BIO Issues Statement On PTO’s Final Gene-Based Patent Guidelines

WASHINGTON, D.C. (January 5, 2001) - Lila Feisee, director of intellectual property for the Biotechnology Industry Organization (BIO), issued the following statement on the U.S. Patent and Trademark Office’s (PTO) final guidelines for determining utility of gene-based inventions.

“BIO welcomes the PTO’s final guidelines,” Feisee said. “Theyreflect the agency’s commitment to solve the significant intellectual property challenges raised by advancing technology. The guidelines published today in the Federal Register are very similar to those first proposed by the PTO in 1999 and will strengthen patents issued for gene-based inventions.

“The final guidelines,” Feisee explained, “fortify standards for demonstrating a gene-based invention’s utility. To secure patents, applicants must demonstrate how the gene-based invention will be used commercially. Under the new guidelines, applicants not only must provide an adequate description of a gene, they also must link the gene with a specific, useful application. Those applications could include using the gene to detect or treat diseases, or to make new drugs based on the gene.

“The PTO’s guidelines provide the biotechnology industry with a clearer framework in which to operate when filing patent applications,” Feisee added. “This leads to issuance of strong, enforceable patents that are essential for the biotech industry to continue developing new drugs and vaccines. These patents give companies limited market protection to try to recoup the enormous financial investment needed to develop a new medicines.

“More than 100 biotech drugs and vaccines on the market todayfor illnesses such as heart attacks, stroke, various cancers, arthritis, hepatitis, diabetes and AIDS have benefited more than a quarter billion people worldwide. Hundreds more biotech medicines are in late-stage development for nearly every disease and disability.”

BIO represents more than 950 biotech companies, academicinstitutions and state biotech centers in all 50 U.S. states and 26 other nations. BIO members are involved in research and development of health-care, agricultural, industrial and environmental biotechnology products.