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Pharmaceutical & Biotechnology Licensing:

PJB Publications USA Inc.
May 1, 2003
143 Pages - SKU: VB889657

Abstract Table of Contents Search inside this report Related Reports

Pharmaceutical & Biotechnology Licensing:

Theta Reports has developed this practical guide report on pharmaceutical and biotechnology licensing as a resource for licensing professionals who are interested in the latest information on deal making; pharmaceutical and biotechnology professional staff who want an introduction to licensing; and all others who want to understand the mechanisms of the licensing process and the issues and trends affecting these arrangements.

This report focuses on and explains the mechanics and reasoning that produce strong and productive licensing agreements within the larger context of the pharma/biotech partnering phenomenon.

Key issues addressed:

The current pharmaceutical and biotechnology industries
The drug discovery process
Forms of partnerships
How-to information for partnering
Recommendations for optimizing partnerships
A review of licensing impact by therapeutic category
Future of pharma partnering and licensing

Please Note: Theta requires that, for PDF orders, clients sign a confidentiality agreement prior to fulfillment of PDF email delivery.

1 Executive Summary

1.1 Introduction
1.2 Scope and Objectives of Report
1.3 Report Organization

2 Process of Drug Development

2.1 Preclinical Testin
2.2 Phase I Clinical Trials
2.3 Phase II Clinical Trials
2.4 Phase III Clinical Trials
2.5 Treatment Investigational New Drug (IND) Status
2.6 New Drug Application (NDA)
2.7 Time to FDA Approval
2.8 Key Points

3 Industry Overview

3.1 Pharmaceutical Industry
3.1.1 Overview
3.1.2 External Forces Impacting Pharma
3.1.3 Internal Forces Impacting Pharma
3.2 Biotechnology Industry
3.2.1 Overview
3.2.2 Genomics
3.2.3 Proteomics
3.2.4 Pharmacogenomics
3.2.5 Information Technology
3.2.6 Forces Impacting Biotech
3.3 Key Points
3.3.1 Pharma
3.3.2 Biotech

4 Intellectual Property Protection

4.1 Patents
4.2 Copyright
4.3 Trade Secrets/Know-How
4.4 Licensing
4.5 Background and Foreground Rights
4.6 Federal Ownership of Intellectual Property
4.7 Intellectual Property Insurance
4.8 Key Points

5 Partnering Models

5.1 Outsourcing
5.2 Cooperative Relationships
5.2.1 Co-marketing
5.2.2 Co-promotion
5.2.3 Co-development
5.3 Licensing
5.3.1 Out-Licensing
5.3.2 In-Licensing
5.3.3 Reach-through Licensing
5.3.4 Product Acquisition
5.3.5 Product Fostering
5.3.6 Early Versus Late Stage Licensing
5.4 Collaborations
5.4.1 Research and Development Agreements
5.4.2 Contract Research Agreements
5.4.3 Evaluation and Option Agreements
5.5 Joint Ventures
5.6 Consortia
5.7 Key Points

6 Partnering Process

6.1 Self-Evaluation
6.1.1 Inventory of Intellectual Property
6.1.2 Initial Financial Analysis
6.1.3 Evaluation of Intellectual Property Versus Strategy
6.2 Project Management Teams
6.3 Partner Profile Development
6.4 Candidate Identification
6.5 Confidentiality Agreements
6.6 Due Diligence: Organizational
6.6.1 Intellectual Property
6.6.2 Infringement of Third Party Rights
6.6.3 Agreements
6.7 Due Diligence: Market and Product
6.7.1 Data Ga
6.7.2 Valuation
6.8 Negotiations
6.9 Working With Public Funds
6.9.1 Overview
6.9.2 Current Concerns
6.9.3 NIH Working Group Recommendations
6.9.4 Recommendations for Contracting With NIH-Funded Recipients
6.10 Key Points
6.10.1 Of the Partnering Process
6.10.2 Of Working With Public Funds

7 Key License Agreement Terms

7.1 Scope of Agreement
7.1.1 Subject
7.1.2 Field of U
7.1.3 Territory
7.2 Intellectual Property Management
7.2.1 Exclusivity
7.2.2 Special Provisions for Collaboration Agreements
7.2.3 Maintenance and Enforcement of Patents
7.2.4 Special Provisions for Agreements With IT Providers
7.3 Rights in I
7.4 Authorized Users of Licensed Rights
7.5 Warranties, Indemnities, Limitation of Liability
7.6 Payment Arrangements
7.6.1 Upfront Payment
7.6.2 Milestone Payments
7.6.3 Equity Investment
7.6.4 Royalties
7.7 Enforceability
7.8 Term and Termination Provisions
7.8.1 Rights on Termination
7.9 Novel Terms From 2002 Activity
7.10 Key Points

8 Partnership Implementation and Success

8.1 Report of Partnering Experience
8.2 Reasons for Suboptimal Performance
8.2.1 Partner Selection
8.2.2 Management of Change
8.2.3 Management of the Deal-Making Process
8.2.4 Planning and Implementation
8.2.5 Commu
8.3 Key Points

9 World Market Impact of Licensing

9.1 Global Pharma/Biotech Market Factors
9.1.1 Harmoni
9.1.2 Patent Expiry and Blockbuster Drug Exposure
9.1.3 U.S. as Drug Development Leader
9.1.4 Information Technology and Drug Delivery
9.1.5 Changes in Japanese Regulation
9.2 Major Therapeutic Categories
9.2.1 Cardiovascular Drug Market
9.2.2 Central Nervous System (CNS) Drug Market
9.2.3 Gastrointestinal/Metabolic Drug Market
9.2.4 Anti-Infectives Market
9.2.5 Respiratory Drug Market
9.3 Key Points 10 Future of Licensing and Partnerships

10.1 Reasons for Permanency of Licensing
10.2 Changes in the Partnership Process
10.2.1 Alliance Management
10.2.2 Financial Structure
10.2.3 Matching Supply and Demand
10.3 Compulsory Licensing
10.4 Integrated Licensing
10.5 Drug Cost Justification and HTAs
10.6 Key Points

11 Partnership Activity Survey 2002

11.1 Survey Criteria
11.2 Volume of Activity Types
11.3 Geographic Regions
11.4 Major Partner Companies
11.5 Partnership Areas of Interest
11.6 Partnership Types by Industry
11.6.1 Pharma Biotech Partnerships
11.6.2 Biotech Biotech Partnerships
11.6.3 Pharma Pharma Partnerships
11.7 Key Points

12 Company Alliance/Partnership Lists

12.1 Abbott Lab
12.2 Amersham PLC
12.3 Amgen
12.4 Aventis
12.5 Bristol-Myers Squibb
12.6 Cambridge Antibody Technology
12.7 Eli Lilly
12.8 Genentech
12.9 Genmab
12.10 Genzyme
12.11 GlaxoSmi
12.12 Johnson & Johnson
12.13 Merck & Co.
12.14 Millennium Pharmaceuticals
12.15 Novartis
12.16 Pharmacia/Pfizer
12.17 Roche
12.18 Schering-Plough
12.19 Wyeth

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