Biotechnology and the inventions arising out of it have spurred the creative geniuses of many inventors and have played an important role in improving the nation’s health, food supply and environment. To enhance the quality of the patents granted under the biotechnology Indian Patent Office has recently published Guidelines for Examining the Biotechnology applications. The guidelines have been designed in consideration to provide uniform and consistent practice in the examination of patent applications in the field of Biotechnology and the allied subjects under the Patents Act, 1970.
The overview of the listed issues under the guidelines is as follows;
Till 2002, as per the prevailing practice in the Patent Office, patents were not granted for inventions relating to living entities of natural or artificial origin, biological materials or other materials having replicating properties, substances derived from such materials and any processes for the production of living substances/entities including nucleic acids. However, patents could be granted for processes of producing non-living substances by chemical processes, bioconversion and microbiological processes using micro-organisms or biological materials. Now, by publishing this guideline patent office has elaborated the bases of examination procedure to maintain transparency.
In case of product by process claims it is specified that the claimed products cannot be considered novel merely due to the novelty in the processes by which they are produced, but rather novelty can only be established, if technical evidences are provided showing that the modifications in the processes result in other products, which are distinct with regard to their properties over the products known in the prior art. Same way in case of polynucleotide sequences and combination/composition of claims have been described to clear the novelty analysis.
In the case of polypeptide sequence if the sequence is disclosed prior without any indication of its activity would considered as an anticipation but if prior art doesn’t exactly match with the sequence then it is considered as novel and examined further for inventive step. For composition claims also if prior art discloses all the features then the subject matter lacks novelty.
For biotechnological inventions same inventive step principle applies. If a polynucleotide/polypeptide having mutation(s) in a known polynucleotide/polypeptide, which does not result in significant change in activity of the claimed polynucleotide/polypeptide, then the subject matter of such claims cannot be said to be inventive.
According to the guideline minor difference in the yield or activity does not constitute as an unexpected property and makes invention non-obvious.
Apart from novelty and inventive step criteria, the guidelines also describe another important patentability criteria i.e. Industrial application as well. It was elaborated for industrial application that “In the context of the gene sequences, it may be said that whatever ingenuity is involved in discovering a gene sequence, one cannot have a patent for it or a protein encoded by it unless it is disclosed how it can be used. It is therefore necessary to consider whether the invention claimed has a useful purpose and whether the specification identifies any practical way of using it”. Biotechnology deals with living subject matters and involves alteration of genomic materials of organisms and hence guidelines have provided many examples to clarify the examination in case of the inventions falls under Section 3 of the Indian Patent Act in addition.
It can be observed on the whole that while designing the guidelines, the Indian Patent Office has made due care and that can reflect by including issue of “Sufficiency of disclosure, Clarity and Support of the claims and unity of inventions”.
Furthermore, guidelines have covered Biodiversity related issues to consider as important as the other requirements. It is noted that to facilitate biodiversity issues, more emphasis is given on Section 10 of the Patents Act, 1970, according to which disclosure of the source and geographical origin of the biological material is mandatory in an application for patent when the said material is used in the invention. In addition, a declaration by the applicant regarding the required permission from the competent authority (NBA) in Form 1 of the Patents Rules, 2003 is made compulsory by the Indian Patent Office.
Finally, it is always noted that patenting in the field of biotechnology poses challenges to the applicants and hence this specific guidelines provide crystal clear transparency to improve the examination procedure will be helpful to the examiners as well to the applicants.