Biotech's victory on patent utility: FDA primer on 'effectiveness': Compromise on off-shore drug sales

The Patent and Trademark Office has published its final utility guidelines for biotechnology patents, culminating a successful 10-month effort by the industry to convince the PTO to treat biotech patents like other patents.

The guidelines instruct patent examiners to start with a presumption that utility claims are valid, and no longer require proof of human clinical efficacy before granting patents. The new guidelines fulfill a pledge that Patent Commissioner Bruce Lehman made last October, after listening to a list of biotech company grievances at a daylong hearing the PTO organized in San Diego (see BioCentury Oct. 24, 1994)...