Case Name: Novartis Pharms. Corp. v. Mylan Inc., Civ. No. 14-777-RGA, 2015 U.S. Dist. LEXIS 31812 (D. Del. March 16, 2015) (Andrews, J.).
Drug Product and Patent(s)-in-Suit: Exelon Patch (rivastigmine); U.S. Patents...more
Case Name: Takeda Pharm. Co., Ltd. v. TWi Pharms., Inc., Civ. No. 13-CV-02420-LHK, 2015 U.S. Dist. LEXIS 32948 (N.D. Cal. Mar. 17, 2015) (Koh, J.).
Drug Product and Patent(s)-in-Suit: Dexilant® (dexlansoprazole); U.S....more
Cadence Pharms., Inc. v. Exela PharmSci Inc.
Case Name: Cadence Pharms., Inc. v. Exela PharmSci Inc., 2014-1184, 2015 U.S. App LEXIS 4700 (Fed. Cir. Mar. 23, 2015) (Circuit Judges Reyna, Linn, and Wallach presiding;...more
Case Name: Civ. No. 3:14-cv-422-HEH, 2014 U.S. Dist. LEXIS 146528 (E.D. Va. Oct. 14, 2014) (Hudson, J.) (Where patent holder disclaims patent and asks FDA to delist, but patent remains in Orange Book, declaratory judgment...more
Case Name: Pfizer Inc. v. Mylan Pharms. Inc., Civ. No. 10-528-GMS, 2014 U.S. Dist. LEXIS 150283 (D. Del. Oct. 22, 2014) (Sleet, J.) (When a POSA would have to undertake significant guesswork to vary the parameters of...more
Case Name: Cubist Pharms., Inc. v. Hospira, Inc., No. 12-367-GMS, 2014 U.S. Dist. LEXIS 169679 (D. Del. Dec. 8, 2014) (Sleet, J.) (Valid certificate of correction results in finding of infringement and validity; remaining...more
Case Name: Allergan, Inc. v. Actavis, Inc., Nos. 14-cv-638, 14-cv-188, 2014 U.S. Dist. LEXIS 176551 (E.D. Tex. Dec. 23, 2014) (Gilstrap, J.) (Only an ANDA “received” by the FDA can form the basis for a patent infringement...more
Case Name: Spectrum Pharms., Inc. v. Sandoz Inc., No. 2:12-cv-111-GMN-NJK, 2014 U.S. Dist. LEXIS 179755 (D. Nev. Dec. 29, 2014) (Navarro, J.) (Because the ANDA product did not meet the claimed dosage strength,...more
Case Name: Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 769 F.3d 1339 (Fed. Cir. Oct. 20, 2014) (Chief Judge Prost, Circuit Judges Newman, Plager, Lourie, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, and...more
Case Name: Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc., Nos. 2014-1439, 2014-1441, 2014-1444, 2014-1445, 2014-1446, 2014 U.S. App. LEXIS 21946 (Fed. Cir. Nov. 18, 2014) (Circuit Judges Lourie, Reyna and Taranto...more
Nature of the Case and Issue(s) Presented: UTC claimed that Sandoz induced infringement of the ’007 patent by instructing physicians to dilute its product for use intravenously. The asserted claim required a particular...more
Nature of the Case and Issue(s) Presented: The one asserted claim in the ’031 patent, claim 7, depends from non-asserted independent claim 1. Claim 7 narrows claim 1 by limiting it to a specific delivery method and requires...more
The defendants include generic ANDA applicants (the “generic defendants”) and the API manufacturer, Johnson Matthey, Inc. and Johnson Matthey Pharmaceutical Materials (collectively “JM”). Six summary judgment motions were...more
Hoffman-La Roche (“Roche”) appeals from the decision of the district court granting defendants summary judgment of invalidity as to claims 1-8 of the ’634 patent and claims 1-10 of the ’957 patent. The asserted claims...more
Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir. Apr. 22, 2014) (Circuit Judges Dyk, Prost, and Moore presiding; Opinion by Prost, J.; Concurrence-in-part and Dissent by Dyk, J.; Dissent by...more
Case Name: Allergan, Inc. v. Apotex, Inc., No. 2013-1245, -1246, -1247, 2014 U.S. App. LEXIS 10710 (Fed. Cir. June 10, 2014) (Circuit Judges Prost, Reyna and Chen presiding; Opinion by Prost, C.J.; Dissent-in-part by Chen,...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more
4/1/2014
/ Abbreviated New Drug Application (ANDA) ,
Burden of Proof ,
Claim Construction ,
Claim Preclusion ,
Eli Lilly ,
Federal Rule 12(b)(6) ,
Food and Drug Administration (FDA) ,
GlaxoSmithKline ,
Hatch-Waxman ,
Inter Partes Reexamination ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Settlement ,
Subject Matter Jurisdiction ,
Written Descriptions