Nick Papadimitriou rounds up worldwide
The anthrax attacks in the US made ciprofloxacin hydrochloride, traded as Cipro, a prescription antibiotic, the most sought-after remedy in the land. Produced by German company Bayer AG, Cipro is subject to strict patent protection in the US and elsewhere.
US senator for New York, Charles Schumer was the first to call for a generic version of the drug to be made available. He approached India’s Ranbaxy laboratories. The US government response was muted even though it would have been possible for them to invoke regulation 28 USC 1498 to issue a compulsory license to competing companies to produce the generic.
Meanwhile Bayer would supply 1.2bn tablets to the US government over the next few months. Each tablet cost $4.67 wholesale and $5.32 for retail buyers, but the US Health Secretary was able to strike a deal with Bayer for $0.9 per pill. A Polish-produced generic can cost as little as 25 cents. Public demand for Cipro was such that some drug stores began charging as much as $700 for a two-month supply that could be got for $20 in foreign markets.
Canada’s health officials came out saying that they would suspend Bayer’s patent so that generic drugmakers could produce a sufficient quantity to safeguard the public. Bayer assured the Canadian government that supplies of Cipro would be forthcoming and warned that ordering a cheap alternative "sets a dangerous precedent" to "bypass the legislative framework". Apotex, the company approached to produce the generic asked, "do we let people die because of a patent?" and offered to reimburse Bayer for any patents breach.
This about-face on drug patents throws into sharp relief the West’s indifference to the plight of sub-Saharan Africa where attempts to produce generics of anti-AIDS drugs met with intense resistance from US and European drug producers.
In the meantime, lawyers began a nation wide class action on behalf of all persons in the US who purchased Cipro at any time since January 1997. Citing US monopoly laws, plaintiffs claim that Bayer paid potential rivals Barr Laboratories and Hoechst Marion Roussel. $50m per year not to produce Cipro, thus depriving people of cheaper generics. The shares of many US biotech companies rose steeply in the wake of the anthrax attacks.
Cipro is only one of a plethora of drugs for which companies stand to be granted lucrative patent extensions by the US government, says a report published by watchdog Public Citizen. The drug industry has been lobbying congress to pass legislation allowing them an additional six-month monopoly on select drugs if they test their products for safety in children. The drug tests will cost the industry about $727m but will earn patent-holding companies an extra $29.6bn in sales. Bayer would make an extra $358m in sales due to the extension of the patent for Cipro. Bayer, who spent $3.7m on campaign contributions and on lobbying for the legislation, would gain a 100% return on this expenditure in just two days as a result of the patent extension.
Public Citizen points out that The Coalition for Children’s Health who also lobbied for the patent extension, is chaired by a former drug industry lobbyist and contains several working groups funded by the drug industry.
A report released by Greenpeace accused Monsanto of trying to monopolise the world’s soya. Monsanto had laid claim to patent rights over a naturally occurring gene-sequence discovered in wild soya originating in China. The sequence connects to yield characteristics in the food plant and would have effectively given Monsanto exclusive rights to plants, seeds and progeny exhibiting high yield traits.
The patent application was filed simultaneously in over a hundred countries apart from Europe and US. The patent would have particular ramifications for China, source of 90% of the world’s strains of wild soya. Sze Ping Lo of Greenpeace China was appalled by the affair. "Monsanto is a ruthless biopirate. The company tries to hijack the genetic resources of a major food crop - basing their claim on a discovery of a gene sequence found in nature," she said.
The patent has not yet been approved and the European Patent Office in Munich has raised doubts about its validity in their initial evaluation.
In India, a parliamentary committee, convened to bring Indian patent laws in line with WTO commitments by 2005, has withheld recognition of product patents for pharmaceuticals.
While patents will apply to the way drugs are actually produced, the drugs themselves are now open to duplication as generics, provided the methods of making them are different. This will allow India to provide cheap drugs in large quantities to the developing world.
US producers are threatened with being undercut in their home markets.
"Low-cost Indian generic drugmakers have major advantages in the US market, and this change will allow them to retain an edge" said one Indian official representing the Indian Pharmaceutical Alliance.
But Ranjit Shahani of the Organisation of Pharmaceutical Producers of India, an organisation dominated by multinationals, was less positive. "This will continue to deter foreign investment…and will not stimulate research," he complained.
Despite the committee’s failure to comply with WTO requirements, the decision accords well with last November’s Doha agreement whereby cheap generics can be made available to the developing world in the event of crises such as the AIDS epidemic in South Africa.
India has worked out a bill to put the WTO rules into national law. Uniquely, the bill integrates farmers’ interest besides the usual plant breeders’ rights, so they have full control over production and commercialisation. The 50 million farmers in India would have the right to save and sell seeds produced in their farms "including seeds of a variety protected under this act", as long as the seeds are not sold under the breeder’s registered name. Already claimed by several NGOs as a sui generis legislation, this is an attempt to protect local farming, which is important for the food security at the national level. The Indian legislation is regarded as a good model for other developing countries.
Multinational companies like Syngenta or Monsanto also welcomed the bill, because hybrid varieties lose vigour after one season and farmers will still have to buy seeds every year.
Other key aspects of the bill are the ban on terminator technology and establishment of a National Gene Fund, to which breeders using farmers’ varieties or original traditional varieties to breed new varieties will have to pay a royalty.
In a move compared to "putting Dracula in charge of a blood bank" Japan Tobacco, producers of some of the biggest selling cigarette brands in the world, have struck a deal with US biotech companies for the rights to develop and market new lung cancer vaccines. The deal involves US companies Corixa and Cell Geneseys who have isolated a gene sequence linked to the cancer. In 1999 Corixa granted Japan Tobacco a 3-year license to develop and sell products for treating lung cancer in the US. The sequences are based on human genes taken from lung cancer sufferers.
Another deal with Cell Genesys grants Japan Tobacco sole marketing rights to its genetically engineered cancer vaccine in Japan, Taiwan and Korea. UK Company British Biotech has also received payments from Japan Tobacco towards developing treatments for strokes and heart attacks.
The US Supreme Court upheld the patentability of plants and seeds last December. The 6-2 judgement, with former Monsanto employee Clarence Carter writing for the majority, preserves the hundreds of patents for plants issued by the US Patent and Trademark Office over the last 16 years. The hearing resulted from a case brought by Pioneer Hi-Bred against J.E.M Ag Supply Inc. in 1998 for selling Pioneer corn without its permission. The farm supplier’s lawyer subsequently argued that a special exemption created for farmers in the Plant Variety Act of 1970 made the patenting of plants illegal. As a result the federal judge dealing with the case forwarded it to the Supreme Court.
A patent on a yellow bean variety has disrupted export markets from Mexican bean growers and made it illegal for small US farmers to grow or sell the bean. Larry Proctor, president of PodNers seed co. owns patent # 5,894,079 on the Enola bean variety. He has sued 16 small farmers in Colorado claiming they have infringed his patent. Farmers and civil society organisations have condemned the patent as a textbook case of biopiracy. Proctor admits the bean seed originates from a bag of beans he purchased in Mexico in 1994.
Indigenous people’s organisations and the Action Group on Erosion, Technology and Concentration (ETC, formally RAFI) forced the closure of an attempt by pharmaceutical prospectors to uncover the biochemical secrets of southern Mexico. The so-called "Maya project" launched by the US government initiative "International Cooperative Biodiversity Groups" sent a team from the University of Georgia to Mexico to identify plants with medicinal ingredients and indigenous methods of preparing them. As the local language - Mayan - has no words for "gene" or "patents", the team tried to use theatre to persuade the locals to permit the bio prospecting.
Locals were also encouraged to assist in the process by starting their own botanical gardens. "Prior informed consent" and "the right to say no" are clearly defined as principles in the Convention of Biodiversity. Nevertheless, it took two years for the indigenous people of Chiapas to convince the International Cooperative Biodiversity Groups that no means no.
A potential US patent on Jasmine rice threatens the Thai rice industry. The University of Florida unwittingly released news about breeding work with a Thai Jasmine variety in order to develop a derivative jasmine rice strain that could be grown in the United States.
Back in 1995, the United States Department of Agriculture improperly received seed samples of Thailand’s Jasmine rice from the International Rice Research Institute in the Philippines, ignoring the Material Transfer Agreement. That Trust Agreement obliges the recipient not to patent or otherwise monopolise the donated seed. Now, an official delegation of Thailand consisting of agriculture ministry officials, legal and agricultural experts are visiting the International Rice Research Institute to inquire why the institute, an international science body dedicated to safekeeping of germplasm, gave samples of the Thai rice to a US researcher.
The Jasmine rice is an important export product and is especially important in the northeast, the poorest region of Thailand. The US-bred Jasmine rice could heavily harm their market. If current WTO rules prevail, a US patent on Jasmine varieties would threaten Thailand with trade sanctions.
The European Court of Justice has rejected an attempt by the Netherlands to have EU Directive 98/44/EC annulled. The Directive allows the patenting of biological material. The Netherlands, alongside Norway and Italy who also opposed the directive, argued that no biological material should be patentable. They are now obliged to implement the Directive. But will they comply?
As the one gene-one protein dogma dissolves, a confusing array of possibilities surfaces for the industry. When gene patents are taken out it is usually assumed that the rights extend to the single proteins encoded. However, it is now known that proteins vastly outnumber genes and patent owners of sets of human genes may have to battle for rights to the additional proteins these genes encode. Some US companies such as Incyte and Celera are building their own proteomics facilities to identify and grab the protein variants linked to disease related genes.
Article first published February 2002