Delhi High Court
Novartis A G & Anr. vs Supermax Drugs And Pharmaceuticals ... on 28 July, 2022
Author: Prathiba M. Singh
Bench: Prathiba M. Singh
NEUTRAL CITATION NO: 2022/DHC/002989
$~15
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of Decision: 28th July, 2022
+ CS (COMM) 511/2022
NOVARTIS A G & ANR. ..... Plaintiffs
Through: Mr. Hemant Singh, Ms. Mamta Rani
Jha, Mr. Siddhant Sharma and Mr.
Abhay Tandon, Advocates.
(M:9557629905)
versus
SUPERMAX DRUGS AND PHARMACEUTICALS PRIVATE
LIMITED & ANR. ..... Defendants
Through: Ms. Rajeshwari H. and Ms. Sugandh
Shahi, Advocates for D-1 & 2.
(M:8130868355)
CORAM:
JUSTICE PRATHIBA M. SINGH
Prathiba M. Singh, J. (Oral)
I.A.11778/2022 (additional documents)
1. This is an application seeking leave to file additional documents under the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Act, 2015 (hereinafter, 'Commercial Courts Act'). The Plaintiff, if it wishes to file additional documents at a later stage, shall do so strictly as per the provisions of the Commercial Courts Act.
2. I.A.11778/2022 is disposed of.
I.A.11779/2022 (u/S 12A)
3. This is an application seeking exemption from instituting pre- litigation mediation. In view of the orders passed in CS (COMM) 132/2022 titled Upgrad Education v. Intellipaat Software, the application is allowed CS (COMM) 511/2022 Page 1 of 6 This is a digitally signed Judgement.
NEUTRAL CITATION NO: 2022/DHC/002989 and disposed of.
4. I.A.11779/2022 is disposed of.
I.A.11780/2022 (exemption from advance service to the Defendants)
5. In view of the fact that the Plaintiff has sought an ex parte ad-interim injunction along with the appointment of a Local Commissioner, the exemption from advance service to the Defendants is granted.
6. I.A.11780/2022 is disposed of.
CS (COMM) 511/2022 & I.As.11776/2022 11777/2022
7. The present suit has been filed by the Plaintiffs seeking permanent injunction restraining the infringement of Indian Patent No. IN 237430 (hereinafter 'IN' 430'), with PCT Application No. PCT/EP2003/007198 along with damages, rendition of accounts, delivery up and other ancillary reliefs.
8. The case of the Plaintiffs is that Plaintiff No. 1 - Novartis A G, incorporated under the laws of Switzerland is one of the leading companies in the world carrying on business through its affiliates and subsidiaries, inter alia, of researching, developing, manufacturing and marketing high-quality pharmaceutical drugs. It has particularly developed a drug formulation in which Nilotinib i.e., the subject matter of IN' 430, is the active ingredient of the said patented drug product. While, Plaintiff No. 2 - Novartis Healthcare Private Limited is an Indian operating company and subsidiary of Plaintiff No. 1, which markets the patented drug product of Plaintiff No. 1 under the trademark/brand Tasigna®, in India. The Plaintiffs sales figures in recent years, from 2019 onwards, with respect to India are to the tune of INR Rs.90 crores and globally are to the tune of USD 1900 millions.
9. The Plaintiffs plead that patent IN' 430, which was granted to CS (COMM) 511/2022 Page 2 of 6 This is a digitally signed Judgement.
NEUTRAL CITATION NO: 2022/DHC/002989 Plaintiff No. 1 on 22nd December, 2009 and is valid upto 4th July, 2023, protects the novel and inventive molecule/compound/pharmaceutical composition with the INN name Nilotinib. It is a synthetic aminopyrimidine, an ATP-competitive inhibitor of BCR-ABL.
10. The case of the Plaintiffs is that Nilotinib was developed as a second- generation inhibitor of BCR-ABL tyrosine kinase that would be effective in patients with Imatinib resistant or intolerant CML and is also indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive CML (Ph+ CML) in chronic phase. It's contained in the form of its monohydrochloride monohydrate salt in the pharmaceutical products that are manufactured and marketed by the Plaintiffs.
11. In June, 2022, the Plaintiffs' business team became aware of a Tender No. RC-22-23/33 dated 3rd June, 2022, floated by the Director General of Armed Forces Medical Services, Ministry of Defence (hereinafter, 'DGAFMS'). Online bids were invited for the manufacture and supply of "PVMS No. 010896 Tab Nilotinib 200mg" on non-PAC (Proprietary Article Certificate) basis (hereinafter, 'AFMS Tender'), which is also the subject matter of the patent IN' 430.
12. In response to the AFMS Tender, Defendant No.1 submitted its bid to DGAFMS dated 11th July, 2022 as Bidder No. 2400588, where it represented that it holds a valid License No. 18/UA/2020 on form 25 & 19/UA/SC/P-2020 on form 28 valid upto 16th July 2025 and has been manufacturing and marketing the Nilotinib tablets for the last three years. The trademark/brand used by the Defendant to sell the Nilotinib tablets was 'BILOLEK-200' with the following packaging.
CS (COMM) 511/2022 Page 3 of 6This is a digitally signed Judgement.
NEUTRAL CITATION NO: 2022/DHC/002989
13. Upon the Plaintiffs gaining knowledge of the above facts, the present suit has been filed against Defendant No.1 - Supermax Drugs & Pharmaceuticals Private Limited and Defendant No. 2 - M/s. Paseca Healthcare LLP due to the apprehension, which has been caused by the Defendants' submission of bids.
14. It was also discovered that in the Defendant No. 1's bid documents a Certificate of Finish Analysis was produced which claimed that a batch size of 50,000 tablets was manufactured as of May, 2022 with an expiry date of April, 2024.
15. Accordingly, the present suit has been filed due to the representation CS (COMM) 511/2022 Page 4 of 6 This is a digitally signed Judgement.
NEUTRAL CITATION NO: 2022/DHC/002989 made by the Defendants to DGFAMS for supply of Nilotinib during the term and life of the patent in favour of the Plaintiffs.
16. For the sake of fair disclosure, the plaint sets out various other applications for formulations, crystalline forms and other forms of Nilotinib, which are either stated to be have been refused or withdrawn or abandoned. However, the submission made by Mr. Hemant Singh, ld. Counsel for the Plaintiffs is that the main molecule Nilotinib is covered and disclosed in suit patent IN430.
17. Further, it is submitted that the Defendants having responded to the bid and having clearly represented that they have the ability to manufacture and have in fact manufactured a batch of products with Nilotinib, have infringed upon the Plaintiffs' patent.
18. The relief sought in the plaint is for permanent injunction restraining the Defendants from manufacturing, importing, selling, offering for sale/supply either by way of promotion or tender or any other means, exporting, directly or indirectly dealing in the molecule Nilotinib in any form and from supplying these products during the life of the patent to the authorities or in any manner commercially. Damages are also sought against the Defendants.
19. The suit is listed today and after noticing the matter in the cause list, Ms. Rajeshwari H., ld. Counsel, who is appearing for both the Defendants, submits that Mr. Chetan Bhatia, on behalf of the Defendants, has given her instructions that the Defendants have not manufactured 50,000 tablets but have merely expressed their ability to manufacture 50,000 tablets. She further submits that the Defendants have no intention to manufacture or sell Nilotinib pharmaceutical preparation during the lifetime of the patent.
CS (COMM) 511/2022 Page 5 of 6This is a digitally signed Judgement.
NEUTRAL CITATION NO: 2022/DHC/002989
20. In view of the statement made on behalf of the Defendants, Ms. Rajeshwari H., ld. Counsel submits that the suit may be decreed for the lifetime of the patent. and the Defendants would refrain from manufacturing, selling and commercially offering for sale any pharmaceutical preparations consisting of API Nilotinib or Nilotinib Monohydrochloride Monohydrate or any other forms of Nilotinib.
21. Ms. Rajeshwari, further, submits that her client is willing to disclose the quantum of stock, if any, lying with the Defendant on an affidavit, which shall be filed. The said affidavit shall also record the undertaking of the Defendants to abide by the decree of permanent injunction.
22. In view of the stand taken by the Defendants, the suit is, accordingly, decreed in terms of paragraph 85(a) of the plaint.
23. Let the affidavit of stock and the affidavit undertaking compliance with the decree passed above, be placed on record.
24. Mr. Hemant Singh, ld. Counsel for the Plaintiffs submits that if the said affidavit is filed, no further reliefs are sought in the present case and the matter can be treated as having been amicably resolved.
25. Decree sheet be drawn accordingly in the above terms.
26. In view of the order passed today, the applications being I.As.11776/2022 and 11777/2022 are not pressed and are accordingly dismissed.
27. List for receiving the affidavit on behalf of the Defendants on 18th August, 2022.
PRATHIBA M. SINGH JUDGE JULY 28, 2022/dk/sr/ms CS (COMM) 511/2022 Page 6 of 6 This is a digitally signed Judgement.