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: 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: 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: 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: 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
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 in this case is not whether the validity of the ’516 patent should be litigated in the antitrust trial, but rather, how the court’s previous finding of invalidity and...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
Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more
Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...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
Nature of the Case and Issue(s) Presented: Apotex appealed the district court’s finding that the ’556 patent was unenforceable due to inequitable conduct. The ’556 patent describes a method for making moexipril tablets used...more
Nature of the Case and Issue(s) Presented: The patents-in-suit claim oral dosage forms and method of treating menorrhagia and require three elements: (i) about 650 mg of tranexamic acid; (ii) a so-called modified release...more
Nature of the Case and Issue(s) Presented: The issue of infringement in this case relates entirely to dissolution rates. Apotex sought to market its generic product by designing around Ferring’s Lysteda. In its 2010 ANDA,...more
Plaintiffs hold an NDA covering tablets containing two strengths of zolpidem tartrate, which is used in the treatment of middle-of-the-night insomnia. In July 2013, TWi Pharms., Inc. (“TWi”) submitted an ANDA containing a...more