Merck has escalated its dispute with Johns Hopkins University (JHU) regarding Keytruda by requesting the intervention of the U.S. Patent and Trademark Office (PTO) after a complaint lodged in 2022. Recently, the pharmaceutical giant submitted petitions for inter-part review proceedings concerning four patents associated with Keytruda, owned by JHU, as reported by JD Supra on March 13. Inter-party reviews essentially seek to ascertain the validity of a patent. Merck’s petitions assert that the patents are obvious and anticipated by prior art.
The genesis of the conflict dates back to a 2013 Keytruda trial conducted by Merck and JHU involving patients with tumors characterized by mismatch repair deficiency or microsatellite instability. Following the success of the trial, JHU secured four Keytruda patents, which Merck alleges were predominantly based on research conducted during the joint trial. These patents were obtained by JHU in 2021 and 2022 without prior notification or involvement of Merck. Merck claims that the patents explicitly encompass aspects related to dosage amounts and features suggested by Merck scientists before the joint study.
Merck contends that without the data from the collaborative trial, JHU would have lacked a basis to acquire the patents. Consequently, JHU licensed these patents to two other entities and demanded “hundreds of millions of dollars” from Merck tied to its Keytruda sales, a demand to which Merck did not accede. Merck filed a complaint in the Maryland district court seeking a declaration that JHU breached its contract, asserting that JHU cannot enforce the patents against Merck, and claiming damages.
JHU responded with a 60-page counterargument, asserting that its inventions predated any involvement by Merck and highlighting that numerous Keytruda approvals stemmed from their research collaboration, resulting in substantial revenue for Merck. JHU emphasized that it is seeking only a small portion of these earnings. Additionally, JHU stated that Merck did not provide funding for the study until preliminary results were published, despite Merck’s contribution of $3.5 million to the research, as noted in their original complaint. JHU emphasized its inventions’ transformative impact, asserting that once deemed incurable, cancers are now treatable, if not curable, due to its breakthrough.
The litigation remains ongoing, amid heightened scrutiny over Keytruda’s existing and potential future patents. Senator Elizabeth Warren recently urged the PTO to investigate Merck’s efforts to extend its patent protection, noting that as of 2021, the company had filed 129 patents related to the drug.
