Kevin E. Noonan

Kevin E. Noonan

McDonnell Boehnen Hulbert & Berghoff LLP

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Federal Circuit Interprets Biosimilars Law in Amgen v. Sandoz

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA or Act) in Amgen Inc. et al. v. Sandoz Inc. In doing so, the court limited the...more

7/22/2015 - Amgen Biologics Biosimilars BPCIA Disclosure FDA FDA Approval Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical Patents Sandoz Sandoz v Amgen

The Medicines Company v. Hospira (Fed. Cir. 2015)

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

7/15/2015 - ANDA Appeals Drug Manufacturers FDA FDA Approval Generic Drugs On-Sale Bar Patent Infringement Patent Invalidity Patent Litigation Patent Term Extensions Patents Pharmaceutical Manufacturers Pharmaceutical Patents Reversal USPTO

FDA Releases "Final" Guidances for Industry regarding the Biosimilar Approval Pathway

About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of...more

5/12/2015 - Biosimilars BPCIA FDA Final Guidance Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz

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

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

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

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

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

11/26/2014 - Books Canada Copyright Copyright Infringement DOHA Exports FDA First Sale Doctrine Generic Drugs Imports International Treaties Medicaid Medicare Patents Pharmaceutical Patents Popular WTO

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

11/6/2014 - ANDA FDA Generic Drugs Information Reports Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

8/14/2014 - Biologics Biosimilars Biotechnology FDA Pharmaceutical PHSA Prescription Drugs

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity

The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more

5/15/2014 - Biosimilars BPCIA FDA Guidance Update Medical Research Pharmaceutical

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

12/4/2013 - 23andMe Class Action FDA Genetic Testing Human Genes

Patients Push Back on FDA Threats to 23andMe Genetic Testing Products

In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe...more

11/27/2013 - 23andMe FDA Genetic Testing Medical Devices

FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing

As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without...more

11/26/2013 - 23andMe DNA FDA Human Genes Medical Devices

Mutual Pharmaceutical Co. v. Bartlett (2013)

The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...more

6/28/2013 - FDA FDCA Generic Drugs Hatch-Waxman Mutual Pharmaceuticals v Bartlett Patents Prescription Drugs SCOTUS

Supreme Court Denies Certiorari in Momenta Case

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

6/26/2013 - ANDA Certiorari FDA Infringement Patents Pharmaceutical Preliminary Injunctions Prescription Drugs Safe Harbors SCOTUS Split of Authority

Supreme Court Oral Argument in FTC v. Actavis

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

4/2/2013 - ANDA Competition FDA FTC v Actavis Generic Drugs Manufacturers Patents Pharmaceutical Reverse Payment Settlement Agreements SCOTUS Watson Pharmaceuticals

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

3/15/2013 - ANDA Drug Manufacturers FDA Generic Drugs Patents Proposed Legislation Reverse Payment Settlement Agreements

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