UCB v. Cipla — Delaware Court Upholds Nayzilam Seizure Drug Patents After Bench Trial, Blocking Generic Entry

Background

Nayzilam is a nasal spray formulation of midazolam, a benzodiazepine, approved by the FDA for the acute treatment of seizure clusters (also called acute repetitive seizures) in patients with epilepsy. UCB, together with co-plaintiffs UCB Biopharma SRL, Hananja EHF, and the University of Iceland, holds patents covering the drug’s formulation and delivery method.

Cipla Limited and Cipla USA Inc. filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Nayzilam. Under the Hatch-Waxman Act, the ANDA filing itself constituted an act of infringement, and Cipla stipulated to infringement of the asserted claims—claim 13 of U.S. Patent No. 8,217,033 and claim 10 of U.S. Patent No. 8,809,322. Both patents relate to methods and compositions for intranasal drug delivery.

The sole issue at trial was patent validity. Cipla challenged the patents as anticipated under 35 U.S.C. § 102 and obvious under § 103, arguing that the prior art disclosed intranasal midazolam formulations that rendered UCB’s claims unpatentable. A four-day bench trial was held in October 2023, and the court issued its findings of fact and conclusions of law on May 15, 2026—just two days before Nayzilam’s orphan drug exclusivity under 21 C.F.R. § 316.31 expired on May 17, 2026.

The Court’s Holding

Judge Hall ruled that Cipla failed to prove by clear and convincing evidence that either asserted claim was invalid. The court’s detailed findings of fact addressed the science of epilepsy and intranasal drug delivery, the differences between the patented formulations and the prior art, and the level of ordinary skill in the relevant field.

On anticipation, the court found that no single prior art reference disclosed every element of the claimed formulations as arranged in the patent claims. On obviousness, the court concluded that a person of ordinary skill would not have been motivated to combine the cited references to arrive at the specific formulation claimed, and that secondary considerations—including the commercial success of Nayzilam and the long-felt need for a reliable rescue medication for seizure clusters—further supported the patents’ validity.

With infringement stipulated and validity upheld, the ruling effectively blocks Cipla from launching a generic version of Nayzilam under its ANDA.

Key Takeaways

• Cipla’s strategy of stipulating to infringement and focusing entirely on invalidity did not succeed—the court required clear and convincing evidence of anticipation or obviousness and found it lacking.
• The timing of the opinion—issued two days before Nayzilam’s orphan drug exclusivity expired—means the patent protection now serves as the primary barrier to generic entry, replacing the regulatory exclusivity.
• The ruling underscores the high bar for invalidity challenges in Hatch-Waxman litigation, especially when the patent holder can point to commercial success and unmet medical needs.
• Two tentative ANDA approvals for generic midazolam nasal spray exist, meaning other generic challengers may attempt market entry and face the same patent barrier.

Why It Matters

For patients with epilepsy who rely on Nayzilam as a rescue medication for seizure clusters, this ruling means generic alternatives remain off the market for now. For the pharmaceutical patent ecosystem, the case illustrates how overlapping layers of protection—orphan drug exclusivity followed by patent enforcement—can extend a brand drug’s market exclusivity well beyond any single regulatory or legal mechanism. Generic manufacturers targeting Nayzilam will need to find either a design-around formulation or a stronger invalidity case to break through.