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Novartis Ag & Anr vs Natco Pharma Limited on 6 February, 2019

Author: Jayant Nath

Bench: Jayant Nath

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*     IN THE HIGH COURT OF DELHI AT NEW DELHI

+     CS(COMM) 62/2019

      NOVARTIS AG & ANR.                         ...... Plaintiffs
                   Through     Mr.Neeraj Kishan Kaul, Sr.Adv. with
                   Mr.Hemant Singh, Ms.Mamta Jha, Ms.Shilpa
                   Arora and Mr.Ankit Arvind, Mr.Devanshu
                   Mr.Sanyat Lodha, Mr.Akash Lamba, Mr.Deepak
                   Joshi, Ms. Hansa Kaul and Mr.Rohan Krishnan,
                   Advs.

                   versus

      NATCO PHARMA LIMITED                   ..... Defendant
                  Through    Mr.Sanjeev Sindhwani, Sr.Adv. with
                  Ms.Rajeshwari H., Mr.Saif Rahman Ansari,
                  Mr.Tahir A.J., Mr.Chitranshu Kumar and
                  Mr.Swapnil Kaur, Advs.

      CORAM:
      HON'BLE MR. JUSTICE JAYANT NATH
                            ORDER

% 06.02.2019 Caveat No.108/2019 Since learned counsel for the defendant has entered appearance, caveat stands discharged.

Exemption allowed subject to all just exceptions. Application stands disposed of.

CS(COMM.) 62/2019 Let the plaint be registered as suit. Learned counsel for defendant enters appearance. Written Statement be filed within two weeks.

List on 28.2.2019.

Issue notice. Learned counsel for defendant has entered appearance and accepts notice. Reply be filed within two weeks.

List on the date fixed above.

1. This application is filed under Order 39 Rules 1 and 2 CPC.

2. The accompanying suit is filed for permanent injunction restraining infringement of Patent No. 229051, damages, rendition of accounts, etc. It has been pleaded in the plaint that on 09.07.2004, plaintiff No. 1 filed an application for the suit patent. Objections were invited in 2006. The suit patent was granted on 13.02.2009 as Patent No. 229051. It is pleaded that the suit patent relates to a pharmaceutical combination comprising of Valsartan + Sacubitril which have different mechanism of action together in combination. It is pleaded that that the combination has demonstrated an unexpected and surprising synergistic antihypertensive effect. It is pleaded that the validity of the suit patent was duly tested in detail by the Controller of Patents and hence, the plaintiff has statutory rights in the nature of monopoly to manufacture, sell and offer for sale the pharmaceutical composition comprising combination of Valsartan + Sacubitril. The plaintiff developed the drug formulation and marketed it under the trade name Vymada in India and Entresto internationally. The Drug Controller approved the drug formulation on 14.07.2016 and 02.09.2016.

3. On 28.01.2019 through press release of the defendant, the defendant claims to have launched the said Sacubitril + Valsartan Tablet under the brand VALSAC. The plaintiff thereafter engaged the services of professional investigating agency to conduct a market survey and confirm whether the infringing product of the defendant is available for sale in the market. It is pleaded that the product being sold by the defendant is in complete infringement of the suit patent and is therefore liable to be injuncted.

4. I have heard learned senior counsel for the parties.

5. Learned senior counsel for the defendant has pointed out that the product of the defendant is not in infringement of the suit patent. It is pointed out that the plaintiff themselves have made a second application for grant of a patent which is patent application No. 4412/DELNP/2007 which was filed on 08.11.2006. Against the said application, the defendant have filed objections. In response to these objections, the plaintiff have stated that the suit patent is materially different and does not teach or suggest the compound as claimed in the new application. It is also pleaded that the process of preparation of the novel compound is not commonly used. It has also been pleaded by the plaintiff that no part of any prior art cited by the examiner suggests or teaches, the compound having the said formula of the suit patent. Based on this, it is pleaded that the drug being made by the defendant is akin to the patent disclosed by the plaintiff which is subject matter of the application filed on 08.11.2006 being application No. 4412/DELNP/2007. Hence, it is pleaded that there is no infringement of the suit patent by the defendant.

6. Learned senior counsel appearing for the plaintiff has however strenuously pleaded that the drug in question is a combination of Sacubitril + Valsartan. The said Sacubitril + Valsartan contains a complex comprised of anionic forms of sacubitril and valsartan, sodium and water molecules in the molar ratio of 1:1:3:3, respectively. He also relies upon page 51 of the plaint to submit that the composition of the structural formula of the product of the defendant is virtually identical to that of the plaintiff. It is stressed that any combination of the chemicals Sacubitril + Valsartan would lead to the infringement of the drug of the plaintiff.

7. Prima facie there appears to be merit in the contentions of the learned senior counsel for the plaintiff.

8. At this stage, learned senior counsel for the defendant states that this court may in exercise of powers under section 115 of the Patents Act, may appoint an independent Expert Advisor to assist the Court as to whether the product/drug of the defendant is made using the suit patent/arises from the suit patent. He further submits that till the next date of hearing, the defendant shall not release any further products of the impugned drug in the market. The defendant will also he submits place on affidavit within three days from today the quantity of the impugned drug which has already been released in the market.

9. I take the above statement on record and bind the defendant to the same.

10. Issue notice. Learned counsel for defendant has entered appearance and accepts notice.

11. Reply be filed within two weeks.

12. I appoint Dr.Prabir Chandra Chakraborti (Mob : 09748415411), E-8, Chister-10, Salt Lake City, Kolkata- 700097 as the Expert Advisor. The plaintiff may send full paper book of the court file to the Expert Advisor expeditiously. His fees is fixed at Rs.3 lakhs. Both the parties will share the expenses. The fees be sent to the Expert Advisor within one week.

13. List on 28.2.2019.

14. This order may be given dasti under signatures of Court Master.

JAYANT NATH, J.

FEBRUARY 06, 2019 n