Genetic Resources and IP protection A weak legal basis for a good cause Conference Torino 8 October...

Genetic Resources and IP protectionA weak legal basis for a good cause

Conference Torino

8 October 2007Sven J.R. Bostyn

[email protected]

© Sven Bostyn 2007 2

Distortions

• Unlimited taking away of genetic resources – biopiracy/biosquatting

• Unrewarded taking away of genetic resources


The distortions

• There may be environmental risks associated with unmonitored taking of biodiversity (is difficult to prove)

• Unrewarded taking of resources places originator developing countries in the difficult position that they have more difficulties in making a profit by trading their resources


The distortions

• By taking patent rights based on the genetic resources, originator countries are again placed in a disadvantageous situation

• James Boyle: TK often flows unrestricted out of developing countries, and returns embedded in foreign patents


Real problem

• Environmental risks for the future of biodiversity

• No rewards flow back to originators countries/communities for taking away the genetic resources

• The above should be the starting point for developing any solution


The misconception

• Strangely enough, all solutions presented in fact only and exclusively touch upon the financial reward

• This demonstrates that the aim is not as much to achieve the goals of preserving biodiversity, but to give financial return to originator countries of the genetic resources, which are predominantly developing countries


The instruments

• (Inter)national legal instruments which try, amongst others, to remedy the distortions:– CBD– FAO IT– TRIPs?– Patent Acts?– SPLT?


CBD

• The Biodiversity Convention was negotiated under the auspices of the United Nations Environment Programme ("UNEP") and was opened for signature at the United Nations Conference on Environment and Development in 1992. The Convention came into force on 29 December 1993.

• The Biodiversity Convention operates at three levels, i.e. genes, species, and ecosystems, and extends to all genetic resources, namely, plant, animal and microbial.

• It affirms that the conservation of biodiversity is "a common concern of humankind", and that States have sovereign rights over the biological resources in their territories.

• Under the Biodiversity Convention, States are responsible for conserving their biological diversity and for using it in a sustainable manner.


CBD • The CBD can be conceptually divided into three subsections. • First set of provisions: duty to promote sustainable uses and

conservation (in-situ and ex-situ) of biological resources, and encourages to "create conditions to facilitate access to genetic resources for environmentally sound uses."

• Second set of provisions: recognition of states' sovereignty over natural resources and their right to give access to third parties. The CBD further establishes that access to genetic sources must be subject to prior informed consent ("PIC") of the party providing such resources, and that once consent has been given, terms of access must be mutually agreed upon.

• Third set of provisions: the CBD promotes "the fair and equitable sharing of the benefits arising from the utilization of genetic resources."


Objectives of the CBD:

• Art. 1: ”The conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising from the use of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding".

• Main issues are: – conservation of biological diversity, both in situ and ex situ– sustainable use of biological diversity– fair and equitable sharing of benefits arising from use if genetic

resources– access to and transfer of technology


CBD = Property rights

• What is apparent from this definition : CBD does not seem to be in first instance concerned about the preservation of biodiversity as common heritage

• It prescribes property rights in genetic resources


CBD – Art. 2 definitions• “Biological resources” includes genetic resources,

organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity.

• “Country of origin of genetic resources” means the country which possesses those genetic resources in in-situ conditions.

• “Country providing genetic resources” means the country supplying genetic resources collected from in-situ sources, including populations of both wild and domesticated species, or taken from ex-situ sources, which may or may not have originated in that country.


CBD – Art. 2 definitions

• “Genetic material” means any material of plant, animal, microbial or other origin containing functional units of heredity.

• “Genetic resources” means genetic material of actual or potential value.


Definitions in FAO -IT

• Art. 2: genetic material as meaning any genetic material of plant origin – that is, any material of plant origin, including reproductive and vegetative propagating material, containing functional units of heredity – of actual or potential value for food and agriculture


+ Other important objective: protection of traditional knowledge

• Art. 8(j) BD: “Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices;”


Traditional knowledge

• Art. 8(j) of the CBD uses the term “knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity”;

• para. 9 of the Bonn Guidelines refers to “traditional knowledge, innovations and practices associated with genetic resources”

• Art. 9.2(a) of the FAO-IT uses the term “traditional knowledge relevant to PGRFA


Traditional knowledge

• Traditional knowledge used herein is used in a strict manner, i.e., TCE’s (Traditional Cultural Expressions) are excluded

• It aims even more specifically at scientific medicinal knowledge and biodiversity


+ Access to genetic resources, Art. 15 CBD:

• “1. Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation.

• 2. Each Contracting Party shall endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention.

• 3. For the purpose of this Convention, the genetic resources being provided by a Contracting Party, as referred to in this Article and Articles 16 and 19, are only those that are provided by Contracting Parties that are countries of origin of such resources or by the Parties that have acquired the genetic resources in accordance with this Convention.

• 4. Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article.

• 5. Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.


Art. 15 CBD contd:• 6. Each Contracting Party shall endeavour to develop and carry out scientific

research based on genetic resources provided by other Contracting Parties with the full participation of, and where possible in, such Contracting Parties.

• 7. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, and in accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by Articles 20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms.”

• Issues:• Access to genetic resources• Use of genetic resources• Prior informed consent as a condition for access • Benefit sharing in case of access to genetic resources


+ CBD recognizes importance of IPRs• Art. 16(5) CBD: “The Contracting Parties, recognizing

that patents and other intellectual property rights may have an influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive of and do not run counter to its objectives.”

• Art. 16(2): “[…] In the case of technology subject to patents and other intellectual property rights, such access and transfer shall be provided on terms which recognize and are consistent with the adequate and effective protection of intellectual property rights. The application of this paragraph shall be consistent with paragraphs 3, 4 and 5 below.”


INTERNATIONAL REGIME ON ACCESS AND BENEFIT-SHARING (COP Decision VIII/4)

• Access to genetic resources [and derivatives and products] • 1. [States have sovereign rights over their own genetic resources, and the authority to

determine access rests with national Governments and is subject to national legislation.] • 2. [[Subject to national legislation,] conditions for access to genetic resources [derivatives

and products] shall be [dependent upon] [related to] benefit sharing arrangements]. • 3. Access procedures shall be clear, simple and transparent and provide legal certainty to

different kinds of users and providers of genetic resources with a view to the effective implementation of Article 15, [paragraph 2], of the Convention on Biological Diversity.

• 4. [Parties] [Countries of origin] providing genetic resources, [derivatives and products][, including countries of origin,] in accordance with Article 2 and Article 15 of the Convention [may] [shall] establish measures requiring that access to such genetic resources [derivatives and products] [for specific uses] shall be subject to prior informed consent.

• 5. [Parties that are not countries of origin of genetic resources or their derivatives they hold shall not give access to those genetic resources without the prior informed consent of the countries of origin of those genetic resources.]

• 6. [Where the countries of origin of genetic resources or derivatives can not be identified, the Parties in whose territories those genetic resources or derivatives are found will grant access to users on behalf of the international community.]

• 7. Mutually agreed terms for access to and specific uses of genetic resources [or derivatives], in accordance with Article 15, paragraph 4 of the Convention on Biological Diversity[, may include conditions for transfer of such genetic resources [or derivatives] to third parties, subject to national legislation of countries of origin].


INTERNATIONAL REGIME ON ACCESS

AND BENEFIT-SHARING • [Recognition and protection of] traditional knowledge associated with genetic

resources [derivatives and products] • The elements of the international regime should be developed and implemented in

accordance with Article 8(j) of the Convention on Biological Diversity:• (a) [Parties may consider developing, adopting and/or recognizing, as

appropriate, [international,] national and local sui generis [models] [systems] for the protection of traditional knowledge, innovations and practices associated to genetic resources, [derivatives and products;]]

• (b) [Subject to its national legislation,] Parties [should] [recognize and protect the rights] [respect, preserve and maintain knowledge, innovations and practices] of indigenous and local communities and [ensure] [encourage] the equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices [regarding benefit-sharing derived from their traditional knowledge associated with genetic resources, [derivatives and products,] subject to the national legislation of the countries where these communities are located [and to applicable international law];

• (c) [[Users [Parties] should comply with the prior informed consent of indigenous and local communities holding traditional knowledge associated with genetic resources, [derivatives and products] in accordance with Article 8(j) of the Convention on Biological Diversity, subject to national legislation of the country where these communities are located [and to applicable international law]].

• (d) [Access and benefit sharing arrangements relating to traditional knowledge should be implemented in the context of national access and benefit-sharing regimes.]


INTERNATIONAL REGIME ON ACCESS AND BENEFIT-SHARING

• Fair and equitable benefit‑sharing• 1. [Minimum conditions for the fair and equitable sharing of the

benefits arising out of the use of genetic resources, derivatives or products shall be stipulated in relevant national [access] legislations [or] [and] under the international regime] and [shall] [may] be taken into consideration in mutually agreed terms [shall] [may] be based on prior informed consent between the provider and user of given resources.]

• 2. [Mutually agreed terms conditions may stipulate benefit‑sharing arrangements regarding derivatives and products of genetic resources.]

• 3. The conditions for the sharing of the benefits arising out of the use of traditional knowledge, innovations or practices and associated [with] genetic resources [derivatives and products] [will] [may] be stipulated in mutually agreed terms [between users and the competent national authority of the provider country with active involvement of concerned indigenous and local communities] [between the indigenous or local communities and the users, and where appropriate with the involvement of the provider country].

• 4. [Mutually agreed terms may contain provisions on whether intellectual property rights may be sought and if so under what conditions.]



• 5. Mutually agreed terms may stipulate monetary and/or non-monetary conditions for the use of genetic resources, [their derivatives and/or products] and associated traditional knowledge, innovations and practices.

• 6. [The international regime should establish basic benefit-sharing [obligations] [conditions], including the distribution of benefits through the financial mechanism, to be applicable in the absence of specific provisions in access arrangements.]

• 7. [Where the country of origin of the genetic resources or derivatives accessed cannot be identified, the monetary benefits there from shall accrue to the financial mechanism and the non-monetary benefits shall be made available to those Parties that need them.]

• 8. [Parties should establish, taking into account Article 20, paragraph 4 of the Convention, measures to ensure the fair and equitable sharing of benefits from the results of research and development, including through facilitating access to the results of such research and development and through technology transfer, and other utilization of genetic resources, [derivatives and products] and associated traditional knowledge, taking into account prior informed consent and mutually agreed terms and respecting national legislations of the country providing genetic resources.]



• 9. [Parties that develop technologies making use of genetic resources, derivatives and product should establish national legislation to facilitate access to and transfer of those technologies to developing countries that are the origin of such resources under mutually agreed terms.]

• 10. [Clarification of the actual nature of benefit sharing, emphasizing the need for differentiation of commercial versus non-commercial uses of genetic resources with resulting differentiated obligations/expectations.]

• 11. [Practical and enforceable benefit sharing clauses in material transfer agreements as agreed to between the providers and the users.]

• 12. [Benefits should be directed in such a way as to promote conservation and sustainable use of biological diversity [in countries of origin of genetic resources.]]

• 13. [Benefit-sharing arrangements should not be limited to mutually agreed terms when these arrangements are supporting prior informed consent.]

• 14. [Disclosure [of [legal provenance] [origin] [prior informed consent and benefit-sharing].



• 15. Intellectual property rights applications whose subject matter [concerns or makes use of] [is directly based on] genetic resources [and/or derivatives and products] and/or associated traditional knowledge should disclose the country of origin or source of such genetic resources, [derivatives and products] or associated traditional knowledge[, as well as evidence that provisions regarding prior informed consent and benefit sharing have been complied with, in accordance with the national legislation of the country providing the resources].

• 16. [National legislation shall provide for remedies to sanction lack of compliance with the requirements set out in the above paragraph which must include inter alia revocation of the intellectual property rights in question, as well as co-ownership of the IPR and its transfer.]

• 17. [If the disclosed information is incorrect or incomplete, effective, proportionate and dissuasive sanctions should be envisaged outside the field of patent law.]]


+ Relevant provisions of TRIPs relating to biodiversity:

• Main objectives of TRIPs: to set minimum standards of intellectual property protection within WTO Members and to ensure that states make available to rights holders judicial and/or administrative procedures to enforce their intellectual property rights.

• The main objectives of TRIPs are set out in Art. 7:• “The protection and enforcement of intellectual property rights should

contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”

• Art. 8(1) TRIPs states: • “1. Members may, in formulating or amending their laws and regulations,

adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.”


TRIPs contd.• Art. 27 TRIPs defines what is protectable subject matter under the

patent regime: – “1. Subject to the provisions of paragraphs 2 and 3, patents shall be

available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.5 Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

– 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protec thuman, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.


Art. 27 TRIPs contd.

• 3. Members may also exclude from patentability:– (a) diagnostic, therapeutic and surgical methods for the

treatment of humans or animals;– (b) plants and animals other than micro-organisms, and

essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”


Aim of linking IP with TK + BD

• Is aim to protect TK + BD from commercial exploitation, then interfering in IP systems is not the solution

• Is aim not to protect TK + BD from commercial exploitation, but to ensure benefit sharing, then it is difficult to see how the IP system could provide a solution



• When would interfering in IP systems be a solution?– When originator countries would themselves

be capable of exploiting the resources and innovations based thereupon

• Hence, proposed solutions in IP system are far from efficient solution



• One has to consider whether the balance between interfering in the IP systems and the goal to provide reward for originator countries justifies the drastic solutions presented today

• Or is there a more fundamental hidden agenda present (see later)



• There is a missing analytical link between the desire to provide reward to originator countries for the use of their genetic resources and the solution to achieve that desire by interfering in IP systems

• What is even more, solutions presented interfering in IP systems will never really work and will never achieve the states objectives

• Will lead to further frustration in developing countries



• Also the ECJ has problems in understanding the link between IP and CBD or benefit sharing for that matter


- ECJ 377/98:

• 65. It cannot be assumed, in the absence of evidence, which is lacking in this case, that the mere protection of biotechnological inventions by patent would result, as is argued, in depriving developing countries of the ability to monitor their biological resources and to make use of their traditional knowledge, any more than it would result in promoting single-crop farming or in discouraging national and international efforts to preserve biodiversity.

• 66. Moreover, while Article 1 of the CBD states that its objective is the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, it specifies that this must be done taking into account all rights over those resources and technologies. There is no provision of the CBD which requires that the conditions for the grant of a patent for biotechnological inventions should include the consideration of the interests of the country from which the genetic resource originates or the existence of measures for transferring technology.


- ECJ 377/98 (2):

• 67. Finally, as regards the possibility that the Directive might represent an obstacle in the context of the international cooperation necessary to achieve the objectives of the CBD, it should be borne in mind that, under Article 1(2) of the Directive, the Member States are required to apply it in accordance with the obligations they have undertaken as regards inter alia biological diversity.”


Why focus on patent system?

• In the discussion regarding benefit sharing and IP, literature focuses predominantly on patent law, even though there is no reason to assume that the desired intervention should be limited to patent law

• Why is UPOV system not a target?• Would be suggested solutions be in conformity

with the UPOV system?


Why focus on patent system?

• Observe that Art. 15(7) CBD does not refer to any particular IP right, but refers in general to “with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources.”

• Reference to commercial utilization of genetic resources: may cover patents, plant variety rights, trademarks?, indication of geographical origin? Etc.

• Why is all attention now focussed on patents?


Disclosure of biological origin in patent applications

• What is it?

• It pertains to a disclosure of the biological origin of the genetic resource which has been used at the occasion of an invention for which a patent application has been filed



• How should it work?

• The idea would be that the patent applicant should disclose in the patent application the origin of the biological material/genetic resource used

• Whether this should be a substantive or formal requirement is under debate



• What should it achieve?• By disclosing the origin of the biological

material used in the invention, benefit sharing systems in place could be triggered to apply the system to the specific biological material

• The disclosure requirement will facilitate identification of the genetic resource used, the origin of that resource and the identification of the user of that genetic resource


Solutions in international, regional and national patent systems


• Various national countries have introduced in varying shape, directly or indirectly disclosure requirements:– BE, DE, CH– NL by referring to CBD– India, Brazil, China etc


EU

• Recital 27 Biotech directive 98/44/EC:– (27) Whereas if an invention is based on

biological material of plant or animal origin or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, if known; whereas this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents


Initiatives taken by EC• Communication from the Commission to the European

Parliament and the Council, The Implementation by the EC of the "Bonn Guidelines" on Access to Genetic Resources and Benefit-Sharing Under the Convention on Biological Diversity, COM (2003) 821 final (Dec. 23, 2003):

• “Thus the Commission believes that there should be a debate over the possible unilateral development, under EC law, of a self-standing obligation for patent applicants to disclose the origin of genetic resources, along the line of what has been proposed in the abovementioned Communication to the TRIPs Council. Therefore, the information to be provided by patent applicants would be limited to information on the geographic origin of genetic resources or TK used in the invention which they know or have reason to know. When the country of origin is not known, the patent applicants' obligation would be to indicate the research centre, gene bank or entity from which they acquired the resources.


Initiatives taken by EC• Such a disclosure requirement could not be retroactive

and could not act, de facto or de jure, as an additional formal or substantial patentability criterion. Legal consequences of the non-respect of the requirement would need to lie outside the ambit of patent law, such as for example in civil law (claims for compensation) or in administrative law (fee for refusal to submit information to the authorities or for submitting wrong information). Furthermore, the Commission intends to also look into the feasibility of a similar disclosure requirement in the context of plant variety rights.”


Swiss proposal PCT Reform• Policy objective of the disclosure requirement proposed by

Switzerland is to increase transparency in the context of access to genetic resources and traditional knowledge and the sharing of the benefits arising out of their utilization, in particular with regard to the obligations of the users of genetic resources and traditional knowledge.

• Increased transparency will allow the providers of genetic resources and traditional knowledge to verify whether the inventor and/or patent applicant complied with the applicable rules and procedures on access to these resources or this knowledge, and whether provision for benefit sharing has been made.


Swiss proposal PCT Reform (2)• The disclosure requirement is examined for the

purposes of determining if a complete patent application has been filed. The disclosure requirement is in the view of Switzerland linked neither to the search, examination or grant of patents, nor to the evaluation of the claims for patentability.

• Accordingly, it has to be considered as a formal requirement, not a formal requirement strongly linked to substance or even a substantive requirement.


Swiss proposal PCT Reform (3)

• By being included in the international publication, the declaration of the source would be publicly accessible, and would thus increase transparency in the context of access and benefit sharing at the global level, without it being necessary that it is mandatory for the Contracting Parties of the PCT to require patent applicants to declare the source.


Text of proposal• New subpara. (g) of Rule 51bis.1:• “(g) The national law applicable by the designated Office may, in

accordance with Article 27, require the applicant• (i) to declare the source of a specific genetic resource to which

the inventor has had access, if an invention is directly based on such a resource; if such source is unknown, this shall be declared accordingly;

• (ii) to declare the source of knowledge, innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity, if the inventor knows that an invention is directly based on such knowledge, innovations and practices; if such source is unknown, this shall be declared accordingly.”

• New subpara. (vi) of Rule 4.17:• “(vi) a declaration as to the source of a specific genetic resource

and/or knowledge, innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity, as referred to in Rule 51bis.1(g).”


Swiss proposal PCT Reform

• The term “source” should be understood in its broadest sense possible. This is because according to the CBD, the Bonn Guidelines and the International Treaty of FAO, a multitude of entities may be involved in access and benefit sharing.

• In the foreground to be declared as the source is the entity competent (1) to grant access to genetic resources and/or traditional knowledge or (2) to participate in the sharing of the benefits arising out of their utilization.


Swiss proposal PCT Reform• With regard to genetic resources, the proposed new Rule

51bis.1(g)(i) makes clear (1) that the invention must make immediate use of the genetic resource, that is, depend on the specific properties of this resource, and (2) that the inventor must have had physical access to this resource, that is, its possession or at least contact which is sufficient enough to identify the properties of the genetic resource relevant for the invention.

• With regard to traditional knowledge, the proposed new Rule 51bis.1(g)(ii) makes clear that the inventor must know that the invention is directly based on such knowledge, that is, the inventor must consciously derive the invention from this knowledge


TRIPs


Proposed Art. 29bis TRIPs• Initiative sponsored by Brazil, China, Colombia, Cuba, India,

Pakistan, Peru, Thailand and Tanzania:• Disclosure of Origin of Biological Resources and/or Associated

Traditional Knowledge• 1. For the purposes of establishing a mutually supportive

relationship between this Agreement and the Convention on Biological Diversity, in implementing their obligations, Members shall have regard to the objectives and principles of this Agreement and the objectives of the Convention on Biological Diversity.

• 2. Where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated traditional knowledge, Members shall require applicants to disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin. Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing arising from the commercial or other utilization of such resources and/or associated traditional knowledge.


Proposed Art. 29bis TRIPs• 3. Members shall require applicants or patentees to

supplement and to correct the information including evidence provided under paragraph 2 of this Article in light of new information of which they become aware.

• 4. Members shall publish the information disclosed in accordance with paragraphs 2 and 3 of this Article jointly with the application or grant, whichever is made first. Where an applicant or patentee provides further information required under paragraph 3 after publication, the additional information shall also be published without undue delay.

• 5. Members shall put in place effective enforcement procedures so as to ensure compliance with the obligations set out in paragraphs 2 and 3 of this Article. In particular, Members shall ensure that administrative and/or judicial authorities have the authority to prevent the further processing of an application or the grant of a patent and to revoke, subject to the provisions of Article 32 of this Agreement, or render unenforceable a patent when the applicant has, knowingly or with reasonable grounds to know, failed to comply with the obligations in paragraphs 2 and 3 of this Article or provided false or fraudulent information.


SPLT


Grounds for refusal

• Art. 13(4) SPLT: “[(4) [Compliance With Applicable Law on Other Matters] A Contracting Party may also require compliance with the applicable law on public health, nutrition, ethics in scientific research, environment, access to genetic resources, protection of traditional knowledge and other areas of public interest in sectors of vital importance for their social, economic and technological development.]”


Grounds for invalidation or revocation

• Art. 14(3) SPLT: “[(3) [Compliance With Applicable Law on Other Matters] A Contracting Party may also require compliance with the applicable law on public health, nutrition, ethics in scientific research, environment, access to genetic resources, protection of traditional knowledge and other areas of public interest in sectors of vital importance for their social, economic and technological development.]”


Refusal and invalidation

• Accepting Art. 13 and 14 would imply signing another blank check

• Such provisions block any attempt to arrive at a consensus


The debate

• Many opponents of the patent system use the biodiversity debate to gain strength and support

• Some of the patents granted may very well be invalid for lack of novelty or at least inventive step

• The relationship between a genetic resource and a patent is in many cases very remote


Why a disclosure requirement?

• Let us go back one step to determine why a disclosure requirement would be necessary

• The official line of reasoning is that it would facilitate and be a necessary step to arrive at benefit sharing of the profits derived from patents obtained with the aid of the genetic resources used, which is the end goal

• A subsequent dogma is then that there is a need to devise a benefit sharing system which is based upon the patent system

• Can these positions be upheld?


Benefit sharing/disclosureRationale

• As said, a benefit sharing system should remedy the injustice committed by collecting genetic resources without giving any reward for their use

• The reasoning further goes that patentees having used genetic resources in their inventions should share the benefits of these inventions



• There are thus two fundamental questions to be answered here:

• Should there be a reward system in place for the “benefits” reaped from patents obtained with the use of genetic resources(whether question)?

• And if the first question is answered in the affirmative, how should this take place (how question)?



• If one accepts that there should be some sharing of benefits between the patent holder and the originator of the genetic resource, one starts from the premise that there is a link between the genetic resource and the patented invention


Link between benefit sharing and patent protection

• There is currently in the patent system no provision which foresees a reward system

• The suggestion is not to incorporate the benefit sharing system directly into the patent system, but to introduce a disclosure requirement, which would then trigger the benefit sharing system, as the user and originator would then be known



• In effect, even though not directly, this would amount to granting rights to the originator of the genetic resource, without such right being patent rights– A derived economic right

• Introducing such a concept would mean a revolution in the patent system



• The patent system only rewards that person who has contributed significantly to the coming into being of the invention

• Only those who have made an inventive contribution to the invention have the right to be mentioned as co-inventor

• A benefit sharing system and the derived disclosure system would undermine one of the most fundamental principles of the patent system, and would grant economic benefits to parties who have made no inventive contribution to the invention



• The concept further starts from the premise that there is a direct link between the patented invention and the genetic resource

• Reality is that it is often very difficult to establish such a link:– In many cases very remote link– Vast research activity has been performed in order to

come to the invention– What is the contribution of the originator to the

invention, apart from the fact the invention would not have been made without the origin


Whether• Accepting that the mere fact that the invention could not have been

made without access to the original genetic resource may create another far-reaching and possibly undesired precedent

• It would encourage reach-through effects:– It is currently accepted in patent law that the patent holder for a

research tool patent cannot extend protection to a further down-stream product

• Allowing the originator of the genetic resource to benefit in some way from the invention might open the gate to reach-through effects -> not desired

• All inventions in biological material must have at some point an origin, they are not developed in a vacuum

• Granting economic rights to the starting material without any inventive activity is unprecedented in patent law, and it is yet to be seen what influence such concept might have on innovation


What is a reach-through claim?• Reach-through claims seek to protect things which have

not yet been discovered by an inventor, but which might be discovered in the future by making use of their invention.

• If the inventor of an upstream invention files a patent application for the upstream invention and attempts to claim downstream inventions which they have not as yet actually made, then the claims to those downstream inventions are referred to as "reach-through" claims.

• The “reach-through” products are identified only by reference to the material or assay used to find or identify them, but they are not described specifically


Reach-through examples

• Small molecule per se claim, where the molecule is only defined as binding to target • “A receptor X agonist.”

• “Functional use” claim• claim is to a method of treating a disease by a

compound defined not by its structure, but by its ability to bind a target

• “A method of treating disease Y by administering a compound which is an enzyme X agonist.” (US style) or in EP as second medical indication type claim

• (agonist: a substance that binds to a specific receptor and triggers a response in the cell)


Reach-through examples• The classic structure of the claims in a reach-

through patent is the following:• 1. Receptor X useful to the treatment of disease Y• 2. Method for identifying an agonist of the receptor

X comprising the following steps:Reach through:• “Agonist of the receptor X identified with the

method subject-matter of claim 2”.• “Use of a receptor agonist for the manufacture of a

medicament for inhibiting disease Y, wherein said receptor agonist is identified by the method of claim ….”


Patentability of Reach-Through Claims

• Reach-through claims normally fail to meet at least one and often several of the patentability criteria i.a. written description, enablement, utility, novelty, or non-obviousness, etc…

• Reach-through is generally accepted to be undesirable, as it would allow patent holders to claim what they have not invented (to reap where they have not sown)


Reach-through and benefit-sharing

• There is thus some inconsistency in the reasoning:– With a view to provide a remedy for the originator of

the invention, rights will be given to the originator which extend beyond what is acceptable under patent law

– It is also to be noted that some of the proponents of the benefit sharing/disclosure system are equally heavy opponents against reach-through effect of patents



• In the US Moore case, claiming rights in removed cancer tissue, on the basis of which an invention has been made and a patent filed, has also been refused



• If rights are granted to originator, what will be the consequences?– Even though the rights granted under a benefit

sharing/disclosure system will not be patent rights but derived economic rights based upon patent applications filed, such a system would generate indirectly reach-through effects, as the originator would reap benefits for all inventions and applications made with the used genetic resource

– As said, reach-through effects are realistic– Concentrates also (too) much strategic power in the

hands of the originator


How

• Another question is how to reward the originator

• Heavily stimulated concept is benefit-sharing

• But what is benefit sharing?– Is it an access fee?– Is it a sharing in the profits of the patent filed

on the basis of the genetic resource?


Benefit-sharing: objective

• The benefit-sharing requirement has as an objective to help stakeholders monitor compliance with legal or contractual obligation to share benefits derived from the commercial use of genetic resources and/or associated traditional knwoledge


Benefit-sharing and disclosure requirement

• The benefit sharing goal will be achieved by means of introducing a disclosure requirement

• Question is however whether linking patent protection to benefit sharing is justified and the appropriate solution



• It is not a proper solution because:– It is based on a misconception of the patent

system– It starts from the premise that all patents

generate profits, quod non– It starts from the premise that there is a direct

link between the genetic resource and the patented invention, quod non



• Does a disclosure requirement promote benefit-sharing?

• It generates information about the use of genetic resources

• As many inventions will never generate any financial revenue, difficult to see how it an promote benefit sharing.



• All systems, whether they are based on disclosure requirement, benefit sharing based on patents etc., which link the entitlement to economic benefits to the existence of patent rights are bound to fail and not to achieve the desired goal


More fundamental underlying strategies

• In view of the above, one may wonder whether there is not a more fundamental goal which some proponents of a benefit-sharing/disclosure of biological origin system want to achieve

• I.e., a fundamental overhaul of the present patent system, if any patent system is to remain at all


More fundamental underlying strategies

• Such a route is adventurous and not without risk, and one should think twice whether this is a desirable route to take

• Also international organisations supporting such initiatives should ask themselves whether the such a route is desirable


Alternative models

• Reichman & Lewis: owners of genetic resources are granted for a limited period the following rights– 1) to prevent second comers from entering TK

owners’ product market with a wholly unoriginal imitation of their product;

– 2) to reasonable compensation from follow-on innovators who make improvements upon the scientific knowledge of the TK owners;

– 3) to make use of second comers’ own technical improvements for purposes of further improving the TK owners’ original products


Critique

• Also the alternative model gives reach-through rights:– E.g., reasonable compensation from follow-on

innovators for innovations made upon the TK scientific knowledge (very similar to traditional benefit-sharing systems)

– Gives even further-reaching rights to TK owners, as they also obtain the right to use second comers’ own technical improvements (i.e., entitles TK owners to use without compensation innovations made by third parties based on the simple fact that at some point the TK owner has provided genetic resource to innovator on the basis of which an invention has been made)


Critique

• Even though the authors admit that TK is sub-protectable, nevertheless, far-reaching user rights are given to TK owners, even without any inventive contribution made to such inventions


Conclusion• There is very little one can have against a reward system for the use

of genetic resources• Such reward system should be linked to a PIC system• Linking reward to IP protection is not only far from sub-optimal, but

also presents precedent with far-reaching consequences which are probably not thought through yet

• Linking IP and benefit sharing is understandable from a political point of view, and has some appeal as being just and justified

• Solutions proposed to link both will not come to the benefit of TK owners

• Link is based on unrealistic assumptions and lack of understanding of how the patent system functions

• Pursuing the link with substantive sanctions and consequences will never work in some parts of the world

• One has to ask the question whether striving for benefit sharing systems linked to IP protection will not lead in the end to even more frustration as the remedy is unlikely to solve the underlying needs and expectations


Thank you!

Date post:	25-Dec-2015
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Genetic Resources and IP protection A weak legal basis for a good cause Conference Torino 8 October...

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