A Blog About Intellectual Property Litigation and the District of Delaware


Entries for tag: Enablement

My feeling (informed, but not rigorously researched until a post later this week), is that enablement is slowly overtaking 101 as the vehicle of choice to attack the overreaching patent.

Preemption is no longer the watchword it once was in 101 jurisprudence (Impact Engine actually filed a petition for cert a couple months back asking "Whether the lodestar for determining patent eligibility under this Court’s two-step framework is whether the patent claims preempt basic technological or scientific building blocks").

Oh preemption, my guiding light.  Lead me on the 101 inquiry.
Oh preemption, my guiding light. Lead me on the 101 inquiry. Casey Horner, Unsplash

At the same time, enablement is on a bit of an upswing following the Supreme Court's decision in Amgen Inc. v. Sanofi, 598 U.S. 594,610 (2023) which reaffirmed the general principle that "if an inventor claims a lot, but enables only a little, the public does not receive its benefit of the bargain."

A few weeks ago, Judge Connolly gave us one of the more interesting decisions in this vein, when he granted a motion for summary judgment of no enablement in Spinal Generations, LLC v. Depuy Synthes, Inc., C.A. No. 22-1368-CFC, D.I. 220 (D. Del. Apr. 11, 2025). The patents there covered a "method and device for delivering medicine to bone." (eds. note -- pretty cool title for a patent). In particular, the relevant claims required a "delivery pathway for [a] substance between at least one end of the insert and a portion of the bone."

To break it down a bit, you've got ...

Pills
HalGatewood.com, Unsplash

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 …