Source: Economic Times
30 Oct 2014
NEW DELHI: Cipla, India’s fifthlargest drugmaker by revenue, has asked the government to revoke five patents that Novartis holds on respiratory drug Onbrez and launched its generic version of indacaterol at a fifth of the price, triggering another confrontation between an Indian generic company and a foreign innovator firm. The domestic drugmaker asked the Department of Industrial Policy & Promotion to cancel the patents on the ground that the Swiss company has held them for six years without making the medicine locally or importing it in the quantity that’s required.
It alleged that Novartis imports only about 54,000 units annually, depriving 99.9% of the 1.5 crore people in India who need the drug. “Novartis’ products do not satisfy even 4,500 patients an nually and our feedback shows the product is urgently needed by the doctor and patient community,” said a Cipla spokesperson. An email sent to a Novartis India spokesperson went unanswered. Cipla’s move is likely to open a new front in the ever-expanding conflict between Indian drugmakers and multinationals that goes back several decades. It’s also likely to become a test case for similar instances. “This case will open Pandora’s box. The government will be forced to take notice of all such cases where MNCs are holding on to patents but not launching or selling very little of their patented products. The government will have to take a stand on how it should monitor the situation,” said the patent head of another top generic firm who didn’t want to be named.
A senior executive at a multinational drugmaker said a company can’t be forced to sell its products in any market. “It’s a decision based on many factors, including commercial reasons,” he said. Foreign innovator or original research companies believe that Indian drugmakers take advantage of the country’s weak patent laws to launch cheaper version of their drugs, depriving them of legitimate profit.
Indian drug companies say they function within the law and by manufacturing cheaper versions they keep drug prices and healthcare costs low not just in the country but in other parts of the world as well. The government contends that India’s patent laws comply with international requirements and have been designed to meet the objectives of availability, accessibility and affordability.
Many of these disputes end up in court and industry experts expect Novartis to legally challenge the launch of Cipla’s generic version. Some of the high-profile innovator-generic patent battles currently going on in Indian courts include Cipla versus Swiss drugmaker Hoffman La Roche over lung cancer drug Tarceva (erlotinib); Natco Pharma vs American firm Bristol-Myer Squibb over cancer drug Sprycel (dasatinib); Glenmark and five other generic drugmakers vs US firm Merck Sharp & Dohme over diabetes drug Januvia (sitagliptin).
Cipla has launched its indacaterol generic, a chronic obstructive pulmonary disease ( COPD) drug, under the Unibrez brand in some parts of the country. An industry executive said the medicine was priced at about Rs 130 per pack of 10 pills, compared with Onbrez, which sells for Rs 677. A Cipla spokesperson confirmed the launch and said “Novartis’ product is over 400% more expensive than Cipla’s product”. Interestingly, Cipla’s chief executive Subhanu Saxena joined the company from Novartis, where he led its global product strategy and commercialisation functions.
In its appeal to DIPP last week, the Indian drugmaker demanded that Novartis’ patents on the drug be revoked under Section 66 of Indian Patents Act. This allows the government to strike down a patent if it concludes that it has been exercised in a manner that doesn’t benefit the state or public. Cipla argued that by not manufacturing the drug locally and importing only limited quantities through Indian licensee Lupin, Novartis was making”mischievous use of its patent rights”, which is “detrimental to public” interest.
It also urged the government to consider COPD as an epidemic worthy of being qualified as a “public health crisis” as it claims 50 lakh lives annually in India, which is more than the toll from HIV-AIDS, malaria, cancer and tuberculosis.
Cipla also accused Novartis “ever-greening”, or seeking to extend its monopoly, by filing five patents for the “same or similar substance”. In 2013, Novartis lost a bitterly fought patent war over cancer drug Glivec with the Indian government, when the Supreme Court turned down its plea on the ground that the substance it was seeking to patent did not enhance therapeutic efficacy over existing drugs.