United States Patent Law and Practice with Special Reference to the Pharmaceutical and Biotechnology Industries

Patents / Biotechnology / US Biotechnology Practice

United States Patent Law and Practice with Special Reference to the Pharmaceutical and Biotechnology Industries [1]

By John Richards

1. Introduction
2. Patentable Subject Matter
3. Utility Requirement

3.1 PTO Utility Guidelines

4. The Written Description

4.1 Written description and enabling disclosure are separate requirements.
4.2 The Written Description Requirement
4.3 USPTO Guidelines and Training Materials on Written Description Requirements
4.4 Enablement
4.5 Best Mode
4.6 Micro-organism Deposits
4.7 Sequence Listings in Biotechnology Cases
4.8 The Effect of Early Publication on Drafting U.S. Patent Applications

5. Inventorship
6. Novelty and Statutory Bars

6.1 Prior Use
6.2 The "On Sale" bar
6.3 The Effect of a Prior U.S. Application or PCT Application designating the United States
6.4 Prior Invention by another who had not Abandoned, Suppressed or Concealed it.
6.5 Novelty of Product by Process Claims

7.1 Special Problems in Chemical Cases
7.2 "Obvious to Try"
7.3 Does disclosure of a genus make all species within it obvious?

8. Infringement

8.1 Direct Infringement
8.2 Process Patent Amendment Act
8.3 Doctrine of Equivalents
8.4 Special Provisions Relating to Drug Patents and Patents for Medical Uses
8.5 Indirect Infringement

9. Patent Term Extension
APPENDIX

[1] This paper was originally delivered by the author at the IIPRP and TIFAC Seminars Delhi and Hyderabad, India during January 2002. Copyright 2002 John Richards. All rights reserved.

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© Copyright 2002 John Richards - Posted July 2002
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