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Novartis Ag & Anr vs Sun Pharmaceutical Industries Ltd on 20 February, 2020

Author: Mukta Gupta

Bench: Mukta Gupta

$~33
*    IN THE HIGH COURT OF DELHI AT NEW DELHI
+     CS(COMM) 85/2020
      NOVARTIS AG & ANR.                                  ..... Plaintiffs
              Represented by:           Ms.Vidhi Gupta, proxy counsel.

                          versus

      SUN PHARMACEUTICAL INDUSTRIES LTD. ..... Defendant
              Represented by: Mr.Deepanshu Choithani, proxy
                              counsel assisted by Mr. Shyam
                              Kumar, Adv. (mob: 9999154100)
      CORAM:
      HON'BLE MS. JUSTICE MUKTA GUPTA
                          ORDER

% 20.02.2020 I.A. 2458/2020 (under Order XI Rule 1 (4) CPC)

1. Additional documents, if any, be filed within 30 days.

2. Application is disposed of.

CS(COMM) 85/2020 & I.A. 2457/2020 (under Order XXVI Rule 9 CPC)

1. Lawyers are abstaining from appearing.

2. Plaint be registered as a suit.

3. Issue summons in the suit and notice in the application to the defendant.

4. Learned proxy counsel for the defendant on instructions from the learned counsel for the defendant accepts summons in the suit and notice in the application.

5. Complete set of paper-book be provided to the learned counsel for the defendant in the course of the day.

6. Written statement to the plaint shall be positively filed within 30 days. Replication be filed within three weeks of the receipt of the advance copy of the written statement.

7. 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 be also filed with the pleadings.

8. Affidavit of admission/ denial of documents shall be filed by the parties along with the pleadings. The affidavit shall include the list of the documents of the other party. The deponents shall indicate their position with regard to the documents against the particulars of each document.

9. List before the learned Joint Registrar for completion of pleadings and admission/denial of documents on 23rd March, 2020.

10. List the suit and the application before Court on 30th April, 2020. I.A. 2456/2020 (under Order XXXIX rule 1 and 2 CPC)

1. Issue notice.

2. Learned proxy counsel for the defendant on instructions from the learned counsel for the defendant accepts notice.

3. Reply affidavit be filed within three weeks.

4. Rejoinder affidavit, if any, be filed within two weeks thereafter.

5. List before Court on 16th March, 2020.

6. Case of the plaintiffs is that the plaintiffs own the suit patent i.e. IN- 237430 for their compound 'NILOTINIB' which is valid till 4th July, 2023. 'NILOTINIB' a synthetic aminopyrimidine, is an ATP-competitive inhibitor of BCR-ABL, the chemical name, formula and structure of 'NILOTINIB' is as under:

4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5- (trifluoromethyl) phenyl]-3-{[4-pyridin-3-yl)pyrimidin-2-yl]amino} benzamide (as per WHO and Merck Index) 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl- 1H-imidazol-1-yl)-3- (trifluoromethyl)phenyl]benzamide (as per claim 2 of IN 237430)

7. The molecular formula and molecular structure of the compound 'NILOTINIB' are as under:

      Molecular Formula:        C28H22F3N7O
      Molecular structure:




CS(COMM) 85/2020                                                  Page 3 of 5

8. NILOTINIB is a potent inhibitor of tyrosine kinase activity of the BCR-ABL onco-protein both in cell lines and in primary Philadelphia chromosome-positive leukemia cells and has been developed as a second generation inhibitor.

9. M/s Cipla Ltd. filed a pre-grant opposition to the patent application of the plaintiff inter alia claiming anticipation, obviousness and that no inventive step was involved. The said pre-grant opposition of M/s Cipla Ltd. was rejected by the Assistant Controller of Patents and Designs vide its order dated 11th December, 2009. As per the plaint neither any post-grant opposition nor any application seeking revocation of the suit patent has been filed till date.

10. The suit patent has successfully worked in India at a reasonable price and number of other companies who proposed to launch the product infringing the plaintiff's suit patent IN 237430 agreed to not launch the same till the validity of the suit patent such as in CS (OS) No.3212/2015 and CS (COMM) 1570/2016.

11. Plaintiffs became aware of the proposed launching of the product compound NILOTINIB by the defendant when the defendant on 7th February, 2020 announced the launch of its product at the 19th Annual Conference RGCON 2020 organised by Rajiv Gandhi Cancer Institute and Research Centre, Delhi. Further on 14th February, 2020 the plaintiff No.2 received a report from Strategic Analysis Pvt. Ltd. (SAI) which confirmed that the defendant has already obtained a manufacturing license for NILOTINIB and intends to commercialise, manufacture and supply the drug on receipt of orders.

12. Considering the material placed on record and that the plaintiffs are the owners of the suit patent which is valid till 4 th July, 2023 and the proposed action of the defendant in launching the drug based on molecule NILOTINIB would amount to infringement of the suit patent, validity whereof has already been tested in the pre-grant opposition, this Court finds that a prima facie case is made out in favour of the plaintiffs and against the defendant and in case no ad-interim injunction is granted, plaintiffs would suffer an irreparable loss. Balance of convenience also lies in favour of the plaintiffs. Consequently, till the next date of hearing, defendant, its directors, associates, agents, distributors and dealers etc. are restrained from manufacturing, importing, selling, offering for sale, importing, exporting, directly or indirectly dealing in molecule/compound/pharmaceutical composition NILOTINIB by itself or in salt or crystalline or any other form alone or in combination with any other compound thereby amounting to infringement of Indian Patent No.237430 of the plaintiff No.1 in terms of para-33 of the application.

13. Order dasti.

MUKTA GUPTA, J.

FEBRUARY 20, 2020 'vn' CS(COMM) 85/2020 Page 5 of 5