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Last Updated: December 9, 2019

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Litigation Details for TEVA PHARMACEUTICALS USA, INC. v. LEAVITT (D.C. 2008)

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Small Molecule Drugs cited in TEVA PHARMACEUTICALS USA, INC. v. LEAVITT
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 , and   Start Trial .

Details for TEVA PHARMACEUTICALS USA, INC. v. LEAVITT (D.C. 2008)

Date Filed Document No. Description Snippet Link To Document
2008-03-04 1 Complaint listed two patents as claiming Risperdal® tablets: the ‘952 patent and U.S. Patent No. 4,804,663 (“the ‘663…listed two patents as claiming Risperdal® tablets; U.S. Patent No. 4:804,663 (“the ‘663 patent”), which …paragraph III certification) to U. S. Patent Number 4,804,663 (the ‘663 patent). We have carefully reviewed….S. Patent 4,804,663 with an expiration of December 29, 2007 remains Please find enclosed a patent certification…status with respect to that patent. Thus, under FDA's pre-MMA, patent~by~ patent approach to exclusivity External link to document
2008-03-11 13 Motion to Intervene 2008 Page 11 of 16 U.S. Patent No. 4,804,663 (“the ‘663 patent”) in connection with Janssen’s …listed two patents as claiming Risperdal® tablets: the ‘952 patent and U.S. Patent No. 4,804,663…paragraph IV certification” to U.S. Patent No. 5,158,952 (“the ‘952 patent”). FDA denied Teva’s petition for…instance—because the ‘952 patent had been removed from the Agency’s patent database at least one month…submission. As FDA acknowledged, only a patent included in the Agency’s patent database at the time of the applicant External link to document
2008-03-14 14 Memorandum in Opposition information to FDA on U.S. Patent Number 4,804,663 (“the ‘663 patent”) and the ‘952 patent for listing in the…Evaluations (Orange Book), therefore only U.S. Patent 4,804,663 with an expiration of December 29, 2007 remains…Evaluations (Orange Book), therefore only U.S. Patent 4,804,663 with an expiration of December…that Teva had submitted a patent certification for a patent (the ‘952 patent) that no longer claimed Risperdal…contained a patent certification only to the ‘663 patent (when, according to Teva, the ‘952 patent was still External link to document
2008-03-20 19 Answer to Complaint 2008 Page 10 of 15 U.S. Patent No. 4,804,663 (“the ‘663 patent”) in connection with Janssen’s …listed two patents as claiming Risperdal® tablets: the ‘952 patent and U.S. Patent No. 4,804,663… refusal to relist U.S. Patent No. 5,158,952 (“the ‘952 patent”) in the Agency’s official…the ‘952 patent, see 35 U.S.C. § 271(e); despite the fact that the ‘952 patent continued…the ‘952 patent from its ANDA. ANSWER: Mylan admits that FDA had delisted U.S. Patent No. 5,158,952 External link to document
2008-03-26 21 Memorandum in Opposition Book. These were U.S. Patent No. 4,444,784 (‘the 7‘ 84 patent), that claimed … of patent information included in the Patent and Exclusivity Data. (See id.) Thus, because patent delistings…: U.S. Patent No. 4,804,663 (“the ‘663 patent”). According to the Orange Book, the ‘663 patent expired…Years ago, Janssen submitted U.S. Patent No. 5,158,952 (“the ‘952 patent”) to FDA as covering Risperdal…subsequently listed that patent in its “Orange Book.” Later, Janssen realized that the ‘952 patent could not lawfully External link to document
2008-04-01 22 Reply to opposition to Motion U.S. Patent No. 4,886,808 ('808 patent); a section viii statement to a method-of-use patent, U.S.…the '714 patent as well as U.S . Patent 4,927,640 (the '640 patent) ; U.S . Patent 4,957,745 (the…(the '745 patent) ; U.S. Patent 5,001,161 (the '161 patent); and U.S. Patent 5,081,154 (the '… of the listed patents and/or that the listed patents were invalid. The listed patents at that time included…certification of the '15 4 patent, the '161 patent and the '745 patent for 100 mg and 200 mg metoprolol External link to document
2008-04-09 23 Notice (Other) U.S. Patent No. 5,158,952; declare the Teva's External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

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