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Compliance under Biodiversity Act for Indian Patent applications

India became a party to the International Convention on Biodiversity which was one of the agreements adopted during the Earth Summit held in Rio De Janeiro in 1992. The Indian Government was aware of the significant costs our nation could incur if the susceptible and much-needed biodiversity would not be put under a protection regimen. The Convention, while endorsing sovereign rights of countries over their biological resources, established three main goals: the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits from the use of genetic resources.

The Indian Biological Diversity Act, 2002 came into effect from 1 October 2003. Considering Article 6 and Article 15 of the CBD (Convention on Bio-Diversity) India standardizes access to its biological resources under the Biological Diversity Act, 2002 and Biological Diversity Rules, 2004. Biological resources/materials according to this Act in section 2(c) are defined as “plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material”.  

The objective of the Biodiversity Act is to govern the conservation of Biological diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of use of Indian biological resources and community knowledge associated therewith. Under the domain of Biodiversity Act, the National Biodiversity Authority (hereinafter ‘NBA’) was established, which is empowered to enforce and regulate the provisions of the Biodiversity Act. Any application for intellectual property rights based on Indian biological resources irrespective of whether such applications are filed by Indians or non-Indians requires the prior approval of the NBA.

(Source:

Authorities established under the Biodiversity Act

A three tiered structure has been established under the Biodiversity Act at the national, state and local levels.
At the local level, the Biodiversity Management Committees (BMCs) are established by institutions of local self-government for implementation of specific provisions of the Act and Rules.

At the state level, the State Biodiversity Boards (SBBs) are established to deal with all matters relating to implementation of the Act and the Rules.

At the national level, the National Biodiversity Authority (NBA) is established to deal with all matters relating to implementation of the Act and the Rules.

Each of these structure are required to be connected for decision making processes on various issues, including on issues of access and benefit sharing (ABS). The NBA Approval for a patent enables the NBA to consult the relevant State Biodiversity Boards and concerned local bodies and involve them in any potential benefit sharing agreement.

Disclosure of Biological Material in the specification

According, to Section 10 (4) (d) (ii) of the Patents Act, 1970, the patent applicant should disclose the source and geographical origin of the biological material when used in an invention. Such a disclosure can be included in the beginning of the specification.

Case 1: When the biological material used is not available in public

In case such material is not available to the public, the application shall be completed by depositing the material to an authorized depository institution as may be notified by the Central Government in the Official Gazette and fulfilling the following conditions namely:

(A) the deposit of the material shall be made not later than the date of the patent application in India;

(B) all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution;

(C) access to the material is available in the depository institution only after the date of the application of patent in India or if a priority is claimed after the date of the priority;

(D) disclose the source and geographical origin of the biological material in the specification, when used in an invention.

In India, Microbial Type Culture Collection and Gene Bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh and Microbial Culture Collection (MCC), Pune India., are the two recognized international depositories of microorganisms. The deposition of the biological material which is not available to the public, shall not be later than the date of filing of patent application in India. Access to such material is made available in the depository institution only after the date of the application of patent in India. As per Rule 13(8) of the Patents Rules, 2003, the reference of deposition of biological material in the patent application shall be made within three months from the date of filing of such application. While the timeline required for mentioning or providing information regarding deposit of biological material at Indian Patent Office is the same for PCT-National phase, Convention and/ first filing ordinary application, i.e., 3 months from the date of filing in India, however in case the PCT International application and/priority application which does not mention the information on biological deposit the same shall be included in the complete specification in India along with a request for amending the specification to include the aforesaid as additional information. Such amendment in the specification can be done by filing Form 13 along the amended copy of specification.  

Case 2: When the biological material used is available in public

Further, according to the provision of Section 6 of the Biological Diversity Act, if the source of origin of biological material is from India then the applicant has to submit the permission from the National Biodiversity Authority of India before the grant of a patent over the application. The Indian Patent Law also makes it mandatory for the applicant of a patent to submit a declaration under Form-1 (Application for Grant of Patent) of the Patent Rules 2003 to the effect that “the invention as disclosed in the specification uses the biological material from India and the necessary permission from the Competent Authority shall be submitted by me/us before the grant of patent to me/us.”

(Source: http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_113_1_The_Patents_Act_1970_-_Updated_till_23_June_2017.pdf;

http://www.ipindia.nic.in/writereaddata/Portal/Images/pdf/Final_FREQUENTLY_ASKED_QUESTIONS_-PATENT.pdf;

http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_39_1_5-tk-guidelines.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620767/

http://www.ipindia.nic.in/writereaddata/Portal/News/159_1_115-public-notice-02july2014.pdf)

Penalties on Non Compliance of Bio-diversity Act in Indian Patent Applications

The Biological Diversity Act, 2002 has a penal provision in this regard under section 55 (1) which provides that “whoever contravenes or attempts to contravene or abets the contravention of the provisions of the section 3 or section 4 or section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten lakh rupees such fine may commensurate with the damage caused, or with both.”

(Source:https://indiacode.nic.in/bitstream/123456789/2046/1/200318.pdf)

Who are exempted from providing approval of the NBA

  • Indian citizens or entities accessing biological resources and/ or associated knowledge, occurring in or obtained from India, for the purposes of research or bio-survey and bio-utilization for research in India;
  • Collaborative research projects, involving the transfer or exchange of biological resources or related information, if such collaborative research projects have been approved by the concerned Ministry Department of the State or Central Government and conform to the policy guidelines issued by the Central Government for such collaborative research projects;
  • Local people and communities of the area, including growers and cultivators of biological resources, and vaids and hakims, practicing indigenous medicine, except for obtaining intellectual property rights;
  • Accessing biological resources for conventional breeding or traditional practices in use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or bee keeping, in India;
  • Publication of research papers or dissemination of knowledge, in any seminar or workshop, if such publication is in conformity with the guidelines issued by the Central Government from time to time;
  • Accessing value added products, which are products containing portions or extracts of plants and animals in unrecognizable and physically inseparable form; and
  • Biological resources, normally traded as commodities notified by the Central Government under section 40 of the Act.
  • The Central Government vide Section 40 of the Biological Diversity Act, 2002 (18 of 2003), for being a signatory to the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)
  • The Central Government in consultation with the National Biodiversity Authority (NBA) has already declared that the Department of Agriculture and Cooperation may exempt the crops listed in Annex-I of the ITPGRFA from Section 3 and 4 of the Biodiversity Act, for the purpose of utilization and conservation of research, breeding and training for food and agriculture. The list of the ITPGRFA is updated in a periodic time interval.

(Source:http://nbaindia.org/content/565/56/1/explanatorynote.html

http://www.fao.org/fileadmin/templates/agphome/documents/PGR/PubPGR/ResourceBook/annex1.pdf)

Objection raised in Examination Stage and Hearing Stage of the Patent Application

It is seen that many a times objections are raised in the examination reports and hearing notices stating that “Source/geographical origin of used biological materials should be specified in the specification u/s 10 & if the origin is from India, NBA approval is required”. In such cases the Applicant must have not complied the mentioned requirement during the filing of the Patent Application.

Remedies 

In a situation when the origin of the biological material is not from India, then the Applicant is required to amend the specification by way of incorporation of a separate heading/paragraph at the beginning of the description that the biological materials used in the invention is not from India and should clearly specify the country of source & geographical origin of the same.

In a situation when the origin of the biological material is from India, and an objection is raised in the examination report as mentioned above, then the Applicant can visit the website of National biodiversity Authority and apply for an NBA approval.

How to apply for National Biodiversity Authority (NBA) approval?

The Applicant, can create a login using the link below and fill in the required details. http://absefiling.nic.in/NBA/login/auth

In case of any assistance required during the procedure for applying for NBA approval, the Applicant can watch the video published by the National Biodiversity Authority, demonstrating the steps of online application, by clicking the below link:

The Applicant may receive an acknowledgement receipt from the National Biodiversity Authority by performing the above process. This acknowledgment receipt can be submitted along with the examination response, mentioning that the Applicant is enclosing the acknowledgement receipt with the examination response and will submit the NBA approval as soon as is received from the National Biodiversity Authority. According to section 6 (1) of the Biological Diversity Act, the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof

Disposal of Patent Application 

Further, in the examination stage or hearing stage, if the applicant has complied with all the objections, except submission of NBA approval, the Controller shall mark the application in the examination module by remark that “NBA approval pending, but in order for grant” and, the System Administrator shall put a tag on such cases so that these applications can be treated as if disposed of the Controller.

Examples of Patent Applications which are granted when the NBA approval is under process.

  1. 1521/DEL/2008
  • 3371/CHE/2012

(Sourcehttp://ipindiaservices.gov.in/patentdecisionsearch/patentsearch.aspx)

Monetary and Non-Monetary benefits obtained after the grant of a patent

  • Benefit sharing fee
  • Royalties
  • Sharing of profits
  • Grant of joint ownership
  • Grant of joint ownership of intellectual property rights to the National Biodiversity Authority, or where benefit claimers are identified, to such benefit claimers;
  • Transfer of technology;
  • Location of production, research and development units  in  such  areas  which  will facilitate better living standards to the benefit claimers;
  • Association of Indian scientists, benefit claimers and the local people with research and development in biological resources and bio survey and bio utilization;
  • Setting up of venture capital fund for aiding the cause of benefit claimers;
  • Money to be deposited in the NBA Fund if not otherwise directed.

Determination of Access and Benefit Sharing

Annual royalty payment which the patentee has to make during the term of the Agreement is as follows:

  1. For a product derived from the use of the biological resource and/or associated knowledge accessed is 2% – 5% of the gross exfactory sale.
  2. For a product derived from the use of biological resources and associated knowledge accessed (as ascertained from the annual progress reports of the user duly certified by chartered 13 reports of the user duly certified by chartered accountants) is 5% of the total ex-factory sales.
  3. For a transfer/license of patent by researcher is 5% of upfront payment & 5% of the exfactory sales in event of commercial production.
  4. For an exporter is 5% of FoB (Free on Board) value of the export consignments as evidenced by a copy of the shipping bill and CA certificate, subject to licensing by Director General of Foreign 14 licensing by Director General of Foreign Trade (DGFT).

An example in which NBA receiving monetary benefits

An applicant Dr. Geeta Pandurang Pawar, an ayurvedic doctor from Pune, India applied in Form – III (Seeking ‘No objection Certificate’ for obtaining a patent) for preparation of an ayurvedic anti snake venom comprising four medicinal plants. In the treatment of victims of snake bite, this anti venom tablet ‘pinak’ acts as a temporary relief instantly before victim is taken to the hospital. With respect to this case, NBA has fixed the benefit sharing as “2% of the Gross sales or Gross revenue of the product derived from the use of biological resources accessed.” On commercialization of the patent product and as per the conditions of the agreement, the applicant has paid two installments towards royalty as benefit sharing to the NBA.

The Indian Patent Number is 236637 and the title of invention is “A PROCESS FOR PREPARATION OF AYURVEDIC ANTI-SNAKE VENOM CAPABLE OF ADMINSTERING ORALLY OR INTRAVENOUS”. The patent is in-force and was an application at the Mumbai Jurisdiction. The Agreement between the Applicant and the NBA is available on http://ipindiaservices.gov.in/PatentSearch/PatentSearch//eRegistrationReport

(Source: http://nbaindia.org/content/19/16/1/faq.html

http://nbaindia.org/uploaded/pdf/ABS_Factsheets_1.pdf

http://www.abs-initiative.info/fileadmin/media/Knowledge_Center/Pulications/ABS_Dialogue_042014/National_study_on_ABS_implementation_in_India_Information_document_20140717.pdf

Countries other than India who seek a disclosure of origin of the biological resource

The countries such as Brazil, Bangladesh, Malawi, Kenya, Guyana, Ethiopia, Bolivia, Philippines, Belgium, Denmark, Germany, China, Norway, Sweden, Italy, European Union, Cuba, Costa Rica mandate or allow disclosure of origin of biological resource.

(Source:http://www.ris.org.in/images/RIS_images/pdf/article4_v11n2.pdf

http://shodhganga.inflibnet.ac.in/bitstream/10603/186547/9/11_chapter-6.pdf)

Conclusion    

The initiative of the Indian Patent Office for disposal of the patent applications towards grant wherein, the applicant has complied with all the objections, except for submission of NBA approval, is a remarkable step towards expansion and growth of business in a long run. However, it is advised that the Applicant should apply for the NBA approval at the stipulated time to avoid further delay in processing the patent applications.  

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