Generic pharmaceutical patent and FDA law:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Eagan, Minn.
Thomson West
2008
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| Ausgabe: | 2008 ed. |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXXIV, 643 S. graph. Darst. |
| ISBN: | 9780314991447 |
Internformat
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| 020 | |a 9780314991447 |9 978-0-314-99144-7 | ||
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| 041 | 0 | |a eng | |
| 049 | |a DE-M382 | ||
| 100 | 1 | |a Upadhye, Shashank |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Generic pharmaceutical patent and FDA law |c Shashank Upadhye |
| 250 | |a 2008 ed. | ||
| 264 | 1 | |a Eagan, Minn. |b Thomson West |c 2008 | |
| 300 | |a XXXIV, 643 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 856 | 4 | 2 | |m GBV Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016521834&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-016521834 | ||
Datensatz im Suchindex
| _version_ | 1804137689541246976 |
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| adam_text | GENERIC PHARMACEUTICAL PATENT AND FDA LAW 2008 EDITION SHASHANK UPADHYE
XMOIVISOISI ^K, WEST FOR CUSTOMER ASSISTANCE CALL 1-800-328-4880 MAT
#40615439 TABLE OF CONTENTS CHAPTER 1. BASICS OF PATENT LAW I.
INTRODUCTION § 1:1 IN GENERAL § 1:2 BASIC PATENT PROCESS § 1:3
STRUCTURAL ORGANIZATION OF A PATENT II. PATENT CLAIMS §1:4 IMPORTANCE OF
PATENT CLAIMS § 1:5 PERSON OF ORDINARY SKILL IN THE ART § 1:6
ORGANIZATIONAL STRUCTURE OF THE CLAIM*PREAMBLE § 1:7 TRANSITION PHRASE §
1:8 ORGANIZATIONAL STRUCTURE OF THE CLAIM*BODY OF THE CLAIM § 1:9 COMMON
TYPES OF PHARMACEUTICAL CLAIMS*BASE CHEMICAL/COMPOUND CLAIMS § 1:10
*SALTS, ESTERS, AND SOLVATES § 1:11 *ENANTIOMERS § 1:12 *POLYMORPHS
§1:13 *COMBINATIONS OF APIS § 1:14 *FORMULATIONS §1:15 *METHODS OF USE §
1:16 *METHOD OF MANUFACTURE OR PROCESS CLAIMS § 1:17 *PRODUCT-BY-PROCESS
CLAIMS § 1:18 *RELEASE PROFILES § 1:19 CONCLUSION III. STATUTORY
PROVISIONS A. IN GENERAL § 1:20 COMMON STATUTORY PROVISIONS OF THE
PATENT LAW B. SECTION 101: SUBJECT MATTER § 1:21 PATENTABLE SUBJECT
MATTER XVII GKNKKIC I HAKMA I T RIC AI I ATK.M AND FDA LAW C. SECTION
102: NOVELTY § 1:22 NOVELTY AND NEW INVENTIONS § 1:23 SECTION 102IAI §
1:24 SECTION 102 § 1:25 *ON-SALE BAR § 1:26 *PUBLIC USE BAR § 1:27
SECTION 102 § 1:28 SECTION 102UL § 1:29 SECTION 102- -UTOPIAN-WORLD
P.-,T.-NI ISSUANCE IN THE UOR 10 § 1:30 ^ ? URSTAN K § L() * THROUGH
EXAMPLE .-IND TIME §1:31 SECTION 102(FT-..I, M .NT,R IS ,,,,NH..
I,IV.-,.L,R § 1:32 SECT.ON 102I K I_LVI,R IRNVMI,,,, L,V ANOTHER 1 JO,
~ CONTRAST »N SECTION L()2(G.( 1 I VERSUS 1()2( M H2) § 1:34 CONCLUSION
D. SECTION 103: OBVIOUSNESS 1 TH3N TNVIAL VARIATIONS ?* ^ FACT
*-PRIMARV OBVIOUSNESS FACTORS F OBVIOU NESS INQUIRY- SML ?FTF T
HIN ^HT-MOTIVATION. SUGGESTION, 8 1 QQ PN^L T0 COMB »NE PRIOR ART
-^BINAHON OF REFERENCES-FLOWING FROM THE PRIOR § 1:40 * REFERENCE V §
1:41 SECONDARY TIJ*? T * F PR BLEM TO BE S LVED § 1:42 UNEXPECTED
ROSULOFIB 10118 1 :- § 1:43 LONG-FELT NEED TU INVENTION § 144 FAILNR
V T R THE INV *NTION 1;S SXLS! W T K § 1;S SXLS! R § 1:46 -ACTIVE I N
^ D ^ ^ FACT R IN OBVI » USNL * 8 §1:47 -FORMULATION 1 1:48
LICENSING BY OTHERS 8 1:49 COMMERCIAL SI § 1:50 SKEPTICISM H ^ SS ~
GENER IC DRUG INFRINGEMENT CASES § 1:51 THIRD-NART, RS AND P ROOF OF
NONOBVIOUSNESS § 1:52 CHEMICAL ^ R R ISE ^ D § 1:53 - ^ S S T Y § 1:54
-ISO^L?! 1 BV , IOUSNES S OF CHEMICAL COMPOUNDS §1:55 CONCLUSTO N D
BVI0USN XVHL TABLE OF CONTENTS E. SECTION 112: SPECIFICATION §1:56 ROLE
OF THE SPECIFICATION § 1:57 FIRST PARAGRAPH § 1:58 *WRITTEN DESCRIPTION
§ 1:59 *ENABLEMENT REQUIREMENT § 1:60 *BEST MODE REQUIREMENT § 1:61
*CONCLUSION § 1:62 SECOND PARAGRAPH: CLAIM PRECISION AND BOUNDARIES §
1:63 THIRD AND FOURTH PARAGRAPHS: DEPENDENT CLAIMS § 1:64 CONCLUSION F.
SECTIONS 119, 120 AND 121: PRIORITIES § 1:65 PRIORITY AND EARLIEST
FILING DATES § 1:66 SECTION 119: CLAIMING FOREIGN PRIORITY § 1:67 *TOOL
FOR EVALUATING PRIOR ART EFFECT § 1:68 *SECTION 102(B) PRIOR ART IS NOT
AFFECTED BY SECTION § 1:69 CLAIMING THE BENEFIT OF EARLIER-FILED
APPLICATIONS § 1:70 CONTINUATION APPLICATIONS FOR A DIFFERENT INVENTION
USING THE SAME SPECIFICATION § 1:71 DIVISIONAL APPLICATIONS FOR
EXAMINER-MANDATED RESTRICTIONS TO DIFFERENT INVENTIONS § 1:72 *SAFE
HARBOR PROVISION OF SECTION 121 FOR DIVISIONAL APPLICATIONS § 1:73
*CONTINUATION-IN-PART APPLICATIONS*INTRODUCING NEW MATTER IV. PATENT
TERM EXTENSION § 1:74 PATENT TERM EXTENSION AND PATENT EXPIRATION § 1:75
EMBROILMENT IN FDA*SECTIONS 155, 155A, 156 § 1:76 *CONGRESSIONAL PATENT
TERM EXTENSIONS § 1:77 *PTO DELAYS § 1:78 *URUGUAY ROUND TERM EXTENSIONS
§ 1:79 *PATENT TERM RESTORATION DUE TO FDA APPROVAL PROCESSES § 1:80 CAP
OF FIVE YEARS § 1:81 PATENT TERM RESTORATION IS A USPTO AND FDA
COOPERATION § 1:82 *SINGLE AND COMBINATION INGREDIENTS V. ENANTIONERS §
1:83 HISTORY OF ENANTIOMER PATENTABILITY XIX GENERIC PHARMACEUTICAL
PATENT AND FDA LAW § 1:84 CASE STUDY*LEVOFLOXACIN § 1:85 *LEVETIRACETAM
§ 1:86 *CLOPIDOGREL § 1:87 LESSONS LEARNED VI. COMBINATION PRODUCTS
§1:88 PATENTABILITY OF COMBINATION PRODUCTS § 1:89 CASE STUDY*SUDAFED §
1:90 *LOPERAMIDE § 1:91 *VICOPROFEN § 1:92 LESSONS LEARNED APPENDIX 1A.
BIBLIOGRAPHY OF RESOURCES CHAPTER 2. PATENT INFRINGEMENT RULES AND
PROCEDURES I. INTRODUCTION §2:1 GENERALLY § 2:2 BASIC INFRINGEMENT TEST
II. CLAIM CONSTRUCTION § 2:3 GENERALLY A. EVIDENCE § 2:4 EVIDENCE
CONSIDERED IN CLAIM CONSTRUCTION § 2:5 INTRINSIC EVIDENCE MUST BE
CONSIDERED FIRST*MANDATORY EVIDENCE § 2:6 EXTRINSIC EVIDENCE CAN BE
CONSIDERED*PERMISSIVE EVIDENCE § 2:7 DICTIONARIES AND TREATISES AS
SOURCES OF EVIDENCE OF CLAIM MEANING B. RULES § 2:8 CUSTOMARY CLAIM
CONSTRUCTION RULES C. NARROW CLAIM CONSTRUCTIONS § 2:9 TOOLS FOR THE
GENERIC COMPANY § 2:10 SPECIFICATION CLEARLY DEFINES CLAIM TERM § 2:11
CLAIM TERM IS IMPLICITLY DEFINED BY CONSISTENT USE THROUGHOUT
SPECIFICATION TABLE OF CONTENTS § 2:12 PATTERN OF EXAMPLES IN
SPECIFICATION DEDUCES CLAIM MEANING § 2:13 EMBODIMENT IS THE INVENTION §
2:14 SPECIFICATION DISAVOWS PARTICULAR MEANING § 2:15 SPECIFICATION
EXPLICITLY DISCLAIMS DEFINITION § 2:16 LIMITING THE CLAIM SCOPE BECAUSE
CONSISTENT WITH INVENTION S PURPOSE § 2:17 SPECIFICATION CONTAINS
IMPLICIT DISCLAIMER OF DEFINITION § 2:18 SPECIFICATIONS AND
UNDERCLAIMING*CLAIMING LESS THAN YOU COULD HAVE § 2:19 PROSECUTION
HISTORY AS INTRINSIC EVIDENCE*MANDATORY OR PERMISSIVE EVIDENCE § 2:20
PROSECUTION HISTORY CONTAINS NARROW DEFINITION WHEN ORDINARY MEANING IS
UNCLEAR § 2:21 CLAIM TERM IS NARROWED BECAUSE OF DISCLAIMER OF ORDINARY
MEANING IN PROSECUTION HISTORY § 2:22 USING PROSECUTION HISTORY OF
PARENT APPLICATION IN SUBSEQUENT APPLICATIONS § 2:23 CHOOSING NARROW
CLAIM SCOPE WHEN COMPETING SCOPES EXIST E. OTHER ISSUES § 2:24 CLAIM
DIFFERENTIATION AND INTERPRETING CLAIMS OF DIFFERENT SCOPE § 2:25
INEXACT MODIFIERS OR RELATIVE TERMINOLOGY § 2:26 ILLUSTRATION REGARDING
SCOPE OF ABOUT § 2:27 TIMING OF CLAIM CONSTRUCTION IN VIEW OF ISSUED
PATENT III. LITERAL INFRINGEMENT § 2:28 GENERALLY § 2:29 LITIGATING MORE
THAN ONE CLAIM CONSTRUCTION AT TRIAL: FEDERAL CIRCUIT REVIEW OF RECORD §
2:30 SPECIAL CASE: INHERENT INFRINGEMENT UNDER SINGLE CRYSTAL THEORY §
2:31 SPECIAL CASE: INHERENT INFRINGEMENT UNDER SINGLE CRYSTAL
THEORY*IMPACT OF SMITHKLINE V. APOTEX ON INFRINGEMENT § 2:32 PROVING
LITERAL INFRINGEMENT § 2:33 LITERAL INFRINGEMENT AS BASED ON THE GENERIC
DRUG APPLICATION IV. DOCTRINE OF EQUIVALENTS § 2:34 DOCTRINE OF
EQUIVALENTS (DOE) INFRINGEMENT XXI GENERIC PMARMACEI TICAL PATENT AND
FDA LAW § 2:35 TESTS FOR DOF §2:36 *INSUBSTANTIAL DIFFERENCES TEST TOR
EQUIVALENCY INFRINGEMENT §2:37 *FUNCTION WAY RESULT TEST § 2:38
*ELCMENT-BY-ELENIENT ANAL.VMS §2:39 SUBJECT MATTER DISCLOSED BUT NOT
CLAIMED DEDICATION TO THE PUBLIC RULE §2:40 DOCTRINE OF PROSECUTION
HISTORY ESTOPPEL 1PHF.1 §2:41 *AMENDMENT-BASED ESTOPPEL §2:42 REBUTTING
THE PRESUMPTION OF ESTOPPEL §2:43 **FESTO IX: FEDERAL CIRCUIT SUMMARY OF
EQUIVALENCY FACTORS §2:44 FESTO TEST PART 7: REBUTTING PROSECUTION
HISTORY ESTOPPEL § 2:45 FESTO TEST PART 7UI: FORESEEABLE CHANGES § 2:46
FORESEEABILITY OF DRAFTING CLAIM TO EQUIVALENT: IS IT NEW MATTER § 2:47
FESTO TEST PART 7: TANGENTIAL RELATIONSHIP § 2:48 FESTO TEST PART 7( III
I: SOME OTHER UNEXPLAINED REASON § 2:49 *ARGUMENT-BASED ESTOPPEL § 2:50
*RELATED APPLICATIONS MAY EVOKE ESTOPPEL 8 2:51 *SCOPE S ? : S ~ PRIOR
ART PRECLUSIONS*HYPOTHETICAL CLAIM ANALYSIS § Z.BD *DETAILED STRUCTURE
TEST: AN ALTERNATE TO THE INSUBSTANTIAL DIFFERENCES AND FUNCTION WAY
RESULT TESTS § 2:54 CASE STUDIES: SMITHKLINC BEECHAM AND EQUIVALENCY-
TAINED RDT A SC BUPROPION 8 2:55 CASE STUDIES: SMITHKUNE BEECHAM
AND EQUIVALENCY*CONCLUSION V. INDIRECT INFRINGEMENT § 2:56 CONTRIBUTORY
AND INDUCEMENT INFRINGEMENT GENERALLY FF T M FNNGEMENT-INDUCEMENT UNDER
35 U.S.C.A. 8 J/KB) §2:58 SUMMARY Y 2:59 C2 ^ UTOR Y P AT ENT
INFRINGEMENT UNDER 35 U.S.C.A. § 2-6? -JPV WIN G COMPONENT IS
ESPECIALLY MADE § 2:63 INFRINGEM ENT UNDER 35 U.S.C.A. § 27 KG
^IMPORTING DRUGS MADE BY PATENTED PROCESS XXII TABLE OF CONTENTS § 2:64
*HYPOTHETICAL DESCRIBING PROBLEM WITH § 271(G) VT. CONCLUSION § 2:65
GENERALLY CHAPTER 3. FOUNDATIONS OF PATENT INVALIDITY I. INTRODUCTION §
3:1 IN GENERAL II. PRIOR ART § 3:2 BURDENS OF PROOF*PRIOR ART*CONSIDERED
OR NOT CONSIDERED BY EXAMINER § 3:3 SOURCES § 3:4 FULLY PRESENTED AND
VETTED § 3:5 CITED BUT NOT VETTED §3:6 NOT CITED III. ANTICIPATION § 3.7
INVALIDATING PATENT BECAUSE INVENTION IS NOT NEW § 3:8
ELEMENT-BY-ELEMENT ANALYSIS, EXPRESS AND INHERENT ANTICIPATION § 3:9
INHERENT ANTICIPATION §3:10 *HYPOTHETICAL § 3:11 SMITHKLINE V. APOTEX
REVISITED IV. OBVIOUSNESS § 3:12 INVALIDITY DEFENSE § 3:13 USPTO
GUIDELINES § 3:14 COMBINING PRIOR ART ELEMENTS ACCORDING TO KNOWN
METHODS TO YIELD PREDICTABLE RESULTS § 3:15 *SIMPLE SUBSTITUTION OF ONE
KNOWN ELEMENT FOR ANOTHER TO OBTAIN PREDICTABLE RESULTS § 3:16 KNOWN
TECHNIQUES TO IMPROVE SIMILAR DEVICES, METHODS, OR PRODUCTS § 3:17
APPLYING KNOWN TECHNIQUE TO YIELD PREDICTABLE RESULTS § 3:18 OBVIOUS TO
TRY *CHOOSING FROM FINITE NUMBER OF ITEMS § 3:19 *APPLICABILITY TO
ENANTIOMERS, SALT SELECTION, AND EXTENDED RELEASE (ER) FORMULATIONS
XXIII GENERIC PHARMACEUTICAL PATENT AND FDA LAW § 3:20 MARKET FORCES AND
DESIGN CONSIDERATIONS § 3:21 TEACHING, SUGGESTION, OR MOTIVATION IN THE
PRIOR ART § 3:22 PERSON OF ORDINARY SKILL IN THE ART POSITA) § 3:23
STRUCTURAL OBVIOUSNESS*BREAKING COMPOUND PATENTS § 3:24 *LANSOPRAZOLE
VERSUS RABEPRAZOLE § 3:25 *ATTACKING OF ANALOGUE OF COMPOUND V.
PRACTICING THE PRIOR ART § 3:26 DEFENSE TO INFRINGEMENT VI. GENUS AND
SPECIES § 3:27 INTERPRETATION § 3:28 CASE STUDY*GENUS AND SPECIES:
ZYPREXAQO (OLANZAPINE) §3:29 *ENANTIOMERS, INVALIDITY, AND PLAVIX
(DOPIDOGREL) VII. SECTION 112 § 3:30 PATENT INVALIDITY THEORIES § 3:31
WRITTEN DESCRIPTION INVALIDITY § 3:32 *MECHANICS OF WRITTEN DESCRIPTION
CHALLENGE § 3:33 ENABLEMENT § 3:34 *UNDUE EXPERIMENTATION § 3:35 * HOW
TO MAKE § 3:36 * HOW TO USE § 3:37 *IN VITRO TO IN VIVO TEACHING §
3:38 *EFFECTIVE AMOUNTS § 3:39 BEST MODE REQUIREMENT § 3:40 CONTRASTING
ENABLEMENT AND BEST MODE § 3:41 WRITTEN DESCRIPTION, ENABLEMENT, AND
BEST MODE- BREAKING CHAINS OF PRIORITY TO INVALIDATE LATER PATENTS §
3:42 ROLLING PROVISIONALS ALLOW FOR CHAINS OF PRIORITY § 3:43 SECTION
112, SECOND PARAGRAPH: CLAIM PRECISION AND BOUNDARIES § 3:44 SECTION
112, THIRD AND FOURTH PARAGRAPHS: DEPENDENT CLAIMS CHAPTER 4.
INEQUITABLE CONDUCT AND PATENT UNENFORCEABILITY § 4:1 INEQUITABLE
CONDUCT*FRAUD ON THE PATENT OFFICE 3 4:2 TYPES OF INEQUITABLE CONDUCT
TEST*COMMON SITUATIONS 8 4:3 PENALTIES FOR INEQUITABLE CONDUCT XXIV
TABLE OF CONTENTS § 4:4 *UNENFORCEABILITY*LATER PATENTS THROUGH
INFECTIOUS UNENFORCEABILITY § 4:5 AWARDING ATTORNEY S FEES AND COSTS §
4:6 FRAUD-BASED DAMAGES (WALKER PROCESS FRAUD) § 4:7 PRIVATE ENFORCEMENT
OF FRAUD § 4:8 CURING INEQUITABLE CONDUCT § 4:9 ASSERTING INEQUITABLE
CONDUCT*NOT A GAME OF GOTCHA § 4:10 MATERIALITY THRESHOLD*CURRENT AND
PAST TESTS FOR MATERIALITY § 4:11 INFORMATION DOES NOT HAVE TO BE
CLAIMED § 4:12 FAILURE TO COMPLY WITH SECTION 112(1) § 4:13 *INFORMATION
DOES NOT HAVE TO VERBATIM § 4:14 FALSE STATEMENTS § 4:15 FAILURE TO
DISCLOSE RELATIONSHIP OF AFFIANT TO APPLICANT §4:16 DATA IS PRESUMED
MATERIAL § 4:17 *FAILURE TO PROVIDE UNFAVOURABLE TEST RESULTS § 4:18
-ACCURATE DESCRIPTION OF TEST CONDITIONS § 4:19 CLAIM FOR PRIORITY §4:20
ISSUES EXAMINER FOCUSES ON § 4:21 **AFFIRMATIVE MISREPRESENTATIONS §
4:22 *INTENT TO DECEIVE § 4:23 STRESSING IMPORTANCE OF SUBMITTED PRIOR
ART § 4:24 GROSS NEGLIGENCE § 4:25 TOTALITY CAN INCLUDE GROSS
NEGLIGENCE § 4:26 MERE DENIAL IS NEVER ENOUGH TO OVERCOME INFERENCE OF
INTENT § 4:27 SEARCHING FOR PRIOR ART § 4:28 PATTERNS OF
MISREPRESENTATIONS OR OMISSIONS* SINGLE ACTIONS § 4:29 CULTIVATED
IGNORANCE*OBTAINING TRANSLATIONS OF FOREIGN LANGUAGE DOCUMENTS § 4:30
BURYING CRITICAL REFERENCE § 4:31 FAILURE TO DISCLOSE PRIOR ART AND
FOREIGN OFFICE ACTIONS FROM FOREIGN SEARCHES § 4:32 FALSE OR MISLEADING
AFFIDAVITS § 4:33 FAILURE TO NAME PROPER INVENTORS § 4:34 *PITFALLS FOR
PATENT APPLICANTS AND CORRECTIVE MEASURES AND PRACTICE TIPS § 4:35
CONCLUSION CHAPTER 5. EQUITABLE DEFENSES TO PATENT INFRINGEMENT §5:1
INTRODUCTION XXV 8 GENERIC PHAKMACKI THAI. PATEN I AND FDA LAW §5:2
ISSUE PRECLUSION, COLLATERAL ESTOPPEL/CLAIM PRECLUSION AND RES JUDICATA
§ 5:3 LACHES*GENERAL PRINCIPLES §5:4 *QUICK COMPARISON OF LACHES AND
EQUITABLE ESTOPPEL § 5:5 *FACTORS §5:6 *LACHES AND PRESUMPTIONS §5:7
EQUITABLE ESTOPPEL - FACTORS §5:8 *PRESUMPTIONS §5:9 *PROSECUTION LACHES
§5:10 RECENT DEVELOPMENTS CHAPTER 6. BASICS OF BRAND DRUG APPROVAL
PROCESS AND ORANGE BOOK LISTINGS §6:1 INTRODUCTION § 6:2 BRAND DRUG
APPROVAL §6:3 INVESTIGATIONAL NEW DRUG APPLICATION IINI) * BEGINNING
CLINICAL TRIALS § 6:4 *CONTENTS § 6:5 NEW DRUG APPLICATION NDA T § 6:6
*DRUG MASTER FILES I DMF § 6:7 TYPES OF NEW DRUGS IN NDA § 6:8
INTERNAL FDA MACHINATIONS § 6:9 PATENT INFORMATION AND THE ORANGE BOOK §
6:10 *LISTABLE AND NONLISTABLE PATENTS § 6:11 *PATENT LISTING AS
CLERICAL NOT SUBSTANTIVE § 6:12 *DELISTING PATENTS § 6:13 *FORCIBLE
LISTING OF UNLISTED PATENTS § 6:14 WHEN PATENTS MAY BE LISTED 9 6:15 WHO
MAY LIST WHICH PATENTS 9 6:16 MEDICAL DEVICE PATENTS AND ANTIBIOTIC
PATENTS*STATUS 9 6:17 POLYMORPH PATENT LISTING 9 6:18 BLINDS AND
CLINICAL TESTING | 6:19 -CLINICAL TRIAL PHASES S RO? PUBLIC USE PATENT
VALIDITY J E L NDAS -NEW DRUG APPLICATIONS/SECTION 505(B)(2)
APPLICATIONS 9 6:22 NDA APPROVAL AND APPROVAL DATES F. ABBREVIATED NEW
LICATION (A PROCESS § 1 REFERENCE LISTED DRUG (RLD) XXVI TABLE OF
CONTENTS § 7:2 SUITABILITY PETITIONS TO REFER TO DIFFERENT RLDS § 7:3
ABBREVIATED NEW DRUG APPLICATION (ANDA) § 7:4 *DIFFERENCES BETWEEN THE
NDA AND ANDA § 7:5 *BIOEQUIVALENCY OF GENERIC DRUG § 7:6 INNER WORKINGS
OF THE FDA § 7:7 LABELING REVIEW § 7:8 CHEMISTRY AND MANUFACTURING
CONTROLS (CMC) § 7:9 BIOPHARMACEUTICAL REVIEW AND BIOAVAILABILITY § 7:10
CLASSIFICATION SYSTEM FOR BIOPHARMACEUTICAL PROPERTIES § 7:11 *PATENTS
CLAIMING PHARMACOKINETICS § 7:12 MICROBIOLOGY REVIEW § 7:13 CLINICAL
REVIEW §7:14 CGMP REVIEW §7:15 DEFICIENCY LETTERS § 7:16 *MAJOR
DEFICIENCY LETTER § 7:17 *MINOR DEFICIENCY LETTER §7:18 TELEPHONE
AMENDMENT § 7:19 APPROVAL MATRIX § 7:20 FINAL APPROVAL VERSUS TENTATIVE
APPROVAL § 7:21 TENTATIVE APPROVAL*REASONS FOR GETTING IT § 7:22 PATENT
ATTORNEY INVOLVEMENT IN ANSWERING DEFICIENCY LETTERS § 7:23 SHOWING
BIOEQUIVALENCY OF GENERIC VERSIONS § 7:24 BIOAVAILABILITY DEFINED § 7:25
BIOEQUIVALENCY DEFINED § 7:26 MEASURING BIOEQUIVALENCE OF TRADITIONAL
SOLID ORAL DOSAGE FORMS*IMMEDIATE AND EXTENDED RELEASE FORMS § 7:27
*EXTENDED RELEASE (ER) FORMS § 7:28 EXTENDED RELEASE TYPES*DIFFUSION
CONTROL SYSTEM § 7:29 *DISSOLUTION CONTROL SYSTEM § 7:30 *EROSION
CONTROL SYSTEM § 7:31 *OSMOTIC PUMP SYSTEM § 7:32 *ION-EXCHANGE RESIN
SYSTEM § 7:33 PROVING BIOEQUIVALENCY § 7:34 *IN VITRO DISSOLUTION
STUDIES § 7:35 *DISSOLUTION TESTING AND STANDARDIZED TESTING PROTOCOLS §
7:36 *PARTICLE SIZE AND DISSOLUTION TESTING § 7:37 IN VITRO
BIOEQUIVALENCY (BE) TESTING*REASONS FOR BE TESTING AND BIOWAIVERS § 7:38
BIOSTUDIES IN HUMAN SUBJECTS*PILOT AND PIVOTAL BIOSTUDIES § 7:39
*FASTING AND FED BIOSTUDIES XXVII GENERIC PHARMACEITICAI. PATENT AND FDA
LAW §7:40 FOOD EFFECT PATENTS ARE NOT PATENTAHLE § 7:41 IMPURITY
SPECIFICATIONS § 7:42 IMPURITY LEVELS AS DEFINED BY A REGULATORY
AUTHORITY § 7:43 AVOIDING IMPURITY PATENT CLAIMS MAY JEOPARDIZE
REGULATORY APPROVAL § 7:44 METERED AND POWDER DOSE INHALERS § 7:45 DRY
POWDER DOSE INHALERS I DPI T §7:46 NASAL SPRAYS AND INHALED SOLUTIONS,
SPRAYS §7:47 SAMPLES AND PATENT ISSUES IN SAMPLES § 7:48 CHANGES TO THE
ABBREVIATED NEW DRUG APPLICATION § 7:49 *MAJOR CHANGES § 7 : 50
*MODERATE CHANGES CHANGES BEING EFFECTED IN 30 DAYS(CBE-30I § 7:51
*MINOR CHANGE*MINIMAL IMPACT CHANGE DOCUMENTED IN ANNUAL REPORT § 7:52
CHANGES TO THE ANDA AND PATENT ISSUES § 7:53 REVIEW OF ANDA APPROVAL
PROCESS CHAPTER 8. PAPER NDA AND SECTION 505(B)(2) APPLICATIONS § 8:1
SECTION 505(B)(2) APPLICATION*GENERAL PRINCIPLES § 8:2 CONTRASTING
505(BK2) APPLICATIONS WITH ABBREVIATED NEW DRUG APPLICATIONS (ANDA) §
8:3 SIMILARITIES BETWEEN 505(B 2 APPLICATION AND ANDA § 8:4 GENERAL
TYPES OF APPLICATIONS §8:5 INFORMATION NEEDED TO SUPPORT THE APPLICATION
§ 8:6 STRATEGIC USES § 8:7 *USE OF A 505(B)(2) APPLICATION TO CIRCUMVENT
THE 180- DAY EXCLUSIVITY § 8:8 CONCLUSION CHAPTER 9. PATENT INFRINGEMENT
SAFE HARBOR EXEMPTIONS §9:1 INTRODUCTION § 9:2 GENESIS OF SAFE HARBOR
EXEMPTION* ROCHE V. BOLAR § 9:3 HATCH WAXMAN ACT/SAFE HARBOR
EXEMPTION*SCOPE OF EXEMPTION § 9:4 INFORMATION DEVELOPMENT AND
INFORMATION SUBMISSION TO FDA § 9:5 REASONABLE SCOPE OF EXEMPTION §
9:6 *MEDICAL DEVICES AND OTHER OSTENSIBLY UNRELATED ACTIVITIES TABLE OF
CONTENTS § 9:7 *EFFECT OF CONGRESSIONAL ACTION ON SCOPE OF EXEMPTION §
9:8 *CHAIN OF EXEMPTION § 9:9 GENERIC DRUG DEVELOPMENT §9:10 ANCILLARY
ACTIVITIES §9:11 RECOURSE FOR PATENT HOLDERS § 9:12 COMMON LAW RESEARCH
EXEMPTION AND DE MINIMIS INFRINGEMENT CHAPTER 10. MECHANICS OF ORANGE
BOOK PATENT CERTIFICATIONS AND NOTICE LETTERS § 10:1 INTRODUCTION § 10:2
PATENT CERTIFICATIONS AND ORANGE BOOK LISTING § 10:3 *PARAGRAPH I, II,
III, OR IV CERTIFICATIONS § 10:4 *IMPACT ON ANDA APPROVAL § 10:5
*HYPOTHETICAL PATENT CERTIFICATIONS*CASE STUDY ON VIAGRA § 10:6 SECTION
(VIII) STATEMENTS*CARVING OUT PATENTED METHODS OF USE § 10:7 *WORKING
EXAMPLE ON SECTION VIII STATEMENTS*SERTRALINE § 10:8 *ONE AND ONLY
INDICATION § 10:9 *CARVING OUT INDICATIONS TO UNLISTED PATENTS § 10:10
REQUEST LISTING § 10:11 USING SUITABILITY PETITIONS TO ALLOW CARVE OUT §
10:12 COMBINING PARAGRAPH I CERTIFICATION IN LIEU OF SECTION VIII
STATEMENT § 10:13 *PARAGRAPH IV CERTIFICATION AND NOTICE LETTER
REQUIREMENTS § 10:14 *IDENTIFYING THE PATENTS IN THE NOTICE LETTER §
10:15 CONTENT AND SUFFICIENCY OF THE NOTICE LETTER § 10:16 HOW MUCH
DETAIL IS NECESSARY § 10:17 DETAILS ON CLAIMS THAT ARE NOT NORMALLY
LISTABLE § 10:18 FORM OF LETTER AND DETAILED STATEMENT § 10:19
ADMONISHMENTS*APPENDING LETTER TO A COMPLAINT § 10:20 PREDICATES TO
ANTITRUST INJURY § 10:21 HOW TO SEND THE NOTICE LETTER § 10:22 WHERE TO
SEND THE NOTICE LETTER § 10:23 WHEN TO SEND THE NOTICE LETTER § 10:24
UPDATING THE FDA ON NOTICE LETTERS XXIX GENERIC PMARMACEI TICAI. PATENT
AND FDA LAW § 10-25 HI-ISSUE PATENTS- NYW PUTEIITS »R ROLLOVERS OF OLD
PATENTS THAT REQUIRE NEW PATENT CERTIFICATIONS § 10:26 ROLL-OVERS FROM
ORIGINAL PATENT § 10:27 NEW PATENT § 10:28 *SUMMARY § 10:29 OFFER FOR
CONFIDENTIAL ACCE I( K .V § 10:30 *WHERE INVAHDITV I ALLEGED § 10:31
*ISSUES WITH THE OFFER FOR CONFIDENTIAL ACCESS TOLAL § 10:32 TRACKING
PARAGRAPH IV CERT ITU AT IONS ON THE FDA WEB SITE CHAPTER 11. THE
30-MONTH INJUNCTION/STAY I. GENERALLY § 11:1 INTRODUCTION § 11:2
CREATING THE 30-MONTH STAY AND COUNTING DAYS § 11:3 WHO NOTIFIES THE FDA
OF THE LAWSUIT II. TERMINATION OF THE 30-MONTH STAY § 11:4 HOW THE
30-MONTH STAY IS NORMALLY TERMINATED § 11:5 COURT DECISION § 11:6
GENERIC COMPANY WINS § 11:7 GENERIC COMPANY WINS ON APPEAL § 11:8
PATENTEE DELAYS III. LENGTHENING, SHORTENING, OR REINSTATING THE STAY §
11:9 EXTENDING STAY BECAUSE COURT MADE NO DECISION §11:10 REINSTATING IF
WRONGFULLY TERMINATED § 11:11 LENGTHENING OR SHORTENING DUE TO LACK OF
COOPERATION § 11:12 CASES EXTENDING THE 30-MONTH STAY § 11:13 CASES
SHORTENING THE 30-MONTH STAY T § 11:14 CASES WHERE THE STAY WAS NOT
ALTERED DESPITE RCQUES TO ALTER IV. EFFECT OF DELAYS § 11:15 BLOWING THE
45-DAY WINDOW*CAN SUIT STILL BE BROUGHT? V. EARNING NEW 30-MONTH STAYS §
11:16 GENERALLY TABLE OF CONTENTS § 11:17 REPETITIVE 30-MONTH STAYS
UNDER THE OLD RULES § 11:18 EARNING 30-MONTH STAYS UNDER THE DECEMBER
2003 RULES § 11:19 EFFECT OF POP-UP (NEWLY ISSUED) PATENTS § 11:20
WORKING EXAMPLES OF THE 30-MONTH STAY VI. STAGGERED EXPIRATIONS § 11:21
MULTIPLE APPLICANTS 30-MONTH STAY; STAGGERED STAY EXPIRIES CHAPTER 12.
BRAND SIDE EXCLUSIVITIES § 12:1 FILING AND APPROVAL EXCLUSIVITIES § 12:2
NEW CHEMICAL ENTITY (NCE) EXCLUSIVITY [FIVE-YEAR] § 12:3 *WHEN TO FILE
ANDAS WITH PARAGRAPH IV CERTIFICATIONS § 12:4 *EXTENSIONS OF THE
30-MONTH STAY § 12:5 *DELISTING PATENTS FROM ORANGE BOOK RIGHT BEFORE
NCE-1 DATE § 12:6 NEW PRODUCT/CLINICAL INFORMATION/SUPPLEMENTAL
EXCLUSIVITY [THREE-YEARL § 12:7 *REQUIREMENTS FOR THE NEW CLINICAL
INFORMATION EXCLUSIVITY § 12:8 *REQUIREMENTS*WORKING EXAMPLE FOR GENERIC
APPROVAL OF LESS THAN ALL INDICATIONS § 12:9 *DIFFERENCE BETWEEN NCE AND
THREE-YEAR EXCLUSIVITY § 12:10 THREE-YEAR EXCLUSIVITY FOR ENANTIOMERS §
12:11 ORPHAN DRUG EXCLUSIVITY [SEVEN-YEAR EXCLUSIVITY] § 12:12 PEDIATRIC
EXCLUSIVITY [SIX MONTHS] § 12:13 *EFFECT § 12:14 *TRACKING § 12:15
*EFFECT ON ANDA FILINGS §12:16 *EFFECT ON THE 30-MONTH STAY § 12:17
WORKING EXAMPLES OF PEDIATRIC EXCLUSIVITY § 12:18 WORKING
EXAMPLES*RANBAXY V. FDA AND PFIZER; FLUCONAZOLE § 12:19 ALZA V.
MYLAN/MYLAN V. FDA; FENTANYL PATCH § 12:20 *EFFECTS ON THE 30-MONTH
STAY*WORKING EXAMPLES* PFIZER V. APOTEX; AMLODIPINE § 12:21 *PEDIATRIC
EXCLUSIVITY AND COMBINATION PRODUCTS § 12:22 PATENT INFRINGEMENT
IMPLICATIONS § 12:23 KEY POINTS ABOUT PEDIATRIC EXCLUSIVITY XXXI GENERIC
PHARMACEUTICAL PATEVI AND FDA LA W CHAPTER 13. THE 180-DAY EXCLUSIVITY §
13:1 INTRODUCTION § 13:2 CREATING THE 180-DAY EXCLUSIVITY § 13:3 AGAINST
WHOM THE 180-DAY EXCLUSIVITY APPLIES §13:4 FDA S PRODUCT-BY-PRODUCT
APPROACH TO PATENT CERTIFICATIONS § 13:5 PRODUCT-BY-PRODUCT APPROACH TO
EXCLUSIVITY § 13:6 180-DAY EXCLUSIVITY NATURALLY EXPIRES WITH THE
UNDERLYING PATENT § 13:7 TRIGGERING THE 180-DAY EXCLUSIVITY CLOCK § 13:8
*UNDER PRE-DECEMBER 2003 MM A RULES § 13:9 *UNDER THE POST-MMA RULES §
13:10 TRACKING THE LHO-DAY EXCLUSIVITY § 13:11 REISSUE PATENTS AND NEW
180DAY EXCLUSIVITIES § 13:12 AUTHORIZED GENERICS § 13:13 *CURBING BY
MEDICAID BEST PRICE LAW § 13:14 WAIVER OR RELINQUISHMENT OF THE 180-DAY
EXCLUSIVITY § 13:15 *MECHANICS OF SELECTIVE WAIVER AND TOTAL
RELINQUISHMENT CHAPTER 14. FORFEITURE OF THE 180-DAY EXCLUSIVITY § 14:1
INTRODUCTION § 14:2 FORFEITURE PROVISIONS § 14:3 *FAILURE TO MARKET §
14:4 *NO LITIGATION PENDING; 30 MONTHS TO APPROVAL, 75 DAYS TO MARKET §
14:5 *LITIGATION PENDING § 14:6 *RATIONALIZING THE FAILURE TO MARKET
PROVISIONS; NO PATENT LITIGATION 14:? C ^ RIVED PATENT LITIGATION,
POSSIBILITY OF SUIT TO AVOID FORFEITS § 14:8 SETTLING LAWSUITS BUT
MAINTAINING THE PARAGRAPH IV TO AVOID FORFEITS UIN F THDRAWAL OF
APPLICATION BILL? MENDMENT OF CERTIFICATION I LL L V T0 BTAIN
TENTATIVE APPROVAL PETITION^ APPR0VA1 CHAN G ED CONDITIONS, AND
CITIZEN I IFU TF REEMENTS THAT VIOLATE ANTITRUST LAWS §14.14 EXPIRATION
OF PATENTS XXXII TABLE OF CONTENTS § 14:15 NO-ROLLING EXCLUSIVITY §
14:16 FORFEITURES IN GENERAL POLICY TERMS CHAPTER 15. DECLARATORY
JUDGMENT § 15:1 INTRODUCTION: PURPOSE OF THE DECLARATORY JUDGMENT ACT
(DJA) § 15:2 WHEN DJS ARE USED IN PHARMACEUTICAL PATENT CASES § 15:3
TRADITIONAL DECLARATORY JUDGMENT STANDARDS § 15:4 POST-MEDLMMUNE
DECLARATORY JUDGMENT STANDARDS § 15:5 *FAMCICLOVIR CASE AND FACTORS
ALLOWING A DECLARATORY JUDGMENT ACTION § 15:6 DECLARATORY JUDGMENTS TO
TRIGGER EXCLUSIVITY § 15:7 *ORANGE BOOK LISTING ALONE COULD CONFER DJ
JURISDICTION § 15:8 PATENTS LISTED BUT STATUTORILY DISCLAIMED DO NOT
CONFER JURISDICTION § 15:9 COVENANTS NOT TO SUE; REMOVING FEAR OF SUIT §
15:10 *COVENANTS DIVESTING COURT S JURISDICTION CHAPTER 16. PATENT
INFRINGEMENT DAMAGES AND REMEDIES § 16:1 INTRODUCTION § 16:2 POTENTIAL
REMEDIES FOR PATENT INFRINGEMENT § 16:3 IMPACT OF THE LOSS ON THE ANDA
APPROVAL STATUS AND REDATING THE ANDA APPROVAL DATE § 16:4 *ANDAS FOR
OLD ANTIBIOTICS SHOULD NOT HAVE REDATED APPROVAL DATES § 16:5 INJUNCTIVE
RELIEF TO STOP FUTURE INFRINGEMENT OR PREVENT AT-RISK LAUNCH § 16:6
*OTHER FACTORS TO CONSIDER IN WHETHER TO GRANT A LAUNCH-PREVENTION
INJUNCTION § 16:7 AWARDING AN INJUNCTION AGAINST FUTURE INFRINGEMENT
WHEN GENERIC COMPANY LOSES § 16:8 PRODUCT RECALL OF GENERIC PRODUCTS IN
THE MARKETPLACE § 16:9 MONEY DAMAGES FOR PATENT INFRINGEMENT § 16:10
*MONEY DAMAGES, REASONABLE ROYALTY OR LOST PROFITS § 16:11 *REASONABLE
ROYALTY §16:12 HYPOTHETICAL NEGOTIATIONS § 16:13 FACTORS TO CONSIDER IN
SETTING THE ROYALTY: GEORGIA PACIFIC TEST XXXI11 (IKNKHK I LLAKMAI HL IK
AL I A I I N I AM) FDA LAW § 16:14 FACTOR.- IN RELATION TO GENERIC
DRUG INFRINGEMENT §16:15 *KFLEET ON PERMANENT INJUNCTION § 16:16 *LOST
PROFITS § 16:17 *LOST PROFIT.- AND MARKET RECONSTRUCTION § 16:18 NO LOST
PROFIT- WHEN SUBSTITUTES EXIST § 16:19 NO LO.-T PROFIT- WHEN SUBSTITUTES
AND AUTHORIZED GENERIC.- EXIST § 16:20 --CALCULATING LOST PROFIT- AND
BRINGING EXPENSES INTO THE CALCULUS §16:21 KXPENSE DEDUCTIONS § 16:22
F.NHANCED DAMAGES AND WILLFUL INFRINGEMENT § 16:23 WILLFUL INFRINGEMENT
AND FACTORS TO CONSIDER § 16:24 LEGAL OPINIONS AND WILLFUL INFRINGEMENT
§ 16:25 *WILLFUL INFRINGEMENT FOR FILING AN ANDA § 16:26 *WILLFULNESS
AND THE NEED TO SPECIFY FACTS IN THE PLEADING § 16:27 EXCEPTIONAL CASES
AND ATTORNEY FEES § 16:28 *WHEN CAN ATTORNEY FEES BE AWARDED § 16:29
*STEPS IN AWARDING ATTORNEY FEES § 16:30 *WHO IS A PREVAILING PARTY §
16:31 *ATTORNEY FEE AMOUNTS § 16:32 *CASE STUDY: PIOGLITAZONE AND
ATTORNEY FEE AWARDED TO PATENTEE TABLE OF CASES INDEX
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| adam_txt |
GENERIC PHARMACEUTICAL PATENT AND FDA LAW 2008 EDITION SHASHANK UPADHYE
XMOIVISOISI ^K, WEST FOR CUSTOMER ASSISTANCE CALL 1-800-328-4880 MAT
#40615439 TABLE OF CONTENTS CHAPTER 1. BASICS OF PATENT LAW I.
INTRODUCTION § 1:1 IN GENERAL § 1:2 BASIC PATENT PROCESS § 1:3
STRUCTURAL ORGANIZATION OF A PATENT II. PATENT CLAIMS §1:4 IMPORTANCE OF
PATENT CLAIMS § 1:5 PERSON OF ORDINARY SKILL IN THE ART § 1:6
ORGANIZATIONAL STRUCTURE OF THE CLAIM*PREAMBLE § 1:7 TRANSITION PHRASE §
1:8 ORGANIZATIONAL STRUCTURE OF THE CLAIM*BODY OF THE CLAIM § 1:9 COMMON
TYPES OF PHARMACEUTICAL CLAIMS*BASE CHEMICAL/COMPOUND CLAIMS § 1:10
*SALTS, ESTERS, AND SOLVATES § 1:11 *ENANTIOMERS § 1:12 *POLYMORPHS
§1:13 *COMBINATIONS OF APIS § 1:14 *FORMULATIONS §1:15 *METHODS OF USE §
1:16 *METHOD OF MANUFACTURE OR PROCESS CLAIMS § 1:17 *PRODUCT-BY-PROCESS
CLAIMS § 1:18 *RELEASE PROFILES § 1:19 CONCLUSION III. STATUTORY
PROVISIONS A. IN GENERAL § 1:20 COMMON STATUTORY PROVISIONS OF THE
PATENT LAW B. SECTION 101: SUBJECT MATTER § 1:21 PATENTABLE SUBJECT
MATTER XVII GKNKKIC I'HAKMA I T RIC AI I'ATK.M AND FDA LAW C. SECTION
102: NOVELTY § 1:22 NOVELTY AND "NEW" INVENTIONS § 1:23 SECTION 102IAI §
1:24 SECTION 102 § 1:25 *ON-SALE BAR § 1:26 *PUBLIC USE BAR § 1:27
SECTION 102 § 1:28 SECTION 102UL § 1:29 SECTION 102- -UTOPIAN-WORLD
P.-,T.-NI ISSUANCE IN THE UOR 10 § 1:30 ^"? URSTAN K § L() * " THROUGH
EXAMPLE .-IND TIME §1:31 SECTION 102(FT-.I, M .NT,R IS ,,,,NH.
I,IV.-,.L,R § 1:32 SECT.ON 102I K I_LVI,R IRNVMI,,,, L,V ANOTHER 1 JO,
~ CONTRAST »N SECTION L()2(G.( 1 I VERSUS 1()2( M H2) § 1:34 CONCLUSION
D. SECTION 103: OBVIOUSNESS 1 TH3N TNVIAL VARIATIONS ?* ^ FACT
*-PRIMARV OBVIOUSNESS FACTORS F OBVIOU NESS INQUIRY- " SML ?FTF T
HIN ^HT-MOTIVATION. SUGGESTION, 8 1 QQ PN^L ' T0 COMB »NE PRIOR ART
-^BINAHON OF REFERENCES-FLOWING FROM THE PRIOR § 1:40 * REFERENCE V §
1:41 SECONDARY TIJ*? T"* F PR BLEM TO BE S LVED § 1:42 UNEXPECTED
ROSULOFIB 10118 " 1 ":- § 1:43 LONG-FELT NEED TU INVENTION § 144 FAILNR
V T R THE INV *NTION 1;S SXLS! W T K § 1;S SXLS! R § 1:46 -ACTIVE I N
^ D ^ ^ FACT " R IN OBVI » USNL * 8 §1:47 -FORMULATION 1 " 1:48
LICENSING BY OTHERS 8 1:49 COMMERCIAL SI § 1:50 SKEPTICISM H ^ SS ~
GENER IC DRUG INFRINGEMENT CASES § 1:51 THIRD-NART, RS AND P ROOF OF
NONOBVIOUSNESS § 1:52 CHEMICAL ^ R R ISE ^ D § 1:53 - ^ S S T Y § 1:54
-ISO^L?! 1 BV , IOUSNES S OF CHEMICAL COMPOUNDS §1:55 CONCLUSTO N D
BVI0USN XVHL TABLE OF CONTENTS E. SECTION 112: SPECIFICATION §1:56 ROLE
OF THE SPECIFICATION § 1:57 FIRST PARAGRAPH § 1:58 *WRITTEN DESCRIPTION
§ 1:59 *ENABLEMENT REQUIREMENT § 1:60 *BEST MODE REQUIREMENT § 1:61
*CONCLUSION § 1:62 SECOND PARAGRAPH: CLAIM PRECISION AND BOUNDARIES §
1:63 THIRD AND FOURTH PARAGRAPHS: DEPENDENT CLAIMS § 1:64 CONCLUSION F.
SECTIONS 119, 120 AND 121: PRIORITIES § 1:65 PRIORITY AND EARLIEST
FILING DATES § 1:66 SECTION 119: CLAIMING FOREIGN PRIORITY § 1:67 *TOOL
FOR EVALUATING PRIOR ART EFFECT § 1:68 *SECTION 102(B) PRIOR ART IS NOT
AFFECTED BY SECTION § 1:69 CLAIMING THE BENEFIT OF EARLIER-FILED
APPLICATIONS § 1:70 CONTINUATION APPLICATIONS FOR A DIFFERENT INVENTION
USING THE SAME SPECIFICATION § 1:71 DIVISIONAL APPLICATIONS FOR
EXAMINER-MANDATED RESTRICTIONS TO DIFFERENT INVENTIONS § 1:72 *SAFE
HARBOR PROVISION OF SECTION 121 FOR DIVISIONAL APPLICATIONS § 1:73
*CONTINUATION-IN-PART APPLICATIONS*INTRODUCING NEW MATTER IV. PATENT
TERM EXTENSION § 1:74 PATENT TERM EXTENSION AND PATENT EXPIRATION § 1:75
EMBROILMENT IN FDA*SECTIONS 155, 155A, 156 § 1:76 *CONGRESSIONAL PATENT
TERM EXTENSIONS § 1:77 *PTO DELAYS § 1:78 *URUGUAY ROUND TERM EXTENSIONS
§ 1:79 *PATENT TERM RESTORATION DUE TO FDA APPROVAL PROCESSES § 1:80 CAP
OF FIVE YEARS § 1:81 PATENT TERM RESTORATION IS A USPTO AND FDA
COOPERATION § 1:82 *SINGLE AND COMBINATION INGREDIENTS V. ENANTIONERS §
1:83 HISTORY OF ENANTIOMER PATENTABILITY XIX GENERIC PHARMACEUTICAL
PATENT AND FDA LAW § 1:84 CASE STUDY*LEVOFLOXACIN § 1:85 *LEVETIRACETAM
§ 1:86 *CLOPIDOGREL § 1:87 LESSONS LEARNED VI. COMBINATION PRODUCTS
§1:88 PATENTABILITY OF COMBINATION PRODUCTS § 1:89 CASE STUDY*SUDAFED §
1:90 *LOPERAMIDE § 1:91 *VICOPROFEN § 1:92 LESSONS LEARNED APPENDIX 1A.
BIBLIOGRAPHY OF RESOURCES CHAPTER 2. PATENT INFRINGEMENT RULES AND
PROCEDURES I. INTRODUCTION §2:1 GENERALLY § 2:2 BASIC INFRINGEMENT TEST
II. CLAIM CONSTRUCTION § 2:3 GENERALLY A. EVIDENCE § 2:4 EVIDENCE
CONSIDERED IN CLAIM CONSTRUCTION § 2:5 INTRINSIC EVIDENCE MUST BE
CONSIDERED FIRST*MANDATORY EVIDENCE § 2:6 EXTRINSIC EVIDENCE CAN BE
CONSIDERED*PERMISSIVE EVIDENCE § 2:7 DICTIONARIES AND TREATISES AS
SOURCES OF EVIDENCE OF CLAIM MEANING B. RULES § 2:8 CUSTOMARY CLAIM
CONSTRUCTION RULES C. NARROW CLAIM CONSTRUCTIONS § 2:9 TOOLS FOR THE
GENERIC COMPANY § 2:10 SPECIFICATION CLEARLY DEFINES CLAIM TERM § 2:11
CLAIM TERM IS IMPLICITLY DEFINED BY CONSISTENT USE THROUGHOUT
SPECIFICATION TABLE OF CONTENTS § 2:12 PATTERN OF EXAMPLES IN
SPECIFICATION DEDUCES CLAIM MEANING § 2:13 EMBODIMENT IS THE INVENTION §
2:14 SPECIFICATION DISAVOWS PARTICULAR MEANING § 2:15 SPECIFICATION
EXPLICITLY DISCLAIMS DEFINITION § 2:16 LIMITING THE CLAIM SCOPE BECAUSE
CONSISTENT WITH INVENTION'S PURPOSE § 2:17 SPECIFICATION CONTAINS
IMPLICIT DISCLAIMER OF DEFINITION § 2:18 SPECIFICATIONS AND
UNDERCLAIMING*CLAIMING LESS THAN YOU COULD HAVE § 2:19 PROSECUTION
HISTORY AS INTRINSIC EVIDENCE*MANDATORY OR PERMISSIVE EVIDENCE § 2:20
PROSECUTION HISTORY CONTAINS NARROW DEFINITION WHEN ORDINARY MEANING IS
UNCLEAR § 2:21 CLAIM TERM IS NARROWED BECAUSE OF DISCLAIMER OF ORDINARY
MEANING IN PROSECUTION HISTORY § 2:22 USING PROSECUTION HISTORY OF
PARENT APPLICATION IN SUBSEQUENT APPLICATIONS § 2:23 CHOOSING NARROW
CLAIM SCOPE WHEN COMPETING SCOPES EXIST E. OTHER ISSUES § 2:24 CLAIM
DIFFERENTIATION AND INTERPRETING CLAIMS OF DIFFERENT SCOPE § 2:25
INEXACT MODIFIERS OR RELATIVE TERMINOLOGY § 2:26 ILLUSTRATION REGARDING
SCOPE OF "ABOUT" § 2:27 TIMING OF CLAIM CONSTRUCTION IN VIEW OF ISSUED
PATENT III. LITERAL INFRINGEMENT § 2:28 GENERALLY § 2:29 LITIGATING MORE
THAN ONE CLAIM CONSTRUCTION AT TRIAL: FEDERAL CIRCUIT REVIEW OF RECORD §
2:30 SPECIAL CASE: INHERENT INFRINGEMENT UNDER SINGLE CRYSTAL THEORY §
2:31 SPECIAL CASE: INHERENT INFRINGEMENT UNDER SINGLE CRYSTAL
THEORY*IMPACT OF SMITHKLINE V. APOTEX ON INFRINGEMENT § 2:32 PROVING
LITERAL INFRINGEMENT § 2:33 LITERAL INFRINGEMENT AS BASED ON THE GENERIC
DRUG APPLICATION IV. DOCTRINE OF EQUIVALENTS § 2:34 DOCTRINE OF
EQUIVALENTS (DOE) INFRINGEMENT XXI GENERIC PMARMACEI'TICAL PATENT AND
FDA LAW § 2:35 TESTS FOR DOF §2:36 *INSUBSTANTIAL DIFFERENCES TEST TOR
EQUIVALENCY INFRINGEMENT §2:37 *FUNCTION WAY RESULT TEST § 2:38
*ELCMENT-BY-ELENIENT ANAL.VMS §2:39 SUBJECT MATTER DISCLOSED BUT NOT
CLAIMED "DEDICATION TO THE PUBLIC" RULE §2:40 DOCTRINE OF PROSECUTION
HISTORY ESTOPPEL 1PHF.1 §2:41 *AMENDMENT-BASED ESTOPPEL §2:42 REBUTTING
THE PRESUMPTION OF ESTOPPEL §2:43 **FESTO IX: FEDERAL CIRCUIT SUMMARY OF
EQUIVALENCY FACTORS §2:44 FESTO TEST PART 7: REBUTTING PROSECUTION
HISTORY ESTOPPEL § 2:45 FESTO TEST PART 7UI: FORESEEABLE CHANGES § 2:46
FORESEEABILITY OF DRAFTING CLAIM TO EQUIVALENT: IS IT NEW MATTER § 2:47
FESTO TEST PART 7: TANGENTIAL RELATIONSHIP § 2:48 FESTO TEST PART 7( III
I: SOME OTHER UNEXPLAINED REASON § 2:49 *ARGUMENT-BASED ESTOPPEL § 2:50
*RELATED APPLICATIONS MAY EVOKE ESTOPPEL 8 2:51 *SCOPE S ? : S ~ PRIOR
ART PRECLUSIONS*HYPOTHETICAL CLAIM ANALYSIS § Z.BD *DETAILED STRUCTURE
TEST: AN ALTERNATE TO THE INSUBSTANTIAL DIFFERENCES AND FUNCTION WAY
RESULT TESTS § 2:54 CASE STUDIES: SMITHKLINC BEECHAM AND EQUIVALENCY-
TAINED RDT ' A ' SC BUPROPION 8 2:55 CASE STUDIES: SMITHKUNE BEECHAM
AND EQUIVALENCY*CONCLUSION V. INDIRECT INFRINGEMENT § 2:56 CONTRIBUTORY
AND INDUCEMENT INFRINGEMENT GENERALLY FF"T M FNNGEMENT-INDUCEMENT UNDER
35 U.S.C.A. 8 J/KB) §2:58 SUMMARY Y 2:59 C2 ^ UTOR Y P AT ENT
INFRINGEMENT UNDER 35 U.S.C.A. § \ 2-6? -JPV WIN G COMPONENT IS
ESPECIALLY MADE § 2:63 INFRINGEM ENT UNDER 35 U.S.C.A. § 27 KG
^IMPORTING DRUGS MADE BY PATENTED PROCESS XXII TABLE OF CONTENTS § 2:64
*HYPOTHETICAL DESCRIBING PROBLEM WITH § 271(G) VT. CONCLUSION § 2:65
GENERALLY CHAPTER 3. FOUNDATIONS OF PATENT INVALIDITY I. INTRODUCTION §
3:1 IN GENERAL II. PRIOR ART § 3:2 BURDENS OF PROOF*PRIOR ART*CONSIDERED
OR NOT CONSIDERED BY EXAMINER § 3:3 SOURCES § 3:4 FULLY PRESENTED AND
VETTED § 3:5 CITED BUT NOT VETTED §3:6 NOT CITED III. ANTICIPATION § 3.7
INVALIDATING PATENT BECAUSE INVENTION IS NOT NEW § 3:8
ELEMENT-BY-ELEMENT ANALYSIS, EXPRESS AND INHERENT ANTICIPATION § 3:9
INHERENT ANTICIPATION §3:10 *HYPOTHETICAL § 3:11 SMITHKLINE V. APOTEX
REVISITED IV. OBVIOUSNESS § 3:12 INVALIDITY DEFENSE § 3:13 USPTO
GUIDELINES § 3:14 COMBINING PRIOR ART ELEMENTS ACCORDING TO KNOWN
METHODS TO YIELD PREDICTABLE RESULTS § 3:15 *SIMPLE SUBSTITUTION OF ONE
KNOWN ELEMENT FOR ANOTHER TO OBTAIN PREDICTABLE RESULTS § 3:16 KNOWN
TECHNIQUES TO IMPROVE SIMILAR DEVICES, METHODS, OR PRODUCTS § 3:17
APPLYING KNOWN TECHNIQUE TO YIELD PREDICTABLE RESULTS § 3:18 "OBVIOUS TO
TRY"*CHOOSING FROM FINITE NUMBER OF ITEMS § 3:19 *APPLICABILITY TO
ENANTIOMERS, SALT SELECTION, AND EXTENDED RELEASE (ER) FORMULATIONS
XXIII GENERIC PHARMACEUTICAL PATENT AND FDA LAW § 3:20 MARKET FORCES AND
DESIGN CONSIDERATIONS § 3:21 TEACHING, SUGGESTION, OR MOTIVATION IN THE
PRIOR ART § 3:22 PERSON OF ORDINARY SKILL IN THE ART POSITA) § 3:23
STRUCTURAL OBVIOUSNESS*BREAKING COMPOUND PATENTS § 3:24 *LANSOPRAZOLE
VERSUS RABEPRAZOLE § 3:25 *ATTACKING OF ANALOGUE OF COMPOUND V.
"PRACTICING THE PRIOR ART" § 3:26 DEFENSE TO INFRINGEMENT VI. GENUS AND
SPECIES § 3:27 INTERPRETATION § 3:28 CASE STUDY*GENUS AND SPECIES:
ZYPREXAQO (OLANZAPINE) §3:29 *ENANTIOMERS, INVALIDITY, AND PLAVIX
(DOPIDOGREL) VII. SECTION 112 § 3:30 PATENT INVALIDITY THEORIES § 3:31
WRITTEN DESCRIPTION INVALIDITY § 3:32 *MECHANICS OF WRITTEN DESCRIPTION
CHALLENGE § 3:33 ENABLEMENT § 3:34 *UNDUE EXPERIMENTATION § 3:35 *"HOW
TO MAKE" § 3:36 *"HOW TO USE" § 3:37 *IN VITRO TO IN VIVO TEACHING §
3:38 *EFFECTIVE AMOUNTS § 3:39 BEST MODE REQUIREMENT § 3:40 CONTRASTING
ENABLEMENT AND BEST MODE § 3:41 WRITTEN DESCRIPTION, ENABLEMENT, AND
BEST MODE- BREAKING CHAINS OF PRIORITY TO INVALIDATE LATER PATENTS §
3:42 ROLLING PROVISIONALS ALLOW FOR CHAINS OF PRIORITY § 3:43 SECTION
112, SECOND PARAGRAPH: CLAIM PRECISION AND BOUNDARIES § 3:44 SECTION
112, THIRD AND FOURTH PARAGRAPHS: DEPENDENT CLAIMS CHAPTER 4.
INEQUITABLE CONDUCT AND PATENT UNENFORCEABILITY § 4:1 INEQUITABLE
CONDUCT*FRAUD ON THE PATENT OFFICE 3 4:2 TYPES OF INEQUITABLE CONDUCT
TEST*COMMON SITUATIONS 8 4:3 PENALTIES FOR INEQUITABLE CONDUCT XXIV
TABLE OF CONTENTS § 4:4 *UNENFORCEABILITY*LATER PATENTS THROUGH
INFECTIOUS UNENFORCEABILITY § 4:5 AWARDING ATTORNEY'S FEES AND COSTS §
4:6 FRAUD-BASED DAMAGES (WALKER PROCESS FRAUD) § 4:7 PRIVATE ENFORCEMENT
OF FRAUD § 4:8 CURING INEQUITABLE CONDUCT § 4:9 ASSERTING INEQUITABLE
CONDUCT*NOT A GAME OF GOTCHA § 4:10 MATERIALITY THRESHOLD*CURRENT AND
PAST TESTS FOR MATERIALITY § 4:11 INFORMATION DOES NOT HAVE TO BE
CLAIMED § 4:12 FAILURE TO COMPLY WITH SECTION 112(1) § 4:13 *INFORMATION
DOES NOT HAVE TO VERBATIM § 4:14 FALSE STATEMENTS § 4:15 FAILURE TO
DISCLOSE RELATIONSHIP OF AFFIANT TO APPLICANT §4:16 DATA IS PRESUMED
MATERIAL § 4:17 *FAILURE TO PROVIDE UNFAVOURABLE TEST RESULTS § 4:18
-ACCURATE DESCRIPTION OF TEST CONDITIONS § 4:19 CLAIM FOR PRIORITY §4:20
ISSUES EXAMINER FOCUSES ON § 4:21 **AFFIRMATIVE MISREPRESENTATIONS §
4:22 *INTENT TO DECEIVE § 4:23 STRESSING IMPORTANCE OF SUBMITTED PRIOR
ART § 4:24 GROSS NEGLIGENCE § 4:25 "TOTALITY" CAN INCLUDE GROSS
NEGLIGENCE § 4:26 MERE DENIAL IS NEVER ENOUGH TO OVERCOME INFERENCE OF
INTENT § 4:27 SEARCHING FOR PRIOR ART § 4:28 PATTERNS OF
MISREPRESENTATIONS OR OMISSIONS* SINGLE ACTIONS § 4:29 CULTIVATED
IGNORANCE*OBTAINING TRANSLATIONS OF FOREIGN LANGUAGE DOCUMENTS § 4:30
"BURYING" CRITICAL REFERENCE § 4:31 FAILURE TO DISCLOSE PRIOR ART AND
FOREIGN OFFICE ACTIONS FROM FOREIGN SEARCHES § 4:32 FALSE OR MISLEADING
AFFIDAVITS § 4:33 FAILURE TO NAME PROPER INVENTORS § 4:34 *PITFALLS FOR
PATENT APPLICANTS AND CORRECTIVE MEASURES AND PRACTICE TIPS § 4:35
CONCLUSION CHAPTER 5. EQUITABLE DEFENSES TO PATENT INFRINGEMENT §5:1
INTRODUCTION XXV 8 GENERIC PHAKMACKI THAI. PATEN I AND FDA LAW §5:2
ISSUE PRECLUSION, COLLATERAL ESTOPPEL/CLAIM PRECLUSION AND RES JUDICATA
§ 5:3 LACHES*GENERAL PRINCIPLES §5:4 *QUICK COMPARISON OF LACHES AND
EQUITABLE ESTOPPEL § 5:5 *FACTORS §5:6 *LACHES AND PRESUMPTIONS §5:7
EQUITABLE ESTOPPEL - FACTORS §5:8 *PRESUMPTIONS §5:9 *PROSECUTION LACHES
§5:10 RECENT DEVELOPMENTS CHAPTER 6. BASICS OF BRAND DRUG APPROVAL
PROCESS AND ORANGE BOOK LISTINGS §6:1 INTRODUCTION § 6:2 BRAND DRUG
APPROVAL §6:3 INVESTIGATIONAL NEW DRUG APPLICATION IINI) * BEGINNING
CLINICAL TRIALS § 6:4 *CONTENTS § 6:5 NEW DRUG APPLICATION NDA T § 6:6
*DRUG MASTER FILES I DMF § 6:7 TYPES OF NEW DRUGS IN NDA § 6:8
INTERNAL FDA MACHINATIONS § 6:9 PATENT INFORMATION AND THE ORANGE BOOK §
6:10 *LISTABLE AND NONLISTABLE PATENTS § 6:11 *PATENT LISTING AS
CLERICAL NOT SUBSTANTIVE § 6:12 *DELISTING PATENTS § 6:13 *FORCIBLE
LISTING OF UNLISTED PATENTS § 6:14 WHEN PATENTS MAY BE LISTED 9 6:15 WHO
MAY LIST WHICH PATENTS 9 6:16 MEDICAL DEVICE PATENTS AND ANTIBIOTIC
PATENTS*STATUS 9 6:17 POLYMORPH PATENT LISTING 9 6:18 BLINDS AND
CLINICAL TESTING | 6:19 -CLINICAL TRIAL PHASES S RO? PUBLIC USE PATENT
'"VALIDITY J E L NDAS "-NEW DRUG APPLICATIONS/SECTION 505(B)(2)
APPLICATIONS 9 6:22 NDA APPROVAL AND APPROVAL DATES F. ABBREVIATED NEW
LICATION (A PROCESS § '1 REFERENCE LISTED DRUG (RLD) XXVI TABLE OF
CONTENTS § 7:2 SUITABILITY PETITIONS TO REFER TO DIFFERENT RLDS § 7:3
ABBREVIATED NEW DRUG APPLICATION (ANDA) § 7:4 *DIFFERENCES BETWEEN THE
NDA AND ANDA § 7:5 *BIOEQUIVALENCY OF GENERIC DRUG § 7:6 INNER WORKINGS
OF THE FDA § 7:7 LABELING REVIEW § 7:8 CHEMISTRY AND MANUFACTURING
CONTROLS (CMC) § 7:9 BIOPHARMACEUTICAL REVIEW AND BIOAVAILABILITY § 7:10
CLASSIFICATION SYSTEM FOR BIOPHARMACEUTICAL PROPERTIES § 7:11 *PATENTS
CLAIMING PHARMACOKINETICS § 7:12 MICROBIOLOGY REVIEW § 7:13 CLINICAL
REVIEW §7:14 CGMP REVIEW §7:15 DEFICIENCY LETTERS § 7:16 *MAJOR
DEFICIENCY LETTER § 7:17 *MINOR DEFICIENCY LETTER §7:18 TELEPHONE
AMENDMENT § 7:19 APPROVAL MATRIX § 7:20 FINAL APPROVAL VERSUS TENTATIVE
APPROVAL § 7:21 TENTATIVE APPROVAL*REASONS FOR GETTING IT § 7:22 PATENT
ATTORNEY INVOLVEMENT IN ANSWERING DEFICIENCY LETTERS § 7:23 SHOWING
BIOEQUIVALENCY OF GENERIC VERSIONS § 7:24 BIOAVAILABILITY DEFINED § 7:25
BIOEQUIVALENCY DEFINED § 7:26 MEASURING BIOEQUIVALENCE OF TRADITIONAL
SOLID ORAL DOSAGE FORMS*IMMEDIATE AND EXTENDED RELEASE FORMS § 7:27
*EXTENDED RELEASE (ER) FORMS § 7:28 EXTENDED RELEASE TYPES*DIFFUSION
CONTROL SYSTEM § 7:29 *DISSOLUTION CONTROL SYSTEM § 7:30 *EROSION
CONTROL SYSTEM § 7:31 *OSMOTIC PUMP SYSTEM § 7:32 *ION-EXCHANGE RESIN
SYSTEM § 7:33 PROVING BIOEQUIVALENCY § 7:34 *IN VITRO DISSOLUTION
STUDIES § 7:35 *DISSOLUTION TESTING AND STANDARDIZED TESTING PROTOCOLS §
7:36 *PARTICLE SIZE AND DISSOLUTION TESTING § 7:37 IN VITRO
BIOEQUIVALENCY (BE) TESTING*REASONS FOR BE TESTING AND BIOWAIVERS § 7:38
BIOSTUDIES IN HUMAN SUBJECTS*PILOT AND PIVOTAL BIOSTUDIES § 7:39
*FASTING AND FED BIOSTUDIES XXVII GENERIC PHARMACEITICAI. PATENT AND FDA
LAW §7:40 FOOD EFFECT PATENTS ARE NOT PATENTAHLE § 7:41 IMPURITY
SPECIFICATIONS § 7:42 IMPURITY LEVELS AS DEFINED BY A REGULATORY
AUTHORITY § 7:43 AVOIDING IMPURITY PATENT CLAIMS MAY JEOPARDIZE
REGULATORY APPROVAL § 7:44 METERED AND POWDER DOSE INHALERS § 7:45 DRY
POWDER DOSE INHALERS I DPI T §7:46 NASAL SPRAYS AND INHALED SOLUTIONS,
SPRAYS §7:47 SAMPLES AND PATENT ISSUES IN SAMPLES § 7:48 CHANGES TO THE
ABBREVIATED NEW DRUG APPLICATION § 7:49 *MAJOR CHANGES § 7 : 50
*MODERATE CHANGES CHANGES BEING EFFECTED IN 30 DAYS(CBE-30I § 7:51
*MINOR CHANGE*MINIMAL IMPACT CHANGE DOCUMENTED IN ANNUAL REPORT § 7:52
CHANGES TO THE ANDA AND PATENT ISSUES § 7:53 REVIEW OF ANDA APPROVAL
PROCESS CHAPTER 8. "PAPER NDA" AND SECTION 505(B)(2) APPLICATIONS § 8:1
SECTION 505(B)(2) APPLICATION*GENERAL PRINCIPLES § 8:2 CONTRASTING
505(BK2) APPLICATIONS WITH ABBREVIATED NEW DRUG APPLICATIONS (ANDA) §
8:3 SIMILARITIES BETWEEN 505(B 2 APPLICATION AND ANDA § 8:4 GENERAL
TYPES OF APPLICATIONS §8:5 INFORMATION NEEDED TO SUPPORT THE APPLICATION
§ 8:6 STRATEGIC USES § 8:7 *USE OF A 505(B)(2) APPLICATION TO CIRCUMVENT
THE 180- DAY EXCLUSIVITY § 8:8 CONCLUSION CHAPTER 9. PATENT INFRINGEMENT
SAFE HARBOR EXEMPTIONS §9:1 INTRODUCTION § 9:2 GENESIS OF SAFE HARBOR
EXEMPTION* ROCHE V. BOLAR § 9:3 HATCH WAXMAN ACT/SAFE HARBOR
EXEMPTION*SCOPE OF EXEMPTION § 9:4 "INFORMATION" DEVELOPMENT AND
"INFORMATION" SUBMISSION TO FDA § 9:5 REASONABLE SCOPE OF EXEMPTION §
9:6 *MEDICAL DEVICES AND OTHER OSTENSIBLY UNRELATED ACTIVITIES TABLE OF
CONTENTS § 9:7 *EFFECT OF CONGRESSIONAL ACTION ON SCOPE OF EXEMPTION §
9:8 *CHAIN OF EXEMPTION § 9:9 GENERIC DRUG DEVELOPMENT §9:10 ANCILLARY
ACTIVITIES §9:11 RECOURSE FOR PATENT HOLDERS § 9:12 COMMON LAW RESEARCH
EXEMPTION AND DE MINIMIS INFRINGEMENT CHAPTER 10. MECHANICS OF ORANGE
BOOK PATENT CERTIFICATIONS AND NOTICE LETTERS § 10:1 INTRODUCTION § 10:2
PATENT CERTIFICATIONS AND ORANGE BOOK LISTING § 10:3 *PARAGRAPH I, II,
III, OR IV CERTIFICATIONS § 10:4 *IMPACT ON ANDA APPROVAL § 10:5
*HYPOTHETICAL PATENT CERTIFICATIONS*CASE STUDY ON VIAGRA § 10:6 SECTION
(VIII) STATEMENTS*CARVING OUT PATENTED METHODS OF USE § 10:7 *WORKING
EXAMPLE ON SECTION VIII STATEMENTS*SERTRALINE § 10:8 *ONE AND ONLY
INDICATION § 10:9 *CARVING OUT INDICATIONS TO UNLISTED PATENTS § 10:10
REQUEST LISTING § 10:11 USING SUITABILITY PETITIONS TO ALLOW CARVE OUT §
10:12 COMBINING PARAGRAPH I CERTIFICATION IN LIEU OF SECTION VIII
STATEMENT § 10:13 *PARAGRAPH IV CERTIFICATION AND NOTICE LETTER
REQUIREMENTS § 10:14 *IDENTIFYING THE PATENTS IN THE NOTICE LETTER §
10:15 CONTENT AND SUFFICIENCY OF THE NOTICE LETTER § 10:16 HOW MUCH
DETAIL IS NECESSARY § 10:17 DETAILS ON CLAIMS THAT ARE NOT NORMALLY
LISTABLE § 10:18 FORM OF LETTER AND DETAILED STATEMENT § 10:19
ADMONISHMENTS*APPENDING LETTER TO A COMPLAINT § 10:20 PREDICATES TO
ANTITRUST INJURY § 10:21 HOW TO SEND THE NOTICE LETTER § 10:22 WHERE TO
SEND THE NOTICE LETTER § 10:23 WHEN TO SEND THE NOTICE LETTER § 10:24
UPDATING THE FDA ON NOTICE LETTERS XXIX GENERIC PMARMACEI TICAI. PATENT
AND FDA LAW § 10-25 HI-ISSUE PATENTS- NYW PUTEIITS »R ROLLOVERS OF OLD
PATENTS THAT REQUIRE NEW PATENT CERTIFICATIONS § 10:26 ROLL-OVERS FROM
ORIGINAL PATENT § 10:27 NEW PATENT § 10:28 *SUMMARY § 10:29 OFFER FOR
CONFIDENTIAL ACCE I( K'.V § 10:30 *WHERE INVAHDITV I ALLEGED § 10:31
*ISSUES WITH THE OFFER FOR CONFIDENTIAL ACCESS TOLAL § 10:32 TRACKING
PARAGRAPH IV CERT ITU AT IONS ON THE FDA WEB SITE CHAPTER 11. THE
30-MONTH INJUNCTION/STAY I. GENERALLY § 11:1 INTRODUCTION § 11:2
CREATING THE 30-MONTH STAY AND COUNTING DAYS § 11:3 WHO NOTIFIES THE FDA
OF THE LAWSUIT II. TERMINATION OF THE 30-MONTH STAY § 11:4 HOW THE
30-MONTH STAY IS NORMALLY TERMINATED § 11:5 COURT DECISION § 11:6
GENERIC COMPANY WINS § 11:7 GENERIC COMPANY WINS ON APPEAL § 11:8
PATENTEE DELAYS' III. LENGTHENING, SHORTENING, OR REINSTATING THE STAY §
11:9 EXTENDING STAY BECAUSE COURT MADE NO DECISION §11:10 REINSTATING IF
WRONGFULLY TERMINATED § 11:11 LENGTHENING OR SHORTENING DUE TO LACK OF
COOPERATION § 11:12 CASES EXTENDING THE 30-MONTH STAY § 11:13 CASES
SHORTENING THE 30-MONTH STAY T § 11:14 CASES WHERE THE STAY WAS NOT
ALTERED DESPITE RCQUES TO ALTER IV. EFFECT OF DELAYS § 11:15 BLOWING THE
45-DAY WINDOW*CAN SUIT STILL BE BROUGHT? V. EARNING NEW 30-MONTH STAYS §
11:16 GENERALLY TABLE OF CONTENTS § 11:17 REPETITIVE 30-MONTH STAYS
UNDER THE OLD RULES § 11:18 EARNING 30-MONTH STAYS UNDER THE DECEMBER
2003 RULES § 11:19 EFFECT OF POP-UP (NEWLY ISSUED) PATENTS § 11:20
WORKING EXAMPLES OF THE 30-MONTH STAY VI. STAGGERED EXPIRATIONS § 11:21
MULTIPLE APPLICANTS 30-MONTH STAY; STAGGERED STAY EXPIRIES CHAPTER 12.
BRAND SIDE EXCLUSIVITIES § 12:1 FILING AND APPROVAL EXCLUSIVITIES § 12:2
NEW CHEMICAL ENTITY (NCE) EXCLUSIVITY [FIVE-YEAR] § 12:3 *WHEN TO FILE
ANDAS WITH PARAGRAPH IV CERTIFICATIONS § 12:4 *EXTENSIONS OF THE
30-MONTH STAY § 12:5 *DELISTING PATENTS FROM ORANGE BOOK RIGHT BEFORE
NCE-1 DATE § 12:6 NEW PRODUCT/CLINICAL INFORMATION/SUPPLEMENTAL
EXCLUSIVITY [THREE-YEARL § 12:7 *REQUIREMENTS FOR THE NEW CLINICAL
INFORMATION EXCLUSIVITY § 12:8 *REQUIREMENTS*WORKING EXAMPLE FOR GENERIC
APPROVAL OF LESS THAN ALL INDICATIONS § 12:9 *DIFFERENCE BETWEEN NCE AND
THREE-YEAR EXCLUSIVITY § 12:10 THREE-YEAR EXCLUSIVITY FOR ENANTIOMERS §
12:11 ORPHAN DRUG EXCLUSIVITY [SEVEN-YEAR EXCLUSIVITY] § 12:12 PEDIATRIC
EXCLUSIVITY [SIX MONTHS] § 12:13 *EFFECT § 12:14 *TRACKING § 12:15
*EFFECT ON ANDA FILINGS §12:16 *EFFECT ON THE 30-MONTH STAY § 12:17
WORKING EXAMPLES OF PEDIATRIC EXCLUSIVITY § 12:18 WORKING
EXAMPLES*RANBAXY V. FDA AND PFIZER; FLUCONAZOLE § 12:19 ALZA V.
MYLAN/MYLAN V. FDA; FENTANYL PATCH § 12:20 *EFFECTS ON THE 30-MONTH
STAY*WORKING EXAMPLES* PFIZER V. APOTEX; AMLODIPINE § 12:21 *PEDIATRIC
EXCLUSIVITY AND COMBINATION PRODUCTS § 12:22 PATENT INFRINGEMENT
IMPLICATIONS § 12:23 KEY POINTS ABOUT PEDIATRIC EXCLUSIVITY XXXI GENERIC
PHARMACEUTICAL PATEVI AND FDA LA W CHAPTER 13. THE 180-DAY EXCLUSIVITY §
13:1 INTRODUCTION § 13:2 CREATING THE 180-DAY EXCLUSIVITY § 13:3 AGAINST
WHOM THE 180-DAY EXCLUSIVITY APPLIES §13:4 FDA'S PRODUCT-BY-PRODUCT
APPROACH TO PATENT CERTIFICATIONS § 13:5 PRODUCT-BY-PRODUCT APPROACH TO
EXCLUSIVITY § 13:6 180-DAY EXCLUSIVITY NATURALLY EXPIRES WITH THE
UNDERLYING PATENT § 13:7 TRIGGERING THE 180-DAY EXCLUSIVITY CLOCK § 13:8
*UNDER PRE-DECEMBER 2003 MM A RULES § 13:9 *UNDER THE POST-MMA RULES §
13:10 TRACKING THE LHO-DAY EXCLUSIVITY § 13:11 REISSUE PATENTS AND NEW
180DAY EXCLUSIVITIES § 13:12 AUTHORIZED GENERICS § 13:13 *CURBING BY
MEDICAID BEST PRICE LAW § 13:14 WAIVER OR RELINQUISHMENT OF THE 180-DAY
EXCLUSIVITY § 13:15 *MECHANICS OF SELECTIVE WAIVER AND TOTAL
RELINQUISHMENT CHAPTER 14. FORFEITURE OF THE 180-DAY EXCLUSIVITY § 14:1
INTRODUCTION § 14:2 FORFEITURE PROVISIONS § 14:3 *FAILURE TO MARKET §
14:4 *NO LITIGATION PENDING; 30 MONTHS TO APPROVAL, 75 DAYS TO MARKET §
14:5 *LITIGATION PENDING § 14:6 *RATIONALIZING THE FAILURE TO MARKET
PROVISIONS; NO PATENT LITIGATION 14:? C ^ RIVED PATENT LITIGATION,
POSSIBILITY OF SUIT TO AVOID FORFEITS § 14:8 SETTLING LAWSUITS BUT
MAINTAINING THE PARAGRAPH IV TO AVOID FORFEITS UIN F THDRAWAL OF
APPLICATION BILL? MENDMENT OF CERTIFICATION I LL\L V T0 BTAIN
TENTATIVE APPROVAL "PETITION^ APPR0VA1 ' CHAN G ED CONDITIONS, AND
CITIZEN I IFU TF REEMENTS THAT VIOLATE ANTITRUST LAWS §14.14 EXPIRATION
OF PATENTS XXXII TABLE OF CONTENTS § 14:15 NO-ROLLING EXCLUSIVITY §
14:16 FORFEITURES IN GENERAL POLICY TERMS CHAPTER 15. DECLARATORY
JUDGMENT § 15:1 INTRODUCTION: PURPOSE OF THE DECLARATORY JUDGMENT ACT
(DJA) § 15:2 WHEN DJS ARE USED IN PHARMACEUTICAL PATENT CASES § 15:3
TRADITIONAL DECLARATORY JUDGMENT STANDARDS § 15:4 POST-MEDLMMUNE
DECLARATORY JUDGMENT STANDARDS § 15:5 *FAMCICLOVIR CASE AND FACTORS
ALLOWING A DECLARATORY JUDGMENT ACTION § 15:6 DECLARATORY JUDGMENTS TO
TRIGGER EXCLUSIVITY § 15:7 *ORANGE BOOK LISTING ALONE COULD CONFER DJ
JURISDICTION § 15:8 PATENTS LISTED BUT STATUTORILY DISCLAIMED DO NOT
CONFER JURISDICTION § 15:9 COVENANTS NOT TO SUE; REMOVING FEAR OF SUIT §
15:10 *COVENANTS DIVESTING COURT'S JURISDICTION CHAPTER 16. PATENT
INFRINGEMENT DAMAGES AND REMEDIES § 16:1 INTRODUCTION § 16:2 POTENTIAL
REMEDIES FOR PATENT INFRINGEMENT § 16:3 IMPACT OF THE LOSS ON THE ANDA
APPROVAL STATUS AND REDATING THE ANDA APPROVAL DATE § 16:4 *ANDAS FOR
OLD ANTIBIOTICS SHOULD NOT HAVE REDATED APPROVAL DATES § 16:5 INJUNCTIVE
RELIEF TO STOP FUTURE INFRINGEMENT OR PREVENT AT-RISK LAUNCH § 16:6
*OTHER FACTORS TO CONSIDER IN WHETHER TO GRANT A LAUNCH-PREVENTION
INJUNCTION § 16:7 AWARDING AN INJUNCTION AGAINST FUTURE INFRINGEMENT
WHEN GENERIC COMPANY LOSES § 16:8 PRODUCT RECALL OF GENERIC PRODUCTS IN
THE MARKETPLACE § 16:9 MONEY DAMAGES FOR PATENT INFRINGEMENT § 16:10
*MONEY DAMAGES, REASONABLE ROYALTY OR LOST PROFITS § 16:11 *REASONABLE
ROYALTY §16:12 HYPOTHETICAL NEGOTIATIONS § 16:13 FACTORS TO CONSIDER IN
SETTING THE ROYALTY: GEORGIA PACIFIC TEST XXXI11 (IKNKHK I'LLAKMAI'HL IK
AL I ' A I I N I AM) FDA LAW § 16:14 FACTOR.- IN RELATION TO GENERIC
DRUG INFRINGEMENT §16:15 *KFLEET ON PERMANENT INJUNCTION § 16:16 *LOST
PROFITS § 16:17 *LOST PROFIT.- AND MARKET RECONSTRUCTION § 16:18 NO LOST
PROFIT- WHEN SUBSTITUTES EXIST § 16:19 NO LO.-T PROFIT- WHEN SUBSTITUTES
AND AUTHORIZED GENERIC.- EXIST § 16:20 --CALCULATING LOST PROFIT- AND
BRINGING EXPENSES INTO THE CALCULUS §16:21 KXPENSE DEDUCTIONS § 16:22
F.NHANCED DAMAGES AND WILLFUL INFRINGEMENT § 16:23 WILLFUL INFRINGEMENT
AND FACTORS TO CONSIDER § 16:24 LEGAL OPINIONS AND WILLFUL INFRINGEMENT
§ 16:25 *WILLFUL INFRINGEMENT FOR FILING AN ANDA § 16:26 *WILLFULNESS
AND THE NEED TO SPECIFY FACTS IN THE PLEADING § 16:27 EXCEPTIONAL CASES
AND ATTORNEY FEES § 16:28 *WHEN CAN ATTORNEY FEES BE AWARDED § 16:29
*STEPS IN AWARDING ATTORNEY FEES § 16:30 *WHO IS A PREVAILING PARTY §
16:31 *ATTORNEY FEE AMOUNTS § 16:32 *CASE STUDY: PIOGLITAZONE AND
ATTORNEY FEE AWARDED TO PATENTEE TABLE OF CASES INDEX |
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| bvnumber | BV023338006 |
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| id | DE-604.BV023338006 |
| illustrated | Illustrated |
| index_date | 2024-07-02T21:00:30Z |
| indexdate | 2024-07-09T21:16:17Z |
| institution | BVB |
| isbn | 9780314991447 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016521834 |
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| physical | XXXIV, 643 S. graph. Darst. |
| publishDate | 2008 |
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| publisher | Thomson West |
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| spelling | Upadhye, Shashank Verfasser aut Generic pharmaceutical patent and FDA law Shashank Upadhye 2008 ed. Eagan, Minn. Thomson West 2008 XXXIV, 643 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016521834&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Upadhye, Shashank Generic pharmaceutical patent and FDA law |
| title | Generic pharmaceutical patent and FDA law |
| title_auth | Generic pharmaceutical patent and FDA law |
| title_exact_search | Generic pharmaceutical patent and FDA law |
| title_exact_search_txtP | Generic pharmaceutical patent and FDA law |
| title_full | Generic pharmaceutical patent and FDA law Shashank Upadhye |
| title_fullStr | Generic pharmaceutical patent and FDA law Shashank Upadhye |
| title_full_unstemmed | Generic pharmaceutical patent and FDA law Shashank Upadhye |
| title_short | Generic pharmaceutical patent and FDA law |
| title_sort | generic pharmaceutical patent and fda law |
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