Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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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

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

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

2/24/2015 - 23andMe Clinical Laboratories FDA Genetic Testing Laboratory Developed Tests Medical Devices

A Genetic Basis for Beak Diversity in Darwin's Finches

One of the most iconic observations in biology is Charles Darwin's study of the finches of the Galapagos Islands, and his realization that they had all arisen from the same ancestral bird population. While pigeon breeding...more

2/18/2015 - Charles Darwin Darwin's Finches Genetic Markers

Game Over for Myriad -- Update: (Or, and then there was one were none)

As discussed for the past month, Myriad has finally given up trying to defend its BRCA gene testing franchise. The one remaining matter, Myriad's case against GeneDx has settled, as announced by the company today....more

2/17/2015 - America Invents Act Genetic Testing Inter Partes Review Proceedings Myriad Patent Litigation Patents

Morocco Decides to Recognize EP Applications and Patents

The President of the EPO and the Minister of Industry, Trade, Investment and the Digital Economy of Morocco announced on January 19th that Morocco would permit EP applications and granted EP patents to be validated in that...more

2/12/2015 - EP Patent European Patent Office Morocco Patents

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