Case Name: AstraZeneca LP v. Breath Ltd., Civ. No. 08-1512 (RMB/AMD), 2015 U.S. Dist. LEXIS 17687 (D.N.J. Feb. 13, 2015) (Bumb, J.).
Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation...more
Case Name: Spectrum Pharms., Inc. v. Sandoz Inc., 12-cv-111-GMN-NJK, 2015 U.S. Dist. LEXIS 22112 (D. Nev. Feb. 20, 2015) (Navarro, J.).
Drug Product and Patent-in-Suit: Fusilev® (levoleucovorin); U.S. Pat. No. 5,800,829...more
Case Name: Forest Labs., Inc. v. Amneal Pharms. LLC, Civ. No. 14-508-LPS, 2015 U.S. Dist. LEXIS 23215 (D. Del. Feb. 26, 2015) (Burke, M.J.).
Drug Product and Patent(s)-in-Suit: Namenda XR® (memantine hydrochloride); U.S....more
Case Name: Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., Civ. No. 11-6936 (FSH), 2015 U.S. Dist. LEXIS 26207 (D.N.J. Mar. 4, 2015) (Hochberg, J.).
Drug Product and Patent(s)-in-Suit: Atelvia® (risedronate /...more
Case Name: Ranbaxy Labs., Ltd. v. Burwell, 14-cv-1923 BAH, 2015 U.S. Dist. LEXIS 29459 (D.D.C. Mar. 11, 2015) (Howell, J.).
Drug Products and Patents-in-Suit: Nexium® (esomeprazole) and Valcyte® (valganciclovir);...more
Case Name: Eli Lilly & Co. v. Mylan Pharms., Inc., Civ. No. 14-cv-00389-SEB-TAB, 2015 U.S. Dist. LEXIS 30175 (S.D. Ind. Mar. 12, 2015) (Barker, J.).
Drug Product and Patents-in-Suit: Effient® (prasugrel hydrochloride);...more
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
Case Name: Otsuka Pharm. Co., Ltd. v. Mylan Inc., No. 14-4508 (JBS/KMW), 2015 U.S. Dist. LEXIS 35679 (D.N.J. Mar. 23, 2015) (Simandle, C.J.) .
Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); U.S. Patents...more
Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) ....more
Case Name: Senju Pharm. Co., Ltd. v. Lupin Ltd., 2013-1630, 2015 U.S. App. LEXIS 4541 (Fed. Cir. Mar. 20, 2015) (Circuit Judges Newman, Plager, and Moore presiding; Opinion by Plager, J.; Dissent by Newman, J.) (Appeal from...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: Apotex Inc. v. Daiichi Sankyo, Inc., 2014-1282, -1291 2015 U.S. App. LEXIS 5134 (Fed. Cir. Mar. 31, 2015) (Circuit Judges Taranto, Mayer, and Clevenger presiding; Opinion by Taranto, J.) (Appeal from N.D. Ill.,...more
Case Name: Teva Pharms USA, Inc. v. Sandoz, Inc., No. 10-13-854, 135 S. Ct. 831 (Mar. 20, 2012) (Breyer, J. delivered opinion of the Court, in which Roberts, C.J., and Scalia, Kennedy, Ginsburg, Sotomayor, and Kagan, JJ.,...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: The Medicines Co. v. Mylan Inc., Civ. No. 1:11-cv-1285, 2014 U.S. Dist. LEXIS 152433 (N.D. Ill. Oct. 27, 2014) (St. Eve, J.) (Generic drug manufacturer was liable for patent infringement as a matter of law when the...more
Case Name: Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp., Civ. No. 14-1268-SLR, 2014 U.S. Dist. LEXIS 155981 (D. Del. Nov. 4, 2014) (Robinson, J.) (Given statements made in the accused product’s proposed labeling,...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: 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: Par Pharm., Inc. v. TWI Pharms., Inc., No. 2014-1391, 2014 U.S. App. LEXIS 22737 (Fed. Cir. Dec. 3, 2014) (Circuit Judges O’Malley, Wallach, and Hughes presiding; Opinion by O’Malley, J.) (appeal from D. Md.,...more
Case Name: Sandoz Inc. v. Amgen Inc., No. 2014-1693, 2014 U.S. App. LEXIS 22903 (Fed. Cir. Dec. 5, 2014) (Circuit Judges Dyk, Taranto, and Chen presiding; Opinion by Taranto, J.) (appeal from N.D. Cal, Chesney, J.) (A...more
2/16/2015
/ Amgen ,
Biosimilars ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
Case Name: Mylan Pharms., Inc. v. FDA, Civ. Nos. 14-1522, 14-1529, 14-1593, 2014 U.S. App. LEXIS 24022 (4th Cir. Dec. 16, 2014) (Circuit Judges Wilkinson, Shedd, and Wynn presiding; Opinion by Wynn, J.) (Appeal from N.D....more
Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more