An invention lacks an inventive step if the combination of features is obvious to a person skilled in the art based on existing prior art. While a mosaic of prior art is permissible to establish obviousness, it must be supported by a logical, non-hindsight rationale for the combination.

JUDGMENT

TEJAS KARIA, J

1. This is an Appeal under Section 117A of the Patents Act, 1970 (“Act”) arising out of order dated 10.07.2018 (“Impugned Order”), issued by Assistant Controller of Patents and Designs (“Respondent / Controller”) under Section 15 of the Act rejecting the grant of patent in the matter of the Patent Application No. 1498/DELNP/2011 titled as “SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS” (“Subject Application”).

FACTUAL MATRIX

2. The Appellants, Amylin Pharmaceuticals, LLC and Astrazeneca Pharmaceuticals LP are corporations of United States of America. The Appellants filed the national phase application with Claims 1 to 32 before the Patent Office, Delhi on 01.05.2011 based on the PCT Application No. PCT/US2009/056058 claiming priority from the US Patent Application No. 61/094,381 dated 04.09.2008.

3. Upon receipt of the First Examination Report dated 29.03.2017 (“FER”), the Appellants filed a detailed response to the same on 27.09.2017 along with amended set of claims. Subsequent to the filing of the response to the FER, the Appellants received a hearing notice dated 16.10.2017. The Counsels for the Appellants attended the hearing as scheduled by the learned Controller on 13.11.2017 (“Hearing”) and filed post-hearing written submissions dated 28.11.2017 (“Post-Hearing Written Submissions”) along with amended set of claims.

4. Subsequent to the filing of the Post-Hearing Written Submissions along with the amended set of claims, the learned Controller rejected the grant of the Subject Application vide order dated 10.07.2018.

SUBMISSIONS ON BEHALF OF THE APPELLANTS

5. The learned Counsel for the Appellants submitted that in the Impugned Order, the Respondent had not considered and failed to appreciate the detailed submissions in respect of objections raised in the Hearing under Sections 2(l)(ja) and 3(d) of the Act, in the Post-Hearing Written Submissions and the amended set of claims as filed along with the Post-Hearing Written Submissions. Therefore, the Respondent is not justified in holding that the amended Claims 1 to 19 does not fulfill the requirements of Section 2(l)(ja) of the Act i.e., lacks inventive step and also falls under Section 3(d) of the Act.

6. The learned Counsel for the Appellants further submitted that the Respondent failed to understand the fact that the present invention involves inventive step under Section 2(l)(ja) of the Act in view of cited prior art documents, US 2004/0224030 (“D1”), US 2008/0146490 (“D2”), JAIN R A et al: “Controlled release of drugs from injectable in situ formed biodegradable PLGA microspheres: effect of various formulation variables”, European Journal of Pharmaceutics And Biopharmaceutics, Vol. 50, No. 2, 01.09.2000, (“D3”) and WO 2005/102293 (“D4”). The Respondent held that it would have been obvious to an ordinary person skilled in the art (“PSITA”) at the time the invention was made to utilize pre-mixed formulations comprising active pharmaceutical ingredient exenatide and stability agent sugar as taught by document D2 in microsphere delivery systems taught by document D1. The Respondent also holds that particularly, document D1 does not disclose a pre-mixed formulati