Teva Pharmaceuticals won a court decision April 11 that ensures the firm 180 days of market exclusivity for its generic version of Risperdal (risperidone) tablets.

Kathleen M. Petrillo, an intellectual-property attorney with Senniger Powers in St. Louis, called the decision "extremely valuable" for Teva. Risperdal sold about $2.5 billion in the U.S. last year, according to IMS Health.

Jerusalem-based Teva had sued FDA to make the agency relist Johnson & Johnson's patent for the schizophrenia drug in the Orange Book, so Teva could challenge the patent (¹ Also see "Teva Sues FDA To Relist Risperdal Patent" - Pink Sheet, 6 March, 2008.).

According to Teva's complaint, the firm filed its ANDA in August 2001, asking for FDA's blessing to market generic risperidone in six different strengths. In October of that year, FDA told Teva that it had delisted U.S. Patent No. 5,158,952, but it remained in the Orange Book until January 2002.

"I think Teva had a good case," Petrillo told "The Pink Sheet" DAILY, since the firm was the first to file an ANDA, and did so while the patent was still listed.

"The timing seems right for what Teva did," she said. "They were first in line." Risperdal goes off-patent in June.

In the latest ruling, the U.S. District Court for the District of Columbia ruled against FDA in the case, rejecting arguments by Mylan, of Pittsburgh, another generic drug maker.

Teva claimed in its complaint that FDA's move "violates the plain language of the Hatch-Waxman Act and flouts" an earlier district-court decision that the agency can't delist a patent from the Orange Book after a generic drug maker submits its ANDA and Paragraph IV paperwork.

The 2006 case involved Indian generics firm Ranbaxy and FDA's wrongful delisting of two Merck patents related to the anti-cholesterol drug Zocor (simvastatin).

Although FDA likely will appeal, the decision puts Teva in the clear to sell risperidone for six months. Competitors would enter the field as soon as the period expires.

"The real value is that 180-day lead, more than any ongoing advantage," Petrillo noted, adding that fights over generics will become more heated in the next few years as more drugs lose patent protection.

"It's likely to be a very active area of the law," she said.

- Randall Osborne (r.osborne@elsevier.com)

Teva Wins Risperidone Case Against FDA

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