Biopiracy: Patenting and commercializing indigenous knowledge
Which of the following statements is incorrect?
1. The use of the spice turmeric for assisting the healing of wounds is recorded in Sanskrit documents over 4000 years old.
2. The use of the spice turmeric for assisting the healing of wounds was granted a U.S. utility patent in 1995.
Sorry – a trick question. Both statements are true. The patent was issued, but later revoked following a legal challenge by India.
Biopiracy is a practice in which traditional knowledge generated and possessed collectively by an indigenous people is commercially exploited without permission from or compensation to said people. Biopiracy is usually practiced by developed countries having limited biodiversity against less-developed countries having robust biological resources.
Is Earth’s biodiversity the common heritage of all peoples, or is it properly associated with geographic, cultural, or historical regions? Ethical and legal issues which one confronts when addressing this problem include:
· Equity – the custodians of traditional knowledge should receive fair compensation.
· Conservation – protection of traditional knowledge and practices contribute to conserving biodiversity and the environment.
· Cultural Practices – protection of traditional practices can be used to increase awareness of the importance of those practices and the people entrusted to maintain them.
· Geographic Identification – given that products and processes can be protected by association with a limited geographic region (e.g., champagne and scotch), on what basis are the regions for traditional knowledge identified/assigned?
Can all of the above be accomplished while respecting the culture and laws of those groups that generated traditional knowledge over hundreds or thousands of years?
There have been significant efforts in international IP law to address the problem of commercial use of traditional knowledge. Perhaps the current treaty with the largest width and depth is the Convention on Biological Diversity (CBD). While representing an impressive attempt to treat the manifold issues associated with balancing commerce and tradition, the CBD has largely been eviscerated by the failure of the US Senate to ratify the treaty, which was signed by President Clinton in 1993.
Not surprisingly, the political issue involves protection of the interests of US-based global biotechnology corporations. Despite continued political pressure, ratification of the CBD seems presently out of sight.
Let’s take a look at additional examples, as there is so little settled law in this area:
Maca (Lepidim meyinii) is a radish-like plant of the mustard family called ‘one of the lost crops of the Incas’ by the US National Research Council. It has been grown by the Andean people for centuries as a food crop and medicinal plant. Among its traditional medical uses is its use as a sexual stimulant and fertility enhancer.
In 2001, the Pure World Botanical Company successfully received a US patent (6,267,995) for making an extract from maca using alcohol to decoct the vital elements. A short translation of the patent abstract would define a process in which crushed maca roots are washed in water to remove an unwanted compound, then extracted using nearly pure alcohol to form a liquor, which can then be concentrated through evaporation. The claims do not address any particular medical use.
According to Dr. Carlos Quiros of the University of California, Davis, a maca extract obtained using an essentially identical extraction process has been used in various Peruvian locales for centuries, where the process and product can still be seen today. While the patent might arguably be considered patentable as an improvement on the traditional process and product, the wide-ranging process and product patent issued by the USPTO is certainly unjustified – you have to invent to obtain a valid patent.
Does traditional knowledge serve as prior art? Under current US patent law, third party uses and sales of an invention in a foreign country do not count as prior art against allowance of a patent. It would appear that the Pure World patent is likely valid under present law, unless a published description of making the maca extract is found.
In 2013, however, the AIA will expand the list of patent bars to include worldwide third party public use and sales. Under this criterion, the Pure World patent would not be valid.
To illustrate the magnitude (and in some cases the silliness) of biopiracy under current law, let’s briefly look at some additional examples:
In 1999, a US patent (5,894,079) was issued for a yellow varietal of the Mexican Mayacoba field bean. Yellow Mayacoba beans have been discovered in 4000-year-old archaeological digs. The claimed bean was cultivated for several generations by self-fertilization and segregating plants with yellow beans until a variety whose yellow color bred true was obtained.
The inventor also received a US Plant Variety Protection Certificate. Combining these protections effectively gave the licensee monopoly protection on all yellow field beans sold in the United States. Following their 10 years of dominating the market and placing a heavy import license fee on yellow beans, an ex parte reexamination certificate was issued on Jan. 25, 2011 that cancelled all claims.
For hundreds of years, the Hoodia cactiform succulents of the Kalahari Desert have been used by the San Bushmen to ward off thirst and hunger on long hunts. Scientists of the Council for Scientific and Industrial Research (CSIR) in South Africa began studying Hoodia after finding a 50-year old report of its medicinal properties. As a result of this study, CSIR isolated and patented the active ingredient of Hoodia (called P57), and licensed the patent to Phytopharm UK, who licensed it to Pfizer for development of a new slimming drug in 1998.
The medicinal fate of P57 is still uncertain – Pfizer has abandoned their research following discovery of harmful side effects. However, when San Bushmen found out about the development and patenting of P57, they threatened legal action for biopiracy, as South Africa, a signatory to the CBD treaty, had not followed the rules of that convention protecting traditional knowledge. In particular the CBD requires the prior informed consent of the original discoverers and users. Fortunately, an agreeable accord was reached between the Bushmen and the CSIR in 2002 that allotted the San a portion of future royalties.
A Native American chieftain once responded to the land claims of European settlers by saying ‘If this is your land, where are your stories?’ The various cultures of mankind differ widely on the meaning of the very basic concepts of property and group identity. Treating all groups with respect is a worthy but difficult goal. The first few steps have been taken.