Under the Patent Act, the government of India may revoke a patent if it is of the opinion that the patent or the mode in which it is exercised is prejudicial to the state or the public. In what is thought to be the first of such decisions, on 18th October 2012 the government invalidated Avesthagen’s Patent Number 252093, titled “A Synergistic Ayurvedic/ Functional Food Bioactive Composition (Cincata) and a Process of Preparation Thereof”, on the aforementioned grounds.

Hot on the heels of the invalidation, on 8th November 2012 the Indian Patent Office (IPO) issued draft guidelines on the examination of patent applications related to traditional knowledge and biological material. The IPO has invited comments and suggestions on the guidelines by 22nd November 2012.

Patents related to traditional knowledge have been under scrutiny for some time now. In recent years the Ministry of Health (Government of India) and the Council of Scientific and Industrial Research launched an ambitious project, the Traditional Knowledge Digital Library (TKDL), aimed at digitising and compiling various traditional knowledge resources in India and developing a searchable database of such resources. A number of agreements were reached with several patent offices, such as the US Patent and Trademark Office (USPTO), the European Patent Office (EPO) and the Japan Patent Office, which resulted in the use of citations from the TKDL to question the novelty and inventive step/non-obviousness of various patent applications. Surprisingly, the IPO has never cited the TKDL when objecting to a patent application. Even in the case of Avesthagen’s patent, the IPO did not cite the TKDL in the examination report, whereas the EPO cited portions of the TKDL to object to the grant of EP2152284, the European equivalent of Avesthagen’s Indian patent.

The draft guidelines issued by the IPO start off by highlighting various provisions of the Patent Act which are of relevance to traditional knowledge or biological material-related patent applications. As per the guidelines, the Receipt, Electronic Data Processing, Classification and Screening Section must classify all traditional knowledge-related patent applications as "Traditional Knowledge". In case of an inappropriate classification, a patent examiner or controller may initiate the reclassification of the patent application. A patent application may be further subclassified based on the subject matter into various sub-groups, such as TK-Mechanical, TK-Chemical and TK-Biotechnology.

The draft guidelines mandate a search for prior art to be made for any such traditional knowledge-classified patent application in the TKDL, and instruct the examiner to provide an English translated citation from the TKDL in the examination report. Additionally, the guidelines set down guiding principles for the assessment of novelty which enhance the scope of the test for novelty beyond what is traditionally followed as the “all-elements rule” or the “reverse infringement test”. For example, isolation of extracts or active ingredients from plants known as part of the traditional knowledge is not considered novel over the teachings of traditional knowledge. As an example, the guidelines state that a patent application whose claims relate to an extract of Withania plant comprising Withania alkaloids (eg, Withanolide glycosides, oligosaccharides and Withanolide aglycones) for the management of stress may be presumed to be anticipated even though the TKDL discloses use of Withania somnifera roots, and not Withania plant extract or isolated alkaloids, for the treatment of stress-related disorders in the Ayurveda and Unani systems of medicine.

In addition, draft examination guidelines for traditional knowledge-related patent applications are provided for the assessment of inventive step or non-obviousness. For example, a combination of plants with the same known therapeutic agents is considered to be obvious. Similarly, a combination of ingredients for treatment of a disease is presumed to be obvious if at least one of the ingredients is known as traditional knowledge effective in treating the disease. The guidelines also state that the selection of a single ingredient from among a combination of ingredients known for their therapeutic effect according to traditional knowledge is not inventive. Further, the use of routine experiments to determine optimum or workable ranges of traditionally known ingredients is not inventive.

Patent applications related to traditional knowledge and biological material must also comply with the enablement and best mode requirements of the Patent Act, which include disclosing the source and geographical region of any biological material used in the invention. The draft guidelines also instruct the applicants to declare, in Form -1, that the applicant has used biological material from India and will provide permission from the National Biodiversity Authority (NBA) for using such material to the IPO before grant of the patent. Further, the examiner may object in the first examination report if permission from the NBA is not submitted. If the biological material is not from India, the applicant must state in the patent specification that the biological material is not from India and specify the source and geographical origin of the biological material.

The IPO is also expected to publish a list of all patent applications which have been granted on or later than 1st July 2012 on its website, and to update this list either in real time or at frequent intervals. In July 2012 the IPO website published a list of around 700 patents and patent applications which may relate to traditional knowledge. This may be seen as a precautionary step, as an applicant may object to its patent application being classified as traditional knowledge. The guidelines reinforce India’s intention to protect its traditional knowledge from becoming the subject matter of patents worldwide. As per the TKDL website, the EPO and the USPTO regularly cite TKDL to prevent the grant of frivolous patent applications. The IPO is likely to follow in their footsteps.

This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.