US Biotech's Problems With Patent Office

The level of proof is too high when it comes to patents, according to one of the complaints the biotechnology industry is putting before the US Patent and Trademark Office at a hearing on patents relating to the industry. The companies also say that examiners delay their applications unfairly; with patents granted only for useful technologies, examiners have told applicants that they need to prove efficacy in humans or animals, not just in the laboratory.

At the hearing, the Biotechnology Industry Organization is presenting over 200 pages of recommendations for changing the examination policy. The law is not under question, says BIO vice president for governmental affairs, Charles Ludlam, rather the fair treatment of all industries.

Industry Reservations Over GATT Bill The Clinton Administration has already given a written commitment that the Office will look at its examination policies relating to biotechnology, even though it is not part of the legislation approved by Congress for the General Agreement on Tariffs and Trade treaty. While this treaty was generally supported by the industry, it has some reservations about increasing patent cover from 17 years from the date of issuance to 20 years from the date of application, because some biotechnology patents can be delayed for five to 10 years. The Patent Commission has continued to speed regulatory review of biotechnology patents, and Congress amended the GATT law with a provision that could add up to five years to a patent initially rejected by an examiner and then granted on appeal.