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Chugai Seiyaki Kabushiki Kaisha & Anr vs Msn Laboratories Private Limited on 6 September, 2022

Author: Prathiba M. Singh

Bench: Prathiba M. Singh

                          $~5
                          *     IN THE HIGH COURT OF DELHI AT NEW DELHI
                          +             CS(COMM) 404/2021 & I.A. 11015/2021
                                CHUGAI SEIYAKI KABUSHIKI KAISHA
                                & ANR.
                                                                               ..... Plaintiff
                                            Through: Mr. Pravin Anand, Mr. Sharwan
                                                      Chopra, Ms. Ridhi Bajaj, Mr. Achyut
                                                      Tiwari, Advocates (M-9958045858)

                                                    versus

                                MSN LABORATORIES PRIVATE LIMITED         ..... Defendant
                                            Through: Mr. Ankur Vyas, Advocate.
                                                     (M:8130459281)

                                CORAM:
                                JUSTICE PRATHIBA M. SINGH
                                             ORDER

% 06.09.2022

1. This hearing has been done through hybrid mode.

2. The present suit has been filed seeking permanent injunction restraining infringement of Indian Patent No.294424 (hereinafter, "suit patent") which is titled "TETRACYCLIC COMPOUND", along with damages, rendition of accounts, delivery up, and other reliefs, against the Defendant. According to the suit patent, the claimed tetracyclic compound, salts or solvates thereof are useful, inter alia, in the treatment of diseases including cancer. The suit patent discloses and covers a compound having the International Non-Proprietary Name (INN) - 'Alectinib', being commercially sold by the Plaintiffs under the brand name Alecensa®. The term of the suit patent of expires on 9th June, 2030.

3. The Plaintiff No.1 - Chugai Seiyaku Kabushiki Kaisha (also known as "Chugai Pharmaceutical Co. Ltd.") is a company headquartered in Japan and is a leading innovator in the healthcare industry. Plaintiff No.2 - F. Hoffmann- La Roche AG is a company headquartered in Switzerland and is also one of the world's largest pharmaceutical company. As per the Plaint, Plaintiff No.1 is the patentee of the suit patent and the Plaintiff No.2 is the exclusive licensee of the suit patent by virtue of an exclusive license agreement dated 31st October, 2012 entered into between the Plaintiffs.

4. The Defendant - MSN Laboratories Private Limited is a pharmaceutical company engaged, inter alia, in the manufacture, sale, and offering for sale various generic pharmaceutical products in India.

5. It is the case of the Plaintiffs that in the last week of May, 2021, an investigation was conducted by an independent investigator at the behest of the Plaintiffs which shed light on the fact that the Defendant had indulged in the import of Alectinib API in October, 2017 and April, 2019 at the Hyderabad Air Cargo, which amounts to infringement of the suit patent as per Section 48 of The Patents Act, 1970. Thereafter, in June 2021, the Plaintiffs discovered the following with respect to the Defendant:

i. It had been listed on an online business directory www.pharmacompass.com as a manufacturer and supplier of Alectinib Hydrochloride API ii. It had been granted an environmental clearance dated 20th March, 2021, for proposed expansion of APIs by the State Level Environment Impact Assessment Authority (SEIAA), Telangana.

iii. It received an MF User Fee Obligation Report.

iv. It has allegedly initiated marketing in the US, dated 28th February, 2019, having National Drug Code - NDC 54893-0087, extracted from the US FDA database v. It has published a research article in the Asian Journal of Pharmaceutical Analysis, Vol. 08 (Issue-04): October - December 2018, titled "Method Development and Validation of Alectinib Drug by RP-HPLC in Bulk and Pharmaceutical Dosage Form"

vi. During a telephonic investigation with the Sr. Executive dated, 24th June, 2021 and Zonal Sales Manager dated 29th June, 2021 it was confirmed that the Defendant is preparing for the launch of Alectinib soon.

vii. It had filed two patent applications, IN 201741044856 dated, 13th December, 2019 and IN 2018841016280 dated 30th April, 2018, both of which are awaiting request for examination. Thus, the Plaintiffs filed the present suit apprehending that the Defendant intends to launch generic Alectinib or its salt or solvates or intermediate(s) thereof or any other product that infringes the suit patent.

6. The suit was listed on 2nd September 2021, on which date, the ld. Counsel for the Defendant had made a statement that the product is being used only for research purposes. The said order records as under:

"1. This application is filed under Order 39 Rules 1 and 2 CPC seeking the following relief:

"a) An order for ad interim injunction restraining the Defendant, its directors, employees, officers, servants, agents, stockists retailers, semi stockists, wholesalers, marketers, distributors, any Signature Not Verified Digitally Signed By:DEVANSHU JOSHI CS(COMM) 404/2021 Page 3 of 6 Signing Date:13.09.2022 11:58:31 other entity/person in the chain of supply and all others acting for and on its behalf from using, making, manufacturing, selling, distributing, advertising, exporting, offering for sale, importing or in any other maimer, directly or indirectly, dealing in any product including but not limited to generic Alectinib or its salt or solvates or intermediate (s) thereof that infringes the subject matter of Indian Patent No.IN 294424."

2. Learned counsel appearing for the defendant, on instructions, states that without prejudice to the rights and contentions of the defendant, for the time being, the defendant is only using the drug in question, namely, Alectinib or its salt etc. which is the subject matter of IN 294424 for research purpose under Section 107A of the Patents Act. He further states that presently, the defendant does not have any license to commercially manufacture the drug. In case the defendant decides to commercially manufacture and launch the said product, the defendant will give four weeks' advance notice to the plaintiffs/learned counsel for the plaintiffs. The above statement is taken on record and the defendant shall be bound by the same.

3. However, it is clarified that the defendant shall not launch the product commercially in the market without prior permission of the court."

7. An affidavit dated 9th June, 2022 has now been filed by Mr. Srinivasan Thirumalai Rajan, the Head of Intellectual Property and Technical of Defendant/MSN Laboratories Pvt. Ltd., on behalf of the Defendant stating inter alia, as under:

"4. That I am under instructions by my Company to state, submit and stipulate as follows:

a. That the Defendant will not be launching any Alectinib product till expiry of IN Signature Not Verified Digitally Signed By:DEVANSHU JOSHI CS(COMM) 404/2021 Page 4 of 6 Signing Date:13.09.2022 11:58:31 294424 on 09.06.2030 or until there is any finding of invalidity in respect of such patent;

b. That this is without prejudice to the submissions in the Written Statement of non-infringement and invalidity defences raised in such Written Statement;

c. That there has been no commercial use of any kind whatsoever in relation to Alectinib till date and there will be no commercial launch of Alectinib products as aforesaid in paragraph 4(a);

d. That the Defendant reserves its rights available under statute including the provisions of Section 107A to carry out such activity in relation to development and submission of information in India or elsewhere where the laws provide for or mandate the submission of such information;......"

8. Ld. Counsel for the Plaintiff submits that the suit can be finally disposed of in view of the above averments in the affidavit. However, ld. Counsel objects to a statement in paragraph 2 of the affidavit of Mr. Srinivasan Thirumalai Rajan, where it is claimed that, "the Plaintiff initiated the present suit on a falsely premised assumption of infringement of IN 294424 purportedly covering a product called Alectinib." Ld. Counsel submits that he has no objection if the word `falsely' is deleted from paragraph

2. Accordingly, the word falsely is deleted from paragraph 2. The remaining contents of the affidavit, particularly those stated in paragraphs 4(a) to 4(d) of the affidavit are accepted as undertakings on behalf of the Defendant. The suit is decreed in terms of paragraphs 4(a) to (d) extracted above. Decree sheet be drawn.

9. Since the matter has been amicably resolved, full court fee is directed to be refunded to the Plaintiff in terms of the judgement in Nutan Batra v. M/s. Buniyaad Associates [2018 (255) DLT 696].

10. Next date of hearing stands cancelled. All pending applications are also disposed of.

PRATHIBA M. SINGH, J SEPTEMBER 6, 2022 dj/sr Signature Not Verified Digitally Signed By:DEVANSHU JOSHI CS(COMM) 404/2021 Page 6 of 6 Signing Date:13.09.2022 11:58:31