Domestic drug industry body, Indian Pharmaceutical Alliance (IPA), and global pharma major Pfizer have locked horns over intellectual property regime in the country. While Pfizer contends that India’s recent ?anti-patent decision underscore a pattern of deteriorating IP protection in India,? the IPA maintains that ?Indian patent law does not discriminate between domestic and the foreign companies?.
The IPA, which represents top domestic pharma firms, last week wrote a letter to Roy F Waldon, the chief intellectual property counsel at Pfizer slamming his testimony before US House Ways and Means Trade Subcommittee on India-US trade relations made on March 13. The IPA said that it is ?riddled with factual inaccuracies and untenable assessments of the state of intellectual property protection in India?.
STOCK MARKETS LINKS
* Best Performing Mutual Funds
In response, Waldon said that he has provided ?a fair assessment of the legal and factual situation in India, a market that has in recent months treated our industry most unfairly?.
In April, the Supreme Court turned down Swiss drugmaker Novartis’ plea for patent protection for its cancer drug Glivec, saying the invention in question did not meet the novelty and therapeutic efficacy criteria, but made it clear that genuine inventions could be rewarded with marketing exclusivity.
Moreover, the Delhi high court in the same month refused to grant interim relief on a patent row to US major Merck Sharp and Dohme (MSD), which sought a restraint on Indian firm Glenmark Pharmaceuticals on manufacturing and marketing generic versions of MSD’s patented drugs. The case is currently pending in the courts.
According to Waldon, if there is no meaningful enforcement of patents and the patents are revoked or licensed to others for the mere asking, there are no discernible rights left to the patent holder in India.
?We stand by our belief that these recent decisions underscore a pattern of deteriorating IP protection in India that undermines our ability to compete fairly, and creates a business environment that is unpredictable and threatens patients? access to innovative medicines,? Waldon said in a letter to DG Shah of IPA.
On the issue of compulsory licensing, IPA had contented that Pfizer’s ?assertions relating to compulsory licensing in India are misconceived?. Waldon in his testimony had stated ?…compulsory licences may be used by competitors as a means to obtain authorisation to use or transfer technology developed by others without having to pay the substantial costs associated with developing and testing the product. These copiers want to obtain a free ride or use the technology at a much reduced cost?.
In his response letter to IPA, Waldon defended his statements and contended that ?routine use of compulsory licences for procurement and industrial policy purposes is abusive of patent rights and make bad policy?.
India has issued only one compulsory licence last year, to Natco Pharma to develop German drug major Bayer’s patented cancer treating medicine Sorafenib (brand name Nexawar). The government is also contemplating grant of compulsory licences for three other cancer drugs.