The Indian Patent Office (IPO) has issued draft guidelines on examination of biotechnology applications. The guidelines detail illustrative examples on various facets of patentability of biotechnology related inventions, including novelty, inventive step, industrial application, sufficiency of disclosure, clarity of claims and biodiversity related issues.

The patentability of biotechnology related inventions particularly genetic engineering has also been discussed. The details of wording of claims, clarity, support and sufficiency of the disclosure are provided. However, for better understanding of the issues related to novelty and inventive step, a preliminary discussion of claims of biotechnology related inventions are covered. These include the polynucleotides or gene sequences, polypeptides or protein sequences, vectors, gene libraries, host cells, micro-organisms and stem cells plants and animals tissue culture, pharmaceutical or vaccine compositions comprising micro-organisms, proteins, polynucleotides and antibodies or antigen binding fragments thereof monoclonal or polyclonal.

The draft guideline has indicated that while conducting a prior search, the examiner should design a comprehensive search strategy by combining various search parameters including key words, IPC, sequences, etc. and thorough search should be carried out in patent as well as non-patent databases.

If a patent application discloses sequence listing of nucleotides or amino acids as per Rule 9 (1) of the Patents Rules 2003, the same will also be filed in electronic form. To facilitate the processing of patent applications, the sequence listings should be filed in computer readable format.

In the case of biotechnological inventions the assessment of novelty would be carried out in the same manner as for other inventions. The Manual of Patent Office Practice & Procedure has set out the guidelines for assessment of novelty of inventions under Chapter 8.

According to Section 2 (1) (j) of the Act, an ‘invention’ means a new product or process involving an inventive step and capable of industrial application. An invention will be patentable only if it is new in the light of prior art, or is not anticipated by prior art. The prior art includes all information related to the invention, which is available in any publication before the date of priority of the patent application. For the purpose of examination, an invention will not be new if it forms part of the prior art or has entered the public domain. For anticipation, such publication must be before the date of priority of the patent application.

In order to prevent misappropriation of biological resources and traditional knowledge of India, the Biological Diversity Act requires that access to the biological resources of India is subject to sharing through the approval of National Biodiversity Authority (NBA). No Intellectual Property Rights (IPRs), including patents based on research or information on biological resources obtained from India will be granted without the approval of the NBA.

The Patents Act provides interfaces with the process of obtaining patents and access to and benefit sharing from utilisation of Indian biological resources. Therefore, disclosure of the source and geographical origin of a biological material used in an application for a patent has been made mandatory as per Section 10 (4) of the Act.

Further the patenting of inventions related to traditional knowledge and biological material obtained from India, the instructions issued by the Controller General of Patents, Designs and Trademarks should be strictly followed, stated the draft document.