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WIPOIIP/BEI/OO/2(B)
ORIGINAL: English
DATE: October2000
ED
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. .A.~··
•.
STATE INTELLECTUAL PROPERTY OFFICE
THE PEOPLE'S REPUBLIC OF CHINA
WORLD INTELLECTUAL
PROPERTY ORGANIZAnON
WIPO ASIAN REGIONAL SEMINAR ON
INTELLECTUAL PROPERTY PROTECTION OF
NEW TECHNOLOGIES
organized by
the World Intellectual Property Organization (WIPO)
in cooperation with
the State Intellectual Property Office (SIPO) of
the People's Republic of China
Beijing, October 10 to 12, 2000
BIOTECHNOLOGICAL INVENTIONS: SCOPE OF PROTECTION UNDER
PATENT AND OTHER FORMS OF INTELLECTUAL PROPERTY: ANOVERVIEW
Document prepared by Mr. Shinjiro Ono,
Director General, Fourth Examination Division,
Japanese Patent Office (JPO), Tokyo
n:\orgaspa\shared\amy\china\bejsernOO\bjono2b.doc
WIPOIIPIBEIIOO/2(B)
page 2
Contents
1. Scope of Protection for Biotechnological inventions
-Expansion of Subject Matter for Patent
• They must not be in their naturally occurring state,
and must be the result of human intervention.
-Comparison between Patent and Plant variety law
(Seeds and Seedlings law in Japan)
-Are Genes and Gene-related inventions patentable?
• Chemicals that have been isolated and purified from
naturally-occurring sources have long been held patentable.
2. Policy of the Japanese Patent Office
(1) Publication of Examination Guidelines and Examples
(2) International Harmonization (Trilateral activities)
1
Trend of Biotechnology Patent Applications in Japan
(Number of Applications)
2600 I
2400
__ Total
2200
2000
IPC: C12N15/00-15/90
7
I
--- Fore gn A pp lcatbns
800
600
400
?
7'
I
~
..
/
~
7.~
7
....
_
~
~&.
.
.'
~
==l
~
80
Dotted
....
.y
60.8%
IlL
J
20~ I..,iF-'7,
*
*
/~"T8
b/~';.;;~
;",
~:~~ ~,=I=========.1
1400
1200
1000
7
Pub I ication
I ines
9 9 (Year)
in this chart are the number of DNA/amino acid sequence
app I j cat ions.
Numbers(%)
in
this
chart
are
ratio
of
DNA/amino
acid
sequen~
WIPO/IP/BEI/OO/2(B)
page 3
Nat iona I ity of App I icants of
Patent Granted in Japan
00%
ers
US 7~
Others22%
'0%
1
,
~I
'0%
I--
JP
0%
an 1-- 1
-
JP 36%
m.1
I
Others 7%
US '"
80" :
US 38%
~ 'OS
US42%
'0% -
i01hers
~'
,
'0%
100% ,
1
JP 85%
'"
JP 45%
,OS
"
".'P)'
BiofeQt
y
y
3
Expansion of Subject Matter for Patent on
Biotechnologv
I v»
1973
Basic Patent of Gene recombination
-"--. --_._----- . -, ... _-_._"" - - - - - " , , - .,~.LG?~e~i.~-,-~;{~_ ___________".
r-)
1975 Rev i e i on of Patent Law for
i ntroduc i ng patent system for
..
Chem i ca I Comocund and Drug.
.---
1979
1980
- -- _._.-
_ __
....
1988
--
"----'-
.._ - - - - -
-----~-"'''-"
----
L---9!1I.br..:<"2~t;"d_ -_._._"""",,---
-- ----
The USPTO's Board of Patent
Appeals granted aoatent
J2..l"',rI~__(l:l.i"2,1:I,,er:c1)_....f.Q;:_______ .
"""_.
"Dnco-mouse "
UnI v
,".
Stipulation ofnimal Patent
in
.!h~~_a!1ljr.!<lt l...o.!!._,§,YLc1~_UD,l:l~, _
.~
..
--
-
-
.... __
....
_--
----
Implementing Guidel ines for
_~.i"S!J"~...i"~,"',,I,,J.[I'!.~nti 2,1},§..
----
f------
-----
-,..
- - - ------ ---- - - - ----"
199B
1999
-"
_-----_.""~,,-"""-"'-
" ..
~_._-".,,"-'"
""'.'-,.,"
-
- ---,,----
-"",-",
__ .-
- _ ..
._._----"'",-,,-----,----,,-
----_.-
-----
-
WTO/TR IPS Agreement went
...
-_"--,"-
-----~-~--,,--
,
1995
1997
--_.""'.,.
._---,.. " "" ..
---- 1--- ....- - - ---- " " , _ . - _..
Stipulation of Microorganism
Patent in the Exam i nat i on
GJ"lide,l,in.e s ----------- fc------ -..-------- - - - - - .. _---'----Supreme Court granted a
patent on the first genetically
engineered bacteria.Di\3mond
--( )--------
f-1985 - --'"
1993
--
-".
.Intc.fczce. _____ ~. _____
--,-_ -
---_._-_.-.-
._-.
"--
- ----,.
----
..
EU Oirective.
--_._ ....._ - - -
..... _._----- ,.
-
-_._---
------
--------
Examples of Examinations on
the Inventions
Genes
(*) Stipulation of
P.I$!1: Pa tcnt
-_ ..
..._ -----
-----
Rev i s i on of EPC r egu Iat ions.
in the Examination Guidelines.
4
WIPO/IP/BEIIOO/2(B)
page 4
Comparison between Patent Law and
Seeds and Seedlings Law
<.
Patent Law
object of Invention
protection Oplant
Othe way of creating new plants
Seeds and Seedlings Law
plant variety
x plant
x the way of creating new plants
scope of Production, use, assignment, Import Production, assignment, export,
protection ... of patented invention
import·· ·of registered plant variety /
harvested material
x products from harvested material
term
of twenty years from the filing date
twenty years from the registration
protection
date
The whole biotechnology on plants is Widely protected by Patent Law.
5
Patent Protection is Broader
than Protection of Plant
One Case of Japanese pat¥fflr i ety
1. A transgenic plant except monocotyledonous grains,
introduced nucleic acids encoding a 3',5'-hydroxylase of claim 1.
2. A transgenic carnation introduced nucleic acids encoding
a 3' ,5'-hydroxylase of claim 1.
Specification
3',5'-hydroxylase is developmentally regulated and the altered inflorescence
includes the
production of blue ... flowers. Suitable plant is meant a plant capable of producing a substrate
for the 3' ,5'-hydroxylase enzyme, and possessing the appropriate physiological properties and
genotype required tor the development of the color desired, This may include but is not limited
to rose, petunia, carnation' ..
Protection of Plant Vriety
A carnation named by "0000"
6
WIPO/IP/BEIIOO/2(B)
page 5
Gene Analysis Technology (Conventional)
Fungi (Mold)
~
Extraction and Purification
Compound having
a function
(e.g., Penicillin)
tt
Human
.-
~ Extraction and Purification
Protein having
a function
(e.g., Erythropoietin)
f\rAl,.Jj;,..,n { Gene encoding
1
"vV \JJ\lJ:1J1J
the protein
H
R..cONH~CHJ
1
1
)~"CH~
1
o
--TACCTGAA--
<OOH
Patentable
CompoundX .- subject matter -+Gl:lh~-X
"",,_ .•.•.L
"""·..,·,,,,_
~ .•"'_ .. _.• """.."';.""_.,,.,,-
7
Advantages of Using DNA
at first
now
Animal Kidney
Human Urine
DNA encoding
Erythropoietin
~rv
Extraction
Purification
Low Efficiency
Long Time
Small Quantity
Costly
Genetic
Engineering
Erythropoietin
Red corpuscle-forming
Medicine
for Anemia etc.
High Efficiency
Short Time
Large Quantity
Cheap
8
WIPOIIP/BEI/OO/2(B)
page 6
Operation of Gene and Genome
r························Amrl·ys"l"·s···················........................................
In vivo
,
'IChfbmb§Ome'lluNA(geneJII rllRNAllArhirio aCids I:
~
i
~
-ATCGATCGATCG-
V
~UCGAUCGAUCG
-AUCGAUCGAUCG-
1111I1I11111
{\
""",,"e,'L.(L.(L.(
""""
"9'
-TAGCTAGCTAGC-
=y
L-----~-:-:-,~I----71::;r::=--l
E"""""""",,-
;:'TAGCTAGCTAGC-
_TAGC_
_TAGCTAGCTAGC_
-CTAGe-
\,
Full-length eDNA
eDNA fragment (ESTs)
D-
IGenome Analyiii]
,"\,
D-
[eDNA analysis I
:'f"
......
..
IProtein I
,·····································'9
Gene Analysis Technology (Current)
.)./solationof SJenomeor gene
Gene(DNA)
Gene (DNA) with its
sequence
having been determined
Gene(DNA) with its sequence
having been determined and
its function merely having
been inferred
Gene(DNA) with its sequence
as well as its function having
been determined
~
l
Analysis of sequence
--TACCTGAA--"
1
I
Inference of function of gene
--TACCTGAA-- . .
1
~ Patent application
~ Patent application
I
Analysisofgene's function
--TACCTGAA--.
~ Patent application
I
10
WIPO/IPIBEIIOO/2(B)
page 7
Challenges Brought by New Gene Analysis
How and to what extent should a function or utility
be clearly determined for a gene to be patentable?
- Particularly, is it sufficient for a gene to be patentable
that a function is inffered solely by "homology search"?
11
Policy of the Japanese Patent Office
(1) Publication of Examination Guidelines and Examples
Feb. 1997 Implementing Guidelines for Biologicai Inventions.
Oct. 1999 Examples of examinations on the lnventions related to Chemical Field.
Oct. 1999 Examples of examinations on the Inventions related to Genes.
June 2000 Examples of examinations on the Inventions related to Chemical Field.
(Supplemental example)
N. B. All material were pUblished on the JPO Web sitl
1
Purpose of Publication of Examination Examples
1
1. I nd i cate
JPO's Po I icy to app I i cants as
supplements for Guidel ines.
2.
Unification of Examination Practices
12
WIPO/IP/BEIIOO/2(B)
page 8
Examples of Examinations on the
Inventions
•.,.d t
~~~~~~~'-
j Case,4FullqellgthcDNA!
0
G
en,
'._~ "
Enablement Requirement: NO
[Claim1]
A polynucleotide consisting of the nucleotide sequence of SEQ 10 NO:?,
[Description of the invention]
The claimed polynucleotide is 2400bp eDNA obtained from human liver
eDNA library.
It encodes a polypeptide of 800 amino acids of SEQ 10 NO:8,
The polynucleotide sequence of SEQ 10 NO:? or the amino acid sequence
of SEQ 10 NO:8 showed 20 to 30% homology to the polynucleotides
encoding factor WW1 of mammalians or the amino acid sequences of
factor WW1 of mammalians such as rats.
1
It was assumed to encode human factor WW1 and to be useful.
[Result of the prior-art search]
[Reasons for rejection]
••
cr . http.//www.jpo-mitLgo.jp/infoe/dnas.htm13
[Attention]
(2) International Harmonization
Activities of the Trilateral Offices in Biotech Patent Practices
Dec.1984 • Launching of the Project 12.3 (Biotechnology) by a Proposal of
USPTO.
Oct 1989 • Final Draft of the Comparative Study.
Jun. 1995 . JPO's Proposal of Resumption of Project 12.3.
Oct 1995 • Launching of Project 24,1 at the Trilateral Meeting.
May 199? • Adoption of the Comparative Study Report at the Trilateral Meeting.
Nov.199B • Launching of New Comparative Study about Patentability
in DNA Fragments(ESTs) by the Proposal of JPO,
f\II~t1,~9.9
• Adoption of the Comparative Study Report at the Trilateral
Jun.2000
*
• Confirmation of Patentability in All Nucleic acid related Invention.
• Launching of New Comparative Study about Patentabllity
in nucleic acid molecule-related inventions, whose functions are
Each l!!Ifi\\\'fllnl~\\ M9\tlllP'o\¥WIisipu~~§lQ(pePnrffig<lfHl!,leral Web site.
14
c'
WIPOIIP/BEI/OO/2(B)
page 9
Epoch-making Topics
1, Human Genome Project (HGP)
-HGP consortium announced a draft of the entire human genome
sequence in June,
-They promised to deliver complete human genome data by 2003.
-A venture company announced that It has sequenced 99% of
the entire human genome.
2. Joint Statement by President Clinton and Prime Minister Blair
-Raw fundamental data on the human genome, including the human
DNA sequence and its variations, should be made freely available to
scientists everywhere.
-Intellectual property protection for gene-based inventions will also
play an important role in stimulating the development of important
new health care products.
3. Statement by President Clinton Interview with BIO
-We've got the people together with the skills and the experience
to draw the line in the right place.
15
Trend of Intellectual Property
1. Trilateral Technical Meeting (June 2000)
2. G8 summit (July 2000)
-We recognise the need for a balanced and equitable intellectual property
protection for gene-based inventions, based wherever possible on common
practices and policies.
-We encourage further efforts in relevant international fora to achieve broad
harmonisation of patenting policies of biotechnological inventions.
16
,
WIPO/IP/BEI/OO/2(B)
page 10
Trilateral Comparative Study (May 1999)
DNA fragment
"
g'<:
.,,~
'
I
Sequence is
detennined by
the Sequencer
~
not a oatentable invention."
-CGATCGATI'AGCCA-
Three Offices are not in a
complete agreement in the
practice.
- JPO and EPO are negative for
inventive step of DNA
--+ fragment
with high homology.
- USPTO is negative for utility
I
Function is
inferred by
computer
homology search.
other search etc.
-CGATCGATIAGCCA.
"A mere DNA fragment without
indication of a function or
I specific asserted uti I ity is
Function X?
of
DNA fragment with high
Functionis analyzed
and determined
by experiment
·CGATCGATIAGCCA-
"A @ffAtlieaSJIootfiotitwbnclliaj Is
tlpemlfica1l:ti I i tv. e. g. use as
a p;mbess:ertiiagnbsei 1ayspec j fie
disease, is disclosed, is a
Function X
patentable invention as long
as there is no other reasons
17
Trilateral Technical Meeting (June 2000)
Nucleic acid molecule
"
'" ",
I
sequence is
determined by
the Sequencer
·CGATCGATTAG-
I
Function is
inferred by
computer
homology search,
other search etc.
-CGATCGATIAGFunction X?
Function is analyzed
and determined
by experiment
~CGATCGATIAG·
Function X
18
-",,-
" ' v """~~'
Sequence alone
determined
~
Ali nucleic acid molecule-related
inventions including full-length
cDNAs, SNPs, without indication
of function or specific, substantial
and credible utility, do not satisfy
industrial applicability (utility),
enablement or written description
requirements
-" IComparative study I
- Sequence
determined
- Function
inferred
-Sequence
determined
_
-Function clearly
determined
All nucleic acid molecule-related
inventions including full-length
cDNAs, SNPs, of which function or
specific, substantial and credible
utility are disclosed, which satisfy
industrial applicability (utility),
inventive step, enablement and
written description requirements
would be otherwise patentable as
long as there is no other reasons
for rejection.
WIPO/IP/BEI/OO/2(B)
page II
Tri lateral Technical Meeting (June 2000)
Commencement of the comparative study on the utility of
nucleic acid molecule-related inventions, whose functions are
inferred based on their similarities to known DNA sequences
obtained by conventional computer search (homology search)
and the relationship to the question of inventive step.
New sequence
•. ATGACCTGAGA
Known sequence
"'*
No.1
• ACGACGTGAGA' . (function • • • ATGACCTGAGA'
No.2
. TTCCACTGATA' • (function
1;16.1
No.3 . . CGAATGTCA:\(i· • (function Z)
l.Homology Search
I
I
I I I I I I I I
•• ACGACGTGAGA .
I~ Function X 1
l;tfff~iteijjfuridfiODJ]
19