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India Revokes Eye Drug Patents in Setback for Western Pharma

Aug. 9, 2013
India's laws are tougher on patent-holders than those in many other countries as it seeks to make medicines more affordable for its vast poor population.

NEW DELHI – In the latest in a series of setbacks for Western firms in the country's fast-expanding pharmaceutical market, India has revoked patents granted to U.S. company Allergan (IW 500/179) for two glaucoma drugs.

The patent appeal board revoked two of the California-based company's patents on medicines for treatment of glaucoma, an illness that damages the optic nerve.

India's laws are tougher on patent-holders than those in many other countries as it seeks to make medicines more affordable for its vast poor population.

The Intellectual Property Appellate Board ruled in a website notice posted late Thursday that the drugs Ganfort and Combigan do not stand the "test of innovation" and are ineligible for patents.

Last week it revoked patents related to GlaxoSmithKline's breast cancer drug Tykerb that would have delayed the launch of generic versions of the medicine for two-and-half years to 2021.

The revocations were signs of how India seeks to prevent so-called "evergreening" -- when drug firms pursue patents for "incremental improvements" of their drugs to extend their patent shelf life.

India insists drugs must show "novelty" to be granted patents. Once drugs go off patent, they can be sold much more cheaply.

India, known as the "pharmacy to the world," has a huge generics industry that turns out cheaper copycat versions of life-saving branded drugs for poor patients at home and in developing nations.

India's Ajanta Pharma, a generics drug company, had challenged the patents held by Allergan on grounds that the glaucoma drugs are "not an invention" and therefore "non-patentable" under the 2005 Indian patent act.

Ganfort is a fixed-dose combination of the ingredients bimatoprost and timolol and Combigan is a fixed-dose combination of the actives brimonidine and timolol.

Spokespeople for both Allergan and Ajanta could not be reached for comment as Friday was a public holiday.

Last year India cancelled patents on Pfizer's (IW 500/22) cancer drug Sutent, Roche Holding's (IW1000/85) hepatitis C drug Pegasys and a Merck (IW 1000/94) asthma drug, saying the medicines lacked innovation.

Western drugmakers are seeking to win a larger part of India's market to compensate for slowing sales in advanced markets.

The vast Indian market is set to touch some $74 billion in sales by 2020 from around $13 billion currently, according to industry studies.

Foreign drugmakers have accused India of failing to respect intellectual property rights so that it can promote its own generics industry -- a charge New Delhi strongly denies.

Copyright Agence France-Presse, 2013

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