July 12, 2005 AIPPI · JAPAN
Preparatory Question: Does Peru Have a System That Requires Patent Applicants to Disclose the Origin of Genetic Resources (or to Submit a Copy of the License Contract) at the Time of Filing an Application?
[ ] Yes
[ ] Such a system is now under development.
[ ] Such a system is implemented under Decision 486 of the Andean Community
[X ] No, however, in accordance with Article 26 of Decision 486 an application for patent shall contain amongst other documents, a copy of the contract for access, if the products or processes for which a patent application is being filed were obtained or developed from genetic resources or byproducts originating in one of the Member Countries.
Furthermore in accordance with Article 29 of the mentioned legislation “Where the invention refers to a product or a process involving biological material and the invention cannot be understood and carried out, as described, by a person skilled in the art, it must be accompanied by a deposit of the said material. The material shall be deposited by the filing date in the Member country or, where priority is claimed, the date of application. Deposits with an international authority recognized under the 1977 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure or any other institution acknowledged by the competent national office as appropriate for this purpose shall be valid. In such cases, the name and address of the depositary institution, the date of deposit, and the number assigned by that institution to the deposit shall be included
- If your answer to the above question is “yes,” please go to Question 1.
- If your answer to the above question is “under development,” please go to Question 1 and answer the following questions to the best of your knowledge.
-If your answer to the above question is “under Decision 486 of the Andean Community,” please go to Question 2.
- If your answer to the above question is “no,” please go to Question 6.
(We understand that “Complementary Provisions” of the “Law introducing a protection regime for the collective knowledge of indigenous peoples derived from biological resources (2002, in force)” provides that “Where a patent is applied for in respect of goods or processes produced or developed on the basis of collective knowledge, the applicant shall be obliged to submit a copy of the license contract as a prior requirement.” However, this provision does not seem to obligate the disclosure of the origin of genetic resources.)
Question 1: Governing Law for Requiring Patent Applicants to Disclose Origin of Genetic Resources (or to Submit a Copy of the License Contract)
(i) Name of the law (or bill) and the relevant provision
The name of (draft) statute or regulation:
(Draft of ) The relevant provision(s):
(ii) Is the above-mentioned law (or bill) available via the Internet? If so, please indicate the URL through which we can access the Law.
URL:
If not available, how can we obtain the law?
Answer:
Question 2:The Inventions for which Disclosure of Origin of Genetic Resources (or a Copy of the License Contract) are Required
Even when an applicant obtains the genetic resource before the CBD becomes effective, he/she is still required to disclose its origin (or to submit a copy of the license contract)?
[ ] Yes [ ] No
Question 3: Information on Origin of Genetic Resources that Should be Disclosed at the Time of Filing a Patent Application
(i) Is the mere disclosure of country name(s) regarded as sufficient disclosure?
Please see our answer to question 2 [ ] Yes
[ ] No
→ What is required to be disclosed in addition to country name(s)?
Answer: See our answer to question 2 (ii) Is it a requirement to disclose the country name of origin, in addition to the country
providing the genetic resource? . See our answer to question 2 [ ] Yes
[ ] No
(iii) Is it permissible to use the description “unknown,” if the applicant cannot identify such information?
[ ] Yes [ X ] No
→ What is required of the applicant in such a case?
Answer: To submit the certificate of deposit of the biological material
(iv) Is there any statute or regulation that governs the above-mentioned aspect? If any, please indicate the name of the statute or regulation and the relevant provision(s).
The name of statute or regulation: Common Regime on Access to the Genetic Resources
The relevant provision(s): Decision 391 Question 4: Other Information Required to be Disclosed (Documents Required to be
Attached, etc.)
Is any other information required to be disclosed in addition to the information referred to in the answers to Q3?
[ ] Yes
→What information is required to be attached?
Answer:
→ Under what legal provision(s) is such information required?
Answer:
[ X ] No
Question 5: Dispositions or Penalties Against a Patent Applicant who Fails to Comply with the Disclosure Requirements
(i) If a patent applicant fails to provide the required information at the time of filing (and he/she does not provide the required information even after an opportunity to remedy the insufficiency), what treatment will be eventually given to his/her
application?
[ ] The application will not be further processed.
[ X ] The application will be rejected by the Patent Office.
[ ] The application will be deemed as being withdrawn.
[ ] Other (Please specify:
) [ ] In our country, the Patent Office does not examine whether or not an
applicant has provided the required information.
(ii) If it is found, during patent prosecution, that the information disclosed by a patent applicant is false (and he/she does not provide the correct information even after an opportunity to remedy the deficiency), what treatment will be given to his/her application?
[ ] The application will not be further processed.
[ X ] The application will be refused by the Patent Office.
[ ] The application will be deemed as being withdrawn.
[ ] Other (Please specify:
) [ ] In our country, the Patent Office does not examine whether or not the
information provided by an applicant is true or not.
(iii) If it is found, after the grant of a patent, that the information disclosed by a patent applicant is false, what treatment will be given to the resultant patent?
[ ] The patent will be invalidated.
[ X ] The patent right will be transferred to the correct party.
[ ] Restriction(s) will be made to the claim(s) of the patent.
[ ] Other (Please specify:
) (iv) We heard that, in your country, a criminal penalty and/or civil penalty will be imposed on the applicant when no relevant information is disclosed or when false information is disclosed. What penalties will be imposed in such a case?
(a) Civil penalties
-Applicable legal provisions: Civil Code
-Penalties to be imposed: Compensation for damages (b) Criminal penalties
-Applicable legal provisions: Penal Code
-Penalties to be imposed: sanction would be imprisonmnt (c) Other penalties
-Applicable legal provisions: non applicable
-Penalties to be imposed:
(v) Are these legal provisions available via the Internet? If so, please indicate the URL through which we can access the provisions.
URL: www.pj.gob.pe If not available, how can we obtain these legal provisions?
Answer:
(vi) If there are any penalties, are they applicable in the same way to a case where insufficiency or falsity is found before the grant of the patent and a case where insufficiency or falsity is found after the grant of the patent?
[ X ] Yes. In accordance with Article 237 of Decision 486 “Where patents have been applied for or obtained by persons with no right to those patents, or in detriment of other parties also possessing that right, the parties affected may claim those those rights from the competent national authority and request the transfer to them of the applications being processed or the rights granted, or their recognition as coapplicants or coowners of those rights
[ ] No
) (vii) Suspension of Penalties
Is there any system that forgives an applicant who fails to satisfy the disclosure requirement from being penalized, if he/she corrects it by making disclosure in a specified period?
[ ] Yes
→Please explain the system in detail.
Answer:
→ Under what legal provision(s) is such a system implemented?
Answer:
[ X ] No. Simply, if the applicant corrects the fail by making disclosure in a specific period, the patent application will follow its normal prosecution.
Question 6: Access and Benefit Sharing Competent National Authority
Please provide us some information on the INRENA (Instituto Nacional de Recursos Naturales), which is your country’s national authority that authorizes access to genetic resources, by answering the following questions.
(i) Position of the INRENA
[ X ] Governmental agency decentralized from the Ministry of Agriculture, created by Decree Law 25902 of November 27, 1992 entrusted with carrying out the
necessary actions for the tolerable exploitation of renewable natural resources, guarding the conservation of the supportable measures of the rural environment and wild biodiversity.
[ ] Independent organization
[ ] Other ( )
(ii) Please indicate the constitution of the INRENA (internal organizations, No. of staff and their functions) as far as you know.
Name of Internal
Organization No. of Staff Function
(Managership) ( 2 ) ( Chief and Secretary ) (Adviser Office ) ( 6 ) ( Advisors ) (General Managership ) ( 5 ) ( Manager, secretary, advisors ) ( Communication Office ( 4 ) ( Manager and Publicists ) (Internal Auditorship ( 2 ) ( Manager and secretary )
Other 11 Int. organizations 103 Managers, secretaries, administrators, etc
(ii) Documents to be submitted for authorization and authorization fee
As stated above INRENA is not the authority that authorizes access to genetic resources.
Documents to be submitted:
Authorization fee:
(iv) How many days are required from application to authorization?
Answer:
(v) How many applications does the INRENA process annually?
Answer: per year.
(vi) Reasons for refusal to give authorization, and ratio of refused applications
Main reasons for refusal:
Ratio of refused applications:
(vii) Legal provisions that govern the INRENA
The name of statute or regulation: Law Decree 25902 The relevant provisions:
Question 7: The Impact on Your Firm’s Operation of the System for Disclosure of
Origin of Genetic Resources and Your Firm’s Opinion (Please answer only if Peru has already introduced a system that requires patent applicants to disclose the origin of genetic resources)
(i) Please inform us of the following information on patent applications that your firm has been involved with.
- The annual number of patent applications that disclose the origin of genetic
resources: approximately 40 patent applications - The ratio of such applications to the total number of applications: 10%
(ii) Has any change occurred to your firm’s operations due to the introduction of the system for disclosure of origin of genetic resources?
[ ] Increased number of staff (Reason: ) [ ] Increased working hours (Reason: ) [ ] Increased number of days required for preparation of filing a patent
application
(Reason: ) [ ] Increased profits (Reason: ) [ ] Decreased profits (Reason: ) [ ] Other changes (Please specify: )
[ X ] No significant changes
(iii) Please give your opinion on consistency between the patent protection system and the system for disclosure of origin of genetic resources from a legal viewpoint.
Since our legislation only provides for the submission of the certificate of
deposit of the biological material, we consider such submission as sufficient.
(iv) In order to resolve the issue of biopiracy or other related issues, do you think that it is necessary not only to require patent applicants to obtain authorization for access to genetic resources, but also to obligate them to disclose origin of genetic resources in their patent application?
It seems to us that it would suffice that the patent applicants obtain
authorization for access to genetic resources
• Questionnaire for Your Corporate Clients
Irrespective of whether Peru has already introduced the disclosure system,
could you please ask one or two of your corporate clients to answer our questionnaire attached as Schedule B.
• Questionnaire for Genetic Resource Providers and NGOs
If possible, please ask genetic resource provider(s) and/or NGO(s) that have an interest in disclosure of origin of genetic resource to answer our questionnaire attached as Schedule C.
Thank you very much for your cooperation.
We would appreciate it if you could send us the answers to Shigeru Kaneko, AIPPI · JAPAN by e-mail ([email protected]) or via facsimile (+81-3-3591-1510) on or before August 15, 2005.
３－４ コスタリカ (1)産業財産登記所
Questionnaire to Costa Rica
I-In Costa Rica, Article 80 of Costa Rican Biodiversity Law No.7788 provides:
“Both the National Seed Office and the Registers of Intellectual and Industrial Property are obliged to consult with the Technical Office of the Commission before granting protection of intellectual or industrial property to innovations involving components of biodiversity.
They must always provide the certificate of origin issued by the Technical Office of the Commission and the prior informed consent.
Justified opposition from the Technical Office will prohibit registration of a patent or protection of the innovation.”
A. Is “The Registers of Intellectual and Industrial Property” so-called Patent Office?
It is important to mention, that the Costarican Biodiversity Law mentions both -the Registry of Intellectual Property, and the Registry of Industrial Property, as if they were two entities. In practice it is called the National Registry of Industrial Property.
Inside, and one of its offices is the Patent Office. For the effects of this law, the Patent Office would be the responsible to consult the Technical Office.
B.-How does “The Registers of Intellectual and Industrial Property” identify whether the innovation is considered as one involves components of biodiversity from Costa Rica or not?
The National Registry of Industrial Property can not identify whether the innovation is considered as one involving components of biodiversity from Costa Rica, because it´s examinators are lawyers. Therefore, the identification of biodiversity components is done by technical and professional experts of different fields that carry out their expert opinions.
The expert opinions are paid by the patent petitioner.
C. Does “components of biodiversity” include “derivative of components of biodiversity”? In that case, What is the definition of “derivative”?
There´s no international agreement which defines the concept of derivative components of biodiversity.
In our biodiversity national legislation we cannot find this concept either.
A possible definition could be “ a product that is generated by the use of genes or by the use of biochemical components of some biodiversity elements such as plants, animals or microorganisms.
D. Would such a system be burdensome for “The Registers of Intellectual and