IMPORTANT POINT
The main legal point established is that patent eligibility under Section 3(c) of the Patents Act requires a thorough analysis of the nature and origin of the claimed invention, emphasizing the need to establish novelty and technical advance for synthesized non-living substances.

JUDGMENT :

(Prayer: This Civil Miscellaneous Appeal is filed under Section 117-A of the Patents Act, 1970, praying to set aside the order dated 30 May 2016 and issued by the Respondent in Indian Patent Application No.4718/CHENP/2007 for patent be allowed to proceed to grant.)

Background

1. The appellant assails an order dated 30 May 2016 by which Indian Patent Application No.4718/CHENP/2007, which is the national phase application derived from PCT Application No. PCT/DK06/00166, was rejected.

2. The appellant filed the above mentioned application dated 23 October 2007 for grant of patent in respect of an invention titled “Antibodies against CD38 for Treatment of Multiple Myeloma” by claiming its priority date from US Application No.60/667,579 dated 01 April 2005. Originally, the appellant had made 84 claims. Upon a request being made, the respondent issued the first examination report (FER) on 27 February 2013. In the FER, objections were raised inter alia on the grounds that the claimed invention is obvious in view of prior arts D1-D7; patent ineligible under Section 3(j), 3(e), 3(i) and 3(c) of the Patents Act, 1970 (the Patents Act) in respect of specific claims; and does not comply with Section 10(4) thereof. By response dated 17 January 2014, the appellant dealt with each objection in the FER, revised its claims and submitted a set of 63 amended claims.

3. In the hearing notice issued on 09 April 2014, the respondent maintained many of the objections set out in the FER and, in particular, raised the objection that amended claims 1-44 fall within the scope of Section 3(c) of the Patents Act. Pursuant to a hearing on 28 April 2014, written submissions were filed as an enclosure to communication dated 17 July 2014, and the claims were amended further to a set of 29 claims. Eventually, by order dated 30 May 2016, the application was rejected.

4. In the impugned order, the respondent recorded that the appellant met objections 1, 2(a), 3,4, 6-11 and 13-27 of the hearing notice, but that objections 2(b) [lack of inventive step], 5 [non-compliance with Section 10(4)(c)] and 12[ineligibility under Section 3(c)] were not met. In particular, the respondent concluded that the DNA and protein of claims 1-24 and 25, respectively, were from homo sapiens as per the sequence listing. Hence, it was held that the antibody claimed is the discovery of a naturally existing molecule/substance and, therefore, not patent eligible under section 3(c) of the Patents Act. The present appeal arises in the above facts and circumstances.

Counsel and their contentions

5. Oral arguments on behalf of the appellant were advanced by Mr.Rahul Balaji, learned counsel, assisted by Mr. Vijay Anand and Dr. Meera Venugopal; and on behalf of the respondent by Mr.M.Karthikeyan, learned SPC.

6. Learned counsel for the appellant contended that the appellant's invention is a monoclonal antibody that binds to human CD38, which is a protein antigen expressed on cancerous cells. After providing an overview of the terms necessary to understand the invention by submitting a glossary, he submitted that the antibody comprises light chain and heavy chain variable regions. By pointing out that these regions are referred to as complementarity determining regions (CDRs), he submitted that it is these regions that contain the antigen binding sites. Such antigen binding sites in the CDRs bind to the epitope, which is the specific site of the antigen to which the antibody binds. He next submitted that the patent claim over the antibody is in respect of three light chain variable regions described as VL CDR1, VL CDR2 and VL CDR3 and three heavy chain variable regions described as VH CDR1, VH CDR2 and VH CDR3.

7. With this introduction, learned counsel turned to the impugned order and contended that all three grounds of refusal are untenable. He first dealt with the rejection under Section 3(c) of the Patents Act. After pointing out that this objection was originally raised only in respect of c