Explanatory Memorandum to COM(2024)3 - Authorisation of the opening of negotiations on an international legal instrument relating to intellectual property, genetic resources and traditional knowledge associated with genetic resources - Main contents
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| dossier | COM(2024)3 - Authorisation of the opening of negotiations on an international legal instrument relating to intellectual property, genetic ... |
|---|---|
| source | COM(2024)3 |
| date | 09-01-2024 |
In their 2002 C om munication to the Trade -Rel ated aspects of Intellectual Prop erty R i g h ts Council (TRIPS Council) , the European Union (EU) and its M ember States agreed to discuss the introduction of a self_standing disclosure requirement allowing M ember States to keep track of patent applications with regard to genetic resources. In 2004 the Wo rid Intellectual Property Organisation (WIPO) G e n e r a I Ass e mbly agreed, at the suggestion of the Conference of the Parties to the Convention on Biological Diversity to consider the relationship between access to genetic resources and disclosure requirements in intellectual prope rty r i g h ts applications.
Out of this arose WIPO discussions on the disclosure of the origin or source of genetic resources and associated traditional knowledge in patent applications. Those discussions aim atestablishing an international disclosure requirement that patent applications for an invention based on genetic resources disclose the country of origin or the source of the genetic resources in question, and where applicable, of the traditional knowledge associated to them.
In 2022, the WIPO G e n e ra I Ass e mbly agreed to hold a diplomatic conference no later than 2024 to conclude an international legal instrument relating to intellectual prop erty, g e n et i c resources and traditional knowledge associated with genetic resources (genetic resources (G R) instrument). To prepare for this, a Special Session of the Intergovernmental Committee on Intellectual Prope rty and Genetic Resources, Traditional Knowledge and Folklore took place on 4 to 8 S e pte m b e r 2023. T he revised text from this session was transmitted to the Preparatory Committee. of the Diplomatic Conference which took place on 11 to 13 September 2023. The P reparatory uom mittee approved the dra ft administrative provisions and final clauses of the basic proposal, the list of invitees and the dra ft rules of procedure of the LJiplomatic uonference, The Preparatory Committee's meeting was adjourned to be reconvened at a future date to consider the dra ft agenda and the dates of and venue for the Diplomatic Conference.
The P reparatory Vvommittee decided to invite the EU to the LJiplomatic L/onference as a Special Delegation.
Contents
- 2. LEGAL ELEMENTSOFTHE RECOMMENDATION
- property, genetic resources and traditional knowledge associated with genetic
- Union comp
- contains such relevant information as is available to the applicant on the characteristics of the biological material deposited ,(iii) recital 27 stati n g that
- including recital 27 in D i re cti v e 98/44/EC points to the legislator's intention that the
- COUNCIL DECISION
- Having regard to the recommendation from the European Cor
- The negotiating directives are set out in the Annex to this D
# The basic proposal on an international legal instrument relating to intellectual
resou rces
(GR instru ment
The aim of establishing an international GR instrument is to improve the efficacy, transparency and quali ty of t h e pa rts of the patent system that deal with genetic resources and the traditional knowledge associated with them, and to prevent patents from being erroneously granted for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge associated with them.
Communication by the EC and its M ember States to the TRIPs Co uncil on the review of Article 27.3(b) of the TRIPs Ag reement, and the relationship between the TRIPs Ag reement and the Convention on Biological Diversity and the protection of traditional knowledge and folklore.
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The scope of the GR instrument, as the basic proposal states, is limited to patents. Mowever, the basic proposal includes a review clause covering a possible extension of the disclosure re q u i re m e nt to other areas of intellectual property (Article 9).
The content of the basic proposal can be divided into (i) substantive provisions and (ii) administrative provisions and final clauses.
As regards the substantive provisions, the key element is the mandatory disclosure requirement contained in Art i cle 3. The basic proposal also foresees sanctions and remedies that would apply in case the disclosure requirement is not respected. In this regard, Art i cle 6 of the basic proposal allows for different measures to be put in place by contracting parties. Other provisions of the basic proposal contain a list of the terms used in the instrument (Arti cle 2), exceptions and limitations to the obligation to disclose (Article 4), a n o n " retroactivi ty clause (Arti cle 5), the establishment of information systems (Arti cle 7), or the relationship this instrument should have with other international agreements (Article 8).
The administrative provisions and final clauses contain the general principles of i m plementation (Article 10), as well as the institutional framework that will govern the instrument, the Ass e mbly, where contracting parties will be represented and that shall deal with all matters concerning the maintenance and development of the instrument, among other tasks, (Article 11), and the International Bureau of WIPO, who shall perform the administrativetasks concerning this instrument (Arti cle 12).
Furthermore, administrative provisions and final clauses provide for rules on the eligibility to become a party (Article 13), the ratification and accession of the instrument (Article 14), the revision and amendments (Articles 15 and 16), the signature (Article 1V), the entry into force (Article 18), the effective date to become a party (article 19), the denunciation (Article 20), the reservations (Article 21), the languages (Article 22) and the depositary (Article 23).
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the m ati c
W ithout prejudice to the final assessment of the nature of the EU's competence once
negotiating parties have agreed on the text of the GR Instrument at the Uiplo Conference, a preliminary assessment on the nature of Union competence must be done before negotiations. In this regard, Arti cles 3(1) and 3(2) of the T r e aty on the Functioning of
the Luropean Union (TFEU) aP ply when deciding on EU's competence ciS far as the GR
instrument is concerned.
Under Article 3(1) TFEU, the EU has exclusive competence on matters pertaining to the common commercial policy. International intellectual prope rty commitments can be considered part of the common commercial policy provided they have a specific link to international trade in that they are (i) essentially intended to promote, facilitate or govern international trade and (ii) have directand immediate effects on it. To assess if this is the case, it is necessary to considerthe GR instrument's purpose and content.
The GR in st ru ment has tw o main aims. \ \) to enhance efficacy, transparency, and q u a I i ty of the patent system and (ii) to prevent patents from being erroneously granted. These objectives are intended to further promote and facilitate fair and transparent commercial transactions. This is buttressed by recital 4 of the proposal stating that the disclosure obligation at the heart of the GR instrument contributes to legal c e rta i n ty and consistency, and therefore benefits the patent system. Furthermore, applying uniform standards in this area, by introducing a common disclosure requirement, contributes to the participation of economic operators in
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international trade on an equal footing. From all this, it could be under stood that the aim of th e GR in st ru ment is to improve the efficacy, transparency, consistency and legal c e rta i n ty of the patent system, thereby promoting, facilitating and governing international trade. The current state ~ of ~ p I a y must also be taken into account, as well as possible developments in this area. lo this end, the GR instrument includes a review clause that could extend the instalment s s cope to other areas of intellectual property law, which would have further effects on international trade.
Furthermore, it should be assessed whether the GR instrument S key provisions could be regarded as affecting patent protection so much that it would have direct and immediate effects on international trade. In this context, the requirement to disclose the origin of genetic resources in Article 3 of the GR instrument applies to the patent granting procedure and will therefore affect the results of an assessment of compliance with the substantive patentabili ty criteria of novel ty and inventive step, which are provided for in Art i cle 27 of the Ag reement on Trade -Rel ated As p e cts of
Intellectual Property Rights ('the TRIPS Agreement'), in terms of the relevant prior
art to be considered. In this regard, the Court of Justice of the European Union has ruled that Article 27 of the TRIPS A greement falls within the field of the common commercial policy . r\ Iso relevant is that the current wording of Article 6.4 o n
sanctions and remedies appears to permit the imposition of pos t" grant sanctions in the case of noncompliance with the disclosure requirement under Article 3 due to fraudulent intent. These could include revoking a patent or rendering it unenforceable. This provision can be considered to establish new grounds for challenging the validity of a patent involving genetic resources, which could be used in patent disputes.
Under Artie,e 3(2) TFEU, the EU has exclusive competence to conclude an international agreement, as long as the agreement in question may affect common EU rules or alter their scope if the commitments concerned relate to an area already covered to a large extent by such rules (without the areas covered by the rules and those the commitments pertain to having to be identical^. r\n analysis done under Article 3(2) TFEU must take into account (i) the areas covered by the rules of EU law and the provisions of the envisaged agreement, \\'\) their foreseeable future development and (iii) their nature and content to determine if the agreement is likely to undermine the uniform and consistent application of EU rules and the proper functioning of the system resulting from them. I here are various pieces of EU p ate nt law, whose relevance to the GR instrument should be assessed, in particular, LJirective 98/44/EC on the legal protection of biotechnological inventions (the Directive 98/44/EC), Regulation (EU) No 1257/2012 implementing enhanced cooperation in the area of the unitary patent protection (the UP R egulationj, Kegulation (EC) No 1610/96 of the Luropean Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, Kegulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products and Kegulation (EU) 2019/933 of the Luropean Parliament and of the Council of 20 May 2019 amending Kegulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (the SPC Regulations).
- As regards Directive 98/44/EC, the relevant provisions concerned by the GR
Instrument are. (i) Article 2(1) stati n g that biological material means any material containing genetic information and capable of reproducing itself or being reproduced
Judgment of th e Co u rt o f 1 8 J u I y 2013, Danoh, Sankyo, CaSC C-414/11, E U \ C \ 201 3 \ 5 20.
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in a biological system, (ii) Art i cle 13, stating that where an invention involves the use of or concerns biological material that is not available to the public and which cannot be described in a patent application in such a way as to enable the invention to be reproduced by a person skilled in the art, the description shall be considered
inadequate for the purposes of patent law unless: ... (b) the application as med
contains such relevant information as is available to the applicant on the characteristics of the biological material deposited ,(iii) recital 27 stati n g that
'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 validi ty of r i g h ts
arising from granted patents.' Under the provisions of the Directive 98/44/EC, the
application as filed should provide the relevant information on the characteristics of the biological material deposited, which may include genetic resources. However, at present, omitting information on the geographical origin of said material does not make its description inadequate, nor does it otherwise prejudice the processing of applications or the validi ty of rights arising from granted patents. In this sense,
issue of disclosing geographical origin of biological material is to be covered by the Biotech Directive. Moreover, Article 13, read in conjunction with recital 27, implies that the disclosure of the geographical origin of biological material is not relevant for examining the sufficiency of disclosure of inventions, where the deposit system is used for describing such inventions. /As stated above, the GR instrument introduces, among other things, a requirement to disclose the origin of genetic resources in patent applications (Arti cle 3), as well as the possibili ty for the parties to impose sanctions and remedies if this requirement is not fulfilled (Article 6). F ro m th is, it is clear that the outcome of the GR instrument negotiation could affect the principles
set up in Uirecti ve 98/44/EC.
As regards the UP R egulation, the conditions for the validi ty of a unitary patent, which as an object of property is to be treated according to applicable national law (Arti cle 7 of the UP R egulation) will be affected by diverging national implementation of Article 6 of the GR instrument on post grant sanctions and remedies. I his would result in the conclusion of the GR instrument affecting such common rules for 25 M ember States under enhanced cooperation.
Regarding the SPC R egulations. Supplementary protection certificates (SPCs) are intellectual prope rty rights that make it possible to extend the patent protection of plant protection products and medicinal products subjectto a marketing authorisation requirement. It can be presumed that their validi ty will be affected by the GR
instrument's current wording, given the basic patent's revocation invalidates an SPC
(Arti cle 15 of th e SPC R egulations], I his means that any effects of the disclosure requirement on the validity of patents (in line with Article 6 of the GR i n str u ment will also affect an SPC. It is also importantto consider the foreseeable future of the SPC system, in particular given the four legislative proposals the Vvom mission presented on 27 Apri, 2023. T hese proposals will replace the existing the SPC Regulations by new ones, for medicinal products and plant protection products respectively. Each will include the current national procedure as well as a new centralised procedure for the granting of national SPCs, available where the basic patent is a European patent, and the product has a market authorisation. Two additional proposals relate to the creation of unitary SPCs for medicinal products and plant protection products respectively.
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Lastly, it is also i m portant to consider the possible developments this area. I he IjK instrument includes a review clause that could result in its application being extended to other areas of intellectual prope rty law, such as copyright and plant vari ety rights. In that respect, it will further affect EU law.
It results from the above that the GR instrument falls within the EU's exclusive competence under Articles 3(1 ) and 3(2) of the TFEU.
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Reco m mendation for a
authorising the opening of negotiations on an international legal instrument relating to intellectual property, genetic resources and traditional knowledge associated with
genetic resources
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Artie,e 218(3) and (4) thereof,
> m m i ss ion,
i e r e a s .
(1 ) In their 2002 Communication to the Trade -Rel ated aspects of Intellectual Prope rty
Rights Council (TRIPS Council), the E uropean Union and its M ember States agreed to discuss the introduction of a self_standing disclosure requirement allowing M ember States to keep track of patent applications with regard to genetic resources,
In 2004 the Wo r Id Intellectual Prope rty Organisation (WIPO) general assembly agreed, at the suggestion of the Conference of the Parties to the Convention on Biological Divers i ty to consider the relationship b etw een access to genetic resources and disclosure requirements in intellectual property rights applications,
Since 2004 WIPO has held discussions on the disclosure of the origin or source of genetic resources and associated traditional knowledge in patent applications,
WIPO general assembly decided to convene a diplomatic conference to conclude an international legal instrument relating to intellectual prope rty, genetic resources and traditional knowledge associated with genetic resources to be held no later than 2024,
The E uropean Union should participate in the negotiations on such international i n str u ment,
HAS ADOPTED THIS DECISION:
Article 1
The Commission is hereby authorised to open the negotiation for an international legal instrument relating to intellectual prope rty, genetic resources and traditional knowledge associated with genetic resources in the context of the Wo rid Intellectual Prope rty Organization on behalf of the Union, in consultation with the Intellectual Prope rty Wo r k i n g Party (the special committee).
Article 2
e c i s i o n .
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Article 3
This Decis ion is addressed to the Vvom mission. Done at Brussels,
Fa r the Co unci/ Th e President
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