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IN THE HIGH COURT OF DELHI
Prathiba M. Singh, J.
Chugai Seiyaku Kabushiki Kaisha - Appellant
Versus
Natco Pharma Limited - Respondent
CS (COMM) 427 of 2021
Decided On : 03-06-2022




A defendant can use patented technology for research without infringing patent rights, provided they do not commercially launch the product before patent expiration or a finding of invalidity.

Headnote:(A) The Patents Act, 1970 - Section 48 and Section 107A - Permanent injunction sought for infringement of Indian Patent No.294424 concerning Alectinib, which is used in cancer treatment - The Defendant admitted to using the drug for research and agreed not to commercially launch until patent expiration on 09-06-2030 - Suit decreed in terms of Defendant's affidavit outlining stipulations regarding launch and use. (Paras 2, 6, 8)

Facts of the case:
The Plaintiffs filed a suit against the Defendant for allegedly infringing their patent on a tetracyclic compound, Alectinib. Following an investigation, the Plaintiffs claimed the Defendant had engaged in activities infringing the patent rights.

Findings of Court:
The Defendant agreed not to launch any Alectinib product until the patent expires or a finding of invalidity is made regarding the patent - The suit was decreed based on this agreement.

Issues: Whether the Defendant's activities constituted infringement and what restrictions should be imposed on the Defendant's use of the patented compound.

Ratio Decidendi: The court held that a party may use patented technology for research purposes without infringing patent rights, as long as there is no commercial launch prior to the expiration of the patent or a finding of invalidity.

Result: Suit decreed as per the Defendant's stipulations.

Table of Content
1. patent infringement and parties involved. (Para 2 , 3 , 4)
2. defendant's alleged infringement activities. (Para 5 , 6)
3. affidavit regarding non-commercial use. (Para 7 , 8)
4. resolution of the matter and conclusion. (Para 9 , 10)

JUDGMENT

Prathiba M. Singh, J. (Oral)--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 - Natco Pharma 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 export of Alectinib API in May 2019, which amounts to infringement of the suit patent as per Section 48 of The Patents Act, 1970. Thereafter, in June 2021, the Plaintiffs discovered that the Defendant has filed a patent application, namely IN 201941022366 in respect of Pharmaceutical compositions comprising Alectinib on June 06, 2019 before the Indian Patent Office. The Plaintiffs also acquired knowledge that another Patent Application was filed by the Defendant pertaining to Alectinib, before the Indian Patent Office bearing application no. 201741029461 in respect of A novel process for the preparation of an intermediate of Alectinib. 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 13th 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 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,

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