Case Study

Commercial Success – ANDA Litigation

4 Patents Invalidated
Jury Verdict
District of Delaware
U.S. Federal Court
Four-Day Bench Trial
Tried to a Jury
1Overview

Dr. DeForest McDuff provided expert economic testimony for generic defendants in a high‑stakes ANDA pharmaceutical patent case involving Acorda Therapeutics’ patents on Ampyra, a drug indicated to improve walking in multiple‑sclerosis (MS) patients. The dispute focused on secondary considerations of non-obviousness, including commercial success, in the context of life‑sciences IP litigation. The role of Dr. McDuff centered on explaining how economic factors and blocking patents factor into an analysis of development incentives and non-obviousness for patented pharmaceutical technologies.

2The Challenge

When strong sales don’t prove a patent is non-obvious

Plaintiffs relied on evidence of sales and market uptake to argue that the asserted patents were non‑obvious. Dr. McDuff and his team evaluated the product’s revenues and profitability relative to development costs and risk, and analyzed how the presence of other patents held by the plaintiff limited competitors’ ability to enter the market even if the claimed inventions were obvious. The task required presenting complex concepts—commercial success, expected returns, and blocking patents—in a clear and compelling way, tailored to pharmaceutical and ANDA litigation.

2Our Approach

Measuring returns against the blocking patents that deterred development

3The Outcome

A Federal Circuit affirmance that credited unrebutted economic testimony

The District Court concluded that the evidence of commercial success did not establish non‑obviousness, finding that blocking patents and related economic constraints would have deterred development by others even if the subject matter were obvious. On appeal, the Federal Circuit affirmed, crediting Dr. McDuff’s unrebutted economic testimony on the blocking‑patent effect. The decision has since become a key reference on how commercial success and other secondary considerations should be evaluated in pharmaceutical patent cases. This matter showcases Dr. McDuff’s strength as a leading expert firm for life‑sciences IP disputes involving commercial success and other economic issues, including in Hatch‑Waxman and ANDA litigation.

Case Experts
DeForest McDuff, Ph.D.
DeForest McDuff, Ph.D.
Managing Director

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