Author: Kenneth L. Dorsney
Publisher: American Bar Association
ISBN: 9781614384786
Category : Biotechnology
Languages : en
Pages : 0
Book Description
Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
ANDA Litigation
Author: Kenneth L. Dorsney
Publisher: American Bar Association
ISBN: 9781614384786
Category : Biotechnology
Languages : en
Pages : 0
Book Description
Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
Publisher: American Bar Association
ISBN: 9781614384786
Category : Biotechnology
Languages : en
Pages : 0
Book Description
Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
ANDA Litigation
Author: Kenneth L. Dorsney
Publisher:
ISBN: 9781614384793
Category : Biotechnology
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781614384793
Category : Biotechnology
Languages : en
Pages :
Book Description
Pre-ANDA Litigation
Author: Kenneth L. Dorsney
Publisher:
ISBN: 9781639051144
Category : Biotechnology
Languages : en
Pages : 0
Book Description
"This book, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that the pharmaceutical litigants could follow"--
Publisher:
ISBN: 9781639051144
Category : Biotechnology
Languages : en
Pages : 0
Book Description
"This book, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that the pharmaceutical litigants could follow"--
Generic drug entry prior to patent expiration an FTC study
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Book Description
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Book Description
Patent Litigation Strategies Handbook
Author: Barry L. Grossman
Publisher: BNA Books (Bureau of National Affairs)
ISBN: 9781570188862
Category : Patent laws and legislation
Languages : en
Pages : 0
Book Description
"Section of Intellectual Property Law, American Bar Association."
Publisher: BNA Books (Bureau of National Affairs)
ISBN: 9781570188862
Category : Patent laws and legislation
Languages : en
Pages : 0
Book Description
"Section of Intellectual Property Law, American Bar Association."
Circuit Conflicts in Antitrust Litigation
Author: John H. Bogart
Publisher: American Bar Association
ISBN: 9781604425444
Category : Law
Languages : en
Pages : 104
Book Description
Publisher: American Bar Association
ISBN: 9781604425444
Category : Law
Languages : en
Pages : 104
Book Description
Antitrust Law Journal
Author:
Publisher:
ISBN:
Category : Energy policy
Languages : en
Pages : 1136
Book Description
Publisher:
ISBN:
Category : Energy policy
Languages : en
Pages : 1136
Book Description
Actavis and Multiple ANDA Entrants
Author: Bruce H. Kobayashi
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
This paper examines the economics of litigation and settlement of patent disputes arising from Paragraph IV ANDA filings under the Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”) within the framework set out in FTC v. Actavis. Recent economic analyses of reverse payment settlements are based upon a monopoly-to-duopoly model that assumes a single generic entrant. These analyses have been used to support antitrust rules that would enjoin reverse payments that exceed the cost of litigation. We demonstrate that the simple monopoly-to-duopoly models providing the analytical basis for the litigation cost benchmark for analyzing reverse payment settlements is incomplete. Our key institutional insight is the fact that entry by multiple firms follows the invalidation of a patent. Accounting for this critical institutional detail in a more generalized monopoly-to-duopoly model results in important and different implications for patent settlements, welfare, and application of the rule of reason pursuant to Actavis. The result is a broader settlement range than under the monopoly-to-duopoly model that yields robust incentives for the brand and generic entrant to settle the case. This broad settlement range makes attempts to regulate the size of patent settlements ineffective at achieving consumer welfare increasing settlements, or inducing the invalidation of “bad” patents through higher litigation rates. Incorporating multiple serial entrants also decouples the litigation-adjusted expected value of the patent and the consumer welfare standard, and further weakens the relationship between patent strength and the size of the settlement which has motivated numerous calls to deem presumptively unlawful all payments greater than anticipated litigation costs.
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
This paper examines the economics of litigation and settlement of patent disputes arising from Paragraph IV ANDA filings under the Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”) within the framework set out in FTC v. Actavis. Recent economic analyses of reverse payment settlements are based upon a monopoly-to-duopoly model that assumes a single generic entrant. These analyses have been used to support antitrust rules that would enjoin reverse payments that exceed the cost of litigation. We demonstrate that the simple monopoly-to-duopoly models providing the analytical basis for the litigation cost benchmark for analyzing reverse payment settlements is incomplete. Our key institutional insight is the fact that entry by multiple firms follows the invalidation of a patent. Accounting for this critical institutional detail in a more generalized monopoly-to-duopoly model results in important and different implications for patent settlements, welfare, and application of the rule of reason pursuant to Actavis. The result is a broader settlement range than under the monopoly-to-duopoly model that yields robust incentives for the brand and generic entrant to settle the case. This broad settlement range makes attempts to regulate the size of patent settlements ineffective at achieving consumer welfare increasing settlements, or inducing the invalidation of “bad” patents through higher litigation rates. Incorporating multiple serial entrants also decouples the litigation-adjusted expected value of the patent and the consumer welfare standard, and further weakens the relationship between patent strength and the size of the settlement which has motivated numerous calls to deem presumptively unlawful all payments greater than anticipated litigation costs.
Generic Pharmaceutical Patent and FDA Law
Author: Shashank Upadhye
Publisher:
ISBN: 9780314991447
Category : Generic drugs
Languages : en
Pages : 643
Book Description
Publisher:
ISBN: 9780314991447
Category : Generic drugs
Languages : en
Pages : 643
Book Description
Drug Wars
Author: Robin Feldman
Publisher: Cambridge University Press
ISBN: 131673949X
Category : Law
Languages : en
Pages : 165
Book Description
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Publisher: Cambridge University Press
ISBN: 131673949X
Category : Law
Languages : en
Pages : 165
Book Description
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.