Orange Book Blog

Barr Pharmaceuticals announced in a press release yesterday that the 2nd Circuit Court of Appeals has denied the plaintiffs’ petitions for rehearing and rehearing en banc of its decision affirming the U.S. District Court for the Eastern District of New York’s dismissal of this antitrust case.

The case involves a $21 million "reverse payment" from the NDA holder, Astra Zeneca, to the generic challenger, Barr Labs, to settle Hatch-Waxman patent litigation between the two companies.  In the 2nd Circuit’s initial opinion in the case, decided by a 2-1 majority last November, the court held that the settlement agreement was not unlawful because, among other reasons, "the settlement agreement did not extend the patent monopoly by restraining the introduction or marketing of unrelated or non-infringing products."

Some experts believe that this case is a better candidate for Supreme Court review of "reverse payment" settlements than was the FTC v. Schering case.  In fact, even the FTC seemed to acknowledge that in its cert petition.  The Supreme Court denied certiorari in FTC v. Schering over the summer.  It should be interesting to follow this case and see whether it makes it to the Court.

Many interested parties had filed amicus briefs in support of or in opposition to the petitions for rehearing of the Tamoxifen case.  Several of the briefs are available in this June 19th Orange Book Blog post.