Answer of the Danish Group

Transcription

1 Questionnaire July 2006 Special Committee Q166 Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore On the Requirement of indicating the source and/or country of origin of genetic resources and traditional knowledge in patent applications Answer of the Danish Group by Ejvind CHRISTIANSEN, Bo HAMMER JENSEN, Torsten NØRGAARD etc. Question 1: Is there a legal requirement in your country that the source and/or country of origin of genetic resources and/or traditional knowledge must be indicated in patent applications for inventions based on such genetic resources or traditional knowledge? Answer 1: Yes If yes, please quote the corresponding text from the law/regulations and reply to the following questions, if applicable: Question 1a) Are these regulations found in patent law, general IP laws or in legislation implementing the Convention on Biological Diversity? Answer 1a: Yes, the Implementing Regulations for the Danish Patent Law comprises in 3. 4: If an invention relates to or uses a biological material originating from plants or animals the patent application must comprise information about the geographical origin of the material if the patent applicant has knowledge thereof. If the applicant does not have such knowledge of the geographical origin of the material this must be disclosed in the patent application. Lack of information concerning the geographical origin or the lack of 1

2 knowledge about this does not have any effect on the prosecution of the application or the validity of any of the rights attached to the issued patent. Stk. 4. Hvis en opfindelse angår eller anvender et biologisk materiale af vegetabilsk eller animalsk oprindelse, skal patentansøgningen indeholde oplysninger om materialets geografiske oprindelse, hvis patentansøger er bekendt hermed. Såfremt patentansøger ikke er bekendt med materialets geografiske oprindelse, skal dette fremgå af ansøgningen. Manglende oplysninger om materialets geografiske oprindelse eller om patentansøgers ukendskab herom berører ikke behandlingen af patentansøgningen eller gyldigheden af de rettigheder, som følger af det udstedte patent. Question 1b: Is it clear what the concept of source or country of origin and based on genetic resource/traditional knowledge means and what information must be included in the patent application? Answer 1b: No, the language is geographical origin. The regulation does not state that the name of a country must be indicated, but the general feeling is that this is the meaning, but then again it is not clear it it should be the country of origin as defined in the CBD or the source country meaning where the material was obtained. Question 1c: Are there ways to complement or amend the corresponding text in the patent application? Answer 1c: Yes, Question1d: Is disclosure of prior informed consent and/or agreements on sharing of benefits required? Answer 1d: No Question 1e: Are human genetic resources treated differently or the same way as animal or plant genetic resources falling under the CBD? Answer 1e: Differently. The Implementing Regulation states in 3.5 that: If an invention relates to or uses a biological material of human origin, the patent application must disclose if the person from whom the material originates has consented 2

3 to the filing of the application. The information abut consent does not have any effect on the prosecution of the application or the validity of any of the rights attached to the issued patent. Stk. 5. Hvis en opfindelse angår eller anvender et biologisk materiale af human oprindelse, skal det fremgå af patentansøgningen, om den person, hvorfra det biologiske materiale hidrører, har givet samtykke til ansøgningens indlevering. Oplysningen om samtykke berører ikke behandlingen af patentansøgningen eller gyldigheden af de rettigheder, som følger af det udstedte patent. Question 1f: Is traditional knowledge properly defined, and is the source of traditional knowledge to be indicated only if it is connected to genetic resources (e.g. falling under the CBD) or in general? Answer 1f: No. The Danish legislation does not comprise any issues of traditional knowledge. There is no requirement for the provision of information concerning traditional knowledge. Question 1g: Are sanctions foreseen for non-compliance (e.g. patent invalidation, patent transfer to the owner of the resource, fines, criminal sanctions etc.)? Answer 1g: No specific sanctions are indicated, but it is clear that a violation of the regulation will have no effect on the patentability of the invention or the validity of a patent. A violation of the regulation would be adjudicated under the rules of providing false information to a government administrative body, most likely resulting in a fine. Question 1h: Does the law make a difference depending on whether the genetic resource was obtained by the patent applicant (or by the person/organisation such as a botanical garden, ex situ collection or a collector company from which the patent applicant obtained the resource) before or after the CBD took effect in 1993 [this should be 1994, respondents remark]? Answer 1h: No. Question 2: Do you know of any project of law in your country dealing with the requirement of indicating the source and/or country of origin of genetic resources and/or traditional knowledge in patent applications for inventions based on such genetic resources or traditional knowledge? If yes please provide the corresponding text and review it for the additional questions a) to h) as under 1). Please include also links to websites which would allow to follow the progress on these projects of law. 3

4 Answer 2: No. Question 3: Is your Group of the opinion that the source and/or country of origin of genetic resources should be indicated in patent applications based on such genetic resources? Answer 3: No. The Danish group believes that this information is without relevance for the examination of the application in respect of (i) the patentability, (ii) the inventorship of, and (iii) the ownership of the rights to the disclosed invention. In spite of the opinion as expressed above, the Danish group would like to express its view in respect of the sub questions posed. If yes: Question 3a: Is it sufficient to indicate the source (e.g. the corresponding material was bought from company X, was obtained from the collection of genetic material Y, was collected in the botanical garden in town Z) or must the patent applicant determine and indicate the actual country of origin? Answer 3a: Yes. The Danish group sees no reason for forcing the applicant to make inquiries into the ancestry of the material. Such investigations may be costly and in some cases in vain and they may even result in false indications. The applicant will normally know (through records) where some biological material was obtained from, but even this may not be the situation since records may have been destroyed or they may be lacking or they may be false (intentional or non intentional). This applies for each level of ancestry for biological material and increases the uncertainty as to the correctness of the information obtained and submitted to the Patent authorities. Question 3b: If the patent applicant is not able to indicate the correct source or correct country of origin, is it acceptable that he indicates in the patent application not to know the true source or country of origin? Answer 3b: The Danish group believes that this should be the only indication in this situation. 4

5 Question 3c: Should the requirement of source/country of origin indication be restricted to nonhuman genetic resources (i.e. the resources subject to the CBD) or also apply to human genetic resources? Is it acceptable or even required that the information on the single person or group of persons from which the human genetic material was originally taken, is indicated in the patent application? Answer 3c: The Danish group is of the opinion that any requirement for indicating the origin of biological material in patent application should be limited to material that falls within the scope of the CBD and has been obtained after the entry into force of the CBD. The reason for this is that the demandeurs for such information have indicated that the information is necessary for monitoring sound practices (or rather violations) of the rules of that Convention. Question 3d: What is the sanction if the source/country of origin indication is missing or incorrect? Patent invalidation? Fine? Other sanctions? Should sanctions only apply if the applicant has had an opportunity to correct the omission or the mistake and did not correct it? Should there be no sanction? Answer 3d: The Danish group believes that the sanction in such a situation should at most be fines if the applicant after having unlimited possibilities to correct an omission or an incorrect indication still fails to do so. Question 4: Is your Group of the opinion that the source of traditional knowledge should be indicated in patent applications based on such traditional knowledge? Answer 4: To the extent that holders of traditional knowledge have contributed to the conception/creation of the invention for which protection is applied for, such persons should be indicated as inventors/co-inventors. Furthermore, the applicant should disclose any relevant traditional knowledge that is known to the applicant and is part of the pertinent prior art. Apart from this it is the view of the Danish group that any traditional knowledge conveyed to the inventors, but not forming part of the invention or the pertinent prior art is of no relevance to the examination of the patent application. If holders of traditional knowledge have in some way been involved in the conception/creation of the invention through the provision of secret traditional knowledge, but without any inventive contribution, any mention of this or compensation for having provided this knowledge should be regulated in the agreement between the relevant parties. 5

6 Question 4a: If the patent applicant is not able to indicate the correct source, is it acceptable that he/she indicates in the patent application not to know the true source? Answer 4a: The Danish group does not understand this question. If the applicant has made the invention on the basis of traditional knowledge, but without knowledge of any traditional knowledge forming part of the prior art, he must necessarily have made it on the basis of secret traditional knowledge that has been conveyed to him, and we cannot see how he would not be able to provide such information, unless a contractual obligation prohibits him from disclosing this. The only solution would be to state that contractual obligations prohibits him from making such a disclosure. We believe that such an indication should be acceptable. Please note that there is no question 4b. Question 4c: Should the requirement of source indication be restricted to traditional knowledge in relation to genetic resources (i.e. the traditional knowledge subject to the CBD) or also apply to any traditional knowledge? Answer 4c: Apart from being opposed to such a requirement, the Danish group does not believe that the requirement should be restricted to traditional knowledge related to genetic resources. We further believe that such a restriction would be against the principle of non discrimination of the TRIPs agreement. Question 4d: What is the sanction if the source is missing or incorrect? Patent invalidation? Fine? Other sanctions? Should sanctions only apply if the applicant has had an opportunity to correct the omission or the mistake and did not correct it? Should there be no sanction? Answer 4d: We believe any sanctions should be outside the patent law as it is at present under the Danish law, which in our opinion strikes a fair and manageable balance. Also, it must be secured that the applicant should have the possibility to file such information at any time during the prosecution of the application both in response to an invitation from the Patent Office and voluntarily. Question 5) Is your Group of the opinion that for patent applications based on genetic resources and traditional knowledge proof of prior informed consent (PIC) must be provided? Answer 5: The Danish group is strongly opposed to any requirements in respect of information relating to PIC. Many countries do not have any legislation concerning access to genetic resources or 6

7 traditional knowledge, and it is known that at least some countries do not intend to introduce such special legislation. A patent is a right granted for inventive activity and not a certificate of good behaviour. Question 5a: Is it acceptable to indicate that no person or organisation (e.g. indigenous group) could be or can be identified who has the right to give such consent? Answer 5a: Yes. Question 5b: Is it acceptable to provide proof of prior informed consent after filing the patent application? Answer 5b: Yes, similarly to the situation in question 4d, it must be secured that the applicant should have the possibility to file such proof at any time during the prosecution of the application both in response to an invitation from the Patent Office and voluntarily. Question 5c: What should the sanction be if it turns out that the consent was not actually given or the person/organisation giving consent did not have the right to give consent? Answer 5c: The Danish group believes any sanctions should be outside the patent system and that the issue should be raised by any persons or organisations that allege to have suffered from the incorrect indication. The patent offices do not have the resources, competences or knowledge to investigate the correctness of such information. Question 6) Is your Group of the opinion that for patent applications based on genetic resources and traditional knowledge proof of an agreement sharing benefits with the person or organisation giving access to such genetic resources and/or traditional knowledge must be provided? Answer 6: The Danish group is strongly opposed to any requirements relating to information on benefit sharing. Many countries do not have any legislation concerning benefit sharing in connection with access to genetic resources or traditional knowledge, and it is known that at least some countries do not intend to introduce such special legislation. A patent is a right granted for inventive activity and not a certificate of good behaviour. Question 6a: Is it acceptable to indicate that no person or organisation could be or can be identified who should benefit from it? 7

8 Answer 6a: Yes. Question 6b: Is it acceptable to provide proof of an agreement sharing benefits after filing the patent application? Answer 6b: Yes, similarly to the situation in question 4d, it must be secured that the applicant should have the possibility to file such proof at any time during the prosecution of the application both in response to an invitation from the Patent Office and voluntarily. Question 6c: What should the sanction be if it turns out that the indicated agreement sharing benefits does not benefit the person/organisation that owns the right to such genetic resources or traditional knowledge? Answer 6c: The Danish group believes any sanctions should be outside the patent system and that the issue should be raised by any persons or organisations that allege to have suffered from the incorrect indication. The patent offices do not have the resources, competences or knowledge to investigate the correctness of such information. 8