Merck takes Keytruda patent dispute with Johns Hopkins University from the court to the patent office

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来源: FiercePharma

Megablockbuster Keytruda was last year's best-selling drug with more than $25 billion in sales.

Merck is kicking its Keytruda-related clash with Johns Hopkins University (JHU) up a notch by asking the U.S. Patent and Trademark Office (PTO) to weigh in following a 2022 complaint.

The drugmaker last week filed petitions for inter partes review proceedings on four Keytruda-related patents owned by JHU, JD Supra reported March 13.

Inter partes reviews essentially seek a determination on the validity of a patent. In Merck’s case, its petitions propose the patents as being obvious and anticipated by the prior art.

According to Merck’s 2022 complaint (PDF) that initiated the dispute, the two linked up for a 2013 Keytruda trial in patients with tumors that were mismatch repair deficient or microsatellite instability-high. Following the successful study, the research university secured four Keytruda patents that Merck claims were largely based on research from the joint trial.

JHU received the patents in 2021 and 2022 and had filed for them without notifying or involving Merck. The patents “expressively recite” aspects tied to the dosage amounts and features that were suggested by Merck scientists ahead of the joint study, the company claims.

Essentially, Merck’s argument is that without the data from the collaborative trial, there would be “no basis” for JHU to get its hands on the patents, it said in the complaint.

Then, JHU licensed out the patents to two other companies and asked Merck to pay “hundreds of millions of dollars” tied to its Keytruda sales, which the drugmaker did not agree to.

The complaint, which was filed in the Maryland district court, seeks a declaration that JHU breached its contract and cannot assert the patents against Merck nor does Merck infringe the patent as well as damages.

JHU later countered in a 60-page response (PDF), detailing its inventions that it claims “began years before any involvement by Merck.” Furthermore, the university points out that several Keytruda approvals stemmed from the research collaboration, resulting in “billions of dollars” for Merck, of which JHU is seeking “only a small portion of,” it said.

Plus, Merck did not offer funding for the study in question until preliminary results were published, according to JHU. The company noted in its original complaint that it contributed some $3.5 million to the research.

“Cancers that were once considered death sentences are now treatable—even curable—as a result of Hopkins’ breakthrough invention,” JHU argued in its response.

The litigation is still ongoing.

Megablockbuster Keytruda’s existing and potential future patents have come under increased scrutiny recently. Last month, Sen. Elizabeth Warren, D-Massachusetts, wrote the PTO to ask it to look into Merck’s attempt to extend its patent protection.

As of 2021, the company had filed 129 patents related to the drug, Warren wrote.

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