House Approves Patent Reform Bill Boosting Medical Research

WASHINGTON, D.C. (August 4, 1999) The Biotechnology Industry Organization (BIO) today applauded the U.S. House for its overwhelming approval of a bill that will help patent applicants recoup years of protection lost during reviews of their claims by the U.S. Patent and Trademark Office (PTO).

The House, by a vote of 376-43, approved the American Inventors Protection Act of 1999 (H.R. 1907), providing day-for-day restoration of patent term lost at the PTO through delays in reviews and in consideration of appeals and interferences. The legislation now goes to the U.S. Senate for its consideration.

"The bill is a victory for biomedical research," said Chuck Ludlam, BIO's vice president for government relations. "It restores patent protections that are essential in helping biotech companies raise the private investment capital they need to develop new life-saving medicines. The legislation will add tens of thousands of years annually to the terms of patents issued to our companies."

The victory, Ludlam said, is the first of a two-part strategy in winning back patent protection lost during regulatory agencies= reviews. The second involves reform of the Hatch-Waxman Act to restore day-for-day patent term lost due to delays at the FDA.

The effort to recoup valuable lost patent term at the PTO and FDA began following U.S. adoption of the worldwide General Agreement on Trade and Tarriffs (GATT) in 1994. The treaty provisions changed the method of calculating patent term. Protections were limited to 20 years from the date a patent application is filed, rather than 17 years from the date a patent is granted.

Because biotech patent applications are more complex than most, their reviews take longer at the PTO. GATT, as a result, shortened the number of years of protection for many biotech patents. The loss tends to be greatest for the most valuable patents.

"We got the bill through the House in 1997," Ludlam said, "but on a much closer vote after a contentious debate, and as a result we lost the bill in the Senate. We need this new momentum from the House to win the day in the Senate."

BIO represents more than 850 biotechnology companies, academic institutions and state biotechnology centers in 47 states and 26 nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental products.