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Delhi High Court - Orders

F. Hoffmann-La Roche Ag & Anr vs Biophore India Pharmaceuticals ... on 28 March, 2024

Author: Sanjeev Narula

Bench: Sanjeev Narula

                                    $~43
                                    *           IN THE HIGH COURT OF DELHI AT NEW DELHI
                                    +           CS(COMM) 263/2024 & I.As. 7076-7079/2024
                                                F. HOFFMANN-LA ROCHE AG & ANR.                  ..... Plaintiffs
                                                              Through: Mr. Pravin Anand, Mr. Shrawan
                                                                           Chopra, Ms. Prachi Agarwal, Ms.
                                                                           Ridhie Bajaj and Ms. Saumya Singh,
                                                                           Advocates.
                                                              versus

                                                BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED
                                                                                          ..... Defendant
                                                             Through: Mr. Sushant Singh, Mr. Sourav
                                                                      Pattanaik and Mr. Piyush Kumar,
                                                                      Advocates.

                                                CORAM:
                                                HON'BLE MR. JUSTICE SANJEEV NARULA
                                                                                      ORDER

% 28.03.2024

1. Let the plaint be registered as a suit.

2. Issue summons. Mr. Sushant Singh, counsel for the Defendant appearing on advance notice, accepts summons. He confirms receipt of the suit paper-book and waives the requirement for Registry to issue formal summons.

3. Plaintiff No. 1- F. Hoffmann-La Roche AG and Plaintiff No. 2- PTC Therapeutics Inc. have filed the instant suit for restraining infringement of Indian Patent No. IN 334397 ["Suit Patent"] titled "COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY". The bibliographic details of the Suit Patent are set out as under:

This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 12/04/2024 at 22:47:15

4. According to the Plaintiffs, the Suit Patent covers and claims, inter alia, a novel pharmaceutical compound which has been assigned the International Non-Proprietary Name (INN) 'Risdiplam'. Risdiplam is the active pharmaceutical ingredient (API) in the Plaintiffs' commercial product which is marketed and sold under the brand name 'Evrysdi®' in various countries, including India. In respect of this brand, Plaintiff No. 1 is the registered proprietor of the trademarks: ' ' under No. This is a digitally signed order.

The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 12/04/2024 at 22:47:15 4241860; ' ' under No. 4239878; and ' ' under No. 4497791.

5. Plaintiffs have approached this Court apprehending that the Defendant, Biophore India Pharmaceuticals Private Limited, is on the verge of commercially launching a pharmecutical preparation which infringes the Plaintiffs' Suit Patent. Plaintiffs' apprehension arose when they came across the information available on the Defendant's website www.biophore.com wherein Risdiplam is listed as one of the products under the 'Orphan Drugs' category. Further, Plaintiffs contend that pursuant to engaging an independent investigator, they have received information that the Defendant is dealing in Risdiplam API, and intends to begin commercial production in India. In such circumstances, since the Defendant claims to be involved in the manufacture of niche pharmaceutical products for global markets, Plaintiffs have filed the instant suit to restrain the Defendant from commercially launching any product in the Indian market which would directly infringe the Suit Patent.

6. Mr. Singh, representing the Defendant, before commencement of the hearing, on instructions states that the Defendant has neither manufactured nor sold any commercial/ non-commercial quantity of Risdiplam in India or anywhere else. He states that presently, the Defendant is using Risdiplam only for the purposes of research, as permissible under Section 107A of the Patents Act, 1970 ["Act"], in terms of the guidelines laid down in Bayer Corporation & Anr. v. Union of India & Ors.1. Mr. Singh further places 1 2019 SCC OnLine Del 8209 This is a digitally signed order.

The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 12/04/2024 at 22:47:15 reliance on Section 48 of the Act to submit that the law does not prohibit conducting further research on a patented technology for further development and improvement. Nonetheless, Mr. Singh confirms and undertakes on behalf of his client that the Defendant shall not manufacture or sell any pharmaceutical product which infringes the Suit Patent till its expiry on 11th May, 2035. Furthermore, Mr. Singh states that the Defendant does not challenge the validity of the Suit Patent, and therefore, the instant suit can be disposed of on the basis of the aforenoted statement.

7. Mr. Pravin Anand, counsel for the Plaintiffs, having heard the undertaking given by Mr. Singh, states that the Plaintiffs are agreeable to the suit being disposed of by binding the Defendant to the aforenoted statement of Mr. Singh.

8. In light of the above, the suit is decreed in terms of the statement made by Mr. Singh, which shall bind the Defendant. The Defendant must also file an affidavit confirming the statement made by Mr. Singh, as recorded above. It is clarified that the Defendant shall be free to carry out research on the pharmaceutical preparation in question, as permissible under law.

9. Decree sheet be drawn up.

10. The suit, along with pending applications, is disposed of in the above terms.

SANJEEV NARULA, J MARCH 28, 2024/as This is a digitally signed order.

The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 12/04/2024 at 22:47:15