Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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Federal Circuit Interprets Biosimilars Law in Amgen v. Sandoz

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA or Act) in Amgen Inc. et al. v. Sandoz Inc. In doing so, the court limited the...more

7/22/2015 - Amgen Biologics Biosimilars BPCIA Disclosure FDA FDA Approval Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical Patents Sandoz Sandoz v Amgen

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 Drug Manufacturers FDA FDA Approval Generic Drugs On-Sale Bar Patent Infringement Patent Invalidity Patent Litigation Patent Term Extensions Patents Pharmaceutical Manufacturers 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 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

Koepsell and Noonan on Gene Patenting

In 2009, the first edition of Dr. David Koepsell's book "Who Owns You: The Corporate Gold Rush to Patent Your Genes" was published. With the second edition of his text about to be published, Dr. Koepsell allowed Patent Docs...more

5/29/2015 - BRCA DNA Gene Patenting Myriad Myriad-Mayo Patent-Eligible Subject Matter Patents

Commil USA, LLC v. Cisco Systems, Inc. (2015)

The Supreme Court handed down its decision in Commil USA, LLC v. Cisco Systems, Inc. today and in doing so reprised several themes that have emerged over the past decade of the Court's activist approach to patent law. The...more

5/27/2015 - Cisco v CommilUSA Frivolous Lawsuits Good Faith Honest Belief Defense Induced Infringement Patent Infringement Patent Invalidity Patent Litigation Patents Sanctions SCOTUS

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

FDA Releases "Final" Guidances for Industry regarding the Biosimilar Approval Pathway

About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of...more

5/12/2015 - Biosimilars BPCIA FDA Final Guidance Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz

Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal

The Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO®...more

5/7/2015 - Amgen Appeals Biosimilars BPCIA Patent Litigation Patents Pharmaceutical Patents Preliminary Injunctions Sandoz v Amgen

U.S. Trade Representative Issues 2015 Special 301 Report

On April 30th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR) issued the 2015 Special 301 Report. According to the USTR website, "[m]ade-in-America exports are an essential source of economic growth and...more

5/1/2015 - Exports Global Economy Global Marketplace Information Reports Job Creation Trade Relations

Biosig Instruments, Inc. v. Nautilus, Inc. (Fed. Cir. 2015)

The Federal Circuit considered the question of indefiniteness on remand from the Supreme Court's reversal in Nautilus v. Biosig and, perhaps not surprisingly, found again that the Biosig's claims were not indefinite....more

4/28/2015 - Indefiniteness Intellectual Property Litigation Medical Devices Nautilus Inc. v. Biosig Instruments Patent Litigation Patents

Fine-structure Genetic Mapping of Human Population in Britain

One of the consequences of the explication of human genomic DNA by the Human Genome Project and related efforts has been a better understanding of anthropological history, i.e., how the human population has changed...more

4/27/2015 - DNA Human Genome Project Scientific Research UK

A Modest Proposal (or Two)

Any observer of the interaction between the Federal Circuit and the Supreme Court over the past decade has recognized that the Court has become increasingly critical of the Federal Circuit's patent jurisprudence and of...more

4/23/2015 - Innovation Legal History Legal Perspectives Patents SCOTUS

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

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 Manufacturers 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

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 ACLU, Working for the Man

The ACLU championed its efforts in the AMP v. Myriad case as being another instance of the group fighting for the rights of the many and the powerless against corporate America and the oligarchical few. In a paradox, it now...more

3/25/2015 - AMP v Myriad BRCA Genetic Materials Myriad Patent Litigation Patents Personalized Medicine Pharmaceutical Patents

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

Immersion Corp. v. HTC Corp. (D. Del. 2015) - District Court Overrules PTO Interpretation of 35 U.S.C. § 120

Judge Richard Andrews, District Court Judge for the District of Delaware rendered a decision on a motion for summary judgment in Immersion Corp. v. HTC Corp. that, if affirmed, could put many more patents at risk than Myriad,...more

3/19/2015 - Continuation Application Patent Litigation Patents

Transparency and the Trans-Pacific Partnership Treaty

Shrouded in secrecy and spawning more than its share of dystopian conspiracy theories, the Trans-Pacific Partnership (TPP) treaty -- being negotiated by the U.S. and eleven foreign governments (Australia, Brunei, Canada,...more

3/12/2015 - Barack Obama Trade Relations Trans-Pacific Partnership

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