The Law of Patents - With a Special Focus on Pharmaceuticals in India

The Law of Patents-With a Special Focus on Pharmaceuticals in India represents the fascinating interface between science and law. It is essentially the study of how a patent specification is understood and interpreted. As a techno-legal document, a patent specification embodies the challenges of both science and law in that it seeks to protect the rights in an invention and explain the scientific advancement it makes. And what is in science is in law as well: the controversies constantly revolve around differences over the meaning of words.

In 23 topic-oriented chapters, this book explains the law of patents in India and addresses the issues faced by inventors, patent owners, licensees, patent agents, patent examiners, lawyers, and judges in dealing with patents. It retains familiarity with the Patents Act 1970 and Patents Rules 2003 as the chapters are drawn and structured around the provisions of the Act and the Rules. It contains a detailed commentary on all aspects of the law with an analysis of Indian and foreign decisions.
This book presents the law in the light of the post-TRIPS amendments and argues for interpreting the patent law in the light of the flexibilities offered by the TRIPS Agreement. It covers the major changes in patent law, including the Patents (Amendment) Act 2005 and the Patents (Amendment) Rules 2006. It also incorporates the recent case laws notably the cases on Novartis-Gleevec Exclusive Marketing Rights and Novartis-Gleevec Patent Application.This book has a special focus on pharmaceutical patents as the law provides for various provisions which may be used more often by pharmaceuticals companies. The provisions under the Patents Act 1970 on selection patents, novelty of use, Swiss form of claims, patentability of pharmaceutical and biotechnological inventions, exclusive marketing rights, pre-grant opposition, compulsory licensing, export of pharmaceutical products, bolar exemptions, parallel importation etc are also discussed.

CHAPTER 1

Patent as an Intellectual Property Right ........................................ 1

INTRODUCTION ....................................................................................... 1
THE ORIGIN OF PATENT LAW .................................................................10
PATENTS IN THE PHARMACEUTICAL INDUSTRY ...........................................16
PATENTS IN INTERNATIONAL LAW ............................................................21

CHAPTER 2

Patentable Inventions ................................................................. 27

INTRODUCTION .....................................................................................27
NATURE OF INVENTIONS .........................................................................28
CONDITIONS FOR PATENTABILITY .............................................................32
INDUSTRIAL APPLICATION ........................................................................36
INVENTIONS NOT PATENTABLE ................................................................42

CHAPTER 3

Pharmaceutical Inventions .......................................................... 57

INTRODUCTION .....................................................................................57
PATENTABILITY OF PHARMACEUTICALS .....................................................59
CONSTITUTIONALITY OF SECTION 3(d) ....................................................86
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Contents

CHAPTER 4

Biotechnological Inventions ........................................................ 99

INTRODUCTION .....................................................................................99
PATENTABILITY OF BIOTECHNOLOGICAL INVENTIONS .............................. 102

CHAPTER 5

Specification ...............................................................................109

INTRODUCTION .................................................................................. 109
TWO KINDS OF SPECIFICATIONS ........................................................... 112
REQUIREMENTS OF A COMPLETE SPECIFICATION ..................................... 115
PRIORITY DATES ................................................................................. 124

CHAPTER 6

Construction of a Patent ............................................................135

INTRODUCTION .................................................................................. 135
GENERAL PRINCIPLES OF CONSTRUCTION .............................................. 140
FORM AND STRUCTURE OF CLAIMS ....................................................... 175

CHAPTER 7

Patent Application ......................................................................181

INTRODUCTION .................................................................................. 181
PERSONS WHO CAN APPLY .................................................................... 183
REQUIREMENTS OF AN APPLICATION ...................................................... 193
TYPES OF PATENT APPLICATIONS .......................................................... 196
PUBLICATION AND EXAMINATION .......................................................... 208
SECRECY OF INVENTIONS ..................................................................... 225

CHAPTER 8

Exclusive Marketing Rights ........................................................229

INTRODUCTION .................................................................................. 229
THE ORIGIN OF EMR ........................................................................ 230
THE GRANT OF EMR ........................................................................ 233
INFRINGEMENT OF EMR ..................................................................... 234
OPPOSITION PROCEEDINGS AND EMR ................................................. 240
PUBLIC INTEREST AND EMR ............................................................... 242
EMR AFTER THE PATENTS (AMENDMENT) ACT 2005 ......................... 244
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CHAPTER 9

Grant of a Patent ........................................................................249

INTRODUCTION .................................................................................. 249
EFFECT OF THE GRANT ....................................................................... 250
RESTRICTIONS ON THE GRANT ............................................................. 252
RIGHTS CONFERRED BY THE GRANT ..................................................... 253

CHAPTER 10

Amendment of a Patent .............................................................259

INTRODUCTION .................................................................................. 259
STAGES OF AMENDMENT ...................................................................... 262
AMENDMENTS BEFORE THE CONTROLLER ............................................. 263
AMENDMENTS BEFORE APPELLATE BOARD AND HIGH COURT ................. 278
SCOPE OF AMENDMENT ....................................................................... 283
EFFECT OF AMENDMENT ..................................................................... 295

CHAPTER 11

Term of a Patent .........................................................................297

INTRODUCTION .................................................................................. 297
PATENT TERM .................................................................................... 298
RENEWAL FEES ................................................................................... 300
RESTORATION OF LAPSED PATENTS ....................................................... 302
SURRENDER AND REVOCATION OF PATENTS ........................................... 306

CHAPTER 12

Patent Office, Appellate Board and Central Government..........309

INTRODUCTION .................................................................................. 309
PATENT OFFICE .................................................................................. 309
APPELLATE BOARD............................................................................... 330
POWERS OF CENTRAL GOVERNMENT .................................................... 337

CHAPTER 13

Opposition Proceedings .............................................................339

INTRODUCTION .................................................................................. 339
OPPOSITION BEFORE THE GRANT ......................................................... 346
OPPOSITION AFTER THE GRANT ........................................................... 362
DIFFERENCES BETWEEN PRE-GRANT AND POST-GRANT OPPOSITION ....... 391
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Contents
POWERS OF THE CONTROLLER ............................................................. 392
APPEALS ........................................................................................ 397

CHAPTER 14

Grounds of Opposition ..............................................................403

INTRODUCTION .................................................................................. 404
INVENTION WRONGFULLY OBTAINED: SECTIONS 25(1)(a)
AND 25(2)(a) ............................................................................. 409
PRIOR PUBLICATION: SECTIONS 25(1)(b) AND 25(2)(b) ....................... 411
PRIOR CLAIMING: SECTIONS 25(1)(c) AND 25(2)(c) ............................ 416
PUBLICLY KNOWN OR PUBLICLY USED: SECTIONS 25(1)(d)
AND 25(2)(d) ............................................................................. 419
LACK OF INVENTIVE STEP: SECTIONS 25(1)(e) AND 25(2)(e) ............... 419
SUBJECT OF CLAIM NOT AN INVENTION OR NOT PATENTABLE:
SECTIONS 25(1)(f) AND 25(2)(f) ................................................. 424
INSUFFICIENCY: SECTIONS 25(1)(g) AND 25(2)(g) ............................... 424
NON-DISCLOSURE OF INFORMATION: SECTIONS 25(1)(h)
AND 25(2)(h) ............................................................................. 425
FALSE CLAIM TO CONVENTION PRIORITY: SECTIONS 25(1)(i)
AND 25(2)(i) .............................................................................. 426
NON-DISCLOSURE OF BIOLOGICAL MATERIAL: SECTIONS 25(1)(j)
AND 25(2)(j) .............................................................................. 431
ANTICIPATION BY TRADITIONAL KNOWLEDGE: SECTIONS 25(1)(k)
AND 25(2)(k) ............................................................................. 432

CHAPTER 15

Revocation Proceedings ..............................................................433

INTRODUCTION .................................................................................. 433
REVOCATION BY CONTROLLER ............................................................. 436
REVOCATION BY APPELLATE BOARD ...................................................... 439
REVOCATION BY HIGH COURT ............................................................. 442
REVOCATION BY CENTRAL GOVERNMENT ............................................. 448

CHAPTER 16

Grounds of Revocation...............................................................451

INTRODUCTION .................................................................................. 452
PRIOR CLAIMING: SECTION 64(1)(a) .................................................... 457
PERSON NOT ENTITLED TO APPLY: SECTION 64(1)(b) ......................... 466
PATENT WRONGFULLY OBTAINED: SECTION 64(1)(c) ........................... 467
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SUBJECT OF CLAIM NOT AN INVENTION: SECTION 64(1)(d) .................. 470
LACK OF NOVELTY: SECTION 64(1)(e) ................................................ 470
LACK OF INVENTIVE STEP: SECTION 64(1)(f) ....................................... 511
LACK OF UTILITY: SECTION 64(1)(g) .................................................. 535
INSUFFICIENCY: SECTION 64(1)(h) ....................................................... 539
CLAIM INDEFINITE OR UNSUPPORTED: SECTION 64(1)(i) ....................... 547
FALSE SUGGESTION OR REPRESENTATION: SECTION 64(1)(j) .................. 551
SUBJECT OF CLAIM NOT PATENTABLE: SECTION 64(1)(k) ...................... 553
SECRET USE IN INDIA: SECTION 64(1)(l) ............................................. 554
NON-DISCLOSURE OF INFORMATION: SECTION 64(1)(m) ....................... 557
CONTRAVENTION OF SECRECY DIRECTIONS: SECTION 64(1)(n) ............. 557
LEAVE TO AMEND OBTAINED BY FRAUD: SECTION 64(1)(o) .................. 558
NON-DISCLOSURE OF BIOLOGICAL MATERIAL: SECTION 64(1)(p) ........... 559
ANTICIPATION BY TRADITIONAL KNOWLEDGE: SECTION 64(1)(q) ........... 559

CHAPTER 17

Declaration of Non-infringement ..............................................561

INTRODUCTION .................................................................................. 561
DECLARATION UNDER THE PATENTS ACT 1970 ................................... 564
DECLARATION UNDER THE SPECIFIC RELIEF ACT 1963 ......................... 573

CHAPTER 18

Threat of Infringement ..............................................................577

INTRODUCTION .................................................................................. 577
ACTION ON THREAT OF INFRINGEMENT................................................. 581
RELIEF IN CASES OF THREATS ............................................................... 597

CHAPTER 19

Infringement of a Patent ............................................................603

INTRODUCTION .................................................................................. 603
DETERMINING INFRINGEMENT .............................................................. 605
ACT WITHIN THE SCOPE OF THE INVENTION ........................................ 606
ACT VIOLATES THE RIGHTS OF THE PATENTEE ...................................... 607
LIABILITY FOR THE ACT ....................................................................... 615
ACT MUST NOT BE AN EXCLUDED ACT ................................................ 621

CHAPTER 20

Infringement Proceedings ..........................................................627

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Contents
INTRODUCTION .................................................................................. 627
JURISDICTION ...................................................................................... 628
PARTIES TO THE PROCEEDING .............................................................. 635
PROCEDURE AND PRACTICE .................................................................. 639
DEFENCES ........................................................................................ 649
RELIEF IN SUITS FOR INFRINGEMENT ..................................................... 655

CHAPTER 21

Transfer of a Patent ....................................................................681

INTRODUCTION .................................................................................. 681
KINDS OF TRANSFERS .......................................................................... 683
OWNERSHIP AND DEVOLUTION ............................................................ 684
ASSIGNMENTS, LICENCES AND MORTGAGES ........................................... 686
CO-OWNERSHIP ................................................................................... 703
REGISTRATION OF ASSIGNMENTS, LICENCES, ETC ................................... 704

CHAPTER 22

Compulsory Licences .................................................................705

INTRODUCTION .................................................................................. 705
APPLICATION FOR THE GRANT OF COMPULSORY LICENCES ....................... 712
GENERAL COMPULSORY LICENCES—SECTION 84 APPLICATION ............... 717
LICENSING OF RELATED PATENTS—SECTION 91 APPLICATION ................ 729
SPECIAL COMPULSORY LICENCES—SECTION 92 APPLICATION .................. 730
COMPULSORY LICENCE FOR EXPORT OF PHARMACEUTICALS—
SECTION 92A APPLICATION ........................................................... 731
REVOCATION OF PATENT FOR NON-WORKING—
SECTION 85 APPLICATION ............................................................. 733
POWERS OF THE CONTROLLER ............................................................. 734
TERMINATION OF COMPULSORY LICENCE ............................................... 744
APPEALS ........................................................................................ 745

CHAPTER 23

Use and Acquisiton of Inventions by Government ....................747

INTRODUCTION .................................................................................. 747
USE OF INVENTION FOR GOVERNMENT PURPOSES .................................. 748
ACQUISITION OF INVENTION BY CENTRAL GOVERNMENT ....................... 755
DISPUTE RESOLUTION ......................................................................... 756
Index ................................................................................................ 759