An interlocutory injunction can be granted if infringement is established, and no credible challenge to patent validity is presented, even when prior publications and claims are involved.

JUDGMENT

I.A.6980/2021 (under Order XXXIX Rules 1 & 2 of CPC)

1. This order decides IA 6980/2021, whereby the plaintiffs have sought an interlocutory injunction against the perceived infringement, by the defendant, Natco Pharma Ltd, of the plaintiffs' suit patent IN 233161 (in short, `IN 161').

2. Arguments were advanced on behalf of the plaintiffs by Mr. Hemant Singh, and on behalf of the defendant by Mr. J. Sai Deepak. Copious written submissions have also been filed by both sides.

3. The plaintiffs would collectively be referred to, hereinafter, for ease of reference, as "Novartis".

Facts

4. The suit patent was originally granted to M/s Smith Kline Beecham Corporation (later renamed "GlaxoSmithKline LLC") on 27th March, 2009. Novartis claims that the suit patent was first assigned by GlaxoSmithKline LLC to the Glaxo Group Ltd on 5th October, 2015, on which date, by a back-to-back assignment deed, the suit patent was assigned by the Glaxo Group Ltd to Novartis Pharma AG, who, by another assignment deed of the same date, i.e. 5th October, 2015, assigned the suit patent to Plaintiff 1. Plaintiff 2 is the Indian subsidiary of Plaintiff 1, which imports and markets the patented product in India. The defendant does not dispute these assertions, at least at this stage.

5. The invention patented by the suit patent was titled "3-[(2Z)-[1-(3,4-Dimethylphenyl)-1,5-Dihydro-3-Methyl-5-Oxo-4H-Pyrazol-4-Ylidene] Hydrazino]-2'-Hydroxy-[1,1'-Biphenyl]-3-Carboxylic Acid Bis-(Monoethanolamine)". Reckoned from 21st May, 2003, being the International Filing Date of the suit patent, the patent would remain alive till 21st May, 2023, by virtue of Section 53 (1) of the PATENTS ACT , 1970 ("the PATENTS ACT "), read with the Explanation thereto¹ . The invention was granted the non-proprietary United States Adopted Name (USAN) name "Eltrombopag Olamine" (abbreviated, for the sake of convenience, as "EO"), and has the following chemical structure:

The Complete Specifications of the suit patent, as filed with the Indian Patent Office (IPO) for grant of the patent declares that Eltrombopag "is a compound which is disclosed and claimed, along with pharmaceutically acceptable salts, hydrates, solvates and esters thereof, as being useful as an agonist of the TPO² receptor, particularly in enhancing platelet production and particularly in the treatment of thrombocytopenia". Further, in respect of EO, the complete specifications declare that "while the free acid is highly useful as an agonist of TPO receptor particularly in enhancing platelet production and particularly in the treatment of thrombocytopenia, the bis-(monoethanolamine) salt of [Eltrombopag] has the added advantages of enhanced solubility and bioavailability." We need not, for the purposes of the present dispute, concern ourselves with the intricacies of EO as a chemical formulation; suffice it to state that EO is used for the treatment of thrombocytopenia, denoting insufficiency of platelets in the body. EO is marketed, by the plaintiffs, under the tradename "REVOLADE". IN 161 claimed the following:

"1. The compound 3'[(2Z)[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-Biphenyl]-3-Carboxylic Acid bis-(monoethanolamine).

2. A compound as claimed in claim 1 as and when used as a pharmaceutical composition along with the pharmaceutically acceptable carrier or diluents of the kind such as herein described.

3. A process for preparing the compound as claimed in claim 1, which process comprises:

i) dissolving 3'-[(2Z)[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H