The court upheld that patent holders are entitled to protection against commercial use of their patented product, while allowing research use under specific exemptions.

JUDGMENT

Prathiba M. Singh, J. (Oral)

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 Defendants - Hetero Labs Limited and Hetero Drugs Limited - are part of a pharmaceutical group of companies engaged, inter alia, in the manufacture, sale, and offering for sale various generic pharmaceutical products all over India and in many foreign countries.

5. As per the plaint in May, 2021, an investigation was conducted by an independent investigator which revealed that Defendant No.1 had imported Alecensa/Alectinib Hydrochloride from Germany on 3rd August, 2018. Further investigation in June, 2021 revealed that an application had been made by Defendant No.1 for enhancement and expansion of the Defendant's plan facilities for manufacturing Alectinib Hydrochloride, as per the Pre- feasibility Report dated June, 2020 filed by Defendant No.1 before the State Level Environmental Impact Assessment Authority. The environmental clearance was obtained from the Telangana Government. In one of the online business directories i.e., www.pharmacompass.com, Defendant No.2 was also listed as a supplier of Alectinib Hydrochloride. This led to the filing of the present suit, prior to the launch of the product by the Defendants. Vide order dated 29th October, 2021, the Court had recorded the statement of the ld. Counsel for the Defendants and had passed the following order:

"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 Defendants, their directors, employees, officers, servants, agents, stockists, retailers, semi stockists, wholesalers, marketers, distributors, affiliates, any other entity/person in the chain of supply and all others acting for and on their behalf from using, making, manufacturing, selling, distributing, advertising, exporting, offering for sale, importing or in any other manner, 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 defendants, on instructions, states that for the time being, the defendants are 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 defendants do not have any license to commercially manufacture the drug. In case the defendants decide to commercially manufacture and launch the said product, the defendants will give four weeks' advance notice to the plaintiffs/learned counsel for the plaintiffs.