The lengthy approval process threatened three important P&G patents set to expire this year.
So in 1991, P&G sought special federal legislation to extend the terms of those patents for 10 years, starting on the date of FDA approval.
In arguments during congressional hearings, P&G contended approval was delayed because of the pioneering nature of review procedures and because there was no clear regulatory approval path at FDA.
But long-time competitor Unilever appeared at the hearings to allege P&G itself had caused the delay, citing lack of diligence and wrong marketing decisions.
After much lobbying by P&G, President Clinton in December signed legislation giving P&G temporary relief: It allowed two one-year extensions on one of the three patents. If olestra is approved within the extension period-that is, by 1996-P&G can request another two years of life for that patent.
P&G has additional patents related to olestra technology and processing that will provide some measure of proprietary protection for many years. But the three that were set to expire this year provided the company with complete protection of the olestra molecule.
"Even under the new statute, the intellectual property rights retained by the company are extraordinarily limited," says Peter Barton Hutt, the Washington attorney who has represented P&G. " ... This is clearly insufficient to induce any company to engage in this type of breakthrough food technology in the future."