Mylan Inc. (NYSE: MYL) has sued the US Food and Drug Administration (FDA) and US Secretary of Health and Human Services Kathleen Sebelius over the FDA's granting Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) 180 days marketing exclusivity for its generic version of Provigil in the US market.
Mylan contends that the FDA cannot grant Teva exclusivity because the permits it held at the time of the acquisition of Cephalon, which produced brand Provigil, were invalid. Mylan contends that federal law encourages generic companies to challenge patents filed by brand drug companies. Provigil helps wakefulness in people suffering from sleep apnea and narcolepsy.
In the lawsuit filed with the US District Court for the District of Columbia, Mylan contends, "Teva did not maintain valid paragraph IV certifications as a result of its acquisition of Cephalon. Once Teva became the owner of Cephalon, Teva could no longer infringe its own patents through a paragraph IV certification and that Teva therefore is not entitled to exclusivity based on patent certifications."
Mylan contends that the FDA should have found that Mylan is the sole first filer on for generic Provigil, that Teva abandoned its abbreviated new drug application (ANDA), and that FDA should have approved Mylan's ANDA for this product. It is seeking an immediate court order to exclusivity and immediate approve its ANDA.
Teva acquired the rights to brand Provigil through its acquisition of Cephalon last year. Last week, it announced that the FDA granted it 180 marketing exclusivity to generic Provigil, as it was the first to file. The announcement hurt Mylan's plan to launch its generic version of the drug this week.
According to IMS sales data, brand Provigil had $1.1 billion in US sales in 2011.
Teva USA spokeswoman Denise Bradley declined to comment on the report to "Bloomberg".
Teva's share price share price fell 0.6% in morning trading on the TASE today to NIS 167.90, after rising 0.4% on Nasdaq on Friday to $45.06, giving a market cap of $39.8 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on April 8, 2012
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