Case Overview

In a case that carries significant weight for ophthalmic biologics patent strategy, the U.S. Court of Appeals for the Federal Circuit dismissed the appeals in Regeneron Pharmaceuticals, Inc. v. Mylan NV (Case No. 23-1395) on July 9, 2024 — 543 days after the action was filed. The dismissal, entered under Fed. R. App. P. 42(b) with each party bearing its own costs, followed a patentability challenge that resulted in an underlying finding of unpatentability against Regeneron’s patents covering the use of VEGF (vascular endothelial growth factor) antagonists in treating angiogenic eye disorders.

At stake were two U.S. patents — US9669069 and US9254338 — central to Regeneron’s intellectual property portfolio around therapies targeting VEGF-driven conditions such as wet age-related macular degeneration (AMD) and diabetic macular edema. For patent attorneys, IP professionals, and R&D teams operating in the biologics and ophthalmic drug space, this dismissal raises critical questions about patent prosecution strategies, invalidity vulnerabilities, and freedom-to-operate considerations in a high-value therapeutic area.

The Parties

The Patents at Issue

This case involved two U.S. patents central to Regeneron’s intellectual property portfolio around therapies targeting VEGF-driven conditions. Both patents protect the clinical use of VEGF pathway inhibition — the mechanism underlying Eylea — in treating conditions where abnormal blood vessel growth threatens vision.

• • US9669069 — Covers methods involving VEGF antagonist use for angiogenic eye disorders.
• • US9254338 — Similarly directed to VEGF antagonist therapeutic applications in ocular conditions.

Litigation Timeline & Procedural History

The case was filed directly at the appellate level before the **Court of Appeals for the Federal Circuit** — the specialized federal court with exclusive jurisdiction over patent appeals — indicating this action arose from a prior tribunal ruling, consistent with the invalidity/cancellation determination noted in the record. The appeal was docketed in the **District of Columbia** circuit region.

The 543-day duration from filing to dismissal reflects a trajectory consistent with contested patent validity appeals at the Federal Circuit, where briefing schedules, oral argument scheduling, and procedural motions routinely extend timelines. The ultimate dismissal under **Fed. R. App. P. 42(b)** — a voluntary dismissal mechanism — suggests the parties reached a resolution or strategic agreement that rendered continuation of the appeal unnecessary, a not-uncommon resolution pathway when the underlying patent claims have been invalidated and litigation economics shift.

Key Dates

The Verdict & Legal Analysis

Outcome

The Federal Circuit entered the following order:

“The above-captioned appeals are dismissed under Fed. R. App. P. 42(b) with each side to bear their own costs.”

No damages were awarded. No injunctive relief was granted. The mutual cost-bearing arrangement is characteristic of negotiated or strategic voluntary dismissals, where neither party sought to further pursue the appellate record following an adverse patentability determination below.

Critically, the basis of termination is recorded as “Unpatentable” — confirming that the patents-at-issue survived neither the invalidity challenge nor the appellate process in any dispositive manner favorable to Regeneron.

Verdict Cause Analysis

The verdict cause is classified under Patentability / Invalidity-Cancellation Action. This framing is significant: rather than a traditional district court infringement trial resolved by a jury, this dispute followed the invalidity/cancellation pathway — consistent with inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB), whose decisions are appealed to the Federal Circuit.

VEGF antagonist method patents have faced persistent invalidity challenges on grounds including obviousness under 35 U.S.C. § 103 and written description/enablement under 35 U.S.C. § 112 — both recurring vulnerabilities for broadly claimed biologic method patents where prior art in the VEGF research literature is extensive. While the specific legal grounds underlying the unpatentability finding are not detailed in the available case record, the invalidity/cancellation classification strongly suggests Mylan successfully challenged one or both patents on such grounds at the PTAB level before the appeal was voluntarily dismissed.

Legal Significance

The dismissal with an “Unpatentable” termination basis carries meaningful precedential weight for the ophthalmic biologics space:

• • VEGF method claims remain vulnerable — broadly drafted method-of-treatment claims in this space continue to face meaningful PTAB scrutiny, particularly where foundational VEGF science predates the priority dates of specific therapeutic claims.
• • Voluntary dismissal under Rule 42(b) preserves flexibility — by dismissing rather than receiving an adverse Federal Circuit merits ruling, Regeneron may preserve some optionality in related patent matters, avoiding a precedential opinion that could damage parallel or continuation patent assertions.
• • The mutual cost-bearing structure reflects neither party’s clear victory at the appellate stage, suggesting a negotiated resolution rather than a contested ruling on the merits of patentability.