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Last Updated: April 18, 2024

Litigation Details for Hospira, Inc. v. Burwell (D. Maryland 2014)


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Small Molecule Drugs cited in Hospira, Inc. v. Burwell
The small molecule drug covered by the patent cited in this case is ⤷  Try a Trial .

Details for Hospira, Inc. v. Burwell (D. Maryland 2014)

Date Filed Document No. Description Snippet Link To Document
2014-08-19 1 licensee of U.S. Patent No. 6,716,867 (“the ’867 patent”), a method-of-use patent containing two independent…submit information about patents that cover the subject drug, including the patents’ expiration dates and…ANDA into the market raises patent issues if the NDA holder claims patent protection for the drug substance…no legal authority to interpret patent claims or to adjudicate patent disputes. To the contrary, as FDA…certifications with respect to each patent listed in the Orange Book: (i) patent information has not been submitted External link to document
2014-09-04 116 statement for Orange Book listed U.S. Patent No. 6,716,867 (“the ’867 patent”), “carving out” the original use…Orange Book patents for its Precedex product, U.S. Patent Nos. 4,910,214 (“the ’214 patent”) and the ’…expiration of the ’214 patent. (Pera Decl. at 11 4.)2 Par took the ’867 patent out of play by submitting… ’867 patent. Par certified under Paragraph III that it Would not market its product until the expiration…expiration of the ’214 patent, which expired on January 15 , 2014. Par reasonably expected to obtain FDA approval External link to document
2014-09-05 122 several patents covering Precedex®. Today, only a method-of-use patent remains: U.S. Patent No. 6,…The ‘840 patent, however, expired on September 6, 2011. Thus, the ’867 patent is the only patent at issue…Orange Book patents for its Precedex® product, U.S. Patent Nos. 4,910,214 (“the ʼ214 patent”) and the …information about the patents protecting the pioneer drug, including “the patent number and the expiration… that the required patent information has not been filed; (II) that the patent has expired; (III) External link to document
2014-08-19 19 . Plaintiff owns U.S. Patent No. 6,716,867 (“the ‘867 Patent”). The ‘867 Patent gives Plaintiff exclusive…certifications with respect to each patent listed in the Orange Book2: (i) patent information has not been submitted…before the date the patent expires; or (iv) the brand’s patent is invalid, unenforceable, or will not be…notice to the holder of the patent. Id. at 6. Following notice, the patent holder then has a 45-day period…in which to bring an action for patent infringement. Id. If a patent infringement action is brought, External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

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