Solicitor General Recommends Supreme Court Deny Certiorari in Tamoxifen "Reverse Payments" Case

Via the Antitrust Review and Pharmalot, the Solicitor General has recommended that the Supreme Court deny certiorari in Joblove v. Barr Labs, the most recent "reverse payments" case to be appealed to the Court.  Last year, the Solicitor General advised the Court not to take the FTC v. Schering case.  At the time, many observers thought this case might better present the reverse payments issue.

But apparently the Solicitor General disagreed.  In an amicus brief requested by the Supreme Court in March and filed this month, the Solicitor General acknowledged that the case raises important questions and criticized the appeals court decision, but advised the Court that "this case does not present a good vehicle for addressing the question presented."  The cert petition presented the following question for review:

Whether the federal antitrust laws prohibit a brand name drug patent holder and a prospective generic competitor from settling patent infringement litigation by agreeing that the generic manufacturer will not challenge the validity of the patent or market its own version of the drug until the expiration of the patent, in exchange for a substantial payment from the patent holder.

The Solicitor General's brief advised the Court that the Second Circuit adopted an insufficiently stringent standard for scrutinizing reverse payment settlements when it held that a settlement is valid unless the underlying lawsuit was "objectively baseless in the sense that no reasonable litigant could realistically expect success on merits."  In the Solicitor General's view, a court evaluating a reverse payment settlement should engage in a "broader inquiry concerning the patent holder's likelihood of success on that claim."

Ultimately, however, the Solicitor General concluded that this is not an appropriate case for review, since the "federal antitrust claims in this case appear to be moot, the factual setting is atypical and unlikely to recur, and subsequent regulatory changes may undercut one of the theories of competitive harm advanced by petitioners."

The Federal Trade Commission, which has campaigned vigorously against reverse payment settlements, is probably very disappointed with the Solicitor General's recommendation to deny cert.  My understanding is that the FTC will not have an opportunity to submit its own brief in this case, since the government may only submit a single amicus brief to the Supreme Court (the FTC was a party in FTC v. Schering, so of course it submitted its own brief in that case).  Officials at the FTC have revealed that their current strategy is to try to create a circuit split that the Supreme Court will have no choice but to resolve.

RELATED READING:

• March 15 OBB post, with links to party and amicus briefs