This week, Judge Bryson issued his findings of fact and conclusions of law following trial in Janssen Pharmaceuticals, Inc., v. Tolmar, Inc., C.A. No. 21-1784-WCB (D. Del. Feb. 26, 2024), and ANDA action. The opinion is long and thorough, and I thought the section on enablement was worth noting.
The patent at issue covers a "dosing regimen" for giving an anti-psychotic drug "to a psychiatric patient in need of treatment for psychotic disorder." According to the method, two loading doses of the drug are given, and then a maintenance dose is given between 21 and 38 days later (a "17-day window").
Defendant argued that the patent was not enabled, first because a person of …
