Red Herring reported on November 24, 2005:
Ranbaxy Laboratories, India’s largest drug maker, vowed to fight Pfizer at a trial in the U.S. courts over the validity of the American company’s patent on a popular blood pressure medication.
Ranbaxy’s announcement followed a U.S. Court of Appeals ruling that upheld a preliminary injunction barring Ranbaxy from marketing the medication under the name Quinapril in the United States. A trial is now planned to take place in New Jersey to determine if the ban should be made permanent. The market for the drug is estimated at about $500 million.
A U.S. District Court imposed the preliminary injunction in March against Ranbaxy’s Jacksonville, Florida-based subsidiary after Pfizer, which sold the drug as Accupril, filed a patent infringement case against Ranbaxy and Teva Pharmaceuticals of Israel, seeking $387 million in lost sales for 2004. The appeals court upheld that ruling this week.
In the last few years Ranbaxy has emerged as the most aggressive patent challengers worldwide, a strategy that it says is built into its business model.
Earlier this week, it was sued by the third-largest drug maker of Europe, AstraZeneca, for “willful infringement” of its patent on the ulcer pill Nexium, which had sales of over $3.8 billion in 2004. Ranbaxy had filed an application with the U.S. Food and Drug Administration last month to begin manufacturing a generic version of Nexium.
Last month, a U.K. court upheld one of the two key patents on Pfizer’s blockbuster drug Lipitor, preventing Ranbaxy from launching a generic copy of the drug before its patent expires. While Pfizer won the basic patent on the $12-billion-a-year Lipitor, which will expire in 2011, it lost the more specific patent expiring in 2010. Both parties plan appeals in that case.
See also the interesting article from the November 14 print issue of Red Herring titled, "IP Law Slows Indian Pharma."
India has the world’s fourth-largest pharmaceutical industry in terms of volume behind the United States, the European Union, and Japan. It is worth $7 billion now and is projected to grow to $35 billion by 2010, according to McKinsey and Co.; two-thirds of its exports go to developing countries.
“The new Act with its clauses will be susceptible to varying interpretations and endless litigation,” warns Utkarsh Palnitkar, a health sciences analyst at Ernst & Young’s Hyderabad office.
Under the new law, more than 8,900 drug patent applications filed since 1995 will have to be tested for compliance with the Trade Related Intellectual Property Rights (TRIPS) treaty, which so narrows the definition of patentability that litigation looks set to explode.