[Ip-health] Press Statement by Novartis issued on day of Supreme Court decision

leena menghaney leenamenghaney at gmail.com
Thu Apr 4 00:13:02 PDT 2013

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, April 1, 2013 - 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

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

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

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.

Leena Menghaney
Tel: 46573730/1

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