Many years ago now, when I was still in the full flagrant flower of youth (38), I wrote a post discussing the relative rates at which various drug patents -- compound, method of treatment, and formulation -- we found invalid in Delaware.
Not analyzed at the time (because who has the time?) was the question of how often these various types of drug patents are found to be infringed in ANDA cases. I'll have a fuller post on this later in the week, but my guess is that it goes compound > method of treatment > formulation. If it turns out I am wrong, you will never be able to prove it because I will edit this post immediately.
In any case, method of treatment patents often follow trends with certain themes going into and out of vogue, so I suspect today's opinion from Chief Judge Connolly in Novo Nordisk, Inc. v. Mylan Pharms. Inc., C.A. No. 23-101-CFC (D. Del July 22, 2025), will be of general interest to our audience.
The patent there -- for blockbuster drug Wegovy -- required that the drug be administered "without another therapeutic agent," which the Court construed to mean "administered without another therapeutic agent as part of the method for reducing body weight, or for treating the conditions of diabetes or hypertension."
Mylan argued that their ANDA label could not induce infringement because, although it cautioned against using the drug with other GLP-1 inhibitors, it was agnostic as to any other weight loss drugs, merely saying that "[t]he safety and efficacy of coadministration with other products for weight loss have not been established."
Plaintiff argued that the this was sufficient to establish inducement because "the proposed label does not require patients to receive other treatment beyond a reduced-calorie diet and physical activity, 'physicians will inevitably prescribe Mylan's ANDA Product without another therapeutic agent.'"
The Court, however, granted Mylan's motion for judgment on the pleadings of no inducement of the claims:
The dispositive question is whether Mylan's proposed label encourages physicians and patients not to use any other therapeutic agent when administering its semaglutide product to reduce a patient's body weight or to treat diabetes or hypertension. And, as noted above, the proposed label does not state or imply that Mylan's semaglutide product should not be coadministered with a therapeutic agent other than other semaglutide-containing products and other GLP-1 receptor agonists, and it makes clear that Mylan expects that physicians will administer its semaglutide product with another therapeutic agent when treating diabetes or hypertension or to reduce a patient's weight.
Id. at 10-11.
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