Amid patent debate, BDR Pharma and Lee Pharma give up battle to copy drugs

Blames lack of government support for cheap generics and pressure from Big Pharma

Drugmakers BDR Pharma and Lee Pharma have given up a battle to copy drugs developed by Bristol Myers Squibb and AstraZeneca, blaming a lack of government support for cheap generics and pressure from Big Pharma.

Both companies had been seeking so-called compulsory licenses that override patents and allow generics firms in India to launch cheap copies of medicines manufactured by big Western drugmakers. But now the two mid-sized generics players say their efforts have been thwarted by Prime Minister Narendra Modi’s target to boost foreign investment in India and the resulting emphasis on protecting intellectual property, which is getting in the way of the government’s promise to provide cheap drugs for the poor.

“There is no point in pursuing it anymore,” Dharmesh Shah, Managing Director, BDR told Reuters.

India first issued a compulsory license for a medicine in 2012, allowing Natco Pharma to sell a copy of German drugmaker Bayer’s cancer drug Nexavar at a tenth of the original price. The move was criticised by large multinationals.

But BDR’s application to copy Bristol Myers’ cancer drug dasatinib, with an aim to sell it at about $122 for a month’s course versus the original price of about $2,491, was rejected in 2013.

Lee Pharma was rejected in January this year after a second review of its application seeking to make a cheaper form of AstraZeneca’s type 2 diabetes drug saxagliptin. The patent controller said Lee did not make a strong enough case. Both BDR and Lee said they were now no longer appealing, in moves they described as emblematic of an exasperated industry.

“If the government itself is not inclined then why unnecessarily slog on this issue?” said A Venkata Reddy, Managing Director, Lee Pharma.

A health ministry official did not comment and referred the matter to the commerce ministry. Officials at the commerce ministry declined to comment. India’s Controller General of Patents and Trademarks, part of the commerce ministry, did not respond to requests for comment.