Regulation

Impact of traditional knowledge on pharma industry

Dr S K Mitra

Mankind has used natural resources for maintaining health and curing diseases. The plant and animal kingdoms provide numerous pharmaceutically exploitable compositions or compounds. Many of the presently available synthetic or partially synthetic medicines are directly or indirectly derived from natural resources. Well known examples are anti-inflammatory salicylic acid derivatives; narcotic analgesic opioids; anti-malarial quinines; antibiotics like gentamycins, macrolides, beta-lactams (penicillins), tetracyclins; anticoagulants (eg heparin), antihypertensives (reserpines), anti-migraine ergotamines; anti-neoplastics (vincristine, taxols, bleomycins, mitomycins); antitussive codeines, cardiotonic digitalin derivatives, vasoactive escin to name only a few.

Pharmaceutically exploitable compositions of natural origin are first identified by bioprospecting either by random screening methods or by a targeted approach using traditional knowledge. Potentially useful compositions are then studied by pharmacognosy that is the branch of pharmacology dealing with natural drugs and their constituents. Once a pharmacologically active component is identified, improvements are possible either through purification and standardisation (higher purity, known content) or identification of the pharmacophore (the part of the molecule responsible for the therapeutic action) and chemical modification of the lead compound in order to improve receptor selectivity, the efficacy-safety profile and drug pharmacodynamics.

In the past, knowledge of pharmaceutically useful plants and animals were collected from the local populations and specimens of these species were collected and analysed. As a rule, there was no benefit for the holders and providers of traditional knowledge even if such knowledge did lead to commercial exploitation. Traditional knowledge was considered as heritage of the public domain that could be used freely in the creations and innovations, which in turn, gave rise to intellectual property rights. As a matter of fact, the indigenous population very often could not afford any of the 'modern' medicaments resulting from their contribution of traditional knowledge (TK).

The term 'traditional' does not imply that it is old or untechnical in nature, but tradition-based; it reflects the information that people in a given community have developed over time based on experience and adaptation to a local culture and environment. The term traditional refers also to the way the knowledge is created, preserved and disseminated. It is now recognised that TK is not static or fossilised. Every successive generation creates new knowledge. It is intimately linked to the biodiversity of local biotopes. Traditional communities have conserved but are not necessarily collective. Given the highly diverse and dynamic nature of traditional knowledge, it may not be possible to develop a singular and exclusive definition of the term. The concept of TK is conceived rather broadly, similar to the concept of 'invention'.

With the emergence of new technologies in applied biology, as for example-improved methods of bioprospecting, the possibilities of ex-situ utilisation of indigenous (genetic) resources and associated traditional knowledge are increasing. Traditional knowledge and especially traditional medicine has the potential of being translated into substantial commercial and humanitarian benefits by providing leads for development of useful products and processes in sectors like, botanical medicines industry, pharmaceutical industry, seeds industry for crop development, horticulture, crop protection industry, cosmetics and natural personal care industry and biotechnology industries in fields other than healthcare and agriculture.

Like in any industry, this utilisation begins with certain raw materials, which are processed through several steps of value-addition in order to produce a final product of potential commercial value. At each of these stages, human innovation and creativity and investments in research and development add value development; add value to the initial resource. However, if access to TK, including traditional medicine, is to be increased substantially, the natural (initial) resources, upon which such products and therapies depend, must be protected in order to prevent eg over-harvesting of wild plant populations and the ecological consequences. The biodiversity of the plant and animal kingdoms must be preserved as a source of potential future benefits for the local population and mankind as a whole, because of the strong interrelation between TK and biodiversity, one aspect of protecting TK lies in the conservation of biological divesity, the sustainable use of its components and fair and equitable sharing of benefits arising out of the utilisation of (genetic) resources, this is the aim of The Biodiversity Act 2002 and Rules 2004.

It is thus largely acknowledged that a share of benefits must accrue to creators and holders of traditional knowledge because of their initial contribution to the successive stages of value addition leading to the commercial exploitation and humanitarian benefits of the final health care product. The traditional way knowledge is created, preserved and disseminated in particular communities is quite different from the way intellectual property is handled in eg the EU or the US. The individuals and communities who excel and who have particular skills and knowledge related to traditional knowledge should be attributed rights for their contributions in order to promote and reward excellence and ensure equitable sharing of benefits. The ongoing debate regarding protection of traditional knowledge involves the different aspects of intellectual property rights like trademark, geographical indication, patent, copyright and related rights, trade secrecy agreements, plant variety protection, defensive disclosures including national laws and international treaties.

One of the existing standards of protecting intellectual property is the patent system. The patent system was not established with the particular aim of protecting the rights of holders of traditional knowledge against unauthorised use of such knowledge. However, if correctly applied, it prevents patenting of traditional knowledge. The general aim of the patent system is to promote innovation by granting an exclusive right to the inventor for a certain period of time in exchange for disclosing the invention.

An invention shall be considered to be new if it does not form part of the state of the art—the state of the art shall be held to comprise everything made available to the public by means of a written or oral description by use or in any other way before the date of filling of the Indian patent application. Traditional knowledge, published or unpublished, but previously used, forms part of the state of the art. Consequently, traditional knowledge, if available to the public, fails to satisfy the criteria for patent protection (lack of novelty.) When the criterion of novelty is applied strictly, no patent will be granted on traditional knowledge and there will be no interference between the patent system and traditional knowledge holders (no negative effects to holders of TK).

However, the particular problem arising here for the search examiner is that prior art with respect to traditional knowledge is not always easily accessible. Another problem is that the laws of some countries do not consider information disclosed abroad in a non-written form to constitute prior art, which made it impossible in these countries to prevent the grant of patents for inventions known to traditional communities.

One possibility to prevent biopiracy at an early stage of the patent procedure is provided for in the The Patents Act, 1970, Section 25(1)—Observations by third parties :

(1) Following the publication of the Indian patent application, any person may present observations concerning the patentability of the invention in respect of which the application has been filed. Such observations must be filed in writing and must include a statement of the grounds on which they are based. That person shall be a party to the proceedings before the Indian Patent Office.

(2) The observations referred to in paragraph one shall be communicated to the applicant for or proprietor of the patent who may comment on them.

However, third party observation requires a constant survey of published applications, a tedious task. Furthermore, it is the task of the patent office to retrieve relevant prior art in order to guarantee the validity of granted patents and the legal rights and legal security of the public, including traditional knowledge holders. In some cases, traditional knowledge has never been made available to the public, and is therefore, patentable.

In view of above findings and explanations it is clear that traditional knowledge is a useful tool for development of new formulations of drugs in the present IPR era subject to complying of requirements of The Biodiversity Act 2002 for benefit sharing with TK holders.

(The author is Assistant Controller of Patents & Designs, The Patent Office, Government of India-Kolkata)