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BIO Comments on the Draft National IPR Policy

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BIO commends the Government of India for recognizing the critical role that intellectual property plays in innovation and for initiating a review of its policies regarding intellectual property.</p>

BIO commends the Government of India for recognizing the critical role that intellectual property plays in innovation and for initiating a review of its policies regarding intellectual property. The biotechnology industry has unique concerns in that it is extremely risky and capital intensive. The industry relies heavily on intellectual property (IP) protection to translate a promising research idea to an utilizable product or technology. The development of a single biotechnology product (specifically a biopharmaceutical) often takes more than a decade, and can require as much as US$2 billion of capital investment, including the cost of failures. Indeed, while pharma-biotech inventions are entitled to the same patent term as all other inventions − 20 years from the time they are filed – they have the additional hurdle of a rigorous pre-launch regulatory review process during which they may lose between 8 to 10 years of the patent life.

Accordingly, we commend the Think Tank for the current draft Policy and we hope to provide such comments as to improve the policy and provide insight into the unique concerns of the biotech sector.

On its face, the Draft Policy primarily defends the status quo in regards to intellectual property rights (IPR) in India and the past positions of the Indian Government. However, given the significant economic initiatives of Prime Minister Modi, we would hope that India would take this opportunity to candidly review its existing rules and policies in IP.

We think the current Draft could be significantly improved if it would address the role of IPR in innovation, why IPR is necessary to India’s economic development, and the current state of innovation and creativity in India. The Draft assumes that IP needs to be protected because of global norms, e.g. World Trade Organization membership, but doesn’t demonstrate an intrinsic understanding of why the IP system was created or how the general public benefits from a strong IP system. Indeed, the current draft does not discuss why a policy is even needed. BIO believes that such a discussion can usefully inform the policies, rules and regulations governing intellectual property rights.

 

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