Controversial Patent Cases involving Traditional Knowledge and Genetic Resources 

• May 3, 2022
• Maichael Bessada

Turmeric [1]

Turmeric (Curcuma longa) is a plant of the ginger family yielding saffron-colored rhizomes used as a spice for flavoring Indian cooking. It also has properties that make it an effective ingredient in medicines, cosmetics, and color dye. As a medicine, it is traditionally used to heal wounds and rashes.  

• In 1995, two Indian nationals at the University of Mississippi Medical Centre were granted US patent no. 5,401,504 on “use of turmeric in wound healing”.
• The Indian Council of Scientific and Industrial Research (CSIR) requested the US Patent and Trademark Office (USPTO) to re-examine the patent.
• CSIR argued that turmeric has been used for thousands of years for healing wounds and rashes and therefore its medicinal use was not novel.
• Their claim was supported by documentary evidence of traditional knowledge, including an ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association.
• Despite arguments by the patentees, the USPTO upheld the CSIR objections and revoked the patent.

Observations: The turmeric case was a landmark case as it was the first time that a patent based on the traditional knowledge of a developing country had been successfully challenged. The legal costs incurred by India, in this case, have been calculated by the Indian Government to be about US $10,000.

Neem

Neem(Azadirachta indica) is a tree from India and other parts of South and Southeast Asia.  It is now planted across the tropics because of its properties as natural medicine, pesticide, and fertilizer.  Neem extracts can be used against hundreds of pests and fungal diseases that attack food crops; the oil extracted from its seeds is used to treat colds and flu; and mixed in soap, it is believed to offer low-cost relief from malaria, skin diseases, and even meningitis.

• In 1994 the EPO granted European Patent No. 0436257 to the US Corporation W.R. Grace and USDA for a “method for controlling fungi on plants by the aid of a hydrophobic extracted neem oil”.
• In 1995 a group of international NGOs and representatives of Indian farmers filed a legal opposition against the patent.
• They submitted evidence that the fungicidal effect of extracts of neem seeds had been known and used for centuries in Indian agriculture to protect crops, and thus the invention claimed in EP257 was not novel.
• In 1999 the EPO determined that according to the evidence “all features of the present claim have been disclosed to the public prior to the patent application… and [the patent] was considered not to involve an inventive step”.
• The patent was revoked by the EPO in 2000.

Ayahuasca

For generations, shamans of indigenous tribes throughout the Amazon Basin have processed the bark of Banisteriopsis caapi to produce a ceremonial drink known as “ayahuasca”. The shamans use ayahuasca (which means “vine of the soul”) in religious and healing ceremonies to diagnose and treat illnesses, meet with spirits, and divine the future.

An American, Loren Miller obtained US Plant Patent 5,751 in June 1986, granting him rights over an alleged variety of B. caapi he had called “Da Vine”. The patent description stated that the “plant was discovered growing in a domestic garden in the Amazon rain-forest of South America.” The patentee claimed that Da Vine represented a new and distinct variety of B. caapi, primarily because of the flower color.

The Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) – an umbrella organization representing over 400 indigenous groups – learned of the patent in 1994. On their behalf, the Center for International Environmental Law (CIEL) filed a re-examination request on the patent. CIEL protested that a review of the prior art revealed that Da Vine was neither new nor distinct. They argued also that the granting of the patent would be contrary to the public and moral aspects of the Patent Act because of the sacred nature of Banisteriopsis caapi throughout the Amazon region.  Extensive, the new prior art was presented by CIEL, and in November 1999, the USPTO rejected the patent claim agreeing that Da Vine was not distinguishable from the prior art presented by CIEL and therefore the patent should never have been issued. However, further arguments by the patentee persuaded the USPTO to reverse its decision and announce in early 2001 that the patent should stand.

Observation: Because of the date of filing of the patent, it was not covered by the new rules in the US on inter partes re-examination. CIEL was, therefore, unable to comment on the arguments made by the patentee that led to the patent being upheld.

Hoodia Cactus

The San, who live around the Kalahari Desert in southern Africa, have traditionally eaten the Hoodia cactus to stave off hunger and thirst on long hunting trips.  In 1937, a Dutch anthropologist studying the San noted this use of Hoodia.  Scientists at the South African Council for Scientific and Industrial Research (CSIR) only recently found his report and began studying the plant.

In 1995 CSIR patented Hoodia’s appetite-suppressing element (P57). In 1997 they licensed P57 to the UK biotech company, Phytopharm.  In 1998, the pharmaceutical company Pfizer acquired the rights to develop and market P57 as a potential slimming drug and cure for obesity (a market worth more than £6 billion), from Phytopharm for up to $32 million in royalty and milestone payments.

On hearing of the possible exploitation of their traditional knowledge, the San People threatened legal action against the CSIR on grounds of “biopiracy.”  They claimed that their traditional knowledge had been stolen, and CSIR had failed to comply with the rules of the Convention on Biodiversity, which requires the prior informed consent of all stakeholders, including the original discoverers and users.

Phytopharm had conducted extensive inquiries but was unable to find any of the “knowledge holders”. The remaining San was apparently at the time living in a tented camp 1500 miles from their tribal lands. The CSIR claimed they had planned to inform the San of the research and share the benefits, but first wanted to make sure the drug proved successful.

In March 2002, an understanding was reached between the CSIR and the San whereby the San, recognized as the custodians of traditional knowledge associated with the Hoodia plant, will receive a share of any future royalties.  Although the San are likely to receive only a very small percentage of eventual sales, the potential size of the market means that the sum involved could still be substantial.  The drug is unlikely to reach the market before 2006, and may yet fail as it progresses through clinical trials.

Observations: This case would appear to demonstrate that with goodwill on all sides, mutually acceptable arrangements for access and benefit-sharing can be agreed upon. The importance of intellectual property in securing future benefits appears to have been recognized by all parties including the San.

[1] – Integrating Intellectual Property Rights and Development Policy, Report of the Commission on Intellectual Property Rights – London September 2002 – Published by Commission on Intellectual Property Rights- p 76.