The Touchstone Effect : The Impact Of Pre-Grant Opposition On Patents

The Touchstone Effect: The Impact of Pre-grant Opposition on Patents explores the strategic use of pre-grant opposition as a touchstone to test the genuineness of an invention. In a comprehensible fashion, it guides you to develop an in-house, efficient and cost-effective strategy for challenging patents before their grant. It also gets to the other side to tell you what you should do if your patent application is opposed—that is, if you really have a Black Swan to protect. This book continues its life online at www.thetouchstoneeffect. blogspot.com

Preface ................................................................................................... v
Contents ............................................................................................... ix
Table of Cases .....................................................................................xvii
CHAPTER 1
The Black Swans of Innovation .................................................... 1
THE PROCESS OF INNOVATION .................................................................. 2
SOURCES OF INNOVATION ......................................................................... 3
New Scientific Knowledge .............................................................. 3
The Elements of Knowledge-based Innovation .............................. 4
Long Lead Time ............................................................................. 4
Convergence of Knowledge .............................................................. 5
Types of Innovation ........................................................................ 5
RADICAL INNOVATIONS ARE THE BLACK SWANS ........................................... 7
Serendipitous Black Swans ............................................................. 7
CHAPTER 2
Why Some Swans are Painted Black .............................................. 9
THE PROCESS OF INNOVATION IN PHARMACEUTICALS .................................. 9
Research & Development .............................................................10
Development of New Drug ..........................................................11
Clinical Trials ................................................................................11
The Cost of R&D .........................................................................12
INNOVATION IN THE PHARMACEUTICAL INDUSTRY .....................................13
PERILS OF KNOWLEDGE-BASED INNOVATION ............................................16
FROM BASIC SCIENCE TO BEST-SELLING DRUGS .......................................16
Retrovir (AZT-zidovudine) ...........................................................17
Gardasil (HPV Vaccine) ................................................................18
Taxol (paclitaxel) ...........................................................................18
Epogen (erythropoietin) ...............................................................18
Gleevec (imatinib mesylate) .........................................................18

Fuzeon (enfuvirtide) .....................................................................19
PROTECTING THE BLACK SWANS .............................................................19
When Blockbusters Go Off-patent ...............................................20
Block in the Pipelines ...................................................................21
Still in Business .............................................................................22
CHAPTER 3
The Art of Re-inventing Inventions ............................................ 25
PROTECTING INVENTIONS .......................................................................25
The Industry and the Role of Patents ..........................................26
KINDS OF PATENTS ................................................................................27
Process and Product Patents .........................................................27
Conditions for Grant of a Patent ..................................................28
Patents for Improvements .............................................................29
‘Me-too’ drugs ..............................................................................29
STRATEGIES ON INNOVATIONS ..................................................................30
Innovation Portfolio ......................................................................31
EXTENDING THE PATENT LIFE .................................................................32
Delaying Generic Entry ................................................................33
HOW TO PAINT A SWAN BLACK ..............................................................33
Secondary Patents .........................................................................34
Protecting Me-too Drugs with Secondary Patents .......................35
Re-inventing Drugs ......................................................................36
Is it a Bright Idea? .........................................................................37
CHAPTER 4
The Touchstone Effect of Pre-grant Opposition ......................... 39
OPPOSTION BEFORE THE GRANT .............................................................39
THE PATENT APPLICATION PROCESS ........................................................40
Requirements of a Patent Application ..........................................41
Publication of Patent Application .................................................41
Examination of Patent Application ...............................................42
SOME ISSUES AT THE PATENT OFFICE .......................................................42
Lack of Transparency in Examination ...........................................43
Amendments Unlimited ...............................................................44
The Standard of Examination.......................................................46
Competence in New Technologies ...............................................47
Examiners’ Exodus ........................................................................48

SOME ISSUES BEYOND THE PATENT OFFICE ..............................................48
THE IMPACT OF PRE-GRANT OPPOSITION .................................................50
Pre-grant Opposition Empowers the Patent Office .....................50
Pre-grant Opposition Reduces the Incidence of
Patent Litigation ......................................................................50
Pre-grant Opposition Promotes Competition ..............................51
Pre-grant Opposition Facilitates the Flow of
Business Information ...............................................................51
Pre-grant Opposition Remedies the Problems
in Transition ............................................................................52
THE HISTORY OF OPPOSITION REFORMS IN THE UNITED STATES ...............53
THE HISTORY OF OPPOSITION REFORMS IN INDIA ....................................54
Patents Enquiry Committee .........................................................55
Report of Justice Ayyangar ...........................................................56
Before the 2005 Amendment Act ................................................57
After the 2005 Amendment Act ..................................................57
CHAPTER 5
The Importance of Pre-grant Opposition ................................... 59
THE CONTEXT OF PRE-GRANT OPPOSITION ..............................................59
Opposition Proceedings ................................................................60
Revocation Proceedings ................................................................61
THE SIGNIFICANCE OF PRE-GRANT OPPOSITION .........................................61
Challenge Before the Granting Authority ....................................62
Challenge by Peers ........................................................................62
Time-bound Proceeding ...............................................................62
Simple and Inexpensive Procedure ...............................................62
CHAPTER 6
Opposition Attraction ................................................................. 63
COST-EFFECTIVENESS .............................................................................63
A Thought Experiment .................................................................63
USER-FRIENDLINESS ...............................................................................64
EASY PROCEDURE ...................................................................................67
Pre-grant Opposition is a Part of the Application Process ...........67
Informal Procedure for Entering Appearance ...............................68
Lack of Procedure for Hearing the Opponent ..............................68
Procedure Subject to the Discretion of Controller .......................68
Access to Applicant’s Defence .......................................................69

Lack of Appeal and Costs for the Opponent ................................69
UNLIMITED OPPORTUNITIES FOR CHALLENGING PATENTS ..........................69
Opposition does not Bar Further Challenge ................................70
Oppositions and Withdrawals ......................................................71
CHAPTER 7
The Grounds of Opposition ........................................................ 73
INVENTION WRONGFULLY OBTAINED .......................................................73
Burden and Standard of Proof ......................................................74
LACK OF NOVELTY ................................................................................74
(A) Prior Publication ....................................................................75
Required Conditions .................................................................... 75
Novelty of Intermediates ............................................................... 76
Mosaic of Prior Art Documents .................................................... 76
Alternatives in a Prior Document ................................................. 77
(B) Prior Claiming ........................................................................77
Required Conditions .................................................................... 77
(C) Publicly Known or Publicly Used .........................................78
(D) Anticipation by Traditional Knowledge ................................78
LACK OF INVENTIVE STEP .......................................................................78
Proof of Obviousness .................................................................... 79
Mosaic of Prior Art Documents .................................................... 79
Obviousness of Intermediates ........................................................ 80
INVENTION IS NOT PATENTABLE .............................................................80
The Ingredients of Section 3(d) ...................................................81
Polymorphs ...................................................................................82
Enhancement of Therapeutic Efficacy ..........................................83
Determining Enhancement of Efficacy ........................................83
Proof of Enhanced Efficacy ...........................................................84
Efficacy and Placebo Comparison .................................................85
Stability is Not Efficacy ................................................................85
Particle Size ...................................................................................85
Enantiomers ..................................................................................86
Stereo Chemical Property .............................................................86
Markush Claims ............................................................................87
New Therapeutic Use ...................................................................87
Selection Patents ...........................................................................88
Novartis’ Patent for Glivec ............................................................89
Formulation and Composition .....................................................91
Combinations ...............................................................................92

Synergistic Effect ..........................................................................93
Method of Treatment ....................................................................93
Software ......................................................................................94
Business Methods .........................................................................94
INSUFFICIENCY OF DESCRIPTION ..............................................................95
Clinical Studies .............................................................................95
Description of Software ................................................................96
Insufficiency of Examples and Illustrations ..................................96
Insufficient Disclosure of Prior Art ...............................................97
NON-DISCLOSURE .................................................................................97
(A) Non-disclosure of Information ...............................................97
(B) Non-disclosure of Biological Material ....................................97
FALSE CLAIM TO CONVENTION PRIORITY .................................................98
Wrong Claiming of Priority ..........................................................98
ADDITIONAL GROUNDS OF OPPOSITION ...................................................98
CHAPTER 8
The Practice of Pre-grant Opposition ........................................101
EIGHT STEPS TOWARDS EFFECTIVE OPPOSITION ..................................... 101
STEP 1: SEARCH OF THE OFFICIAL JOURNAL........................................... 102
STEP 2: IDENTIFICATION OF THE PATENT APPLICATION .......................... 103
STEP 3: RESEARCH ON MERITS ............................................................ 104
Internal and External Requirements ......................................... 104
Online Research Tools ............................................................... 105
STEP 4: PREPARATION OF WRITTEN REPRESENTATION ............................. 106
Statement ................................................................................... 106
Evidence ................................................................................... 107
Affidavits and Documents ......................................................... 107
Late Submission of Documents ................................................. 108
International Grants .................................................................. 108
STEP 5: DECISION ON REQUEST FOR HEARING ...................................... 109
Right of Hearing ........................................................................ 109
Adverse Inference from Absence ................................................ 111
STEP 6: FILING THE OPPOSITION .......................................................... 111
Time is the Essence .................................................................... 111
Who Can File ............................................................................. 112
Filing a Revised Opposition ...................................................... 113
STEP 7: COUNTERING THE APPLICANT’S CASE ....................................... 113
Reply of the Applicant .............................................................. 114

Applicant’s Failure to File Reply ............................................... 114
Interlocutory Applications ......................................................... 114
STEP 8: ATTENDING THE HEARING ...................................................... 115
Withdrawal of the Opposition .................................................. 115
Oral Withdrawal of Grounds .................................................... 116
Transfer of Opposition ............................................................... 116
Costs on Frivolous Opposition .................................................. 117
Amendment Pursuant to Opposition........................................ 117
Scope of Amendment ................................................................. 118
Filing of Divisional Application ................................................. 118
CHAPTER 9
Beyond Opposition ....................................................................119
DECISION OF THE CONTROLLER ........................................................... 119
Remedies of the Aggrieved Party ............................................... 120
REVIEW ............................................................................................. 120
APPEAL ............................................................................................... 121
CHAPTER 10
Strategic Opposition of Patents ..................................................123
Patents and Competition ........................................................... 123
THE VALUE OF PATENTS ..................................................................... 125
Why Firms File Patents .............................................................. 125
THE ROLE OF STRATEGY ..................................................................... 126
Strategy for Surviving Legal Changes ........................................ 127
Global Strategy in a Semi-globalised World ............................. 128
Calling the Shots from Elsewhere .............................................. 130
THE RS 120 CRORE (OR MORE) QUESTION ....................................... 130
What Strategy Can Do for You ................................................. 131
DEVELOPING AN IN-HOUSE STRATEGY ON OPPOSITION ........................... 132
The Problem of Free-rider ......................................................... 133
LOOK WHO’S OPPOSING ..................................................................... 134
Bajaj Auto Ltd ............................................................................ 134
Hindustan Unilever Ltd............................................................. 134
Proctor & Gamble ..................................................................... 135
Ranbaxy ................................................................................... 135

APPENDIX 1
Provisions on Opposition under the Patents Act 1970 ...............137
APPENDIX 2
Provisions on Opposition under the Patents Rules 2003 ...........143
Chapter Notes ................................................................................. 147
Index .............................................................................................. 157