By Dennis Crouch

FTC v. Watson Pharmaceuticals, 12-416 (SCOTUS 2012)

The Supreme Court has granted certiorari in the pharmaceutical reverse-payment case.

Issue presented:

Whether reverse-payment agreements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the court below held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held).

Justice Alito has recused himself. This means that only four justices are required to maintain the per se lawful standard.

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Other pending petitions include:

Upsher-Smith Laboratories v. Louisiana Wholesale Drug Company – Whether the Third Circuit erred by holding, contrary to the Second, Eleventh, and Federal Circuits, that an agreement settling patent litigation that does not restrict competition outside the scope of the exclusionary right granted by the patent itself may presumptively violate the antitrust laws.

Merck & Co. v. Louisiana Wholesale Drug Company – Whether the federal antitrust laws permit a brand-name manufacturer that holds the patent for a drug to enter into a settlement of patent litigation with a prospective generic manufacturer, where the settlement includes a payment from the brand manufacturer to the generic manufacturer but does not exclude competition beyond the scope of the patent.    

Montgomery v. Kappos – Whether a research proposal which was never in fact performed can, as a matter of law, inherently anticipate a patent claim under Tilghman v. Proctor.    

Retractable Technologies v. Becton, Dickinson and Co. – (1) Whether a court may depart from the plain and ordinary meaning of a term in a patent claim based on language in the patent specification, where the patentee has neither expressly disavowed the plain meaning of the claim term nor expressly defined the term in a way that differs from its plain meaning; and (2) whether claim construction, including underlying factual issues that are integral to claim construction, is a purely legal question subject to de novo review on appeal.    

GlaxoSmithKline v. Classen Immunotherapies – Whether the Federal Circuit’s interpretation of 35 U.S.C. § 271(e)(1)’s safe harbor from patent infringement liability for drugs – an interpretation which arbitrarily restricts the safe harbor to pre-marketing approval of generic counterparts – is faithful to statutory text that contains no such limitation and decisions of this Court rejecting similar efforts to impose extra-textual limitations on the statute.

Ninestar Technology Co. v. US International Trade Commission – Whether the initial authorized sale outside the United States of a patented item terminates all patent rights to that item.

W.L. Gore v. C.R. Bard – Whether it is consistent with Section 116 to deny joint-inventor status to the maker of the successful material, and instead deem the experimenter the sole inventor, on the ground that the maker did not communicate to the experimenter the exact property that turned out to be key.”

One thought on “

  1. Re: “The Supreme Court has granted certiorari in [a] pharmaceutical reverse-payment case.” Plus Upsher-Smith Laboratories v. Louisiana Wholesale Drug Company.

    I find it curious that not a single comment has been posted on this extremely important* “hot potato” issue in 24 hours. Is it terrorized silence?

    *As I noted several years ago, patent owners paying money to infringing defendants is certainly not a normal feature of patent litigation. It outraged FTC staff from its first use, and has ever since. Yet this tactic has been a successful high stakes gamble made by pharmicutical company G.C.’s for several years. IF the Supremes now find this tactic to be anti-trust suspect, the follow-up could be billions of dollars in private treble damage suits claiming that this tactic increased subject drug prices for subject time periods, and maybe some rolling heads?

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