NATCO PHARMA LIMITED Vs. UNION OF INDIA

JUDGEMENT

(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 dtd. 16/9/2021 passed by the Asst. Controller refusing the Opponent's application seeking cross-examination of the Applicant's witnesses. The reliefs sought are:

(2.) The background of the present petition is that the Applicant filed PCT application being PCT/US2006/043710 on 8/11/2006 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 8/6/2007 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 Sec. 11A of the Patents Act, 1970 (hereinafter 'Act') on 24/8/2007. A request for examination was made on 6/11/2009 and the First Examination Report (hereinafter 'FER') was issued on 30/1/2015. In the FER, Form-13 filed on 8/6/2007 and 16/1/2008 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 27/11/2015 in response to a FER. A hearing was held on 27/5/2016 and on 30/5/2016 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 sec. 3(d) of the Act in the hearing notice.