Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore,...more
7/23/2015
/ Generic Drugs ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Teva Pharmaceuticals ,
Teva v Sandoz ,
Vacated
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: 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
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: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...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
Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...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