, and is generally directed to methods for treating microsatellite instability high or DNA mismatch repair deficient colorectal cancer with pembrolizumab.  Merck’s petition (IPR2024-00240), filed on November 30, 2023, challenged the patentability of all 42 claims of the ’393 patent on the grounds of novelty under 35 U.S.C. 102 and obviousness under 35 U.S.C. 103.  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 the inter parties review on all challenged claims and on all asserted grounds.

In March 2024, Merck had also filed petitions for IPR on eight other patents owned by Johns Hopkins, all generally related to methods of treatment using pembrolizumab.

Merck and Johns Hopkins are also litigating the same patents in a federal district court.  In November 2022, Merck filed a Complaint against Johns Hopkins in the District for the District of Maryland, alleging breach of contract, promissory estoppel, and declaratory judgment of noninfringement of several patents.  Merck alleged that the “patents emerg[ed] from a joint research collaboration by Merck and [Johns Hopkins] regarding the use of Merck’s breakthrough cancer drug pembrolizumab,” sold under the trade name KEYTRUDA.  According to Merck, “Merck and [Johns Hopkins] partnered to design and conduct a clinical study administering KEYTRUDA to cancer patients having tumors that had the genetic biomarker known as microsatellite instability-high (“MSI-H”) or were mismatch repair deficient (“dMMR”).”  John Hopkins, in its Answer to Merck’s complaint, asserts that “the patent rights to Hopkins’ MSI-High inventions are not subject to any agreement between Hopkins and Merck, and Merck has no rights in or to these Hopkins’ patented inventions.”  According to Johns Hopkins, the “concept for the groundbreaking clinical study developed by Hopkins researchers was . . . prepared before there was any agreement between Hopkins and Merck, and the contributions Merck alleges to have made to the study protocol were known, trivial and have never been claimed as inventions by the Hopkins Inventors.”  Johns Hopkins filed counterclaims for patent infringement of several additional patents, including the ’393 patent.

On June 14, 2024, Merck moved for a stay of the district court litigation pending final resolution of the ’393 patent IPR.  The Court has not yet ruled on the motion.

Stay tuned to Big Molecule Watch for more updates on this litigation.


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