Examining the Senate and House versions of the "Greater Access to Affordable Pharmaceuticals Act": hearing before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, first session, August 1, 2003 |
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180-day exclusivity period 180-day period 30-month stay 45 days 45-day period Access to Affordable actual controversy Affordable Pharmaceuticals Act ANDA applicant appellate court applicant's ARMITAGE Article III Article III's blockbuster drug Boyden Gray brand companies brand-name company Chairman HATCH Committee competing generic companies Congress constitutional consumers controversy requirement Declaratory Judgment Act declaratory judgment action declaratory judgment provision delay double patenting drug application drug approval drug companies drug entry drug manufacturer drug product FDA approval FDA's Federal Circuit federal courts filed GOODWIN PROCTER GPhA Greater Access Hatch-Waxman Act House bill incentive infringement suit innovator issue John Yoo Judd Gregg Judiciary June 11 legislation litigation loophole NDA holder paragraph IV certification patent challenge patent holder patent information patent infringement patent is invalid patent listing patent owner prescription drugs reasonable apprehension Senate and House Senate bill Senate version subject matter jurisdiction submitted terminal disclaimer testimony treble damages trigger
Popular passages
Page 155 - 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 155 - 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 154 - In a case of actual controversy within its jurisdiction, except with respect to Federal taxes, any court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought. Any such declaration shall have the force and effect of a final judgment or decree and shall be reviewable as such.
Page 70 - 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 acting within its delegated power over the jurisdiction of the federal courts which the Congress is authorized to establish.
Page 124 - Drug Price Competition and Patent Term Restoration Act of 1984.
Page 155 - 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...
Page 130 - ... (II) that such patent has expired, (III) of the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted...
Page 87 - It calls, not for an advisory opinion upon a hypothetical basis, but for an adjudication of present right upon established facts.
Page 137 - NDA holder must have test data demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the NDA...
Page 137 - McClcllan announced a new regulation to be effective in 60 days that will streamline the process for making safe, effective generic drugs available to consumers. This rule was first proposed on October 24, 2002, in response, in part, to the FTC recommendations and other changes the Agency identified as being useful in improving generic competition. The new rule will limit an innovator drug company to only one 30-month stay of a generic drug applicant's entry into the market for resolution of a patent...