Struggle over Hoodia patent continues

Business Day, Johannesburg: Jul 12, 2006, pg. 6

War rages on for rights to hoodia An indigenous cactus has raised some of the thorniest problems in patent law and rights to traditional knowledge. reports on wrangles over hoodia gordonii LITTLE did the Council for Scientific and Industrial Research (CSIR) suspect when it patented the appetite suppressant substance, P57, in the 1990s, that it was seizing hold of a prickly problem that would not go away anytime soon. The miracle plant that tells your brain you are full was used by San hunters in the deserts of southern Africa. They chewed the pulp of the hoodia gordonii cactus to suppress thirst and hunger. When the CSIR took possession of this age-old herbal knowledge by gaining a patent on the molecule, P57 the active agent in the plant there was an international outcry. Research of indigenous plants had been going on at the CSIR since the 1960s and its scientists isolated the molecule in 1996. Patent hell broke loose. Representatives of San clans demanded restitution of their right to communal intellectual property, supported by a global chorus of well wishers and patent-law critics. It happened while the new democratic SA was on honeymoon. Nothing could have been more embarrassing to the venerable CSIR than the claim that it had ripped off defenceless rural people in an act of biopiracy.

The issue was only settled in 2002 or so everyone thought when the CSIR apologised and ceremonially signed an agreement with the San Council of SA agreeing to pay royalties. The agreement was announced at the World Summit on Sustainable Development after what San council chair Petrus Vaalbooi described as three years of tough negotiations.

By that stage, the CSIR's first potential partner in P57's development and sales, pharmaceutical giant Pfizer, had pulled out, saying the San clans who originated the knowledge no longer existed. The CSIR then signed up another transnational, Phytopharm, as licensee. The San would now receive 8% of milestone payments made by Phytopharm during the drug's clinical development over the next three to four years. They could then earn 6% of all royalties if and when the drug is marketed, possibly in 2008.

Phytopharm is a UK company with a solid reputation for focusing on plant extracts as functional foods and veterinary products. It proceeded to clinical trials and at the same time started plantations to grow sustainable quantities of hoodia gordonii, a rare plant which would certainly be endangered by commercial exploitation.

But by 2003, things had got out of hand. Hoodia preparations in capsule and liquid form were pouring into the marketplace, sold by farmers, fly-by-night internet hucksters, and legitimate nutritional diet supplement companies. Our attorney advised us that the CSIR patent was on the molecule, P57, and not on the plant itself, says Anje van Zyl, a Klerksdorp supplier who sells the product, Hoodia Magic, in SA. The 300mg of capsules retails for about R185-R195 in over-the-counter pharmacy sales. The only reason we stopped production in 2005 was that we couldn't get a permit to continue harvesting the plant. We will reapply for a permit later this year and hope to start again. Provincial departments of nature conservation issue permits in terms of conservation laws and the spirit of the Convention on International Trade in Endangered Species of Wild Fauna and Flora. This is an international agreement between governments to ensure that trade in specimens of wild animals and plants does not threaten their survival.

As far as Phytopharm is concerned, the roaring trade in hoodia products is unacceptable. In a recent statement, the company said only Phytopharm's patented product was botanically verified to contain pure hoodia gordonii with quantified levels of the chemical constituents that produce the anti-obesity effects. Importantly, only Phytopharm's hoodia gordonii product has had extensive safety studies performed and been clinically proven to reduce calorie intake and body fat. Phytopharm and its marketing partner, Unilever, insist that benefits of the patent go to the San people. And the companies assert their right to ownership. Phytopharm and Unilever are aware of companies that are selling products over the internet and in stores claiming to contain hoodia and causing weight loss. Phytopharm and Unilever are in discussion with the authorities concerning this development. Trouble is, the patented product is not yet on the market. The necessary clinical trials and other studies to ensure the safety of the extract will take a few years before a product will be available, says the Phytopharm statement. Meantime, all of the hoodia products that are on sale seek to bypass the patent. Isolation of the molecule requires complex processes that do not apply to the raw plant extract. Though it is possible to get a patent on a rare and unusual use of a natural plant, it is difficult to acquire and defend such patents. Molecules seemed a safer bet, until now.

While the patent holders follow the medical route for approvals, the fat is literally burning up in the marketplace. MIMS News Service MIMS is SA's leading independent publisher of medical reference information. In its 45-year history, it has built a reputation as a credible source of information on medicines and the management of medical conditions. It has also branched out into the consumer arena with reference publications.