Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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Cubist Pharmaceuticals, Inc. v. Hospira Inc. (Fed. Cir. 2015)

Mistakes happen; there is even a book, entitled Human Error, that discusses how and why they happen. The Federal Circuit addressed the consequences of human error (or perhaps more accurately, instances where there was a...more

12/30/2015 - ANDA Claim Construction Eli Lilly Hospira Patent Infringement Patent Invalidity Reissue Patents Written Descriptions

Prometheus Labs., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2015)

The Federal Circuit affirmed a judgment of invalidity based on obviousness in a decision rendered in Prometheus v Roxane. In doing so, the Court might also have given an indication of the types of claims for "personalized...more

11/13/2015 - ANDA Obviousness Patent Infringement Patent Invalidity Patent Litigation Personalized Medicine Prometheus Roxane Laboratories

Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)

Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more

10/15/2015 - ANDA De Novo Standard of Review Doctrine of Equivalents Estoppel FDA Approval Generic Drugs Obviousness Orange Book Patent Infringement Patent Invalidity Patent Litigation Patents Pharmaceutical Patents Prescription Drugs Prior Art Sandoz

The Medicines Company v. Hospira (Fed. Cir. 2015)

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

7/15/2015 - ANDA Appeals FDA FDA Approval Generic Drugs On-Sale Bar Patent Infringement Patent Invalidity Patent Litigation Patent Term Extensions Patents Pharmaceutical Industry Pharmaceutical Patents Reversal USPTO

King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp. (3rd Cir. 2015)

Ever since the Supreme Court's decision in FTC v. Actavis in 2013, courts (predominantly district courts) have grappled with the scope of the decision. It was evident that the presence of a large cash payment from the...more

7/1/2015 - Actavis Inc. ANDA FTC FTC v Actavis Generic Drugs Pharmaceutical Industry Prescription Drugs Reverse Payment Settlement Agreements Rule-of-Reason Analysis SmithKline Beecham

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)

Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more

6/25/2015 - ANDA Generic Drugs Infringement Obviousness Patent Infringement Patent Invalidity Patent Litigation Patents Pfizer Pharmaceutical Industry Pharmaceutical Patents Prescription Drugs

Senate Judiciary Committee Passes PATENT Act

The Senate Judiciary Committee passed the Protecting American Talent and Entrepreneurship Act (S. 1137, otherwise known as the PATENT Act) yesterday on a vote of 12-4, with Senators Grassley (R-IA), Hatch (R-UT), Sessions...more

6/5/2015 - ANDA Innovation Act PATENT Act Patent Reform Patents Pharmaceutical Industry Startups

AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

4/17/2015 - ANDA Apotex AstraZeneca Exclusivity Patent Litigation Patents Pharmaceutical Industry Royalties

InSite Vision Inc. v. Sandoz, Inc. (Fed. Cir. 2015)

The Federal Circuit showed once again the importance of a district court's factual findings (and the deference the appellate court gives those findings, particularly when supported by expert testimony), in InSite Vision Inc....more

4/15/2015 - ANDA Generic Drugs Obviousness Orange Book Patent Litigation Patents Pharmaceutical Patents Sandoz

Exela Pharma Sciences LLC v. Lee (Fed. Cir. 2015)

Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences...more

4/9/2015 - ANDA Cadence Pharmaceuticals Inc. Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents

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

Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. (Fed. Cir. 2014)

That it is more difficult today to be a patentee able to defend her patent rights than any time since the 1940's is nicely illustrated by the Federal Circuit's decision in Par Pharmaceutical, Inc. v. TWI Pharmaceuticals,...more

12/4/2014 - ANDA Par Pharmaceutical Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

11/6/2014 - ANDA FDA Generic Drugs Information Reports Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents

In re Lipitor Antitrust Litigation (D.N.J. 2014)

In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust...more

9/25/2014 - ANDA Antitrust Investigations Antitrust Provisions Class Action Complex Litigation Generic Drugs Motion to Dismiss Patent Litigation Patents Pfizer Pharmaceutical Industry Pharmaceutical Patents Settlement Sherman Act

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

In the second of a pair of decisions issued last Friday, styled Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that the generic ANDA challenger had not shown the...more

9/2/2014 - ANDA Patent Infringement Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents

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 Industry Pharmaceutical Patents

Braintree Laboratories, Inc. v. Novel Laboratories, Inc. (Fed. Cir. 2014) - Whither the Meaning of "a" as a Claim Term

Every once in a while a Federal Circuit panel construes a common claim term contrary to how it has been construed in prior precedent, usually based on the particular situation or circumstance the Court is addressing and...more

6/13/2014 - ANDA Claim Construction Generic Patent Infringement Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents

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 Industry Prescription Drugs

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for...more

9/17/2013 - ANDA Biopharmaceutical Patent Litigation Patents Pharmaceutical Industry

The FTC Is at It Again

In a move that will surprise almost no one (except perhaps members of the Supreme Court majority in FTC v. Actavis), the Federal Trade Commission has filed an amicus curiae brief with the District Court of New Jersey in In re...more

8/23/2013 - ANDA Antitrust Litigation FTC FTC v Actavis SCOTUS

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 FTC FTC v Actavis Generic Drugs Pharmaceutical Industry Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Supreme Court Denies Certiorari in Momenta Case

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

6/26/2013 - ANDA Certiorari FDA Infringement Patents Pharmaceutical Industry Preliminary Injunctions Prescription Drugs Safe Harbors SCOTUS Split of Authority

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 Industry 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 Industry Reverse Payment Settlement Agreements SCOTUS Watson Pharmaceuticals

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