Essentially Biological Processes as per Section 3(j) of Indian Patent Act, 1970

According to Section 3(j) of the Patents Act, 1970:

"Plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not patentable inventions"

Plant breeders need to protect their genetically modified plants to compensate for the high levels of investment in developing plants with desired genotypic and/or phenotypic trait. The guidelines for examination of Biotechnology applications for patent explicitly state that transgenic/modified microorganisms which do not constitute discovery of living things occurring in nature are patentable subject matter under the Patents Act.

However, the decision (Monsanto Technology LLC v. The Controller of Patents & Designs and Ors., OA/02/2012/PT/DEL) of the Intellectual Property Appellate Board (IPAB) on July 5, 2013, refusing Monsanto’s patent application (2407/DELNP/2006) relating to “method of producing transgenic plant with increased heat tolerance, salt tolerance or drug tolerance” made patent protection an unclear issue in India.

The application was rejected by the controller under Section 3(j) for relating to essential biological processes of regeneration and selection which include growing plants in specific stress conditions; under Section 3(d) for being an application of already known cold shock protein in producing a stress tolerant plant and lack of inventive step as the structure and function of cold shock protein was already known in cited prior art and it is obvious to person skilled in the art.

IPAB concluded that the claimed method included an act of human intervention and that the Controller had erred in finding the method to be an essentially biological process and this set aside the Controller’s rejection of the claims under Section 3(j) but upheld the rejections under Section 3(d) and lack of inventive step.

After this decision, the fate of claims relating to method of obtaining transgenic plants is uncertain. This decision as well as the guidelines for examination of Biotechnology applications for patent fail to elucidate on what is essential biological processes; the extent of human intervention required to make the method of producing transgenic plants not essentially biological and thus patentable. The result of which could be the rejection of any claim which may remotely relate to the growing of plants, germination of seeds etc.

In its decision T 1054/96 (Transgenic plant/NOVARTIS, OJ EPO 1998, 511), Technical Board of Appeal considered following three approaches with regard to the question whether a process can be defined as an essentially biological process excluded under Article 53(b) of EPC:

1.    By analogy with the case law applying to Article 52(4) EPC, only processes comprising exclusively non- biological process steps could be considered as non-essentially biological within the meaning of Article 53(b) EPC.

2.      In T 320/87, it was held that the decision had to be taken on the basis of the essence of the invention taking into account the totality of human intervention, and its impact on the results achieved. As discussed in T 356/93, this would have the consequence that a process containing at least one essential technical step, which could not be carried out without human intervention and which had a decisive impact on the final result, did not fall under the exclusion.

3.      To escape the prohibition of Article 53(b) EPC, the approach adopted in Article 2 No. 2 of the draft EC Biotechnology Directive would require at least one clearly identified non-biological process step but would allow any number of additional essentially biological steps.

However, the decisions of Enlarged Board of Appeal in G 1/08 and G 2/07, overruled the Technical Board’s decision in T 320/87 wherein scope of exclusion under Article 53(b) EPC was extended. The order in G 1/08 and G 2/07 noted: 

1.      A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC. 

2.     Such a process does not escape the of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants. 

3.   If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC.

Thus, if the technical step has a decisive impact on the desired outcome and could not occur without human intervention then it can be concluded that the process as a whole was “not essentially biological”.