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 Philippines Group

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?
If yes, please quote the corresponding text from the law/regulations and reply to the following
questions, if applicable:

ANSWER: Yes. Specifically, Section 26.1 of the Joint DENR-DA-PCSD-NCIP

Administrative Order No. 1, Series of 2005 (“DENR-DA-PCSD-NCIP 2005”) states:
Section 26. Overseas monitoring
26.1 The implementing agencies may seek the assistance of the Department of
Foreign Affairs (“DFA”) and Department of Science and Technology in
monitoring inventions and commercialization undertaken in foreign countries.
These Departments shall be notified in writing by the implementing agencies
about Bioprospecting Undertakings (“BU”) with foreign entities. The DFA,
through its Embassies and Missions abroad, is encouraged to report to the
implementing agencies any breach of the BU. In particular, the DFA is
encouraged to make representations with concerned foreign authorities
particularly on the following aspects:

a) Prevention of biological resources from entering countries

without a BU;
b) Requiring disclosure of country of origin (CO) and
presentation of BU in patent applications;
c) Facilitation of enforcement of claims against collectors or
commercializing entities. (Emphasis supplied)

Indirectly, the following laws require the acknowledgement of indigenous people in

writings or data as a result of research. They are as follows:
1. Rule VI, Section 15 of the implementing rules of Republic Act No. 8371, otherwise known
as the Indigenous Peoples’ Rights Act of 1997 (“IPRA”), provides:
 Section 15. Protection and Promotion of Indigenous Knowledge Systems
and Practices (IKSPs). The following guidelines, inter alia, are hereby
adopted to safeguard the rights of IPs to their indigenous knowledge systems
and practices:

a) The ICCs/IPs have the right to regulate the entry of researchers into
their ancestral domains/lands or territories. Researchers, research
institutions, institutions of learning, laboratories, their agents or
representatives and other like entities shall secure the free and prior
informed consent of the ICCs/IPs, before access to indigenous
peoples and resources could be allowed;

b) A written agreement shall be entered into with the ICCs/IPs

concerned regarding the research, including its purpose, design and
expected outputs;

c) All data provided by the indigenous peoples shall be

acknowledged in whatever writings, publications, or journals
authored or produced as a result of such research. The
indigenous peoples will be definitively named as sources in all
such papers;

d) Copies of the outputs of all such researches shall be freely provided

the ICC/IP community; and

e) The ICC/IP community concerned shall be entitled to royalty from the

income derived from any of the researches conducted and resulting
publications.

To ensure effective control of research and documentation of their

IKSPs, the IPOs’ initiatives in this regard shall receive technical and financial
assistance from sources of their own choice. (Emphasis supplied)

2. Executive Order No. 247 (“EO 247”) dated 18 May 1995, provides for the regulatory
framework for the prospecting of biological and genetic resources for scientific and
commercial purposes. In its whereas clause, it is enunciated:
WHEREAS, it is in the interest of the State’s conservation efforts to ensure
that the research, collection and use of species, genes and their products be
regulated; and to identify and recognize the rights of indigenous cultural
communities and other Philippine communities to their traditional knowledge
and practices when this information is directly and indirectly put to
commercial use.

3. Rule IX of the implementing rules of Republic Act No. 8423, otherwise known as the
Traditional and Alternative Medicine Act of 1997 (“TAMA”) states:
SECTION 2. Access to Biological and Genetic Resources Including
Indigenous Knowledge Systems. — The Institute shall endeavor to
effectively implement laws, executive issuances and ordinances governing
access to the country's biological and genetic resources. It shall assume the
responsibilities of the Traditional Medicine Unit as a member of the Inter-
Agency Committee on Biological and Genetic Resources under Executive
Order No. 247, the Sub-Committee on Biodiversity of the Philippine Council
for Sustainable Development, the National Committee on Biosafety of the
Philippines and other developmental bodies and councils provided by law
and executive issuances. In order to carry out this transfer, the Board shall
make the appropriate representations to the Secretary of Health.

The provisions of existing laws and regulations, particularly

Executive Order 247 and Republic Act 8371 or the Indigenous Peoples
Rights Act must be complied with before access to biological and
genetic resources can be made. Biodiversity prospecting activities
that do not comply with existing laws and regulations on the subject
as well as these rules shall be deemed an act of biopiracy. The Board
shall take the appropriate steps, in collaboration with all branches of
government, in order to penalize the perpetrators of these acts as well as to
minimize and/or stop these activities.

SECTION 3. Documentation of Indigenous Knowledge Systems on

Traditional and Alternative Health Care. — The Board shall endeavor to
develop workable mechanisms, in accordance with the customary practices
of the place, for the identification and documentation of indigenous
knowledge systems relevant to the utilization of biological and genetic
resources that are applied in traditional and alternative health care
practices of the community.

SECTION 4. Intellectual Property Rights. — All products and by-products

derived from Philippine medicinal plants using the resources and facilities of
the Institute in their development shall be the property of the Institute and
the Philippine Republic.

The Institute shall likewise endeavor to develop its intellectual

property rights portfolio to maximize the benefits that can be derived from
the various intellectual properties that it may secure from its research and
development activities.

Assistance to Filipino inventors, scientists and entrepreneurs in the

form of efforts in securing appropriate intellectual property rights and
technology transfer agreements in the Philippines and abroad shall be
provided by the Institute. Whenever appropriate and necessary, the Institute
shall apply for intellectual property rights protection in accordance with
applicable treaties and laws for any material, products and by-products
derived from medicinal plants including patents for the processes utilized in
the manufacture of these natural products and by-products in behalf of the
Philippine Government, Philippine Herbal Industry and other stakeholders.

The Institute shall endeavor to monitor and inventory Philippine

natural health products that have been inappropriately applied for
intellectual property rights protection in the Philippines and abroad
without complying with applicable laws and regulations and shall
make representations with the appropriate international institutions
and agencies with the assistance of other institutions and agencies of
the Government of the Philippines, to cancel this rights or to
renegotiate the terms and conditions thereof that are favorable to
Philippine interests.

The application of existing forms of intellectual property rights on

biological and genetic resources as well as indigenous knowledge systems
shall be without prejudice to the application of whatever sui generis rights
 that may be provided by law to the appropriate local and indigenous
communities. The Board or other appropriate governmental bodies shall
also intervene, whenever it becomes necessary for the protection of the
general welfare of the communities involved, to protect and ensure the
rights of the communities during the negotiations for benefit sharing.
(Emphasis supplied)

a) Are these regulations found in patent law, general IP laws or in legislation

implementing the Convention on Biological Diversity?

ANSWER: These laws are not found in patent or IP laws but rather in legislation
implementing the Convention on Biological Diversity?

b) 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: Yes, such concepts are clear and adequately defined by DENR-DA-PCSD-
NCIP 2005 and the IPRA.

c) Are there ways to complement or amend the corresponding text in the patent
application?

ANSWER: Yes. Philippine patent laws allow for amendment of the patent application.
Furthermore, in the event that subsequent legislation would require amendment to
patent applications to reflect disclosure on source and country or origin, such
subsequent law will govern.

d) Is disclosure of “prior informed consent” and/or agreements on “sharing of benefits”

required?

ANSWER: Existing patent laws do not explicitly provide for such disclosure in patent
applications. However, other laws, such as the IPRA, DENR-DA-PCSD-NCIP
2005 and Republic Act No. 9147 or the Wildlife Resources Conservation and
Protection Act, require the disclosure of prior informed consent and agreements on
sharing benefits before any research or bioprospecting can be conducted regarding
traditional knowledge and genetic and biological resources.,
 e) Are human genetic resources treated differently or the same way as animal or plant
genetic resources falling under the CBD?

ANSWER: No because under Philippine laws, genetic material is broadly defined as

any material of plant, animal, microbial or other origin containing functional units of
heredity. As such, it includes human genetic resources. However, there are specific
laws which only address animal and plant genetic resources.

f) 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: Yes, traditional knowledge or Indigenous Knowledge Systems and

Practices, as coined in the Philippines, is properly defined. The disclosure on
source of traditional knowledge in research is required in general.

g) Are sanctions foreseen for non-compliance (e.g. patent invalidation, patent transfer
to the owner of the resource, fines, criminal sanctions etc.)?

ANSWER: Yes because DENR-DA-PCSD-NCIP 2005 requires the disclosure in the

Bioprospecting Undertaking. Non-compliance with the required provisions in the
Bioprospecting Undertaking shall result in the automatic cancellation or revocation
of the agreement and confiscation of collected materials in favour of the
government, imposition of a perpetual ban on access to biological resources in the
Philippines. Said violation shall also be published in national and international
media and shall be reported to relevant international and regional monitoring
bodies. Furthermore, other national laws provide for criminal, administrative and
civil sanctions.

h) 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?

ANSWER: The law does not make any distinction.

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.

ANSWER: There is none. According to the Philippine Intellectual Property Office, the issue
on the protection of traditional knowledge is still in the discussion level. Presently, included
in the National Intellectual Property Strategy of the Philippine Intellectual Property Office is
the proposal to have a database for patent applications regarding traditional medicine. Such
proposal was recommended by the State Intellectual Property Office and the European
Patent Office in their visit to the Philippines last July 2006. If such goal is effectuated,
consultations will be conducted and only then will the issue on disclosure be addressed.

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?
If yes:
ANSWER: Yes
a) 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: The patent applicant must disclose not only the source but also the actual
country of origin. As a country rich in genetic resources and traditional knowledge, it is the
Philippines’ thrust to afford the utmost protection to indigenous people and their
corresponding traditional knowledge.

b) 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: No, the disclosure must be complete. To allow the patent applicant to assert
lack of knowledge would open the floodgates to abuse and would enable an applicant to
feign ignorance of the country of origin so as not to comply with the disclosure requirement.
 c) Should the requirement of source/country of origin indication be restricted to non-
human 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: There should be no distinction between non-human and human genetic

resources when it comes to disclosure. The thrust of the law remains the same whether the
application deals with non-human or human genetic resource.

d) 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: Section 31 of DENR-DA-PCSD-NCIP 2005 provides for sanctions for violation of

a Bioprospecting Undertaking as follows:

Section 31. Sanctions and Penalties

31.1 Non-compliance with the provisions in the Bioprospecting Undertaking
shall result in the automatic cancellation/revocation of the said agreement
and confiscation of collected materials in favor of the government, forfeiture
of bond and imposition of a perpetual ban on access to biological resources
in the Philippines by the violator. Such breach is considered a violation of the
Wildlife Act and shall be subject to the imposition of administrative and
criminal sanctions under existing laws. Any person who shall conduct
bioprospecting without a BU shall be subject to penalties for collection
without a permit.

31.2 The violation committed shall be published in national and international

media and shall be reported by the agencies to the relevant international and
regional monitoring bodies, through the Philippine CBD Focal Point.

So long as the law or implementing rules are clear as to the required disclosure, any
omission on the part of the patent applicant is unacceptable. However, it is believed that the
sanctions be relaxed in cases of inadvertent omissions.

4) Is your Group of the opinion that the source of traditional knowledge should be indicated in
patent applications based on such traditional knowledge?
If yes:
ANSWER: Yes.
 a) 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: It is unacceptable for the patent applicant to indicate that he does not know the
source. In the course of the applicant’s research, it is highly improbable for him not to know
the source. Furthermore, Philippine laws have strict standards when it comes to research
involving biological and genetic resources and traditional knowledge.

b) 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: The requirement on source indication should apply to any traditional knowledge.
The protection of traditional knowledge extends further than genetic resources. Other
matters pertaining to traditional knowledge are equally important.

c) 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: please see item 3 (d).

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?
If yes:

ANSWER: Yes. Although not explicitly required under patent laws, the IPRA, DENR-DA-
PCSD-NCIP 2005, EO 247, TAMA and other laws require compliance with proof of prior
informed consent. In addition, it is the policy of the Philippines to protect the rights of
indigenous people. In this regard, prior informed consent is an instrument to effectuate this
goal.

a) 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: No. The provision on prior informed consent is an instrument of empowerment
of the indigenous people. To allow the non-identification of an indigenous group as an
exempting circumstance would defeat the very purpose of the law to protect indigenous
peoples’ rights.

b) Is it acceptable to provide proof of prior informed consent after filing the patent
application?

ANSWER: No. DENR-DA-PCSD-NCIP 2005, the IPRA and other cognate laws require the
prior informed consent of the indigenous community concerned before conducting any
research. Thus, it will be too late to secure prior informed consent after the filing of patent
applications.

c) 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: In order to give teeth to the thrust of the law, criminal, civil and administrative
sanctions must be imposed. In fact, the IPRA provides for imprisonment as a penalty for
misrepresentation in giving the consent of indigenous people. In addition, DENR-DA-PCSD-
NCIP 2005 provides for cancellation of the bioprospecting undertaking [Please see item 3
(d)]. Furthermore, we recommend the cancellation of the patent application.

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?
If yes:

ANSWER: Yes. The IPRA provides for a mechanism whereby there must be an agreement
on benefit sharing. Moreover, in the bioprospecting undertaking, DENR-DA-PCSD-NCIP
2005 mandates that there be a provision on benefit sharing.

a) Is it acceptable to indicate that no person or organisation could be or can be

identified who should benefit from it?
ANSWER: No. To do so will run contrary to the IPRA and the thrust of the Philippine
government to protect indigenous people and traditional knowledge.

b) Is it acceptable to provide proof of an agreement sharing benefits after filing the

patent application?

ANSWER: No. Under Philippine laws, before any bioprospecting activity is undertaken, a
BU must first be executed, which embodies an agreement on sharing benefits. Besides, an
agreement on the sharing of benefits is necessary to enable the indigenous communities to
come up with an informed consent.

c) 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: please see item 5 (c).