The need for a systematic manner in conducting pre-grant oppositions and the right to file affidavits of own experts in rebuttal.

JUDGMENT

Prathiba M. Singh, J. (Oral)

1. The present petition has been filed by the Petitioner/Opponent-Natco Pharma Ltd. (hereinafter `Opponent') in respect of pre-grant opposition proceedings against the patent application of Respondent No.4/Applicant- Novartis A.G. (hereinafter `Applicant'). The prayer in the petition is to set aside the order dated 16th September, 2021 passed by the Asst. Controller refusing the Opponent's application seeking cross-examination of the Applicant's witnesses. The reliefs sought are:

"a. A writ in the nature of certiorari quashing/setting aside the Impugned Order dated 16.09.2021, and a writ in the nature of mandamus and/or any other appropriate writ, order or direction, directing the Respondent Authorities to pass appropriate directions to enable the Petitioner an opportunity to cross examine Dr. Michael Motto, Dr. Allan S. Myerson and Dr. Gauri Billa in an expeditious and time bound manner in pre grant opposition proceedings preferred by the Petitioner in Application No. 4412/DELNP/2007; and

b. A writ in the nature of mandamus and/or any other appropriate writ, order or direction, directing the Respondent Authorities to pass appropriate directions to first disposing of the pending Interlocutory Applications I and III, particularly the petition under 137 dated 27.01.2020 preferred by the Respondent No. 4 and the Form-13 with amended claims dated 06.06.2020, respectively; in an expeditious and time bound manner preferred by the Respondent No. 4 in Application No. 4412/DELNP/2007 followed by a final hearing under Section 25(1);

c. For an appropriate writ order or direction restraining the Respondent Authorities from proceeding with the determination/ disposal/ decision on the Patent Application No. 4412/DELNP/2007 during the pendency of the instant Writ Petition;

d. Pass such further order or issue any other appropriate writ(s)/ order(s) further to the Prayers, as to this Hon'ble Court may deem fit and proper;"

2. The background of the present petition is that the Applicant filed PCT application being PCT/US2006/043710 on 8th November, 2006 which had 85 claims (Claim Set 1). Thereafter, Indian application bearing no. 4412/DELNP/2007 titled "PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INIBITOR" was filed on 8th June, 2007 with the Indian Patent Office. The Indian application was filed along with an amendment vide a Form-13 with only 29 claims (Claim Set 2). The application was published under Section 11A of the Patents Act, 1970 (hereinafter `Act') on 24th August, 2007. A request for examination was made on 06th November, 2009 and the First Examination Report (hereinafter `FER') was issued on 30th January, 2015. In the FER, Form-13 filed on 8th June, 2007 and 16th January, 2008 were not allowed by the Patent Office for not being filed in the prescribed manner. The Applicant is stated to have made a representation in respect of this decision of the Patent Office.

3. Another amendment (Claim Set 3) with 17 claims was filed by the Applicant on 27th November, 2015 in response to a FER. A hearing was held on 27th May, 2016 and on 30th May, 2016 a fourth amendment (claim Set 4) was filed along with the written submissions whereby claims 1 to 17 were reduced to claims 1 to 8. The amendment inter alia was for the deletion of crystalline, amorphous form which were objected to by the Controller under section 3(d) of the Act in the hearing notice.

4. The Opponent- NATCO filed a pre-grant opposition under section 25(1) of the Act read with Rule 55 of the Patent Rules, 2003 (hereinafter `Rules') against the grant of the patent on 6th September, 2016 on the basis of Claim Set 3 i.e., which contained claims 1 to 17. In the said pre-grant opposition, various grounds were raised by the Opponent including lack of inventive step, insufficiency and non-compliance of Section 8 and non- patentability [ under Sections 3(d) and 3(e) of the Act].

5. In response to the pre-grant Represent