This section contains the nature of the case and procedural background.

P manufactures Synagis, a drug used to prevent respiratory tract disease in infants and young children. P entered into a patent license agreement with D. The license covered an existing patent relating to the production of 'chimeric antibodies' and a then-pending patent application relating to 'the co-expression of immunoglobulin chains in recombinant host cells.' In December 2001, the patent-pending drug was approved. D delivered a letter expressing its belief that Synagis was covered by the Cabilly II patent and that P would be obligated to pay royalties beginning March 1, 2002. P believed that the Cabilly II patent was invalid and unenforceable and that its claims were in any event not infringed by Synagis. If D was to prevail in a patent infringement action, P could be ordered to pay treble damages and attorney's fees and could be enjoined from selling Synagis, a product that has accounted for more than 80 percent of its revenue from sales since 1999. P paid the demanded royalties 'under protest and with reservation of all of its rights.' P then sought declaratory relief. The court granted D's motion to dismiss the declaratory-judgment claims for lack of subject-matter jurisdiction. The Gen-Probe case held that a patent licensee in good standing cannot establish an Article III case or controversy with regard to validity, enforceability, or scope of the patent because the license agreement 'obliterates any reasonable apprehension' that the licensee will be sued for infringement. The Federal Circuit affirmed the District Court, also relying on Gen-Probe. The Supreme Court granted certiorari.

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