Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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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

Game Over for Myriad - (Or, and then there was one)

As discussed at the end of January, Myriad has given up its Quixotic quest to validate its BRCA gene testing franchise and has abandoned its several lawsuits (many of which were consolidated before the District of Utah under...more

2/11/2015 - Genetic Materials Myriad Patent Litigation Patent-Eligible Subject Matter Patents Pharmaceutical Manufacturers Pharmaceutical Patents

Rep. Goodlatte Introduces His Patent Reform Bill (Again) -- Part II

As discussed in a prior post, Rep. Bob Goodlatte (R, VA-6th) and a bipartisan collection of sponsors* introduced a bill, once again entitled the "Innovation Act" (H.R. 3309 in the last Congress; H.R. 9 in this one) directed...more

2/10/2015 - Innovation Act Patent Reform Patents Proposed Legislation

Rep. Goodlatte Introduces His Patent Reform Bill (Again)

As expected by almost everyone (and anticipated by several groups who urged him not to do so; see "Pro-Patent Coalition Writes Letter to the House and Senate Judiciary Committees" and "Big Ten Lobbies Congress to Tread...more

2/6/2015 - Innovation Act Patent Litigation Patent Prosecution Patent Reform

Porcine Breed Diversity in China

It seems that Orwell was right: all pigs are equal, but some are more equal than others. The question of how diverse different breeds of domesticated animals may be has begun to be addressed with the completion of many...more

2/3/2015 - China Genetic Materials Patents

Pro-Patent Coalition Writes Letter to the House and Senate Judiciary Committees

Last week, what is described as "a broad coalition" representing patent holders and inventors sent a letter to Representatives Bob Goodlatte (VA, 6th) and John Conyers (MI, 13th), Chairman and Ranking Member, respectively, of...more

1/30/2015 - CLS Bank v Alice Corp Highmark v. Allcare Innovation Act Inventors Legislative Committees Limelight v Akamai Nautilus Inc. v. Biosig Instruments Octane Fitness v. ICON Patent Reform Patents

Big Ten Lobbies Congress to Tread Lightly on "Patent Reform"

One of the frustrations for participants in the patent wars of the early 21st Century has been the failure of many of the most vulnerable stakeholders to take a stand against overreaching proposals by proponents of a crisis...more

1/30/2015 - Big Ten Conference Innovation Act Legislative Agendas Lobbying Patent Reform Patents

Myriad Throws in the Towel

In the aftermath of the Supreme Court's decision in AMP v. Myriad Genetics in 2013, Myriad (paradoxically to those either not paying attention or who over interpreted the scope of the Court's holding in its opinion) filed...more

1/28/2015 - AMP v Myriad Covenant Not to Sue Declaratory Judgments DNA Genetic Testing Multidistrict Litigation Myriad Myriad v Ambry Patent Infringement Patent Litigation Patents SCOTUS Settlement Agreements

House Fly Genome Sequenced

The phylogenetic Order Diptera comprises the "true" flies (defined as having a single pair of wings arising from the thorax) and is first found in the fossil record in the Middle Triassic (~245 million years ago). It is one...more

1/27/2015 - Genetic Materials Scientific Research

What's Next? Some Consequences of the Teva v. Sandoz Decision

Supreme Court Building #3It has escaped almost no one's notice that the Supreme Court has spent the past decade or so being much more involved in patent law than in preceding twenty years. Evident but perhaps less discussed...more

1/23/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

Teva v. Sandoz: The Dissent

The recent history of Supreme Court patent cases has made the dissent a seemingly endangered species, the Court consistently deciding important patent cases by 9-0 votes and, at best, garnering concurring opinions for...more

1/22/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

The Uncomfortable Intersection between the Practice of Medicine and Reality

The disconnect between patents and medicine (and more particularly, between physicians who prescribe patented drugs and the pharmaceutical companies who produce them) was illustrated nicely in a recent dustup between doctors...more

12/30/2014 - Patents Pfizer Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Physicians UK

Some Human Embryonic Stem Cells Are Once Again Patent-eligible in Europe

Last Thursday, the European Court of Justice rendered a decision in International Stem Cell (ISCO) Corporation v. Comptroller General of Patents, Designs and Trademarks (UK) that significantly modified the landscape for human...more

12/24/2014 - EU Patent-Eligible Subject Matter Patents Popular Stem cells

In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014)

In a decision that will surprise no one (written by Judge Dyk, which made the conclusions foregone from the first page of the opinion), the Federal Circuit today affirmed the Utah District Court's decision denying Myriad...more

12/18/2014 - Multidistrict Litigation Myriad Patent Litigation Patents Popular Preliminary Injunctions

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

12/15/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA Intellectual Property Litigation Life Sciences Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Japanese Foundation for Cancer Research v. Lee (Fed. Cir. 2014) - When you file a disclaimer, you'd better mean it

The Federal Circuit reversed a District Court decision this week in a case involving an improperly filed statutory (terminal) disclaimer, in Japanese Foundation for Cancer Research v. Lee. Caught between miscommunication...more

12/12/2014 - Patents Terminal Disclaimer

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