Orrin Hatch: “With regard to my amendment, which is the text of the Judiciary Committee bill, the court would consider expenses…”

“With regard to my amendment, which is the text of the Judiciary Committee bill, the court would consider expenses related to the generic drug application and other activities, such as plant construction and equipment purchases, made specifically in connection with particular generic drugs. Our compromise would prevent applicants from gaming the system by precluding approval of applications submitted for products that come off-patent beyond 1998. Also, at the suggestion of Senator Biden, we have included language that would make clear that pioneer drug patents could receive both the restoration extension afforded by the Hatch-Waxman Act and any additional time received under the URAA. This is only fair, because these extensions derive from separate statutory sources. Mr. President, I have worked long and hard on this issue and have endeavored to find a reasonable middle ground which will accommodate the interest of all my colleagues. The Judiciary bill is a good compromise, and I urge my colleagues to support the amendment.”