Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

10/19/2016 - Allergan Inc ANDA Inter Partes Review (IPR) Proceeding Obviousness Patent Invalidity Patent Litigation Patent Trial and Appeal Board Patents Pharmaceutical Industry Pharmaceutical Patents Public Interest Qui Tam USPTO

Hartig Drug Co. v. Senju Pharmaceutical Co. (3rd Cir. 2016)

Perhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure. Particularly when the professor is bold enough to engage students on the intricacies...more

9/8/2016 - Allergan Inc ANDA Article III Federal Rule 12(b)(1) Federal Rules of Civil Procedure Patent-Eligible Subject Matter Patents Pharmaceutical Industry Sherman Act Standing

The Medicines Company v. Hospira, Inc. (Fed. Cir. 2016) (en banc)

The past decade or so of U.S. patent law has been characterized by a consistent theme between Federal Circuit decisions and the Supreme Court's invalidation of them (and sometimes can be discerned even in those rare instances...more

7/13/2016 - ANDA Claim Construction FDA Hospira On-Sale Bar Patent Infringement Patent Litigation Pharmaceutical Patents SmithKline Beecham

Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA (Fed. Cir. 2016)

The Federal Circuit and the Supreme Court spent an inordinate amount of time wrestling with each of their conceptions of the scope and application of the doctrine of equivalents a dozen years ago, coming to an accommodation...more

5/18/2016 - ANDA Doctrine of Equivalents Orange Book Patent Infringement Pharmaceutical Industry Pharmaceutical Patents

Merck & Cie v. Watson Laboratories, Inc. (Fed. Cir. 2016)

The Federal Circuit had the occasion to revisit the proper application of the on-sale bar under 35 U.S.C. § 102(b) in ANDA litigation over claim 4 of U.S. Patent No. 6,441,168, which reads...more

5/17/2016 - ANDA Bayer Contract Disputes Merck Patent Litigation Pharmaceutical Industry Watson 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

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

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