Supreme Court Denial of Glivec Patent Clarifies Limited Intellectual Property Protection and Discourages Future Innovation in India

-Patent denied despite global recognition of Glivec as a life-saving, breakthrough drug for certain forms of cancer, with patents granted in nearly 40 countries
-Novartis has never been granted an original patent for Glivec in India
-More than 9 out of 10 patients currently taking Glivec in India will continue to receive drug free of charge through Novartis Oncology Access programs
-Patents are the foundation of innovative drug discovery and essential to advancing medical science and treatment of patients

Mumbai, India, - - A decision issued today by the Indian Supreme Court regarding the Novartis breakthrough medicine Glivec® (imatinib mesylate) provides clarification on Indian patent law and discourages innovative drug discovery essential to advancing medical science for patients.

Novartis has never been granted an original 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.

“Novartis has never been granted an original patent for Glivec in India. We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs,” said Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited. “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.”

The primary concern of this case was with India’s growing non-recognition of intellectual property rights that sustain research and development for innovative medicines. As a leader in both innovative and generic medicines, Novartis strongly supports the contribution of generics to improving public health once drug patents expire.

Novartis remains committed to patients and access to medicine. Through its full donation programs, Novartis provides Glivec free of charge to 95% of patients prescribed the drug in India, currently more than 16,000 patients. The remaining 5% of patients are either reimbursed, insured, or participate in a very generous co-pay program. Since Novartis began its first donation program in 2002, the company has provided more than 1.7 billion dollars’ worth of Glivec to patients in India.

Engaging with society to improve access to healthcare is integral to the way Novartis operates. In 2012, our contributions and programs in this area were valued at USD 2 billion, providing medicine to more than 100 million patients, and health education, infrastructure development and other programs to another 7.2 million people worldwide.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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