Glenmark gets a boost in cholesterol drug battle with Merck

MUMBAI: Glenmark Pharmaceuticals has gained the upper hand in a legal battle against Merck over a cholesterol control pill after a US court rejected most of the American drug company’s patent claims.

A New Jersey District court rejected 10 of the 13 patent claims after Glenmark challenged Merck’s patent so that it can launch a generic version of Ezetimibe by around November, said a person familiar with the matter.

Glenmark was the first company to mount a challenge against Merck as it automatically gives it a six-month marketing lead over other generic players.

Ezetimibe, known by its brand name Zetia, notched up sales of $1.4 billion last year. Glenmark stands to earn nearly Rs 667 crore in the six months through the drug’s launch, said an analyst with a domestic brokerage who asked not to be named.

A Glenmark spokesman declined comment and ET’s email to Merck was unanswered.

Glenmark has a tentative approval from Food and Drug Administration (FDA), the US pharma regulator, to market the drug.

The FDA grants a stay of 30 months for products caught in a patent suit before giving a final approval. In Glenmark’s case, the period ends in October, the person said.

At the end of 30 months, companies can launch a drug, but face the risk of legal penalties.

Merck’s patent expires in 2016, but the company bagged a reissued patent in 2002-03 that makes the patent more foolproof. The US court overturned the extended parts of the second patent, the person said. Glenmark markets generic drugs in the US through a wholly owned subsidiary, Glenmark Generics.