US Biotech Patent Rules Eased

US pharmaceutical companies are no longer required to conduct human clinical trials on products derived from biotechnology before they can be granted a patent. Commissioner of Patents and Trademarks and Assistant Secretary of Commerce Bruce Lehman announced in late December that the policy change, contained within new guidelines for patent examiners, was being made to remedy the "Catch-22" situation in which companies found themselves, in that they could not afford to conduct the human trials if they did not hold patents on the drug because they could not be sure of gaining exclusive rights to the product.

Companies still have to demonstrate the product's potential usefulness, but this can be achieved by submitting "any kind of evidence" to support the claims, he said. "Our examiners will no longer impose unrealistic and unattainable evidentiary requirements on patent applicants." Also, he noted that discussions between the Office and the industry had revealed that agency examiners had routinely challenged the "sound scientific conclusions of recognized experts in the field," including Nobel Prizewinners, in support of a product's utility claims. "This practice will cease under the new guidelines," he said.

The biotechnology industry has welcomed the policy change as a big step forward, saying it will make it easier for companies to obtain funding to conduct human clinical trials, particularly for smaller companies, and would speed new drug discoveries. "When you have a patent, you can go to investors," said Genzyme vice president Lisa Raines. "You can't get investors for clinical trials without patents."