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August 13, 2020

Export Of Patented Goods In Commercial Quantity Not Exempted Under S. 107A (Bolar Exemption)

Author: Siddharth Varshney

In the matter of Bayer Intellectual Property GMBH v. Titan Laboratories Pvt. Ltd. [CS(COMM) 243/2020], the Delhi High Court, in its ex-parte order dated July 8, 2020, granted an ad-interim injunction restraining the Defendant from exporting the Plaintiff’s patented drug RIVAROXABAN in commercial quantities. The Court ruled that such use will amount to use in India and the Defendant cannot claim exemption under Section 107A of the Patents Act.

Plaintiff’s suit patent for the drug RIVAROXABAN is valid in India till November 11, 2020. Plaintiff filed the suit of patent infringement alleging that the Defendant is exporting the drug RIVAROXABAN in large quantities to Peruvian entities. Plaintiff alleged that at least two shipments of the drug RIVAROXABAN (under brand “MEZOSER-S”) have been exported from India to Peru, and that Peruvian entities have commenced commercial dealing of the drug RIVAROXABAN in Peru. The Plaintiff also submitted that the Defendant was in the business of contract manufacturing and while Defendant’s website lists a product “Rivaroxaban IR Tablets I0/25/20 mg”, it has not yet launched the product in India.

While this was an ex-parte order, the Court did consider the possibility of defence under Section 107A, which provides that the use of a patented invention solely for the purpose reasonably related to the development and submission of information required under any law for the time being in force in India, or in any other country, shall not be considered as infringement of patent rights.

The court, while granting the ad-interim injunction against the Defendant, observed that “…exports have been of finished RIVAROXABAN products and that too in commercial quantities, the defendant primarily is not exempted under Section 107-A of the Patents Act and use of the defendant while exporting will be considered as use in India”.

Disclaimer: Views, opinions, interpretations are solely those of the author, not of the firm (ALG India Law Offices LLP) nor reflective thereof. Author submissions are not checked for plagiarism or any other aspect before being posted.

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