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Impax Laboratories, Inc. v. Federal Trade Commission

Paid petition · United States Court of Appeals for the Fifth Circuit, No. 19-60394 · judgment April 13, 2021


Certiorari denied · December 13, 2021
Pre-decision estimate: 7% cert probability (95% interval 4%–10%)

Before the decision, about 1.6× the 4.1% base rate. The model weighted this up for a Fifth Circuit decision below, a circuit split argued in the petition, and a business petitioner.

Question presented

Because settlement agreements that permit a “generic manufacturer to enter [a] patentee’s market prior to the patent’s expiration” increase competition, lower prices, and redound “to the consumer’s benefit,” this Court in FTC v. Actavis, Inc., 570 U.S. 136 (2013), explicitly “decline[d]” “to hold that reverse payment settlement agreements are presumptively unlawful”; instead, “the FTC must prove its case as in other ruleof-reason cases,” and courts must ensure that the inquiry is not “too abbreviated to permit proper analysis” into what matters most: a settlement’s actual effects on competition. Id. at 158-60. Despite these clear instructions, the Fifth Circuit here adopted an abbreviated form of review under which patent settlements effectively are conclusively unlawful anytime they convey “valuable consideration” from the brand to the generic—which is just another way of saying they contain a large reverse payment—and “replace[] the ‘possibility of competition [during the patent term] with the certainty of none’”—which is true of all patent settlements. App.17-18. Even more, and creating a textbook split with the Third Circuit, the Fifth Circuit held that the strength of the patents at issue is categorically irrelevant to the inquiry even when (as here) the patents have been deemed valid and infringed in separate litigation. The questions presented are: 1. Whether the presence of a “reverse payment” that exceeds a patentee’s saved litigation costs and the value of any services provided by a patent challenger suffices to render a patent settlement unlawful, despite this Court’s holding to the contrary in Actavis.

Counsel of record

For petitioner
Jay Philip Lefkowitz
Kirkland & Ellis LLP

For respondent
Elizabeth B. Prelogar
Solicitor General

Case

Conference history
Distributed for 1 conference

Amicus briefs
1 cert-stage

Proceedings

  1. Dec 13 2021
    Petition DENIED.
  2. Nov 23 2021
    DISTRIBUTED for Conference of 12/10/2021.
  3. Nov 23 2021
    Reply of Impax Laboratories, Inc. not accepted for filing. (November 23, 2021)
  4. Nov 23 2021
    Reply of petitioner Impax Laboratories, Inc. filed. (Distributed)
  5. Nov 22 2021
    Waiver of the 14-day waiting period under 15.5 filed.
  6. Nov 15 2021
    Brief of respondent Federal Trade Commission in opposition filed.
  7. Oct 15 2021
    Brief amicus curiae of Association for Accessible Medicines filed.
  8. Oct 06 2021
    Motion to extend the time to file a response is granted and the time is extended to and including November 15, 2021.
  9. Oct 05 2021
    Motion to extend the time to file a response from October 15, 2021 to November 15, 2021, submitted to The Clerk.
  10. Sep 10 2021
    Petition for a writ of certiorari filed. (Response due October 15, 2021)