In a recent court order, Delhi High Court gave a setback to German company Bayer, by lifting a suspension order that restrained an Indian drug company, Ajanta, from producing and selling overseas a generic version of Bayer’s erectile dysfunction drug, vardenafil.

The patents filed by Bayer, that form the basis of the case, were originally applied for in 1998, after which they came into effect from 2003 for one salt of the drug and since 2008 for another. Ajanta had appealed to lift the stay order by claiming that Bayer was not manufacturing the drug in India and that Bayer’s interest could be protected by payment of royalty to Bayer consisting of some percentage of the amount gained by Ajanta from the exports. In fact, Ajanta also agreed to provide a track of its records regarding sales and profit received from exports of Bayer’s drug.

In furtherance, Bayer accepted that it has not exploited its drug commercially in India. Based on all this, the court said "In these circumstances, though the non-user cannot be set up as a defence to the suit for infringement, upon the self-interest of the patentee being balanced against the larger public interest, equity demands that absolute or unconditional temporary injunction be not granted inasmuch as it would result in the manufacturing activity and the resultant exports of the impugned products of the defendant being ground to a halt resulting possibly in not only loss of employment but revenue to the State as well.”

The court also indicated that the stay order was suspended subject to the condition that Ajanta shall provide the court with all records of the production and export of the drug on a quarterly basis. In addition, Ajanta cannot distribute or sell the drug in India until a patent infringement lawsuit that was filed by Bayer is resolved. Thus, the application by Ajanta was disposed of and the infringement suit by Bayer remains due for hearing.

Read the court order here.

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