Patents act 1970 as amended by

the patents (amendment) act

2005
 Introduction

 The patent(amendment) act 2005 was passed by the

parliament in its budget session of 2005 to amend the
patent act of 1970 and meet its obligations under TRIPS
agreement of WTO.

 Although the act makes wide ranging changes to India’s

patent regime,the most controversial provision is the one
introducing product patents in area of pharmaceuticals.
 MEANING OF PATENT

 In simple words, Patent is a document which is generally

issued by government conferring a monopoly right on an
inventor to exploit his invention for a limited period.
 The person to whom patent is granted is called as
Patentee.
 The purpose of a patent is to provide protection for
technological advances i.e. inventions. It provides an
award for the disclosure of the creation of something new
as well as for the further development, or refinement, of
existing technologies. In short, through patents, progress
in changing.
 Some Major Changes Introduced by The
2005 Amendment

The 2005 Amendment amended many provisions of the Act; these

amendments were absolutely necessary for India to meet its obligation under
TRIPS Agreement. Some of important amendments are discussed below -
1. Software Patentability
 Section 3(k) of the Patents Act, 1970 excluded “a computer programme”
from the scope of patentability.
 The 2004 Ordinance therefore qualified this exclusion by stating that
software with a “technical application” to industry or when “combined
with hardware” would be patentable. Owing to vigorous opposition from
the free software movement[11],
 this provision was removed from the 2005 Act. The earlier position under
the Patents Act, 1970 that a computer programme is not patentable now.
 2. Deletion of the provisions relating to Exclusive
Marketing Rights (EMRs)

 Section 21 of 2005 Amendment deleted the Chapter IVA of the

Act.
 The 1999 Amendment inserted this chapter in the Act to provide
that applications claiming pharmaceutical inventions would be
accepted and put away in a mailbox, to be examined in 2005.
 These applications are commonly referred to as ‘mailbox
applications’.
 By virtue of this ‘mailbox facility’, applications would be
judged for ‘novelty’ on the basis of the filing date and not with
reference to 2005, the year in which product patents were first
incorporated into the patent regime.
3. Compulsory Licensing Regime

Section 84 of The Act provides for the grounds on and

procedures by which, a compulsory license will be
granted. After this amendment, the grounds on which a
compulsory license will be granted are:
 Reasonable requirements of the public with respect to
the patented invention have not been satisfied;
 The patented invention is not available to the public at
a reasonably affordable price; or,
 The patented invention is not worked (i.e. not used or
performed) in the territory of India.
4. Extension of product patent protection to all fields of
technology
 The most prominent and controversial change of the 2005
Amendment has been the deletion of section 5 of the Act,
thereby paving the way for product patents in the area of
pharmaceutical and other chemical inventions.
 Section 5 of the Act (as it stood after the 2002
amendments) had provided that, in the case of inventions
being claimed relating to food,medicine, drugs or
chemical substances, only patents relating to the methods
or processes of manufacture of such substances could be
obtained.
 Before this Amendment in the Act,Product Patent was not
granted on the inventions related to drugs, foods and
chemicals and only process patents were granted on these
inventions.
5.No Swiss Claims and Expansion of Exclusion under
Section 3(d)

 A ‘Swiss Claim’ is a claim for patent wherein the use of a substance or

composition that has already been used for a medical purpose is
intended or specified to be used for a new medical purpose.
 Section 3(d) as amended by the 2005 Amendment clarifies that mere
discovery of a new form of a known substance, which does not result
in the enhancement of the known efficacy of that substance is not an
invention and therefore not patentable.
 For the purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size isomers, mixtures of isomers,
complexes, combinations and other derivatives of known substances
are to be considered to be the same substances, unless they differ
significantly in properties with regard to efficacy.
Implications of 2005 Amendment on Indian
Economy
 Some possible implications of product patent regime in the field of food, medicine,
drugs or chemical substances can summarised as below —
 Price rise and access to medicine –In a nutshell, there is no doubt that, after 2005
Amendment, the prices of above mentioned drug will rise but the question which really
needs to be answered is to what extent this price rise will eventually affect the access
and affordability of life saving or very essential drugs to most of the Indian population.
 On the other hand fear of substantial price rise, in life saving drugs patented after 2005
can be addressed to a certain extent by safeguards built in the 2005 Amendment and
other related laws for the time being in force,such as —
 Compulsory licensing,
 Parallel import of products,
 Acquisition of patent rights by the government,
 Opposition mechanism, and
 Price control regime like Essential Commodities Act, 1955, etc
Cultivating Innovation Culture in India

 In the fear substantial price rise pepole are ignoring one

of the biggest advantages of the 2005 Amendment. The
Indian Pharmaceutical Industry today consist of about
8174 bulk drug manufacturing units and 2389 formulations
units spread across the country.
 The 2005 Amendment by giving an extra incentive to new
and innovative drugs will also cultivalte an innovation
culture in Indian pharma industries.