The drugs manufacturing industry is on a state of alert following two landmark developments over a cancer treatment medicine.
For one, the first application for a compulsory licence filed in India, has put a key provision of the Indian Patents (Amendment) Act, 2005 under the scanner. The application has been filed by Natco Pharma of Hyderabad for Roche's erlotinib (brand name Tarceva), which is used in the treatment of lung cancer.
For another, Cipla -- India's top drug maker -- has announced it will soon launch a generic version of the drug, which could be the first instance of violation of a patent in the country.
Natco Company Secretary Adi Narayana told Business Standard that the company had decided on a compulsory licence rather than a post-grant opposition to the drug as this seemed a better strategy. The application is for the export of 30,000 tablets to Nepal and Natco has offered Roche a five per cent royalty.
The industry sees this as a test case for compulsory licensing as the law stipulates a two-year waiting period for exports after a patent is granted. The erlotinib patent was granted in July last year.
Natco filed a pre-grant opposition to erlotinib but lost the case. It subsequently filed the application for compulsory licence with the Controller General of Patents on September 15. Narayana believes it should be easier to secure the licence for an LDC (least developed country) like Nepal.
Natco, a small generics manufacturer (turnover of Rs 217 crore in 2006-07), shot into the limelight with a case against Novartis over the blood cancer drug Glivec, the first major tussle with a global pharma firm since the introduction of the product patent regime.
In the landmark case against the Swiss pharma giant that is now before the Supreme Court, Natco has challenged the composition of the patent office's appellate board, which is hearing the Glivec matter.
The patents office has yet to convene a hearing on the compulsory licence with Roche.
While Narayana says Natco applied for the CL as "a law-abiding company, not wanting to invite trouble", Cipla is taking a risk against the Roche patent to launch its version of erlotinib "very soon". Cipla Joint Managing Director Amar Lulla, however, feels there is no risk because the patent is very weak.
Patent experts point out that erlotinib belongs to the tyrosine kinase family of inhibitors that are used in the treatment of various cancers. Erlotinib is a derivative of gefitinib which was introduced by Astra Zeneca before 1995, the cut-off year for patents in India. Astra Zeneca has been denied a patent for gefitinib in India.
Legal opinion suggests that Cipla could seek revocation of the patent through a counter claim when Roche files a suit for infringement. This may also explain why it has not opted for a post-grant opposition.
The patent for erlotinib was initially sought by Pfizer in the US. Roche, OSI Pharmaceuticals and Genentech have an agreement for the global development and commercialisation of the lung cancer inhibitor.
It is a high-cost drug with each tablet costing Rs 4,800. This means that a lung cancer patient could pay close to Rs 1.5 lakh a month for treatment. Cipla plans to sell the drug for a third of this cost (Rs 1,600 a tablet) while Natco will price it at about Rs 1,000.
This is why organisations such as Medecins Sans Frontieres, which treat poor patients the world over, are watching these developments with interest.
"This is a test case and we are watching and waiting to see the government's response to the application," says Leena Menghaney, India coordinator of MSF.
Menghaney thinks India's compulsory licensing provisions are restrictive and discourage generic competition which cuts prices of essential drugs. "No other country has a three-year waiting period, not even the US," she points out.
Although compulsory licenses are given in the case of a public health emergency when drugs are either unavailable or unaffordable, health officials argue that it is incorrect to make a distinction between one disease and another.
So, although heart ailments, cancer, diabetes and asthma are not classified as a public health emergency, they say all patients who suffer from life-threatening conditions should have access to medicines at affordable prices.
