Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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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

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 (IPR) Proceeding 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

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