Patent pangs

BIOTECH: The exclusion of micro-organisms from patent protection would be violative of the TRIPs agreement.

The technical expert group on patent law issues, headed by noted scientist R A Mashelkar, has recommended in its report presented to the government recently that micro-organisms should not be kept outside the patenting purview.

It said the exclusion of micro-organisms per se from patent protection would be violative of the global agreement on trade related intellectual property rights (TRIPs). It has recommended that guidelines should be evolved to ensure that only micro-organisms modified by substantial human intervention are patented.

The biotechnology-related industry, notably the pharmaceutical sector, feels that this recommendation, if accepted, would have far reaching implications for the entire bio-science sector.

Microbes have tremendous commercial value as donors of genes, antibiotics, enzymes, proteins and other useful ingredients. Though they are available in abundance in nature, a sizeable chunk of them is, in any case, patent-protected by companies abroad.

If the validity of such patents is extended to India as well through the amendment of the present patent act, Indian companies may be denied access to many of these micro-organisms for developing new drugs, the industry feels.

According to Indian Council of Agricultural Research (ICAR) principal scientist P L Tandon, an estimated 86 per cent of the global microbial collections are held in industrialised nations.

The US-based Type Culture Collection, the world's biggest microbial culture collection, contains thousands of specimens. Many of these are subject to patent claims by pharmaceutical companies such as Bristol-Mayer, Pfizer, Eli Lilly and others.

However, the present intellectual property regime for micro-organisms is a little vague, being governed by several treaties. The global Convention of Biological Diversity, which applies to most natural germplasms, excludes from its scope all ex-situ germplasm collected prior to the convention coming into force in 1993.

"This clearly means that all microbial collections, the vast majority of which are located in the industrial world, are the legal property of the depositor and not the donor country, regardless of where the germplasm was collected", Tandon points out.

But Section 5 of Article 27.2 of TRIPs stipulates that the micro-organisms may not be excluded from patent protection. All WTO member countries are, therefore, obliged to adopt and implement patent laws for microbes and biotechnology processes applied to them.

Patent culture depositories are regulated globally also by the Budapest Treaty on international recognition of the deposit of micro-organisms for the purpose of patent procedure administered by the World Intellectual Property Organisation (WIPO) in Geneva.

This apart, a network of microbial resource centres for the developing world (MIRCENs) was established in the early 1970s by the UN Environment Programme (UNEP) and UNESCO.

But, despite all this, says Tandon, "there are no policies in place to protect microbials genetic resources from privatisation or to ensure equitable exchange of microbial genetic resources in culture collections worldwide. Normally, MIRCEN has a policy of free exchange of microbial materials within the network, but each MIRCEN may decide on a case-by-case basis."

SNIPPETS

Royalty betrayal
In 1949, Filipino scientist Abelardo Aguilar, an employee of Eli Lilly, gave to the company samples of an antibiotic isolated from soil samples collected in his home province, Iloilo.

Some three years later, the company sent a congratulatory letter to Aguilar promising to name the new anti-biotic "Illosone" after the name of the province where the soil sample containing it was found.

The fast selling drug, erythromycin, sold under the brand name of Illosone, has since earned the company millions of dollars, but neither Aguilar nor the Philippines has received any royalty, according to P L Tandon, intellectual property right expert of the ICAR.

Lab effort
Powerful anti-fungal agent "papuamine" comes from the sponges growing on a coral reef off the coast of Papua New Guinea.

But since these sponges normally yield only very small quantities of the antifungal agent, Myco Pharmaceutical (USA) is reportedly attempting to synthesise papuamine in the laboratory.

Gut effect
Bacteria found in the whale gut from the last legally allowed Eskimo whale hunt are believed to be capable of breaking down toxic petrochemicals.

A scientist of the Oregan State University is said to have applied for seeking patent on some of the gut bacteria of this whale.