Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical Marketplace: Hearing Before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, First Session, June 17, 2003
U.S. Government Printing Office, 2003 - Competition - 116 pages
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180-day exclusivity 30-month stay abuses action additional Administration affordable agency agreements alleged allow Amendments American ANDA antitrust applicant believe bill billion brand brand name brand-name company bring Bristol-Myers Chairman Hatch challenge claim Committee competition concerns conduct Congress consumers continue controversy costs court decision Declaratory Judgment delay discussed drug application drug manufacturers drug product effective enforcement ensure enter entry exclusivity FDA approval FDA's Federal Trade Commission filed FTC Study going Hatch-Waxman hearing holder improper incentive increase innovator invalid involved issue lawsuit legislation limit litigation medicines months Orange Book paragraph IV certification passed patent expiration patent infringement patent listing percent period pharmaceutical potential prescription drugs prior proposed protection provision question raised recommendations regarding regulations rule Senate settlements statement submitted suit Thank trigger Troy
Page 34 - The controversy must be definite and concrete, touching the legal relations of parties having adverse legal interests. ... It must be a real and substantial controversy admitting of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.
Page 46 - IV certification begins a process, in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts prior to the expiration of the patent. The ANDA applicant who files a paragraph IV certification to a listed patent must notify the patent owner and the NDA holder for the listed drug that it has filed an ANDA containing a patent challenge. The notice must include a detailed statement of the factual and legal basis for the...
Page 45 - Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the HatchWaxman Amendments and recent Congressional action on amendments to Hatch- Waxman.
Page 34 - A justiciable controversy is thus distinguished from a difference or dispute of a hypothetical or abstract character; from one that is academic or moot.
Page 17 - Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed; Proposed Rule, 67 Fed.
Page 38 - Consumers Union is a nonprofit membership organization chartered in 1936 under the laws of the State of New York to provide consumers with information, education and counsel about goods, services, health, and personal finance; and to initiate and cooperate with individual and group efforts to maintain and enhance the quality of life for consumers. Consumers Union's income is solely derived from the sale of Consumer Reports, its other publications and from noncommercial contributions, grants and fees....
Page 46 - This certification must state one of the following: (I) that the required patent information relating to such patent has not been filed; (II) that such patent has expired; (III) that the patent will expire on a particular date; or (IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought.
Page 34 - Where there is such a concrete case admitting of an immediate and definitive determination of the legal rights of the parties in an adversary proceeding upon the facts alleged, the judicial function may be appropriately exercised although the adjudication of the rights of the litigants may not require the award of process or the payment of damages.
Page 26 - GPHA represents manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry.
Page 34 - The Declaratory Judgment Act of 1934, in its limitation to "cases of actual controversy," manifestly has regard to the constitutional provision and is operative only in respect to controversies which are such in the constitutional sense. The word "actual" is one of emphasis rather than of definition. Thus the operation of the Declaratory Judgment Act is procedural only. In providing remedies and defining procedure in relation to cases and controversies in the constitutional sense the Congress is...