IA--3986/2018. Case: ASTRAZENECA AB & ORS Vs. P KUMAR & ANR. High Court of Delhi (India)
| Case Number | IA--3986/2018 |
| Citation | NA |
| Judgement Date | August 08, 2019 |
| Court | High Court of Delhi (India) |
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* IN THE HIGH COURT OF DELHI AT NEW DELHI % Pronounced on : 08.08.2019. + IAs.3986/2018 & 5096/2018 in CS(COMM) 749/2018
ASTRAZENECA AB & ORS ..... Plaintiffs versus
P KUMAR & ANR ..... Defendants
+ IA No.4771/2018 in CS(COMM) 792/2018
ASTRAZENECA AB & ANR ..... Plaintiffs versus
T RAO & ANR ..... Defendants
+ IA No.9332/2018 in CS(COMM) 1023/2018
ASTRA ZENECA AB & ANR. ..... Plaintiffs versus
DR. REDDYS LABORATORIES LIMITED ..... Defendant
Present: Mr.Pravin Anand, Ms.Archana Shankar,
Rawat, Mr.Nishchal Anand and Mr.Sanchith Shivakumar, Advs. the plaintiffs.
Mr.J.Sai Deepak and Mr.G.Nataraj, Advs. for the defendant CS(COMM) 749/2018
Mr.C.M.Lall, Sr.Adv. with Ms.Rajeshwari, Adv. for the defendant CS(COMM) 792/2018.
Mr.Sai Krishan, Adv. and Ms.Gitanjali Mathew, Adv. for defendant in CS(COMM) 1023/2018
CORAM:
HON'BLE MR. JUSTICE JAYANT NATH
JAYANT NATH, J.
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 permanent injunction to restrain the defendants from marketing, distributing, etc. any product that infringes the subject matter of Patent Nos. IN 209907 (hereinafter referred to as ―IN 907‖, i.e. the Patent), IN 247984 (hereinafter referred to as ―IN 984‖, i.e. the Patent) and IN 272674 (hereinafter referred to as ―IN 674‖, i.e. Formulation Patent).
2. By the present judgment, I will deal with the injunction filed by the plaintiffs being IA No. 3986/2018 filed in 749/2018, IA No.4771/2018 filed in CS(COMM) 792/2018,
No.9332/2018 filed in CS(COMM) 1023/2018 and IA 5096/2018 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 dealing with TICAGRELOR or any product which is in violation 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 restraining the defendants from selling, marketing or dealing TICAGRELOR tablet or any drug which is in violation of the patents of the plaintiffs being IN 907, IN 984, and IN 674. On 23.04.2018 similar interim order was passed in IA No.4771/2018 in 792/2018. This court had then noted that when the written statement 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 matter was pending in court, the defendant had launched the 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 the scope of Indian Patent No.907 and 984. The finished formulation TICAGRELOR is said to be covered within the scope of IN 674. The compound TICAGRELOR is said to have proved to be an effective aggregation inhibitor. The said TICAGRELOR is the INN (internationa non- proprietary name) assigned to the molecule having the IUPAC (1S,2S,3R,5S)-3-[7-[(1R,2S)-2-(3,4-Difluorophenyl) cyclopropylamino] (propylthio)-3H-[l,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy) cyclopentane-l,2-diol. The empirical formula of TICAGRELOR C23H28F2N6O4S and its molecular weight is 522.57. TICAGRELOR following structural formula:
7. Claim 1 of IN '907 discloses a class of compounds with the Markush formula:
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 atoms, R3 and R4 are hydroxyl groups. Further, TICAGRELOR specifically claimed as the third compound in Claim 5 of the said patent. The process for making TICAGRELOR has also been specifically disclosed example 3 of IN '907.
7. The Indian Patent No.907 is said to be a valid and subsisting 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 under sections 25(1) and 25(2) of the Patents Act, 1970. However, in Micro Labs Limited i.e. defendant No.2 in CS(COMM) 749/2018 petition for revocation of the said patent which is said to be pending the Intellectual Property Appellate Board.
8. The plaintiff has also made reference to two other patents Indian Patent No.984(polymorph patent) which is said to be a form of A Triazolo (4.5-D) Pyrimidine Compound. It is stated that Crystalline forms of TICAGRELOR are disclosed in patent No. IN 984.
The said patent is said to be a subsisting patent.
Similarly, reference is made to Indian Patent No.674(formulation patent) which relates to a pharmaceutical composition of TICAGRELOR.
is said to be disclosed in claims 1-10 of IN 674.
It is pleaded that by virtue of section 48 of the Patents Act, plaintiffs have exclusive rights to prevent others from making, using, selling, offering for sale or importing TICAGRELOR as well as its crystalline (IN ‗984) and its finished formulation (as claimed in IN‘674) or any product that falls within the scope of the claims of IN‘907 and the above two noted patents.
9. TICAGRELOR is said to be an antiplatelet drug prescribed to patients who have suffered a recent heart attack or unstable angina (chest pain) reducing the chances of a thrombotic events such as a heart attack stroke. It is stated that before the introduction of TICAGRELOR, despite the widespread adoption of intensive monitoring and prompt treatment existing medications, approximately 1 in 3 ACS patients died or had a repeat myocardial infraction, or required re-hospitalisation within six TICAGRELOR works by preventing the formation of new blood clots, maintaining blood flow in the body to help reduce the risk of cardiovascular event.
10. It is stated that TICAGRELOR was first approved in the and is marketed under the trademark BRILINTA. It has been approved more than 100 countries. In India the plaintiff received drug approval in May 2012 and was commercially launched in India in 2012 under the same trademark BRILINTA. The price of a tablet is be Rs.50/-.
11. In CS(COMM) 749/2018 where defendant No.2 is Micro Labs the plaintiff states that in the month of March 2018 plaintiff business information through credible market sources that the defendants are planning to launch a generic version of TICAGRELOR under the name BIGRELOR in the first week of April 2018. It was also learnt defendants have printed their packaging for their generic product and representatives are speaking with doctors about the same. It is stated that the defendants have filed revocation petition in respect of trademark IN IN 907 before the Intellectual Property Appellate Board (IPAB). pleaded that the acts of the defendant would cause immense damage plaintiff‘s business and public interest which cannot be accounted monetary terms. It would also be in blatant disregard of the intellectual property rights. Hence, the suit.
12. In CS(COMM) 792/2018, where defendant No.2 is Natco Ltd., the plaintiff has been pleaded that in the first week of April 2018, plaintiffs received business information regarding the plan of the to launch a generic version of TICAGRELOR in the third week of 2018. It has also been stated that the defendants have uploaded their product list on the website where TICAGRELOR has been listed under the of ‗APIs-Under Development‖. It has also been pleaded that to the plaintiffs‘ best knowledge, the defendants have not yet launched/marketed TICAGRELOR but based on the background facts credible business intelligence, the defendants‘ imminent launch product TICAGRELOR has been received by the plaintiffs. It has also pleaded that the defendants are known habitual offenders. Hence, the present suit was filed against the said defendants.
13. In CS(COMM) 1023/2018, where the defendant is Laboratories Ltd. the plaintiff has pleaded that in April 2018, plaintiff received certain caveats filed by the defendant which were vague unambiguous. On 17.07.2018, it is stated that the plaintiffs received business information that the defendant is planning to launch a generic version TICAGRELOR under the brand name TICAFLO. In fact, it is pleaded, defendant has taken steps to introduce and offer the same for sale business partners and C&F Agents. The defendant has also obtained manufacturing license for TICAGRELOR and is ready for a full commercial launch of the product. Hence, the present suit filed against the defendant.
14. The defendants have filed their respective written statement to that the suit has no merit. Most of the submissions raised by the are common. I may note some of salient submissions made which relevant for disposal of these applications.
15. In CS (COMM) 749/2018 (defendant No.2 here is Micro Labs the defendant has broadly pleaded in the written statement as follows:
(i) that the pharmaceutical formulation containing TICAGRELOR purportedly sold in India by the plaintiffs under the name BRILINTA AXCER. It is stated that it is the own admission of the plaintiff formulation is not manufactured in India but is apparently imported Sweden and China. It is stated that the plaintiffs‘ own affirmations Regulatory Agencies, Courts and different patent offices would show TICAGRELOR is covered by several patents with different dates of including Indian Patent 241229 and its equivalents.
(ii) It is further pleaded that the plaintiffs have deliberately material facts. The plaintiff has failed to mention that the patent (the genus patent) expressly covers and discloses TICAGRELOR expired on 14.7.2018. It is stated that the plaintiff has given a impression that the TICAGRELOR cannot be recognized from the patent No.241229. It is pleaded that there is sufficient material which comprises admissions by the plaintiffs to show that TICAGRELOR encompassed and claimed in IN241229 (hereinafter referred to as IN and its...
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