First - SLING Diffusion

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14 Δεκ 2012 (πριν από 7 χρόνια και 6 μήνες)

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The Patent System



Who is it

for
?


How to find

patent

publications
?


How to protect

your

development results?

Mara

Rozenblate


Leading expert, Department
o
f Examination

Latvian
Invention

Patent Office


EU

project

SLING


Riga Seminar, November 3, 2011

A patent is the

proof

that its holder

has

the sole

right to
use

(=

ban

others)the
patented invention

(technical solution)


Patents are

intended

as a tool

to gain

maximum income

for
those who

are developing new

technical
solutions
,

which

must be implemented

in any

sector of the
economy


For scientific
institutions

and

universities
,

patents

are
a
tool

to obtain additional
income from
their

developments
through

the sale of

patents, licensing, or

creating a

business

The patent owner

has the
exclusive

right to:

1)

a patented product

-

make

-

Offered for sale

-

The placing on

the market (sell)

-

to use

-

Imported

from abroad

-

To keep

the above

purposes

2)

use

a patented process

3) to offer

for sale,

marketing, use,

import or

store it for
these

purposes

-

The product

obtained directly

by

patented process

4)

prohibit the

supply

and offering to supply

the essential
elements of

the
patented product

(if you

knew that they

exist)

5)

prohibit

the above steps

with equivalent

solutions

The role of

the
patent:


prevent

competitors

from the desire to

imitate


demonstrate the commitment

to defend
your

IP
rights


increase
the income

from
the

exclusive
rights


psychological

coercion

of
competitors


good

image: using
the

patents

in
advertising


"
bargaining

agent"

with partners
and

competitors


(means

an arrangement

in case of
dispute)


the

published application

stage

becomes a

barrier
to

competitors'

patents


active

patent

policy operates

likean

insurance


strategic

use of

-

the company's

share capital

Patents

as

capital:


EXIQON

A / S (Denmark)
-

www.exiqon.com,

founded in
1996.

per
year owns

two unique

technologies that are

based
on

product


AQ

(
anthraquinone
)
technology,

basic

WO96/31557

(sold

under the brand name

of
AQ
-
Link)


LNA

(locked

nucleic

acid) technology,

which

won
the

1997th

per
year

basic

WO99/14226

-

new

nucleic
acid

analogues

with high affinity to

RNA and

DNA

Two

inventors:

prof.

Imanishi
,

Osaka

University

and
prof.

J.

Wengel
, etc.,

University of

Copenhagen


Began

with two

private funding

-

16

m DKK
;

29

employees

Now

the company is quoted at the

NASDAQ
OMX

Copenhagen;with

a wide

network of distributors

around
the world

Patents:



20
-
year

monopoly on

the
use


In the
country where the

patent has been
granted


as
defined

by the claims



Particular case
:

pharmaceutical products

and agriculture
:



Supplementary protection certificates

for

up to 5

years


human
and veterinary

medicine


plant
protection

agents (agrochemicals)

B
iotechnology

inventions

have

a specific regulatory
framework

(Directive

98/44/EC)in the European Union



Biotechnology

inventions:

=

Products containing

biological material;

=

The methods by which

biological material

is
produced,

processed and

used;


=

Biological material

containing genetic information and

is able
to

reproduce

the same

biological system

or it may be

reproduced
in

a biological system

Patented invention

may be

of interest:


biological
material

-

obtained,

divided by the

technique used
:


"
dead

material"

-

proteins
structure,

enzymes
,


antigens
,

DNA, RNA, genes,

partial
genes
,

vectors,

plasmids


"live

material"

-

microorganisms, cell

lines,

hybridoma
,
plants,

animals


plants
and animals

-

if you

are not limited

to a specific

variety
(genetically

modified
organisms)


microbiological

methods (the cloning

techniques

of genetic
engineering techniques
)

Patent

granted
:




Human

cloning

techniques;


Modifying
the genetic identity

of human

germ cells
;



Human
embryos for industrial

or commercial purposes
;



Modifying
the genetic identity

of animals

means
that

they

can

cause them
suffering without
any substantial
medical

benefit to man

or animals,

as well as

in the
following
treatments

produced animals

The human body

and its

elements:


The
human body is

different

in its formation

and

development
stages,

and the simple

discovery

of one of its

elements,
including

full or partial

gene

sequences

is not

a patentable
invention
;


An
element isolated

from the human body

or

otherwise
produced by means

of a technical method

as a result, including

a
complete

or partial

gene

sequences

can be
patented
,

even if
the

structure of that element

is identical to the

natural element;

Full

or

partial

gene

sequences

application the

industrial use



Why

a specific
regulation for biotechnological inventions?


Answer

-

morality

and public order

provision

in patent
law


Traditionally
,

biotechnology

objects
-

no problem
:

structural

proteins,

antigens,

enzymes, microorganisms,

cell
lines


Modern

biotechnology

facilities

-

a problem
:

genetically

modified plants, higher

animals,

DNA, RNA,

gene,
or

part of

a
complete gene

Example:

"
Onkopele
"

Harvard

University

"Transgenic

mammal, except

man,

whose

germ
cells

and

somatic cells

contain

an
activated

oncogene

sequence,

which is

incorporated into
the

chromosome containing

the genome

of the
animal

or

the

animal

ancestor

genome,

which

in addition
to

defined

oncogenic

third

-
10.

Claim

'

Objections

and appeals

for nearly 20 years

(Greenpeace,
etc.)>

transgenic

rodent>transgenic

mouse.

In this case,

was developed in

the balancing test:

the
suffering of

an animal

/a
benefit

for humans

Example:

"Use of non
-
transformed

plant

cells

whose

genome

stably

integrated

foreign

DNA
sequence

encoding a

protein

that has a

variety

of non
-
specific

enzymatic

activity
,
which

is able to

neutralize or

inactivate

glutamine

synthetase

inhibitor

promoter

in
the chair,

which

recognizes

the

cell

polymerase"


Greenpeace's

objections:

form of life,

environmental damage,

if

spread

in nature
.
The
modified

crop

is resistant

to herbicides


In this

case,

transformed

plant

(T356/93), the EPO

defined

morality

and public
policy

criteria:

"public policy"

include

public safety

and human

society

as

part of

the physical
integrity

and environmental

protection;


"morality"

is based on the

belief

that certain

behaviors

are correct, but others

-
wrong.

These

beliefs

are rooted

in each

culture.

European

patent system

takes into
account

the European

society and civilization

inherent

cultural

Directive

provision
:


DNA sequence

is

patentable,

DNA

cloning

is

patentable

because
it

is not in itself

a discovery

or a

"form of life."

Patent

mandatory
in

industrial

uses.



This provision is Not
implemented
uniformly in all

the

patent

laws
of the
EU

Member
States.

Most

require that

utility

should be

indicated in the
description,

some (DE,

LU)
-

must be defined

by the claims,

FR

-

a
single

patent

can

define

only one

type of use

EU Court of

explanations

for

some of

biotechnological inventions
in

the rules:



C
-
428/08

(Monsanto

v

Cefetra
)

dir.

9th

Article:

The protection

conferred by a patent

on a product
containing

genetic information

or consisting
of
genetic

information shall extend

to all material,

including
a

product which
contains

genetic

information and carry out

their
functions.


Patented

genetically

modified soybean (DNA
sequence

that

encodes

an
enzyme that
is

resistant
to

glyphosate

exposure).

Or patent relates

to the

soybean

meal

produced
from

modified

soy

plants?

Answer: The

patent

applies only to

material that
contains

genetic

information and carry out

their functions.

C
-
34/10

stem cell

patenting

O.

Bruestle

v

Greenpeace,

dir.

6.2.c

The


"...

patents

shall be granted

to biotechnological inventions

relating
to

...

of human embryos for

industrial or commercial purposes

"

First,

What is a "human embryo"?

What

stage of development

does
this
involves?

Answer:

The human

embryo

is:

-

The egg

after fertilization

-

Unfertilised egg,

in which

transplanted

cells

mature


-

Unfertilised egg

whose

division and

further

development is
encouraged

by
partenogenese

method

Second

What is

an industrial or commercial

use?

Answer:

includes

also the use

of human embryos

for
research.

Only

the use of

therapeutic

or

diagnostic

methods are
patentable
,

which relates to the

embryo.


C
-
34/10

stem cell

patenting

O.

Bruestle

v

Greenpeace,

dir.

6.2.c

The


"...

patents

shall be granted

for
biotechnological inventions

relating
to

...

of human embryos for

industrial or commercial purposes

"

Third

Is there a

patentable invention

(stem cells,

pluripotent

cells?), In
which

a human

embryo

is not

defined

by the claims,

but the

invention
is

a necessary precondition for

the
implementation

of

embryo

destruction?

Answer:

It is not

a patentable invention,

if the object of the invention
implies the

destruction

of human embryos

or

embryo

as

starting
material


(
even if

it is not mentioned in the patent).

The Patent
system

implicitly

includes
a "public

contract…….

You reveal
the
Invention

..you get
exclusivity

….so
that others

can learn
from

it


and make improvements!

Get

exclusivity

Patent

documents are

a valuable

source of information

for
those

who do not themselves

patent

their

design,




they contain

valuable technical

information

which can’t be
found in

other publications; there may be

a source of
inspiration



they contain

legal information, which

allows you to avoid
infringement,


they help
to choose
the

direction of
development in
a timely
manner



they contain commercial

information,


they

allow

to know

the industry
-
leading companies

and to find
partners, or identify

competitors



The best

source of information for

a

patent is

the EPO

database
:

www.espacenet.com

A
good

search

criterion is the

IPC

(International Classification of

the invention)

Biotechnology

inventions

generally

are classified into

classes

C12N


Microorganisms

OR

Enzyme;

composition

THEREOF

(biocides,

pestrepellants

or

attr
actants,

or

plant

growth

regulator

Containing

micro
-
organisms,
viruses,

microbial

fungi,

Enzyme,

fermentates
,

or

substances

produced by,

or
extracted from
,

microorganism

or

animal

material

A01N

63/00
;


Medicinal preparation

A61K
;

fertilizer

C05F
);

PROPAGATING,

Preserving,
OR

MAINTAINING
MICROBODY
,

OR

Genetic

mutations

ENGINEERING;

CULTURE

MEDIA

(
microbiological

testing

media

C12Q

1 /

00
)


C12Q

MEASURING

OR

PROCESSES

Testing

Involving

Enzyme

or microorganisms
(
immuno

assay

G01N

33/53
);

Composition

or test
papers

therefor;

PROCESSES

for

preparing

s
uch a

composition
; CONDITION
-
RESPONSIVE

CONTROL

IN

MICROBIOLOGICAL

PROCESSES

OR ENZYMOLOGICAL

A01N BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS
HERBICIDES (preparations for medical, dental or toilet purposes
which kill or prevent the growth or proliferation of unwanted
organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT
GROWTH REGULATORS (mixtures of pesticides with fertilisers C05G)


A61K MEDICAL OR VETERINARY SCIENCE; HYGIENE


G01N33/00 Investigating or analysing materials by specific methods
not covered by groups G01N 1/00
-
G01N 31/00

The situation in

Latvia:
biotechnological inventions

in

the last 20
years


The total number of patents granted to the

Latvian

applicants

during the last 20
years is approximately
2500



thereof 53

(2.1
%) in biotechnology

-

The most active

active

applicant

in the field:

Latvian University,

MB

&

GT

Institute for

Biomedical Research

Center

-

17

Biochemical

Preparations Plant

-

11

RTU

RSU

of 1


A.

Lielpētere

-

8

V.

Ramniece

-

1

G.

Feldmane

-

1

A.

Muceniece

-

1

(RIGAVIR)

What not to do, if
you wish

to submit a

patent application

Don’t publish

a

submission

for example.,

articles, press releases,
presentations

/

posters

/

materials for

the
conference

or blog


Don’t market
products

before submitting the
application,

which

is included in the

invention



Do not
give

a lecture

or

presentation

prior to
submission

except
when this action
is

covered by
a
confidentiality

agreement



As soon as possible

seek

professional advice!

Submit

an application

before the

others!

Where to

file patent applications

National

Patent Office

National

patent is

valid only

in the country

where

it has been granted

Also,

residents

can

submit an application

the date of filing of the national application can be used
as

"priority"

for

the

following

applications in other countries


European Patent Office

European

patent is

equivalent

to national
patents

in countries where

it has been
validated

(chosen by

the applicant

countries)


Patent

Cooperation Treaty

Only

one
application for

141

States

After the

initial phase of

international
application,

a number of

national

examination
procedures must take place

May help to
postpone

the procedure costs

until
the

30th

or 31.

month after
the filing
date

(e.g.,

the final

choice of countries)

It is NOT an International Patent, it is a
common Filing procedure
for many different
pate
nts

R
ecommended

actions to protect

scientific

developments:

First


Designate
a

professional

advisor
for

patenting

issues

(or

train

one

of
your staff member)

Second


File first

a
patent

application

(
if you continue your research, and
there are
significant

new enhancements

file successive patents)

Third


Extend your protection by filing in the
maximum possible

number
of countries (sub
-
optimal

use of

the PCT

procedure).


NOTE
:

one

procedure can last
more

than 3 years!

Fourth

After

the first application

(establishing your priority) activities like
advertising
,

publications (articles, conferences
,

speeches,

etc
.),
research of
the optimal

commercialization

mechanism (spin
-
off

company

creation, licensing, sales
) are possible and safe.