AstraZeneca’s lung-cancer drug Iressa may be poised to go the way of Novartis AG’s Glivec, whose patent scrap with rivals resulted in a court case between the company and the government that essentially challenges India’s patent law. The next hearing of that case starts today in Chennai.
The European drug maker’s Iressa first attracted the ire of domestic rivals when the company applied for an exclusive marketing right (EMR) in India two years ago; the EMR was not granted. Now, its patent application has been opposed by two domestic rivals that make a version of the drug. If the patent is granted, the Indian companies will have to withdraw their products from the market.
Hyderabad-based Natco Pharma Ltd and Mumbai-based JM Pharmaceutical Ltd have told the Patent Office, Delhi, which oversees issuance of patents in North India, that granting a patent for Iressa would be a violation of the Indian patent law.
In 2005, the country amended its patent law to allow product patents, but excluded new combinations of existing compounds and derivatives from the list of drugs that could be patented.
Adi Narayana, company secretary at Natco, said his company had filed a pre-grant opposition against AstraZeneca’s drug since it was not a new drug by definition of the law. “The scientific data regarding the efficacy and therapeutic functions of the chemical entity, Gefitinib, had been in the public domain before AstraZeneca filed its patent application in India,” he added. Natco, he explained, was opposing the grant of a patent to Iressa under “knowledge of prior use of the entity (Gefitinib)” and “lack of inventive steps”.
AstraZeneca India’s spokesperson Anjali Chandavarkar declined comments as the patent application was filed by the parent. The company’s press office in the UK did not respond to an email.
The Patent Office, Delhi has already heard the pleas of the companies against Iressa, although no decision has yet been made. The Chennai court hearing the Glivec (also sold as Gleevac outside India) case is yet to pass its judgement. India’s patent office turned down Novartis’ patent application for the drug, which fights stomach tumours and lukaemia, claiming that it did not meet the law’s definition of what constituted innovation in the country.
Laxmi Kumaran, a patent lawyer who represented one of Novartis’ Indian opponents in the Glivec case, said that a patent application can be opposed “on the grounds of known prior use, if the inventor failed to file an application within 12 months from the date of its first patent application in any country”. A person close to the developments who did not wish to be identified claimed that AstraZeneca had not done this.
In the Glivec case, Novartis was granted an EMR in 2004. Consequently, seven Indian pharmaceutical firms, including Ranbaxy Laboratories Ltd, Cipla Ltd, Sun Pharmaceutical Industries and Natco Pharma, had to withdraw their products. The local firms challenged the EMR in the Patent Office, Chennai, which subsequently rejected Novartis’ application. The Swiss firm then filed a case against the patent office in a Chennai court.
A representative of Cancer Patients’ Aid Association, a Mumbai-based non-governmental organization that seeks to improve the lot of cancer patients in India, said that granting a patent protection to Iressa would shut the door on low-cost treatment to around 4,00,000 patients, half the estimated 8,00,000 people who suffer from lung cancer in the country.
That’s because of “high cost”, said Y.K. Sapru, chairman, Cancer Patients’ Aid Association. That’s despite the relative low cost of the versions being sold by Indian firms.
AstraZeneca’s Iressa costs around Rs85,000 for a month’s treatment; Indian versions can be had for around Rs10,000. If a patent is awarded to Iressa, added Sapru, “the local players will withdraw (their drugs) from the market, leaving a large majority of lung cancer patients untreated”.
A rejection, he explained, would see more local companies start to produce the drug and result in even lower prices. Natco is the market leader in the Rs30 crore Gefitinib market in the country with an 80% market share.
Novartis’ Glivec, too, costs much more than local versions, Rs1,20,000 for a month’s medication compared with Rs12,000. However, the company gives away the drug free to 6,700 Indian members of its international patient assistance programme. It isn’t known if AstraZeneca has a similar programme in India for Iressa.
AstraZeneca received a marketing approval for Iressa from the US Food and Drug Administration (FDA) in early 2004. The US market still accounts for half of Iressa’s global sales of around $300 million (Rs1,320 crore).