Cholesterol :: Patent Victory in Spanish Court Favoring Ranbaxy on Atorvastatin Unaffected

Ranbaxy Laboratories Limited said that recently, in two separate rulings, the Spanish courts (the Mercantile Court of Barcelona, No. 2) found Spanish patent ES 2,167,306 (counterpart of Pfizer’s EP 409 281) to be invalid for lack of novelty. The two rulings made on September 26, 2006, in Lek Pharmaceuticals v. Warner Lambert Co. and in Laboratorios Cinfa et al. v. Warner Lambert, found claims 1 to 3 of Pfizer to be invalid. These decisions came after considering the views of the Spanish Patent Office (SPO), in addition to technical expert reports.

On Friday, October 27, 2006, the European Patent Office (EPO) provided an advisory opinion at the request of the Mercantile Court of Barcelona, No. 4, presiding in the case of Ranbaxy v. Warner Lambert, wherein this Spanish patent was viewed as valid. It may be noted that the EPO’s advisory opinion does not constitute a legal judgment upholding the patent, since only a Spanish court of law may decide on the validity (or not) of a Spanish patent

To date, Ranbaxy has successfully invalidated counterparts of this same patent in the UK, Austria, the Netherlands, and in the U.S. for lack of novelty, lack of inventive step, and for improper claim dependency. The company will actively pursue its efforts to bring in affordable Atorvastatin to patients across the world.

Atorvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body.

Atorvastatin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take atorvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take atorvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies”, resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 8 countries.


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