Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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The Fantastical World of Justice Stephen Breyer

In a recent book entitled Imbeciles: The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck, author Adam Cohen examines the case of Buck v. Bell, where Justice Oliver Wendell Holmes wrote that "[t]hree...more

4/29/2016 - Innovation IP License Justice Breyer Patent Infringement Patent Trolls Patents SCOTUS Small Business Software Patents USPTO

PTAB Statistics From Spring BIO IPCC Meeting

At the end of March, the Intellectual Property Counsels' Committee (IPCC) of the Biotechnology Innovation Organization (BIO) held its Spring meeting, convening in-house counsel and outside counsel involved in patenting the...more

4/18/2016 - Biotechnology Inter Partes Review Proceedings Orange Book Patent Trial and Appeal Board Pharmaceutical Industry

PTAB Denies IPR Petitions against Cold Spring Harbor Laboratory Patents

Cold Spring Harbor Laboratory (CSHL) is a storied institution in molecular biology, being the site of annual meetings related to this view of life since Schrodinger proposed to use quantitative methods to examine biology in...more

4/14/2016 - Genetic Materials Inter Partes Review Proceedings Pharmaceutical Patents Prior Art

Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016)

The Federal Circuit affirmed the latest invalidation of genetic diagnostic claims last week, in Genetic Technologies Ltd. v. Merial L.L.C. While consistent with (and expressly relying upon) recent Federal Circuit precedent...more

4/11/2016 - Diagnostic Method DNA Genetic Technologies Ltd. Patent Infringement Patent Litigation

FDA Releases Naming Guidance

The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA...more

4/7/2016 - Affordable Care Act BPCIA FDA New Guidance Pharmaceutical Patents Warning Labels

TriVascular, Inc. v. Samuels (Fed. Cir. 2016)

Early last month, the Federal Circuit addressed an important question regarding the interplay between a decision to institute inter partes review before the Patent Trial and Appeal Board and the ultimate determination by the...more

3/30/2016 - Burden of Proof Claim Construction Inter Partes Review Proceedings Obviousness Patent Infringement Patent Litigation Patent Trial and Appeal Board Patents Prior Art

Purdue Pharma L.P. v. Depomed, Inc. (Fed. Cir. 2016)

Last Thursday, the Federal Circuit handed down its non-precedential decision in Purdue Pharma v. Depomed, reviewing the decision of the Patent Trial and Appeal Board on three related inter partes reviews. While not quite a...more

3/28/2016 - Evidence Inter Partes Review Proceedings Obviousness Patent Litigation Patent Trial and Appeal Board Patents Pharmaceutical Industry Pharmaceutical Patents Prior Art

CRISPR Interference Motions Set

The Patent Trial and Appeal Board has made its decision regarding the motions each party will be able to bring in Interference No. 108,048 between the Broad Institute and the University of California ("University") over...more

3/24/2016 - DNA Interference Proceeding Patent Trial and Appeal Board Patents University of California

Sequenom Petitions for Certiorari

Sequenom filed its anticipated petition for certiorari today for Supreme Court review of the Federal Circuit's decision in Ariosa v. Sequenom. The petition advises the Court that it "should take this opportunity to provide...more

3/22/2016 - Biotechnology DNA Genetic Testing Myriad-Mayo Patent-Eligible Subject Matter Patents Petition for Writ of Certiorari Product of Nature Doctrine Sequenom

Will "Open Source" be the Future of Genetic Diagnostics?

One of the effective arguments made by the ACLU in the AMP v. Myriad case was that somehow permitting patents on genes implicated a patient's privacy right in her genetic material. This was also the theme of their public...more

3/21/2016 - ACLU AMP v Myriad BRCA Genetic Materials Patents Patient Privacy Rights

Amgen files Declaratory Judgment Action against Sandoz over NEULASTA® Biosimilar

Last Friday, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, in the latest iteration of biosimilar litigation between the parties (see complaint). Amgen's and Sandoz's actions...more

3/8/2016 - aBLA Amgen Biosimilars BPCIA Declaratory Rulings FDA Patent Infringement Pharmaceutical Patents Sandoz

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

Zika Virus Vector (Aedes aegypti): Genomic Sequence

The rise and spread of the Zika virus, although limited for now to South America, has raised concerns globally, particularly with the prospect of the Summer Olympics in Rio de Janeiro later this year. And with those concerns...more

2/26/2016 - DNA Genome Project Zika

Sandoz Petitions for Certiorari over 180-day Notice Provision in BPCIA

As reported on February 17, 2016 in IP Law360, Sandoz has petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision that reversed the District Court in Amgen v. Sandoz. In its decision, two...more

2/18/2016 - Biosimilars BPCIA eBay Test Injunctive Relief Notice Requirements Patent Litigation Petition for Writ of Certiorari Sandoz Sandoz v Amgen SCOTUS

Illumina Cambridge Ltd. v. Intelligent Bio-Systems, Inc. (Fed. Cir. 2016)

The Federal Circuit affirmed a decision of obviousness, and that a patentee not be able to amend claims in an inter partes review proceeding, in an opinion handed down January 29th in Illumina Cambridge Ltd. v. Intelligent...more

2/5/2016 - America Invents Act Burden-Shifting Cuozzo Speed Technologies v Lee Inter Partes Review Proceedings Obviousness Patent Infringement Patent Litigation Patent Trial and Appeal Board SCOTUS

CRISPR Interference Declared

CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats), which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9,...more

1/29/2016 - DNA First-to-Invent Interference Proceeding Patent Applications Patent Litigation Patent Trial and Appeal Board Reduction to Practice USPTO

Q&A from Webinar on Top Patent Law Stories of 2015

Earlier today, we presented a live webinar on the "Top Patent Law Stories of 2015." The webinar covered seven of the twenty stories that made it onto Patent Docs ninth annual list of top patent stories. The seven stories...more

1/22/2016 - America Invents Act Chevron Deference CLS Bank v Alice Corp En Banc Review Limelight v Akamai Patent Infringement Patent-Eligible Subject Matter Patents Sandoz v Amgen Section 101 Sequenom USPTO

Cuozzo Speed Technologies, LLC v. Lee

The Supreme Court on Friday granted certiorari to review the Federal Circuit's decision that the U.S. Patent and Trademark's Patent Trial and Appeal Board was entitled to perform claim construction in inter partes review...more

1/19/2016 - Administrative Appeals Appeals Broadest Reasonable Interpretation Standard Certiorari Claim Construction Cuozzo Speed Technologies Inter Partes Review Proceedings Judicial Review Patent Trial and Appeal Board Patents SCOTUS Statutory Authority

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

Merck & Cie v. Gnosis S.P.A. (Fed. Cir. 2015)

As she has done many times before (and so many times that she has been unfairly characterized as a scold on the Federal Circuit), Judge Lorraine Newman dissented from the panel majority decision affirming an obviousness...more

12/18/2015 - Administrative Procedure Act Agency Deference Inter Partes Review Proceedings Merck Obviousness Patent Trial and Appeal Board Substantial Evidence Standard

In re Commonwealth Scientific & Industrial Research Organization, Bayer Cropscience NV (Fed. Cir. 2015)

Interferences, the U.S. Patent and Trademark Office's procedure for determining which of a plurality of inventive entities were the "first to invent," were eliminated by the Leahy-Smith America Invents Act, but they are not...more

12/16/2015 - America Invents Act Interference Claims Patent Litigation Patent Trial and Appeal Board USPTO

Federal Circuit Denies Rehearing En Banc in Ariosa v. Sequenom

The Federal Circuit declined to rehear en banc the panel decision in Ariosa v. Sequenom. This decision was not surprising but what may be surprising was that only three judges wrote opinions, one in dissent (Judge Newman)...more

12/3/2015 - Abstract Ideas AMP v Myriad Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter Precedential Opinion Preemption SCOTUS Sequenom

Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. (Fed. Cir. 2015)

The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by...more

11/30/2015 - Biogen Idec Classen Immunotherapies Generic Drugs Hatch-Waxman Patent Infringement Patent Litigation Safe Harbors Teva Pharmaceuticals

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

What Are the IP Provisions of the TPP?

The Obama Administration released the approved text of the Trans Pacific Partnership (TPP) agreement last week, and it is substantially (and perhaps entirely; there has not been sufficient time to compare) the same as the...more

11/10/2015 - Biologics Intellectual Property Protection Pharmaceutical Patents Trans-Pacific Partnership TRIPS Agreement

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