Delhi High Court - Orders
Boehringer Ingelheim Pharma Gmbh And ... vs Natco Pharma Limited on 10 November, 2022
Author: Navin Chawla
Bench: Navin Chawla
$~9
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 256/2020
BOEHRINGER INGELHEIM PHARMA GMBH AND CO. KG &
ANR. ..... Plaintiffs
Through: Mr.Sandeep Sethi, Sr. Adv. with
Dr.Sanjay Kumar, Ms.Arpita
Sawhney, Mr.A.K.Jana, Ms.Meenal
Khurana, Mr.Priyansh Sharma,
Mr.Harshit Dixit, Advs.
versus
NATCO PHARMA LIMITED ..... Defendant
Through: Mr. J. Sai Deepak, Mr. Guruswamy
Nataraj, Mr. Avinash Kumar Sharma
and Mr. Shasikant Tandan, Advs.
CORAM:
HON'BLE MR. JUSTICE NAVIN CHAWLA
ORDER
% 10.11.2022
CCP(O) 35/2021
1. This contempt petition has been filed by the petitioners/plaintiffs alleging violation of the undertaking given by the contemnor/defendant and as recorded in the order of this Court dated 15.07.2020, subsequently modified vide order of this Court dated 10.08.2020.
2. While issuing summons in the suit on 15.07.2020, this Court recorded the undertaking of the contemnor/defendant through its counsel, as under:
"9. Learned counsel for the defendant on instructions submit that between today till the next date of hearing in the application, that is, 22nd July, 2020, the defendant will not go ahead with release of the impugned products in the market."Signature Not Verified Digitally Signed By:SHALOO BATRA Signing Date:11.11.2022 18:56:43
3. The above undertaking was modified by the order of this Court dated 10.08.2020, to the following effect:
"2. Order dated 15th July, 2020 will continue till the next date of hearing however, it is clarified that para- 9 of the order dated 15th July, 2020 would read as under:
9. Learned counsel for the defendant on instructions submit that between today till the next date of hearing in the application, that is, 22nd July, 2020, the defendant will not go ahead with release of the impugned products in the market w.e.f. 15th July, 2020."
4. The order of this Court dated 10.08.2020 further directed the defendant to file on record an affidavit indicating the batch number of the goods, which were released by the defendant in the market till 14.07.2020.
5. In compliance with the said direction, the defendant filed an affidavit dated 17.08.2020 of Mr.Madineedi Adinarayana, disclosing the batch numbers of the 'AFANAT' product released by the defendant till 14.07.2020. One of the batch numbers disclosed for 'AFANAT 30 (28's BT) is 702431.
6. The petitioners/plaintiffs have filed the present contempt petition stating that the contemnor/defendant has, after giving the undertaking to this Court on 15.07.2020, released further medicinal preparation of the 'AFANAT' product giving the same batch number, that is, 702431. In support of this assertion, the petitioners/plaintiffs have produced photographs of the products bearing the same batch numbers, however, different expiry dates; one being 09/2021 [with an MRP of Rs. 6200.00] and Signature Not Verified Digitally Signed By:SHALOO BATRA Signing Date:11.11.2022 18:56:43 the other being 03/2022 [with an MRP of Rs. 5630.00]. The photographs are reproduced herein under:-
7. The contemnor/defendant has filed reply to the contempt petition, contending that on 10.3.2011, the Central Drug Standard Control Organization (in short, 'CDSCO') released a notice relating to Schedule-Y of the Drugs and Cosmetics Rules, 1945, clarifying that the extension of shelf life can be made on basis of submission of real-time stability studies data. The learned counsel for the contemnor/defendant submits that initially, the contemnor/defendant had published an expiry of eighteen months based on the developmental stability data for the batches of 'AFANAT' Tablet manufactured before 14.07.2020. Later on, on 04.06.2021, after having satisfactory stability data for six months accelerated storage condition and twelve-month long term storage condition, the defendant extended the expiry as per the internal Standard Operating Protocol (in short, 'SOP') with due notification to the local Drug Authority. These changes were thereafter made to the packaging of the 'AFANAT' Signature Not Verified Digitally Signed By:SHALOO BATRA Signing Date:11.11.2022 18:56:43 tablets under the batch number 702431 by recalling the same. Similar changes were also made on the MRP of the drug to make it more affordable for the patients. The packaging was re-labelled on the returned products in line with the provisions of the Drugs (Price Control) Order, 2013 (in short, 'DPCO').
8. To a pointed query to the learned counsel for the contemnor/defendant whether the drugs in question under the batch number 702431 with the changed/modified expiry date and the MRP were sold prior to 15.07.2021, the learned counsel for the contemnor/defendant fairly admits that the containers though sold earlier, were recalled and re-labelled with the fresh expiry date and the MRP, and then returned to the distributors. He, however, submits that in this process, there was no fresh sale made by the contemnor/defendant.
9. I am unable to accept the submission of the learned counsel for the contemnor/defendant.
10. The order of this Court dated 15.07.2020, as modified by the order of this Court dated 10.08.2020, is clear in recording the undertaking of the learned counsel for the contemnor/defendant, on instructions, that till the hearing of the application, the contemnor/defendant will not go ahead with the 'release of the impugned products in the market w.e.f. 15.07.2022'. If for any reason, whatsoever, the contemnor/defendant was to recall the products which were already released to the market, the prohibition as contained in the undertaking recorded in the above orders of this Court would set in. The contemnor/defendant could not have released the recalled products even that with a modified labelling, be it in the form of either the change of expiry date or the MRP, to the market. The submission of the Signature Not Verified Digitally Signed By:SHALOO BATRA Signing Date:11.11.2022 18:56:43 learned counsel for the contemnor/defendant that were was no fresh sale of these products, is not relevant. The prohibition was for release of the impugned product in any manner whatsoever. The product had been undertaken not to be released beyond 15.07.2020, be it in form of a fresh sale or on recall of the products. The reason why the products were to be re-labelled with respect to the expiry date or the MRP is also not relevant to the present contempt petition. Once the products were in custody of the contemnor/defendant, they could not have been released back to the market without seeking the permission of this court.
11. In view of the above, I find the defendant to be guilty of having intentionally violated the undertaking given to this Court, thereby making itself liable to be proceeded against under Order XXXIX Rule 2A of the Code of Civil Procedure, 1908 (in short, 'CPC').
12. On the question of the consequences of the above act of contempt, the learned counsel for the contemnor/defendant submits that there was no intent to breach the undertaking given to this Court; and that the contemnor/defendant acted bona fide and in accordance with the SOP prevalent in the market.
13. The above submission also cannot be accepted as the contemnor/defendant is a leading pharmaceutical company and would, therefore, have the best of legal advice, which I am sure it must have taken before acting in the manner that it did. The undertaking given to this Court was unequivocal and clear. There was no iota of doubt in the same, to which the contemnor/defendant can claim any benefit.
14. In view of the above, the contemnor/defendant shall disclose, on an affidavit, the number of units of 'AFANAT' tablets released by the Signature Not Verified Digitally Signed By:SHALOO BATRA Signing Date:11.11.2022 18:56:43 contemnor/defendant to the market w.e.f. 15.07.2020, be it in any form, and deposit the entire sale proceeds of such products in this Court, within a period of four weeks from today. The amount so deposited shall be kept in a Fixed Deposit by the Registry of this Court till awaiting further directions.
15. The contemnor/defendant shall further pay costs quantified at Rs.15 Lakh to the petitioners/plaintiffs and Rs.15 Lakh in favour of the Delhi High Court Legal Services Committee.
16. The contempt petition is disposed of with the above directions.
I.A. 373/202117. The learned counsel for the defendant/non applicant submits that the reply has been filed this morning.
18. The learned counsel shall have the same placed on record. Rejoinder, if any, be filed within a period of four weeks.
19. List on 28th February, 2023.
I.A. 5617/2020 & I.A. 6965/2020
20. The learned senior counsel for the plaintiffs prays for an adjournment.
21. At request, list on 28th February, 2023 for hearing.
NAVIN CHAWLA, J NOVEMBER 10, 2022 RN Signature Not Verified Digitally Signed By:SHALOO BATRA Signing Date:11.11.2022 18:56:43