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No High Court Review of Drug Exclusivity Rights

(CN) - Generic drugmaker Apotex lost its bid Tuesday to challenge marketing exclusivity rights before the Supreme Court.

Apotex had argued that the D.C. Circuit misinterpreted the congressional safeguards to ensure competition among generic drug companies. Currently, the first generic drugmaker to successfully challenge a dubious patent held by a brand-name company wins a 180-day period of generic market exclusivity. When the 180-day window is open, only the one generic company can compete with the brand-name company.

To encourage further competition, Apotex says there are six circumstances in which market exclusivity could be stripped from a generic company.

The D.C. Circuit ruled to limit those circumstances, finding that a generic manufacturer does not forfeit market exclusivity through "unilateral" action by the brand-name manufacturer.

In its petition for high court review of the ruling, Apotex argued that the D.C. Circuit seriously damaged the Hatch-Waxman Act, which regulates approval by the Food and Drug Administration in the multibillion-dollar generic drug industry, and gave all drug companies "massive anti-competitive advantages."

"If left undisturbed, the [aforementioned] decision ... will benefit brand-name manufacturers, who want nothing more than to see a first applicant win exclusivity and thereby delay full-scale competition with multiple generic manufacturers," Apotex's petition to the Supreme Court states. "It will also richly reward the generic manufacturer who wins a race to file a paragraph IV certification but is unable promptly to bring the generic drug to market."

The D.C. circuit's unreported ruling stems from exclusivity rights obtained by Apotex's generic competitor, Teva Pharmaceuticals, over two brand name hypertension drugs, Cozaar and Hyzaar (losartan), manufactured by Merck.

The Supreme Court did comment on its decision to deny Apotex's petition, except to state that Justice Elena Kagan did not participate in the court's consideration or vote.

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