India - Changes in Patent Law
As a developing country, India was given until January 1, 2005 to effect full implementation of its obligations under TRIPS. This implementation was effected by two separate pieces of legislation. The first was the Patents Act 2002 which for the most part came into effect on May 20, 2003. It had been intended that the second would be enacted in 2004. However, a change of government in 2004 led to a delay. In order to meet the TRIPS deadline of January 1, 2005, a presidential ordinance (The Patents Ordinance 2004) was proclaimed in December 2004. Subsequently, Parliament passed the Patents Act 2005 that was similar to but, as a result of political pressure by left wing parties forming part of the government coalition, not identical with the presidential ordinance. The Act specifically states that most of its provisions are “deemed to have come into effect on January 1, 2005”, but it also ratified and maintained the validity of acts taken under the presidential ordinance.
Probably the most important change effected by the 2005 legislation was the repeal of the provision barring the grant of patents for chemical or pharmaceutical products. As a consequence of this change, provisions relating to exclusive marketing rights for pharmaceutical products that have existed for the previous ten years were repealed on the basis that full patent protection has become available. Changes in the law to make it easier to obtain protection for computer-related inventions were included in the presidential ordinance but did not survive in the Act as enacted by Parliament.
Other significant changes included:
Further provisions for establishment of an Appellate Board that could possibly be the precursor of a special patents court. The creation of the Appellate Board was provided for in 2002, but it has not yet come into operation. It will have jurisdiction not only over appeals from the patent office in pre-grant matters but will also have original jurisdiction with respect to post-grant petitions for revocation of a patent if these arise otherwise than as a counter-claim to an action for patent infringement.
Provisions relating to compulsory licensing of pharmaceutical products which have been expanded to make it clear that such licenses can be granted for manufacture and export to “any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided that compulsory license has been granted by such country.”
“Bolar-type” exclusions from patent infringement for steps reasonably relating to development of data required for marketing approval were added to the law in 2002. In 2005, it was made clear that the exemption extends to the import of products for carrying out such testing.
India has traditionally had a pre-grant opposition system. The 2005 presidential ordinance replaced this by a post-grant opposition coupled with the possibility of third parties making comments on pending applications after they had been published. The final legislation as passed by parliament provides for both pre- and post- grant oppositions. As with the prior law, not all grounds of possible invalidity can be raised in opposition proceedings, a few being reserved for consideration by the new Appellate Board or the courts only during revocation proceedings.
Pre-grant oppositions may be filed at any time between publication of the application and its grant. Post grant oppositions can be brought within one year of the grant of the patent.
The grounds on which an application or patent may be opposed are:
a) that the applicant or patentee wrongly obtained the invention from the opponent or a person from whom the opponent derives title;
b) that the invention was previously published, subject to the limitations on anticipation discussed above;
c) that the invention was previously claimed in an Indian application having an earlier priority date;
d) that the invention was publicly known or publicly previously used in India, again subject to the qualifications on “anticipation” discussed above;
e) lack of inventive step over any prior publication or over any prior use in India;
f) that the application or patent claims unpatentable subject matter;
g) lack of sufficient and clear description of the invention or the method by which it is to be performed;
h) failure of the applicant to provide the Controller with details of corresponding foreign applications as required;
i) in the case of a convention application that it was not made within twelve months of “the first application for protection of the invention in a convention country by the applicant or a person from whom he derives title”;
j) failure to provide information or including wrong information on the source or geographical origin of biological material used in the invention; and
k) that the invention is anticipated by knowledge “oral or otherwise available within any local or indigenous community in India or elsewhere”.
Under the new procedure for oppositions, a three person opposition board will be set up to make recommendations on the disposition of the opposition after receipt of the statements and evidence from both sides but prior to the final hearing on the opposition which shall take place before a Controller.
