Statement of Administration Policy: H.R. 5536 - Agricultural Patent Reform

(House Rules)
(Boucher (D) Virginia and DeWine (R) Ohio)

The Administration would not object to House passage of H.R.5536 if it were amended to:

— apply to animal drugs and veterinary products and enable manufacturers of such substances to obtain Federal premarket approval to market generic versions of these drugs without having to duplicate studies required of pioneer manufacturers;

— eliminate the requirement that the patent term extension be reduced because of failure by the product sponsor to exercise due diligence during the regulatory review period;

— eliminate the provision allowing use or sale of a product for testing during the last two years of the pesticide patent by persons other than the owner; and

— eliminate the provision that prevents a patent owner from obtaining an extension for a new use of a patent if the product was the subject of a prior regulatory review process.