As we have said for several years now, Rahway is not likely to lose patent protection much before 2040, on this ultra blockbuster franchise — and this step, as ably reported by Fierce Pharma, is designed to cement that outcome.

JHU sought four patents, all of which were granted by the USPTO examiner — and all of which, Merck correctly asserts were based on joint research with Merck — and funded entirely by Merck. The patents go to ways of making the agent more effective in a human body (dosing, etc.) which were in fact Merck’s prior art / know-how (unpatentable) from the clinical trials Merck funded and conducted. At best, JHU might argue it deserves a “tip” for filing on them, but it is unlikely that the JHU ‘356 ‘974,’975 and ‘219 patents will ultimately be held to require that Rahway must pay licenses, for them (if ultimately allowed to stand). It was primarily Merck’s effort that led to these method of use patent claims at JHU.

In any event back in 2022, in federal court in Maryland, Merck began litigation to invalidate these JHU patent claims. Here’s the latest, from Fierce:

…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….

[Ed. nota bene — In Merck’s complaint, it stated “JHU faced repeated rejections (from the PTO) for the use of “wherein” in certain claims requiring an improved outcome comparison. In attempting to overcome the Patent Office’s rejections, JHU referred to the claim limitation, “wherein the patient exhibits an outcome that is improved as compared to a corresponding outcome that would be observed in a reference patient that has been administered pembrolizumab,” and represented that, “this clause” was necessary to prevent the claim from “simply requir[ing] giving an effective amount of pembrolizumab to a patient,” which would “effectively ignor[e] the unexpected relationship between MSI-high/MMR deficiency status and anti-PD-1 antibodies, as described in the specification.”

JHU argued that, to omit this clause from the presented claims, would “ignore a core concept disclosed in the specification: the unexpected relationship between MSI-high/MMR deficiency status and improved relative response to anti-PD-1 antibodies….” But in Condor’s estimation, these are not novel claims as made by JHU.]

Now you know — but at over $22 billion a year in cash revenue now, Merck is going to move forcefully to keep all interlopers off its playing field (even university affiliated ones) — by litigation, inter partes challenges and “evergreening” formula and delivery changes (like subcutaneous injection versions of the therapy)… into the 2040s time frame.

You read it here first. Onward, smiling — happy Pi Day ’24!

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