June 8, 2005 AIPPI · JAPAN
In your country, a patent applicant for an invention involving a genetic resource is required to disclose the origin of the genetic resource at the time of filing the application. We would like to ask you to provide us with the details of this requirement by answering the following questions.
Question 1:The Inventions for which Disclosure of Origin of the Genetic Resources are Required
Even when an applicant obtains the genetic resources before the CBD becomes effective, he/she is still required to disclose its origin?
[ X] Yes [ ] No Answer:
Under Section 10(4) (d) (ii)(D) of the Indian Patents Act, if the biological material is not available to the public, the applicant is required to deposit and disclose the source and geographical origin of the biological material in the specification, when used in an invention.
Also, failure to comply with this requirement or wrongly mentioning the source and origin of the biological material is a ground for opposition and revocation under Sections 25 and 64 of the Indian Patents Act.
Under the Biological Diversity Act 2002, Section 6 creates an obligation on all persons to take approval of the National Biodiversity Authority (NBA) before applying for an intellectual property right for an invention, in or outside India, which ‘ is based on a biological resource, obtained from India.
However if a person applies for a patent the said permission may be obtained after acceptance of a patent but before its grant.
The obligation of obtaining the prior approval of the NBA does not apply for plant variety protection.
Question 2: Information on Origin of Genetic Resources that should be Disclosed at the Time of Filing a Patent Application
The India Patent Act requires patent applicants to disclose “the source and geographical origin of the biological material in the specifications, when used in an invention.” What does this phrase mean precisely?
(i) Is the mere disclosure of country name(s) regarded as sufficient disclosure?
[ ] Yes [ ] No
What is required to be disclosed in addition to country name(s)?
Answer:
The Indian Patents Act only provides for the disclosure of source and geographical origin of the biological material. Additionally the applicant has to provide a declaration to the effect that he has obtained the necessary approval from competent authority (National Biodiversity Authority) and as proof thereof, he has to submit approval certificate as obtained from the NBA under Section 6 of the Biological Diversity Act, 2002.
(ii) Is it a requirement to disclose the country name of origin, in addition to the country providing the genetic resource?
[ X ] Yes [ ] No Answer:
The Indian patents Act or the draft patent office manual does not provide any guidelines as to the requirement of disclosing the name of the country providing the genetic resources in addition to the country of origin. However, over the years the
position in this regard will become clear. The minimum obligation can include:
- declaration of the source of genetic resource to which the inventor has had access
- if the source is unknown, a declaration to that effect should also be made.
In this regard, it is important that the patent applicant has made best endevour in good faith to ascertain the geographical origin of the biological material used in the invention
(iii) Is it permissible to use the description “unknown”, if the applicant cannot identify such information?
[ X ] Yes [ ] No
What is required of the applicant in such a case?
Answer:
If the source of the biological material is unknown, the defence of good faith has not been interpreted by the Indian Courts on this issue so far as this provision was introduced in the Indian Patents Act in 2002.
(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).
Answer:
The name of statute or regulation:
The Patents Amendment Act, 2005 and The Biological Diversity Act, 2002 The relevant provision(s):
Section 10 (4), Section 25, Section 64 of the Patents Amendment Act, 2005.
Section 6 and Section 55 of the Biological Diversity Act, 2002
Question 3: 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 Q2?
[ X ] Yes
→What information is required to be attached?
→ Under what legal provision(s) is such information required?
[ ] No Answer:
→ Proof of obtaining approval of access to the biological material from the NBA under Section 6 of the Biological Diversity Act, 2002.
→ Under the “declaration section” in Application form 1 of the Indian Patents Act.
Question 4: 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.
Answer:
A patent application is examined for compliance with formal requirements provided by the Act and Rules by the Indian Patent Office at the time of examination of the application. In the circumstances, if the applicant is requested to provide the information under Section 10 and he fails to meet this requirement, his application for patent can be refused under Section 15.
(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.
Answer:
Under Section 15 of the Indian Patents Act, if the Controller is of the opinion that the specification does not meet any of the requirements under the Indian Patent Act and Rules, he can refuse the application. Therefore, if the complete specification does not disclose or wrongfully discloses, the source and geographical origin of the biological material, the application can be refused by the Controller.
Also, under Section 25(1) (j) of the Patents Amendment Act, 2005, there is a provision of pre grant opposition wherein any person may in writing file by way of representation of opposition to the Controller against the grant of the patent on the ground that the complete specification does not disclose or wrongly mentions the source and geographical origin of the biological material used in the invention.
(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?
[ X] The patent will be invalidated.
[ ] 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) Answer:
Under section 25(2)(j) of the Patents Amendment Act, 2005, any time after the grant of a patent but before the expiry of one year from the date of publication of grant of the patent any person interested may give notice of opposition to the Controller in the prescribed manner on the ground that the complete specification does not disclose or wrongly mentions the source and geographical origin of the biological material used in the invention.
Further under section 64(1)(p) of the Patents Amendment Act, 2005 a patent may be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter claim in a suit for the infringement of the patent by the high court on the ground that the complete specification does not disclose or wrongly mentions the source and geographical origin of the biological material used in the invention.
However, since the provision relating to the constitution of the Appellate Board has still not come into force, a revocation action can be instituted before the High Court of appropriate jurisdiction.
(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: ___
-Penalties to be imposed:
(b) Criminal penalties
-Applicable legal provisions: ___
-Penalties to be imposed:
(c) Other penalties
-Applicable legal provisions: ___
-Penalties to be imposed:
Answer:
Under Section 55 of the Biological Diversity Act, if any person applies for an intellectual property in or outside India for an invention based on any research or information on a biological resource obtained from India without obtaining the approval of NBA, he shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to Rs 10 lakh (US $ 23,000) and where the damage caused exceeds Rs. 10 lakh such fine may commensurate with the damage caused or with both.
(v) Are these legal provisions available via the Internet? If so, please indicate the URL through which we can access the provisions.
If not available, how can we obtain these legal provisions?
Answer:
URL: www.ipindia.nic.in and
envfor.nic.in/divisions/biodiv/act/biodivact
(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?
[ ] Yes
[ ] No (Please specify:
) (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:
[ ] No
Question 5: Access and Benefit Sharing Competent National Authority
Please provide us some information on the National Biodiversity Authority (NBA), which is your country’s national authority that authorizes access to genetic resources, by answering the following questions.
(i) Position of the NBA
[ X ] Governmental agency [ ] Independent organization
[ ] Other ( )
Answer:
Section 8 of the Biological Diversity Act, 2002 deals with the establishment of the National Biodiversity Authority (NBA). The head office of the NBA is at Chennai.
(ii) Documents to be submitted for authorization and authorization fee
Answer:
Under Rule 14, any person seeking approval of the Authority for access to biological resources and associated knowledge for research or for commercial utilization shall make an application in Form I with the prescribed fee of Rs. 10,000
Under Rule 17, any person desirous of transferring results of research relating to biological resources obtained from India for monetary consideration to foreign nationals, company and Non Residents Indians (NRIs), shall make an application to the Authority in the Form II along with a fee of Rs. 5000.00
Under Rule 18, any person desirous of applying for a patent or any other intellectual property based on research on biological material and knowledge obtained from India shall make an application in Form III along with a fee of five hundred rupees.
(iii) How many days are required from application to authorization?
Answer:
Under Rule 14(3) of the Biological Diversity Rules 2004, the Authority shall after consultation with the concerned local bodies and collecting such additional information from the applicant and other sources, as it may deem necessary, dispose of the application, as far as possible, within a period of six months from the date of its receipts.
Under Rule 17(3) of the Biological Diversity Rules 2004 every application shall be decided upon by the Authority, as far as possible within a period of three months from the receipt of the same.
Under Rule 18(3) the Authority after due appraisal of the application and after collecting any additional information, on the basis of merit shall decide on the application, as far as possible within a period of three months of receipt of the same (iv) How many applications does the NBA process annually?
Answer:
So far NBA has received approximately 19 applications. However, so far none of them has received approval.
(v) Reasons for refusal to give authorization, and ratio of refused applications Ratio of refused applications:
(vi) Legal provisions that govern the NBA Answer:
The name of statute or regulation: Biological Diversity Act, 2002 and the Biological Diversity Rules, 2004.
The relevant provisions: Section 8 of the Biological Diversity Act, 2002 Question 6: The Impact on Your Firm Operation of the System for Disclosure of Origin of Genetic Resources and Your Firm’s Opinion
(i) Please inform us of the following information on patent application that your firm has been involved with.
- The annual number of patent applications that disclose the origin of genetic resources.
- The ratio of such applications to the total number of applications:
Answer:
The Patent Office is unable to provide us with this information.
(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 days required for preparation of filing a patent application (Reason: ) [ ] Increased profits (Reason: ) [ ] Decreased profits (Reason: ) [ ] Other changes (Please specify: )
[ ] No significant changes
Answer:
We have created a separate department with adequate staff to look into the issues
which deals with biological material.
(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.
Answer:
In addition to the obligation created under the Biological Diversity Act, Section 10 of the Patents Act creates an obligation on the applicant of a patent to deposit and disclose the source and geographical origin of the biological material in the patents specification.
(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?
Answer:
India contains a great wealth of biological diversity in its forests, its wetlands and in its marine areas. In order to evolve a gainful and beneficial relationship between the bio-prospector and the right holders (including the country of origin) and with a view to prevent bio-piracy, in our opinion, the disclosure requirement will to a great extent keep a check on biopiracy.
• Questionnaire for the Patent Office
Please ask your country’s Patent Office to answer our questionnaire attached as Schedule A.
• Questionnaire for Your Corporate Clients
It would be appreciated if you could 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 resources 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 June 30, 2005.
(2)インド企業
Annexure B