On 26th September, 2014, a Hyderabad Trial Court denied an interim injunction to Bristol-Myers Squibb (BMS) in a suit against generic manufacturer Mylan regarding the export of HIV Drug Atazanavir to Venezuela. While BMS had no product patents in either India or Venezuela, they had brought the suit on the basis of two secondary process patents.
The Trial Court had earlier denied them an ex-parte interim injunction, following which BMS had approached the High Court to secure a status quo order. The High Court had amended the Trial Court order and asked Mylan to deposit Rs. 30 lakh with the Court following which they could continue exporting 1/8th of the purchase order until the Trial Court decides on the interim injunction application after hearing both sides. This application has now been dismissed by the Court. Unfortunately, the order of the Court is not available online.
What is interesting is that BMS is also suing Mylan (then known as ‘Matrix) in a US Court regarding the export of the same drug to Venezuela. BMS and Mylan had entered into an “immunity from suit agreement” (similar to a voluntary license) where Mylan could distribute Atazanavir in certain territories without being sued for patent infringement by BMS. When Mylan sold the drug to the Pan American Health Organisation, who supplied it in Venezuela, BMS sued Mylan for breach of the agreement (as the agreement had only covered India and Sub-Saharan Africa). While the District Court held that though Mylan may be liable for patent infringement, it is not liable for breach of the Immunity from Suit Agreement, the Federal Appeals Court has overturned this order on October 7th.
Coming back to the Indian case, I found this decision to not grant an interim injunction heartening for two reasons. The first is because of the dangers of granting interim injunctions in patent suits, which we have blogged about before on SpicyIP (here, here and here, for example). Patent suits are often complicated and involve issues that require expert evidence, and a wrong decision often has dire consequences- especially in this case, where it is regarding a life-saving drug for HIV patients.
The second reason is because Mylan raised the defense of ‘public interest’ in its arguments. It argued that the export of a drug to a sovereign government in pursuance of a WHO order does not strictly constitute “sale for commercial purpose” due to the larger interests at stake. In Roche v. Cipla, Justice Ravindra Bhat of the Delhi High Court had read in “public interest” into the 3 step test for temporary injunction, by making it a factor to consider when testing whether there is irreparable injury. That was a big moment in India’s Access to Medicines jurisprudence. While I don’t know if the public interest argument was instrumental in the Court’s decision in the present case, it is still great to see an Access to Medicines angle being argued in the Courts.
News Source: Pharmabiz