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Term of Patent
The term of every patent in India is twenty years from the date of filing
the patent application, irrespective of whether it is filed with provisional
or complete specification. However, in case of applications filed under
the Patent Cooperative Treaty (PCT), the term of twenty years begins
from the international filing date.
What are the Rights granted by Patent?
If the grant of the patent is for a product, then the patentee has a right to
prevent others from making, using, offering for sale, selling or importing
the patented product in India. If the patent is for a process, then the
patentee has the right to prevent others from using the process, using the
product directly obtained by the process, offering for sale, selling or
importing the product in India directly obtained by the process.
Before filing an application for grant of patent in India, it is important to
note
What is not Patentable in India
Following i.e. an invention which is (a) frivolous, (b) obvious, (c)
contrary to well established natural laws, (d) contrary to law, (e)
morality, (f) injurious to public health, (g) a mere discovery of a
scientific principle, (h) the formulation of an abstract theory, (i) a mere
discovery of any new property or new use for a known substance or
process, machine or apparatus, (j) a substance obtained by a mere
admixture resulting only in the aggregation of the properties of the
components thereof or a process for producing such substance, (k) a
mere arrangement or rearrangement or duplication of known devices, (l)
a method of agriculture or horticulture and (m) inventions relating to
atomic energy, are not patentable in India.
Maintainability of Secrecy by the Indian Patent Office (IPO)
All patent applications are kept secret up to eighteen months from the
date of filing or priority date, whichever is earlier, and thereafter they
are published in the Official Journal of the Patent Office published every
week. After such publication of the patent application, public can inspect
the documents and may take the photocopy thereof on the payment of
the prescribed fee.
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. 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
2. 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.
In order to fully understand the amended Section 3(d), one need to first
address the issue of what exactly the term “efficacy” means. The term has
not been defined in the Act, but in Novartis AG v. Union of India, the High
Court of Madras , while answering the question, whether section 3(d), as
amended by the
3. Software Patentability
Section 3(k) of the Patents Act, 1970 excluded “a computer programme per
se” from the scope of patentability. This exclusion met with conflicting
interpretations at the patent office, with some examiners granting patents to
software combined with hardware or software with a demonstrable technical
application of some sort. 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, this provision was removed
from the 2005 Act. The earlier position under the Patents Act, 1970 that a
computer programme per se is not patentable now prevails.
4. 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’. This amendment was in pursuance of a TRIPS
obligation aimed at preserving the novelty of pharmaceutical inventions in
those developing and least developed country (LDC) members that did not
grant product patents for pharmaceutical inventions in 1995. 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.
To obtain an EMR, the following conditions must be fulfilled:
a) The product must be patentable, that is, it must be an invention as per
Section 2 of the Patents Act 1970, and must not fall under the non-patentable
products listed in Sections 3 and 4, such as products derived from traditional
knowledge or atomic energy-related products.
b) The invention must have been made in India or in a WTO Convention
country. If made in a convention country, the invention must have been:
(i) Filed on or after January 1, 1995, and
(ii) Before getting a patent in India, the applicant must have obtained such a
patent in the Convention country.
c) If the invention has been made in India,
(i) The application for patent for the method or process of production of such a
substance should have been filed on or after January 1, 1995, and
(ii) The patent must have been granted on or after the date of filing of such
EMR.
5. Compulsory Licensing Regime
Section 84 of The Act provides for the grounds on and procedures by which, a
compulsory license will be granted. The 1999 Amendment adds an entire chapter
to the Patents Act on the working of patents, compulsory licenses, and revocation
of licenses. After this amendment, the grounds on which a compulsory license will
be granted are:
a. Reasonable requirements of the public with respect to the patented invention
have not been satisfied; or,
b. The patented invention is not available to the public at a reasonably
affordable price; or,
c. The patented invention is not worked (i.e. not used or performed) in the
territory of India.
In respect to the 2005 Amendment following amendments have been made in
respect of compulsory licencening regime -
a) Automatic Compulsory Licences for Mailbox Applications
The 2005 Amendemt provides that in the case of those mailbox applications that
result in the grant of a patent, an automatic compulsory licence would issue to
those generic companies that made a ‘significant investment’ and were ‘producing
and marketing’ a drug covered by the mailbox application prior to 2005. Such
licence is subject to a payment of a ‘reasonable royalty’. However, no specific
yardstick is provided to determine ‘reasonableness’ and this term is likely to lead
to disputes in coming years.
b) Compulsory Licences for Exports
In order to incorporate what is commonly referred to as the Paragraph 6 Decision,
the Ordinance introduced section 92A, which provides for compulsory licences to
enable exports of pharmaceutical products to those countries with no
manufacturing capacity of their own. Unfortunately, this suffered from a handicap
- the provision required that the exporter obtain a compulsory licence from the
importing country as well. In the process, the provision failed to cater to those
situations where there was no patent in such importing country and no requirement
for obtaining a compulsory licence there. The 2005 Amenment therefore seeks to
rectify this by adding that an exporter can resort to section 92A where the
importing country “has by notification or otherwise allowed importation of the
patented pharmaceutical products from India”.
c) Procedural Changes
The general compulsory licensing procedure under Chapter XVI states that in most
cases, a compulsory licensing application can be entertained only if negotiations
towards a voluntary licence have not borne fruit within a reasonable time period. In
order to prevent patentees from dragging on voluntary negotiations to the detriment
of applicants, the Act caps a ‘reasonable’ period of negotiations at six months.
6. Other Amendments
There are many changes brought by the 2005 Amendment in the provisions of
the Act, that can be summarized as follows -
a) The 2005 Amendment amend the definition of “New Invention”,“Inventive
Step” and insert a new entry of “Pharmaceutical Substances” in the definition
clause.
b) Provision of 'acceptance of specification' and its advertisement have been
deleted.
c) Modification in the provisions relating to opposition procedures with a view
to streamlining the system by having both Pre-grant and Post-grant opposition in
the Patent Office.
d) Application for patent will be published in Official Journal. At that time
opposition can be made on limited grounds but hearing is not mandatory.
e) After grant of patent, opposition can be made within 12 months.
f) Suit for infringement of patent cannot commence before date of
publication of publication of the application.
g) Penalties enhanced substantially.
h) Strengthening the provisions relating to national security to guard against
patenting abroad of dual use technologies.
i) Rationalisation of provisions relating to time-lines with a view to introducing
flexibility and reducing the processing time for patent applications, and simplifying
and rationalising procedures.
Conclusion