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Federal Trade Commission "Meets the Press"

Federal Trade Commission Chairwoman Edith Ramirez and Debbie Feinstein, Director of the Commission's Bureau of Competition, held a thirty-minute press conference on Monday to discuss the latest foray in the Commission's...more

9/10/2014 - AbbVie Federal Trade Commission Act FTC FTC v Actavis Generic Drugs Media Pharmaceutical Pharmaceutical Manufacturers SCOTUS Teva Pharmaceuticals

Ferring B.V. v. Watson Laboratories, Inc. (I) (Fed. Cir. 2014)

In the first of a pair of decisions issued last Friday, Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that a generic company could moot ANDA litigation by amending its...more

8/29/2014 - ANDA Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

Shire Development, LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2014)

Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...more

4/10/2014 - Claim Construction Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

4/9/2014 - ANDA FTC v Actavis Generic Drugs Patent Litigation Patents Pharmaceutical Prescription Drugs

AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the...more

12/31/2013 - AstraZeneca Drug Manufacturers Generic Generic Drugs Nexium Patent Infringement Patents Pharmaceutical Prescription Drugs Prilosec

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

7/19/2013 - ANDA Drug Manufacturers FTC FTC v Actavis Generic Drugs Pharmaceutical Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Mutual Pharmaceutical Co. v. Bartlett (2013)

The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...more

6/28/2013 - FDA FDCA Generic Drugs Hatch-Waxman Mutual Pharmaceuticals v Bartlett Patents Prescription Drugs SCOTUS

U.S. Supreme Court Rules That “Reverse Payment” Settlements in ANDA Litigation Are Not Presumptively Unlawful But Must Be Assessed...

The Supreme Court ruled 5-3 on June 17, 2013 in favor of the Federal Trade Commission in FTC v. Actavis. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer’s opinion...more

6/19/2013 - Actavis Inc. ANDA FTC FTC v Actavis Generic Drugs Patents Pay-For-Delay Pharmaceutical Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Federal Trade Commission v. Actavis, Inc. (2013)

The Supreme Court ruled 5-3 today in favor of the Federal Trade Commission in FTC v. Actavis, Inc. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer's opinion reversed the...more

6/18/2013 - Actavis Inc. ANDA FTC FTC v Actavis Generic Drugs Patents Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Supreme Court Oral Argument in FTC v. Actavis

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

4/2/2013 - ANDA Competition FDA FTC v Actavis Generic Drugs Manufacturers Patents Pharmaceutical Reverse Payment Settlement Agreements SCOTUS Watson Pharmaceuticals

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

3/15/2013 - ANDA Drug Manufacturers FDA Generic Drugs Patents Proposed Legislation Reverse Payment Settlement Agreements

Par/Paddock Answers FTC Before Supreme Court

Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more

2/28/2013 - Actavis Inc. ANDA Anti-Competitive FTC Generic Drugs Hatch-Waxman Par/Paddock Patents Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

2/15/2013 - ANDA Cephalon Clear and Convincing Evidence Expert Testimony Generic Drugs Hatch-Waxman Infringement Patents Pharmaceutical Presumption of Validity Reversal Reverse Payment Settlement Agreements Standard of Proof

FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation

As it has frequently in the past decade, the Federal Trade Commission on Thursday released a Report on the frequency of reverse payment settlement agreements in ANDA litigation between generic and branded drug makers,...more

1/18/2013 - ANDA Drug Manufacturers FTC Generic Drugs Medicare Medicare Modernization Act Pharmaceutical Reverse Payment Settlement Agreements Reverse Payments

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