Drug companies have always fought long battles when it came to securing a patent in India. It has never been an easy ride to seek patent protection on drugs in India. For instance, the revocation of Swiss Company, Roche’s six year old patent on hepatitis C drug Pegasys. Even if the companies did manage to get a patent for their drug in India, more often than not, they do not enjoy patent protection for complete 20 years. For instance, the issuance of compulsory license on, German Pharma Company, Bayer’s cancer drug Nexavar.
Section 3 (d) of the Indian Patent Act has always been a hurdle for these drug companies. Time and again, big global pharma companies have been denied patents because of this provision which aims at preventing ever-greening of patents. Many drug companies tweak existing patents and seek a fresh period of protection. The law requires the drugs to establish significant efficacy when compared to existing products in the market to qualify for a fresh patent.
This time around, Astrazeneca has faced the brunt for its anti-cancer drug Gefitinib. Astra Zeneca’s patent application was earlier opposed by Natco and GM Pharma at the pre-grant stage for lacking novelty, and inventive step. Subsequently, Indian patent office in 2007 refused patent protection, citing lack of invention. Following which, Intellectual Property Appellate Board (IPAB) upheld the decision passed by the Indian patent office in 2007 by denying patent protection to AstraZeneca's anti-cancer drug Gefitinib. The IPAB dismissed the British drugmaker, AstraZeneca’s petition citing that the molecule lacked invention.
Outcomes of these patent battles are crucial, as it would greatly impact the balance of providing critical medicines at affordable costs to the public, yet leaving enough motivation for innovator companies to work on drugs to improve the practice of medicine.
Contributed by Sneha Ashok