Exploitation of traditional knowledge (TK) and indigenous biological resources (IBRs) such as plants, microbes and genetic materials) of developing countries for the development of new medicinal products or synthetic reproduction of natural products, previously recognized for their therapeutic value, by the research-based companies typically from the developed world is a practice commonly referred to as “bio-prospecting”. This practice when is done unlawfully (i.e. without obtaining the TK or IBRs stakeholder’s prior consent and without compensation or the fair and equitable sharing of the benefit arising out of the utilization of the TK or IBR is termed as “bio-piracy”. The most well-known example of this is the US Patent 5,401,504 (now stands revoked) relating to the medicinal properties of turmeric in wound-healing. Use of turmeric in wound –healing is well-known in Pakistan and India (Indo-Pak) since olden times. Other examples of this sort are – i) US patent 5,663,424 on Basmati rice (a biological diversity of Indo-Pak);  ii) Ayahuasco used by indigenous people of Peruvian Amazon for healing; iii) EP 436257 and US patents referring to the use of Neem tree for medicines and insecticides – a traditional plant of Indo-Pak;  iv) patent applications (not complying with the patentability requirements) filed and/or granted abroad referring to inventions obtained or developed through the use of resources of Peruvian origin (for example LepidiumMeyenii (Maca); hercampuri, Camu camu (Myrciaria Dubia); yacon; caigua; sacha inchi and chancapiedra). 

The Convention on Biological Diversity (CBD) and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITRGRFA) are the two instruments that offer a potential basis to control the use of traditional knowledge (TK) and IBRs; recognize the desirability of access and benefit- sharing relevant to the conservation of biological diversity equitably; acknowledge the need to obtain the stakeholder’s consent to provide and give access to the IBR (the so-called prior informed consent (PIC) and their participation in decision-making relating to the conservation and sustainable use of biological diversity. So far Pakistan has not ratified either of the two instruments, however, to indirectly give effect to the key provisions of CBD, in  the TRIPs compliant legislation regime, the following provisions were introduced in the Patents Ordinance, 2000 (2000 Ordinance):

 Section 13(8) which provides:

 “an application for an invention relating to a genetically modified organism shall require clearance from the Federal Government and shall comply with the requirement as may be prescribed”. 

Section 15(2)(b) which states: 

“Where a biological material is used, the specification shall disclose the place of origin and source of such biological material and also exhibit compliance with the relevant applicable rules on access, export and use of that material and where such a material is obtained from Pakistan for use outside Pakistan, the provision of the Federal Gov’t shall be necessary as may be prescribed”. 

Sanction on failure to comply with the provisions relating to bio-diversity 

While the rules on access, export and use of biological material (plants, micro-organism and genetic materials) are yet to be formulated by the Gov’t of Pakistan yet the refusal or failure to furnish to the Controller any information or statement which is required to furnish by or under the provision of the 2000 Ordinance, is punishable with a fine which may extend to five thousand rupees. On the other hand, if the information or a statement made is false, and which the person either knows or has reason to believe to be false or does not believe to be true, he is liable to be punished with a fine which may extend to fifty thousand rupees.

 Whether contribution of TK adds to “inventivity”

 It is well-recognized that for a contribution to rise to the level of joint-inventorship, the contribution must be concrete and specific. Also, as the law currently formulated mere supply of information or knowledge relating to the medicinal properties or therapeutic values of local plants/herbs, for example; that is traditionally developed and/or already known to the indigenous people may not be qualified as a contribution which is “inventive”. In a debate surrounding the issue whether indigenous people should be compensated for the use of their TK (such as providing information about the medicinal properties of local plants/ herbs; the origin/whereabouts of such plants/herbs; the traditional form of use; identification of starting material etc.) in the creation of inventions,  the question has been raised whether such contribution is of the sort that entitles the TK holder to be named as co-invenor in the determination of structure and composition of the resulting synthetically produced drug, many have ranked the use of information already falling in the public domain as “non-inventive” contribution while the others urged on the need for a parallel system (such as a sui generis system as envisaged by the TRIPs) to reward or compensate the indigenous people for the use that is made of their knowledge.

In accordant with the provisions of section 8(2)(c) of the 2000 Ordinance, “traditionally developed and existing knowledge available or in possession of a local or indigenous community” constitutes part of the “state of the art”. For the sake of better illustration, for example- i) use of neem tree in medicines and insecticides; ii) turmeric for wound-healing; iii) foeniculum vulgare (“Saunf”) for regulation of menstruation, as carminative; iii) solanum  indicum (“Mulli”) in asthma, dry cough; chronic febrile affection; iv) glycyrrhiza glabra (“malathi”) as an antiviral agent, an expectorant in cough and cold preparations; vi) laurus cinamomum (Darchini) in atony of stomach, looseness of bowels with gripping and flatulence; nervous depression; sympathetic nausea and vomiting viii) galega purpurea (Kalonji) as an antioxidant and antimicrobial agent etc. is traditionally known for centuries in the Asian strip including Pakistan. To give access to the IBR to a research group and supply information about its medicinal properties which is then either synthetically reproduced or used for the development of further new drugs is a “non-inventive” contribution. On the other hand, the act of mere isolation and re-production of a natural material, well-known for its properties, synthetically falls amongst the statutory list of subject-mater excluded from patent protection in Pakistan.  

To be anticipatory TK needs not to be “made available to the public” 

The general qualification for a prior disclosure (whether it be in writing, by oral disclosure, by use or in any other way) to be anticipatory is that, it renders the invention “made available to the public”. This means that a novelty attack may fail if the prior art disclosure is inadequate (i.e., non-enabling -failing to teach or give clear and unmistakable direction to enable the person skilled in the art to reproduce/work the invention without undue burden or the necessity of making further experiments). However, with reference to TK (passed down from generation to generation) which has never written down or of which previous disclosure is not proven, enablement in the sense as aforesaid to render the TK a part of the “state of the art” is not a requirement. The mere fact that something is known to and/or in use of the indigenous people or community even without knowledge of the chemical composition or the molecular structure of the actives of the IBRs is all that is required for the TK to fall in the public domain. In this respect, the below observation of Lord Hoffmann in Merrell Dow v. Norton [1996] RPC 76, 88 is referred to that may have impact on the determination of question of TK “made available to the public”:

“I recognize that there is a distinction between cinchona bark (known to Amazonian Indians for centuries to treat malarial and other fevers in the form of powdered bark) and terfenadine (pills of sulphate of quinine: an alkaloid extracted from cinchona bark). The former is a substance occurring in nature and the later is an artificial product. This might have been relevant if the medicinal qualities of the bark had been unknown and a person who discovered them had tried to patent the bark or the natural alkaloid………………………………The quinine example shows that there are descriptions under which something may in a relevant sense be known without anyone being aware of its chemical composition or even that it has an identifiable molecular structure. This proposition is unaffected by whether the substance is natural or artificial”. 

Exclusion of IBRs known to the Indigenous community for their medicinal properties does not extend to “unknowns”

 The statutory requirement that where a biological material is used, the specification shall disclose information about the place of origin and source of the biological material, at one hand, aims to avoid unlawful misappropriation of the IBRs by the research-based companies; while on the other hand, it does have the objective to promote technological innovations. Therefore the said requirement does not restrict the use of IBRs, capable of being protected by IP, for the development of new drugs or for the purpose of bio-prospecting. The patent law, however, makes it incumbent upon the user of IBRs to seek permission from a holder of the IBR (here the Gov’t of Pakistan) to provide or give access to the IBR  as well as comply with the other rules on access, export and use of that material before any research, based on or derived from any IBR can be conducted.  

Scope of protection for inventions making use of IBRs 

Section 15(8) of the 2000 Ordinance provides that for a per se claim to a product, the product must have a structural description and where structural description is not possible as in the case of a biological product, the “product-by-process” claims can be made. This means that protection to a structurally indefinable product is limited to the product obtained with the claimed process only. This is particularly the case in relation to certain biotechnological and biological inventions. Apart from the structural description requirement, for product per se claims, inventions making use biological materials (product of nature) also met with “not a patentable invention” restriction issue. Section 7(2)(e) of the Ordinance provides that “substances that exist in nature or if isolated therefrom” are not regarded as invention that merits protection. Therefore, if the  invention making use of IBR (say a micro-organism known to produce an antibiotic) involves mere reproduction of a previously known and identified product, having a utility well-known to the indigenous people, by the process of  biotechnology or chemical synthesis, it is a “known desiderata”, hence not patentable. On the hand, if the IBR is used to identify a previously unrecognized substance (say a micro-organism or a gene) which is found to have a therapeutic effect or use in gene therapy, it may itself be patentable. However, as the rules on access, export and use of IBR are yet to be formulated, therefore, it is difficult to comment precisely what form of claim(s) may be drafted and scope of protection acquired for inventions that are based on or derived from IBRs.