The panic of a potential bird-flu pandemic has again brought into light the ongoing conflict between patents and health rights. Due to its geographical location, India is highly susceptible to the outbreak of the Avian Flu that killed several people in East and South East Asia. The Ministry of Health, Government of India has set up a task force on give its recommendations on the matter. Roche owns patents on oseltamivir with the brand name “Tamiflu”, the only drug effective against H5N1 strain of the Bird Flu virus.

In August 2005, a national consultation for assessing the India’s preparedness to meet this imminent danger was held wherein concern over the insufficiency of stock of medicines was expressed. The International Health Agencies like WHO are contemplating production of this anti-viral in India and Thailand. Roche has sought permission from the Union Health Ministry to market “Tamiflu” in India and pursuant to this request its mailbox application (Application No.- 396/DEL/96) being processed on fast track.

The pending patent application of “Tamiflu” raises a set of fundamental questions. What is the legal basis if the Government mandates Roche to grant compulsory license to a generic drug maker for Tamiflu, if a patent application for Tamiflu is only pending? The Indian patent law envisages grant of Compulsory Licenses only for granted patents and not when an application is pending. The grant of Compulsory License with respect to an invention, the application for which is still pending, is difficult to reconcile with the existing statutory provisions.

Even in the presence of Roche’s mailbox application, the companies like Cipla are contemplating manufacturing and marketing “Tamiflu” in India. Under proviso 2 of Section 11 (A) of the Patents Act, liability for infringement will accrue only from the date of grant of the patent application. Can the Government by notification exclude generics from their liabilities for infringement computed from the date of grant of a patent to Roche through Mail Box route? There is no provision in the Act that covers this action.

Is the ‘Government Use’ a possible route? The Patents Act permits the government to use or authorize the use of an invention after an application for a patent has been filed in the Patent office, for the purposes of government. Under these provisions the authorization can be given even before the grant of patent in India. However it is to be remembered that the ‘use for the government purposes’ means the use of the invention only on a non-commercial basis. The government has also the power to acquire the invention from the applicant for a public purpose.

Sweeping powers are given to the Central government to meet any emergency arising out of health crisis in India. Considering the peculiar circumstances of this case, the route that the government will adopt to tackle the situation is uncertain and may raise a variety of jurisprudential conundrums!