The Andhra Pradesh High Court on December 5, 2014 allowed generic drug maker Mylan to export HIV medicine Atazanavir to Venezuela, rejecting the appeal of Bristol Mayer Squibb (Bristol) against the order of the trial court.
The trial court had rejected the application for interim injunction by Bristol against Mylan over the export of HIV drug Atazanavir to Venezuela. The High Court upholding the decision of the trial court in the present appeal felt that there is no reasonable ground to interfere with the decision of the trial court. However the High Court directed Mylan to maintain a separate account in respect of export of Atazanavir to Venezuela for safeguarding Bristol’s rights in case it succeeds in the suit and also to furnish bank guarantee for export of the product.
On April 17, 2011, Mylan had entered into a commercial agreement with Bristol regarding HIV drug Atazanavir, which was recommended by WHO as the first option for second-line treatment. Under the agreement, Bristol authorized generic drug maker Mylan to manufacture, distribute and sell Atazanavir in certain listed developing countries and an assurance of immunity from any law suit in this regard was given to Mylan.
Issue arose when Mylan sought permission from Bristol to supply generic Atazanavir in Venezuela which was not included in the countries listed in the agreement. Bristol refused because it had been supplying branded Atazanavir to the government of Venezuela for at least 5 years. Subsequently in 2012, Mylan entered into an agreement with Pan American Health Organization (PAHO) for the supply of Atazanavir in Venezuela. Bristol filed a suit before a U.S. court against this action of Mylan over breach of commercial agreement alleging that Mylan violated their agreement by providing PAHO with over a year’s supply of Atazanavir for use in Venezuela and Bristol had already lost approximately in excess of 15 million USD profits on sales. Furthermore, Bristol claimed that as a consequence of Mylan’s actions, its negotiation strength with the Venezuelan government going forward had been severely damaged. However, the U.S. Court rejected Bristol’s application and directed that Bristol should file a case against Mylan under relevant patent laws.
Aggrieved by the order of U.S. Court, Bristol filed a patent infringement before the trial court in Hyderabad against Mylan. The trial court rejected the application for interim injunction and the decision of the trial court is now upheld by the High Court in the present appeal observing that “Though the appellant is able to prove that it has obtained process patents, but at this stage, it is not clearly proved that there is an infringement by the respondent. In such circumstances,refusal of injunction at this stage, without production of scientific evidence, as held by the trial Court, cannot be faulted. In view of the aforesaid decisions, injunction can be granted only when prima facie, appellant is able to prove his case that his patented process is being infringed by the respondent, the balance of convenience lies in its favour and that irreparable loss would be caused to the appellant, if injunction is not granted in its favour.”