From Clones to Claims: A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents
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| Main Authors: | , , , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Hürth
Carl Heymanns Verlag
2023
|
| Edition: | 7th edition |
| Series: | Heymanns intellectual property
|
| Subjects: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033237621&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Physical Description: | XXII, 1410 Seiten |
| ISBN: | 9783452298232 345229823X |
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MARC
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| 100 | 1 | |a Jaenichen, Hans-Rainer |e Verfasser |0 (DE-588)1030592500 |4 aut | |
| 245 | 1 | 0 | |a From Clones to Claims |b A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents |c by Dr. Hans-Rainer Jaenichen (Patentanwalt, European Patent Attorney, UPC Representative), Richard Enmon, Ph.D., J.D. (US Patent Attorney, European Patent Attorney), Dr. Florian Grasser (Patentanwalt, European Patent Attorney, UPC Representative), Dr. Andreas Heiseke (Patentanwalt, European Patent Attorney, UPC Representative) [und 8 weitere] |
| 250 | |a 7th edition | ||
| 264 | 1 | |a Hürth |b Carl Heymanns Verlag |c 2023 | |
| 300 | |a XXII, 1410 Seiten | ||
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| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
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| 610 | 2 | 7 | |a Europäisches Patentamt |0 (DE-588)1052705-9 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Biotechnologie |0 (DE-588)4069491-4 |2 gnd |9 rswk-swf |
| 653 | |a European Patent office | ||
| 653 | |a Entscheidungssammlung | ||
| 653 | |a Biotechnologie | ||
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| 689 | 0 | 1 | |a Biotechnologie |0 (DE-588)4069491-4 |D s |
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| 700 | 1 | |a Enmon, Richard |e Verfasser |0 (DE-588)1308882912 |4 aut | |
| 700 | 1 | |a Grasser, Florian |e Verfasser |4 aut | |
| 700 | 1 | |a Heiseke, Andreas |e Verfasser |4 aut | |
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Record in the Search Index
| _version_ | 1819364636946857984 |
|---|---|
| adam_text | TABLE
OF
CONTENTS
-
OVERVIEW
PREFACE
.......................................................................................................................
V
1
PRODUCTS
OF
NATURE:
WHAT
IS
PATENTABLE
IN
THE
EPO
(COMPOUNDS,
STEM
CELLS,
PLANTS,
ETC.)
DR.
CHRISTIAN
SCHLORB
......................................................................................................
1
2
THE
PERSON
SKILLED
IN
THE
ART
DR.
ANDREAS
HEISEKE
..............................................................................................
21
3
THE
PRINCIPLES
APPLIED
BY
THE
TECHNICAL
BOARDS
IN
ASSESSING
THE
DISCLOSURE
OF
A
DOCUMENT
AND
THEIR
IMPLICATIONS
OSWIN
RIDDERBUSCH
......................................................................................................
35
4
THE
PRINCIPLES
APPLIED
BY
THE
TECHNICAL
BOARDS
IN
CLAIM
CONSTRUCTION
OSWIN
RIDDERBUSCH
.........................................
69
5
PLAUSIBILITY
AS
A
MEANS
TO
ASSESS
QUID
PRO
QUO
DR.
HANS-RAINER
JAENICHEN
..........................................................................................
91
6
THE
PRINCIPLES
OF
PATENTING
MEDICAL
AND
DIAGNOSTIC
USES
OSWIN
RIDDERBUSCH
......................................................................................................
153
7
PATENTING
NUCLEIC
ACID
INVENTIONS
DR.
HANS-RAINER
JAENICHEN
.............................................................................................
243
8
PATENTING
PROTEIN
INVENTIONS
DR.
HANS-RAINER
JAENICHEN
.............................................................................................
439
9
PATENTING
ANTIBODY
INVENTIONS
DR.
JURGEN
MEIER
...............................................
582
10
PATENTING
MICROORGANISMS
AND
FERMENTATION
TECHNOLOGIES
DR.
STEFAN
MULLER
..............................................................................................................
672
11
PATENTING
VIRUSES
DR.
ANDREAS
HEISEKE
......................................................................................................
802
12
PATENTING
STEM
CELLS
AND
CELL-BASED
THERAPEUTICS
DR.
JURGEN
MEIER
..........................................................................................................
914
13
PATENTING
NUCLEIC
ACID
AMPLIFICATION
TECHNOLOGIES
RICHARD
ENMON,
PH.
D.,
J.
D
.............................................................................................
942
14
PATENTING
GENOME
EDITING
TECHNOLOGIES:
CRISPR
ET
AL.
DR.
ANDREAS
HEISEKE
......................................................................................................
997
15
PATENTING
NEXT
GENERATION
SEQUENCING
TECHNOLOGIES
DR.
FLORIAN
GRASSER
........................................................................................................
1023
16
PATENTING
PERSONALIZED
MEDICINES
AND
COMPANION
DIAGNOSTICS
DR.
CHRISTIAN
SCHLORB
......................................................................................................
1055
17
PATENTING
PLANTS
AND
ANIMALS
DR.
OLAF
MALEK
...................................................................................................
1067
18
PRIORITY
-
HURDLES
OF
SAME
SUBJECT
MATTER
AND
LEGAL
ENTITLEMENT
DR.
OLAF
MALEK
...................................................................................................
1174
19
DEPOSIT
DR.
STEFAN
MULLER
..........................................................................................................
1225
20
HOW
TO
DRAFT
A
EUROPEAN
PATENT
APPLICATION
AND
CLAIMS
DR.
PHILIPP
MARCHAND
.......................................................................................
1243
21
A
BRIEF
INTRODUCTION
TO
SUPPLEMENTARY
PROTECTION
CERTIFICATES
OSWIN
RIDDERBUSCH
.........................................................................................
1259
22
BIOTECH
LITIGATION
IN
GERMANY
AND
THE
NETHERLANDS,
PERSPECTIVES
ARISING
FROM
THE
IMPLEMENTATION
OF
THE
UPC
DAAN
DE
LANGE,
DR.
KAI
RUTING
...................................................................................
1267
DECISIONS
OF
THE
EPO
..................................................................................................
1325
INDEX
......................................................................................................................
1403
TABLE
OF
CONTENTS
-
DETAILED
PREFACE
.........................................................................................................................
V
1.
PRODUCTS
OF
NATURE:
WHAT
IS
PATENTABLE
IN
THE
EPO
(COMPOUNDS,
STEM
CELLS,
PLANTS,
ETC.)
DR.
CHRISTIAN
SCHLORB
....................................................................................................
1
1.1
THE
LEGAL
FRAMEWORK:
PATENTABLE
INVENTIONS
AND
EXCEPTIONS
...................................
1
1.2
PATENTABLE
BIOTECHNOLOGICAL
INVENTIONS
.......................................................................
2
1
3
THE
PATENTING
OF
HUMAN
DNA
IS
NOT
INTRINSICALLY
UNETHICAL
.....................................
5
1.3.1
T
1213/05,
BREAST
AND
OVARIAN
CANCER/UNIVERSITY
OF
UTAH
,
EPB1
705
902
.................................................................................
5
1.4
COMPOUNDS
AND
DISCOVERIES,
INDUSTRIAL
APPLICABILITY
...............................................
7
1.4.1
RECOMBINANT
HETERODIMERIC
RECEPTORS
ARE
NO
DISCOVERY
WHEN
INDUSTRIALLY
APPLICABLE:
T
338/00,
MULTIMERIC
RECEPTORS/SALK
INSTITUTE
,
EP-B1
619
842
.................................................................................
7
1.4.2
INDUSTRIAL
APPLICABILITY
OF
NEWLY
IDENTIFIED
POLYPEPTIDES:
T
870/04,
BDP1
PHOSPHATASE/MAX-PLANCK ,
EP-AL
914
425
.............
7
1.4.3
INDUSTRIAL
APPLICABILITY:
T
604/04,
PF4A
RECEPTORS/GENENTECH
,
EPB
1
577
752
.................................................................................
9
1.4.4
INDUSTRIAL
APPLICABILITY:
T
898/05,
HEMATOPOIETIC
RECEPTORS/
ZYMOGENETICS
,
EP-B1
910
635
...........................................
10
1.4.5
INDUSTRIAL
APPLICABILITY:
T
641/05,
GPCR-LIKE
RECEPTOR/PHARMACIA
,
EP-A1
1
238
076
.....................................................
12
1.4.6
INDUSTRIAL
APPLICABILITY:
T
1452/06,
SERINE
PROTEASE/BAYER
,
EP-A1
1
309
676
............................................................................
12
1.4.7
INDUSTRIAL
APPLICABILITY:
T
1165/06,
IL-17
RELATED
POLYPEPTIDE/SCHE
RING
,
EP-A1
1
141
297
..............................................................
13
1.4.8
DNA
SEQUENCES
ISOLATED
FROM
NATURAL
SOURCES
ARE
NO
DISCOVERY,
INDUSTRIAL
APPLICABILITY:
T
1213/05,
BREAST
AND
OVARIAN
CANCER/
UNIVERSITY
OF
UTAH
,
EP-B1
705
902
.................................
13
1.4.9
INDUSTRIAL
APPLICABILITY:
T
1450/07,
TGFA-HII/HUMAN
GENOME
SCIENCES
,
EP-B1
826
041
.......................................................
15
1.4.10
INDUSTRIAL
APPLICABILITY:
T
1540/07,
CYTOKINE
RECEPTOR/HUMAN
GENOME
SCIENCES
,
EP-A1
1
093
457
................................
15
1.4.11
T
18/09,
NEUTROKINE/HUMAN
GENOME
SCIENCES
,
EP-B1
939
804
.................................................................................
16
1.4.12
INDUSTRIAL
APPLICABILITY
OF
NEWLY
IDENTIFIED
POLYPEPTIDES:
T
1109/10,
INDUSTRIAL
APPLICATION/LEXICON
(MARCH
13,
2014),
EP-B1
1
461
425...
18
1.5
NO
INVENTION:
SCHEME,
RULE
OR
METHOD
FOR
PERFORMING
A
MENTAL
ACT
OR
DOING
BUSINESS
.........................................................................................................
19
1.5.1
MERE
MENTAL
ACT:
T
758/12,
SELECTING
PSYCHOTROPIC
MEDICATIONS/MAYO
FOUNDATION
,
EP-B1
2
046
996
.............................................
19
1.6
INVENTIONS
RELATING
TO
BIOINFORMATICS
.........................................................................
19
1.6.1
MATHEMATICAL
METHODS:
T
784/06,
GENOTYPE
DETERMINATION/BECKMAN
,
EPB1
0
736
107
..............................................................................
19
1.6.2
MATHEMATICAL
METHODS:
T
2070/07,
DNA
MIXTURE
ANALYSIS/PERLIN
,
EPB1
1
229
135
...............................................................................
20
2.
THE
PERSON
SKILLED
IN
THE
ART
DR.
ANDREAS
HEISEKE
............................................................................
21
2.1
WHO/WHAT
IS
THE
PERSON
SKILLED
IN
THE
ART?
.................................................................
21
2.2
THE
ATTITUDE
OF
THE
PERSON
SKILLED
IN
THE
ART
.................................................................
26
2.3
THE
COMMON
GENERAL
KNOWLEDGE
OF
THE
PERSON
SKILLED
IN
THE
ART
..............................
29
3.
THE
PRINCIPLES
APPLIED
BY
THE
TECHNICAL
BOARDS
IN
ASSESSING
THE
DISCLOSURE
OF
A
DOCUMENT
AND
THEIR
IMPLICATIONS
OSWIN
RIDDERBUSCH
.........................................................................................
35
3.1
A
UNIFORM
CONCEPT
OF
DISCLOSURE
..............................................................................
35
3.2 THE
STANDARD
OF
DIRECT
AND
UNAMBIGUOUS
DISCLOSURE
................................................
36
3.2.1
BASIC
PRINCIPLES
...............................................................................................
36
3.2.2
IMPLICIT
DISCLOSURE
.........................................................................................
37
3.2.3
ASSESSING
THE
DISCLOSURE
OF
A
DOCUMENT
AS
A
WHOLE
.....................................
40
3.3
THE
RELEVANT
POINT
IN
TIME
FOR
DETERMINING
THE
DISCLOSURE
OF
A
DOCUMENT
........... 40
3.4
INHERENT
DISCLOSURE
......................................................................................................
41
3.5
COMBINATIONS
WITHIN
A
DOCUMENT
........................................................
53
3.5.1
ALL
FEATURES
HAVE
TO
BE
DISCLOSED
IN
A
SINGLE
EMBODIMENT
........................
53
3.5.2
THE
TWO-LIST
PRINCIPLE:
SELECTIONS
FROM
MULTIPLE
LISTS
OF
ALTERNATIVES
....
55
3.5.3
INTERMEDIATE
GENERALIZATIONS
.........................................................................
66
3.5.4
COMBINATIONS
OF
NUMERICAL
RANGES
..............................................................
67
4.
THE
PRINCIPLES
APPLIED
BY
THE
TECHNICAL
BOARDS
IN
CLAIM
CONSTRUCTION
OSWIN
RIDDERBUSCH
.....................................................................................
69
4.1
DIFFERENT
APPROACHES
TO
CLAIM
CONSTRUCTION:
THE
PATENT
AS
ITS
OWN
DICTIONARY
VERSUS
INTERPRETATION
AS
A
MEANS
TO
RESOLVE
AMBIGUITIES
............................
69
4.2
THE
MIND
WILLING
TO
UNDERSTAND
................................................................................
72
4.3
THE
RELEVANCE
OF
ARTICLE
69
EPC
FOR
CLAIM
CONSTRUCTION
.......................................
75
4.4
FURTHER
PRINCIPLES
OF
CLAIM
CONSTRUCTION
...................................................................
85
4.4.1
CLAIM
CONSTRUCTION
AS
A
POINT
OF
LAW
.........................................................
85
4.4.2
INTERPRETATION
OF
CLAIMS
IN
THE
BROADEST
TECHNICALLY
SENSIBLE
MANNER
....
85
4.4.3
INTERPRETATION
OF
INDEPENDENT
CLAIMS
IN
VIEW
OF
THEIR
SUBORDINATE
DEPENDENT
CLAIMS
..........................................................................
87
4.4.4
INTERPRETATION
OF
DEPENDENT
CLAIMS
IN
VIEW
OF
THEIR
SUPERORDINATE
INDE
PENDENT
CLAIMS
..............................................................................
87
4.4.5
INTERPRETATION
OF
DIFFERENT
TERMS
AS
HAVING
DIFFERENT
MEANINGS
.................
87
4.4.6
INTERPRETATION
OF
THE
TERMS
COMPRISING
,
CONSISTING
OF
AND
HAVING
.
.
.
88
4.4.7
ADMISSIBLE
MEANS
OF
CLAIM
CONSTRUCTION
...................................................
89
5.
PLAUSIBILITY
AS
A
MEANS
TO
ASSESS
QUID
PRO
QUO
DR.
HANS-RAINER
JAENICHEN
...............................................................................
91
5.1
INTRODUCTION
..................................................................................................................
91
5.2
T1329/04,
FACTOR-9/JOHNS
HOPKINS
(JUNE
28,
2005),
EP-A1
678
101
...
.
94
5.3
T
18/09,
NEUTROKINE/HUMAN
GENOME
SCIENCES
(OCTOBER
21,
2009),
EP-B1
939
804
..............................................................................................
96
5.4
DECISIONS
DENYING
PLAUSIBILITY
....................................................................................
99
5.5
DECISIONS
ACKNOWLEDGING
PLAUSIBILITY
.........................................................................
118
5.6
THE
ESSENCE
..................................................................................................................
144
6.
THE
PRINCIPLES
OF
PATENTING
MEDICAL
AND
DIAGNOSTIC
USES
OSWIN
RIDDERBUSCH
.....................................................................................
153
6.1
FUNDAMENTALS
OF
FIRST
AND
SECOND
MEDICAL
USE
CLAIMS
AND
THE
AVAILABLE
CLAIM
FORMATS
.........................................................................................................
153
6.1.1
LEGAL
BASIS
FOR
FIRST
AND
SECOND
MEDICAL
USE
CLAIMS
IN
THE
PURPOSE
LIMITED
PRODUCT
FORMAT
153
6.1.2
SECOND
MEDICAL
USE
CLAIMS
IN
THE
SWISS-TYPE
FORMAT
UNDER
THE
EPC1973
155
6.1.3
THE
INTERPRETATION
OF
PURPOSE-LIMITED
PRODUCT
CLAIMS
DEPENDS
ON
WHETHER
THE
EPC
1973
OR
THE
EPC2000
IS
APPLICABLE
....................
156
6.1.4
THE
AVAILABILITY
AND
INTERPRETATION
OF
SWISS-TYPE
CLAIMS
UNDER
THE
EPC2000
159
6.1.5
CLAIMING
SECOND
MEDICAL
USES
IN
BOTH
THE
PURPOSE-LIMITED
PRODUCT
FORMAT
AND
THE
SWISS-TYPE
FORMAT
.................................................
160
6.2
DIFFERENT
TYPES
OF
SECOND
MEDICAL
USES
....................................................................
163
6.2.1
ALL
SPECIFIC
THERAPEUTIC
USES
ARE
PATENTABLE
UNDER
G
2/08
.........................
163
6.2.2
THE
DEFINITION
OF
THE
THERAPEUTIC
TREATMENT
IN
A
SECOND
MEDICAL
USE
CLAIM
...............................................................................................
165
6.2.3
TREATMENT
OR
PREVENTION
OF
SPECIFIC
DISEASES
..............................................
187
6.2.4
TREATMENT
OF
SPECIFIC
PATIENT
GROUPS
...........................................................
193
6.2.5
SPECIFIC
ROUTES
OF
ADMINISTRATION
..................................................................
203
6.2.6
SPECIFIC
DOSAGE
REGIMENS
...............................................................................
204
6.2.7
SPECIFIC
MECHANISMS
OF
ACTION
......................................................................
205
6.2.8
SPECIFIC
CONTRAINDICATIONS
.............................................................................
218
6.2.9
SPECIFIC
COMBINATION
THERAPIES
....................................................................
219
6.3
THE
TYPES
OF
PRODUCTS
THAT
CAN
BE
CLAIMED
IN
A
MEDICAL
USE
CLAIM
.....................
222
6.4
INVENTIVE
STEP
CONSIDERATIONS
REGARDING
MEDICAL
USE
CLAIMS
.................................
226
6.5
SURGICAL
AND
DIAGNOSTIC
USE
INVENTIONS
......................................................................
236
7.
PATENTING
NUCLEIC
ACID
INVENTIONS
DR.
HANS-RAINER
JAENICHEN
..........................................................................
243
7.1
SOME
OF
THE
HISTORY
OF
PATENTING
NUCLEIC
ACIDS
AND
SYSTEMS
FOR
THEIR
EXPRES
SION:
OPTIONS
AND
LIMITS
.............................................................................
243
7.1.1
THE
GENENTECH
POLYPEPTIDE
EXPRESSION
CASES
T
292/85,
T
293/85
AND
T
794/94,
EP-B1
1
929
...............................................................................
243
7.1.2
T
19/90,
^ONCO-MOUSE/HARVARD^
AND
T
694/92,
MODIFYING
PLANT
CELLS/
MYCOGEN^
................................................................................................
246
7.1.3
T
301
/87
AND
T
500/91,
ALPHA-INTERFERONS/BIOGEN
............................
248
7.1.4
T
412/93,
.......................................................................................................
251
7.1.5
T
18/09,
NEUTROKINE/HUMAN
GENOME
SCIENCES
........................
254
7.1.6
T
923/92,
T-PA/GENENTECH
................................................................
256
7.1.7
T
1213/05,
BREAST
AND
OVARIAN
CANCER/UNIVERSITY
OF
UTAH
.........
260
7.2
CORRECTION
OF
SEQUENCE
ERRORS
.......................................................................................
266
7.3
CLARITY
...........................................................................................................................
270
7.3.1
THE
CLARITY
REQUIREMENT
FOR
CLAIMS
IS
SET
OUT
IN
ARTICLE
84
EPC:
..................
270
7.4
ENABLEMENT
..................................................................................................................
273
7.4.1
GENERAL
PRINCIPLES
DEVELOPED
IN
BIOTECH
CASES
..............................................
273
7.4.2
PRINCIPLES
DEVELOPED
IN
BIOTECH
CASES
ON
THE
ENABLEMENT
OF
NUCLEIC
ACID
SEQUENCE
INVENTIONS
........................................................................
281
7.5
NOVELTY
..........................................................................................................................
310
7.5.1
GENERAL
PRINCIPLES
DEVELOPED
IN
BIOTECH
CASES..............................................
310
7.5.2
PRINCIPLES
DEVELOPED
IN
BIOTECH
CASES
ON
THE
ASSESSMENT
OF
NOVELTY
OF
NUCLEIC
ACID
SEQUENCE
INVENTIONS
.....................................................
324
7.6
INVENTIVE
STEP
...............................................................................................................
353
7.6.1
GENERAL
PRINCIPLES
AND
A
SUMMARY
OF
WHAT
HAS
BEEN
DEVELOPED
IN
BIOTECH
CASES
ON
THE
ASSESSMENT
OF
INVENTIVE
STEP
OF
NUCLEIC
ACID
INVENTIONS
..........
353
7.6.2
BIOTECH
DECISIONS
ON
INVENTIVE
STEP
OF
NUCLEIC
ACID
INVENTIONS
...................
363
7.6.3
BIOTECH
DECISIONS
ON
INVENTIVE
STEP
OF
SYSTEMS
FOR
THE
EXPRESSION
OF
DNA
SEQUENCES
.........................................................................................
411
7.6.4
BIOTECH
DECISIONS
ON
INVENTIVE
STEP
OF
PLASMIDS
..........................................
436
8.
PATENTING
PROTEIN
INVENTIONS
DR.
HANS-RAINER
JAENICHEN
..................................................................
439
8.1
CLARITY
...........................................................................................................................
439
8.1.1
SOME
GENERAL
PRINCIPLES
FOR
THE
ASSESSMENT
OF
CLARITY
OF
PROTEIN-RELATED
CLAIMS
...............................................................................................
439
8.1.2
BIOTECH
DECISIONS
ON
THE
CLARITY
OF
PROTEIN
CLAIMS
..........................................
439
8.2
ENABLEMENT
..................................................................................................................
441
8.2.1
GENERAL
PRINCIPLES
FOR
THE
ASSESSMENT
OF
ENABLEMENT
OF
PROTEIN-RELATED
CLAIMS
...............................................................................................
441
8.2.2
BIOTECH
DECISIONS
ON
THE
ENABLEMENT
OF
PROTEIN
INVENTIONS
.........................
442
8.3
NOVELTY
...........................................................................................................................
480
8.3.1
GENERAL
PRINCIPLES
FOR
THE
ASSESSMENT
OF
NOVELTY
OF
PROTEIN-RELATED
CLAIMS
..
.
480
8.3.2
BIOTECH
DECISIONS
ON
THE
NOVELTY
OF
PROTEIN
INVENTIONS
.................................
483
8.4
INVENTIVE
STEP
................................................................................................................
513
8.4.1
GENERAL
PRINCIPLES
FOR
THE
ASSESSMENT
OF
INVENTIVE
STEP
OF
PROTEIN-RELATED
CLAIMS
...............................................................................................
513
8.4.2
BIOTECH
DECISIONS
ON
INVENTIVE
STEP
OF
PROTEIN
INVENTIONS
...........................
515
9.
PATENTING
ANTIBODY
INVENTIONS
DR.
JURGEN
MEIER
........................................................................................................
582
9.1
GENERAL
CONSIDERATIONS
ON
ANTIBODY
PATENTING
IN
THE
EPO
........................................
582
9.1.1
ALLOWABLE
CLAIMS
AND
FORMATS
........................................................................
583
9.1.2
ANTIBODY
DEFINITIONS
BY
STRUCTURAL
FEATURES
...................................................
583
9.1.3
ANTIBODIES
DEFINITIONS
BY
FUNCTIONAL
FEATURES
...............................................
584
9.1.4
ANTIBODY
DEFINITIONS
BY
COMBINED
STRUCTURAL
AND
FUNCTIONAL
FEATURES
........ 586
9.2
CLARITY
...........................................................................................................................
589
9.2.1
GENERAL
CONSIDERATIONS
ON
CLARITY
OF
ANTIBODY
CLAIMS
...................................
589
9.2.2
CLARITY
OF
ANTIBODY
SPECIFICITIES
AND/OR
AFFINITIES
...........................................
589
9.2.3
CLARITY
OF
STRUCTURAL
FEATURES
OF
ANTIBODY
CLAIMS
...........................................
591
9.2.4
CLARITY
OF
FUNCTIONAL
FEATURES
OF
ANTIBODY
CLAIMS
...........................................
592
9.2.5
CLARITY
OF
THE
TERM
ANTIBODY
OF
ANTIBODY
FORMATS
AND
OF
ANTIBODY
DESIGNATIONS
....................................................................................
593
9.2.6
CLARITY
OF
EPITOPES
AND/OR
ANTIBODY
TARGET
STRUCTURES
..................................
595
9.2.7
CLARITY
OF
PRODUCT-BY-PROCESS
ANTIBODY
CLAIMS,
ANTIBODY-RELATED
DIAGNOSTIC
METHODS
AND
MEDICAL
USE
CLAIMS
..................................
596
9.3
ENABLEMENT
.................................................................................................................
598
9.3.1
GENERAL
CONSIDERATIONS
ON
ENABLEMENT
OF
ANTIBODY
CLAIMS
.........................
598
9.3.2
ENABLEMENT
OF
STRUCTURAL
FEATURES
OF
ANTIBODY
CLAIMS
..................................
605
9.3.3
ENABLEMENT
OF
FUNCTIONAL
FEATURES
OR
COMBINATIONS
OF
STRUCTURAL
AND
FUNCTIONAL
FEATURES
..........................................................................
607
9.3.4
ENABLEMENT
OF
EPITOPES,
ANTIGENS
AND/OR
ANTIBODY
TARGET
STRUCTURES
........... 612
9.3.5
ENABLEMENT
OF
METHOD/PRODUCTION
CLAIMS
...................................................
613
9.3.6
ENABLEMENT
OF
MEDICAL/DIAGNOSTIC
USE
CLAIMS
CONCERNING
ANTIBODIES
.........
617
9.4
NOVELTY
...........................................................................................................................
625
9.4.1
GENERAL
CONSIDERATIONS
ON
NOVELTY
OF
ANTIBODY
CLAIMS
POLYCLONAL
VERSUS
MONOCLONAL
..................................................................................
625
9.4.2
NOVELTY
OF
STRUCTURAL
FEATURES
........................................................................
625
9.4.3
NOVELTY
OF
FUNCTIONAL
FEATURES
........................................................................
628
9.4.4
NOVELTY
BY
EPITOPE,
ANTIGEN
AND/OR
TARGET
AND/OR
STRUCTURES
AND
FORMS
.
.
.
630
9.4.5
NOVELTY
OF
PRODUCT-BY-PROCESS
CLAIMS
AND
OF
PRODUCTION
PROCESSES
PER
SE.
.
631
9.4.6
NOVELTY
OF
MEDICAL/DIAGNOSTIC
USE
OF
ANTIBODIES
...........................................
634
9.5
INVENTIVE
STEP
................................................................................................................
636
9.5.1
GENERAL
CONSIDERATIONS
ON
INVENTIVE
STEP
OF
ANTIBODY
CLAIMS
POLYCLONAL
VERSUS
MONOCLONAL
AND
THE
PROVISION
OF
ALTERNATIVE
(MONOCLONAL)
ANTIBODIES
VERSUS
(MONOCLONAL)
ANTIBODIES
WITH
SPECIFIC
UNEXPECTED
PROPERTIES
...............................................................
636
9.5.2
INVENTIVE
STEP
OF
STRUCTURAL
ANTIBODY
FEATURES
..............................................
643
9.5.3
INVENTIVE
STEP
OF
FUNCTIONAL
FEATURES
ALONE
OR
IN
COMBINATIONS
WITH
STRUCTURAL
FEATURES
-
THE
REQUIREMENT
OR
THE
NON-REQUIREMENT
OF
FRAMEWORKS
......................................................................................
647
9-5.4
INVENTIVE
STEP
OF
EPITOPES
AND/OR
TARGET
STRUCTURES
......................................
654
9.5.5
INVENTIVE
STEP
OF
METHODS
FOR
MAKING,
MODIFYING
AND/OR
PURIFYING
ANTIBODIES/ANTIBODY
CONSTRUCTS
.......................................................
656
9.5.6
INVENTIVE
STEP
OF
ANTIBODIES
IN
MEDICAL
USES
................................................
661
10.
PATENTING
MICROORGANISMS
AND
FERMENTATION
TECHNOLOGIES
DR.
STEFAN
MULLER
........................................................................................................
672
10.1
CLARITY
.............................................................
672
10.1.1
PRINCIPLES
ESTABLISHED
IN
BIOTECH
CASES
...........................................................
672
10.1.2
BIOTECH
DECISIONS
ON
THE
CLARITY
OF
MICROORGANISMS
AND
FERMENTATION
TECHNOLOGY
INVENTIONS
......................................................................
672
10.2
ENABLEMENT
.................................................................................................................
690
10.2.1
PRINCIPLES
ESTABLISHED
IN
BIOTECH
CASES
...........................................................
690
10.2.2
BIOTECH
DECISIONS
ON
ENABLEMENT
OF
MICROORGANISMS
AND
FERMENTATION
TECHNOLOGY
INVENTIONS
......................................................................
691
10.3
NOVELTY
..........................................................................................................................
719
10.3.1
PRINCIPLES
ESTABLISHED
IN
BIOTECH
CASES
...........................................................
719
10.3.2
BIOTECH
DECISIONS
ON
THE
NOVELTY
OF
MICROORGANISMS
AND
FERMENTATION
TECHNOLOGY
INVENTIONS
......................................................................
719
10.4
INVENTIVE
STEP
...............................................................................................................
747
10.4.2
BIOTECH
DECISIONS
ON
INVENTIVE
STEP
OF
MICROORGANISMS
AND
FERMENTATION
TECHNOLOGIES
.......................
747
11.
PATENTING
VIRUSES
DR.
ANDREAS
HEISEKE
...................................................................................................
802
11.1
CLARITY
...........................................................................................................................
802
11.2
ENABLEMENT
..................................................................................................................
809
11.3
NOVELTY
...........................................................................................................................
837
11.4
INVENTIVE
STEP
................................................................................................................
854
12.
PATENTING
STEM
CELLS
AND
CELL-BASED
THERAPEUTICS
DR.
JIIRGEN
MEIER
........................................................................................................
914
12.1
TO
WHAT
EXTENT
ARE
EMBRYONIC
STEM
CELLS
PATENTABLE?
............................................
915
12.1.1
ARE
HUMAN
EMBRYONIC
STEM
CELLS
PATENTABLE?
..............................................
917
12.2
PATENTING
STEM
CELLS:
FACTS
AND
SUMMARY
ON
MOST
RELEVANT
DECISIONS
IN
THE
EPO.
.
.
934
12.2.1
PATENTING
STEM
CELLS:
T
522/04,
MAMMALIAN
MULTIPOTENT
NEURONAL
STEM
CELLS/CALIFORNIA
INSTITUTE
OF
TECHNOLOGY
,
EP-AL
658
194
.................................................................................
935
12.2.2
PATENTING
STEM
CELLS:
T
1199/08,
SELECTED
SPERM/XY
................................
935
12.2.3
PATENTING
STEM
CELLS:
T
2221/10,
CULTURING
STEM
CELLS/TECHNION
.
.
.
937
12.2.4
PATENTING
STEM
CELLS:
T
1836/10,
ISOLATION
OF
EMBRYONIC
STEM
CELLS/WURFEL
...............................................................................
940
13.
PATENTING
NUCLEIC
ACID
AMPLIFICATION
TECHNOLOGIES
RICHARD
ENMON,
PH.D.,
J.D
..........................................................................................
942
13.1
CLARITY
(ARTICLE
84
EPC)
...............................................................................................
942
13.1.1
THE
SKILLED
PERSON
KNOWS
THE
LIMITS
OF
RELATIVE
TERMS
SUCH
AS
SUITABLE
AND
SUFFICIENT
IN
THE
PRACTICE
OF
NUCLEIC
ACID
AMPLIFICATION
..........
942
13.1.2
FEATURES
TAUGHT
IN
THE
DISCLOSURE
NECESSARY
FOR
THE
PRACTICE
OF
THE
INVENTION
ARE
ESSENTIAL
FEATURES
THAT
MUST
BE
REFLECTED
IN
THE
CLAIMS
..............
948
13.2
SUFFICIENCY
OF
DISCLOSURE
(ARTICLE
83
EPC)
..................................................................
951
13.2.1
T
289/96,
DETECTING
SEQUENCES/ZENECA
,
EPB1
332
435
.....................
951
13.2.2
T
965/98,
DNA
AMPLIFICATION/HOFFMANN-LA
ROCHE
,
EPA1
509
612
................................................................................
952
13.2.3
T
216/96,
PROCESS
FOR
AMPLIFYING,
DETECTING
AND/OR
CLONING
NUCLEIC
ACID
SEQUENCES/F.
HOFFMANN-LA
ROCHE
AG
,
EPB1
200
362
...
952
13.2.4
T
364/06,
MULTIPLEX
DNA
AMPLIFICATION/BAYLOR
,
EPB1
363
255
...
955
13.2.5
T
415/07,
RIBOSOMAL
DISPLAY/DISCERNA
LTD.
,
EPB1
985
032
.........
956
13.2.6
T
2533/10,
AMPLIFICATION
QUENCHED
FLUOROPHOBES
PRIMER
PROBES
RESTRICTION
ENDONUCLEASE
RECOGNITION
SITE/BECTON
DICKENSON
,
EPB1
878
554
.................................................................................
957
13.2.7
T
842/14,
PCR
ANTI-FOAM
REAGENTS/QIAGEN
,
EPB1
1
540
009
...........
958
13.2.8
T
2255/18,
DETECTION
OF
METHICILLIN-RESISTANT
STAPHYLOCOCCUS
AUREUS/
GENEOHM
SCIENCES
CANADA
,
EPB1
2
781
604
..............
959
13.2.9
T
29/19,
CELL
FREE
NUCLEIC
ACIDS/CNRS
,
EPA1
2
611
935
.......................
960
13.3
NOVELTY
(ARTICLE
54
EPC)
............................................................................................
960
13.3.1
T
902/94,
DNA
AMPLIFICATION/BAYLOR
COLLEGE
OF
MEDICINE
,
EPA1
364
255
................................................................................
960
13.3.2
T
78/96,
PROCESS
FOR
AMPLIFYING
NUCLEIC
ACID
SEQUENCES/
F.
HOFFMANN-LA
ROCHE
AG
.............................................................
961
13.3.3
T
216/96,
PROCESS
FOR
AMPLIFYING,
DETECTING
AND/OR
CLONING
NUCLEIC
ACID
SEQUENCES/F.HOFFMANN-LA
ROCHE
AG
,
EPB1
200
362
.
964
13.3.4
T
445/04,
HOMOGENEOUS
ASSAY
SYSTEM/F.
HOFFMANN-LA
ROCHE
AG
,
EPB1
543
942
........................................................................
965
13.3.5
T
707/03,
MISMATCH
PRIMER/ZLB
BEHRING
,
EPA1
930
3702
...........
966
13.3.6
T
1091/02,
METHODS
FOR
DETECTION
II/EHOFFMANN-LA
ROCHE
AG
,
EPB1
520
794
........................................................................
967
13.3.7
T
313/05,
APPARATUS
FOR
MONITORING
A
POLYMERASE
CHAIN
REACTION/
APPLERA
,
EPB1
872
562
............................................................
968
13.3.8
T
2050/07,
DNA-MIXTURE
ANALYSIS/PERLIN
,
EPA1
1
229
135
.............
969
13.3.9
T
72/10,
PATHOGENIC
ORGANISMS/BJORN
,
EPB1
1
254
258
.....................
970
13.3.10
T
2111/09,
FLUOROMETRIC
METHOD/THE
SECRETARY
OF
STATE
FOR
DEFENCE
,
EPB1
1
044
283
.............................................
971
13.3.11
T
2533/10,
AMPLIFICATION
QUENCHED
FLUOROPHOBES
PRIMER
PROBES
RESTRICTION
ENDONUCLEASE
RECOGNITION
SITE/BECTON
DICKENSON
,
EPB1
878
554
.................................................................................
971
13.3.12
T
2012/10,
NUCLEIC
ACID
PURIFICATION/ROCHE
DIAGNOSTICS
GMBH
,
EPB1
1466
018
..............................................................
972
13.3.13
T
1634/15,
CODIS
CORE
STR
LOCI
FORENSIC
HUMAN
IDENTIFICATION/
PROMEGA
,
EPB1
1
135
530
.....................................................
973
13.3.14
T
842/14,
PCR
ANTI-FOAM
REAGENTS/QIAGEN
,
EPB1
1
540
009
...........
974
13.3.15
T
2042/19,
DNA
DETECTION
METHOD/DOW
AGROSCIENCES
,
EPA1
2
931
950
..............................................................................
975
13.3.16
T
1608/16,
DETECTION
OF
MRSA
STRAINS/BIOMERIEUX
,
EPB1
2
231
869
..............................................................................
976
13.4
INVENTIVE
STEP
(ARTICLE
56
EPC)
.................................................................................
976
13.4.1
T
289/96,
DETECTING
SEQUENCES/ZENECA
,
EPB
1
332
435
...................
976
13.4.2
T
965/98,
DNA
AMPLIFICATION/HOFFMANN-LA
ROCHE
AG
,
EPA1
509
612;
T
966/98,
DNA
DETECTION/HOFFMANN-LA
ROCHE ,
EPA1
502
589
............................................................
977
13.4.3
T
1118/98,
NUCLEIC
ACIDS/DU
PONT
DE
NEMOURS
,
EPB1
520
039
........
978
13.4.4
T
78/96,
PROCESS
FOR
AMPLIFYING
NUCLEIC
ACID
SEQUENCES/
F.
HOFFMANN-LA
ROCHE
AG
,
EPB
1
201
184
...............................
978
13.4.5
T
216/96,
PROCESS
FOR
AMPLIFYING,
DETECTING
AND/OR
CLONING
NUCLEIC
ACID
SEQUENCES/F.
HOFFMANN-LA
ROCHE
AG
,
EPB1
200
362
............
979
13.4.6
T
302/02.
AUTOMATED
AMPLIFICATION/APPLERA
,
EPB1
236
069
...........
980
13.4.7
T
239/01,
COUPLED
TRANSCRIPTION
AND
TRANSLATION/PROMEGA
,
EPB1
566
714
...............................................................................
980
13.4.8
T
707/03,
MISMATCH
PRIMER/ZLB
BEHRING
,
EPA1
930
370
.............
981
13.4.9
T
445/04,
HOMOGENEOUS
ASSAY
SYSTEM/F.HOFFMANN-LA
ROCHE
AG
,
EPB
1
543
942
.....................................................................
982
13.4.10
T
1091/02,
METHODS
FOR
DETECTION
II/EHOFFMANN-LA
ROCHE
AG
,
EPB
1
520
794
.....................................................................
983
13.4.11
T
781/06,
AMPLIFICATION
OF
NUCLEIC
ACIDS/SANOFI-AVENTIS
,
EPA1
829
542
...............................................................................
983
13.4.12
T
531/05,
EXTRACELLULAR
TUMOR-ASSOCIATED
NUCLEIC
ACID/PENN
STATE
RESEARCH
FOUNDATION
,
EPA1
929
694
.......................
983
13.4.13
T
768/06,
MOLECULAR
EVOLUTION/MAXYGEN
,
EPB1
876
509
...............
984
13.4.14
T
415/07,
RIBOSOMAL
DISPLAY/DISCERNA
LTD.
,
EPB1
985
032
........
985
13.4.15
T
1739/07,
ADDRESSABLE
ARRAY/CORNELL
RESEARCH
FOUNDA
TION
,
EPA1
920
440
................................................................
985
13.4.16
T
1958/09,
ELONAS/GILEAD
,
EP
A1
832
291
........................................
986
13.4.17
T
1588/10,
DETECTION
JAPANESE
ENCEPHALITIS
VIRUSES/ROCHE ,
EPA1
1
611
254
...........................................................................
987
13.4.18
T
2264/09,
MULTIPLEX
AMPLIFICATION
OF
STRS/PROMEGA
,
EP
BL
960
207
.............................................................................
988
13.4.19
T
2012/10,
NUCLEIC
ACID
PURIFICATION/ROCHE
DIAGNOSTICS
GMBH
,
EPB
1
1
466
018
..........................................................
989
13.4.20
T
1631/10,
MAGNETISCHE
PARTIKEL/ROCHE
,
EPB
1
1
577
349
...............
989
13.4.21
T
14/12,
EMULSION
ASYMMETRIC
PCR-PRE-HYBRIDISATION
SINGLE
STRAN
DED
TEMPLATE
IMMOBILIZED
PRIMER
BEAD/454
LIFE
SCIENCES
,
EPB
1
1
594
980
...........................................................................
990
13.4.22
T
300/13
NORO
VIRUS/BML
INC
,
EPB
1
1
329
522
.............................
991
13.4.23
T
1119/12,
ORTHOGONAL
OLIGONUCLEOTIDES/SIEMENS
HEALTHCARE
DIAGNOSTICS
,
EPA1
1
844
163
............................................
992
13.4.24
T
1904/16,
ASSAY
FOR
TOXINOGENIC
C.
DIFFICILE
STRAINS/KONINKLIJKE
PHILLIPS
,
EPB1
2
419
527
......................................................
993
13.4.25
T
2042/19,
DNA
DETECTION
METHOD/DOW
AGROSCIENCES
,
EPA1
2
931
950
...........................................................................
995
13.4.26
T
2255/18,
DETECTION
OF
METHICILLIN-RESISTANT
STAPHYLOCOCCUS
AUREUS/
GENEOHM
SCIENCES
CANADA
,
EPB
1
2
781
604
..........
996
14.
PATENTING
GENOME
EDITING
TECHNOLOGIES:
CRISPR
ET
AL.
DR.
ANDREAS
HEISEKE
...................................................................................................
997
14.1
HISTORY
OF
GENOME
EDITING
TECHNOLOGIES
..................................................................
997
14.2
GENOME
EDITING
WITH
MEGANUCLEASES
.........................................................................
998
14.3
GENOME
EDITING
WITH
ZINC
FINGER
NUCLEASES
(ZFNS)
.................................................
998
14.4
GENOME
EDITING
WITH
TRANSCRIPTION
ACTIVATOR-LIKE
EFFECTOR
NUCLEASES
(TALENS)
.
.
.
999
14.5
GENOME
EDITING
WITH
CRISPR-CAS9
...............................................................................
1000
14.6
PATENTING
THE
GENOME
EDITING
TECHNOLOGIES
MEGANUCLEASES,
ZFNS
AND
TALENS
IN
THE
EPO
.....................................................................................................
1002
14.7
PATENTING
THE
GENOME
EDITING
TECHNOLOGY
CRISPR-CAS9
IN
THE
EPO
...................
1008
15.
PATENTING
NEXT
GENERATION
SEQUENCING
TECHNOLOGIES
DR.
FLORIAN
GRASSER
...............................................................................
1023
15.1
HISTORYOFNGS
............................................................................................................
1023
15.2
CURRENT
STATE
OF
THE
ART
OF
NGS
..................................................................................
1023
15.3
MARKET
POTENTIAL
AND
FUTURE
PERSPECTIVE
OF
NGS
..........................................................
1025
15.4
DECISIONS
OF
THE
TECHNICAL
BOARDS
OF
APPEAL
RELATING
TO
NGS
.....................................
1025
16.
PATENTING
PERSONALIZED
MEDICINES
AND
COMPANION
DIAGNOSTICS
DR.
CHRISTIAN
SCHLDRB.....................................................................................
1055
16.1
INTRODUCTION
..................................................................................................................
1055
16.2
EXCLUSION
FROM
PATENTABILITY
.........................................................................................
1055
16.2.1
T
1038/00,
APOPTOTIC
CELLS/NEXINS
RESEARCH
,
EP-B1
755
516
...
1055
16.2.2
T
310/99,
DOWN
SYNDROME/MACRI
,
EP-B1
409
956
............................
1055
16.2.3
T
2050/07,
DNA
MIXTURE
ANALYSIS/PERLIN
,
EP-A1
1
229
135
...........
1056
16.2.4
T
606/96,
RADIOLABELLED
ANTIBODIES/RHOMED
INC.
,
EP-B1
234
612..
.
1056
16.3
NOVELTY
...........................................................................................................................
1057
16.3.1
INTRODUCTION
..................................................................................................
1057
16.3.2
T
734/12
,
ARTHRITIS
PATIENTS
WITH
AN
INADEQUATE
RESPONSE
TO
A
TNF-ALPHA
INHIBITOR/GENENTECH,
INC.
,
EP-B1
1
613
350
.
1057
16.3.3
T
1399/04,
COMBINATION
THERAPY
HCV/SCHERING
,
EP-B1
956
861
.
.
1058
16.3.4
T
694/16,
FOOD
COMPOSITION
FOR
PRODROMAL
DEMENTIA
PATIENTS/
NUTRICIA ,
EP-B1
2
170
104
...................................................
1058
16.3.5
T
108/09,
FULVESTRANT
FOR
TREATING
RESISTANT
BREAST
CANCER/ASTRA
ZENECA
AB
,
EP-B1
1
272
195
.................................................
1059
16.4
INVENTIVE
STEP
...............................................................................................................
1059
16.4.1
T
777/17,
DEGARELIX
IN
METASTATIC
STAGE
PROSTATE
CANCER/FERRING
,
EPA2
2
249
859
..............................................................................
1059
16.4.2
T
967/16,
OXCARBAZEPINE
STEVENS-JOHNSON
SYNDROME/ACADEMIA
SINICA
PHARMIGENE ,
EPB
1
2
016
198
..............................
1060
16.4.3
T
2197/10,
APRIL
RECEPTOR/BIOGEN
,
EPB
1
1
223
964
.....................
1060
16.5
CLARITY
.........................................................................................................................
1061
16.5.1
T
241/95,
SEROTONIN
RECEPTOR/ELI
LILLY
,
EP-A2
0
449
562
.................
1061
16.5.2
DECISION
OF
THE
OPPOSITION
DIVISION
ON
EP-B1
785
216
(SEPTEMBER
12,
2005)
ANDT
156/08,
BRCA2/UNIVERSITY
OF
UTAH
,
EP-A1
1
260
520
1061
16.5.3
T
1845/11,
ASIAN
RACE/MERCK
SERONO
,
EP-A1
1
509
242
...............
1062
16.6
SUFFICIENCY
OF
DISCLOSURE
..............................................................................................
1062
16.6.1
T
1031/09,
GST-PI
GENE/COMMONWEALTH ,
EP-A1
1
071
815
...
1062
16.6.2
T
734/12
,
ARTHRITIS
PATIENTS
WITH
AN
INADEQUATE
RESPONSE
TO
A
TNF-ALPHA
INHIBITOR/GENENTECH,
INC.
,
EP-B1
1
613
350
.
1063
16.6.3
T
1474/12,
DIAGNOSTIC
MARKER/ANTIBODYSHOP
,
EP-B1
1
831
699.
.
.
1065
16.6.4
T
50/10,
BCRP/UNIVERSITY
OF
MARYLAND
,
EP-B1
1
054
894
...................
1065
17.
PATENTING
PLANTS
AND
ANIMALS
DR.
OLAF
MALEK
............................................................................................................
1067
17.1
EXCEPTIONS
TO
PATENTABILITY
(ARTICLE
53(A)
AND
(B)
EPC)
...........................................
1067
17.1.1
ORDRE
PUBLIC
AND
MORALITY
(ARTICLE
53(A)
EPC)
.........................................
1067
17.1.2
EXCLUSIONS
WITH
RESPECT
TO
PLANTS
(ARTICLE
53(B)
EPC)
.................................
1070
17.1.3
EXCLUSIONS
WITH
RESPECT
TO
ANIMALS
(ARTICLE
53(B)
EPC)
...............................
1087
17.2
CLARITY
AND
SUPPORT
IN
THE
DESCRIPTION
(ARTICLE
84
EPC)
...........................................
1090
17.2.1
DEFINITION
BY
REFERENCE
TO
SPECIES
...................................................................
1090
17.2.2
DEFINITION
BY
REFERENCE
TO
GENETIC
MARKERS
....................................................
1090
17.2.3
PRODUCT-BY
PROCESS
DEFINITION
.........................................................................
1091
17.2.4
CLARITY
AND
SUPPORT
........................................................................................
1094
17.3
SUFFICIENCY
(ARTICLE
83
EPC)
........................................................................................
1098
17.3.1
FAIR
BALANCE
BETWEEN
CLAIMED
SCOPE
AND
THE
INVENTION
S
CONTRIBUTION
........
1098
17.3.2
FUNCTIONAL
FEATURES
..........................................................................................
1102
17.3.3
EVIDENCE
REQUIRED
FOR
DENYING
ENABLEMENT
.................................................
1103
17.3.4
UNDUE
BURDEN/RESEARCH
PROJECT
....................................................................
1106
17.3.5
EFFECT
PLAUSIBLY
DISCLOSED
IN
APPLICATION/EXAMPLE
SUFFICIENT
.......................
1109
17.3.6
ELITE
EVENT
......................................................................................................
1111
17.3.7
STARTING
MATERIAL
...........................................................................................
1112
17.3.8
SCREENING
REQUIRED
FOR
CARRYING
OUT
THE
INVENTION
.......................................
1114
17.4
NOVELTY
(ARTICLE
54
EPC)
............................................................................................
1115
17.4.1
PUBLIC
AVAILABILITY
(INCLUDING
DATABASE
ENTRIES
AND
INTERNET
DISCLOSURE)
....
1115
17.4.2
MEANING
OF
TERMS
.........................................................................................
1116
17.4.3
IS
THE
PRIOR
ART
ENABLING?
..............................................................................
1118
17.4.4
FEATURE
COMBINATION
DIRECTLY
AND
UNAMBIGUOUSLY
DERIVABLE
......................
1121
17.4.5
WHOLE
CONTENTS
APPROACH
.............................................................................
1123
17.4.6
ANTICIPATION
OF
COMPOUND
CLAIMS................................................................
1125
17.4.7
COMPOSITION
OF
CHEMICAL
COMPOUNDS
MADE
AVAILABLE
...............................
1125
17.4.8
INHERENCY
......................................................................................................
1126
17.4.9
INEVITABLE
RESULT
OF
CARRYING
OUT
A
PROCESS
...................................................
1127
17.4.10
DENIAL
OF
NOVELTY
REQUIRES
CERTAINTY
............................................................
1132
17.5
INVENTIVE
STEP
(ARTICLE
56
EPC)
.................................................................................
1133
17.5.1
SELECTION
OF
THE
CLOSEST
PRIOR
ART
..................................................................
1133
17.5.2
TECHNICAL
PROBLEM
TO
REFLECT
ACTUAL
CONTRIBUTION
.........................................
1135
17.5.3
SURPRISING
ADVANTAGEOUS
EFFECT
....................................................................
1138
17.5.4
NO
INCENTIVE
.................................................................................................
1139
17.5.5
OBVIOUSNESS
WHEN
THE
PRIOR
ART
GUIDES
TO
EXACTLY
THE
CLAIMED
FEATURE
COMBINATION
.....................................................................................
1143
17.5.6
FOR
OBVIOUSNESS,
THE
PRIOR
ART
DOES
NOT
ALWAYS
HAVE
TO
GUIDE
TO
EXACTLY
THE
CLAIMED
FEATURE
COMBINATION
..........................................................
1154
17.5.7
TECHNICAL
DIFFERENCES
BETWEEN PLANTS
AND
OTHER
KINGDOMS
OF
LIFE
...............
1158
17.5.8
REASONABLE
EXPECTATION
OF
SUCCESS................................................................
1158
17.5.9
CLAIMS
TO
ELITE
EVENTS
..................................................................................
1163
17.5.10.
......................................................................................................................
1166
17.5.11
AVOID
EX
POST
FACTO
ANALYSIS
...........................................................................
1167
17.5.12
NON-OBVIOUS
ALTERNATIVE
................................................................................
1168
17.5.13
TECHNICAL
DIFFICULTIES
OVERCOME
IN
NON-OBVIOUS
WAY
....................................
1171
18.
PRIORITY
-
HURDLES
OF
SAME
SUBJECT
MATTER
AND
LEGAL
ENTITLEMENT
DR.
OLAF
MALEK
.............................................................................................................
1174
18.1
THE
SAME
INVENTION
HURDLE
........................................................................................
1174
18.1.1
DIRECT
AND
UNAMBIGUOUS
DISCLOSURE
.............................................................
1174
18.1.2
ENABLEMENT
..................................................................................................
1202
18.1.3
PLAUSIBILITY
.....................................................................................................
1212
18.1.4
THE
FIRST
APPLICATION
(ARTICLE
87(1)
AND
(4)
EPC)
........................................
1215
18.2
THE
LEGAL
ENTITLEMENT
HURDLE
....................................................................................
1216
18.2.1
THE
ORIGINAL
PRIORITY
RIGHT
.............................................................................
1217
18.2.2
THE
PRIORITY
RIGHT
OBTAINED
AS
SUCCESSOR
IN
TITLE
............................................
1219
18.3
OTHER
PRIORITY
MATTERS
.................................................................................................
1222
18.3.1
EXHAUSTION
OF
PRIORITY
RIGHT
.........................................................................
1222
18.3.2
DEVIATING
PRIORITY
DOCUMENTS
IN
OFFICIAL
FILE
................................................
1223
18.3.3
EXHIBITION
PRIORITY
........................................................................................
1223
19.
DEPOSIT
DR.
STEFAN
MULLER
........................................................................................................
1225
19.1
GENERAL
PRINCIPLES
DEVELOPED
IN
BIOTECH
CASES
AND
THE
LEGAL
BASIS
.............................
1225
19.2
PROCEDURAL
LAW
QUESTIONS
...............................................................................................
1227
19.2.1
INFORMATION
WITH
REGARD
TO
THE
BIOLOGICAL
MATERIAL
AND
THE
DEPOSIT
TO
BE
GIVEN
IN
THE
APPLICATION
..................................................................
1227
19.2.2
INFORMATION
WITH
REGARD
TO
THE
BIOLOGICAL
MATERIAL
IN
CASE
OF
A
DEPOSIT
BY
A
PERSON
OTHER
THAN
THE
APPLICANT
.............................................
1229
19.2.3
CHOICE
OF
THE
EXPERT
SOLUTION
UNDER
RULE
32
EPC
......................................
1230
19.3
SUBSTANTIAL
LAW
QUESTIONS/DECISION
DEALING
WITH
THE
TIME
LIMIT
IN
CONTEXT
WITH
A
DEPOSITION
OF
BIOLOGICAL
MATERIAL
...................................................................
1231
19.4
SUBSTANTIAL
LAW
QUESTIONS/CASE
LAW
DEALING
WITH
THE
QUESTION
WHETHER
THE
REPRODUCIBILITY
OF
BIOLOGICAL
MATERIAL
WAS
ASSURED
BY
THE
WRITTEN
DESCRIPTION
IN
THE
ABSENCE
OF
A
DEPOSIT
...........................................................................
1234
20.
HOW
TO
DRAFT
A
EUROPEAN
PATENT
APPLICATION
AND
CLAIMS
DR.
PHILIPP
MARCHAND
...................................................................................
1243
20.1
THE
EUROPEAN
PATENT
APPLICATION
................................................................................
1243
20.2
HOW
TO
FILE
A
EUROPEAN
PATENT
APPLICATION
(ARTICLE
75
EPC)
.......................................
1243
20.3
REQUIREMENTS
FOR
A
EUROPEAN
PATENT
APPLICATION
.......................................................
1245
20.3.1
REQUEST
FOR
GRANT
.........................................................................................
1245
20.3.2
DESCRIPTION
....................................................................................................
1246
20.3.3
DRAWINGS
AND
LEGENDS
TO
FIGURES
................................................................
1248
20.3.4
EXAMPLES
OF
THE
INVENTION
...........................................................................
1249
20.3.5
THE
CLAIMS
....................................................................................................
1250
20.3.6
THE
ABSTRACT
..................................................................................................
1251
20.4
MINIMAL
REQUIREMENTS
TO
OBTAIN
A
FILING
DATE
..........................................................
1251
20.5
CONTENT
OF
A
EUROPEAN
PATENT
APPLICATION
.................................................................
1253
20.5.1
SUFFICIENCY
OF
DISCLOSURE
...............................................................................
1253
20.5.2
CLARITY
AND
SUPPORT
......................................................................................
1254
20.5.3
SEQUENCE
LISTINGS
..........................................................................................
1255
20.5.4
DEPOSITS
........................................................................................................
1257
21.
A
BRIEF
INTRODUCTION
TO
SUPPLEMENTARY
PROTECTION
CERTIFICATES
OSWIN
RIDDERBUSCH
...................................................................................................
1259
21.1
INTRODUCTION
..................................................................................................................
1259
21.2
TERRITORIAL
AVAILABILITY
OF
SPCS
IN
EUROPE
...................................................................
1259
21.3
SUBJECT-MATTER
OF
AN
SPC
.............................................................................................
1260
21.4
CONDITIONS
FOR
OBTAINING
AN
SPC
..............................................................................
1260
21.4.1
BASIC
PATENT
..................................................................................................
1260
21.4.2
MARKETING
AUTHORIZATION
.............................................................................
1261
21.4.3
ONLY
THE
FIRST
MARKETING
AUTHORIZATION
ALLOWS
THE
FILING
OF
AN
SPC
.........
1262
21.4.4
MULTIPLE
SPCS
FOR
DIFFERENT
PRODUCTS
BASED
ON
A
SINGLE
PATENT
..................
1262
21.4.5
MULTIPLE
SPCS
FOR
THE
SAME
PRODUCT
..........................................................
1262
21.4.6
RELATIONSHIP
BETWEEN
THE
SPC
APPLICANT
AND
THE
HOLDER
OF
THE
MARKETING
AUTHORIZATION
...............................................................
1262
21.5
SCOPE
OF
PROTECTION
........................................................................................................
1263
21.6
TIME
LIMIT
FOR
FILING
AN
SPC
......................................................................................
1264
21.7
SPC
TERM
......................................................................................................................
1264
21.8
PAEDIATRIC
EXTENSIONS
OF
SPCS
.......................................................................................
1265
22.
BIOTECH
LITIGATION
IN
GERMANY
AND
THE
NETHERLANDS,
PERSPECTIVES
ARISING
FROM
THE
IMPLEMENTATION
OF
THE
UPC
DAAN
DE
LANGE,
DR.
KAI
RUTING
1267
22.1
INTRODUCTION
..................................................................................................................
1267
22.2
OVERVIEW
ON
PATENT
LITIGATION
IN
GERMANY,
THE
NETHERLANDS
AND
THE
UPC
............
1269
22.2.1 CHARACTERISTICS
OF
PATENT
LITIGATION
IN
GERMANY
..........................................
1269
22.2.2
PATENT
LITIGATION
IN
THE
NETHERLANDS
.............................................................
1270
22.2.3
PATENT
LITIGATION
BEFORE
THE
UPC
.................................................................
1271
22.3
SCOPE
OF
PROTECTION
.......................................................................................................
1272
22.3.1
DETERMINATION
OF
THE
SCOPE
OF
PROTECTION
IN
GERMANY
...............................
1273
22.3.2
DETERMINATION
OF
THE
SCOPE
OF
PROTECTION
IN
THE
NETHERLANDS
..................
1277
22.3.3
DETERMINATION
OF
THE
SCOPE
OF
PROTECTION
BEFORE
THE
UPC
.........................
1280
22.4
DIRECT
INFRINGEMENT
.....................................................................................................
1281
22.4.1
PRODUCT
CLAIMS
..............................................................................................
1282
22.4.2
PROCESS
CLAIMS
..............................................................................................
1288
22.4.3
PRODUCTS
MADE
BY
AN
INFRINGING
PROCESS......................................................
1290
22.4.4
INDIRECT
INFRINGEMENT
....................................................................................
1293
22.5
SECOND
MEDICAL
USE
PATENTS
........................................................................................
1296
22.5.1
ENFORCEMENT
OF
SECOND
MEDICAL
USE
PATENTS
IN
GERMANY
.........................
1297
22.5.2
ENFORCEMENT
OF
SECOND
MEDICAL
USE
CLAIMS
IN
THE
NETHERLANDS
..............
1300
22.5.3
ENFORCEMENT
OF
SECOND
MEDICAL
USE
CLAIMS
AT
THE
UPC
...........................
1300
22.6
LIMITATIONS
TO
THE
EXCLUSIVE
RIGHTS
OF
THE
PATENTEE
....................................................
1300
22.6.1
EXPERIMENTAL
USE
EXEMPTION
.......................................................................
1301
22.6.2
BOLAR
EXEMPTION
..........................................................................................
1302
22.7
PHARMACIST
EXEMPTION
.................................................................................................
1305
22.8
PROVING
OF
THE
CASE
AND
EVIDENCE
COLLECTION
............................................................
1305
22.8.1
BURDEN
OF
PROOF
............................................................................................
1305
22.8.2
PRODUCTION
OF
EVIDENCE/REQUEST
FOR
DISCLOSURE
.........................................
1308
22.9
REMEDIES
......................................................................................................................
1310
22.9.1
OVERVIEW
ON
REMEDIES
.................................................................................
1310
22.9.2
PRELIMINARY
INJUNCTIONS
...............................................................................
1310
22.9.3
PERMANENT
INJUNCTIONS
AND
PROPORTIONALITY
DEFENSE
..................................
1316
22.9.4
RECALL
AND
DESTRUCTION
.................................................................................
1320
22.9.5
RENDERING
OF
ACCOUNT
...................................................................................
1321
22.9.6
DAMAGES
........................................................................................................
1321
22.9.7
COST
OF
THE
PROCEEDINGS
...............................................................................
1322
DECISIONS
OF
THE
EPO
..................................................................................................
1325
INDEX
.........................................................................................................................
1403
|
| any_adam_object | 1 |
| author | Jaenichen, Hans-Rainer Enmon, Richard Grasser, Florian Heiseke, Andreas |
| author_GND | (DE-588)1030592500 (DE-588)1308882912 |
| author_facet | Jaenichen, Hans-Rainer Enmon, Richard Grasser, Florian Heiseke, Andreas |
| author_role | aut aut aut aut |
| author_sort | Jaenichen, Hans-Rainer |
| author_variant | h r j hrj r e re f g fg a h ah |
| building | Verbundindex |
| bvnumber | BV047854857 |
| classification_rvk | PS 3800 PU 1547 |
| ctrlnum | (OCoLC)1409126761 (DE-599)DNB1250264901 |
| discipline | Rechtswissenschaft |
| edition | 7th edition |
| format | Book |
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| genre | (DE-588)4152408-1 Entscheidungssammlung gnd-content |
| genre_facet | Entscheidungssammlung |
| id | DE-604.BV047854857 |
| illustrated | Not Illustrated |
| indexdate | 2024-12-20T19:30:16Z |
| institution | BVB |
| institution_GND | (DE-588)2041207-1 |
| isbn | 9783452298232 345229823X |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-033237621 |
| oclc_num | 1409126761 |
| open_access_boolean | |
| owner | DE-M382 DE-703 DE-19 DE-BY-UBM DE-11 |
| owner_facet | DE-M382 DE-703 DE-19 DE-BY-UBM DE-11 |
| physical | XXII, 1410 Seiten |
| publishDate | 2023 |
| publishDateSearch | 2023 |
| publishDateSort | 2023 |
| publisher | Carl Heymanns Verlag |
| record_format | marc |
| series2 | Heymanns intellectual property |
| spellingShingle | Jaenichen, Hans-Rainer Enmon, Richard Grasser, Florian Heiseke, Andreas From Clones to Claims A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents Europäisches Patentamt (DE-588)1052705-9 gnd Biotechnologie (DE-588)4069491-4 gnd |
| subject_GND | (DE-588)1052705-9 (DE-588)4069491-4 (DE-588)4152408-1 |
| title | From Clones to Claims A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents |
| title_auth | From Clones to Claims A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents |
| title_exact_search | From Clones to Claims A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents |
| title_full | From Clones to Claims A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents by Dr. Hans-Rainer Jaenichen (Patentanwalt, European Patent Attorney, UPC Representative), Richard Enmon, Ph.D., J.D. (US Patent Attorney, European Patent Attorney), Dr. Florian Grasser (Patentanwalt, European Patent Attorney, UPC Representative), Dr. Andreas Heiseke (Patentanwalt, European Patent Attorney, UPC Representative) [und 8 weitere] |
| title_fullStr | From Clones to Claims A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents by Dr. Hans-Rainer Jaenichen (Patentanwalt, European Patent Attorney, UPC Representative), Richard Enmon, Ph.D., J.D. (US Patent Attorney, European Patent Attorney), Dr. Florian Grasser (Patentanwalt, European Patent Attorney, UPC Representative), Dr. Andreas Heiseke (Patentanwalt, European Patent Attorney, UPC Representative) [und 8 weitere] |
| title_full_unstemmed | From Clones to Claims A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents by Dr. Hans-Rainer Jaenichen (Patentanwalt, European Patent Attorney, UPC Representative), Richard Enmon, Ph.D., J.D. (US Patent Attorney, European Patent Attorney), Dr. Florian Grasser (Patentanwalt, European Patent Attorney, UPC Representative), Dr. Andreas Heiseke (Patentanwalt, European Patent Attorney, UPC Representative) [und 8 weitere] |
| title_short | From Clones to Claims |
| title_sort | from clones to claims a handbook on patenting biotech and biopharmaceutical inventions in the european patent office and on enforcing such patents |
| title_sub | A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents |
| topic | Europäisches Patentamt (DE-588)1052705-9 gnd Biotechnologie (DE-588)4069491-4 gnd |
| topic_facet | Europäisches Patentamt Biotechnologie Entscheidungssammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033237621&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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