IMPORTANT POINT
The main legal point established in the judgment is the interpretation of Section 3(c) of the Patents Act, 1970, and its application to the claimed invention. The court's decision clarified the scope of the exclusion under Section 3(c) and its implications for patent protection.

JUDGMENT :

(Prayer: This Civil Miscellaneous Appeal is filed under Section 117-A of the Patents Act, 1970, praying to set aside the order dated 31 January 2018 and issued by the Respondent in Indian Patent Application No.6334/CHENP/2009 for patent be allowed to proceed to grant.)

Background

1. The appellant assails an order dated 31 January 2019 by which Indian Patent Application No.5808/CHENP/2007, which is the national phase application derived from PCT Application No. PCT/US2006/023856, was rejected.

2. The appellant filed the above mentioned application dated 17 December 2007 for grant of patent in respect of an invention titled “Receptor Antagonists for Treatment of Metastatic Bone Cancer” by claiming its priority date from US Application No.60/691,920 dated 17 June 2005. Originally, the appellant had made 80 claims. Upon a request being made, the respondent issued the first examination report (FER) on 10 March 2014. In the FER, objections were raised in respect of claims 1 to 43 and 64 to 80 on the ground that they are not patent-eligible under Section 3 (i) of the Patents Act, 1970 (the Patents Act). As regards claims 44 to 59, the respondent raised objections by relying on the exclusion in Section 3(c) of the Patents Act. With regard to claim 60 to 63, objections were raised under Section 3 (j) of the Patents Act. In addition, other objections were also raised. By response dated 13 February 2015, the appellant revised its claims by deleting claims 1 to 43 and 64 to 80, and submitting a set of amended claims.

3. Apart from submitting amended claims, the appellant responded to the objections. The objection under Section 3(c) was refuted by contending that the antibody in respect of which claims 44 to 59 were made was not isolated from nature. The appellant asserted that paragraphs [00153] and [00154] of the complete specification clearly recite that the antibody was generated by immunising transgenic mice (engineered mice) that express human gamma heavy and kappa light immunoglobulin (Ig) chains with porcine aortic endothelial (PAE) cells expressing plateletderived growth factor receptor alpha(PGDFR alpha), which were subsequently boosted with PGDFR alpha extracellular domain (ECD). The appellant further asserted that the material generated in response by such transgenic mice was extracted from the cells of the spleen of the mice, fused with immortal myeloma cells by using hybridoma technology so as to produce the antibody therefrom through the processes of cloning and chromatography. Thus, the appellant asserted that the antibody was not isolated from nature and that the above-mentioned chain of events does not occur in nature. On the above basis, the appellant called upon the respondent to withdraw the objection.

4. In the hearing notice issued on 20 November 2017, the respondent maintained all the objections set out in paragraphs 2 to 7 of the FER. The hearing notice was responded to on 10 January 2018. In the said reply, the appellant asserted that the amended claims annexed thereto are in respect of a recombinant antibody or antibody fragment specific for human PDGFR alpha. It was also submitted that immunisation, somatic recombination and selection were all absolutely necessary to engineer the claimed antibody. The appellant further asserted that engineered PAE cells expressing human PDGFR alpha and recombinant PDGFR alpha ECD were used as antigens during immunisation of the mice, and that these antigens do not normally exist in nature. By pointing out that three different species are involved in the process, it was reiterated that the antibody was neither naturally occurring nor isolated from a human being. The appellant further submitted that the antibody does not freely occur in nature because PDGFR alpha is necessary for embryonic development and, consequently, the natural production of an antibody by the human body to the PGDFR alpha would impede and arrest embryonic development.

5. In the impugned order, the respond