EPIP 2 Research Tools in Genetics Sandy Thomas Nuffield Council on Bioethics 23 November 2003

EPIP 2Research Tools in Genetics

Sandy ThomasNuffield Council on Bioethics

www.nuffieldbioethics.org

23 November 2003

http://www.nuffieldbioethics.org/

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


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


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


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




Genetic information as technology

• To consider eligibility

• To consider legal criteria for patentability

• To consider the public interest


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


Context

• Two key trends:

• Protection of investment

• Protection of information

• ………..rather than inventions


The patent systemGoals:

• Stimulate innovation for the public good

• To reward people for new and useful ideas and inventions

Are these being achieved?


Patenting DNA

• Will patenting DNA promote the public good?

• Do patents on DNA unfairly reward inventors?


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


Eligibility changes as technology evolves

• New techniques in isolating DNA

• In silico research

• Europe vs US

Brings eligibility (and inventiveness) into question


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?


Research tools

• Scientific findings which have no immediate commercial or therapeutic use

• Growing category

• Many patented

• Case studies: CCR5 and MSP-1


Consequences of patents on research tools?

• Cost of research

• Practical difficulties

• Patent owners may withhold licenses

• “Royalty-stacking”

• Evidence?


Do patents on research tools meet the legal criteria?

• Novelty

• Inventiveness/Non-obviousness

• Utility


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.


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


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


Golden rice

• Rice with Vitamin A

• Development involved 60+ patents

• Negotiation of licences: access agreed

• time consuming, costly

• MTA more of a problem


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.


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


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.”


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


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


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



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


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



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


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


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


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?


Conclusions



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

23%

39%

1%

9%

6%

14%

3%1% 4%0% US public

US private

Jap Public

Jap Private

Euro Public

Euro Private

Other Public

OtherPrivate

IndependentInventorsUnclassified

Documents

EPIP 2 Research Tools in Genetics Sandy Thomas Nuffield Council on Bioethics 23 November 2003