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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

Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc.

Nature of the Case and Issue(s) Presented: BMS owns the ’244 patent, which covers a nucleoside analogue composed of two regions: a carbocyclic ring and a guanine base. Nucleoside analogues are known to mimic the activity of...more

7/23/2014 - Bristol-Myers Squibb Patent Infringement Patent Litigation Patents Teva Pharmaceuticals

Clones Not Patent-Eligible?

Thanks to recent advances in cloning technology, treating degenerative diseases with replacement tissue that matches a patient’s genetic makeup exactly is no longer science fiction. Just last month, for example, two research...more

5/9/2014 - DNA Medical Research Myriad Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents Stem cells USPTO

GENERICally Speaking - Vol. 4, No. 1

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 - ANDA Burden of Proof Claim Construction Claim Preclusion Eli Lilly FDA Federal Rule 12(b)(6) GlaxoSmithKline Hatch-Waxman Inter Partes Reexamination Obviousness Patent Infringement Patent Litigation Patent-in-Suit Patents Pfizer Pharmaceutical Pharmaceutical Patents Prior Art Settlement Subject Matter Jurisdiction Written Descriptions

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