Abstract
By 2001, the United States Patent and Trademark Office (USPTO) received 34,527 biotechnology patent applications. A new report indicates patents on genes and proteins--representing potential drug targets--are quickly becoming the currency of the postgenomic era. D&MDs Patents in the Postgenomic Era: Proprietary Drug Targets and Therapies is the first report to attempt to assess the impact of human genome sequencing efforts on drug discovery research and to focus on the implications for the drug targets industry. The report offers information from past experiences with patenting of genes and proteins to secure potential drug targets by obtaining suitable patent protection and the results of a new survey of 9,972 postgenomic patents to assist the reader in predicting how soon products of genomics may reach advanced clinical trials.
Table of Contents
Chapter 1: Executive Summary
Chapter 2: Trends in Postgenomic Biotechnology
- Biomedical Innovation in the Postgenomic Era
- The Role of Patents in the Biomedical Industry
- Post-Genomic Technologies
- Functional Genomics
- Pharmacogenomics
- Transcriptomics
- Proteomics
- Glycomics
- Metabolomics
- Other Omics
- Established and Emerging Therapies
- Small Molecules
- Protein-Based Biotherapies
- Nucleic Acid-Based Biotherapies
- Gene Therapy
- Antisense Including RNA Interference
- Molecular Diagnostics
Chapter 3: Patent Law, Procedures, and Biomedical Inventions
- What is a Patent?
- Patents Confer an Exclusionary Right
- Patents Do Not Confer Ownership of Products
- Patents and Property Rights
- Patents and Monopolies
- Consideration for Grant
- Patents Require International Cooperation
- The Paris Convention
- The European Patent Convention
- GATT-TRIPs
- Recent Developments
- Patents are Time-Limited
- What can be Patented?
- Novelty
- The Inventive Step
- Effect of Unpublished Prior Applications
- Industrial Application
- Exceptions to Patentability
- Patents in the Postgenomic Era
- US Utility Patents
- Patent Costs
- The Patent Document
- Inventors and Assignees
- "First-to-Invent"
- Provisional Applications
- The American Inventors Protection Act
- Novelty Requirement
- Non-Obviousness Requirement
- Recent Growth in Patenting
- Grace Periods
- Post-Issue Challenges to Patent Validity
- EPO Opposition Procedure
- US Reexamination Procedures
- Proposals for Post-Grant Review
- Patenting Chemical Compounds
- Patenting Pharmaceuticals
- Overview
- First Pharmaceutical Use
- Second Pharmaceutical Use
- Other Aspects of Pharmaceutical Patenting
- Patenting Natural Products
- Patenting Microbiological Inventions
- Patent Infringement
- Overview
- Remedies for Infringement
- Patent Litigation in the US
- Litigation Costs
- Doctrine of Equivalents
- Research Use of an Invention
- Patent Litigation in Europe
Chapter 4: Patenting of Genes and Proteins
- Introduction
- Patenting of Genes
- Background on Genes
- The Drive Toward Patenting
- Protection Afforded by Patent Law
- Growth in DNA-related Patenting
- Patenting of Proteins
- Background on Proteins
- Structural Initiatives
- The Drive Toward Patenting
- Patents in the Postgenomic Era
- Protection Afforded by Patent Law
- Regulatory Developments Relevant to Genes
- Tightening Patentability Requirements
- Areas of Controversy
- Patenting of ESTs
- Patenting DNA Sequence Variations
- Regulatory Developments Relevant to Proteins
- Patenting of 3-D Structures 4--12
- Areas of Controversy
- Computational Prediction of Function
- Broadly Interpreted Patents 4--15
- Patent Claims and Risk of Litigation
- Solutions to the Patent Thicket Problem
- Issues Raised by Exclusive Licensing
Chapter 5: Analysis of US Patents 1990 -- 2005
- Patent Activity Survey: Aims and Methodology
- Overview of Therapy Areas
- Cancer
- CNS Therapy
- Metabolism/Cardiology
- Infection/Immunology
- Patent Activity in Major Drug Target Classes
- GPCRs
- Enzymes
- Kinases
- Phosphatases
- Proteases
- ATPases and ABC Transporters
- Monamine Oxidases
- Glycoenzymes/Glycobiology
- Ion Channels
- Nuclear Receptors
- Cytokines and Chemokines
- Patent Activity in Gene Therapy
- Patent Activity in RNA Interference
- Patent Activity in Pharmacogenomics
- Summary of Patent Activity Survey
- Analysis of Patents by Filing and Publication Year
- Analysis of Patent Maintenance
- Analysis of Patents by US Classification
- Patents in the Postgenomic Era
Chapter 6: Patent Competitive Intelligence
- Mining Patents for Competitive Intelligence
- Patent Searching
- Internet-Based Patent Resources
- Computational Patent Mapping
- Indicators of Patent Quality
- Patent Citations Weights
- Length of Life and Spatial Weights
- Composite Index of Patent Quality
- Competitive Analysis of Biopatents Survey
- Most Prolific Assignees
- Most Frequently Cited Patents
TABLE OF EXHIBITS
- Exhibit 3.1 Legal Definitions of Patentable Inventions
- Exhibit 5.1 Biopatents Search Syntax (Using Delphion)
- Exhibit 5.2 Biopatents Dataset by Target/Technology
- Exhibit 5.3 Patent Activity Analysis for GPCRs
- Exhibit 5.4 US Patents on Novel Target Proteins (n=23)
- Exhibit 5.5 Patent Activity Analysis for Kinases
- Exhibit 5.6 Patent Activity Analysis for Phosphatases
- Exhibit 5.7 Patent Activity Analysis for Proteases
- Exhibit 5.8 Patent Activity Analysis for ATPases
- Exhibit 5.9 Patent Activity Analysis for ABC Transporters
- Exhibit 5.10 Patent Activity Analysis for MAOs
- Exhibit 5.11 Patent Activity Analysis for Glycobiology
- Exhibit 5.12 Patent Activity Analysis for Ion Channels
- Exhibit 5.13 Patent Activity Analysis for Nuclear Receptors
- Exhibit 5.14 Patent Activity Analysis for Cytokines and Chemokines
- Exhibit 5.15 Patent Activity Analysis for Gene Therapy
- Exhibit 5.16 Patent Activity Analysis for RNAi
- Exhibit 5.17 Patent Activity Analysis for Pharmacogenomics
- Exhibit 5.18 Activity Analysis for All Patents
- Exhibit 5.19 Proportion of Mainly Methodological Patents in Each Group
- Exhibit 5.20 Proportion of Therapy-oriented Patents in Each Group
- Exhibit 5.21 Proportion of Therapy-oriented Tatents Disclosing One or More Novel Target Proteins
- Exhibit 5.22 Proportion of Therapy-oriented Patents Reporting One or More Novel Target Sequences
- Exhibit 5.23 Proportion of Therapy-oriented Patents Disclosing One or More Novel Peptides
- Exhibit 5.24 Proportion of Patents Describing Therapy with One or More Novel Small Molecules
- Exhibit 5.25 Proportion of Therapy-oriented Patents Focusing on Cancer
- Exhibit 5.26 Proportion of Therapy-oriented Patents Docusing on CNS Disorders
- Exhibit 5.27 Proportion of Therapy-oriented Patents Focusing on Metabolism and/or Cardiology
- Exhibit 5.28 Proportion of Therapy-oriented Patents Focusing on Infection and/or Immunology
- Exhibit 5.29 Proportion of Therapy-oriented Patents Describing Diagnostics and/or Biomarkers 5--37
- Exhibit 5.30 Percent Published Patent Applications by Group
- Exhibit 5.31 Numbers of Mainly Methodological Patents in Each Group
- Exhibit 5.32 Numbers of Therapy-oriented Patents in Each Group
- Exhibit 5.33 Numbers of Patents Disclosing One or More Novel Target Proteins
- Exhibit 5.34 Numbers of Patents Reporting One or More Novel Target Sequences
- Exhibit 5.35 Numbers of Patents Disclosing One or More Novel Peptides
- Exhibit 5.36 Numbers of Patents Describing Therapy with One or More Novel Small Molecules
- Exhibit 5.37 Numbers of Patents Focusing on Cancer
- Exhibit 5.38 Numbers of Patents Focusing on CNS Disorders
- Exhibit 5.39 Numbers of Patents Focusing on Metabolism and/or Cardiology
- Exhibit 5.40 Numbers of Patents Focusing on Infection and/or Immunology
- Exhibit 5.41 Numbers of Patents Describing Diagnostics and/or Biomarkers
- Exhibit 5.42 Numbers of Published Patent Applications by Group
- Exhibit 5.43 US Patents and Published Applications, 1990-2005
- Exhibit 5.44 Analysis of US Applications and Patents by Filing and Publication Year: ABC Transporters (103)
- Exhibit 5.45 Analysis of US Applications and Patents by Filing and Publication Year: ATPases (556)
- Exhibit 5.46 Analysis of US Applications and Patents by Filing and Publication Year: Cytokines and Chemokines (836)
- Exhibit 5.47 Analysis of US Applications and Patents by Filing and Publication Year: Gene Therapy (423)
- Exhibit 5.48 Analysis of US Applications and Patents by Filing and Publication Year: Glycobiology (390)
- Exhibit 5.49 Analysis of US Applications and Patents by Filing and Publication Year: G-Protein Coupled Receptors (1,097)
- Exhibit 5.50 Analysis of US Applications and Patents by Filing and Publication Year: Ion Channels (852)
- Exhibit 5.51 Analysis of US Applications and Patents by Filing and Publication Year: Monoamine Oxidase Inhibitors (273)
- Exhibit 5.52 Analysis of US Applications and Patents by Filing and Publication Year: Nuclear Receptors (453)
- Exhibit 5.53 Analysis of US Applications and Patents by Filing and Publication Year: Protein Kinases (1,559)
- Exhibit 5.54 Analysis of US Applications and Patents by Filing and Publication Year: Pharmacogenomics (1,122)
- Exhibit 5.55 Analysis of US Applications and Patents by Filing and Publication Year: Phosphatases (800)
- Exhibit 5.56 Analysis of US Applications and Patents by Filing and Publication Year: Proteases (1,396)
- Exhibit 5.57 Analysis of US Applications and Patents by Filing and Publication Year: RNA Interference (824)
- Exhibit 5.58 Comparison of 15-Year Patenting Activity in Biopatents with Mechanical Engineering and Software
- Exhibit 5.59 Patent Shares 1990--2005 for Biopatents, Mechanical Engineering, and Software
- Exhibit 5.60 Patent Shares 1990--2005 for Biopatents and Technologies
- Exhibit 5.61 Patent Shares 1990--2005 for Biopatents Applications and Categories
- Exhibit 5.62 Biopatents Publication Rates 1990--2005 by Category and Application
- Exhibit 5.63 Analysis of Patent Maintenance
- Exhibit 5.64 Analysis of Patents by US Classification
- Exhibit 6.1 Analysis of US Patents by Top 20 Assignees
- Exhibit 6.2 Analysis of Most Frequently Cited US Patents
