Developing Countries Urged To Beat Biopiracy With Patent Examination, Regulatory Frameworks

While World Intellectual Property Organization members seek ways to address the issue of biopiracy, speakers at a side event to this week’s negotiations said the phenomenon is widespread. According to them, very few patent applicants source the origin of the resources they have used and on which they seek claims. Some measures can be taken by countries within the intellectual property system to stem the problem, they said.

The side event, entitled, Tackling Bio-piracy: Policy and Legal Options, was organised by the South Centre and the Third World Network (TWN) on 5 February.

The WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) is meeting from 3-7 February.

Edward Hammond, a researcher specialised in policy issues related to biodiversity, agriculture, infectious disease, and IP rights, presented on two items: some details of recently identified cases of possible misappropriation, and the results of disclosure analysis of 187 recent international patent applications claiming genetic resources.

Among the recently identified cases is a barley gene used by Sapporo, a Japanese brewer, to give its beer a longer shelf life. The patent application dating from 2004 simply referred to the gene as coming from a “landrace” without identifying the country of origin. The gene appears to have come from India.

Another case is an African microbe, a strain of Sorangium cellulosum, that “has yielded a fairly important new cancer drug, which has gained regulatory approval in the United States for use in breast cancer,” he said. The drug “Ixempra” is sold by Bristol Myers Squibb, which showed a US$120 million annual sale for it.

There are also candidate drugs derived from the same microbe under development by Bayer and Novartis, he underlined. This is a case of a microbe “which has yielded lead compounds for three different pharmaceutical companies, all of them large.”

There are now more than 600 international patent applications mentioning this drug in their claims, he said. Although a lot of those patents relate to the administration of the drug, not to the compounds themselves, only five of them “gave any indication of the origin of this microbe.”

The ones which did, asserted that it was “collected on the bank of the Zambezi river,” he said, a river that crosses a large territory and several countries such as Namibia and Mozambique. It appears, according to Hammond, the sample of the microbe may in fact have been collected on a family farm in Orange State, South Africa.

He gave other examples such as a patent from Pioneer Hi-bred International (WO2012112411), which claims a root-specific promoter gene from sorghum. In the patent application, he said the source was identified as BTX623, with no indication on the country of origin or access and benefit sharing measures.

According to Hammond, it appears that BTX623 refers to a cross made in Texas between an Ethiopian sorghum and one “likely” from South African origin.

Study Shows Poor Rate of Disclosure

Hammond also disclosed the results of a study soon to be published by TWN, on 187 international patent applications relating to claims on genetic resources. The search was restricted to a specific class of patents (C12N “Micro-organisms or enzymes”), published from 2010 to 2013.

Using a conservative approach that considered as disclosure any cases where scientific names of species included geographic references, he found that close to three-quarters of the applications contained no disclosure at all.

Improving Search and Application Process

Margo Bagley, professor at the University of Virginia School of Law, said a key issue for developing countries is to improve their search and application process in patent offices. A set of tools could help countries with the issue of misappropriation, she said.

In particular, developing countries should include a requirement for information (RFI) provision in their legislation to require information from applicants, such as the location of origin of genetic material.

Another important tool, she said, is involving third parties. This involves publishing pending applications promptly and inviting third party submissions of prior art, through the education of the public and incentives such as crowd-sourcing initiative Article One Partners (IPW, Innovation, 5 March 2013).

She also advised to enhance the examination of patent applications. Work-sharing, such as “patent prosecution highways,” can be useful, but using other office examination should be considered a floor, not a ceiling, she said. This is because there is no way to know what happens to patents at a collaborating office after examination. For example, she said, some 60 percent of challenged European Patent Office patents were revoked or narrowed, and US courts decisions invalidate “thousands of patents”.

She noted WIPO CASE (Centralized Access to Search and Examination) as a useful tool for developing country patent offices. An initiative born in 2008 between the IP offices of the United Kingdom, Canada and Australia, it is now open to any patent office as accessing office, depositing office, or both, she said.

Also of importance, she said, is the patent claim format in order to avoid claims that are too broad and in some cases, can circumvent restrictions on patentability. She cited the recently challenged Syngenta patent on an insect resistant sweet pepper (IPW, IPW Briefs, 3 February 2014).

Treaties Useful but Institutional Framework Key

According to Biswajit Dhar, director general of the Research and Information System for Developing Countries in New Delhi, very few countries signatory to the Convention on the Biological Diversity have put into place a specific legislation.

He said India for this purpose has enacted the Biological Diversity Act, but this does not prevent commercial entities – which are supposed to get permission from Indian’s national biodiversity authorities – from operating and accessing resources in any other mega-diverse country.

A major problem, he said, is that in mega-diverse countries there is substantial use of bio-resources commercially, in particular in the area of traditional medicines. The challenge is to check these cases of accession without proper rules being followed.

The key issue is the setting up of regulatory structures, he said. Treaty obligations and policies are widely discussed but the implementation is overlooked, he said.

India has a lot of experience to share, he said, and it will be useful for member states to look at countries like India, Brazil and South Africa, which have been making efforts to put into place these kind of legislations to see how the problem of biopiracy can be addressed.

“Adding new instruments will not take us very far unless … you take real serious steps to get the right institutions in place,” he said.

TWN published a book [pdf] in August titled “Biopiracy Watch,” authored by Hammond, presenting a compilation of recent biopiracy cases.