Delhi HC upholds Bristol Myers' patent for anti-cancer drug Dasatinib, imposes Rs 5L penalty on SP Labs

BMS initially filed the case in 2015, asserting that SP Labs infringed on its patent by marketing a generic dasatinib product in India before the patent’s expiry in April 2020. Despite repeated notices, SP Labs failed to appear in court, leading to an ex-parte ruling and financial penalty in favor of BMS.

On August 27, 2024, the Delhi High Court delivered its ruling in the patent infringement case between Bristol-Myers Squibb Holdings Ireland (BMS) and multiple defendants, including SP Labs, over the drug dasatinib, used in cancer treatment.

BMS sought a permanent injunction against the defendants for infringing its Indian Patent No. IN 203937, which covered dasatinib and its pharmaceutically acceptable salts, solvates, isomers, and prodrugs. This patent was valid until April 12, 2020, yet BMS contended that unauthorized actions by SP Labs and other entities in India, such as advertising and attempting to distribute a generic version, constituted infringement before the expiration date.

In the initial proceedings, the High Court had issued an ex-parte injunction on September 4, 2015, restraining the defendants from manufacturing or selling dasatinib-based products. This order was later made permanent until the patent’s expiry in 2020. Despite the injunction, BMS discovered in November 2016 that a product branded "DASA SPL," which contained dasatinib, was being marketed at the distributor level in India. Investigations revealed that this product was manufactured by SP Labs, based in Bangladesh, which was connected to the Indian entity SP Labs Pvt. Ltd. According to BMS, SP Labs was attempting to bypass Indian patent laws by manufacturing in Bangladesh, where dasatinib was not under patent protection, and then importing the product to India.

The court documents highlighted that BMS had obtained evidence connecting SP Labs in Bangladesh to the Indian defendants, despite the defendants’ claims to the contrary. In previous rulings, including a December 2023 court order, the Delhi High Court had noted connections between SP Labs and Indian distributors, further supporting BMS's argument that SP Labs was circumventing the injunction through its operations in Bangladesh.

In the present 2024 hearing, the court confirmed that SP Labs had been properly notified about the case but had not appeared in court or presented a defense. Given the lack of response from SP Labs and the evidence provided by BMS, the court ruled in BMS's favor. It decreed a cost of Rs 5,00,000 against SP Labs, payable to the Delhi High Court Bar Association Employee Welfare Fund, as a penalty for its non-compliance and continued infringement actions.

The court also acknowledged the validity of BMS's patent and noted that other defendants, who appeared in court, had not commercially launched any infringing products during the patent’s term and had respected the patent’s validity.

The court’s final ruling imposed several notable restrictions and penalties on SP Labs. First, due to SP Labs' absence in court despite receiving proper notification, the court issued an ex-parte decree, holding SP Labs liable for patent infringement and ordering financial penalties.

Furthermore, the defendants who did appear in court acknowledged the validity of BMS’s patent and refrained from launching dasatinib-based products in India during the patent’s active period. It observed;

“The defendant nos. 1 to 3, 5 and 6, did not launch any dasatinib containing product till the expiry of the suit patent on 12 th April, 2024. II. There has been no commercial use by defendant nos. 1 to 3, 5 and 6, of any kind, whatsoever, in relation to dasatinib till date. III. The defendant nos. 1 to 3, 5 and 6, acknowledge the validity of the Patent No. IN 203937, during its term, till the expiry of such patent on 12th April, 2020.”

The court, however, confirmed that SP Labs, identified as Defendant No. 7, infringed upon BMS’s patent by marketing dasatinib under the brand name DASA SPL, thereby substantiating BMS’s infringement claim. Additionally, a significant fine of Rs 5,00,000 was levied against SP Labs.

Subsequently, the court noted;

“The defendant no. 7 has not entered appearance in the matter and had in fact launched the impugned product dasatinib, under the brand name DASA SPL. Considering the fact that the defendant no. 7 has not appeared before this Court despite valid service, and not raised any defence and has rather introduced the impugned product dasatinib under the brand name DASA SPL, and considering the fact that the present suit has been pending since the year 2015, cost of ₹ 5,00,000/- is imposed against defendant no. 7 in favour of DHCBA Employee Welfare Fund. ”

To view the original order, click on the link below:

https://indiankanoon.org/doc/111815577/