On June 12, 2017, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of...more
6/13/2017
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Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
On April 26, 2017, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. Sandoz was represented by Deanne E. Maynard, and Amgen was represented by Seth P. Waxman. In addition, Anthony A. Yang presented the...more
4/28/2017
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Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Sandoz ,
Sandoz v Amgen
On Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be...more
4/25/2017
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Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Litigation ,
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Pharmaceutical Industry ,
Sandoz ,
Sandoz v Amgen
On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals. Sandoz had petitioned the Court on February 16, 2016...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar -
The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
6/7/2016
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Amended Regulation ,
America Invents Act ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Community Trademark ,
Declaratory Judgments ,
EU ,
Filing Fees ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inventions ,
Notice Requirements ,
On-Sale Bar ,
Patent Dance ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Preliminary Injunctions ,
Prior Art ,
Public Use ,
Renewal Fees ,
Sandoz ,
Sandoz v Amgen ,
Trademark Registration ,
Uniform Commercial Code (UCC) ,
USPTO
In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more
6/3/2016
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Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen
BIO and Biosimilars -
The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more
9/11/2015
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Disclosure Requirements ,
En Banc Review ,
FDA Approval ,
First Impression ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more
7/24/2015
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Biosimilars ,
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FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) -
On June 18, 2015, the Federal Circuit handed down...more
6/26/2015
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Nautilus Inc. v. Biosig Instruments ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz ,
SCOTUS ,
Teva Pharmaceuticals ,
Teva v Sandoz
The Federal Circuit heard oral arguments in the Amgen v. Sandoz case on Wednesday, June 3, 2015. The three judges on the panel were Judge Newman, Judge Lourie, and Judge Chen. This case is on appeal from the U.S. District...more
The 2015 BIO International Convention begins in two weeks in Philadelphia. For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at...more
As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more
Last week, at their January 7, 2015 meeting, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN® biologic drug....more
Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more
12/10/2014
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Biosimilars ,
Declaratory Judgments ,
Hoffman LaRoche ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Subject Matter Jurisdiction
The Supreme Court will begin its 2014-2015 term next Monday. Last year, the Court heard a record number of patent law cases, at least for recent history. Nevertheless, it is scheduled to hear another one on October 15. ...more
A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This...more
7/30/2013
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Enablement Inquiries ,
Indefiniteness ,
Infringement ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Teva Pharmaceuticals