US planning to cut back generic patent challenges
The US government wants to limit pharmaceutical manufacturers to a one-month window in which to challenge a generic patent. Washington says multiple, consecutive patent challenges have been costing America billions of dollars in drugs costs.
The US government wants to limit pharmaceutical manufacturers to a one-month window in which to challenge a generic patent. Washington says multiple, consecutive patent challenges have been costing America billions of dollars in drugs costs.
The Bush administration estimates that its planned regulatory changes will save consumers an estimated US$35bn (€30.5bn) over 10 years.
The US FDA will also be hiring 40 experts in its generic drugs programme to review generic drugs applications more quickly and initiate targeted research to expand the range of those drugs available to consumers. 'The increased availability of lower-cost generic drugs will benefit all Americans, especially seniors,' said Health and Human Service Secretary Thompson.
The Pharmaceutical Research and Manufacturers of America association is opposing the proposal. Testifying before the US Senate judiciary committee, senior vice president Bruce N. Kuhlik said: 'Better treatments and new cures can come only from pharmaceutical research companies, and only if patent incentives are maintained.'