BIO Comments on India Guidelines for Examining Biotechnology Applications

The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments in response to the Controller General of Patents Designs and Trademarks in India on the &quot;Draft Guidelines for Examination of Biotechnology Applications&quot; hereafter referred to as &quot;Draft Guidelines&quot;, or &quot;Guidelines&quot;.</p>

Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in India, BIO has reviewed the Guidelines and is pleased to provide suggestions for possible improvement within the framework of the Indian patent law. At the outset it is important to note that BIO recognizes there are countries, including India, that view aspects of biotechnology to be controversial. BIO supports, and often participates in robust discussions on ethical issues pertaining to biotechnology. Indeed BIO’s Statement of Ethical Principles espouses the use of biotechnology in a socially responsible manner to save or improve lives, improve the quality and abundance of food, and clean up hazardous waste.

Nevertheless, BIO recognizes, as does India, that such soaring goals cannot be met without the appropriate legal and regulatory framework, and the necessary investment. Biotechnology is a global industry. As such biotechnology inventors file for patent protection in many different jurisdictions for the various reasons stated above. While patent protection is territorial, inventors, in general, expect to find relative consistency in most jurisdictions. For example, what is considered an invention in the U.K. is most likely patentable in the U.S. or in India. Accordingly, to the extent possible, patent office guidelines should provide uniformity in examination and direction to the examining corps, while at the same time being relatively consistent with other jurisdictions. In this regard, BIO’s comments reflect the experiences of our members in varying jurisdictions.

As a general comment, the Draft Guidelines provide several Illustrative Examples attempting to show what subject-matter may not be allowable under the considered provisions. For a complete guidance of the examiners, it is suggested to include more illustrative examples showing what subject-matter could be allowable.