Compilation of Selected Acts Within The Jurisdiction of The Committee on Energy and Commerce, March 2005, 109-1 Committee Print 109-A, *2005 |
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Page 127
... patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could ...
... patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could ...
Page 127
... patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could ...
... patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could ...
Page 128
... patent information has not been filed , ( 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 ...
... patent information has not been filed , ( 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 ...
Page 129
drug before the expiration of the patent referred to in the certification ; and ( ii ) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed . ( 4 ) ...
drug before the expiration of the patent referred to in the certification ; and ( ii ) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed . ( 4 ) ...
Page 130
... patent num- ber and the expiration date of any patent which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent in- fringement could reasonably ...
... patent num- ber and the expiration date of any patent which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent in- fringement could reasonably ...
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Common terms and phrases
action active ingredient amendment animal drug application animal feed appropriate approved new animal Attorney authorized bioequivalence cation certification classification clause clause iv clinical containing controlled substance court described dispensing distribution dosage form drug or device drug product ecgonine electronic product enactment established exemption expiration Federal Food Federal Register filed fiscal Food and Drug graph Health Service Act infant formula investigational issued labeling licensed listed chemical listed drug manufacturer ment notice notification panel paragraph patent period person pesticide petition phenylpropanolamine premarket prescribed proposed pseudoephedrine Public Law purposes referred registration regulation request respect retary route of administration safety and effectiveness safety or effectiveness schedule III Secretary determines Secretary finds section 351 sentence specified spect standard subchapter subclause submitted subparagraph substance in schedule supplement term of imprisonment tion United States Code United States Pharmacopoeia unless violation