Brand-Generic Settlements Face Tough Questions At Supreme Court As “Rule Of Reason” Analysis Finds Support
This article was originally published in The Pink Sheet Daily
During oral arguments in FTC v. Actavis several justices were critical of the “scope of the patent” test advocated by pharma that presumes reverse settlements are lawful; they questioned the ability of generic companies to be paid more than they would get if they won the patent suit.
You may also be interested in...
The high court will determine whether brand-generic reverse payments to settle patent disputes are presumptively anticompetitive and unlawful when it takes up FTC v. Actavis; a ruling affirming the lower court would enable companies to enter agreements without the threat of litigation.
FTC ends its losing streak on patent settlement suits as the Third Circuit says “rule of reason” rather than “scope of patent” analysis should be applied to brand/generic settlements; appeals court reinstates suit by direct purchasers challenging Schering’s payments to Upsher-Smith and ESI Lederle.
Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’