Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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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 King Drug Co. of Florence Pharmaceutical Pharmaceutical Manufacturers 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 Drug Manufacturers Generic Drugs Infringement Obviousness Patent Infringement Patent Invalidity Patent Litigation Patents Pfizer Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs

Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)

Disaster survivors, and even people who just hear about a disaster, are often first overwhelmed by it; they can only rationally process its significance after some time. During that time they overcome the initial visceral...more

6/23/2015 - DNA Intellectual Property Litigation Myriad-Mayo Patent Infringement Patent Invalidity Patent Litigation Patent-Eligible Subject Matter Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Section 101 Sequenom

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 Pharmaceutical Manufacturers Startups

Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015)

The Federal Circuit affirmed a decision by the U.S. District Court for the District of Massachusetts that it lacked subject matter jurisdiction under 35 U.S.C. § 146 pursuant to changes in the statute provided by the...more

5/20/2015 - America Invents Act Biotechnology First-to-File First-to-Invent Interference Proceeding Patent Trial and Appeal Board Patents Pharmaceutical Pharmaceutical Manufacturers Subject Matter Jurisdiction

Genes Associated with ALS Identified

One of the promises of the Human Genome Project was that knowledge of the entirety of the human genetic complement would permit researchers to identify genetic bases for diseases that had been intractable to conventional...more

5/13/2015 - DNA Human Genome Project Medical Research Pharmaceutical

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 Pharmaceutical Manufacturers Royalties

Cadence Pharmaceuticals Inc. v. Exela Pharmsci Inc. (Fed. Cir. 2015)

The Federal Circuit availed itself of another opportunity to demonstrate that the Supreme Court's recent decision in Teva v. Sandoz may be relevant in cases that are the exception rather than the rule. The Federal Circuit's...more

3/27/2015 - Doctrine of Equivalents Patent Infringement Patents Pharmaceutical Pharmaceutical Patents SCOTUS

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

3/24/2015 - Biosimilars BPCIA FDA Patent-Eligible Subject Matter Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz v Amgen SCOTUS

FDA Approves Sandoz Filgrastim Biosimilar

On Friday, the Food and Drug Administration approved a biosimilar version of Amgen's Neupogen® (filgrastim) product for sale in the U.S. This is the first biosimilar to be approved under the provisions of the Biologics Price...more

3/9/2015 - Biosimilars BPCIA FDA Pharmaceutical Pharmaceutical Manufacturers Sandoz

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 Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs Price Manipulation Standing

What's Next? Some Consequences of the Teva v. Sandoz Decision

Supreme Court Building #3It has escaped almost no one's notice that the Supreme Court has spent the past decade or so being much more involved in patent law than in preceding twenty years. Evident but perhaps less discussed...more

1/23/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

Teva v. Sandoz: The Dissent

The recent history of Supreme Court patent cases has made the dissent a seemingly endangered species, the Court consistently deciding important patent cases by 9-0 votes and, at best, garnering concurring opinions for...more

1/22/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

The Uncomfortable Intersection between the Practice of Medicine and Reality

The disconnect between patents and medicine (and more particularly, between physicians who prescribe patented drugs and the pharmaceutical companies who produce them) was illustrated nicely in a recent dustup between doctors...more

12/30/2014 - Patents Pfizer Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Physicians UK

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

12/15/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA Intellectual Property Litigation Life Sciences Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

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 Pharmaceutical Manufacturers 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 Pharmaceutical Patents Settlement Sherman Act

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. (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 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 Pharmaceutical Manufacturers Pharmaceutical Patents

Apotex Inc. v. UCB, Inc. (Fed. Cir. 2014)

Last week, the Federal Circuit affirmed a finding of inequitable conduct in Apotex v. USB, a relatively rare occurrence in the years after the Federal Circuit's decision in Therasense v. Becton, Dickenson. In the Therasense...more

8/20/2014 - En Banc Review Inequitable Conduct Patent Litigation Patents Pharmaceutical Pharmaceutical Patents USPTO

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

8/14/2014 - Biologics Biosimilars Biotechnology FDA Pharmaceutical PHSA Prescription Drugs

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 Pharmaceutical Patents

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity

The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more

5/15/2014 - Biosimilars BPCIA FDA Guidance Update Medical Research Pharmaceutical

Sherry Knowles Speaks Truth to the Power of the PTO on § 101 Guidelines

Last week, Sherry Knowles, former chief patent counsel for GlaxoSmithKline and now principal at Knowles Intellectual Property Strategies, LLC submitted to Managing Intellectual Property magazine a detailed critique of the...more

5/2/2014 - AMP v Myriad Biotechnology GlaxoSmithKline Mayo v. Prometheus Patent Litigation Patents Pharmaceutical SCOTUS Section 101 USPTO

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