- Two Indian companies, BDR Pharma and Lee Pharma, are no longer pursuing compulsory licenses for the manufacture of generic versions of drugs from Bristol-Myers Squibb and AstraZeneca, reports Reuters. BDR wanted to copycat BMS' cancer drug, dasatanib while Lee Pharma aimed to create a generic of AstraZeneca's diabetes drug saxagliptin.
- Governments can issue compulsory licenses permitting generics companies to override patents in order to improve drug access or respond to a public health crisis. India has issued one before, in 2012.
- However, international pharma companies have pushed to limit the use and applicability of such licenses, arguing they undermine intellectual property and innovation. The two companies said their efforts to win licensing had been stymied by the pressure, along with Prime Minister Narendra Modi's renewed emphasis on protecting IP.
Both BDR and Lee Pharma are medium-sized companies, part of the India's $15 billion generics industry which supplies 40% of the the generics in the US market. Domestically, generics are even more important and are relied on by many of India's 1.2 billion people.
Compulsory licensing has become a hot-button issue recently, after it appeared the Indian government promised an industry group in the U.S. it would refrain from using the authority in commercial settings. However, the Indian government later publicly disavowed the reports.
Because of the strength of India's generics industry, many human rights groups rely on Indian drugs for their supplies and are concerned increased pressure from Big Pharma could mean higher prices.
BDR had hoped to sell dasatanib, which costs roughly $2,491 per month, for $122 per month, according to Reuters. Its application was rejected in 2013. Meanwhile, Lee Pharma's application to market a cheaper version of saxagliptin was rejected for the second time earlier this year.
India has stricter patent and pricing rules than other emerging markets but also represents an area of potential growth for the pharmaceutical industry. This creates a tough balancing act for the Indian government which wants to simultaneously protect its existing generics industry, woo foreign firms, and keep public health costs low.