Financial Daily from THE HINDU group of publications
Thursday, Nov 24, 2005
Financial Daily from THE HINDU group of publications Thursday, Nov 24, 2005 |
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Corporate
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Courts/Legal Issues Marketing - IPR US court upholds bar against Ranbaxy blood pressure drug Our Bureau
New Delhi , Nov. 23
IN what could be a setback of sorts to Ranbaxy Laboratories Ltd, the US Court of Appeals for Federal Circuit (CAFC), today upheld an earlier injunction granted by a New Jersey District Court barring sale of the generic version of Pfizer's blood pressure drug, Accupril (quinapril HCl). In the US market, the generic quinapril product was manufactured by Ranbaxy Pharmaceuticals Inc (the US subsidiary of the Indian pharma major) and marketed by Teva Pharmaceuticals USA Inc. The lower court decision handed down in March had immediately halted the sale of generic quinapril by Ranbaxy and Teva, which had launched the product last December. The Indian company had appealed to the CAFC to reverse a preliminary injunction, after Pfizer had asserted that Ranbaxy's quinapril tablets, marketed by Teva were infringing its US patent both literally and under the doctrine of equivalents. The merits of the principal case will now be argued at the District Court in New Jersey. In a statement, Mr Jay Deshmukh, Ranbaxy's Vice-President of Global Intellectual Property, said: "The Appeals Court explained that its decision was based on a preliminary record and noted that claim construction, a legal issue, is subject to change based on a more developed factual record. Moreover, the preliminary injunction did not address the invalidity or enforceability of the patent. Accordingly, Ranbaxy intends to vigorously challenge infringement, validity and enforceability of the patent in further proceedings before the district court." In a statement posted on Pfizer's Web site, Mr Jeff Kinder, Vice-Chairman and General Counsel of the company, said: "Today's decision sends a clear message that the law does not encourage or excuse infringement of valid pharmaceutical patents by generic companies. The ruling also reinforces the importance of intellectual property protection to the development of new, life saving medicines." The company stated that it is seeking damages resulting from lost sales in its patent infringement action against the two companies pending in a district court in New Jersey. Meanwhile, other non-infringing formulations remain in the US market. Companies such as Mylan Laboratories Inc and Par Pharmaceuticals also sell generic Accupril as there are no litigations involving these products. Accupril and some related drugs generated $665 million in sales last year for Pfizer, including US sales of $278 million. The patent for the key ingredient quinapril hydrochloride expires in August 2007. According to analysts tracking the sector, "It is unlikely that there would be any immediate impact on the company due to damages claimed by Pfizer as the case is likely to carry on for a couple of years. Also, since Ranbaxy is only a manufacturer while Teva is marketing the drug under its own label, the Indian company may have to fork out just a part of the damages." They had estimated that Ranbaxy could generate about $8-10 million from this product in the first year. The Ranbaxy stock today fell 2.91 per cent to close at Rs 365.95 on the BSE.
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