The Place Of Generics In A Product Patent Regime.

The product patent regime in India fulfilled a long standing need of the pioneer drug makers across the world wanting to market their drugs in India but at the same time forced the generic drug makers to stop their activities. Generic drugs come cheaper in comparison to the patented drugs hence are crucial to fulfill the gaps in access to medicines, specifically the life saving drugs. This was anticipated therefore flexibilities were provided in the TRIPS Agreement so as to enable the Members to design their patent laws according to their specific needs. The Indian patent law keeping in view such flexibilities provides for compulsory licensing and parallel import provisions. Examination of the use of such flexibilities in context of affordable generic versions of patented drugs will help to gain some insight into the future of the generic industry and also on the issue of access to drugs, in India.

Compulsory Licensing 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 including public health crises.

The mention of epidemics such as Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or like relating to the inclusive definition of public health crises which in turn is explained as a case of public non-commercial use under the provision amply reflects the use of the flexibilities suitable to the Members as provided under the TRIPS Agreement. 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."

Parallel Import Section 107A of the Patent Act, 1970 states certain acts not to be considered as infringement wherein importation of patented products by any person from a person who is duly authorized under the law to produce and sell or distribute the product is not an infringement. Thus, parallel import can also be a tool for the generic industry to bridge the 'access' gap with regard to high priced drugs for critical cures.

In conclusion we thus see that India has made a beneficial use of the flexibilities which does pave a way for the generic drug industry. Recently, not going by the rule book, CIPLA Ltd launched its generic version of the drug patented by F. Hoffman-La Roche Ltd which has consequently resulted in a patent infringement suit filed by Roche and CIPLA counterclaiming the invalidity of the granted patent.1 The case is presently undergoing preliminary hearings and CIPLA presumably will base its strategy on the difference in pricing of the drugs. The strategy of courting a litigation suit for establishing the justifiability of 'access' is a new phenomenon for the industry, which with bated breath watches every move of the litigation process.

Footnote:

1. the case number for the Roche / Cipla matter at Delhi High Court is: CS(OS) 89/2008 F. HOFFMANN-LA ROCHE LTD. Vs. CIPLA LIMITED [I.A. 642/2008 & I.A. 727/2008]

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