Agitha, T.G – BIOTECHNOLOGY AND IPR

Agitha, T.G, Biotechnology and IPR, (Ed.) S.Jisha, B.Hari & T.K.Remesan, Proc. Nat. Sem. on Env. Biotech. Chall. and Oppor.,  Envirotech-2008, P.G. Dept. of Zoology, S.N.C. Natiika, pp57-62

(IPR Chair, School of Legal Studies, CUSAT, Cochin, agitha1@rediffmail.com)

Abstract

The recent advancements in the research and inventions in the field of biotechnology paved way for the demand for strengthening IPR protection, especially patent protection, in that area of research. As far as India was concerned, prior to signing the Final Agreement on GATT and thereby submitting itself to the obligations under the TRIPS Agreement, India was not extending patent protection for products or processes of biotechnological inventions. However, signing of the TRIPS agreement changed the entire scenario and India changed its Patents Act so as to extend its protection to the field of biotechnological research. It also enacted the Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PVFRA) to protect the Plant Breeders’ Rights so as to meet the TRIPS obligation.

The problems created by IPR protection of biotech-based inventions are increasing rate of bio-piracy, depletion of indigenous genetic resources, blocking of further research etc. As India is a signatory to the GATT Agreement, what we can now do solve theses problems is to make our laws more congenial to Indian environment within the available limits of TRIPS, making use of the flexibilities therein and also by interpreting the law to suit this objective. One mode of achieving this objective is to strictly interpret the patentability requirements such as novelty, inventive-step and industrial application. This ensures that knowledge already in the public domain is not allowed to be privatized and it could, to a large extent, remove the blocking on further research. Attempts could also be made to enforce the obligation under Convention on Biological Diversity (CBD) to allow access to genetic resources only after getting prior informed consent from the owners of genetic resources and associated traditional knowledge and disclosing the source and origin of the genetic resource and traditional knowledge and after agreeing to share the benefits arising out of the commercial exploitation of such genetic resources. Admitting that intellectual property protection may act as incentive to further research and invention, one should not forget about the ultimate goal of Intellectual property protection, namely, public access to the subject matter of protection at an affordable price. Simultaneously access to genetic resources and associated traditional knowledge also is attempted to be controlled by the Biological Diversity Act, 2002 enacted for implementing the objectives of the CBD.

Introduction

Though biotechnology and research could be dated back to centuries, its relevance in industry and commerce is of very recent origin.  This relevance is due to the modern developments in biotechnology like molecular biotechnology, especially, recombined DNA Technology. Commercial success of biotechnology and increasing private investment in the biotechnological research necessitated IP protection for the successful exploitation of biotechnological research by the industry.  This demand resulted in the inclusion of the TRIPS Agreement in the GATT final text with demands like patent protection for biotechnological inventions, protection of new plant varieties either by patent or by other effective sui generis system etc.

Before the TRIPS Agreement many countries excluded biotechnological inventions from the purview of patentable inventions as such inventions were considered naturally occurring and it was thought unethical to allow monopoly over such products.  However, under the TRIPS it is now mandatory for the member countries to extent patent protection to all fields of technology including biotechnology provided such inventions are new, involving  inventive step  and capable of industrial application. Thus now though plants, animals, essentially biological processes for the production of plants and animals are not patentable, micro-organisms and non-biotechnological and micro-biotechnological processes for the production of plants and animals are patentable.

The major problems with the extensive protection of biotechnological inventions are 1) Blocking of further research by diluting the patentability standards like novelty, inventive step and industrial application, 2) increasing cost of product of  biotechnological research making them unaffordable to the common man; (3) increasing tendency to indulge in bio-piracy i.e., plundering of genetic resources and associated traditional knowledge without consent and without  remunerating  its holders/owners (4) depletion of indigenous genetic resources etc.

These problems, however, could be solved to some extent by making full use of the flexibilities available in the TRIPS agreement in national IP laws.  Though the TRIPS agreements has stated that biotechnological inventions are to be given patent protection, it does not lay down the standard of novelty, inventive step and industrial application.  If the standards of novelty and inventive step in the national patent law is made stricter, minor modifications or minor innovations will be excluded from patent protection and thus it reduces the blocking Effect of Patent Protection

The novelty requirement under the patent Act excludes inventions which is published or used prior to the filing of patents.  The inventive step requirement demands that inventions, to be patented, should not be obvious to a “person skilled in the art” in the light of prior knowledge or information.  An invention could be considered as obvious to a person skilled in the art if it is an expected result of the research.  The main problem with biotechnological research is that mostly the results of such researches are expected and the researcher’s skill lies in successfully accomplishing the result which is the real tough job in the biotechnological researches.  However, a strict definition of patentability standards avoid monopolization of knowledge in the public domain under the guise of minor modifications.

India tries to accomplish this result by rendering the novelty & inventive step standards comparably strict.  In order to satisfy the inventive step standard, under Indian law, the invention should have technical advancement as compared to existing knowledge or economic significance on both.  Similarly mere discovery of a new form of a known substance or any new property or new use for a known substance etc are considered as non-patentable.  It also excludes methods of agriculture or horticulture, from patentable inventions.  Any process for the medicinal, surgical, curative or diagnostic techniques for the treatment of animals and human beings one also not patentable.  Similarly, plants, animals, seeds etc are not patentable.

In order to curtail the other risks associated with IP protection of biotechnological inventions the most effective method is to ensure the requirements under the Convention on Biological Diversity (CBD) are effectively complied with.  The CBD, inter alia, insists that the IP protection of inventions based on biological resources are to be in tune with the requirements in the CBD in this respect.  The CBD recognizes national sovereignty of over biological resources. Therefore it stipulates that access to genetic resources and traditional knowledge (T.K) associated with such resources are to be strictly controlled/regulated.  The CBD mandates that such access has to be made only after getting the ‘prior informed consent’ of the Genetic resources and TK.  In order to ensure this, the source and geographical origin of the Genetic Resources (CGRS) and TK has to be disclosed in the patent application.

The CBD also necessitates benefit shaping if the Genetic Resources & TK is commercially exploited or used in producing any form of IP.  Measures to ensure compliance with the CBD requirements are introduced in the patents Act, protection of plant varieties and Farmers’ Right Act, and the biological diversity Act in India.

The Patents Act: The patents Act excludes an invention which is in effect traditional knowledge or which is an aggregation or duplication of known properties of traditionally known components from patent protection.  The Indian patents Act also requires disclosure of source and geographical origin of biological materials in the patent application.  But the Act does not require any such disclosure with respect to any traditional knowledge associated with such genetic resources.  Neither does it require PIC it also does not envisage benefit sharing.  However, in order to ensure compliance with the disclosure requirement the Act has included provisions for opposition to grant of patent if there is no such disclosure.  The Act also provides for revocation of patent if the patent holder fails to disclose or wrongly discloses the source and origin of the biological material.  There is also provision for revoking the patent if the invention is anticipated due to knowledge within my local or indigenous communities in India or elsewhere.

The Biological Diversity Act (BDA): The Biological Diversity Act attempts to regulate access to genetic resources and associated TK and ensures benefit sharing as envisaged by the CBD.  The national Biodiversity Authority (NBA) is entrusted with the duty to grant approval for accessing biological resources by non-citizens or NRIs and for transferring the result of research relating to Biological materials from India for monetary consideration to non-Indians or NRIs.  The power to grant approval to any person for applying for Intellectual Property Rights is also entrusted to the NBA.  NBA has also the duty to ensure that Benefit sharing is agreed upon while accessing biological resources.  And the amount collected by way of benefit sharing has to be deposited in the National Biodiversity Fund if the owners of the biological materials and TK are not identifiable.  If they are identifiable the amount can go directly to them.  However, such a system envisaged under the Biological Diversity Act often proves to be faulty.

Since the mechanism to control access and ensure benefit sharing is highly centralized, more often, there is no effective supervision over these matters.  The State Biodiversity Boards and the Biodiversity Management Committees constituted in the local level are absolutely powerless.  An effective implementation of the provisions in the Act necessitates absolute decentralization.  Only the local level bodies are capable of identifying and controlling bio-piracy.  And the participation of interested persons could ensure the effective working of the system.  The Fund, which is also now centralized, needs to be decentralized.

Protection of Plant Varieties and Farmers Rights Act (PVFRA): For ensuring disclosure requirement, the Act provides that the application for registration should contain 1) Complete passport data of the parental line from which the variety has been derived; 2) Geographical location in India from where the genetic material has been taken; 3) All information relating to contribution of any farmer, village community etc. in developing the variety; 4) Information regarding the use of genetic material conserved by any tribal or rural families. For ensuring benefit sharing it necessitates that 1) after issuing the certificate of registration the Authority invites claims of benefit sharing from any person, group, or govtal or non-govtal organization 2) any person, group, or governmental or non-governmental organization may also file, with the prior permission of the Central Govt., any claim attributable to the contribution of the people of that village or local community 3) The amount in both the cases is recoverable as arrears of land revenue, and shall be deposited by the breeder in the Gene Fund. In order to ensure prior informed consent the Act requires that 1) the application should contain a declaration that the genetic material acquired for breeding has been lawfully acquired and if the information required for registration is not given or if wrong information is given the right granted under the Act can be revoked.

There is also provision in the Act to control terminator technology. For example, every application for registration of new varieties has to be accompanied by an affidavit stating that the variety does not contain any gene or gene sequence involving terminator technology. The Act also excludes varieties which involve any technology which is injurious to life or health of human beings animals or plants, including terminator technology from registrability. There is also provision in the PVFRA to exclude from registration a variety if the commercial exploitation of it is injurious to animal or plant health or environment. The Act enables any person to oppose registration of new varieties on the grounds of public interest and adverse effect on environment.