Francisco A. Laguna & Priya Lamba
Growing up, Priya’s South Aisan family cooked with neem, haldi (turmeric), karela (bitter-gourd), and basmati rice. Raised in Northern Virginia, her family knew that turmeric was a great herbal remedy for the common cold, for evening out skin tone and for cuts and burns. Neem was used for clearing acne and curing dry skin. Karela, a vegetable she did not particularly like as a child, was taken by her grandparents, aunts and uncles to help control diabetes. This was not knowledge gained through research, but rather knowledge imparted by her ancestors, passed on from one generation to the next. It is this type of traditional knowledge that the Indian government and Indian organizations have been arguing is not patentable because it constitutes prior art, lacking any novelty. In the eyes of the Indian government, patenting this type of traditional knowledge amounts to bio-piracy, and the argument has proven to be successful in the United States, Europe as well as India.
When the University of Mississippi Medical Center was granted a patent for the wound-healing properties of turmeric in March 1995, the Indian Council for Scientific and Industrial Research (CSIR) challenged the patent on the grounds that it did not contain prior art because the wound-healing properties of turmeric were common, traditional knowledge in India. The CSIR presented ancient Sanskrit texts as well as a paper published in 1953 in the Journal of the Indian Medical Association documenting this traditional knowledge. The objection was upheld by the USPTO, and the patent was cancelled.
Similarly, when WR Grace and the U.S. Department of Agriculture were granted a patent for an anti-fungal product derived from neem, the EU Parliament’s Green Party, India-based Research Foundation for Science, Technology and Ecology (RFSTE), and the International Federation of Organic Agriculture Movements (IFOAM) challenged the patent on the grounds that the fungicide qualities of neem and its use had been traditional knowledge in India for over 2,000 years. In 2000, the European Patent Office upheld “that the patent amounted to bio-piracy” and that the process for which it was “granted had been actually in use in India from time immemorial.” Although this decision was appealed, the appeal was lost and the patent was successfully revoked in 2005.
More recently, this past November 2012, the Indian government revoked a patent granted by the Indian Patents Office. The patent was for a diabetes medicine made from the extract of jamun (native Indian evergreen tree), lavangpatti, and chandan (sandalwood). The patent was revoked on the grounds that it was prejudicial to the public interest because the use of these plant extracts to control diabetes has long been an integral part of ayurvedic medicine. Avesthagen, the drug maker holding the patent, presented an interesting argument: the patent was not prejudicial and was novel because it scientifically validated Indian traditional knowledge. However, the government held the view “that a patent cannot be granted for validating something that is part of traditional knowledge.” This recent case has led to the challenging of other Indian patents that originated from traditional knowledge, including those granted for the medicinal uses of amla (gooseberry), methi (fenugreek), and ashwagandha (Indian ginseng).
As these cases demonstrate, striking a balance between the protection of traditional knowledge and the promotion of biotechnology continues to be a prevalent issue. Next week, we will discuss the steps India has taken in an effort to achieve this balance.
TransLegal has strategized with clients to work with indigenous communities and achieve benefit sharing agreements for access to genetic samples and their traditional knowledge. Contact us to discuss these and other issues related to bioprospecting in India and other countries.