Glivec patent case in India
The Indian Supreme Court on April 1, 2013 denied a patent for the Novartis breakthrough medicine Glivec® (imatinib mesylate). This decision discourages innovative drug discovery essential to advancing medical science for patients.
Novartis has never been granted any other patent for Glivec in India. The Court denied an appeal challenging the rejection of a patent for Glivec, a life-saving medicine for certain forms of cancer, patented in nearly 40 countries including China, Russia, and Taiwan. Novartis filed a Special Leave Petition with the Indian Supreme Court in 2009 challenging the denial of the Glivec beta crystal form patent on two grounds, based on Sections 3(d) and 3(b) of the Indian patent law. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects of the patent law.
To continue to provide patients with safe and effective new treatment options, we believe every society has a responsibility to support research and development. Nations with international rights and obligations share this responsibility. Novartis contributes to medical progress through innovative drug research that targets diseases currently without adequate treatment options.
What drives medical progress?
Innovative and generic medicines —
What are patents and how do they work?
How do patients gain greater access to medicine?
What is the Glivec patent case all about?
- The purpose of patents is to protect pharmaceutical company profits for about 20 years.
- Patents exist in all industries to foster innovation by supporting long-term investment in research and development. In the case of drug development, patent protection often begins more than 10 years before a medicine's launch, leaving only a limited period of time to regain the investment.
- Enhancing access to medications is solely about affordability. Generics solve the access challenge and enable patients to afford the medications they need.
- Generics alone do not guarantee access to medications. 98% of the World Health Organization's (WHO) essential drugs are available at off-patent prices, yet more than a third of the world population still lacks access due to political, economic and logistical barriers1,2,3. Without patents there will be few new medicines and without new medicines there will be no new generics.
- If the Supreme Court of India rules in favor of Novartis, the outcome will have a devastating impact on patient access to essential medications in the developing world.
- The outcome of the case will not hinder the supply of essential medicines because international trade agreements include safeguards to ensure patient access. Novartis' legal case does not challenge these safeguards. Currently available generic drugs launched in India before 2005 – including HIV/AIDS medicines and generic versions of Glivec – will continue to be available regardless of the legal outcome of the case.
- Lybecker, Kristina. "The Economics of Access to Medicines: Meeting the Challenges of Pharmaceutical Patents, Innovation, and Access for Global Health." Harvard International Law Journal. Presented December 2011. Available at: http://www.harvardilj.org/wp-content/uploads/2011/12/HILJ-Online_53_Lybecker.pdf . Accessed December 2012.
- World Health Organization. "The World Medicines Situation 2011 - Access to Essential Medicines as Part of the Right to Health." Available at: http://apps.who.int/medicinedocs/en/m/abstract/Js18772en/ . Accessed December 2012.
- World Health Organization. "WHO's new Model Formulary - promoting consumer rights and patient safety." Available at: http://apps.who.int/medicinedocs/en/d/Js4940e/17.html . Accessed December 2012.
- Hirschler, Ben. "Drug pipelines improving after years in doldrums," Reuters. Published June 26 2012. Available at: http://www.reuters.com/article/2012/06/26/us-drug-improving-idUSBRE85P06H20120626 . Accessed December 2012.
- The Pharmaceutical Research and Manufacturers of America (PhRMA). "Drug Discovery And Development." Available at: http://www.phrma.org/research/drug-discovery-development . Accessed December 2012.
- Bloom, J. Making the Case for Longer Pharmaceutical Patent Protection. 26 Jan 2012. Available at: http://www.medicalprogresstoday.com/spotlight/2012/01/drug-patents-unbound.php . Accessed December 2012.