The Intellectual Property Appellate Board's (IPAB) decision to deny patent protection to AstraZeneca
for its lung cancer drug Gefitinib is the latest setback for a Big Pharma company in India. Big Pharma refers to global pharmaceutical companies with sales of more than $20 billion.
This is the third significant ruling on a patent case this year. Earlier this month, IPAB revoked Roche's patent for Pegasys
, its hepatitis C drug. In March, the Indian Patent Office granted Hyderabad-based Natco Pharma a "compulsory licence" to sell a generic version of German company Bayer AG's kidney and liver cancer drug, Nexavar
. It was the first instance of an Indian company getting a compulsory licence.
While it is too early to see a trend in these developments, analysts, doctors and representatives from Big Pharma believe there could be two potential implications. One: Big Pharma may desist from launching cutting-edge anti-cancer drugs in India. Two: Indian generics companies could launch generic versions of patented drugs, making them available at a fraction of the innovator's price.
In the latter case, millions of Indians who cannot afford expensive medicine, especially in specialties such as cancer care, would benefit. This is already happening in the case of Nexavar and its generic version. Natco charges Rs 8,800 for a month's dosage of 120 tablets against Bayer's price of Rs 2.8 lakh for the same dosage.
"Innovative companies are in the business of making innovative drugs. If they cannot be marketed because of patentability, then it will send out a wrong signal. It will have an adverse impact on foreign investments in pharmaceuticals in India,'' says Tapan Ray, Director General of the Organisation of Pharmaceutical Producers of India. The industry lobby counts many Big Pharma companies as its members.
Others, however, dismiss such statements as posturing by Big Pharma. They point out that to date, very few patents have been denied or reversed in India. Some estimates suggest that the number could be just one per cent of the total patents granted in India.
Among diseases, cancer is a growing concern. Doctors estimate that one out of every 1,000 people in India can get cancer. The odds are longer on lung cancer, the category to which the AstraZeneca drug belongs - one out of every 10,000 people. While those figures may seem small, in absolute numbers, they are significant in a country with a population of 1.2 billion.
In a statement on the IPAB ruling, AstraZeneca said: "We are disappointed by the Intellectual Property Appellate Board's decision. We are confident in the validity of the claims in this patent application and are now evaluating our next steps."
The British company's statement also noted that it has "a long-standing commitment to India". The company cited its new investments to underline that commitment: "We launched our patented antiplatelet drug Brilinta (Ticagrelor) in India this October and have just invested $17 million in a new tablet-manufacturing facility in Bangalore, which will open in 2013."
AstraZeneca sells and markets medicines in seven therapy areas: cardiovascular, respiratory, maternal healthcare, oncology, infection, gastrointestinal and neuroscience.
On Thursday, shares of AstraZeneca Pharma India declined 2.5 per cent on the Bombay Stock Exchange to close at Rs 1,526.