Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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Apotex Inc. v. Wyeth LLC (Fed. Cir. 2016)

Perhaps the most significant Supreme Court decision in the past quarter century for the working patent practitioner is Dickinson v. Zurko, which strictly speaking is less a patent case than an administrative law decision. ...more

8/19/2016 - Administrative Procedure Act Agency Deference Apotex Appeals Inter Partes Review Proceedings Obviousness Patents Preponderance of the Evidence

Icon Health & Fitness, Inc. v. Polar Electro Oy (Fed. Cir. 2016); Icon Health & Fitness, Inc. v. Garmin Int'l., Inc. (Fed. Cir....

In parallel decisions regarding litigation over the same patent, the Federal Circuit affirmed a District Court decision that the claims were invalid for indefiniteness under 35 U.S.C. § 112(b). This decision, expressly...more

8/9/2016 - Claim Construction Direct Infringement Expert Testimony Indefiniteness Markman Hearing Patent Infringement Patent Litigation Patents Reaffirmation Standard of Review

Genzyme Therapeutic Products Ltd. v. Biomarin Pharmaceutical Inc. (Fed. Cir. 2016)

The Federal Circuit affirmed the decision by the Patent Trial and Appeals Board (PTAB) in an inter partes review (IPR) that the claims of Genzyme's U.S Patent Nos. 7,351,410 and 7,655,226 were obvious, in Genzyme Therapeutic...more

7/28/2016 - Administrative Procedure Act Administrative Proceedings Claim Construction Evidence Genzyme Inter Partes Review Proceedings Notice Requirements Obviousness Patent Trial and Appeal Board Patents Pharmaceutical Industry

Amgen and Allergan Report Progress in Herceptin® Biosimilar Clinical Trial

In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human beast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science...more

7/22/2016 - Allergan Inc Amgen Biosimilars Cancer Clinical Laboratory Testing Pharmaceutical Patents Popular

USPTO Releases Memorandum on Subject Matter Eligibility

On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update...more

7/19/2016 - Ariosa New Guidance Patent Examinations Patent-Eligible Subject Matter Patents Petition for Writ of Certiorari Pharmaceutical Industry Pharmaceutical Patents Product of Nature Doctrine PTO Sequenom USPTO

The Medicines Company v. Hospira, Inc. (Fed. Cir. 2016) (en banc)

The past decade or so of U.S. patent law has been characterized by a consistent theme between Federal Circuit decisions and the Supreme Court's invalidation of them (and sometimes can be discerned even in those rare instances...more

7/13/2016 - ANDA Claim Construction FDA Hospira On-Sale Bar Patent Infringement Patent Litigation Pharmaceutical Patents SmithKline Beecham

Rapid Litigation Management Ltd. v. Cellzdirect, Inc. (Fed. Cir. 2016)

As we have had the occasion to say before regarding subject matter eligibility, "[o]ne swallow does not a summer make, nor one fine day . . . ," but the Federal Circuit may have engendered a glimmer of hope that it will once...more

7/7/2016 - Appeals CLS Bank v Alice Corp Myriad-Mayo Patent-Eligible Subject Matter Patents Product of Nature Doctrine Reversal Section 101 Summary Judgment

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal...more

6/30/2016 - Biologics Biosimilars Biotechnology BPCIA Federal Budget Generic Drugs Medicare Obama Administration Patents Pharmaceutical Industry Product Exclusivity

MAG Aerospace Industries, Inc. v. B/E Aerospace, Inc. (Fed. Cir. 2016) - Equitable Assignor Estoppel Doctrine Expanded by Federal...

Arcane aspects of the law are frequently analogized as constituting "traps for the unwary," and patent law seems to have more than its share of minutiae that fall within that characterization. The equitable principle of...more

6/24/2016 - Aerospace Estoppel IP Assignment Agreements Patent Infringement Patents Privity of Contract Summary Judgment

The CREATE Act of 2016: Senate Listens to Generics Industry

Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES...more

6/23/2016 - Biologics Biosimilars BPCIA CREATE Act Drug Pricing FDA Generic Pharmaceutical Industry Proposed Legislation

Cuozzo Speed Technologies LLC v. Lee (2016)

In its first pronouncement regarding the post-grant reviewing proceedings established by the America Invents Act ("AIA"), the Supreme Court ruled that the Patent and Trademark Office's positions on two of the law's provisions...more

6/21/2016 - Administrative Proceedings America Invents Act Appeals Broadest Reasonable Interpretation Standard Chevron Deference Claim Construction Cuozzo Speed Technologies v Lee Inter Partes Review Proceedings Judicial Review Patent Trial and Appeal Board Patents SCOTUS Standard of Review USPTO

Supreme Court Rules District Courts to Have More Discretion in Finding Willful Patent Infringement by Malicious Pirates

On June 13, 2016, the Supreme Court ruled unanimously, in an opinion by Chief Justice Roberts, that an award of enhanced damages pursuant to 35 U.S.C. § 284 should be within the sound discretion of a district court, albeit...more

6/14/2016 - 35 U.S.C. § 284 Abuse of Discretion Appeals Enhanced Damages Halo v Pulse Highmark Octane Fitness v. ICON Patent Infringement Patents SCOTUS Standard of Proof Standard of Review Stryker v Zimmer Totality of Circumstances Test Willful Infringement

Halo Electronics, Inc. v. Pulse Electronics, Inc. and Stryker Corp. v. Zimmer, Inc. (2016)

The aphorism that "[t]he race is not always to the swift nor the battle to the strong, but that's the way to bet," variously attributed to Damon Runyon, Franklin P. Adams, and Hugh Keough, could readily be updated to include...more

6/14/2016 - 35 U.S.C. § 284 Abuse of Discretion Enhanced Damages Halo v Pulse Highmark Octane Fitness v. ICON Patent Infringement Patents SCOTUS Standard of Proof Standard of Review Stryker v Zimmer Totality of Circumstances Test Willful Infringement

Bloomberg/BNA Releases Report on Biopharma IPRs

As part of a session on the effects of inter partes review on biopharma patents presented today at the 2016 BIO International Convention, Bloomberg/BNA released a report on more than 300 biopharma patents that have been...more

6/8/2016 - Biopharmaceutical Bloomberg Inc. Inter Partes Review Proceedings Patents Pharmaceutical Industry Pharmaceutical Patents

The Recent PTO Guidance on Subject Matter Eligibility: Lessons

A few years ago, former PTO Solicitor General Nancy Linck arose from the audience at the BIO International Conference to provide her thoughts on how the Office had responded to the Supreme Court's decisions in Mayo v....more

5/26/2016 - Abstract Ideas CLS Bank v Alice Corp Myriad-Mayo New Guidance Patent-Eligible Subject Matter Patents Product of Nature Doctrine Section 101 USPTO

U.S. Trade Representative Issues 2016 Special 301 Report

On April 27th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR), issued the 2016 Special 301 Report. According to the USTR website, "[i]ntellectual property is a critical source of economic growth and...more

5/20/2016 - Copyright Counterfeiting Film Industry Global Market Innovation Intellectual Property Protection Inter Partes Review Proceedings Life Sciences Medical Research Patents Pharmaceutical Patents Piracy Software Trade Secrets Trademarks USTR WIPO

Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA (Fed. Cir. 2016)

The Federal Circuit and the Supreme Court spent an inordinate amount of time wrestling with each of their conceptions of the scope and application of the doctrine of equivalents a dozen years ago, coming to an accommodation...more

5/18/2016 - ANDA Doctrine of Equivalents Orange Book Patent Infringement Pharmaceutical Industry Pharmaceutical Patents

Merck & Cie v. Watson Laboratories, Inc. (Fed. Cir. 2016)

The Federal Circuit had the occasion to revisit the proper application of the on-sale bar under 35 U.S.C. § 102(b) in ANDA litigation over claim 4 of U.S. Patent No. 6,441,168, which reads...more

5/17/2016 - ANDA Bayer Contract Disputes Merck Patent Litigation Pharmaceutical Industry Watson Pharmaceuticals

USPTO Holds Patent Quality Symposium

On April 27th, the U.S. Patent and Trademark Office held a Patent Quality Community Symposium at the Office in Alexandria, VA (consistent with its efforts to disseminate its workforce into regional offices, the offices in...more

5/5/2016 - EPO IPO JPO KIPO Patent Quality Metrics Patents Symposium USPTO WIPO

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

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