Using RTI Act in the battle to capture the Indian Pharmaceutical market
The use of the Right to Information (RTI) Act for commercial purpose by industries is not unknown and another such trend of using the Act has come to notice. Indian firms are known internationally for producing low cost generic alternatives of the patented drugs produced by Multinational Corporations (MNC). These Pharmaceutical MNCs are now using the RTI Act to launch pre-emptive legal action against the local generic manufacturers when their marketing approval is still pending to delay / prevent the entry of generic medicines in the domestic drug market said to be worth nearly Rs. 60,000 crore.
Suits have been filed in the past by the P Pharmaceutical MNCs in the past claiming patent infringement whenever a generic manufacturer tried to sell a competing drug in the market. Now, MNCs are trying to obtain information regarding which generic firms have applied for a marketing licence for patented drugs, which gives them time to prepare and launch legal suits rather than waiting for the grant of the marketing right being made public. Usually, there is a few months' window period between the grant of approval and the actual launch of the drug in the market which is now used by the MNCs to prepare and file the legal pursuit. At least 8 petitions are pending in the Delhi High Court alone by the patent holder MNC.
- Bristol-Myers Squib, with headquarters in US, has filed cases against:
- Hetero Drugs and Natco Pharma over the cancer drug Dasatanib.
- Ranbaxy Labs over Hepatitis B bulk drug Entecavir.
- French firm Sanofi Aventis has filed a case against MSN Labs over cardiac drug Dronedarone,
- Bayer Pharma AG, a German firm, has sued Intas Pharma over anti-coagulant Rivaroxaban.
These recent suits being launched to pre-empt any effort to launch the generic drug are a recent phenomenon and the generic firms are reacting by challenging the whole concept of launching a legal offensive against 'paperwork'. It is being argued that merely filing an application doesn't necessarily have to translate into a product launch and filing of an application with the DCGI for marketing approval of patented drugs does not tantamount to patent infringement. MNCs have sought ex-parte injunctions demanding that the generic manufactures should be restrained from launching the generic version without having heard the generic firms. Despite the cases slapped against them, Natco and Ranbaxy have gone ahead with their product launches in case of Dasatanib and Entecavir.
Would the RTI emerge as a tool for the board room fights and as a barrier to affordable drugs?