Meaning of Patent

A grant made by a
government that confers
upon the creator of an
invention the sole right to
make, use, and sell that
invention for a set period
of time. It is a part of
Intellectual property.
 Why patenting needed?

1.To encougre people to do more

innovation
2.To protect inventions to get
rewards or
3.To earn profit
 Pharmaceuticals patent
Pharmaceutical patents protect manufacturers
of prescription drugs, prohibiting others
from producing a drug during the length of
its patent protection, because
pharmaceutical companies spend large
sums on research and development and
patents are essential to earning a profit.
The length of these patents varies in
different countries, though they are usually
between 15-20 years. For example: In the
U.S., A pharmaceutical patent is valid for
20 years.
 Pharmaceuticals patent
Drug companies usually apply for patent
protection before they actually begin
producing the drug, opting instead to
secure their rights to a particular
compound at the beginning of the testing
process. By the time a drug comes to
market, there may only be 8-10 years of
patent protection remaining, which is
significantly less than the 20 offered by the
patent.
 Pharmaceuticals patent
Companies often attempt to extend these
patents by making slight reformulations
of the original compound or proving its
effectiveness at treating a condition other
than the one for which it was originally
granted a patent. This is referred to
as "EVERGREENING", a practice which
many criticize.
In order to meet its obligations
under TRIPs agreement of
WTO, the Government of
India has inserted a new
Chapter IV A in the Patents
Act, 1970 on Exclusive
Marketing Rights in Sections
24 A to 24 F by the Patents
(Amendment) Act 1999.
 Application for Grant of Exclusive
Rights (SEC. 24A)
Sec. 24A of Chapter VI A of the Patents Act, 1970, provides that
when an application for the grant of patent for the process of
manufactures of drugs or medicines as covered under sub-
section(2) of sec.5 of the Patents Act, 1970, is made to the
controller, the controller shall not refer such application to the
examiner under sec.12 for the examination of application for the
purpose of grant of patent to the process of manufacture. The
controller shall not make such reference for the purpose of the
grant of patent for the process of manufacture of drugs or
medicines as covered under sub-sec(2) of sec.5 till the 31st day
of Dec, 2004. however, the controller may grant exclusive right to
sell or distribute the articles or substances with respect to which
patent is not granted.
 Grant of Exclusive Rights (SEC. 24B)

Acc. To sec. 24B, the marketing rights to sell or distribute drugs or

medicines is granted for a period of 5 years or till the date of grant of
patent or the date of rejection of application for the grant of patent,
whichever is earlier:
But following conditions shall also be fulfilled:
(a) Before making a claim in respect of an invention made in India or some
other country, an application has been filled for the same convention
claiming identical article or substance in a convention country on or after
1.1.1995 and the approval of patent as well to sell or distribute the article
on the basis of appropriate tests conducted in that country.
(b) Before filing a claim in respect of an invention made in India, the
applicant has applied for a patent on or after1.1.95 for the method or
process of manufacture for that invention relating to identical article or
substance, and the grant of patent has been given besides the approval
to sell or distribute the article.
 Compulsory licences (SEC. 24C)

Compulsory licensing is when a government allows someone

else to produce the patented product or process without the
consent of the patent owner. In current public discussion,
this is usually associated with pharmaceuticals, but it could
also apply to patents in any field.
The agreement allows compulsory licensing as part of the
agreement’s overall attempt to strike a balance between
promoting access to existing drugs and promoting research
and development into new drugs. But the term “compulsory
licensing” does not appear in the TRIPS Agreement. Instead,
the phrase “other use without authorization of the right
holder” appears in the title of Article 31. Compulsory
licensing is only part of this since “other use” includes use
by governments for their own purposes.
 Special Provision For Selling or
Distribution (SEC. 24D)
The Central Government can sell or distribute an
article or substance in public interest by itself or
through any person other than that to whom
exclusive right has been granted provided that such
authority has been given in writing.
After the grant of exclusive right to sell or distribute,
the Central Government may direct in public
interest by notification in the official Gazette that the
said article or substance shall be sold at a price
determined by an authority specified in this behalf
 Suits Relating to Infringements
(SEC. 24E)

All suits relating to infringement of a right under

sec.24B shall be dealt with in the same
manner as if they are suits concerning
infringement of patents under Chapter XVIII
 Central Government and its officers not
to be liable (SEC. 24F)
• The examination and investigations required under
this chapter shall not be deemed in any way to
warrant the validity of any grant of exclusive right to
sell or distribute, and no liability shall be incurred by
the Central Government or any officer thereof by
the reason of , or in connection with, any such
examination or investigation or any report or other
proceedings consequent thereon.
 ELIGIBILITY FOR PATENTING

Governments can refuse to grant patents for three reasons that may
relate to public health:
1. Under Article 27.2 – Inventions whose commercial
exploitation needs to be prevented to protect human, animal
or plant life or health
2. Under Article 27.3a – diagnostic, therapeutic and surgical
methods for treating humans or animals
3. Under Article 27.3b – certain plant and animal inventions

Under the TRIPS Agreement, governments can make limited

exceptions to patent rights, provided certain conditions are met.
For example, the exceptions must not “unreasonably” conflict with
the “normal” exploitation of the patent. Article 30.
 RESEARCH EXCEPTION
AND “BOLAR”
PROVISION

Many countries use this provision to advance science and

technology. They allow researchers to use a patented
invention for research, in order to understand the invention
more fully. In addition, some countries allow manufacturers
of generic drugs to use the patented invention to obtain
marketing approval from public health authorities without
the patent owner’s permission and before the patent
protection expires. The generic producers can then market
their versions as soon as the patent expires. This provision is
sometimes called the “regulatory exception” or “Bolar”
provision.
 Doha Declaration
The Fourth Ministerial meeting of the WTO
was heal in Doha in November 2001 in
which ministers from 142 member
countries participated. The ministerial had
attracted a lot of attention because of the
conflict of interests of the developed and
developing countries.
Each Member has the right to grant
compulsory licences and the freedom to
determine the grounds upon which such
licences are granted.
 Doha Declaration
Each Member has the right to determine
what constitutes a national emergency or
other circumstances of extreme urgency,
it being understood that public health
crises, including those relating to
HIV/AIDS, tuberculosis, malaria and
other epidemics, can represent a national
emergency or other circumstances of
extreme urgency
 Doha Declaration
The effect of the provisions in the TRIPS
Agreement that are relevant to the
exhaustion of intellectual property rights
is to leave each Member free to establish
its own regime for such exhaustion
without challenge, subject to the MFN
and national treatment provisions of
Articles 3
THANKS