Proposed Changes to Patent Rules Would Harm Biotechnology Companies

WASHINGTON, D.C. (May 3, 2006) – In January, the U.S. Patent and Trademark Office (PTO) proposed changes to patent rules that would restrict the number of claims examined  in a single application and limit inventors’ rights to file continuation applications. The Biotechnology Industry Organization (BIO) opposes these rule changes because they would have a negative impact on biotechnology companies.

“BIO believes that the PTO’s proposed rule changes will stifle biotech innovation,” BIO President & CEO Jim Greenwood stated. “It can take decades to develop a patented biotechnology invention, in part because these inventions must go through a rigorous regulatory approval process. Strong patent protections are needed to allow biotech companies to attract the investment needed to survive the long process of bringing a product to market. The changes in the PTO’s proposed rule will discourage investors from investing money in biotech innovations.”

“The PTO claims the rule changes are needed to address concerns about patent quality and to reduce the large number of backlogged patent cases. BIO believes that the proposed rules will not only lead to an increase in the number of application filings but also do nothing to address the quality concerns of the PTO. BIO recommends that the PTO hold public hearings and post advance notices of proposed rules before making such sweeping changes to patent rules,” Greenwood continued.

In comments to the PTO’s proposed rule filed yesterday, BIO recommended alternative means for reducing the backlog of patent applications, including an accelerated/deferred examination system, changes in the PTO examiner production system, increased examiner education, and improved cooperation with other patent offices.

To read BIO’s comments, visit the BIO web site at http://www.bio.org/ip/letters/.

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.

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