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Services In Contract Don't Trump "Non-Manufacturer Rule"

Client Alert | less than 1 min read | 09.13.06

In Rotech Healthcare Inc. v. United States (July 24, 2006), a pre-award bid protest of small business set-aside procurements, the Court of Federal Claims held that the Small Business Act's "non-manufacturer rule" requires recipients of small business set-aside contracts to provide products only of domestic small business manufacturers, even if the contract is for both products and services. Finding, inter alia, that the statute is "clear and unambiguous" in its application of the rule to "any" contract for the supply of a product, Judge Bush rejected government pleas for deference to SBA's less-restrictive applications of the rule and permanently enjoined set-aside awards to offerors who failed to certify compliance.

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Client Alert | 3 min read | 05.26.26

pH, Prosecution History Estoppel, and Patent Scope: Three Lessons from the Federal Circuit's Latest Hatch-Waxman Ruling

On May 13, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed a district court judgment of no infringement in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 24-1641. The decision offers important guidance for patent holders and generic manufacturers on the role of industry standards in interpreting scientific terminology during claim construction, prosecution history estoppel, and the disclosure-dedication rule....