首页 >
法律 >
知识产权法 >
Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law

作者： Amalia Athanasiadou
出版商： Kluwer Law International
ISBN: 9789403501130
出版时间 August 2018
规格： Hardback
适应领域： International ? 免责申明：
Countri(es) stated herein are used as reference only

List Price: ￥1,497.30

￥1,452.38 Save ￥44.92 (3%)

或

下载订单表

加入收藏
| 加入比较

描述
大纲

详细
Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law examines patent settlements between originators and generic pharmaceutical manufacturers under United States (US) antitrust and European Union (EU) competition law. The major focus is on patent settlements involving reverse payments, commonly known as “pay-for-delay” settlements. Reverse payment settlements or “pay-for-delay agreements” create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals on the one hand and the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals on the other hand. This book is one of the first to analyse critically and comparatively how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by US and European courts as well as enforcement authorities, focusing on the applicable legal tests and the main criteria used by courts and enforcement authorities when applying antitrust scrutiny.

What’s in this book:

The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and EU competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including:
- the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavis and subsequent jurisprudence;
- the decision of Lundbeck v. Commission by the European General Court and the Servier decision of the European Commission;
- the Roche/Novartis decision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU;
- an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals and mechanisms affecting generic substitution;
- the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests;
- the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law.
The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book argues that even though patent settlements and other types of potentially exclusionary and abusive conduct change form rapidly, the main criteria for their assessment remain broadly the same.

How this will help you:

This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. This book is also beneficial to legal counsels, practicing attorneys, competition authorities and judges wishing to have the overview of the current legal standards in both the US and the EU. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant case law, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Preface

List of Abbreviations

Acknowledgements

Introduction

PART I
Pharma Innovation and Settlements

CHAPTER 1
Pharma R&D and Settlements

PART II
Pharma Settlements in the US

CHAPTER 2
The US Regulatory Framework

CHAPTER 3
The US Circuits’ Split on Reverse Payment Settlements

CHAPTER 4
FTC v. Actavis

PART III
Pharma Settlements in the EU

CHAPTER 5
The European Regulatory Framework

CHAPTER 6
Delaying Generic Entry in the EU

Conclusion

Bibliography

Table of Cases

Tables of Statutes & Legislation

Index

你可能需要


The Hong Kong Company Secretary's Handbook: Practice and Procedure (11th Edition): List Price: ￥497.55

￥482.62 Save ￥14.93 (3%)


Hong Kong Tax & Accounting Practical Toolkit (Basic Package): ￥3,161.07


Hong Kong Company Secretary Checklist, 2nd Edition: List Price: ￥1,283.40

￥1,244.90 Save ￥38.50 (3%)


Law of Companies in Hong Kong, 4th Edition (Hardcopy + e-Book): List Price: ￥3,255.00

￥3,157.35 Save ￥97.65 (3%)


Butterworths Hong Kong Discrimination Law Handbook, 4th Edition: List Price: ￥1,395.00

￥1,353.15 Save ￥41.85 (3%)


Sentencing in Hong Kong, 11th Edition: List Price: ￥3,329.40

￥3,229.52 Save ￥99.88 (3%)


Butterworths Hong Kong Company Law (Winding-Up and Miscellaneous Provisions) Handbook, 6th Edition: List Price: ￥2,120.40

￥2,056.79 Save ￥63.61 (3%)


Butterworths Hong Kong Company Law Handbook, 26th Edition: List Price: ￥4,092.00

￥3,969.24 Save ￥122.76 (3%)


Cross-Border Crime in Hong Kong: Extradition, Mutual Assistance & Financial Sanctions, 3rd Edition: List Price: ￥1,934.40

￥1,876.37 Save ￥58.03 (3%)


Clough & Clough on Personal Injuries: List Price: ￥1,395.00

￥1,353.15 Save ￥41.85 (3%)


Hong Kong Personal Insolvency Manual, 3rd Edition: List Price: ￥1,860.00

￥1,804.20 Save ￥55.80 (3%)


Butterworths Hong Kong Conveyancing and Property Law Handbook, 6th Edition: List Price: ￥1,674.00

￥1,623.78 Save ￥50.22 (3%)


A Practical Guide to Resolving Shareholder Disputes, 2nd Edition: List Price: ￥1,674.00

￥1,623.78 Save ￥50.22 (3%)


Tort Law in Hong Kong, 5th Edition (Hardcopy + ebook): List Price: ￥2,325.00

￥2,255.25 Save ￥69.75 (3%)


Company Law in Hong Kong: Practice and Procedure 2023 (Hardcopy + e-Book): List Price: ￥2,974.14

￥2,884.92 Save ￥89.22 (3%)


Company Law in Hong Kong: Insolvency 2023 (Hardcopy + e-Book): List Price: ￥2,643.99

￥2,564.67 Save ￥79.32 (3%)


Hong Kong Company Law, 15th Edition: List Price: ￥457.56

￥443.83 Save ￥13.73 (3%)


Private Equity in Hong Kong and China, 4th Edition: List Price: ￥1,860.00

￥1,804.20 Save ￥55.80 (3%)


Hong Kong Family Court Practice, 4th Edition: List Price: ￥2,511.00

￥2,435.67 Save ￥75.33 (3%)


Brooke's Notary Hong Kong, 3rd Edition: List Price: ￥1,581.00

￥1,533.57 Save ￥47.43 (3%)

“

Ordering from Professional Bookshop is fantastic, quick delivery great products, great customer service Siti L.
This is a great bookstore and have had no problems with them and all my orders have come on time and in good condition. Yang X.
Everything is perfect. Fast delivery. I highly recommend this website to all my friends and colleagues. Thanks Hoi Man L.
So thankful I am receiving all my books, thank you to all for a great service and excellent products Clinton K.
Professional Bookshop is amazing! I've been a loyal customer for over 5 years. Returns are easy to request, book or delivery complaints are taken seriously and the customer service team is friendly and patient. Mick D.
I wanted to informed you that the customer service is excellent. They were so polite and nice. I would continue to buy books from Professional Bookshop. Jingsong C.
Fast and quick service. Easy transaction method, arrived sooner than expected. Excellent packaging and the books received are in perfect condition! Thank you very much! I love the book and its quality. Saori B.
I can order any accounting books from worldwide from Professional Bookshop. Love this website and save my time to search from internet. Lingxiao R.
It is just so easy to find what you are always looking for and sometimes you can even find it up to 80% off what you would in the normal store. Graeme R.
I love shopping on Professional Bookshop! They have a wide range of accounting book with competent prices. Free shipping in Hong Kong is also really handy! Fergus Y.
Professional Bookshop is a great bookstore, I must say. Buying books in Professional Bookshop is so easy, great and reliable. It is highly recommendable. Deborah D.
A great site to shop accounting books and everything and with discountable prices. It’s my first choice whenever i want to shop something. Most trusted site. Zeng Z.
I found the books I needed and at a very low price. I am very happy and will definitely use it in the future Brian W.
I have been using Professional Bookshop for a while now. I am very impressed with customer service and delivery. When I need to have a return it is done very diligently. Olivia L.
Professional Bookshop is my default go to for finding the best prices and reading details of law books before buying. Detailed book description is very helpful. Tracy W.
I've been using Professional Bookshop since 2011 and they actually great, I always received great service and my book arrives on time. Lisa C.

所有书籍

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law

Free delivery Hong Kong?

详细

你可能需要

What Our Customers Say?

所有书籍

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law

Free delivery Hong Kong?

详细

你可能需要

What Our Customers Say?

video title