United States: Medimmune Challenge To Genentech Patent Permitted To Continue

On January 9, 2007, Justice Scalia delivered the opinion of the U.S. Supreme Court in MedImmune, Inc. v. Genentech, Inc., et al; reversing the U.S. Court of Appeals for the Federal Circuit in an 8-1 decision. Justice Thomas was the sole dissenter. The Supreme Court originally granted cert to consider the issue of whether, under the Declaratory Judgment (DJ) Act (the Act), a licensee in good standing must breach its license prior to challenging the underlying patent.

In 1997, Genentech granted a patent license to MedImmune in a patent covering the production of chimeric antibodies and a then-pending patent application (now the Cabilly II patent) covering the coexpression of immunoglobulin chains in recombinant host cells. Several years later MedImmune began to manufacture Synagis, a drug administered to infants and young children to protect against respiratory tract diseases. Soon after the Cabilly II patent issued, whereupon Genentech informed MedImmune of its belief that Synagis was covered by the patent and that it expected royalty payments to commence. MedImmune believed Genentech’s letter provided notice that Genentech would enforce the Cabilly II patent, terminate the license agreement and sue for patent infringement if it did not pay the demanded royalties. Although MedImmune believed the Cabilly II patent to be invalid and its product, Synagis, to be non-infringing, it began paying the demanded royalties "under protest and with reservation of all of [its] rights." MedImmune feared the possibility of actual damages, treble damages, attorney’s fees and an injunction against its product, from which it realized 80 percent of its revenues. Unwilling to risk the possible consequences of an infringement action, MedImmune commenced payment of royalty and soon after sought declaratory relief that the Cabilly II patent was invalid.

Genentech moved to dismiss the DJ complaint for lack of subject matter jurisdiction. Its motion was granted by the district court and affirmed by the Federal Circuit. Both courts based their decision on the Federal Circuit’s decision in Gen-Probe Inc. v. Vysis. Inc., holding that a patent licensee in good standing cannot establish the requisite case or controversy under Article III to invoke the Act because the license agreement removes any reasonable apprehension of a suit for infringement.

Avoiding a direct conflict with the Federal Circuit’s decision in Studiengesellschaft Kohle v. Shell Oil (requiring repudiation of a license, cessation of royalty patents and notice to the patentee that the patent claims are deemed invalid before invoking the Lear v. Adkins doctrine), the Court viewed MedImmune’s DJ complaint as raising a contract dispute, i.e., that it had no obligation to pay royalties on an invalid patent. After finding a contract dispute had been properly pled, the Court found subject matter jurisdiction under the Act.

The Court noted that disputes that satisfy the case or controversy requirement must be "‘definite and concrete, touching the legal relations of parties having adverse legal interests’; and that it be ‘real and substantial’ and ‘admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.’" The Court articulated the case or controversy test as follows: "Basically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment."

Based on its review of Federal Circuit jurisprudence, the Supreme Court noted that the requirement for a case or controversy would undoubtedly have been met if MedImmune had refused to pay the royalty payments. The issue then was whether MedImmune, having made royalty payments "under protest and with reservation of all of [its] rights," pre-empted the existence a case or controversy (as MedImmune was protected from suit by Genentech under a patent infringement theory).

The Court analyzed the dispute to one "where threatened action by government is concerned," noting that "we do not require a plaintiff to expose himself to liability before bringing suit to challenge the basis for the threat—for example, the constitutionality of a law threatened to be enforced." Turning to its own precedent, Altvater v. Freeman, Justice Scalia characterized the decision as holding that "a licensee’s failure to stop its royalty payments did not render a dispute over the validity of the patent non-justiceable." In Altvater, the licensee paid, "under protest," royalties required by an injunction the patentee had obtained in an earlier case and filed a declaratory judgment that the patents were invalid. The Altvater Court reasoned that payment of royalties did not make the "dispute of a hypothetical or abstract character" since the royalties "were being paid under protest and under the compulsion of an injunction decree." The Court concluded that "the requirements of [a] case or controversy are met where payment of a claim is demanded as of right and where payment is made, but where the involuntary or coercive nature of the exaction preserves the right to recover the sums paid or to challenge the legality of the claim."

The Court recognized that the Federal Circuit, in its Gen-Probe decision, distinguished Altvater on the basis that in Altvater there was compulsion in the form of an injunction. However, as viewed by Justice Scalia, the Altvater opinion did not hinge on governmental action and did not address the threat of prosecution for contempt or other governmental sanction. Rather, the Court reasoned that the result in Altvater was based simply on the consequences of stopping payment, not the existence of an injunction. Analogizing Altvater to the case at hand, the Court viewed the possibility of actual and treble damages as coercive where it threatened the solvency of MedImmune’s business.

The Court disregarded Genentech’s contentions that the license agreement and royalty payments prohibited MedImmune from challenging the validity of the patent, explaining that "[p]romising to pay royalties on patents that have not been held invalid does not amount to a promise not to seek a holding of their invalidity." The Court held that the "petitioner was not required, insofar as Article III is concerned, to break or terminate its 1997 license agreement before seeking a declaratory judgment in federal court that the underlying patent is invalid, unenforceable, or not infringed. The Court of Appeals erred in affirming the dismissal of this action for lack of subject-matter jurisdiction."

Justice Thomas, in a rare disagreement with Justice Scalia, dissented. Justice Thomas reasoned that in order to meet the case on controversy requirements a patentee must breech its license before challenging the patent validity. Justice Thomas found no controversy or standing where a license remained in good standing and the threat of a lawsuit was only hypothetical. Justice Thomas also found error in the Court’s equating governmental coercion to private contractual obligations, stating that "[b]y holding that contractual obligations are sufficiently coercive to allow a party to bring a declaratory judgment action, the majority has given every patent licensee a cause of action and a free pass around Article III’s requirements for challenging the validity of licensed patents."

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