New Delhi: Supreme Court’s landmark ruling to reject Novartis AG’s attempt to win patent for cancer drug Glivec will not only act as a breather for poor patients in India but will also give a boost to the Indian drug makers.

Poor patients will have easier access to quality medicines of life-threatening diseases after the SC move, which is also in support of Indian pharma companies, feel domestic manufacturers.

Imatinib (Glivec) is on the National List of Essential Medicines and is an important drug in the treatment of several cancers such as certain blood and stomach cancers.
Among the chief beneficiaries of Monday's ruling will be India's Cipla Ltd - whose shareholders include Oppenheimer Developing Markets Fund and Virtus Emerging Markets Opportunities Fund - and Natco Pharma Ltd, which already sell 'generic' Glivec in India that costs around one-tenth of the branded drug.
"The multinational companies will have to find new ways of doing business in India," said Deepak Malik, healthcare analyst at brokerage Emkay Global, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs like Glivec.

"It's a victory for patients who take these medicines and also for the government," said M Adinarayana, company secretary at Natco Pharma.
Reacting to the news, shares of Indian pharmaceutical companies gained momentum on Bombay Stock Exchange. Stocks witnessing rallies were Cipla, Natco Pharma and Sun Pharma.  


"The decision of the Supreme Court will come as a relief to patients suffering from these dreadful diseases as several Indian companies, including Cipla, Ranbaxy and Natco, can continue marketing imatinib at a fraction of the cost of the Novartis product," Indian Pharmaceutical Alliance (IPA) Secretary General D G Shah said terming the judgement as a 'landmark judgement'.

Terming the judgement as a 'landmark judgement' in favour of poor patients, domestic drug manufacturer associations, including Indian Pharmaceutical Alliance (IPA) and Indian Drug
Manufacturers' Association (IDMA), hailed the Apex Court's decision.

"The decision of the Supreme Court will come as a relief to patients suffering from these dreadful diseases as several Indian companies, including Cipla, Ranbaxy and Natco, can
continue marketing imatinib at a fraction of the cost of the Novartis product," IPA Secretary General D G Shah said in a statement.

Expressing similar sentiments, IDMA Secretary-General Daara B Patel said the order was in favour of poor patients.
"It is a good judgement. It is in favour of the country's poor patients and is in support of Indian generic companies. Though I feel sorry for Novartis but I feel happy that rules of the country have prevailed and this help the poor patients," Patel added.

Commenting on the development, Cipla Chairman Y K Hamied said the judgement in the Novartis case is a victory for patients both in India and around the world.
"We are pleased with the judgement which prevents the use of frivolous patents to deny access to medicines for patients," he added.

Novartis, however, termed the judgement as a 'setback for patients'. "We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options," Novartis India Ltd Vice- Chairman and Managing Director Ranjit Shahani said.
He further added: "Novartis has never been granted an original patent for Glivec in India. We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs."
A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the claim of the Swiss firm for getting exclusive rights for manufacturing the cancer drug on the ground that a new substance has been used in the medicine.
While a one-month dose of Glivec costs around Rs 1.2 lakh generic drugs, manufactured by Indian companies, for the same period are priced at Rs 8,000.
The Indian Patent Office had rejected the patent application of Novartis for the ß-polymorphic form of imatinib mesylate on various grounds in 2006, including that a patent could not be granted for the ß-polymorphic form under section 3(d) as it did not have any increase in efficacy over the previously known substance.
Novartis appealed against the rejection of the patent by the Patent Office before the Intellectual Property Appellate Board (IPAB) in 2007, but the appeal was dismissed in 2009.
Aggrieved by this dismissal, Novartis went to the Supreme Court which has now confirmed the rejection of the patent.

Novartis has previously said it needs legal certainty if it is to plan further investment in drug research in India.
"Henceforth, multinational pharma companies are likely to want that their patents are first recognised in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co.
Novartis has been fighting since 2006 to win a patent for an amended form of Glivec. In 2009 it took its challenge against a law that bans patents on newer but not radically different forms of known drugs to the Supreme Court.
India has refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound. By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China.
Indian law bans firms from extending patents on their products by making slight changes to a compound, a practice known as "evergreening".
The Supreme Court said Glivec does not satisfy a patent's "novelty" requirement, Pravin Anand, lawyer for Novartis, told reporters.
Novartis can file a review petition within 90 days. "The Supreme Court has taken a strong stand against evergreening. This will pave way for affordable medicines in India," Y.K. Hamied, chairman of Cipla, told.


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