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INDIAN BIOTECH


the protection of plants under the Protection of Plant Varieties and Farmers’ Rights Act.


T e Indian Patent Offi ce, during prosecution, has consistently maintained a defi nition of what constitutes an ‘essentially biological process’ for the production or propagation of plant and animals. Section 3(j) prohibits the grant of a patent to an ‘essentially biological process’ and not a process in which essentially biological steps have been carried out. T e process for production of a plant or animal is essentially a biological process if it consists entirely of biological phenomena such as crossing or selection. Whether or not a micro-biological process is considered as being essentially biological is judged by the patent offi ce on the basis of essence of the invention, taking into account the extent of human intervention and its impact on the result. Micro-organisms were not considered patentable. However, pursuant to the amendment of the Indian Patents Act in 2005, genetically modifi ed micro-organisms are allowable.


Having had a look at the protection and


prosecution of patent applications, the role of judiciary becomes equally important in ensuring eff ective enforcement of patents in India.


T e main events that led to the speeding up of litigation are the amendments to the Code of Civil Procedure in 2002; the case management culture built up in the courts in India; and the remarks made by the Supreme Court in TVS v Bajaj. T e Supreme Court remarked that “all intellectual property matters should be disposed off within four months from the date of institution of the suit”. Since then, there have been several instances where the High Court has been passing such four-month orders. T e Delhi High Court also became an e-court in December 2009, adding to the speed of disposal of cases.


With the above background, the prosecution and enforcement of IP in India has been evolving in recent times. T is is because companies and organisations are keen to assert


their rights


and ensure that the high investments made by them in research and development of products are protected. T is has been well supported by the Indian government through appropriate legislation, and by the Indian courts in enforcement of laws.


We believe that India is currently in the middle of a revolution in this area.


Archana Shanker is a senior partner at Anand and Anand. She can be contacted at: archana@anandandanand.com


Archana Shanker heads the patents and designs practice at the fi rm. A graduate of Delhi Law School, she went on to complete her post-graduate diploma in bioinformatics and pharmaceutical regulatory aff airs. She is an active member of various international bodies, including the APAA, the AIPPI and the FICPI.


www.worldipreview.com


Life Sciences Intellectual Property Review 2011


71


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