Dr Reddy’s wins US court case against Pfizer

In a major breakthrough verdict for Indian pharma companies, Dr Reddy’s Laboratories has won a US court ruling against the world’s top drugmaker Pfizer Inc, allowing it to sell a version of Pfizer’s blockbuster drug Norvasc in the US. A New Jersey district court dismissed Pfizer’s plea on the grounds that a patent extension on Norvasc till 2007 does not cover Dr Reddy’s amlodipine maleate product, Reddy’s said in a statement. Pfizer could not be reached for comment.

Dr Reddy’s plans to launch the drug next August after final US regulatory approvals and the expiry of what it called Pfizer’s pediatric exclusivity rights on the hypertension drug. Pediatric exclusivity is a six-month period of sole marketing rights given to a drug’s originator if it establishes safety for use in children. Amlodipine maleate differs chemically from the amlodipinebesylate form of Pfizer’s anti-angina and hypertension drug, which had sales of $2.5 billion in 2001. “This victory will help us lay the foundations of a specialty drug business in the US,” Dr Reddy’s chief executive G. V. Prasad said. Reddy’s strategy of challenging the validity of a patent extension by producing a different salt of the drug was probably unique, Prasad said. Reddy’s shares vaulted 7.03 per cent to Rs 875.95 after the announcement.

The company aimed to make the transition from a generic producer to a specialty drug maker in the next five years, on the way to becoming a research-led multinational, he said.