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news.Merck and Co shares have sunk by more than 10% after a US court of appeals declared the company's patent claims for osteoporosis drug Fosamax invalid, enabling Teva to plan its generic launch for much earlier than expected. The drop also follows news that the SEC has begun a formal investigation regarding Merck's ill-fated and now infamous arthritis and pain drug, Vioxx.
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In August 2003, a US District Court held Merck’s US patent for once-weekly administration of Fosamax (alendronate sodium) to be valid and infringed by Teva Pharmaceuticals’ abbreviated new drug application (ANDA) filing. However, the US Court of Appeals for the Federal Circuit in Washington DC has now found Merck’s patent claims for once-weekly administration of Fosamax to be invalid.
Merck disagrees with the opinion of the Court of Appeals and is considering its options, including a request for reconsideration.
Merck’s basic patent for the administration of Fosamax, which covers both once-weekly and once-daily administration of Fosamax, is set to expire in August 2007. Because Merck is entitled to an additional six months of marketing exclusivity following patent expiration, the earliest date for marketing of any generic alendronate is February 2008. Prior to the court’s decision, Merck’s patent for once-weekly administration of Fosamax was set to expire in July 2018.
Teva believes that as a result of the new ruling, its ANDA will be eligible for final approval in February 2008, when Merck’s US patent expires.
Meanwhile, in an update on Vioxx proceedings, Merck reported that the judicial panel on multidistrict litigation has heard motions to precede with various pending product liability and shareholder actions relating to Vioxx.
In addition, the company received notice that the SEC has issued a formal notice of investigation relating to its formal Vioxx investigation. This action was expected and Merck intends to continue to cooperate with the SEC on this matter.