A decision issued on April 1st 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 recognised 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 US$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.