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Last Updated: December 14, 2019

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Litigation Details for APOTEX INC. v. FOOD AND DRUG ADMINISTRATION (D.C. 2006)

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Small Molecule Drugs cited in APOTEX INC. v. FOOD AND DRUG ADMINISTRATION
The small molecule drugs covered by the patents cited in this case are   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial ,   Start Trial , and   Start Trial .

Details for APOTEX INC. v. FOOD AND DRUG ADMINISTRATION (D.C. 2006)

Date Filed Document No. Description Snippet Link To Document
2006-11-06 1 Complaint including: U.S. Patent No. 4,695,578 (“the ‘578 patent”), which has expired; U.S. Patent No. 5,578,628 …Book-listed patent for the NDA drug: (l) that there is no patent information; (II) that the listed patent has …5,578,628 (“the ‘628 patent), which has expired; U.S. Patent No. 4,753,789 (“the ‘789 patent), which has expired…the listed patent, a so-called “paragraph III certification”; or (IV) that the listed patent is invalid… any ANDA applicant in any patent infringement case involving the patent-at-issue. Thus, the first generic External link to document
2006-11-17 12 relevant patents in the Orange Book with respect to its drug; U.S. Patent Nos, 4,346,227 ("the…relevant patents in the Orange Book with respect to its drug: U.S. Patent i+los. 4;346,227 ("…`658 patent, and alleging that the ` 658 patent is not infringed and/or that the patent is invalid… the `658 patent, and alleging that the `658 patent is not infringed and/or that the patent is invalid….S. Patent NV. Patent -r J ("the '658 patent"), entitled External link to document
2006-11-17 13 Memorandum in Opposition on any patent that claims the drug or a method of using the drug and for which a claim of patent infringement… to such patent has not been filed; (II) that such patent has expired; …that such patent will expire on a particular date; or (IV) that such patent is invalid…has not been filed with FDA or the patent has expired, then the patent, by itself, will not delay approval… applicable patent has expired, and FDA will not approve the ANDA until after the patent has expired. External link to document
2006-11-17 14 Memorandum in Opposition them, U.S. Patents Nos. 4,695,578, 5,578,628, and 4,753,789 (the ‘578, ‘628 and ‘789 patents, respectively…Book process patent, the ‘720 patent. By instituting suit on the ‘578, ‘628 and ‘789 patents, GSK received…infringe the ‘658 patent because it avoided the particle size limitations of the patent. DRL anticipates…are now expired. The last, U.S. Patent No. 5,344,658 (the ‘658 patent), expires on September 6, 2011 (…mg and 24 mg strengths. The ‘658 patent is, however, the only patent relevant for 180-day marketing exclusivity External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

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