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HindustanTimes Sat,01 Nov 2014

SC decision on Glivec: 'landmark judgement' for pharma cos, 'setback ruling' for Novartis

PTI  New Delhi, April 01, 2013
First Published: 16:21 IST(1/4/2013) | Last Updated: 16:24 IST(1/4/2013)

Poor patients will have easier access to quality medicines with the Supreme Court rejecting Swiss firm Novartis' patent plea for its cancer drug Glivec, according to domestic manufacturers.

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Novartis, however, said: "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options".

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 DG Shah said in a statement.

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.

Shah further said: "This is a landmark judgement that will serve to set at rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions."

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 YK 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.


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