The US-based pharmaceuticals major has decided to withdraw the case filed against Cipla, alleging unauthorised sales of its osteoarthritis drug, Fosamax.
MUMBAI: The US-based pharmaceuticals major, Merck &Co, has decided to withdraw the case filed against Mumbai-based Cipla, alleging unauthorised sales of its osteoarthritis drug, Fosamax. Cipla has been selling Ostefos-the 70 mg generic version of Fosamax in the US.
Fosamax is used to treat osteoporosis and Paget’s disease conditions. Merck alleged that Cipla had been selling the drug unauthorised in the US by violating its patent. Fosamax, which accounts for 15% of Merck’s total sales, will lose patent protection in 2008. Merck registered sales of more than $22 billion during 2006.
On August 22, 2006, Merck filed the case against Cipla in the US International Trade Commission (ITC) alleging violations of section 337 of the Tariff Act of 1930 in the import into the US and the sale within the US after import of certain alendronate salts, the main ingredient in Fosamax. Merck alleged that this infringed a patent it owned.
Merck had requested ITC to issue a permanent exclusion order and a permanent cease and desist order. In September last year, ITC voted to institute an investigation in the case. However, the commission is yet to make any decision on the merits of the case. Paget’s disease causes a malfunction in the normal process of bone re-modeling.
When contacted, Amar Lulla, MD, Cipla, told DNA Money, that they have received the official letter from Merck saying withdrawal of the case against Cipla.
Last month, a Budapest court rejected Merck’s patent-infringement case against one Hungarian company, over Fosamax, reaffirming an appellate court ruling from one year ago.
Meanwhile, more than 100 cases have been filed against against Merck alleging Fosamax causes osteonecrosis, or a decaying of the jaw bone.
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