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FTC v. Cephalon, Inc.

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

10/28/2014 - Antitrust Litigation Cephalon Collateral Estoppel Fraudulent Procurement FTC Generic Patent Infringement Patent Litigation Patents Settlement

Takeda Pharm. Co., Ltd. v. Mylan Inc.

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

10/27/2014 - ANDA Generic Drugs Hatch-Waxman Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs Takeda Pharmaceuticals

Depomed, Inc. v. Actavis Elizabeth LLC

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

10/24/2014 - Actavis Generic Drugs Hatch-Waxman Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

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

10/23/2014 - ANDA Fresenius Generic Drugs Hatch-Waxman Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

United Therapeutics Corp. v. Sandoz, Inc.

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

10/22/2014 - ANDA Induced Infringement Patent Infringement Patent-in-Suit Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz

Novartis Pharms. Corp. v. Par Pharm., Inc.

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

10/21/2014 - Novartis Patent-in-Suit Patents Pharmaceutical Manufacturers Pharmaceutical Patents

Hospira, Inc. v. Burwell

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

10/20/2014 - ANDA FDA Generic Drugs Hatch-Waxman Pharmaceutical Pharmaceutical Patents Prescription Drugs

Apotex Inc. v. UCB, Inc.

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

10/17/2014 - ANDA Generic Drugs Hatch-Waxman Patent Infringement Patent Litigation Patents Prescription Drugs

Ferring B.V. v. Watson Labs., Inc.—Florida II

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

10/16/2014 - Patent Infringement Patent Litigation Patents Pharmaceutical Patents Watson Pharmaceuticals

Ferring B.V. v. Watson Labs., Inc.—Florida (I)

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

10/15/2014 - ANDA Patent Infringement Patent Litigation Patents Prescription Drugs

Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC (D.N.J.)

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

8/13/2014 - ANDA Non-Disclosure Agreement Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs Purdue Pharma Restrictive Covenants

United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/9/14)

This matter arises from a motion for summary judgment by Sandoz alleging that the ’117 patent is invalid since it was previously disclosed in the prior art U.S. Patent No. 4,668,814 (“the ’814 patent”). More specifically,...more

8/12/2014 - Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents

United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/16/14)

The ’007 patent covers pharmaceutical preparations in which treprostinil or treprostinil sodium is diluted with a high pH glycine buffer, and the methods of using those preparations in order to facilitate safer intravenous...more

8/11/2014 - Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

FTC v. Actavis, Inc. (In re Androgel Antitrust Litigation (II) (N.D. Ga.)

In FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013), the Supreme Court reversed and remanded to the district court to apply a rule of reason analysis to defendants’ reverse payment settlement. On remand, defendants Solvay and...more

8/8/2014 - Actavis Inc. FTC FTC v Actavis Noerr-Pennington Doctrine Reverse Payment Settlement Agreements SCOTUS

Avanir Pharms., Inc. v. Actavis South Atlantic LLC (D. Del.)

The ’115 patent relates to formulations containing dextromethorphan and quinidine for the treatment of chronic or intractable pain. The ’282 and ’484 patents relate to the use of dextromethorphan and quinidine for the...more

8/7/2014 - Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

Reckitt Benckiser Pharms., Inc. v. Biodelivery Services Ltd. (E.D.N.C.)

The issues presented were whether defendant’s actions were sufficient to support declaratory judgment jurisdiction and whether defendant’s conduct supports a claim for patent infringement under 35 U.S.C. §...more

8/6/2014 - Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents

Prometheus Labs., Inc. v. Roxane Labs., Inc. (D.N.J.)

Lotronex was initially launched in 2000, but was subsequently removed from the market in light of serious side effects attributed to the drug. It was re-launched in 2002 with a new label. At the time, the ’770 patent was...more

8/5/2014 - ANDA FDA Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs Prometheus

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

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

8/4/2014 - ANDA FDA Hatch-Waxman Marketing Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Preliminary Injunctions

Novartis Pharms. Corp. v. Par Pharm., Inc. (D. Del.)

Nature of the Case and Issue(s) Presented: Novartis sued Watson and Par alleging infringement of the patents-in-suit. Both patents share the same specification. The ’031 and ’023 patents claim pharmaceutical compositions,...more

8/1/2014 - Novartis Patent Infringement Patent Litigation Patents Pharmaceutical Patents

Shire LLC v. Amneal Pharms., LLC (D.N.J.)

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

7/31/2014 - ANDA Obviousness Patent Infringement Patent Litigation Patent-in-Suit Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

Hoffmann-La Roche Inc. v. Apotex Inc. (Fed. Cir.)

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

7/30/2014 - Appeals Hoffman LaRoche Patent Litigation Patent-in-Suit Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms. Inc. (Fed. Cir.)

Case Name: Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms Inc., 748 F.3d 1354 (Fed. Cir. Apr. 21, 2014) (Circuit Judges Newman, Linn and Wallach presiding; Opinion by Newman) (Appeal from D.N.J., Cavanaugh,...more

7/29/2014 - Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Braintree Labs., Inc. v. Novel Labs., Inc. (Fed. Cir.)

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

7/28/2014 - ANDA Patent Litigation Patent-in-Suit Patents Pharmaceutical Pharmaceutical Patents

Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir.)

Case Name: Gilead Sciences, Inc. v. Natco Pharma Ltd., 2013-1418, 2014 U.S. App. LEXIS 7494 (Fed. Cir. Apr. 22, 2014) (Circuit Judges Rader, Prost, and Chen presiding; Opinion by Chen, J.; Dissent by Rader, C.J.) (appeal from...more

7/25/2014 - Gilead Sciences Natco Pharma Patent Infringement Patent Litigation Patents

Allergan, Inc. v. Apotex, Inc. (Fed. Cir.)

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

7/24/2014 - Allergan Inc Obviousness Patent Infringement Patent Litigation Patent-in-Suit Patents Pharmaceutical Pharmaceutical Patents Prior Art

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