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Oct 22, 2013 (3 years and 11 months ago)

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EPIP 2

Research Tools in Genetics

Sandy Thomas

Nuffield Council on Bioethics
www.nuffieldbioethics.org


23 November 2003


The ethics of patenting DNA: a discussion paper

The role of genetics


Biomedicine
-

drugs, diagnostics


Life sciences
-

model organisms


improved




understanding


Agriculture
-

crop and animal




breeding


The ethics of patenting DNA: a discussion paper

Role of genetics


Goals


to promote the public
interest


Making available medicines,
diagnostics, crop plants


Diffusion
-

diverse paths


Balance between incentives for
investment


require IP protection


Spread of technology


widely
accessible




The ethics of patenting DNA: a discussion paper

Role of genetics


Increased level of IP protection in
public sector


Patenting of biological molecules,
animals, plants


Trend to patent upstream


May restrict technology diffusion


Open access: SNPs, PPIRA



The ethics of patenting DNA: a discussion paper

Progress in genetics

Fundamental tension:


need to promote sharing of
knowledge in research, especially in
public sector and developing world
and


need to promote innovation in health
by protecting inventions



The ethics of patenting DNA: a discussion paper


The ethics of patenting DNA: a discussion paper




The ethics of patenting DNA: a discussion paper

Genetic information as
technology



To consider eligibility


To consider legal criteria for
patentability


To consider the public interest


The ethics of patenting DNA: a discussion paper


Context: DNA



Well established that patents play a


key role in pharmaceutical innovation


IP in biotechnology and genomics has
encouraged investment


Small companies: assets as IP


Still relatively few products on the


market


The ethics of patenting DNA: a discussion paper

Context


Two key trends:



Protection of investment


Protection of information



………..rather than inventions


The ethics of patenting DNA: a discussion paper

The patent system

Goals:



Stimulate innovation for the public
good



To reward people for new and useful
ideas and inventions


Are these being achieved?


The ethics of patenting DNA: a discussion paper

Patenting DNA



Will patenting DNA promote the
public good?



Do patents on DNA unfairly reward
inventors?


The ethics of patenting DNA: a discussion paper

Types of information


Information about a natural phenomenon


Scientific knowledge


Discovery


Not eligible for patenting



A natural phenomenon which is itself
information


Genetic information


Encoded in an artificial molecule


Eligible for patenting



The ethics of patenting DNA: a discussion paper

Eligibility changes as
technology evolves



New techniques in isolating DNA


In silico research


Europe vs US




Brings eligibility (and
inventiveness) into question


The ethics of patenting DNA: a discussion paper

Patenting DNA



Product patents:

on the DNA sequence itself


restricting
new applications of information?



Use patents:

on the use of the sequence


other
applications possible?





The ethics of patenting DNA: a discussion paper

Research tools


Scientific findings which have no
immediate commercial or
therapeutic use


Growing category


Many patented


Case studies: CCR5 and MSP
-
1



The ethics of patenting DNA: a discussion paper

Consequences of patents on
research tools?


Cost of research



Practical difficulties



Patent owners may withhold licenses



“Royalty
-
stacking”



Evidence?



The ethics of patenting DNA: a discussion paper

Do patents on research tools
meet the legal criteria?



Novelty



Inventiveness/Non
-
obviousness



Utility



The ethics of patenting DNA: a discussion paper

Malaria vaccines


PATH seeking to access IP in relation


to antigens to malaria vaccines



MSP
-
1 antigens: 34 patent families,


complex: similar and some overlapping



Negotiation time consuming, costly,
uncertain.



The ethics of patenting DNA: a discussion paper

CCR5


HGS originally isolated the gene for
this receptor and filed for the patent;
its 'best guess' of utility: the CCR5
protein product would be a cell
-
surface receptor



Later shown that the CCR5 receptor
is the route by which the HIV/AIDS
virus enters a host cell



The ethics of patenting DNA: a discussion paper

CCR5


Is it reasonable that gambles, ie a 'best
guess' of utility for a very important cell
receptor, be rewarded?




Should the established principle that a patent
applies even to an unanticipated utility apply
to genes, where the effort of isolation is low?



Freedom to operate






The ethics of patenting DNA: a discussion paper

Golden rice


Rice with Vitamin A


Development involved 60+ patents


Negotiation of licences: access
agreed


time consuming, costly


MTA more of a problem



The ethics of patenting DNA: a discussion paper

Utility


Claims, which amount to routine
discoveries with weakly
demonstrated or speculative uses,
will seldom deserve the status of
patentable inventions



The criterion for utility must be
rigorously applied so that the grant
of a patent more properly reflects
the inventor’s contribution.



The ethics of patenting DNA: a discussion paper

Recommendations


Product and use patents should
rarely be granted



In general, the granting of patents
which assert rights over DNA
sequences as research tools should
be discouraged



USPTO utility guidelines



The ethics of patenting DNA: a discussion paper

ESTs


No ‘reach through’ by ESTs to whole


genes


“We recommend that when rights are
asserted in terms intended to cover
all sequences that contain the EST
that is the subject of the original
patent, no patent should be
granted.”




The ethics of patenting DNA: a discussion paper

Existing patents


Non
-
exclusive licensing wherever
possible



The ‘research exemption’ should be:


given statutory basis in US


clarified in Europe


extended by industry for patented DNA
sequences that have a use in research



The ethics of patenting DNA: a discussion paper

Limiting the scope


One gene often produces more than
one product


If a patent protects all the uses of a
sequence, this can give extensive
rights, and unjustified rewards


Scope of protection should be
limited to specific defined uses




The ethics of patenting DNA: a discussion paper

Recommendations


Patents on DNA will become the
exception rather than the rule



Recommendations are aimed at
patent offices, patent lawyers, courts
and policy
-
makers



International perspective




The ethics of patenting DNA: a discussion paper


The ethics of patenting DNA: a discussion paper

CIPR


Danger of imposing drag on
innovation


Danger that single product or
service will infringe many patents


Need for institutions and strategies
in development to mitigate such
effects


Guidance for public sector use of IP




The ethics of patenting DNA: a discussion paper

Conclusions


Grounds for eligibility should be re
-
examined


Rigorous application of patenting criteria

exclude majority of patents claiming
sequences as research tools (and
diagnostics)


Use of research exemption and
compulsory licensing to encourage
diffusion of technology and applications
when in the public interest



The ethics of patenting DNA: a discussion paper


The ethics of patenting DNA: a discussion paper

Diagnostics: BRCA1


Test for faulty gene associated with
a disease, based on knowledge of
the structure of the gene



Both product and use patents can
have same effect of powerful
monopoly



The ethics of patenting DNA: a discussion paper

Diagnosis:BRCA1



Myriad has monopoly on the use of the gene;
BRCA1 under opposition


All diagnostic uses of the gene


Broad patents would be dominant over other


uses


Cannot ‘invent around’ the sequences


High cost of tests: $2,400 in UK



The ethics of patenting DNA: a discussion paper

Diagnostic tests


Do patents on diagnostic tests
cause adverse effects?

-

difficulty of ‘inventing around’

-

broad patents create a powerful
monopoly



Are they needed?

-

to encourage development of new tests

-

R&D to identify genes for diagnosis



The ethics of patenting DNA: a discussion paper

Diagnostic tests


Use patents?


Yes, if specific


Product patents? Rarely




the
protection by use patents
could
provide an effective means of rewarding the
inventor while providing an incentive for
others to develop alternative tests.”



Use of compulsory licensing?


The ethics of patenting DNA: a discussion paper

Conclusions



The ethics of patenting DNA: a discussion paper


The ethics of patenting DNA: a discussion paper

Patents claiming DNA sequence filed between 1996
-
1999: by country and sector