The plaintiffs in In re: Taxmoxifen Citrate Antitrust Litigation (who include pharmaceutical consumers, third party payors, and a health care advocacy group) have filed a Petition for Writ of Certiorari asking the Supreme Court to review the Second Circuit's decision affirming the dismissal of this antitrust case. The plaintiffs alleged antitrust violations based on a $21 million payment from AstraZeneca (the tamoxifen NDA holder) to Barr Labs (the ANDA filer) in exchange for Barr's promise to withdraw its Paragraph IV certification and abandon its challenge of the tamoxifen patent.
Plaintiffs' cert petition presents the following question:
Under what circumstances is an agreement by a brand pharmaceutical manufacturer (and patent holder) to share a portion of its future profits with a generic market entrant (and alleged patent infringer), in exchange for the generic's agreement not to market its product, a violation of the antitrust laws?
The most recent such "reverse payments" case appealed to the Supreme Court, FTC v. Schering-Plough, was turned away this past summer. In that case, the Court asked the Solicitor General whether cert should be granted, and the Solicitor General recommended denial.
The Tamoxifen cert petition acknowledges that the legal issue is the same as that in Schering, but suggests that the case is more appropriate for Supreme Court review:
In Schering, the United States (by the Solicitor General) recognized the importance of the issues raised, but opposed the FTC petition for certiorari because of factual findings unique to that particular case. The same important issues are raised in this case without the complications that caused the Solicitor General to oppose certiorari in Schering.
A number of parties filed briefs in support of and in opposition to the Schering petition, and I would expect the same to happen here. The Court may once again ask the Solicitor General to file a brief as well.
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