Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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Evidence of Geographic Change in Central America from Genome Studies of Eciton Ant Species

"It was a sight no one could ever forget. Over the range of hills, as far as eye could see, crept a darkening hem, ever longer and broader, until the shadow spread across the slope from east to west, then downwards,...more

1/24/2017 - Life Sciences

FDA Issues Guidance Regarding Interchangeability of Biosimilar and Biologic Drugs

On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This...more

1/19/2017 - Biologics Biosimilars BPCIA FDA Interchangeability Pharmaceutical Industry

FDA Issues Guidance Regarding Biologic Drug Naming

Late last week, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...more

1/18/2017 - Biosimilars BPCIA FDA Pharmaceutical Industry

Ex parte Itagaki and Nishihara (PTAB 2016)

A great deal of angst has been generated by the Patent Trial and Appeal Board's decision, in Ex parte Itagaki and Nishihara, regarding the panel's application of Section 101 (sua sponte as a new ground of rejection under 37...more

1/17/2017 - Alice Corporation Ex Parte Patent Litigation Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents Section 101

FDA Issues Newest Guidance Regarding Biosimilar Application Process

On December 29, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...more

1/12/2017 - Biosimilars BPCIA FDA Pharmaceutical Industry

Addressing Increased Drug Costs -- A Proposal

The New York Times in a recent video (see "'Could You Patent the Sun?'") has returned to its theme against patenting, particularly with regard to patents for life-saving drugs. This time the paper invokes the meme of Jonas...more

1/3/2017 - Drug Pricing Patents Pharmaceutical Industry Pharmaceutical Patents Prescription Drugs

Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen

The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more

12/13/2016 - Amgen Biologics Price Competition and Innovation Act of 2009 Biosimilars BPCIA Patent Dance Patent Infringement Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Popular Sandoz Sandoz v Amgen

The Failed Trans-Pacific Partnership: What It Might Have Meant To Biotech and Pharma

The Trans-Pacific Partnership (TPP) was the latest in a series of multination international agreements aimed at reducing trade barriers and promoting global free trade. Most of these agreements are “regional,” like the North...more

12/12/2016 - Copyright Enforcement Intellectual Property Protection Patents Popular Trade Agreements Trademarks Trans-Pacific Partnership

In re Nuvasive (Fed. Cir. 2016)

In a precedential decision the Federal Circuit vacated and remanded a Patent Trial and Appeal Board decision invalidating claims from Nuvasive's U.S. Patent No. 8,361,156 in an inter partes review instituted on a petition by...more

12/9/2016 - Inter Partes Review (IPR) Proceeding NuVasive Obviousness Patent Applications Patent Invalidity Patent Trial and Appeal Board Patents Prior Art

Perfect Surgical Techniques, Inc. v. Olympus America, Inc. (Fed. Cir. 2016)

Diligence is a patent concept whose applicability was severely restricted under the changes in U.S. patent law created under the Leahy-Smith America Invents Act. Diligence is important when determining whether an invention...more

12/1/2016 - America Invents Act Inter Partes Review (IPR) Proceeding Obviousness Patent Applications Patent Invalidity Patent Trial and Appeal Board Patents

Roxane Laboratories, Inc. v. Camber Pharmaceuticals Inc. (Fed. Cir. 2016)

The patent prosecutor's art requires exquisite foresight, if not prescience, in balancing the requirements for specificity needed to satisfy the disclosure requirements of § 112 while anticipating efforts to design around the...more

11/29/2016 - Appeals Obviousness Patent Infringement Patent Litigation Patents Pharmaceutical Patents Roxane Laboratories

Does President Trump Provide an Opportunity for Patent-friendly Policies?

Now that the dramatic change in the political climate that is the election of Donald Trump as President has had time to settle, it may be fruitful to consider whether the election provides opportunities for technology-based...more

11/18/2016 - Donald Trump Patents Popular Presidential Elections Trump Administration

Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc. (Fed. Cir. 2016)

The Federal Circuit recently affirmed a district court's claim construction and determination that claim terms were not indefinite in Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc....more

10/26/2016 - Claim Construction Patent Infringement Patent Invalidity Patent Litigation Patents Pharmaceutical Industry Prior Art

Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc. (Fed. Cir. 2016) - Federal Circuit Denies Petition for Rehearing in...

One of the aspects of inter partes review that differed from other post-grant review proceedings before the Board of Patent Appeals and Interferences (succeeded by the Patent Trial and Appeal Board) is a requirement for...more

10/24/2016 - America Invents Act Cuozzo Speed Technologies v Lee Inter Partes Review (IPR) Proceeding Medtronic Patent Infringement Patent Litigation Patent Trial and Appeal Board Patents

Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

10/19/2016 - Allergan Inc ANDA Inter Partes Review (IPR) Proceeding Obviousness Patent Invalidity Patent Litigation Patent Trial and Appeal Board Patents Pharmaceutical Industry Pharmaceutical Patents Public Interest Qui Tam USPTO

Supreme Court Again Refuses to Clarify Scope of Hatch-Waxman Safe Harbor

The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...more

10/4/2016 - Certiorari FDA Hatch-Waxman Patent Infringement Patents Pharmaceutical Industry Safe Harbors Teva Pharmaceuticals

Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016)

Before the Supreme Court's recent forays into the topic of subject matter eligibility in patent law, the most contentious line of cases (from the Federal Circuit) concerned the written description requirement of Section 112. ...more

9/23/2016 - Patent Applications Patent Invalidity Patent Litigation Patent Trial and Appeal Board Patents Prior Art Research and Development USPTO Written Descriptions

LifeNet Health v. LifeCell Corp. (Fed. Cir. 2016)

The complexities that can be attendant on defending against an infringement allegation, and the possibility that a straightforward path to non-infringement can be complicated by claim construction even for terms construed...more

9/21/2016 - Appeals Claim Construction Life Sciences Patent Infringement Patent Invalidity Patent Litigation Patents Prior Art

Hartig Drug Co. v. Senju Pharmaceutical Co. (3rd Cir. 2016)

Perhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure. Particularly when the professor is bold enough to engage students on the intricacies...more

9/8/2016 - Allergan Inc ANDA Article III Federal Rule 12(b)(1) Federal Rules of Civil Procedure Patent-Eligible Subject Matter Patents Pharmaceutical Industry Sherman Act Standing

Investment in Biotechnology Companies -- Nature Biotechnology Report

Despite an understandable amount of gloom and doom in patenting circles regarding the effects of the recent Supreme Court and Federal Circuit jurisprudence on life sciences patents (Mayo v. Prometheus; AMP v. Myriad Genetics;...more

9/1/2016 - AMP v Myriad Ariosa Biotechnology Global Economy Investment Funds Investors Life Sciences Mayo v. Prometheus Patent-Eligible Subject Matter Patents Product of Nature Doctrine Sequenom Venture Capital

Genzyme Petitions Federal Circuit for Rehearing in Genzyme Therapeutic Products, Inc. v. Biomarin Pharmaceutical, Inc.

Many of the complaints from patent holders over the PTO's inter partes review process under the Leahy-Smith America Invents Act (codified in pertinent part at 35 U.S.C. §§ 311-319) stem from how the Office has implemented...more

8/29/2016 - Administrative Procedure Act Administrative Proceedings Appeals Genzyme Inter Partes Review (IPR) Proceeding Notice Requirements Obviousness Patent Invalidity Patent Trial and Appeal Board Patents Pharmaceutical Industry Prior Art

The Effect of Patents and Drug Price Regulation on New Drug Diffusion Globally

One of the great benefits of scientific inquiry is the capacity for presumptions and prejudices from experience to be challenged and explained in ways that are counter-intuitive. This is true even for disciplines like...more

8/24/2016 - Drug Pricing GATT Global Marketplace Patents Pharmaceutical Industry TRIPS Agreement

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 (IPR) Proceeding 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 (IPR) Proceeding Notice Requirements Obviousness Patent Trial and Appeal Board Patents Pharmaceutical Industry

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