Recently the Indian Patent Office (IPO), while examining Indian patent applications, has been taking into account certain provisions of the Biological Diversity Act (2002) (BD Act) for the inventions that use biological resources originating from India. This is more common for patent applications in the field of life sciences.
The BD Act came into effect from 1 October 2003 with the constitution of the National Biodiversity Authority (NBA), which is empowered to enforce and regulate the provisions of the act.
The objectives of the act broadly can be stated as: the conservation of biodiversity of India, sustainable use of its components, and fair and equitable sharing of benefits arising out of utilisation of biological resources, knowledge and for matters connected with or incidental to these factors.
The BD Act defines the term “biological resources” under section 2(c) to mean: “plants, animals and micro-organisms or parts of, their genetic material and by-products (excluding value-added products) with actual or potential use or value, but does not include human genetic material”.
Accordingly, the requirement under section 6 of the act makes it compulsory for an applicant of intellectual property rights (IPR) to get the approval of the NBA if the IPR uses any biological resource originating from India, or if the invention is based on any research or information on a biological resource obtained from India.
This is to prevent unauthorised use or abuse of any biological material from India and/or to ensure consequent benefit sharing with the community so that national, or the public, interest of India is protected.
This article analyses the provisions of the BD Act and related provisions of the India’s Patents Act (1970) on this requirement, and the practice of the IPO in dealing with such requirements.
The requirements under section 10 of the Patents Act and Patent Rules (2003) in Form-1 mandate the applicant to provide details of the source and geographical origin of biological material in the patent application, along with a declaration regarding the permission required from the competent authority in respect of the biological material used in the invention. This is to prevent unauthorised use or abuse of any biological material from India and to ensure that national, or the public, interest of India is protected.
Other provisions of the BD Act further provide that if the biological resources originating from India are being used for purposes such as bio-survey [section 2(d)], bio-utilisation [section 2(d)] and commercial utilisation [section 2(f)], then the applicant is required to seek permission from the NBA.
Therefore, the IPO, while examining patent applications that use any biological resource for the purpose of any bio-survey and/or bio-utilisation activity – “such as collection of species, sub-species, genes, components and extracts of biological resources for any purpose and includes characterisation, inventorisation and bioassay” – is asking the applicant to clarify the source and origin of biological materials/resources in its patent applications.
The situation is similar for patent applications that use biological resources from India for the purpose of commercial utilisation – “such as drugs, industrial enzymes, food flavours, fragrance, cosmetics, emulsifiers, oleoresins, colours, extracts and genes used for improving crops and livestock through genetic intervention, but does not include conventional breeding or traditional practices in use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or bee keeping” – where the IPO is rigorous in examining such patent applications, and even for the applications where examination reports have been issued, the IPO is instructing applicants to obtain permission from the NBA before such applications can proceed to grant.
The recent actions of the IPO to pay closer attention to the BD Act requirements when processing patent applications is of prime concern for applicants whose applications are based on biological resources obtained from India. In particular, such applicants would include Indian companies, Indian individuals or foreign companies conducting research and development in India.
However, the BD Act offers some respite for the applicant, as it allows the applicant to obtain NBA permission before granting a patent application. This means that an applicant need not withhold its application until it obtains NBA approval, but can proceed with filing the application, and while it is pending can obtain NBA permission, but before the issuance of a letters patent document.
The applicants who are filing their patent applications in India, need not apply for this permission, as long as biological resources recited in their application do not originate from India. However, to ensure compliance with the BD Act, the IPO sometimes can ask to include a disclaimer in the specifications stating that the biological material noted in the application does not originate from India.
At present the IPO provides no guidelines on the non-compliance of section 6 provisions of the BD Act, however, one can anticipate refusals of patent applications due to non-compliance with section 10 of the Patents Act. However, under section 55 of the BD Act, any person who contravenes, or attempts to contravene, or abets the contravention of, the provisions of section 6 is liable for imprisonment for a term that may not exceed five years, or with a fine that may extend to INR1 million (US$16,700), and where the damage caused exceeds INR1 million, such a fine may be commensurate with the damage caused, or with both.
The real challenge is for those applicants whose applications are pending – specifically those applications that are under examination, or have reached the approval stage – before the IPO, as there is lack of clarity and absence of any specific guidelines as to how the IPO is going to deal with such applications.
The IPO appears to be accommodating in this matter by giving time to applicants in obtaining NBA approval for such pending patent applications. But for new applications, or pending applications where an examination report has not been issued, or where request for examination has not been filed, it is advisable to initiate this process either at the time of filing the application or during pendency of the application.
It is clear that the IPO is going to continue this practice while examining patent applications, and it is recommended to seek appropriate advice and guidance from local lawyers to ensure suitable legal compliance.g