Patent strategy in pharmaceutical industry : : are additional patents valuable? / / Monica Donghi.

• Superior document: Munich Intellectual Property Law Center Studies ; Volume 20
• VerfasserIn: Donghi, Monica,
• Place / Publishing House: Baden-Baden, [Germany] : : Nomos,, 2014.; ©2014
• Year of Publication: 2014
• Edition: 1. Auflage.
• Language: English
• Series: MIPLC studies ; Volume 20.
• Physical Description: 1 online resource (85 p.)
• Notes: Description based upon print version of record.

This book investigates lifecycle management strategies used by pharmaceutical companies attempting to maximize the value of their product portfolio. Such strategies are sometimes referred to by generic drug companies as “evergreening”. The analysis focuses on two of these strategies, namely product improvements and product line extensions. In particular, an evaluation of the patents that follow the basic one and that accompany the development of a drug from research to market is attempted. Two “blockbuster” drugs, Taxotere and Xalatan, were randomly chosen to carry out such analysis. The patent portfolio of the originator companies is outlined and some important patents for each area of research (e.g. formulations, combinations, delivery devices) are shortly described. Patent filing trends for the two drugs, both in regards of the originator and in regards of other competing companies (amongst these also the generics) are schematically shown.

Table of Contents

Acronyms and Abbreviations; I. Introduction; II. Background; A. Pharmaceutical Industry - The Development of a New Drug.; B. New Drug Approval Regulations; C. Generic Drugs Approval.; III. Case Studies-Facts; A. Taxotere; 1. General; 2. Patent Portfolio; a) Process; b) Formulation; c) Combination Therapy; d) New Uses; e) Derivatives; 3. Use of Procedural Provisions: Supplementary Protection Certificates (SPCs)/Patent Term Extension; 4. Conclusion; B. Xalatan; 1. General; 2. Patent Portfolio; a) Process; b) Formulation; c) Combination Therapy; d) New Uses; e) Delivery Devices

f) Packaged Product3. Use of Procedural Provisions; a) Divisional of Basic Patent; b) Supplementary Protection; 4. Conclusion; IV. Discussion; A. Lifecycle Management: Criticism and Supports; B. Further Filing Strategy: Commercial Value; 1. Innovation Tracks; a) Formulations; b) Combinations; c) Process; d) New Uses; e) Delivery Devices; 2. Xalatan SPC Request: a Case for Competition Law?; C. Patent Strategy and Innovation; D. Summary: Taxotere v Xalatan; E. Conclusion and Suggestions; V. Final Remarks; List of works cited; Periodical Materials in English; Periodical Material in German

Non Periodical MaterialTable of books; Table of Cases; European Union; EPO Board of Appeal; France; Germany; Italy; United Kingdom; United States; Statutes; Speeches and Reports; Press release; Others