Press Esc to close
Monday 25 July 2016
News updated at 9:23 PM IST
Weather
Max: 27.6°C
Min : 20.4°C
In Bengaluru
Sunny day

Apex court verdict in Glivec case on Monday

Kalyan Ray, New Delhi, March 30, 2013 DHNS

After seven years of legal wranglings, the Supreme Court on Monday will deliver its verdict on the contentious patenting status of Glivec, an expensive anti-cancer drug, manufactured by pharmaceutical major Novartis.

After being denied protection on the molecule in India, Novartis challenged a key provision in the Indian Patent Act that inhibits protection of intellectual property rights on variants of an existing molecule unless there is significant therapeutic improvement.

The court verdict may also touch upon the price of leukaemia drug Glivec and other expensive drugs whose cheap generic versions are available in the market.

Glivec (imatinib mesylate) is the salt form of a previously known anti-cancer drug, sold in India for a price of Rs 1, 20,000 ($2,400) per patient per month. Indian firms sell its generic versions for Rs 8,000– 10,000 ($160–200) per patient per month. Since the original molecule was developed before 1995, it does not have a product patent in India.

Because of the World Trade Organisation requirement, India in 1995 agreed to allow patenting of pharmaceutical products and processes under Trade Related Aspects of Intellectual Property Rights (TRIPS) within 10 years.

While amending the patent law to meet this requirement in 2005, the government introduced Section 3(d) of the Indian Patent Act, prohibiting patents on variants of existing compounds that do not show enhanced efficacy. It was done ostensibly to take care of public health taking advantage of a TRIPS provision.

The pharmaceutical industry argues this clause establishes an unacceptably high barrier to patenting and limits incentive for research. But many others defend the law as a way to promote public health by enabling more drugs—particularly those who are hugely expensive—to be produced as generics.

Citing 3(d), Indian Patent Office in 2006 rejected Novartis’ application for a patent on the crystalline form of the basic compound in Glivec.

The company not only challenged the decision in Chennai High Court but also moved a separate petition questing the constitutional validity of the section 3(d). The High Court ruled against Novartis in 2007 and two years later Intellectual Property Appellate Board turned down Novartis plea on the patent cover for Glivec. Novartis moved the apex court in 2009.

The Supreme Court’s judgment could very well be a watershed verdict setting the ground rule on patent protection of many new medicines, which may only have an incremental benefit from its predecessor.


Go to Top

Photo Gallery
Legendary Santoor player Pandit Shivkumar Sharma being felicitated during an event...

Legendary Santoor player Pandit Shivkumar Sharma being felicitated during an event...

Members of the Indian archery team, the first to reach Brazil for the upcoming Olympics...

Members of the Indian archery team, the first to reach Brazil for the upcoming Olympics...

Kanwarias on their way to offer holy water to Lord Shiva on the occasion of holy month of Shravan...

Kanwarias on their way to offer holy water to Lord Shiva on the occasion of holy month of Shravan...

Actress Kajal Aggarwal receiving an award at 'Femina Power List South 2016'...

Actress Kajal Aggarwal receiving an award at 'Femina Power List South 2016'...

Coast Guard IG Rajan Bargotra briefing on the search operations of missing IAF AN-32 aircraft...

Coast Guard IG Rajan Bargotra briefing on the search operations of missing IAF AN-32 aircraft...

Mumbai crowned Premier Futsal champions in Mapusa...

Mumbai crowned Premier Futsal champions in Mapusa...

Chief of Army Staff, General Dalbir Singh paying homage to the martyrs of OP VIJAY...

Chief of Army Staff, General Dalbir Singh paying homage to the martyrs of OP VIJAY...

School studentsí celebrate Kargil Vijay Diwas in Jalandhar...

School studentsí celebrate Kargil Vijay Diwas in Jalandhar...

Forest officials patrolling in a boat on the flooded Kaziranga National Park on Monday...

Forest officials patrolling in a boat on the flooded Kaziranga National Park on Monday...

KSRTC buses were parked on following the State Transport Unions strike...

KSRTC buses were parked on following the State Transport Unions strike...

Copyright 2014, The Printers (Mysore) Private Ltd., 75, M.G Road, Post Box 5331, Bengaluru - 560001
Tel: +91 (80) 25880000 Fax No. +91 (80) 25880523