Biopiracy Killer App?

The Traditional Knowledge Digital Library, (TKDL), almost five years in development during which it translated and coded nearly 200,000 traditional Indian formulations, has begun challenging overseas patents it believes are pirated from traditional Indian medical formulations and having them overturned at an uncharacteristic clip. In recent months, the European Patent Office (EPO) set aside two patents and seven other companies quickly abandoned their applications after TDKL challenged 35 patent claims with the EPO.

Says V K Gupta, director of TKDL, “In the balance 25 cases or so, we are confident that they will get rejected or the applicants will withdraw.” Over the next several weeks the library will be setting its sights on the United States. Gupta plans to file third party objections with the U.S. Patent and Trademark Office against 31 patents and exudes confidence that all those patents will either be revoked or withdrawn within a matter of months.

TDKL’s effectiveness is remarkable compared to previous biopirated patent challenges, which typically took more than 10 years to resolve. For instance, the battle to overturn American chemical conglomerate W R Grace’s patent of the insecticide properties of neem, which was copied from the commonly known and used practices of Indian farmers, was waged for a full decade. Two other celebrated biopiracy disputes involving Mexico’s Enola beans and American agricultural giant Monsanto’s soybean patents were fought for 10 and 13 years respectively at a cost of millions of dollars. By contrast, the EPO set aside its intention to grant a patent to the Italian company Data Medica Padova for an anticancer drug Pistacia Vera in a week and to a Spanish company Perdix Eurogroup for an anti-vitiligo cream in just three weeks of TKDL submissions demonstrating that the products were already used in traditional Indian medications and thus lacked the “novelty and inventive step,” which is required to secure a patent. Likewise, seven multinationals, including Unilever, abandoned their challenged patents in a matter of three to 11 weeks after the first representations against them by TKDL (see sidebar).

The library documents the “prior art,” the term used for evidence of previous existence of the knowledge, which precludes the granting of a patent under international patent law, since a patent requires that a claimant demonstrate either a novelty or an inventive step in the product.

Gupta expects that in 2010, “We may get 250 cases reversed at zero cost to us,” compared to the 15 to 20 patent reversals achieved by government and community activists who had to fight “through complex legal procedures” over the past decade.

More importantly, Gupta claims that in the past four months, because multinationals fear being tripped up by the TDKL, the number of patent applications copied from Indian traditional medicines submitted to patent offices have declined 44 percent. He boasts: “Basically biopiracy is completely addressed. As far as India is concerned we have solved the problem of biopiracy 100 percent.”

TKDL a joint project of the Council of Scientific & Industrial Research (CSIR) and the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy (AYUSH), patiently transcribed, translated, digitized and classified more than 200,000 formulations from 148 classical texts of the Ayurveda, Unani and Siddha medicine systems over several years. The 30-million-page database, developed at a cost of $1.5 million, is available in five international languages, English, German, French, Japanese and Spanish, and uses a classification system that matches international patent classifications.

TKDL has also signed access agreements with the EPO, USPTO and the German Patent Office, allowing their patent examiners access to TKDL while reviewing patent applications. It expects to sign similar agreements with other patent offices and expand the library’s database to 50 million pages with 173 additional texts covering a total of 350,000 medicinal formulations over the next two years.

The national agreements and the uniform translations and matching classifications of the evidence have given the TDKL’s challenges credibility and clout with patent examiners. TKDL is such a “great weapon that there is not much scope for NGOs,” who have traditionally led the biopiracy wars, Gupta says. “Now the whole world is looking at us to replicate the system. We have established ourselves the undisputed leaders.”

The library is offering its technical expertise to other countries seeking to establish their own traditional knowledge databases and Gupta insists that once the 70 countries most impacted by biopiracy implement similar libraries, “The biopiracy debate will be over and if multinationals want this knowledge they will have to come through the front doors and pay upfront.”

Patrick Roy Mooney, executive director of the ETC Group, a Canadian nonprofit that is a global leader in the biodiversity movement and which sponsors the annual Captain Hook awards for biopiracy, says that while TDKL’s approach is helpful, it’s absurd to believe that it resolves the problem: “I think there is no way this problem can be solved so easily as there are so many ways and routes, so many channels around these things these days. It’s just not realistic. In the absence of a global agreement, there is no way this is going to be resolved by a single country.”

Vandana Shiva, founder of India’s Navdanya Research Foundation for Science, Technology and Ecology, which led several international campaigns against biopiracy, including that of neem, Basmati and other products, likewise, ridicules Gupta’s contention that the TKDL is some kind of silver bullet in the biopiracy wars. “Whatever is being digitalized is the evidence. It doesn’t become evidence because it is in digital form. So I think it is a misconception to imagine that just putting it into the digital form now adds additional weight, because absolutely the same material in black and white is available, which is how it would have been taken to the court.”

She is also critical of the TKDL, which is only accessible to foreign patent offices under access agreements, for not making the library available to the Indian public: “Why is it that we have a secret of our national heritage? It should be our public knowledge first. The best defense against bio piracy is in fact to use it and make it more available to the public of India, so more people continue to use it. The more it stays in the public domain as a living tradition the more stupid a piracy claim becomes.”

Mooney also points out that bio products can be easily transported out of a country and not all indigenous knowledge can be recorded or digitized. TKDL’s database is presently limited to just 148 classical texts and the library has no plans to record oral traditions.

In addition, thousands of patents have already been granted. ETC Group’s investigation of plant patents at the Australian patent office in 1998 found that roughly 10% of the patents had elements of biopiracy, many blatant, including several from India. Gupta acknowledges that his library’s analysis concluded that almost 2,000 biopirated patents are filed annually in the West based on Indian formulations, resulting in 20,000 such patents during the past decade alone. It would be impractical to challenge most of these past patents.

Mooney also argues that pharmaceutical companies are presently bio prospecting hundreds of species and often the plants or the knowledge for relatively similar purposes exists in several communities. Once a company determines that a particular plant holds promise, it asks itself which country would be best source or give it the best deal? “So they can barter down to get the cheapest deal. Or they can say that’s pretty interesting, which botanical garden has that already, because a majority of higher level species are found in botanical gardens somewhere in the world in New York, in London, or whatever. So why don’t we go there and get it there instead.”

One “tragedy” of 1992 Bio Diversity Convention, Mooney says, is that everything collected prior to 1994, when the convention came into force, belongs to the country that collected it. Most species and knowledge already reside in some herbarium, botanical garden or zoo or gene bank in the world.

“Increasingly the need for large quantities of botanical materials is declining. You need less and less all the time to be able to find the active ingredient that you really want to develop. You can look for a similar plant in another country. For example, neem can be gotten from the Pacific Islands to the east coast of Africa,” Mooney says.

As a result companies can take the indigenous knowledge from one country and the plant from another or use another plant entirely, adjusting it to serve the same medicinal purpose. Mooney cites the example of an anti cancer compound from Madagascar’s periwinkle plant. “They discovered the indigenous knowledge of peoples in Madagascar, but they actually found the same plant species in Hawaii and the Philippines and Jamaica. Finally, I think the plant is from Jamaica and the knowledge came from Madagascar. Now how is that protecting India’s interest? It simply can’t be defended against by a single country. It is silly.”

Resolving the issue of biopiracy, Shiva insists, requires modifying international laws, not a digital library. The American patent system, for example, does not recognize the “prior art” or existing knowledge on the subject of other countries and until that law is changed the problem will remain unresolved, Shiva argues. “Now all the effort the Government of India is undertaking is, like you are saying, by going after nine cases. Well it should spend that kind of effort to just tell the United States that sorry piracy of Indian knowledge is not acceptable, or piracy of Amazonian knowledge or African knowledge.”

Just as India has declared biopiracy illegal under its laws, it should demand that the United States and European countries declare it illegal under their laws as well as in international law, Shiva says. “It will take one line or four sentences. That’s all it takes.”

India now has the international clout to demand changes from the United States, “It’s a very different situation from 1999 when US could bully the rest of the world,” Shiva says. “I think India should exert its power to change U.S. domestic laws because the problem has to be stopped in America.”

Mooney expresses bewilderment and disappointment at the “passive” role of the Indian government in the biopiracy debate. “The absence of India in most of these discussions is amazing. Brazil has been very effective in defending its interest, very aggressively defending, as is Colombia, Mexico. Even Ethiopia has been fairly effective in terms of industrialized countries. Maybe there is an ambiguity in India because it’s got so many researchers, institutions so active in industrialized countries, or there’s a feeling that India has done reasonably well by getting access to other materials.”

Activists, such as Mooney, argue that the best solution lies in an international agreement that guarantees that a proportion of the profits of the pharmaceutical and seed industries are shared with farmers and communities from which the knowledge originated. The pharmaceutical industry is receptive to the idea of profit sharing if the costs are low and reasonable, Mooney says. “I‘ve been surprised as to how open the companies have been to discussing this and taking it seriously. They don’t want to get tangled in complex material transfer agreements that are going to require a team of lawyers. They don’t want to be accused of piracy all the time — that is embarrassing. They want to be on an equal playfield for all of the industry. As long as the transaction costs are low — that’s really important — and the price is reasonable, they know they can pass it on to the consumers.”

Current revenue sharing models being tossed around propose that pharmaceutical companies contribute 1 to 2 percent of their profits to a U.N. fund to be shared with traditional knowledge contributing communities. Shiva contends, however, companies should be required to secure prior informed consent from the contributing communities, who should be free to negotiate the compensation. That would of course make the process far more complicated than the pharmaceutical industry would like. Shiva remains unfazed: “So what if it is complicated. The complication is being created by those who want to commercialize their knowledge rather than go through complicated processes, because life is going on, people are using the plants, they are using the seeds and the crops. It’s a big commercial interest that is interfering in that process. They jolly well should go through a series of hard steps. Why should it be easy for them?”

So just how much progress has been made in addressing biopiracy in the 15 years that it has been in the spotlight? Mooney says, “Obviously none frankly. There is more awareness. In the late 1990s we proved that it was happening. People started to act, but I am not aware of any progress.”

The Problem of Biopiracy The commercial exploitation and patenting of the genetic resources and traditional knowledge and technologies of developing countries by agricultural and pharmaceutical multinationals is considered biopiracy. Industry advocates refer to it by the less pejorative term bioprospecting. Biopiracy critics argue that since the knowledge and practice already exists in traditional cultures, the requirement of novelty or an inventive step is missing for a patent. Many patents have circumvented this requirement because often the “prior art” is unknown to patent examiners as it exists either in oral traditions or texts of unfamiliar languages. Biopiracy is a red button issue in countries such as India, China and Brazil, all which have enormous biodiversity and voluminous tracts on traditional medicines. V K Gupta, director of the Traditional Knowledge Digital Library, recalls, “At the time of the patent by the U.S. patent office, which went into effect in 1995, on the wound healing property of turmeric, our parliament did not function for one week. There was so much emotion involved.” He says there is enormous economic value in this knowledge, “The cost of discovering a new molecule has become very huge. It costs $1.5 billion dollars and takes 15 to 20 years…. Once you have a lead from traditional knowledge, you can develop new medicine in a few million dollars and in a matter of few years. So if someone, some multinational is doing it why would anyone tolerate it. If it is to be done, it should be done by the nation where the knowledge is preserved.” The controversy over biopiracy erupted famously in 1995 after several researchers and companies patented various medicinal and pesticide products derived from the neem tree and turmeric, whose medicinal values have been long known and widely used in India. American chemical giant W R Grace, which had patented a neem insecticide and set up a neem oil extraction plant in India, argued in its defense that the knowledge had not been previously patented or recorded in established academic journals, the most commonly recognized source of “prior art” by U.S. and European patent offices. After worldwide protests and challenges W R Grace’s patent was revoked in 2005. Over a dozen successful public challenges have since been made against several biopirated patents claimed by U.S. and European multinationals and researchers, such as the Mexican enola bean, Basmati rice, turmeric, karela, etc. At the same time, in the past several decades, tens of thousands of patents derived from traditional knowledge have been issued. Canada’s ETC Group, which administers the biannual Captain Hook Awards for biopiracy, reported in 1998 that its analysis found that nearly 10 percent of Australian plant patents were biopirated. Gupta estimates that nearly 2,000 patents derived from traditional Indian medicinal formulations are filed every year in the United States and Europe, which would imply that almost 20,000 such patents have been issued in the past decade alone. Thousands of patents similarly copied from Chinese, Amazonian and African plants have likely been granted.