Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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Latest Posts › Hatch-Waxman


Supreme Court Again Refuses to Clarify Scope of Hatch-Waxman Safe Harbor

The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...more

10/4/2016 - Certiorari FDA Hatch-Waxman Patent Infringement Patents Pharmaceutical Industry Safe Harbors Teva Pharmaceuticals

FTC Issues Report on ANDA Settlement Agreements

In January, the Federal Trade Commission issued a report on the terms of settlement agreements between branded and generic drug companies in ANDA litigation under the Hatch-Waxman Act, according to the provisions of the...more

3/1/2016 - ANDA Antitrust Litigation FTC FTC v Actavis Generic Drugs Hatch-Waxman Pay-For-Delay Pharmaceutical Industry Reverse Payment Settlement Agreements

Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. (Fed. Cir. 2015)

The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by...more

11/30/2015 - Biogen Idec Classen Immunotherapies Generic Drugs Hatch-Waxman Patent Infringement Patent Litigation Safe Harbors Teva Pharmaceuticals

Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. (Fed. Cir. 2015)

Senju PharmaceuticalEarlier this month, the Federal Circuit affirmed a District Court judgment of obviousness in ANDA litigation under the Hatch Waxman Act having a long provenance of earlier litigation, in Senju...more

4/1/2015 - ANDA Hatch-Waxman Patent Litigation Patents Pharmaceutical Patents

The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

2/26/2015 - America Invents Act Hatch-Waxman Hedge Funds Inter Partes Review Proceedings Market Manipulation Patent Trial and Appeal Board Patents Pharmaceutical Industry Pharmaceutical Patents Prescription Drugs Price Manipulation Standing

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

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 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 Industry Presumption of Validity Reversal Reverse Payment Settlement Agreements Standard of Proof

Supreme Court to Review Reverse Payment Settlement Agreements

The Supreme Court granted certiorari Friday in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment settlement agreements in ANDA...more

12/10/2012 - FTC Hatch-Waxman Patents Pharmaceutical Industry Reverse Payment Settlement Agreements Watson Pharmaceuticals

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