BMS tries to block access to generic HIV drug in Venezuela,
Tries to obtain injunction in India but fails before the Trial Court
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.
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 (under the 2013 tender) to Venezuela.
There are no product patents in India or in Venezuela for Atazanavir itself, but BMS used two secondary patents granted in India, that – cover processes for preparing precursors which are used to make an epoxide intermediate in the Atazanavir synthesis – 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. High Court Order of August 28 modifying the status quo is in public domain on AP High Court website and can also be accessed here
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 (represented by local counsel and Guru Nataraj).
On Friday (26th September), the Trial Court in Hyderabad denied an interim injunction to BMS. Details of the order are not yet available (would be useful to see what principles were used by the Judge to deny the injunction).
BMS is likely to appeal the decision quickly, perhaps within this week itself.
Additional Background to the case
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, with Mylan being permitted to sell only in certain specific territories listed in the VL. BMS (US) had sued Mylan in USA for breach of contract based on the 2012 tender, and had lost. See details of the US case in our previous posting here
The case – BRISTOL-MYERS SQUIBB COMPANY vs. MATRIX LABORATORIES LIMITED, now known as Mylan Laboratories Limited was filed before the district judge in New York. See here
The New York District Judge had expressly held that there is nothing in the agreement that would prohibit Mylan from exporting to Venezuela.US District Court Order can be accessed here and BMS’ appeal to Federal Circuit can be accessed here
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.
What is happening in Indian courts – injunctions block access to medicines
Patent enforcement cases where the courts are requested to blindly hand out injunctions (stay orders) 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 grant a CL on datatinib, grant of ex-parte and interim injunctions in patent infringement suits to BMS against generic competitors by Indian court have caused irreparable injury to Indian patients who were dependent on the generic version.
Besides, atazanavir for Venezuela, this is the second case where an affordable generic version of a drug is sought to be prevented from being exported from India. The drug – copolymer-1, or glatiramer acetate – popularly known as Copaxone for the treatment of multiple sclerosis, was meant for export to the US where it is very expensive with many patients paying over US$40,000 per year for the drug. The drug was going off patent in the US in June 2014 and competition would have brought prices down significantly. In India the product patent on glatiramer acetate, 93/ Del/2003, was rejected by the Indian Patent Office in March 2009. NATCO is collaborating with US based Mylan to launch glatiramer acetate in the US after the US patent expired. See announcement made by Natco here. However, Teva filed a suit for infringement and sought an injunction alleging infringement of a process patent 190759. Read more on this here