Pharmaceutical patent law / John R. Thomas.
2010
KF3133.D78 T46 2010 (Map It)
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Details
Author
Title
Pharmaceutical patent law / John R. Thomas.
Published
Arlington, VA : BNA Books, [2010]
Copyright
©2010
Call Number
KF3133.D78 T46 2010
Edition
Second edition.
ISBN
9781570188985 (hbk.)
157018898X (hbk.)
157018898X (hbk.)
Description
xxiv, 828 pages ; 26 cm
System Control No.
(OCoLC)748581130
Note
No longer updated.
Bibliography, etc. Note
Includes bibliographical references and index.
Record Appears in
Library Has
Main Volume; 2014.Suppl
Main text, 2014 print supplement, and 2010 CD-ROM supplement
Main text, 2014 print supplement, and 2010 CD-ROM supplement
Note
Ceased publication.
Table of Contents
Forword
vii
Preface
ix
Summary Table of Contents
xi
I.
Introduction
1.
Introduction to Pharmaceutical Patents
3
I.
The Drug Patent Debate
4
II.
Overview of the Patent Law
5
III.
Overview of the Marketing Approval Process
6
IV.
A Brief History of Pharmaceutical Patent Law and Food and Drug Law
9
A.
Roche v. Bolar
9
B.
The Hatch-Waxman Act
12
1.
The Statutory Experimental Use Exception
13
2.
Abbreviated New Drug Applications
14
3.
Certifications for Orange Book-Listed Patents
15
4.
Patent Infringement Proceedings
16
5.
Patent Term Extension
18
6.
Marketing Exclusivities
18
7.
Generic Exclusivity
19
8.
The Impact of the Hatch-Waxman Act
19
C.
The Generic Animal Drug and Patent Term Restoration Act
20
D.
The Prescription Drug User Fee Act
20
E.
The Uruguay Round Agreements Act of 1995
21
F.
The FDA Modernization Act
21
G.
The American Inventors Protection Act of 1999
22
H.
The 2002 FTC Study
22
I.
The 2003 FDA Regulations
23
J.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003
24
1.
Single 30-Month Stay
24
2.
Notice of Applications
24
3.
Counterclaim for Patent De-Listing
25
4.
Declaratory Judgment Actions
25
5.
Generic Exclusivity
25
6.
Notice of Agreements
26
K.
The Biologics Price Competition and Innovation Act
26
II.
Patent Acquisition
2.
Patent Eligibility
29
I.
Basic Concepts
29
II.
Product and Process Claims
30
A.
Abstract Ideas
31
B.
Products of Nature
33
C.
Living Inventions
36
D.
Process Claims for New Uses
39
III.
Types of Pharmaceutical Patent Claims
39
A.
Drug Substances
40
B.
Formulations
40
C.
Chemical Intermediates
41
D.
Metabolites and Prodrugs
41
E.
Crystals and Polymorphs
43
F.
Isomers
44
G.
Salts
45
H.
Combination Therapies
45
I.
Methods of Using
46
J.
Methods of Making
47
K.
Methods of Diagnosis
47
IV.
Methods of Medical Treatment
52
3.
Utility
57
I.
Introduction
57
II.
Moral Utility
60
III.
Practical Utility
64
IV.
Practical Utility for Pharmaceutical Patents
67
A.
Brenner v. Manson
68
B.
Leading Case Law of the Court of Customs and Patent Appeals
70
C.
Early Case Law of the Federal Circuit
72
D.
The 1995 PTO Utility Examination Guidelines
73
E.
The 2001 PTO Utility Examination Guidelines
75
F.
In re Fisher
77
V.
Recurring Issues
80
A.
Safety and Efficacy Considerations
80
B.
Structural Similarity to Compounds with an Established Utility
84
C.
In Vitro and In Vivo Tests
85
D.
Human Clinical Data
88
E.
Chemical Intermediates
90
F.
Inoperable Species Within a Genus
91
G.
Assertions of Multiple Utilities
91
H.
The Utility Requirement in Adversarial Proceedings
92
I.
The Utility Requirement and Priority Applications
95
4.
Novelty
97
I.
Introduction
97
II.
Anticipation
100
A.
Genus and Species
101
B.
The Enablement Requirement
107
III.
Inherency
109
IV.
The 35 U.S.C. [§]102(b) Statutory Bar
123
A.
"Public Use" Under 35 U.S.C. [§]102(b)
124
B.
"On Sale" Under 35 U.S.C. [§]102(b)
128
C.
"In This Country"
132
D.
Experimental Use
134
E.
Patents
139
F.
Printed Publications
140
V.
Abandonment Under 35 U.S.C. [§]102(c)
142
VI.
Delayed U.S. Filing Under 35 U.S.C. [§]102(d)
143
VII.
Prior Invention Under 35 U.S.C. [§]102(a)
145
VIII.
Prior Invention Under 35 U.S.C. [§]102(g)
149
A.
Prior Art Under 35 U.S.C. [§]102(g)
152
B.
Priority Under 35 U.S.C. [§]102(g)
153
C.
Inventive Activity in Foreign Countries
153
D.
Conception
155
E.
Reduction to Practice
156
F.
Diligence
158
G.
Corroboration
160
H.
Patent Award to the Second Inventor
163
IX.
Disclosure in U.S. Patent Applications Under 35 U.S.C. [§](e)
167
X.
Derivation Under 35 U.S.C. [§](f)
170
5.
Nonobviousness
173
I.
Introduction
174
II.
Prior Art for Nonobviousness
174
A.
Section 102 as the Source of Prior Art
174
B.
35 U.S.C. [§](c)(1)
175
C.
The CREATE Act
177
III.
The Nonobviousness Inquiry
178
A.
The Historical Standard of Invention
178
B.
The Modern Standard of Nonobviousness
180
C.
The Person of Ordinary Skill in the Art
192
D.
The Prima Facie Case of Obviousness
195
E.
Obvious to Try
196
IV.
The Secondary Considerations
198
A.
Commercial Success
200
B.
Copying
203
C.
Licenses
204
D.
Long-Felt Need
205
E.
Praise and Skepticism
205
F.
Prior Failures of Others
206
G.
Unexpected Results
208
V.
Structural Similarities as Evidence of Obviousness
209
A.
Introduction
209
B.
Homologues
218
1.
Adjacent Homologues
218
2.
Ring Expansion and Contraction
220
3.
Remote Homologues
222
C.
Isomers
223
1.
Structural Isomerism
223
a.
Position Isomerism
223
b.
Tautomers
225
c.
Stereoisomers
226
2.
Bioisomerism
233
D.
Esters
234
1.
Prior Art Alcohols
235
2.
Prior Art Free Acids
236
E.
Analogs
237
VI.
Product and Process Claims
237
6.
The Patent Instrument
241
I.
Enablement
243
A.
Basic Concepts
243
B.
Working and Prophetic Examples
250
C.
Exhibits and Biological Samples
251
II.
Best Mode
252
III.
Written Description
256
A.
New Matter
256
B.
Originally Filed Claims
260
IV.
The Claims
263
A.
Basic Claim Drafting
264
1.
The Preamble
264
2.
The Transition Phrase
267
3.
The Body
270
B.
Claim Formats
271
1.
Dependent Claims
271
2.
Markush Claims
272
3.
Product-by-Process Claims
274
4.
Jepson Claims
276
5.
Functional Claims
278
6.
Skuballa Claims
281
7.
First Medical Use and Swiss-Style Claims
282
C.
Definiteness
284
7.
Patent Acquisition Procedures
289
I.
Fundamentals of Patent Prosecution
290
A.
Preparation of Applications
290
B.
Provisional Applications
291
C.
Examination of Applications
292
D.
Continuing Applications
294
E.
The Restriction Requirement and Divisional Applications
295
F.
Publication of Applications
296
G.
Petition and Appeal
298
H.
Petition and Appeal
298
II.
Other PTO Proceedings
299
A.
Interferences
299
B.
Protests
301
C.
Citation of Prior Art
301
D.
Public Use Proceedings
302
III.
Post-Grant Proceedings
302
A.
Certificates of Correction
303
B.
Disclaimers
303
C.
Reissue
303
D.
Reexamination
306
1.
Ex Parte Reexamination
307
2.
Inter Partes Reexamination
308
E.
Intervening Rights
309
IV.
Abuses of Patent Acquisition Procedures
310
A.
Double Patenting
311
1.
Basic Principles
311
2.
Double Patenting and the Restriction Requirement
317
3.
Two-Way Double Patenting
319
B.
Inequitable Conduct
320
C.
Misjoinder or Nonjoinder of Inventors
337
D.
Prosecution Laches
340
8.
Duration of Rights
343
I.
Fundametals of Patent Term
343
II.
Maintenance Fees
345
III.
The Patent Term Guarantee Act
345
IV.
Specialized Legislation
346
V.
The Hatch-Waxman Act
346
A.
Eligible Patents
347
1.
Drug Products
347
2.
Combination Therapies
352
3.
Metabolites
353
4.
Stereoisomers
354
5.
Medical Devices
355
6.
Patents Subject to a Terminal Disclaimer
357
B.
Application for Term Extension
358
1.
Time Limit for Filing
358
2.
Identity of the Applicant
361
3.
Contents
361
4.
Review of the Application
362
5.
Interim Extensions
363
6.
Strategic Considerations
364
C.
Period of Extension
364
D.
Limitation Upon Scope of Rights
366
III.
Marketing Approval Procedures
9.
The FDA Drug Approval Process
371
I.
Marketing Approval for Innovative Drugs
371
A.
Preclinical Investigations
372
B.
Investigational New Drug Applications
373
1.
Phase I Investigations
373
2.
Phase II Investigations
374
3.
Phase III Investigations
374
4.
Treatment INDs
374
5.
Screening INDs
375
C.
New Drug Applications
375
D.
Postmarketing Surveillance / Phase IV Investigations
376
II.
Marketing Approval for Generic Drugs
376
A.
FDA Practices Prior to Hatch-Waxman
377
B.
Abbreviated New Drug Applications
378
C.
Section 505(b)(2) Applications
380
D.
Patent Certifications
382
E.
Section viii Statements
383
F.
Thirty-Month Stay of Marketing Approval
388
1.
Multiple 30-Month Stays
391
2.
Judicial Modification of the 30-Month Period
393
III.
Antibiotics
398
10.
The Orange Book
401
I.
Overview of the Orange Book
401
II.
Patents Appropriate for Orange Book Listing
403
A.
The Hatch-Waxman Act
403
B.
FDA Regulations
409
1.
General Rules
409
2.
Polymorph Patents
412
3.
Product-by-Process Patents
413
C.
Third-Party Patents
413
III.
The Timing of Patent Listings
415
IV.
Orange Book Listing Disputes
416
A.
The Role of the FDA
417
B.
Delisting Litigation Prior to the MMA
418
1.
Efforts by Generic Firms to Delist
418
2.
Delisting by Brand Name Firms
422
C.
Delisting Litigation Under the MMA
425
1.
Efforts by Generic Firms to Delist
425
2.
Delisting by Brand Name Firms
429
D.
FTC Enforcement
430
11.
Marketing Exclusivities
431
I.
Marketing Exclusivity Concepts
431
II.
New Chemical Entity Exclusivity
432
III.
New Clinical Study Exclusivity
435
IV.
Generic Marketing Exclusivity
437
A.
Basic Concepts
437
B.
Pre-MMA Standards
439
1.
Entitlement
439
2.
Timing of Notice
445
3.
Commencement of the 180-Day Period
446
4.
Separate Exclusivities for Distinct Dosages and Strengths
448
5.
Patent-by-Patent Approach
448
6.
Relationship to Pediatric Exclusivity
450
7.
Transferability
450
C.
Standards Under the MMA
451
1.
Entitlement
451
2.
Forfeiture
451
3.
Timing of Notice
454
4.
Commencement of the 180-Day Period
454
5.
Product-by-Product Approach
455
D.
Unresolved Issues
455
1.
Authorized Generics
455
2.
Award of Exclusivity for Judgments of Noninfringement
460
V.
Pediatric Marketing Exclusivity
460
VI.
Orphan Drug Marketing Exclusivity
463
IV.
Infringement
12.
Scope of Patent Rights
469
I.
Basic Concepts
470
A.
Direct Infringement
470
B.
Indirect Infringement
472
1.
Active Inducement
473
2.
Contributory Infringement
474
3.
Deepsouth and 35 U.S.C. [§]271(f)
477
4.
Bioconversion as Infringement
477
C.
Process Patents
479
1.
The Process Patent Amendments Act
479
2.
Screening Methods
482
D.
Government Infringers
483
1.
The Federal Government
484
2.
The Bayh-Dole Act
487
3.
State and Local Governments
489
II.
Infringement Under the Hatch-Wasman Act
491
A.
Patent Implications of ANDAs and Section 505(b)(2) Applications
491
B.
Notification of a Paragraph IV Certification
493
C.
Offers of Confidential Access
494
D.
Biobatch Data Versus the ANDA Specification
494
E.
Generic Submissions for Unapproved Uses
497
III.
Patent Litigation
499
A.
Subject Matter Jurisdiction
499
B.
Supplemental Jurisdiction
501
C.
Personal Jurisdiction
502
1.
General Principles
502
2.
Implications of the Hatch-Waxman Act
503
D.
Venue
504
E.
Declaratory Judgment
505
1.
General Principles
505
2.
Declaratory Judgment Actions in the Hatch-Waxman Framework
508
F.
The Availability of Jury Trials Under the Hatch-Waxman Act
518
IV.
Infringement Defenses
520
A.
Invalidity and Unenforceability
520
B.
Issue Preclusion
521
C.
Laches and Estoppel
522
D.
Licenses
523
1.
Basic Concepts
523
2.
Licensee and Assignor Estoppel
526
3.
Implied Licenses
528
4.
Shop Rights
530
E.
Prior User Rights
532
V.
Remedies
535
A.
General Principles
535
1.
Injunctions
535
2.
Compensatory Damages
540
a.
Reasonable Royalties
540
b.
Lost Profits
542
i.
"But For" Causation
543
ii.
Proximate Causation
546
iii.
The Entire Market Value Rule
547
3.
Marking
549
4.
Provisional Rights
551
5.
Enhanced Damages
551
B.
Remedies Under the Hatch-Waxman Act
555
1.
Remedies Available for Infringing Generic Applications
555
2.
Generic Filings as Willful Infringements
555
C.
Implications of Generic Market Entry During Patent Litigation
557
13.
Claim Interpretation and the Doctrine of Equivalents
559
I.
Claim Interpretation
559
A.
Basic Concepts
559
B.
Markman v. Westview Instruments
560
C.
Canons of Claim Construction
563
D.
Dictionaries, the Specification, and the Phillips Case
566
E.
Representative Claim Construction Cases
571
II.
The Doctrine of Equivalents
580
A.
Basic Concepts
580
1.
Graver Tank and the Function-Way-Result Standard
581
2.
Warner-Jenkinson and the Insubstantial Differences Standard
584
3.
Functional Equivalents
586
B.
Limitations on the Doctrine of Equivalents
587
1.
The All Elements Rule
587
2.
Prior Art Limitations
592
3.
Prosecution History Estoppel
596
4.
The Public Dedication Doctrine
604
C.
The Reverse Doctrine of Equivalents
608
14.
Parallel Importation
611
I.
Introduction
611
II.
FDA Practices with Respect to Importing Prescription Drugs
612
A.
The Prescription Drug Marketing Act of 1987
612
B.
The MEDS Act of 2000
614
C.
The MMA of 2003
615
D.
Reform Proposals
616
III.
Patent Implications of Parallel Importation
617
A.
The Exhaustion Doctrine
617
B.
International Exhaustion
618
C.
Reform Proposals
621
D.
Potential Legal Issues
622
1.
The Takings Clause
622
2.
State and Local Governments
627
3.
The TRIPS Agreement
629
4.
Free Trade Agreements
630
5.
Label Licenses
633
15.
The Experimental Use Privilege
635
I.
The Common Law Experimental Use Privilege
637
A.
Origins of the Experimental Use Privilege
637
B.
Cases Upholding the Privilege
640
C.
Experimental Use as a Matter of Remedies
642
D.
Cases Rejecting the Experimental Use Privilege
644
E.
The Common Law Experimental Use Privilege in Pharmaceutical Cases
649
F.
The Common Law Experimental Use Privilege in Academic Settings
650
G.
Experimental Use Policy
655
II.
The Statutory Experimental Use Privilege
659
A.
Introduction to 35 U.S.C. [§]271(e)(1)
659
1.
Roche v. Bolar
659
2.
The Hatch-Waxman Act
662
3.
Basic Analytical Framework
663
B.
Application of 35 U.S.C. [§]271(e)(1)
669
1.
Manufacture
669
2.
Preclinical Trials
670
3.
Clinical Trials
673
4.
Other Product Testing
674
5.
Sales
675
6.
Displays and Demonstrations
676
7.
Publications and Promotions
677
8.
Foreign Patenting and Regulatory Approval
678
9.
Medical Devices
679
10.
Research Tools
684
11.
Importation
687
16.
Antitrust Considerations
689
I.
Introduction
689
II.
Notice of Patent Settlements
691
III.
Judicial Treatment of Reverse Payment Settlements
692
A.
Sixth Circuit
692
B.
Eleventh Circuit
695
C.
Second Circuit
701
D.
Federal Circuit
707
E.
Concluding Observations
708
V.
International and Comparative Aspects
17.
International and Comparative Patent Law
715
I.
The Paris Convention
717
A.
National Treatment
717
B.
Independence of Patents
717
C.
International Priority
718
D.
Benefits of Paris Convention Priority
719
E.
Limitations of the Paris Convention
722
II.
The Patent Cooperation Treaty
723
III.
Foreign Filing Licenses
724
IV.
Regional Agreements
725
A.
NAFTA
725
B.
Other Regional Agreements
726
V.
The TRIPS Agreemment
727
A.
National Treatment and Most-Favored-Nation Status
728
B.
Minimum Standards of Protection
728
C.
Compulsory Licenses
730
1.
TRIPS Agreement Article 31
730
2.
The Doha Declaration
731
D.
Other Provisions
733
E.
Effective Dates
734
1.
Pipeline Protection
735
2.
Exclusive Marketing Rights
736
F.
Dispute Settlement
736
1.
India Pharmaceutical Products
737
2.
Canada Pharmaceutical Products
739
G.
Debate on the TRIPS Agreement
741
VI.
Free Trade Agreements
742
A.
Patent Term Restoration
742
B.
Data Exclusivity
742
C.
Confidential Status of Experimental Data
743
D.
Accelerated Generic Marketing Approval
743
E.
Experimental Use Privilege
744
F.
Parallel Importation
744
G.
Implications
745
VII.
Comparative Patent Law
745
A.
Deferred Examination
746
B.
Experimental Use Privilege
746
C.
Grace Period
748
D.
Methods of Medical Treatment
748
E.
Oppositions
749
F.
Patent Validity as an Infingement Defense
749
G.
Priority Principle
750
H.
Publication of Pending Applications
750
I.
Patentable Subject Matter
751
18.
International and Comparative Data Protection Law
753
I.
International Data Protection Standards
755
A.
The TRIPS Agreement
755
1.
Basic Principles
755
2.
Eligible Data
756
3.
Protection Against Unfair Commercial Use
757
4.
Protection Against Disclosure
760
B.
Free Trade Agreements
761
II.
Comparative Law
763
A.
European Data Protection Law
763
1.
Introduction
763
2.
The Pre-2005 6/10 Formula
764
3.
2005 and Beyond: The 8+2+1 Formula
765
4.
Orphan Drugs
766
5.
The Pediatric Testing Incentive
767
B.
European Supplementary Protection Certificates
767
C.
Japan
768
VI.
Biologics
19.
Follow-On Biologics
771
I.
Introduction
771
II.
The Regulatory Pathway
774
A.
Biosimilars
774
B.
Interchangeable Biologics
774
C.
The Role of the FDA
774
III.
Marketing Exclusivities and Data Protection
775
A.
Brand-Name Products
775
B.
First Interchangeable Products
776
IV.
Patent Dispute Resolution
777
V.
Observations and Potential Issues
781
Appendices
List of Documents Included on CD-ROM
783
Table of Cases
787
Index
815