Delhi High Court - Orders
Novartis Ag & Anr vs Cdymax (India) Pharma Private Limited on 31 January, 2025
Author: Amit Bansal
Bench: Amit Bansal
$~30
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 86/2025 with I.A. 2589/2025, I.A. 2590/2025, I.A.
2591/2025, I.A. 2592/2025, I.A. 2593/2025 and I.A. 2594/2025
NOVARTIS AG & ANR. .....Plaintiffs
Through: Mr. Hemant Singh, Ms. Mamta Jha,
Mr. Siddhant Sharma, Ms. Garima
Mehta, Mr. Sanchit Sharma and Mr.
Kartikey, Advocates.
versus
CDYMAX (INDIA) PHARMA PRIVATE LIMITED .....Defendant
Through: None.
CORAM:
HON'BLE MR. JUSTICE AMIT BANSAL
ORDER
% 31.01.2025 I.A. 2591/2025 (under Section 12 A of the Commercial Courts Act, 2015)
1. As the present suit contemplates urgent interim relief, in light of the judgment of the Supreme Court in Yamini Manohar v. T.K.D. Krithi, 2023 SCC Online SC 1382, exemption from the requirement of pre-institution mediation is granted.
2. The application stands disposed of.
I.A. 2593/2025 (seeking exemption from advance service to defendant)
3. The plaintiffs seek urgent interim relief against infringing products and for this purpose, an ex-parte appointment of Local Commissioner is also sought to inventorize the allegedly infringing products. It is submitted that there is a probability that the defendant may remove the allegedly infringing CS(COMM) 86/2025 Page 1 of 9 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 28/02/2025 at 22:28:49 products if the defendant is given advance service of the plaint paper book.
4. Therefore, in the peculiar facts and circumstances of this case, exemption from effecting advance service upon the defendant is granted.
5. The application is disposed of.
I.A. 2592/2025 (u/O XI Rule 1 (4) of CPC)
6. The present application has been filed on behalf of the plaintiffs seeking leave to file additional documents under the Commercial Courts Act, 2015.
7. The plaintiffs are permitted to file additional documents in accordance with the provisions of the Commercial Courts Act, 2015 and the Delhi High Court (Original Side) Rules, 2018.
8. Accordingly, the application is disposed of.
I.A. 2594/2025 (seeking time to file court fees)
9. Mr. Hemant Singh, counsel appearing on behalf of the plaintiffs submits that the court fees has been paid.
9.1 The statement of the counsel is taken on record.
10. The application stands disposed of.
CS(COMM) 86/2025
11. Let the plaint be registered as a suit.
12. Issue summons.
13. Summons be issued to the defendant through all modes. The summons shall state that the written statement shall be filed by the defendant within thirty days from the date of the receipt of summons. Along with the written statement, the defendant shall also file affidavit of admission/denial of the documents of the plaintiffs, without which the written statement shall not be taken on record.
CS(COMM) 86/2025 Page 2 of 9This 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 28/02/2025 at 22:28:49
14. Liberty is given to the plaintiffs to file replication(s), if any, within thirty days from the receipt of the written statement. Along with the replication(s) filed by the plaintiffs, affidavit of admission/denial of the documents of the defendant be filed by the plaintiffs.
15. The parties shall file all original documents in support of their respective claims along with their respective pleadings. In case parties are placing reliance on a document, which is not in their power and possession, its detail and source shall be mentioned in the list of reliance, which shall also be filed with the pleadings.
16. If any of the parties wish to seek inspection of any documents, the same shall be sought and given within the timelines.
17. List before the Joint Registrar on 26th March, 2025 for completion of service and pleadings.
18. List before the Court on 2nd May, 2025.
I.A. 2589/2025 (u/O XXXIX Rules 1 and 2 of CPC) and I.A. 2590/2025 (u/O XXVI Rule 9 of CPC)
19. The present suit has been filed on behalf of the plaintiffs seeking relief of permanent injunction restraining the defendant from infringing the Indian Patent No.283133 titled "Pyrrolopyrimidine Compounds and their Uses" (hereinafter "the suit patent"), along with other ancillary reliefs.
20. It is stated that the plaintiff no. 1 is one of the leading companies in the world carrying on business of manufacturing, marketing, research, and development of high-quality pharmaceutical preparations. Plaintiff no. 2 is an Indian company, which is an affiliate of the plaintiff no. 1 and markets the patented product in India (hereinafter, collectively referred to as "the plaintiffs").
CS(COMM) 86/2025 Page 3 of 9This 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 28/02/2025 at 22:28:49
21. The plaintiffs were granted the suit patent on 5th May, 2017 in respect of a novel and inventive compound of Formula I, covering Ribociclib, used in the treatment of breast cancer. The suit patent has a PCT filing date of 24th May, 2007. No pre-grant opposition was filed against the grant of the suit patent during the prosecution period by the defendant or any other person. Similarly, no post-grant opposition was filed by the defendant within the post-grant period ending 12th May, 2018. The suit patent is valid and subsisting and will expire on 24th May, 2027.
22. It is averred that the plaintiff no.1 globally spends USD 11.4 billion on research and development. Likewise, the plaintiffs have made a huge investment in inventing the compound covered by the suit patent and disclosed the invention publicly in good faith and pursuant to a statutory protection conferred upon them against anybody else using the said invention during the patent period.
23. The plaint asserts that, through an RTI request dated 25th July, 2024 filed with the Drug Control Department, Government of Karnataka, it came to the knowledge of the plaintiffs that the defendant has obtained a manufacturing license for the drug 'Ribociclib Succinate' from the Drug Control Department, Government of Karnataka for export purposes.
24. It is further asserted that the plaintiffs came to know in last week of December, 2024 that the defendant has started commercial manufacture of 'Ribociclib API' (Active Pharmaceutical Ingredient), which is the subject matter of the suit patent and exported/supplied the same for commercial purposes to Russia, Egypt and Bhutan. This is evident from the defendant company's listing on third-party websites, offering for commercial sale/supply of 'Ribociclib API'. Screenshots from the one such third-party CS(COMM) 86/2025 Page 4 of 9 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 28/02/2025 at 22:28:49 website are provided at pgs. 475-476 of the plaintiffs' documents filed along with the plaint.
25. Mr. Hemant Singh, learned counsel appearing on behalf of the plaintiffs submits that the suit patent covers Ribociclib compound as per the claim mapping provided in paragraph 51 of the plaint. Ribociclib is an International Non-Proprietory Name (INN) given to the suit patent compound applied for by the plaintiff no.1 and approved by WHO. The said chemical name can only be used to refer to the suit patent compound. The defendant is commercially manufacturing and exporting/supplying the plaintiffs' suit patent compound Ribociclib and committing infringement thereof.
26. Upon getting to know that the defendant is manufacturing the aforesaid product, the plaintiffs engaged an independent research agency, Strategic Analysis India Pvt. Ltd. (hereinafter "SAI"), to investigate the matter. As per the SAI assessment report dated 3rd January, 2025 at pgs. 470-474 of the plaintiffs' documents filed along with the plaint, the defendant has successfully developed 'Ribociclib Active Pharmaceutical Ingredient (API)' in its API facility and is manufacturing and exporting/supplying 'Ribociclib API' in international markets i.e. Russian, Egypt, and Bhutan, for commercial purposes. The SAI assessment report dated 3rd January, 2025 further confirmed that the defendant is conducting stability studies for Ribociclib formulation and has plans to commercially manufacture and launch the formation for domestic markets in the first quarter of the year 2025.
27. Based on the averments made in the plaint and the submissions noted above, a prima facie case has been made out on behalf of the plaintiffs. It CS(COMM) 86/2025 Page 5 of 9 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 28/02/2025 at 22:28:49 appears that the defendant is yet to commercially launch the impugned drug in India.
28. Balance of convenience is in favour of the plaintiffs and against the defendant. Irreparable injury would be caused to the plaintiffs if the defendant commercially launches the impugned drug in the Indian Market.
29. Consequently, defendant is restrained from commercially launching in India the Ribociclib by itself or in combination with any other compound, excipient or salt, as an API or as a pharmaceutical product/formulation containing patented compound Ribociclib (hereinafter "the impugned drug") till the next date of hearing. However, for the time being, the defendant is not restrained from exporting the same.
30. The plaintiffs also seek appointment of a Local Commissioner to visit the premises of the defendant to ascertain the stock of the aforesaid drug already manufactured and stocked by the defendant and also to verify whether the defendant has commercially launched the impugned drug in the Indian market and if so, what is the quantity of the impugned drug already commercially launched in the Indian market.
31. In view of what is stated above, the plaintiffs have made out a case for appointment of Local Commissioner.
32. Accordingly, Ms. Radhika Sikri, Advocate (Mobile No. +91- 9999904320) is appointed as Local Commissioner to visit the premises of the defendant situated at:
CDYMAC (INDIA) PHARMA PRIVATE LIMITED 116/117 KIADB Industrial Area, Jigani, 2nd Phase, Bengaluru Karnataka, India - 560105 CS(COMM) 86/2025 Page 6 of 9 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 28/02/2025 at 22:28:50
33. The following directions are passed in this regard:
i. The Local Commissioner, along with a representative of the plaintiffs and their counsel, shall be permitted to enter upon the premises of the defendant mentioned above or any other location/premises that may be identified during the course of commission.
ii. The Local Commissioner shall conduct a search at the defendant's premises and make an inventory of all the impugned drug available at the aforesaid premises. It is clarified that no seizure of the impugned drug are to be done and the above direction for making the inventory of the impugned drug is only to safeguard the plaintiffs' rights in the present suit.
iii. The defendant and its representatives are directed to provide full assistance to the Local Commissioner for executing the present commission.
iv. To ensure an unhindered and effective resolution of this order, the SHO of the local police station and the concerned DCP having jurisdiction of the aforesaid premises are directed to render the necessary protection and assistance to the Local Commissioner, if and when sought.
v. The Local Commissioner shall take photographs and/or videos of the inventorized stock.
vi. The Local Commissioner shall sign the books of account and stock registers, register of batch numbers as maintained by the CS(COMM) 86/2025 Page 7 of 9 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 28/02/2025 at 22:28:50 defendant pertaining to sale of the infringing drug products, if any.
vii. The Local Commissioner shall take a sample of infringing drug, if any, which may be lying or stocked or stored for sale in the above-mentioned premises for submitting before Court along with the its report.
34. The Local Commissioner shall file her Report(s) within two (2) weeks of executing the commission, along with photographs taken and photocopies of the books of account and the inventory procured pursuant thereto.
35. The fees of the Local Commissioner, to be borne by the plaintiffs, is fixed at Rs. 1,50,000/-. 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.
36. In view of the fact that the plaintiffs have sought appointment of a Local Commissioner to seize the infringing goods, the very purpose of grant of ex-parte ad interim injunction would be defeated if the defendant is given notices contemplated in Order XXXIX Rule 3 of Code of Civil Procedure, 1908 (hereinafter "CPC") prior to the execution of the commission. Hence, it is directed that the plaintiffs shall serve notices under Order XXXIX Rule 3 of CPC at the time of execution of the commission which shall not be later than two (2) week from today.
37. Issue Notice.
38. Notice be issued to the defendant via all permissible modes, including e-mail.
39. Reply(ies) be filed within four (4) weeks.
CS(COMM) 86/2025 Page 8 of 9This 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 28/02/2025 at 22:28:50
40. Rejoinder(s) thereto, if any, be filed within two (2) weeks thereafter.
41. The applications stand disposed of in the above terms.
42. The order passed today shall not be uploaded for a period of two (2) weeks from today.
43. Dasti under signatures of the Court Master.
AMIT BANSAL, J JANUARY 31, 2025 Vivek/-
CS(COMM) 86/2025 Page 9 of 9This 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 28/02/2025 at 22:28:50