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IN THE HIGH COURT OF DELHI AT NEW DELHI

Date of Decision: 12^th July, 2022

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W.P.(C)-IPD 91/2021 & CM 28/2022, CM 33-34/2021

NATCO PHARMA LIMITED

..... Petitioner

Through:

Mr. Adarsh Ramanujan, Ms. Mitul

Dasgupta, Mr. Samik Mukherjee, Mr.

S. Shekher & Mr. Afzal B. Khan,

Advocates (M-9881880037)

versus

UNION OF INDIA & ORS.

..... Respondents

Through:

Mr. Hemant Singh, Ms. Mamta Rani

Jha, Mr. Siddhant Sharma & Mr.

Abhay Tandon, Advocates for R-4

(M-9557629905).

CORAM:

JUSTICE PRATHIBA M. SINGH

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 16^th September, 2021 passed by the Asst. Controller

refusing the Opponent’s application seeking cross-examination of the

Applicant’s witnesses. The reliefs sought are:

2022:DHC:2632

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 8^th 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 8^th 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

2022:DHC:2632

11A of the Patents Act, 1970 (hereinafter ‘Act’) on 24^th August, 2007. A

request for examination was made on 06^th November, 2009 and the First

Examination Report (hereinafter ‘FER’) was issued on 30^th January, 2015.

In the FER, Form-13 filed on 8^th June, 2007 and 16^th 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 27^th November, 2015 in response to a FER. A hearing was held

on 27^th May, 2016 and on 30^th 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 6^th 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 Representation, the Applicant filed its

reply statement dated 3^rd March, 2017 but no evidence was attached with the

same. The claim set attached with the reply of the Applicant was Claim Set

4.

2022:DHC:2632

6. In the meantime, a suit for infringement was filed by the Applicant-

against the Opponent being CS(COMM) 62/2019 titled Novartis AG v.

Natco Pharma Ltd. wherein an ad-interim injunction order dated 27^th

March, 2019 was granted protecting right in IN 229051 in the following

terms:

the Plaintiff No.1.”

7. A Hearing was fixed in the pre-grant opposition on 9^th January, 2020.

However, adjournment was sought by the Applicant. In the meantime,

further pre-grant oppositions against Applicant’s patent applications have

also been filed by -

•Indian Pharmaceutical