Teva Trying to Assert Its Rights

A reader recently e-mailed me about an interesting citizen petition that Teva (TEVA) filed last August. In the petition, (pdf) Teva requested that the FDA:

1) Relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets.

2) Confirm Teva's right to 180-day exclusivity for risperidone tablets.

3) Refrain from approving any other ANDAs for risperidone tablets until Teva's exclusivity expires.

Risperdal is Johnson & Johnson's (JNJ) blockbuster treatment for schizophrenia and other neurological disorders.

Teva filed its ANDA for risperidone tablets on August 28, 2001, with a paragraph III certification to U.S. Patent No. 4,804,663, and a paragraph IV certification to the '952 patent. At the time, both patents were listed in the Orange Book for Risperdal. On October 12, 2001, the FDA notified Teva that it had delisted the '952 patent from the Orange Book and informed Teva that it would not accept Teva's ANDA for filing unless Teva amended its paragraph IV certification to reflect the fact that the '952 patent had been delisted. Teva complied by amending its ANDA.

Five years later, in Ranbaxy v. Leavitt, the D.C. Circuit ruled that the FDA had improperly delisted two patents on Zocor because the effect of delisting would be to deny the first ANDA filer of 180-day exclusivity on simvastatin tablets. According to Teva's citizen petition, following that decision "Teva began reviewing its portfolio of pending ANDAs to determine whether the FDA's unlawful delisting practices had deprived Teva of its entitlement to 180-day exclusivity for any other generic product."

In its risperidone petition, Teva contends that because the '952 patent was listed in the Orange Book when it filed its ANDA for risperidone tablets, it had no choice but to certify as to the '952 patent.

Teva thus did precisely what it was obligated to do under the plain text of the governing statute and Agency regulations, and it therefore earned its exclusivity as the first applicant to file a paragraph IV certification to a patent listed as claiming the reference listed drug.

Teva argued that the Ranbaxy decision compels the FDA to relist the '952 patent and restore Teva's right to 180-day exclusivity. Teva further argued that "the fact that the FDA never accepted Teva's paragraph IV ANDA for filing has no bearing on the fact that the FDA must relist the '952 patent."

The '663 patent (whose validity was affirmed in a Federal Circuit decision last year) expired on December 29, 2007. Pediatric exclusivity on Risperdal extends to June 29, 2008. Thus, the FDA must decide the issues presented in Teva's citizen petition before then. The FDA will post its decision in the docket established for Teva's petition.