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2019 Supreme(Del) 1561
IN THE HIGH COURT OF DELHI
JAYANT NATH, J.
Astrazeneca AB & Others - Plaintiffs
Versus
P. Kumar & Others - Defendants
IAs. Nos. 3986 & 5096, 4771, 9332 of 2018 in CS(COMM). Nos. 749, 792, 1023 of 2018
Decided On : 08-08-2019
For the Plaintiffs :Pravin Anand, Archana Shankar, Devinder Rawat, Nishchal Anand, Sanchith Shivakumar, Advocates.
For the Defendants :J. Sai Deepak, G. Nataraj, Rajeshwari, Sai Krishan, Gitanjali Mathew, Advocates.
A patent holder is not entitled to an interim injunction if the defendant raises a credible challenge to the validity of the patent, rendering it vulnerable to challenge.
Headnote:
The Court examined the validity of the patent in light of the defendant's challenge under Section 64 of the Indian Patent Act. The Court found that the defendant had raised a credible challenge to the validity of the patent, particularly under Section 64(1)(f) read with Section 3(d) and Section 64 (1) (a), 64(1)(d), 64(1)(f) and 64 (1)(k) of the Patent Act. The Court held that the issues raised rendered the suit patents vulnerable to challenge and vacated the interim injunction previously granted.
Fact of the Case:
The plaintiffs, holders of patents for the drug TICAGRELOR, sought a decree of permanent injunction to restrain the defendants from marketing, selling, or dealing with any product that infringed their patents. The defendants challenged the validity of the patents under various provisions of the Indian Patent Act, including Section 64.
Finding of the Court:
The Court found that the defendants had raised a credible challenge to the validity of the patent, particularly under Section 64(1)(f) read with Section 3(d) and Section 64 (1) (a), 64(1)(d), 64(1)(f) and 64 (1)(k) of the Patent Act. The Court held that the issues raised rendered the suit patents vulnerable to challenge and vacated the interim injunction previously granted.
Issues: 1. Whether the defendants had raised a credible challenge to the validity of the patents under Section 64 of the Indian Patent Act. 2. Whether the balance of convenience favored the plaintiffs or the defendants.
Ratio Decidendi: The Court held that the defendants had raised a credible challenge to the validity of the patent, particularly under Section 64(1)(f) read with Section 3(d) and Section 64 (1) (a), 64(1)(d), 64(1)(f) and 64 (1)(k) of the Patent Act. The Court found that the issues raised rendered the suit patents vulnerable to challenge and vacated the interim injunction previously granted.
Final Decision: The Court vacated the interim injunction previously granted and directed the defendants to maintain and file quarterly accounts regarding the sale of the impugned drugs.
JUDGMENT :
IAs.3986/2018 & 5096/2018 in CS(COMM) 749/2018
IA No.4771/2018 in CS(COMM) 792/2018
IA No.9332/2018 in CS(COMM) 1023/2018
1. These are three suits filed by the plaintiffs seeking a decree of permanent injunction to restrain the defendants from marketing, selling, distributing, etc. any product that infringes the subject matter of Indian Patent Nos. IN 209907 (hereinafter referred to as “IN 907”, i.e. the Species Patent), IN 247984 (hereinafter referred to as “IN 984”, i.e. the Polymorph Patent) and IN 272674 (hereinafter referred to as “IN 674”, i.e. the Formulation Patent).
2. By the present judgment, I will deal with the injunction applications filed by the plaintiffs being IA No. 3986/2018 filed in CS(COMM) 749/2018, IA No.4771/2018 filed in CS(COMM) 792/2018, IA No.9332/2018 filed in CS(COMM) 1023/2018 and IA 5096/2018 filed in CS(Comm.) 749/2018 by the defendants under Order 39 Rule 4 CPC seeking vacation of the interim orders.
3. The injunction applications are filed under Order 39 Rule 1 and 2 CPC seeking an injunction to restrain the defendants from selling, marketing or dealing with TICAGRELOR or any product which is in violation of the registered patent of the plaintiff‘s company IN 907, IN 984 and IN 674.
4. CS(COMM) 749/2018 came up for hearing on 22.03.2018 when in IA No. 3986/2018 this court passed an interim order in favour of the plaintiffs restraining the defendants from selling, marketing or dealing with TICAGRELOR tablet or any drug which is in violation of the registered patents of the plaintiffs being IN 907, IN 984, and IN 674. On 23.04.2018 a similar interim order was passed in IA No.4771/2018 in CS(COMM) 792/2018. This court had then noted that when the written statement was filed a stand had been taken by the defendants that they had not launched the drug in question. However, this court on 23.04.2018 noted that while the matter was pending in court, the defendant had launched the drug. In CS(COMM) 1023/2008, a similar interim order was passed on 18.07.2018 in IA No. 9332/2018.
5. The case of the plaintiff is that the drug TICAGRELOR falls within the scope of Indian Patent No.907 and 984. The finished formulation of TICAGRELOR is said to be covered within the scope of IN 674. The said compound TICAGRELOR is said to have proved to be an effective platelet aggregation inhibitor. The said TICAGRELOR is the INN (international non- proprietary name) assigned to the molecule having the IUPAC name (1S,2S,3R,5S)-3-[7-[(1R,2S)-2-(3,4-Difluorophenyl) cyclopropylamino] 5- (propylthio)-3H-[l,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy) cyclopentane-l,2-diol. The empirical formula of TICAGRELOR is C23H28F2N6O4S and its molecular weight is 522.57. TICAGRELOR has the following structural formula:
“IMAGE”
7. Claim 1 of IN 907 discloses a class of compounds with the following Markush formula:
“IMAGE”
6. TICAGRELOR is said to fall within the scope of claim 1 wherein R is OCH2CH2OH1, R' is propyl, R2 is phenyl group substituted by two fluorine atoms, R3 and R4 are hydroxyl groups. Further, TICAGRELOR is specifically claimed as the third compound in Claim 5 of the said patent. The process for making TICAGRELOR has also been specifically disclosed in example 3 of IN 907.
7. The Indian Patent No.907 is said to be a valid and subsisting patent which has remained unchallenged even though it was published way back in the year 2005. It was not subjected to any pre-grant or post-grant opposition under sections 25(1) and 25(2) of the Patents Act, 1970. However, in 2015 Micro Labs Limited i.e. defendant No.2 in CS(COMM) 749/2018 filed a petition for revocation of the said patent which is said to be pending before the Intellectual Property Appellate Board.
8. The plaintiff has also made reference to two other patents including Indian Patent No.984(polymorph patent) which is said to be a Crystalline form of A Triazolo (4.
