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2015 Supreme(Del) 2127
IN THE HIGH COURT OF DELHI AT NEW DELHI
MANMOHAN SINGH, J.
ROCHE PRODUCTS (INDIA) PVT. LTD. & ORS. - Plaintiffs
Versus
DRUGS CONTROLLER GENERAL OF INDIA AND ORS - Defendants
I.A. No.11225/2015 in CS(OS) No.355/2014
Decided on : 13.08.2015
Mr. Rajiv Nayar, Sr. Adv. and Mr. Sandeep Sethi, Sr. Adv. with Mr. Darpan Wadhwa, Ms. Niti Dixit, Mr. N.Mahabir, Ms. Samiksha Godiyal, Mr. Anugrah Robin Frey, Ms. Roshni Namboodiry & Mr. Tanmay Singh, Advs.
Mr. Sanjay Jain, ASG with Mr. Amit Mahajan, CGSC and Mr. Rishi Kant Singh, Adv. for D-1.
Dr.Abhishek M. Singhvi, Sr. Adv. & Mrs. Pratibha M. Singh, Sr. Adv. with Mr. Vijay K. Sondhi, Mr. Sanjay Kumar, Mr. Mayank Grover, Ms. Cauveri Birbal, Mr. Anshul Sehgal, Mr. Arjun Sawhney, Ms. Pallavi Sharma & Ms. Suhasini Raina, Advs. for D-2.
Mr. C.S.Vaidyanathan, Sr. Adv. with Ms. Gayatri Roy, Mr. Nirupam Lodha, Mr. Ayush Dhawan & Ms. Rhyea Malik, Advs. for D-3 & D-4.
The main legal point established in the judgment is that parties approaching the court are bound to disclose all relevant documents and information, and that obtaining approval in breach of interim orders and withholding vital information from the court is not permissible.
Headnote:
Injunction - Drugs Act, 1940, Drugs and Cosmetics Rules, 1945 - The court discussed the approval and launch of CANMAb for additional indications, the approval of Carton, Labels and Package Insert, and the use of data in the Package Insert. The court found that the defendants obtained approval for additional indications and Package Insert in breach of interim orders, and that the defendants did not disclose vital information to the court. The court declined to pass an interim order for the launch of the drug for additional indications but restrained the defendants from using data in the Package Insert contrary to the interim orders.
Fact of the Case:
The plaintiffs filed a suit for injunction against the defendants, seeking to restrain them from relying upon or referring to HERCEPTIN®, HERCLONTM or BICELTIS® data in any public announcements for their drugs. The defendants obtained approval for additional indications and Package Insert, and the plaintiffs sought to challenge these approvals.
Finding of the Court:
The court found that the defendants obtained approval for additional indications and Package Insert in breach of interim orders. The court also noted that the defendants did not disclose vital information to the court. The court declined to pass an interim order for the launch of the drug for additional indications but restrained the defendants from using data in the Package Insert contrary to the interim orders.
Issues: The issues included the approval and launch of CANMAb for additional indications, the approval of Carton, Labels and Package Insert, and the use of data in the Package Insert.
Ratio Decidendi: The court held that the defendants obtained approval for additional indications and Package Insert in breach of interim orders and did not disclose vital information to the court. The court declined to pass an interim order for the launch of the drug for additional indications but restrained the defendants from using data in the Package Insert contrary to the interim orders.
Final Decision: The court restrained the defendants from using data in the Package Insert contrary to the interim orders and declined to pass an interim order for the launch of the drug for additional indications.
MANMOHAN SINGH, J.
I.A. No.11225/2015 (u/o XXXIX R.1 & 2 CPC)
1. The plaintiffs have filed the suit for injunction. The said suit was listed before Court along with the interim application on 5th February, 2014. After hearing, the summons in the suit were issued to the defendants for 28th February, 2014 and in the interim application, the defendants No.2 to 4 were restrained from relying upon or otherwise referring to HERCEPTIN®, HERCLONTM or BICELTIS® or any data relating to Trastuzumab marketed as HERCEPTIN®, HERCLONTM or BICELTIS® including data relating to its manufacturing process, safety, efficacy and sales, in any press releases, public announcements, promotional or other material for the defendants’ drugs, i.e. CANMAB and HERTRAZ and from claiming any similarity with HERCEPTIN®, HERCLONTM or BICELTIS®.
2. By order dated 14th February, 2014, the earlier order passed by the Court on 5th February, 2014 was modified to the extent that if defendant No.2 has already obtained the approval of Package Insert in question, then the defendant No.2 is entitled to use the same. However, it was clarified that the remaining interim order already passed would continue. The said order dated 5th February, 2014 was modified for the reason as the statement was made on behalf of defendant No.2 that on 13th December, 2013 the defendant No.2 also obtained the approval from the Drugs Controller General of India with regard to the Carton, Labels and Package Insert.
3. The interim applications for vacating the interim order and for rejection of the plaint were heard from time to time. For rejoinder arguments, the same are kept for 13th August, 2015.
4. During pendency of hearing, both parties have filed large numbers of applications, the details of which are mentioned in para 5 of my order dated 6th July, 2015. Out of many, few applications were disposed of in the said order.
5. The hearing of rejoinder arguments on behalf of the plaintiffs was stuck due to subsequent events in the matter when the plaintiffs filed the fresh application being I.A. No.11224/2015 under Order VI Rule 17 CPC for amendment of the plaint as well as the fresh application being I.A. No.11225/2015 under Order XXXIX Rules 1 & 2 CPC for passing the interim order.
6. As per order dated 6th July, 2015, the remaining applications were put up for hearing on 13th August, 2015. The operative part of para 45 of my order dated 6th July, 2015 reads as under:-
“45. With regard to interim application sought by the plaintiffs in view of subsequent events, admittedly the approval for additional indications, i.e. early breast cancer and metastatic gastric cancer for specimen of carton, labels and package insert is still sub-judice. Mr. Sanjay Jain, ASG has assured the Court that the request for approval would be considered as per rules and regulations and as per routine procedure and while considering the same, defendant No.1 will also examine the orders passed by this Court. Under these circumstances, the directions are passed that in case defendant No.2 gets approval from defendant No.1 for specimen of the carton, labels and package insert for the proposed additional indications, copy of the same shall be filed along with an affidavit within one week from the date of approval. Under such situation, the defendant No.2 shall also inform the Court as well as the other side two weeks in advance if after such approval they have any intention to launch the products for the additional indications, i.e. early breast cancer and metastatic gastric cancer. The prayer of the plaintiffs’ application would be considered at that stage.”
7. On 6th August, 2015, it was informed by both the sides that the defendants filed appeals against the order dated 6th July, 2015 being FAO (OS) Nos.425/2015 & 427/2015 and the same came up for hearing before the Division Bench of this Court on 4th Aug
