Compulsory Licencing: Delhi High Court orders to restrain NATCO from exporting generic version of Bayer’s Nexavar [Read Order]

Compulsory Licencing: Delhi High Court orders to restrain NATCO from exporting generic version of Bayer’s Nexavar [Read Order]

In Bayer Corporation v. Union of India, the Delhi High Court orders to restrain exporting generic version of Bayer’s Nexavar. Justice Manmohan issued the injunction order restraining NATCO from exporting generic version of Bayer’s Nexavar under Compulsory Licence.

Section 90 of the Patents Act, 1970 deals with the terms and conditions of Compulsory Licence, as follows:

Terms and conditions of compulsory licences.

(1) In settling the terms and conditions of a licence under section 84, the Controller shall endeavour to secure—

(i) that the royalty and other remuneration, if any, reserved to the patentee or other person beneficially entitled to the patent, is reasonable, having regard to the nature of the invention, the expenditure incurred by the patentee in making the invention or in developing it and obtaining a patent and keeping it in force and other relevant factors;

(ii) that the patented invention is worked to the fullest extent by the person to whom the licence is granted and with reasonable profit to him;

(iii) that the patented articles are made available to the public at reasonably affordable prices;

(iv) that the licence granted is a non-exclusive licence;

(v) that the right of the licensee is non-assignable;

(vi) that the licence is for the balance term of the patent unless a shorter term is consistent with public interest;

(vii) that the licence is granted with a predominant purpose of supply in the Indian market and that the licensee may also export the patented product, if need be in accordance with the provisions of sub-clause (iii) of clause (a) of sub-section (7) of section 84;

(viii) that in the case of semi-conductor technology, the licence granted is to work the invention for public non-commercial use;

(ix) that in case the licence is granted to remedy a practice determined after judicial or administrative process to be anti-competitive, the licensee shall be permitted to export the patented product, if need be.]

The grant of licence is strictly for the sale of Sorafenat in the territory of India. The Present Writ petition was filed seeking direction to the Custom Authorities to seize and confiscate the consignments containing Sorafenat as NATCO has violated this provision.

Contention of the Petitioners: Violation of the terms and conditions stipulated for Compulsory License as the drug Sorafenat is available abroad.

Contention of Respondents: Sorafenat is being sold by certain purchasers or retailers abroad individually. This is in no fault of NATCO.

Further NATCO prayed for permission to send samples of the active ingredients of Sorafenat abroad for experimentation and generation of clinical trial data and for submission to the Drug Controlling Authorities.

The Court granted the permission.

After hearing the parties, the Court directed NATCO to ensure that no shipment containing the drug covered by the Compulsory License was exported.

Six weeks’ time have been granted to file the counters

 Read the Order