Examining biotechnology applications: IPO issues draft guidelines

In addition to finalising the guidelines for examination of patent applications related to traditional knowledge and biological materials (for further details please see "IPO releases guidelines for processing traditional knowledge-related patent applications"), on 19th December 2012 the controller general of patents issued draft guidelines for the examination of biotechnology patents. The Indian Patent Office (IPO) has invited comments and suggestions on the guidelines by 11th January 2013 and is expected to publish the finalised guidelines shortly after.

Patents related to biotechnology have been under scrutiny for some time, including product and/or process claims pertaining to polynucleotides or gene sequences (polypeptides or protein sequences), vectors (eg, plasmids), gene constructs or cassettes, gene libraries, host cells, plant and animal tissue culture techniques or pharmaceutical or vaccine compositions.

The draft guidelines issued by the IPO broadly highlight the provisions of Sections 2, 3 and 10 of the Patent Act 1970 with respect to biotechnological inventions. Consistent with the requirements of Section 2(1)(j) of the act, a biotechnological invention must possess the three prerequisites of novelty, inventive step and industrial applicability in order for an application to be granted.

Section 13 (read with Sections 29 to 34) of the act sets down guiding principles for the assessment of novelty of an application. As per the draft guidelines, the product-by-process claims are admissible only if the products themselves fulfil the requirement of patentability over prior art. Establishment of novelty for a product-by-process claim necessitates technical evidence for production of novel products by the process, which have distinct properties over products known in the art. Further, a sequence claim directed to a specific fragment of polynucleotide/polypeptide may be considered novel if prior disclosure of the same sequence does not indicate the activity of the sequence. Although an application for a polynucleotide/polypeptide sequence almost identical to one already disclosed in the prior art may satisfy the novelty requirement, the fulfilment of the inventive step requirement may still cause concern.

The draft examination guidelines for biotechnology-related patent applications provide grounds for the assessment of inventive step or non-obviousness. For example, structurally and functionally similar sequences of polynucleotide/polypeptide are considered to be obvious. Similarly, mutation(s) in known polynucleotide or polypeptide not resulting in a significant change in the activity or function of the nucleotide sequence or the encoded protein thereof is also presumed to be obvious. Thus, the onus to highlight the difference between the encoded protein disclosed in the prior art and that encoded by the claimed DNA lies with the applicant.

Additionally, the draft guidelines mandate a prior art search by the examiner using, among other things, keywords, the International Patent Classification and sequences. The guidelines also instruct the applicant to provide the sequence listing in electronic format. 

In addition, the guidelines prescribe the disclosure of the utility and industrial applicability of an invention in the specification in a distinct and credible manner. For instance, a patent for a gene sequence and/or the protein encoded by it can be granted only if a non-speculative industrial implication of the gene sequence is also disclosed. The industrial implication of a gene sequence can be established by stating the use and/or the significance of the product encoded by the sequence.

Moreover, the guidelines state that a patent for gene fragments or expression sequence tags may be granted only if a credible, specific and substantial use of the expression sequence tag is identified in the application (eg, use as a probe for disease diagnosis).

The draft guidelines also set down grounds for non-patentability, under Section 3 of the act, for biotechnology-related applications. According to the guidelines, issues adversely impacting the environment and affecting public order and morality are not patentable under Section 3(b) (eg, cloning of mammals, modifications in the germline and genetic identity of living organisms, terminator gene technology and use of human embryos). The guidelines underline that products directly isolated from nature such as nucleic acid sequences, proteins and enzymes are not patentable subject matter under Section 3(c) of the act. The section precludes subject matter related to genes which are identified, purified and made available in an isolated form; claims for isolated sequences of nucleic acids or proteins require identification of its utility to prove its industrial applicability. Further, the provisions of Section 3(d) are elaborated by means of an example of three-dimensional or crystal structure of a polypeptide. The guidelines state that a polypeptide sequence is patentable only if it differs significantly in its properties with regards to therapeutic efficacy.

The draft guidelines elaborate on Section 3(e) by stating that a composition comprising a combination of substances naturally occurring in nature is not patentable subject matter unless the synergistic effect of the components is established. Further, agricultural and horticulture practices (eg, a method of spraying insecticide for controlling pests or intercropping) have been included as non-patentable subject matter under Section 3(h) of the act. Moreover, the guidelines emphasise that a method of treatment including diagnostic procedures or method of drug administration either to humans or animals will be caught by Section 3(i). The examples provided in the guidelines also impose a complete bar on the patenting of any gene-based diagnostics. Claims relating to essential biological processes of growing plants or the germination of seeds are objectionable under Section 3(j) of the act. However, microorganisms are exempt from non-patentability and, on reading in conjunction with Section 3(c) of the act, only genetically modified microorganisms can be considered patentable subject matter. In view of non-patentability under Section 3(k), an application pertaining to bioinformatics is susceptible to rejection if the subject matter claimed in an application relates to bioinformatics tools for identification of a purified and isolated DNA sequence with particular sequence identification.

The guidelines mandate disclosure of the best method of performing the invention known to the inventor under Section 10(4) of the act, and further state that there must a set of claim(s) at the end of the specification that define the scope of invention for which protection is sought.

Section 10(5) of the act lays down principles related to the unity of claim or claims of a complete specification by a single inventive concept. According to the guidelines, the subject matter should possess a common special technical feature which must be indicative of a single invention. The draft explains that lack of unity in an application may be evident at two stages: a priori (before consideration of prior art) and a posteriori (after prior art search).The application is liable for rejection on grounds of lack of unity in invention in both of these cases.

The draft guidelines emphasise India’s intention to prevent the misappropriation of biological resources and traditional knowledge by introducing provisions for mandatory prior permission from the National Biodiversity Authority by the applicant for any patent application based on research or any information related to biological resources obtained from India. In addition, the guidelines provide that the patent applications related to traditional knowledge and use of 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 guidelines further state that an application for an invention related to a biological material which cannot be described in a sufficient manner and which is not available to the public is considered to be complete only after the deposit of the material with an international depositary authority under the Budapest Treaty. The deposit should be made before the date of filing of the application in India and a reference of the deposit should also be included in the specification within three months of the date of filing the patent application in the country.

The substantive patent guidelines for biotechnological inventions have made the patentability of inventions in the area more stringent. The subject matter faces restriction in nine of the 15 clauses of non-patentable subject matter under Section 3 of the act. The imposition of stringent requirements and guidelines is intended to bring uniformity to the practice of examining biotechnological applications.