Pipeline Drugs: Proposed Remedies for Relief in the Drug Patent Term Restoration Review Procedure Act of 1999: Hearing Before the Committee on the Judiciary, United States Senate, One Hundred Sixth Congress, First Session, on S. 1172 ... August 4, 1999

OCLC Number: (OCoLC)45788192 Subject: Drugs -- United States -- Patents. Excerpt: ...ble to Congress acting on an ad hoc case-by-case basis, which ... Show synopsis OCLC Number: (OCoLC)45788192 Subject: Drugs -- United States -- Patents. Excerpt: ...ble to Congress acting on an ad hoc case-by-case basis, which certainly has been the case over the last number of years.Under the bill, only pipeline drugs that were involved in an FDA review process that took more than 60 months would be eligible for review. There is no doubt that the protections afforded a patent holder were significantly reduced and this delay may have been due to circumstances that were beyond the control of the applicant.On the other hand, critics of S. 1172 will argue that this legislation is unwarranted because the resulting additional period of exclusivity will result in additional costs to consumers. Opponents have suggested that inequities of the past should be given little consideration and that as a matter of public policy Congress' constitutional responsibility to promote the progress of science should be prospective in approach. Our focus, they argue, should be given exclusively to advancing policies which rely on innovation to replace products whose patents have expired.Finally, critics argue that S. 1172 creates a procedure for granting partial patent restoration through an entity, the Patent and Trademark Office, that may inherently favor a patentholder. There is some question about whether the PTO is the appropriate forum to make decisions relating to the details of an agency review.As we examine this important issue, I hope we can examine some of the following questions. Is legislation of this sort in the interest of the American public? Many believe that it is, and they may be right. Was the type of delay suffered by these drug manufacturers one that warrants legislative action, and will such action benefit others? What impact will S. 1172 have on the generic drug industry? Should the committee only be reviewing administrative delays affecting pipeline drugs, or is it a much broader problem wh... Hide synopsis