Natco Pharma is once again seeking compulsory licensing as per news reports. This time it is for manufacturing a generic version of Celzentry for local market as well as exports. Celzentry is Pfizer’s new anti HIV/AIDS drug which was patented last year however it is not yet launched. It is known as maraviroc in generic terms and is a second line HIV/AIDS drug used in patients who develop resistance to medication given in the early stages of infection. Maraviroc also known as anti-retroviral drug is considered a salvage therapy, in medical community, for patients not responding to preliminary HIV/AIDS medication. Natco’s earlier two applications on compulsory licensing await the decision of the Patent Controller. The two earlier applications pertain to cancer drugs, Sutent of Pfizer and Roche’s Tarceva.

Section 84 of the Patents Act 1970 provides for compulsory licenses at any time after the expiration of three years from the date of the grant of patent. The provision on compulsory licensing can be invoked on following grounds –

• The reasonable requirement of the public with respect to the patented invention has not been satisfied;


• The patented invention is not available to the public at reasonably affordable price;


• The patented invention is not worked in the territory of India.

The bar of the expiry of three years may in some cases be restrictive therefore as if to mitigate the risks, section 92 provides for compulsory licenses on notifications by Central Government on the following grounds –

• A circumstance of national emergency;
or

• A circumstance of extreme urgency; or


• A case of public non-commercial use,

The above grounds include public health crises relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics.

The Patent (Amendment) Act 2005 added another ground which provides for compulsory licenses to enable export to countries with inadequate manufacturing capabilities. Section 92 A reads as follows –

"Compulsory licenses shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory license has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India."

The Delhi High Court, recently allowed CIPLA Ltd to continue selling ‘Erlocip’, the generic copy of Roche’s patented lung cancer drug Tarceva after hearing an interlocutory application for interim injunction in the patent infringement suit filed by the Swiss drug major. The decision considered the difference in prices of the patented product vis-à-vis the generic copy among other features. With this in background and HIV/AIDS being already categorized as an epidemic and a public health crisis in the statute, it would be worthwhile watching the course this compulsory license will take.

With the earlier two applications, Natco Pharma will have three applications for compulsory licensing. An expedite decision on the applications will pave way for compulsory licensing in India which is still untested.