Indian Court Decision Weakens Incentives
For New Innovations that Benefit Patients

Washington, D.C. (August 6, 2007) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin issued the following statement today regarding the patent decision by the High Court in Chennai, India:

“We are disappointed the Indian court dismissed the challenge to Section 3(d) of India’s 2005 Patent Law. We are concerned that the result is likely to be reduced patient access to better medicines discovered through ‘incremental innovation.’

"’Breakthrough innovations’ are important but rare in medical research. Most medical advances – like in other technological fields – happen by ‘incremental innovation’; that is, innovation that builds on previous inventions. In the pharmaceutical industry, incremental innovation means the continuous improvement of medicines that have been key to delivering therapeutic advances to patients worldwide. Incremental innovation requires large-scale research and development, including clinical trials, along with approval from regulators before the new product can be offered to patients.

“Incremental innovation takes many forms, including improved safety and effectiveness, fewer side effects, new formulations allowing greater ease of use and improved compliance, new indications, and new versions of the medicine developed for specific groups of patients (such as children). It can also take the form of greater product stability during storage and transport, which can be especially important in tropical climates like some regions of India. As a result of Section 3(d), and the Indian High Court’s decision to let it stand, the current Indian law fails to recognize these important benefits for Indian patients and reduces incentives for companies to research and develop these advances in medical technology.

“Beyond the impact on Indian patients, a second set of unfortunate consequences of the High Court decision is likely to impact India’s own domestic pharmaceutical industry, and especially its burgeoning research sector. Indian companies in this industry have the capacity to be world leaders, but without an effective patent system to encourage long-term domestic research and development efforts, India’s pharmaceutical industry will remain an imitator and not realize its potential as an innovator.

“PhRMA recognizes, however, that this court case is only one milestone in India’s long-term development of its patent system. PhRMA encourages dialogue among all involved groups on the path forward, and how to best support the interests of Indian patients.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.
 

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.

PhRMA Internet Address: www.phrma.org

PhRMA en Español: www.nuestraphrma.org

For information on how innovative medicines save lives, visit: www.innovation.org

For information on the Partnership for Prescription Assistance, visit: www.pparx.org

For information on the danger of imported drugs, visit: www.buysafedrugs.info