Even after India’s attempt to remove traditional knowledge (TK) from the list of things that can be patented, Indian Patent Office is granting patents on the use of TK of India which is related the Ayurveda, Unani and Siddha systems of medicine, and patents are also being granted on inventions related to biological resources obtained from India without taking adequate care. This is being done in spite of the fact that International Patent Offices are objecting to the grant of such patents on the basis of prior art evidence which they get from Traditional Knowledge Digital Library (TKDL).
INTRODUCTION TO TK According to the definition of TK, it is already in public domain and thus, it does not qualify as an invention under section 2 (1) (j) of the Patents Act, 1970 according to which “invention means a new product or process involving an inventive step and capable of industrial application”. Section 3(e) of the Patents Act states “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or process for producing such substances” is not an invention and is not patentable.
For Biological resources, section 6 (1) of Biological Diversity Act, 2003 clearly states that, “no person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of National Biodiversity Authority before making such application; provided that, if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned; provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof”.
OPPOSITION TO TK AND BIOLOGICAL MATERIAL
Under section 15 and in pre grant opposition under clauses (d), (f) and (k) of section 25 (2) of the Patents Act, 1970, patent application related to TK or biological material can be refused. These patents can also be refused for nondisclosure or wrong mention of the source or geographical origin under clause (j) of Sections 25 (1) and 25 (2) respectively of the Patents Act, 1970.
Due to negligence of Examiners of Indian Patent Office on the patent applications related to TK and biological sources, Indian Patent Office have laid down new guidelines for the examiners which are related to screening, allotment and examination. Complete notice can be read at official website of CGPDTM.
Guidelines for Screening Indian Patent Office has asked examiners to correctly identify, screen and classify patent applications related to TK as “Traditional Knowledge” by RECS Section. It is the duty of the RECS in-charge that no case of TK is wrongly screened and classified. It is the duty of the examiner to provide appropriate IPC to these patent applications so that these applications can be properly routed for examination to the respective groups such as Chemistry, Pharmaceuticals, Agrochemicals, Biotechnology, Microbiology, Biochemistry, Food, Mechanical, etc. e.g., C07D, C07G5/00 (for Chemical) etc. If applications are not screened or classified properly than that application should be brought to the notice of the Group Leader by the concerned Examiner/Controller and re-screening and/or re-classification should be done by the Group Leader (GL) forthwith. I
Guidelines for Allotment In a group, the Group leader will himself act as the Controller for all applications related to TK. The Group leader will ensure that the provisions related to TK are fully complied with. The Group leader will select one examiner from his group for dealing with all applications related to TK. The concerned Group leader and examiner will endeavor to increase their knowledge about TK or biological resources. Any application/case already under process including pre-grant opposition related to TK will be re-allotted to the identified pair in the respective Group. Whenever any Examiner/Controller comes across a case related to TK, he will bring it to the notice of Group leader for re-allotment.
Guidelines for Examination The examiner will have to carry out thorough search for anticipation in TKDL or other databases for every case related to TK or biological material and if any citation is made from TKDL database, then copy of the citation (English translated) has to be sent along with the examination report. Assessment of Novelty and Inventive step According to the Patents Act an invention has to be novel and must contain an inventive step to make it patentable. In case of TK based invention, the following guiding principles have to be followed to assess novelty and inventive step.
Guiding Principle 1: If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be considered as novel and/or inventive when use of such plants is pre-known as part of teachings of Traditional Knowledge.
Guiding Principle 2: Combination of plants with known-therapeutic effect with further plants with the same known-therapeutic agents wherein all plants are previously known for treating the same disease is considered to be an obvious combination.
Guiding Principle 3: In case an ingredient is already known for the treatment of a disease, then it creates a presumption of obviousness that a combination product comprising this known active ingredient would be effective for the treatment of same disease.
Guiding Principle 4: Discovering the Optimum or Workable Ranges of Traditionally known ingredients by Routine experimentation is not inventive.
Guiding Principle 5: In case multiple ingredients are known to have the same therapeutic activity as per traditional knowledge, taking out one single component out of them cannot be considered as inventive.
Guiding Principle 6: In case individual ingredients are already known for the treatment of a disease as a part of Traditional Knowledge, then it is obvious that a combination product comprising these known ingredients with further plants with the same known therapeutic effect would be more effective than each of the medicinal plants when applied separately (additive effect).
NBA permission The applicant is required to furnish a declaration in the Form-1 of the Patent Rules 2003 in which the invention has to be disclosed in the specification and use the biological material from India also to be disclosed and also the necessary permission from the competent authority should be submitted by the applicant before the grant of patent. If the above declaration in Form-1 is not submitted than the Examiner/Controller should raise the objection in the FER about the requirement of permission from NBA in the matter, if already not submitted. If the objection has not been raised in the FER, the same may be raised at any stage thereafter. In any case, the patent cannot be granted unless the NBA permission is submitted by the applicant.