Delhi High Court - Orders
Incyte Holdings Corporation & Ors vs Lotus Labs Private Limited & Ors on 30 May, 2024
Author: Sanjeev Narula
Bench: Sanjeev Narula
$~23
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 496/2024
INCYTE HOLDINGS CORPORATION & ORS. ..... Plaintiffs
Through: Mr. Hemant Singh, Ms. Mamta Rani
Jha, Mr. Siddhant Sharma, Mr. Abhay
Tandon and Mr. Rishabh Paliwal,
Advocates.
versus
LOTUS LABS PRIVATE LIMITED & ORS. ..... Defendants
Through: None.
CORAM:
HON'BLE MR. JUSTICE SANJEEV NARULA
ORDER
% 30.05.2024 I.A. 31178/2024(seeking exemption from advance service)
1. By way of the instant application, Plaintiffs seek exemption from effecting advance service on the Defendants. Mr. Hemant Singh, counsel for Plaintiffs, urges that given the facts of the instant suit, an exemption from effecting advance service is necessary. He emphasises that as per the information received by Plaintiffs from the market survey conducted by them, Defendants have not yet launched their products in the market. However, there is a strong apprehension that on the service of advance copy of the paper-book, the Defendants would flood the market with their infringing products containing the Plaintiff's patented compound. Further, since Plaintiffs also seek the appointment of a Local Commissioner, there is CS(COMM) 496/2024 Page 1 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:48 a strong likelihood that their apprehensions will become a reality in case advance service is effected.
2. Such a situation would severely prejudice the Plaintiffs, as the Defendants would then misleadingly assert that their product is already available in the market. Moreover, even in the event that this Court were to grant an injunction after hearing the Defendants, recall of such infringing products from the market would be an arduous task. Accordingly, the instant suit has been filed as a quia-timet action, which is an equitable relief in the species of precautionary justice, intended to prevent apprehended/ anticipated mischief as opposed to undoing a wrong that has already been done. Since the Defendants have not yet launched their products, the balance of convenience clearly lies in favour of the Plaintiff.
3. Thus, Mr. Singh submits that to ensure that the statutory rights of the Plaintiff are not infringed, it is imperative that the requirement for advance service be exempted. In support of his contentions, Mr. Singh relies upon the following:
3.1. Judgments of the Supreme Court of India in Kuldip Singh v. Subhash Chander Jain and Ors.1; and Wander Ltd. and Anr. v. Antox India P. Ltd.2;
3.2. Judgment of the House of Lords in American Cynamid Company v. Ethicon Limited3; and, 3.3. Judgment of this Court in Autodesk Inc. and Anr. v. A.V.T. Shankardass and Anr.4 1 AIR 2000 SC 1410 2 1990 (Supp) Supreme Court Cases 727 3 [1975] R.P.C. 21 4 2008 SCC OnLine Del 775 CS(COMM) 496/2024 Page 2 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:48
4. Having considered the aforenoted, the Court is of the opinion that, given the peculiar facts and circumstances of this case as urged by Mr. Singh, it is a fit case to exempt advance service to the Defendant.
5. Accordingly, the exemption is granted and the application is disposed of.
I.A. 31177/2024(seeking exemption from pre-litigation mediation)
6. As the present suit contemplates urgent interim relief, in light of the judgment of Supreme Court in Yamini Manohar v. T.K.D. Krithi,5 exemption from attempting pre-institution mediation is granted.
7. Disposed of.
I.A. 31179/2024(seeking leave to file additional documents)
8. This is an application seeking leave to file additional documents under the Commercial Courts Act, 2015.
9. If Plaintiffs wish to file additional documents at a later stage, they shall do so strictly as per the provisions of the said Act.
10. Disposed of.
I.A. 31180/2024(seeking exemption from filing the pleadings in the present suit with the seal of the companies)
11. Exemption is granted, subject to all just exceptions.
12. Accordingly, the application stands disposed of.
CS(COMM) 496/2024
13. Let the plaint be registered as a suit.
52023 SCC OnLine SC 1382.
CS(COMM) 496/2024 Page 3 of 11This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:49
14. Upon filing of process fee, issue summons to the Defendants by all permissible modes. Summons shall state that the written statement(s) shall be filed by the Defendants within 30 days from the date of receipt of summons. Along with the written statement(s), the Defendants shall also file affidavit(s) of admission/denial of the documents of the Plaintiff, without which the written statement(s) shall not be taken on record.
15. Liberty is given to the Plaintiff to file replication(s) within 15 days of the receipt of the written statement(s). Along with the replication(s), if any, filed by the Plaintiff, affidavit(s) of admission/denial of documents of the Defendants, be filed by the Plaintiff, without which the replication(s) shall not be taken on record. If any of the parties wish to seek inspection of any documents, the same shall be sought and given within the timelines.
16. List before the Joint Registrar for marking of exhibits on 4th September, 2024. It is made clear that any party unjustifiably denying documents would be liable to be burdened with costs.
17. List before Court for framing of issues thereafter.
I.A. 31175/2024(u/O XXXIX Rules 1 and 2 of CPC)
18. The present suit pertains to alleged infringement of Plaintiff No. 1's Indian Patent bearing No. IN 269841 ["Suit Patent"]. The facts and the contentions as presented by Mr. Hemant Singh, counsel for Plaintiffs, are as follows:
18.1. The Suit Patent protects the novel and inventive compound 'Ruxolitinib'. In particular, Claims No. 1, 17 and 21 of the Suit Patent cover and claim the patented compound 'Ruxolitinib', pharmaceutically acceptable salt, and composition thereof respectively. This drug is used in CS(COMM) 496/2024 Page 4 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:49 the treatment of intermediate or high-risk myelofibrosis, a type of myeloproliferative disorder that affects the bone marrow, and for polycythemia vera (PV) when there has been an inadequate response to or intolerance of hydroxyurea. It works by blocking a group of enzymes known as Janus kinases (JAKs), which are involved in the production and growth of blood cells.
18.2. The bibliographic details of the Suit Patent are as follows:
Indian Patent No. 26981
Indian Patent Application No. 2365/KOLNP/2008
Priority details dates US60/749905 (13.12.2005),
US60/810231 (02.06.2006),
US60/850625 (10.10.2006),
US60/856872 (03.11.2006),
US60/859494 (61.11.2006)
PCT Application no. PCT/U52006/047369
International Filing Date 12.12.2006
International Publication No. WO/2007/070514
Filing date of National 12.06.2008
phase Application
Publication under Section 11A 23.01.2009
Request for examination 03.12.2009
Pre-grant representation filed under 12.11.2012
Section 25(l) r/w Rule 55(l)
First Examination Report (FER) 23.12.2013
Notice of Opposition under Rule 5(3) 03.01.2014
Reply Statement and evidence filed 04.04.2014
by the Applicant under Rule 55(4)
Reply to FER 30.06.2014
Hearing before the Controller of 29.09.2015
Patents
Controller's design on the pre-grant 30.10.2015
opposition
Date of grant 10.11.2015
Post grant publication 13.11.2015
Date of expiry of suit patent 12.12.2026
18.3. The pre-grant opposition to the Suit Patent was withdrawn and there CS(COMM) 496/2024 Page 5 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:49 has been no post-grant opposition or rectification filed by any interested person.
18.4. The drug 'Ruxolitinib' is a new chemical entity, and has been given an International Non-Proprietary Name (INN), which is a name designated by the WHO which are given to new Active Pharmaceutical Ingredients ('APIs') to provide a unique name per pharmaceutical drug to help avoid the confusion that can be caused by the number of different ways in which an API can be chemically named based on their chemical structure. The invented compound 'Ruxolitinib' is marketed and sold in India and other countries (except the United States of America) under the brand name 'JAKAVI®', which is a prescription drug containing Ruxolitinib as its phosphate salt. The copies of Form 27, pertaining to the working of the Suit Patent, have been annexed with the plaint. Further, the sales figures pertaining to the drug in question have also been extracted in Paragraph No. 31 of the plaint.
18.5. Defendant No. 1 is a clinical research organisation engaged in the service of providing clinical trials, bioanalytical research, etc. Defendants No. 2 and 3 are Indian companies engaged in the manufacture and sale of pharmaceutical preparations/ APIs. The Defendants are all fully owned subsidiaries of 'Teva Pharmaceuticals Industries Limited', an Israel-based pharmaceutical company.
18.6. In April 2024, Plaintiffs received information that Defendant No. 1 had submitted their proposal for 'Bioavailability'/ 'Bioequivalence' (BA/BE) studies of Ruxolitinib ER (Early Release) Tablets 50 mg for export purposes, to the Subject Expert Committee (Oncology), Central Drugs Standard Control Organisation (CDSCO). Plaintiffs have conducted CS(COMM) 496/2024 Page 6 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:49 extensive market surveys through their representatives but have not come across any pharmaceutical drug produced by the Defendants containing the patented compound 'Ruxolitinib' which is currently in sale in the Indian market. Further, reliance is placed on the investigation report by an independent investigating agency, i.e. Strategic Analysis India Private Limited (SAI). As per the said report, Defendant No. 1 is importing Ruxolitinib API into India from its parent company in Israel, and is now in the final advanced stages of Ruxolitinib formulation development. In such circumstances, Plaintiffs apprehend that the Defendants intend to launch infringing pharmaceutical drugs containing the patented compound in June- July of 2024.
18.7. Since Claims No. 1, 17 and 21 of the Suit Patent cover and claim the drug Ruxolitinib, pharmaceutically acceptable salt, and composition thereof respectively, the Defendants do not have any right whatsoever to embark upon production using the said compound. Thus, manufacture and supply for use by the Defendants would infringe Plaintiff No. 1's exclusive rights under Section 48 of the Act.
19. In light of the aforenoted contentions urged by Mr. Singh, the Court is satisfied that the Plaintiffs have made out a prima facie case in their favour. Further, the balance of convenience lies in favour of the Plaintiffs and irreparable loss would be caused in case the Defendants are permitted to launch their product, which would constitute an infringement of the Suit Patent.
20. Accordingly, till the next date of hearing, the Defendants, and anybody acting on their behalf, are restrained from using, manufacturing, stockpiling, importing/ exporting, offering for sale and/or supplying, directly CS(COMM) 496/2024 Page 7 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:49 or indirectly, the pharmaceutical drug product containing the compound Ruxolitinib and/or Ruxolitinib API, along with any other form or compound or formulation which would amount to infringement of the Suit Patent bearing No. 'IN 269841'.
21. Compliance of Order XXXIX Rule 3 of the Code of Civil Procedure, 1908, be done within two weeks from today.
22. Issue notice, upon payment of process fee, by all permissible modes upon the Defendants. Reply, if any, be filed within four weeks from the date of service. Rejoinder thereto, if any, be filed within two weeks thereafter.
23. List on 6th November, 2024.
I.A. 31176/2024(u/O XXVI Rule 9 of CPC)
24. Mr. Hemant Singh, counsel for Plaintiffs, contends that the Defendants are likely to remove all physical evidence or deny their involvement in the infringing activities. Accordingly, he seeks appointment of Local Commissioners for visiting and examining the premises of the Defendants. Plaintiffs believe that the infringing products are stored at Defendants' premises.
25. Accordingly, following Local Commissioners are appointed to visit premises of said Defendants:-
Name of Local Premises to be Visited Fixed Fees Commissioner LOTUS LABS PRIVATE LIMITED Mr. Abhishek Floor 1 to 5, Brigade Senate - Singh, Advocate 1 No. 242/189/48, 49, INR 1,50,000/- [Contact No.:
Bhadrappa Layout, Nagashetty +91 9015203289] Halli, Hebbal, Bangalore, 560094, Karnataka, India CS(COMM) 496/2024 Page 8 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:50 TEVAPHARM INDIA Ms. Anju Gupta, PRIVATE LIMITED Advocate [Contact Plot No. A-1, Phase I-A, Verna INR 1,50,000/- No.: 9811582955] Industrial Estate, Verna, Goa -
403722, India
TEVAPHARM INDIA
Mr. R.K. Ruhil, PRIVATE LIMITED
Advocate [Contact Plot No. A3 to A6, Phase I-A
INR 1,50,000/-
No.: Verna Industrial Estate, Verna,
+91 8010074443] Salcetta, Goa, Pin-403 722,
India
Ms. Sitamsini TEVA API INDIA
Cherukumalli, PRIVATE LIMITED
Advocate [Contact 2-G, 2-H, 2-I, Ecotech-II, INR 1,10,000/-
No.: Udyog Vihar, Greater Noida,
+91 7702682425] Pin-201308, India
TEVA API INDIA
PRIVATE LIMITED
Mr. Vaibhav
Plot. Nos. A-1, A-1/1 & A-1/2
Sharma, Advocate
UPIDC Industrial Area. Bijnor INR 1,50,000/-
[Contact No.:
Road, Dist. J.P.Nagar Gajraula
+91 9871955550]
(Uttar Pradesh), Pin-244235,
India
26. The Local Commissioners, along with a representative of the Plaintiffs and their counsel, shall be permitted to enter upon the above-noted premises of the Defendants, as well as any other location/ premises that may be identified during the course of commission, in order to conduct search and seizure.
27. The Local Commissioners shall conduct a search of the premises and seize any infringing drug products (including unfinished/ semi-finished goods) containing the compound 'Ruxolitinib', which may be lying or stocked or stored for sale.CS(COMM) 496/2024 Page 9 of 11
This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:50
28. After seizing infringing material, the same shall be inventoried, sealed and signed by the Local Commissioners, in the presence of the parties, and released on superdari to the respective Defendants on their undertaking to produce the same as and when further directions are issued in this regard.
29. The Local Commissioners shall also be permitted to make copies of the books of accounts including ledgers, cash registers, stock registers, invoices, books, etc. insofar as they pertain to the infringing products. Further, the Local Commissioners is permitted to undertake/ arrange for photography/ videography of the execution of the commission. Both the parties shall render full assistance to the Local Commissioners for carrying out the aforenoted directions.
30. In case any of the premises are found locked, the Local Commissioners shall be permitted to break open the lock(s). To ensure an unhindered and effective execution of this order, the SHO of the local police station is directed to render all assistance and protection to the Local Commissioners, if and when sought.
31. The fee of the Local Commissioners, to be borne by the Plaintiffs, has been specified above. The Plaintiffs shall also bear expenses for travel and lodging of the Local Commissioners and other miscellaneous out-of-pocket expenses for the execution of the commission. Entire fee of the Local Commissioners shall be paid in advance by Plaintiffs.
32. The commission shall be executed within a period of two weeks from today.
33. Report of the commission shall be filed by Local Commissioners within a period of four weeks from the date of execution. The report shall specifically address whether the Defendants have already embarked on CS(COMM) 496/2024 Page 10 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:50 production of infringing drug products containing the compound 'Ruxolitinib' and whether the said products, if any, are already available in the market.
34. With the above directions, the application stands disposed of.
35. Copy of this order shall not be uploaded for a period of two weeks from today.
36. Dasti under the signatures of Court Master.
SANJEEV NARULA, J MAY 30, 2024 d.negi CS(COMM) 496/2024 Page 11 of 11 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/06/2024 at 20:33:50