Intellectual Property RightspatentWhether Export of Patented Product for Commercial Value is Exempted under Section 107-A of the Patent Act, 1970?

HIGH COURT OF DELHI

Bayer Intellectual Property GMBH & Another v. Titan Laboratories Pvt. Ltd. 

CS (COMM) 243/2020 | Date: 08 July 2020

FACTS

In the present case, Bayer Intellectual Property (hereinafter referred to as “the Plaintiff”) is a company established in Germany, which owns the Suit Patent IN 300 for the compound named, RIVAROXABAN. Now, the Plaintiff has registered this Patent in over sixty countries over the world including India, whose validity has been acknowledged by number of third parties.

Now, Plaintiff sells his patented compound in India, through Plaintiff No. 2 and through license, which has validity upto 11 December 2019. Now, Plaintiff No 2 is a company established in India under the Companies Act 1956, which has obtained the required permission under the Drugs and Cosmetics Rules, 1945 to import the compound RIVAROXABAN, in India and sell it under the trademark XARELTO.

Now, in the present case, Titan Laboratories Pvt. Ltd (hereinafter to referred as “the Defendant”) is a company established in India, which is engaged in the business of dealing in pharmaceutical products and providing WHO-GMP facility for contract manufacturing of Pellets, Granules, Capsules, Sachets and Tablets, for their domestic as well as International Clients, has exported RIVAROXABAN to two Peruvian entities in large quantities under the name MEZOSER-S from India without authorization.

Thereafter, the said application was filed by Plaintiff before High Court of New Delhi to grant ad-interim injunction against the Defendant.

ISSUE BEFORE THE HIGH COURT

Whether the export of RIVAROXBAN compound by defendant from India to other countries is exempted under Section 107-A of The Patent Act, 1970?

CONTENTIONS OF THE PARTIES

In regards to the Issue, The Plaintiff contended that, the Defendant has exported RIVAROXABAN to two Peruvian entities in large quantities under the name MEZOSER-S from India without authorization. Further, during investigation it was revealed that, Defendant has published “RIVAROXABAN IR Tablets I0/25/20 mg” in its Product list as anticoagulant product, wherein the Defendant was not authorized to publish it as their product, when it is patented by us and we have license for it, which is valid upto the period of 11 December 2019.

Therefore, the Plaintiff contended that, High Court should issue ad-interim injunction against the Defendant to stop them from exporting RIVAROXABAN compound from India, as it is their patented product and the act undertaken by Defendant is causing huge losses and severe injury to the Company.

In regards to the Issue, The Defendant contended that, they have not infringed the rights of Plaintiff, as their act of exporting RIVAROXABAN compound, under the name of MEZOSER-S from India, is exempted under Section 107–A of The Patent Act, 1970. Section 107-A of The Patent Act, 1970 is as under –

“107-A – Certain acts not to be considered as an infringement.

a) any act of making, constructing (using, selling or importing) a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction (use, sale or import) of any product;

b) Importation of patented products by any person from a person, who is duly authorized under the law to produce and sell or distribute the product shall not be considered as an infringement of patent rights”

DISCUSSION AND FINDINGS 

The High Court after hearing contention of both the parties agreed with the contention of Plaintiff and held that, since Defendant has exported Finished Product of the patented compound RIVAROXABAN, under the name of MEZOSER-S from India, in large commercial quantities with two Peruvian entities, without authorization. Therefore, the act of export of patented product, in large quantities to gain commercial value, will not be exempted, under Section 107-A of The Patent Act, 1970 and it will be considered as the use of product in India.

Therefore, High Court after considering contentions and the documents presented by Plaintiff concluded that they have made a prima facie case in their favour and because of the act of Defendant, they are suffering from huge losses. Further, the balance of convenience also lies in the favour of Plaintiff.

Henceforth, High Court decided to pass an ad-interim injunction against the Defendant to stop them from exporting RIVAROXABAN the patented product of the Plaintiff out of India.

AMLEGALS REMARKS 

In the present case, High Court decided on the question that, whether the act of Plaintiff of exporting patented product out of India will be exempted under Section 107-A of The Patent Act, 1970 and decided that, since Defendant has exported Finished Product of the patented compound RIVAROXABAN, under the name MEZOSER-S from India, in large commercial quantities to gain commercial values, with two Peruvian entities. Such act will not fall under the exemption, provided under Section 107-A of The Patent Act, 1970 and it will be considered as the use of patented product in India.

Thus, High Court held that, Defendant has infringed the Patent rights of the Plaintiff and passed ad-interim injunction against the Defendant to stop them from exporting RIVAROXABAN the patented product of the Plaintiff out of India.

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