In this post Parth Singh, discusses issues surrounding biopiracy in light of the recent order of the Supreme Court in Research Foundation for Science Technology and Ecology & Anr. V Union of India. Parth is a fifth year student at NLS, Bangalore. This is his first submission for the fellowship.
The astounding range of ecosystems which flourish in India have provided India with immense species and genetic diversity rendering India as a mega-diverse country, as per Conservation International. The increasing demand for bio-products over the last few decades has led to commercialisation of Traditional Knowledge (“TK”) associated with bio-resources with deleterious impact on biodiversity and on local communities dependent on TK.
The global North has used IPR to exclude local communities and monopolise commercial exploitation of TK, sparking outrage within the South, with many commentators referring to the act as “Biopiracy”. Biopiracy does not involve the informed consent of local communities or benefit sharing of the money accrued from the commercial exploitation of TK with the local community.
The traditional way of cooperative innovation and community sharing of knowledge has come under severe stress from patent applications across the world by multi-national corporations leveraging the knowledge rights framework created by TRIPS for commercial exploitation. Not only are there compelling economic reasons for protection of TK, there also exist “social” reasons centred on traditions, cultures and knowledge-systems of indigenous and local communities.
The misappropriation of TK from the local communities through the usage of IPR has had a severe impact on India as the Indian society. Traditionally, India did not have structures in place for private ownership of knowledge, rendering it especially vulnerable.
India first woke up to the biological plunder in 1995, when USA granted a patent for medical use of turmeric. The Council of Scientific & Industrial Research (“CSIR”) filed a re-examination claim at the US Patent Office and the patent was invalidated on the grounds of prior art. Ancient scriptures along with a 1953 article in Journal of Indian Medical Association were cited, to establish a lack of novelty. The case was a landmark decision, being the first one wherein, a patent based on TK of a developing country was revoked.
This case, coupled with cases involving neem and basmati had pushed the debate around exploitation of TK to the forefront leading to legislative interventions by the government.
Legal Framework
In 2001, India enacted the Plant Varieties and Farmer’s Rights Act granting exclusive rights to the breeder while stipulating benefit sharing mechanisms U/S 26 (5)(a) between breeders and local communities who were instrumental in bringing about the genetic diversity relied upon by the breeder. Further the Biological Diversity Act was passed in 2002 ( “BDA”) to prevent biopiracy. The BDA created a three-tier implementation structure to regulate access to TK through a National Biodiversity Authority (“Authority”) with heavy restrictions on foreigners and an enhanced role for local communities through the Biodiversity Management Committees.
Section 6 of BDA, 2002 stipulates that no patent application can be filed, in or outside India, without the prior approval of the Authority, if, the underlying research or information comes from Indian biological resources. The BDA, 2002 envisages benefit sharing with local communities through shared IP rights, technology transfer or monetary payment with the mechanism being decided on a case-by-case basis, through, an agreement between the relevant authorities, local communities and applicant. Further, Section 10.4(d)(ii)(D) of the Indian Patents Act, 1970 incorporates “mandatory disclosure” requiring the patent applicant to disclose the source and geographical origin of the biological resource.
Chapati Chor: Monsanto’s wheat patent
In the backdrop of legislative enactments and public anger over biopiracy, the European Patent Office granted a patent on Galahad 7 (Number EP 445929), a wheat variety which relied on a traditional variety from India called Nap Hal in 2003, under the plant category. Due to the low levels of gluten, Nap Hal possessed low viscoelasticity rendering the dough ideal for making chapatis and biscuits, a valued speciality. USA had granted similar patents in 1997 and 1998 for low viscoelasticity wheat blends as US patent number 5859315 and US patent number 5763741.
The matter was discussed in the Parliament as possibility of paying royalties for making biscuits and chapatis became a frightening possibility. The Indian government stated in Parliament that litigation would be imprudent in USA and Europe, given the high costs involved and the fact that the patent would not apply to India as Nap Hal itself had not been patented.
In 2004, a writ of mandamus was filed by Vandana Shiva’s Research Foundation for Science Technology and Ecology at the Supreme Court praying that the court direct the centre to challenge the patenting of wheat before the EPO. The petitioner also prayed for setting up a government body to actively pursue litigation globally against patenting of misappropriated TK. The petitioner averred that the patent specification involved an Indian wheat variety which was a result of indigenous research over thousands of years.
The government submitted that since Nap Hal itself had not covered by the European patent, Nap Hal would be available for Indian researchers and farmers.It maintained that Monsanto could not enforce the patent in India through the Patent Cooperation Treaty, 1970 as the same could not undermine the national legislation of convention countries.
While the Supreme Court issued notices to various government departments, a petition was filed at the EPO by a consortium involving Bharat Krishak Samaj, Navdanya and Greenpeace, Germany for revoking the patent. The EPO withdrew the patent, agreeing with the then patent holders, who had requested a withdrawal citing no commercial viability.
The report by the Co-ordinate Group, set up under the chairmanship of Secretary, Department of Agricultural Research and Education recommended in 2007 that no action be pursued as the huge cost of litigation was unwarranted, given how, one of the two US patents had lapsed in 2007 due to non-payment of maintenance fee while the second one would expire in 2010 and a subsequent affidavit by Indian Council of Agricultural Research reiterated the same.
Noting that the patents in question had all been, either revoked or expired, the Supreme Court dismissed Research Foundation for Science Technology and Ecology & Anr. V Union of India, Writ Petition (Civil)NO. 64 OF 2004 in 2016. The Supreme Court lauded the efforts of the government in combating biopiracy but refused to direct setting up of a board to pursue litigation against patents based on traditional knowledge. In its written order, it requested the petitioner to make a representation to the Central government of its proposals.
TRIPS CBD: Need for Convergence
India submitted a proposal to the TRIPS Council in 2000, advocating mandatory disclosure of the source of biological material and proof of Prior Informed Consent along with mutually agreed benefit sharing agreements before the grant of patents. The proposals came about due to the fact that India’s municipal legislation was helpless in petitions in different jurisdictions for revocation of patents, along with the not so insignificant matter of costs. The possibility of a convergence between the TRIPS council and the 1992 Convention on Biological Diversity (CBD) seems narrow. In fact, WTO refuses to have a briefing for the TRIPS council by the CBD on Nagoya protocol. The Nagoya Protocol is a supplementary agreement signed in 2010 for the fair and equitable sharing of benefits arising out of the utilization of genetic resources even though, it does not mandate disclosures and restricts itself to principles of Prior Informed Consent and benefit sharing.
India cannot afford to rest on its laurels apropos its municipal laws and the coming into force of Nagoya Protocol as the Indian state continues to flounder in its efforts to implement the provisions of the BDA, 2002. There continue to be significant question marks on the enforcement and institution-building capabilities of Indian agencies too. India must be careful that it does not become rigid in its approach as can be gauged from CSIR’s Traditional Knowledge Digital Library initiative, a closed access system for chronicling prior art. In an era of “absolute novelty” wherein, prior public use/sale globally amounts to invalidating prior art, if done so before the filing date, the economic viability of TKDL needs to be assessed but the government’s rigid, path dependent approach has led to more money being sunk into the initiative. In an attempt to prevent Biopiracy, it is necessary that India does not over-compensate as the same would have huge attendant costs for ease of scientific research and development of the agriculture sector.
As things stand today, India is definitely out of the dark days of the 1990s with a comprehensive municipal legislative framework but it must continue to strive for incorporating mandatory disclosures within the framework governed by TRIPS and prepare for possible challenges which would emerge from the recent trend of multi-lateral trade treaties, over and above the WTO.
Image from here
Please note the the request for withdrawal of EP0445929 filed by the patent proprietor on 10.9.2004 did not make any comment on lack of commercial viability. The patent proprietor merely stated that it did not agree with the text of the patent as granted.