Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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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

University of Pittsburgh v. Varian Medical Systems, Inc. (Fed. Cir. 2014)

The Federal Circuit used its decision that the District Court erred in certain of its claim construction determinations to reverse a jury award of greater than $100 million, but left intact large portions of the District...more

4/16/2014 - Biotechnology Patent Infringement Patent Litigation Patents Pharmaceutical

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

Senju Pharmaceutical Co. v. Apotex Inc. (Fed. Cir. 2014)

Applying the doctrine of claim preclusion (previously termed res judicata), a fractured majority of the Federal Circuit held that prior ANDA litigation to final judgment precluded reassertion of amended claims in the same...more

4/8/2014 - Patent Infringement Patent Litigation Patents Pharmaceutical

Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)

The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo...more

3/19/2014 - AMP v Myriad Mayo v. Prometheus Myriad Patent-Eligible Subject Matter Patents Pharmaceutical SCOTUS USPTO

Utah Judge Denies Myriad's Preliminary Injunction Motion

In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more

3/12/2014 - AMP v Myriad BRCA DNA Genetic Materials Human Genes Myriad Myriad v Ambry Patent Litigation Patents Pharmaceutical Preliminary Injunctions

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