Of Mice and Men: The Patentability of Biotechnology

AuthorRachel Casey
PositionJunior Sophister Law student, Trinity College, Dublin
Pages86-105
OF
MICE
AND
MEN:
THE
PATENTABILITY
OF
BIOTECHNOLOGY
RACHEL
CASEY*
Introduction
In
recent years, concern
has
increased
regarding
"the dominion
that
was
sought
to
be exercised
by
man
over
the natural
world"'
through
the use
of
genetic
engineering
techniques. The
biotechnology
industry
has long
recognised the potential
for
misuse
and
ultimate destruction
inherent
in
genetic
manipulation.
The
question remains:
how
can
we
justify
the
patenting
of
life
forms?
Biotechnological
research
is
often
capital
intensive,
laborious
and
commercially risky.
It
is
argued
on
behalf
of
the
industry
that
by
reason
of
the
high
research
and
development
costs
incurred,
some level
of
intellectual
property
right
should
be
granted
to protect
the
resulting
invention.
2
The
patent
system
is
seen
as
the
most appropriate
since
it
would
grant
to
the
inventor
the
right
to
exclude
all
others
from
using
the
invention
for
a
limited time
in
order
to
ensure
a
return
on
his
investment.
Without
this
system
of
protection
of
innovation,
there
would
be little
incentive
for
invention and
the
industry could
resort
to
imposing
obligations
of
confidentiality,
which
have
proven
a
barrier
to
the
necessary
dissemination
of
information.'
Criteria
of
patentability
were
established
by
Article
1
of
the
Strasbourg Convention
on
The
Unification
of
Certain
Points
of
Substantive
Law
on
Patents For
Inventions,
1963,
4
subsequently
adopted
by
Article
52
of
the
European Patent Convention,
1973,
5
and
incorporated
into
Irish
law
Junior Sophister
Law
student,
Trinity College, Dublin.
I
am grateful
for
the
helpful
comments
and
encouragement
of
Mr.
Paul
Coughlan.
All
errors
and
omissions
are
entirely
my
own.
1
Opposition
to
the
patent
application
in
T356/93
Plant
Genetic
Systems/Glutamine
Synthetase
Inhibitors
(1995)
10
EPOR
357
(Technical Board
of
Appeal).
2
See
Roberts,
"Broad
Claims
for
Biotechnological Inventions"
[1994]
9
EIPR
371.
3
See Keane,
"The Patentability
of
Biotechnological Inventions"
(1992)
10
ILT
139.
4
Article
I
provides
that "patents
shall
be
granted
for
any
inventions which
are
susceptible
of
industrial
application,
which
are
new
and
which involve
an
inventive step.
An
invention
which
does
not
comply with
these
conditions shall
not
be
the
subject
of
a
valid patent."
(emphasis
added.)
'Hereinafter
referred
to as
the
EPC
where
convenient.
©
1999
Rachel Casey and
Dublin
University
Law
Society
1999]
Of
Mice
and
Men:
The
Patentability
of
Biotechnology
87
by
section
9
of
the Patents
Act,
1992.
The
exceptions
to
patentability
are
contained
in
Article
53
of
the
EPC
which
states
that European
patents
shall
not
be
granted
in
respect
of:
(a)
inventions,
the
publication
or exploitation
of
which would
be
contrary
to
ordre public
or
morality,
provided
that
the
exploitation
shall
not
be
deemed
to
be
so
contrary
merely
because
it
is
prohibited
by
law
or regulation
in
some
or
all
of
the
Contracting
States;
(b)
plant
or
animal
varieties
or
essentially
biological
processes
for
the
production
of
plants
or animals;
this provision
does
not
apply
to
microbiological processes or
the
products
thereof.
6
This
Article
and
its
interpretation by
the
European
Patent
Office
(EPO)
have
been
the
source
of
much
of
the
controversy
surrounding
the
appropriate
subject matter
of
patents,
and
recent
decisions
of
the
Technical
Board
of
Appeal
have
revived
the
debate.
7
The
Approach
of the
European
Patent
Office
The leading case to date
concerning
the
patenting
of
a
higher
living
organism
is
Harvard
College's Onco-Mouse
Application.
8
Here
a
patent
application
was
made
for
a
genetically engineered
mouse which had
been
injected
with
the
onco
gene
at
the
embryonic
stage,
making
it
more
susceptible
to
developing
a
cancerous tumour.
Initially
developed
by
Harvard
University,
the
mouse
later became
the
property
of
the
pharmaceutical
company,
Du
Pont,
for
use
in
conducting
cancer research.
In
1988,
the
US
Patent
Office
granted
a
patent
for
the
mouse,
9
but
an
identical
application'
°
filed
at
the EPO
proved
more
controversial.
6
Article
2,
Strasbourg Convention,
1963,
and
section
10
of
the
Patents
Act,
1992.
7
Ford,
"The
Morality
of
Biotech
Patents:
Differing
Legal
Obligations
in
Europe?"
[1997]
6
EIPR
315.
8
T19/90
Harvard/Onco-Mouse
[1989
OJ
EPO
451
(Examining Division);
(1990)
5
EPOR
501
(Technical
Board
of
Appeal);
(1991)
6
EPOR
525
(Examining
Division).
9
US
Patent
No.
4,736,866.
10
The
application
had
as
its
principal
claims
the
following:
1.
A
method
for
producing
a
transgenic
non-human
mammalian animal
having
an
increased
probability
of
developing neoplasms,
said
method
comprising
introducing
an
activated
oncogene
sequence into
a
non-human mammalian
animal
at
a
stage
no
later
than
the
eight-cell
stage.
2.
A
transgenic
non-human mammalian
whose
germ
cells
contain
an
activated
oncogene sequence
introduced into said
animal
...
at
a
stage
no later
than
the
eight-
cell
stage....

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