In a huge relief to scores of HIV patients across Venezuala, on 26th September a Trial Court in Hyderabad denied an interim injunction to Bristol-Myers Squibb (BMS). On denying injunction the judge has expressly ruled that BMS has not made out a prima facie case of infringement and that the granting the injunction affects people living with HIV.
Emboldened by the series of ex-parte injunctions granted by Indian courts against generic manufacturers, BMS represented by the law firm Anand & Anand, sued Mylan in Hyderabad in August of this year to prevent export of Atazanavir to Venezuela. There are no product patents in India or in Venezuela for Atazanavir itself, but BMS used two secondary process patents granted in India to try and obtain an ex-parte injunction.
The patents in suit are 206217 (stereoselective process for preparing substituted oxobutanes) and 210496 (process for preparing alpha-chloroketones). The Trial Court refused to grant ex parte interim injunction saying that he would have to hear both parties. The Judge ordered BMS to serve notice and provide copies immediately to Mylan.
BMS moved an urgent application in the High Court and secured a status quo order, preventing Mylan from exporting the drug to Venezuala. The order was challenged by Mylan and the High Court amended the order (28th August) to a limited export permission (1/8th of the purchase order i.e.12,500 bottles), subject to deposit of Rs. 30 lakhs and direction to the Trial Court to hear and conclude the interim injunction application within three weeks.
Mylan main defence was it did not use either of the two processes and in fact obtained the intermediate from a third party. The second argument was interestingly based on public interest – that export of a HIV drug to a sovereign government, in respect of a WHO order – was not a sale for commercial purposes only.
BMS has filed an appeal on Monday, 29th September 2014, and it is likely to be heard on Wednesday.
The Pan American Health Organisation (PAHO) had issued a tender earlier in 2012 and again in 2013 for supply of atazanavir to the Ministry of Health in Venezuela. BMS did not bid for the tender. Mylan did and was awarded the tender both times.
Patent enforcement cases where the courts are requested to blindly hand out injunctions to keep out more affordable generic versions from the market are increasing in India. It can be anticipated that injunctive relief issues will play an important role in future patent litigation in India and the development of case law in this regard is quite crucial from an access to medicines perspective. This dispute is a case in point.
BMS has used ex-parte and interim injunctions in the past to effectively block access to affordable generic versions of the cancer drug dasatinib. The generic version which was available at one sixth (Rs. of the price 9000 vs. 60,000 per patient per month) is no longer available in the market after multiple court injunctions barred generic drugmakers from marketing their version.
With the Indian government reluctant to grant a CL on datatinib, grant of the injunctions to BMS against generic competitors by Indian courts have caused irreparable injury to Indian patients who were dependent on the generic version.
BMS has already tried once in 2012 to try and block export of atazanavir to Venezuala. BMS (US) and Mylan had signed a voluntary license in respect of Atazanavir. BMS (US) had sued Mylan in USA for breach of the VL contract based on the 2012 tender, but lost the case. The dispute clearly highlights some of the pitfalls of hastily signed, loosely worded voluntary licensing agreements, which are used by companies like BMS not to facilitate access but to in-fact block competition in middle income developing countries.