At present, the requirements for protection provided under international standards for patent law and by most national patent laws are inadequate to protect traditional knowledge and biodiversity. For example, traditional skills in manual and spiritual therapies are different from those in modern practice and there is no record of who was the inventor. Similarly, other traditional non-medication therapies are very difficult to protect using current standards of patent protection.
Existing conventional patent law can and does protect pharmaceutical products. However, herbal medicines and herbal products are different from chemical drugs. The intellectual property standards established by the Agreement of Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (1994) allows innovation to be protected by the discovery of new chemical components, know-how in producing the product, trademarks and trade secrets. However, for herbal medicines it is difficult to meet all the requirements of patentability due to their intrinsic characteristics.
Firstly, herbal medicines are crude plant materials, such as leaves, flowers, fruits, seeds, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered. As such, it is often not possible to obtain existing patent law protection for herbal medicines by claiming the discovery of new chemical entities, which are novel, involve an inventive step and are industrially applicable.
Secondly, herbal products are powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials prepared by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials. The production process is usually simple. There is no know-how or invention in the preparation process that is sophisticated enough to justify protection under existing patent laws.
Thirdly, except for pharmaceutical companies and industries, other holders of traditional knowledge, such as research institutes and practitioners, often do not have the financial and human resources that are necessary to obtain protection through trademarks.
Fourthly, it is extremely difficult, if not impossible, to keep knowledge a secret, because disclosure of the composition of the product is a prerequisite for registration of herbal medicines before the product can be sold.
Fifthly, it is very expensive to acquire, exercise and enforce patent rights in most countries, particularly if international coverage is required. The cost is prohibitive for traditional practitioners and research institutions, particularly in the poorer countries.