BIO-DIVERSITY
Bio-diversity means variety among the entire planet. Bio-diversity is the foundation of life in the earth.
It is crucial for the functioning of the ecosystems which provide us the products and the services without
which we cannot survive. Ecosystem includes the entire animal kingdom, plant kingdom, every trivial fraction
of lives, microbes, aquatic living organisms, Oxygen, food, fresh water, fertile soil, medicines, shelter,
protection from storms and floods, stable climate and recreation within the biosphere.
It provides much more than the bio-logical context affecting our social relations and gives us freedom
and choice. Bio-diversity is the extremely difficult and complex feature on earth. In the contemporary world
bio-diversity is getting influenced by human very rapidly, day by day. This degradation of bio-diversity and the
eco system will strongly affect the animal kingdom and its well being.
Bio-diversity is everywhere. It occurs both in the land and water, from the high altitude to the deep
ocean. Variability among the living organisms, species, between species of the ecosystem results diversity. By
the Millennium Ecosystem Assessment only 1.7 t-2 million out of 30 million species have been identified.
Unlike foods and other products that we buy in supermarkets, many ecosystem services have no price
tag attached to them. This means that the importance of biodiversity and natural processes in providing
benefits to people is ignored by financial markets. If the full economic value of these services was taken into
account in decision-making, the degradation of ecosystem services could be significantly slowed down or even
reversed.
This is what the Economics of Ecosystems and Biodiversity (TEEB) study is working towards. The study
aims at developing mechanisms to assess the value of nature, drawing attention to the global economic
benefits of biodiversity and highlighting the growing costs of its loss. IUCN plays a central role in this work.
Our food and energy security strongly depends upon the bio-diversity. Components like -tree, food
grains, landscapes, hills, forests mostly regulate the food and energy system of the planet. Bio diversity loss
can negatively affect the medical health, well being of lives, and wealth of the society. It is scientifically proved
that preservation of forest surrounding an area, village definitely improves the agricultural production within
that particular area, and even the scarcity of rain problem can be counterbalanced. Bio-diversity is a very
essential element to the global food security and nutrition. It also provides safety net to the poor households
in their crisis period. There are many elements in the nature which are used in a traditional way or in newly
invented way for preparing medicines, cosmetics. E.g. -basil leaves, hibiscus leaves are used for the medical
treatment from the ancient time and now new medicine era is also taking the core idea from the nature.
Human activities are gradually affecting the balance of the ecosystem. Modern inventions of breeds, grains,
mix-breed genes are causing huge production and which is resulting in scarcity of water, rain, global warming
etc. This type of commercial utilization may have great influence in short term economy but in long run it is
degrading the balance of bio-diversity.
Bio-diversity is a key weapon in the fight against climate change. Maintaining healthy biodiversity can
play a significant role in climate change mitigation and the world’s protected areas - national parks, marine
reserves, wilderness areas and so on - are essential in safeguarding this role.
Already, the protected areas, rain forests, geo engineering, bio-prospective, bio-diversity banking are
doing magnificent jobs to preserve the bio-diversity, ecosystem and the environment. National parks through
vegetation are storing 15% of the world’s terrestrial carbon. Deforestation, other use of lands, outrageous
activities in nature are causing global warming by emitting 20% of the green house gas.
By protecting the health of ecosystem the protected areas also help in preventing or degrading the
earthquake, landslides, floods, coastal storms, scarcity of water, scarcity of rain, wild fires and other natural
calamities and disasters.
Protected areas also help maintain the ecosystem services on which we depend including water
purification, protection of fish stocks, other food resources and traditional medicines. Again, wide-ranging
benefits can already be seen: 33 of the world’s 105 largest cities derive their drinking water from forest
protected areas and in Kenya; coral reef protection has resulted in improved fishery health, bringing economic
benefits to local people.
PATENT SYSTEM.
A patent is an exclusive right granted to a person who has invented a new and useful article or an
improvement of an existing article or a new process of making an article. It’s an exclusive right to legal
monopoly for the period of 14 years which is now enhanced by 20 years. After the expiry of the duration of
patent, anybody can make use of the invention. Patents are awarded in accordance with three criteria, they
must be:
a) New (or novel);
b) Involve an inventive step (be non-obvious), and;
c) Be capable of industrial application (be useful or of utility).
OBJECTThe object of granting a patent is to encourage and develop new technology and industry.
 It encourages research and invention,
 It induces an inventor to disclose his discoveries instead of keeping them as a trade secret,
 It offers a reward for the expenses of developing inventions to the stage at which they are
commercially practicable,
It also provides an inducement to invest capital in new lines of production which might not appear profitable if
many competing producers embarked on them simultaneously.
PATENT
T.R.I.P.S.
BUDAPEST
TREATY
PATENT
COOPERATION
TREATY
EUROPEAN
PATENT
TREATY
T.R.I.P.S.
Objective:
The protection and enforcement of
intellectual property rights should
contribute to the promotion of
technological innovation and to the
transfer and dissemination of technology,
to the mutual advantage of producers and
users of technological knowledge and in a
manner conducive to social and economic
welfare, and to a balance of rights and
obligations.
Scope & Standars of using I.P.R in TRIPS:
- Copyright & related Rights
- Trademarks
- Geographical Indications
- Industrial Designs
- Patents
INDIAN APPLICATION OF T.R.I.P.S.
THE PROTECTION OF PLANT VARIETIES & FARMERS' RIGHTS ACT, 2001
THE PROTECTION OF PLANT VARIETIES & FARMERS' RIGHTS RULES, 2003
THE PROTECTION OF PLANT VARIETIES & FARMERS' RIGHTS
REGULATIONS, 2006
BUDAPEST TREATY
About Budapest Treaty:
Patent of Microorganisms are relatively complex
than that of other aspects. It requires the deposition
of the samples which are required to be preserved
rather than kept. Moreover, the documents
claiming such microorganisms to be genetically new
have to be cross examined to verify such genuinity
& grant of patent rights, which is not possible for a
person of ordinary knowledge. Consequently this
generates the need of expertise & authenticity of
such expertise.
The Budapest Treaty on the International
Recognition of the Deposit of Microorganisms for
the Purposes of Patent Procedure was introduced in
1980 in an effort to implement such
recommendations. The Budapest Treaty recognizes
'international' depositary authorities for
microorganisms, sets out the minimum standards
for such collecting authorities, and also sets out the
guidelines for the deposit of microorganisms. This
treaty enables the deposit of the microorganism to
help to satisfy the patentability requirements and
also ensures that the microorganism is fully
disclosed to the public.
Under the Treaty, certain culture collections are
recognized as " international depositary authorities"
(IDA) and a deposit made in the IDA is recognized by
all Contracting States to the Treaty.
How to Apply under the Treat ?
- The applicant require to deposit the sample of
micro-organisms with a statemant of fact of the
original sample to the International Depository
Authority.
-The International Depository Authority may
require the microorganisms be deposited in the
form & quantity necessary.
- The applicant must submit the microorganisms by
filling up the prescribed form along with the fees.
- That the International Depository Authority shall
communicate any such requirements and any
amendements thereof to the International Bureau
& to the applicant.
- The samples stored in the International
Depository shall be subjected to any reports that
are to be processed by the Patent office of any
Country.
Patent Cooperation Treaty
Provisions for International Application under P.C.T.
- For obtaining services under P.C.T., one is required
to file an application in the National Office,
International Bureau or through online application.
- Then the International Search Authority (I.S.A)
constructed by P.C.T will conduct an inspection about
the prior relevant article.
- The International Search Report would be prepared
by the I.S.R.
- The international application together with the
International search report will be communicated to
each designated offices of Contracting States.
- On demand of the applicant the International
Preliminary Examining Authority will examkine the
novelty & non-obviousness of the invented article &
will make a report.
Need for P.C.T.:
In order to protect invention in different countries of
the world, an applicant is required to file an
independent patent application in each country of
interest, in some cases, within a stipulated time to
obtain priority in the different countries. This would
entail a large investment, within a short time, to meet
costs towards filing fees, translation, attorney charges
etc.
Inventors of Contracting States of PCT on the other
hand can simultaneously obtain priority for their
inventions without having to file separate applications
in the countries of interest; thus saving the initial
investments towards filing fees, translation etc.
- The International Bureau would then along with the
Search reports publish the application.
INDIAN APPLICATION OF PATENT COOPERATION TREATY.
INDIAN PATENTS ACT, 1970.
INDIAN PATENT RULES, 2003.
EUROPEAN PATENT TREATY’1973
The European Patent Convention is a special
agreement within the meaning of Art-19 of
the Convention for the Protection of
Industrial Property.
European Patent Convention is a multilateral
treaty instituting the European Patent
Organisation and providing an autonomous
legal system according to which European
Patents are granted. European Patent
Convention covers the grant of patent in the
European contracting countries.
European Patents shall be granted for,
Any inventions in all fields of technology,
New and novel inventions,
Involve an inventive step, and
Inventive articles which are susceptible of
industrial application.
The European Patent Convention provides a
legal framework for the granting of
European Patent via a single harmonized
procedure before the European Patent
Office. A single patent application in one
language may be filed at the European
Patent Office at Munich, at its branches at
Hague or Berlin or at a National Patent
Office of a contracting state, if the national
law of the state permits.
The Protection of Plant Varieties and Farmers
Rights ACt’ 2001.
This ACT comes under TRIPS treaty. The main object of the said ACT
is to provide an effective system for protection of plant varieties,
rights of farmers and plant breeders and to encourage the
development of new varieties of plants.
Provisions regarding Registration of Plant
Varieties and Essentially Derived Variety:
 The breeder, successor or assignee of the breeder, farmer may
make an application for registration of any variety of species
or genera to the Registrar.
 The species must be of novel and distinctive in character.
 Form of Application: Every application for registration must be
accompanied by a specific description, affidavit of not
containing any matter involving Terminator Technology. A
complete passport data of the parental line of the genetic
material within the Indian geographical location, a statement
containing breed description of the species of novelty and its
distinctiveness also must be accompanied by the said
application with such fees as prescribed.
 Every applicant should make the sample seeds available for
the test conducted by the registrar for evaluation before its
registration.
 After accepting an application the Registrar makes
advertisement of such application for calling objection from
the interested persons within three months.
 Afterwards the Registrar issues a certificate of registration to
the applicant within maximum period of 12 months. This
certificate of registration shall be valid for 9 year (for trees and
vines) & 6 years (for crops).This validity can be reviewed and
renewed on payment of fees.
 Thus, the authority shall within such interval publish the list of
registered varieties.
THE PROTECTION OF PLANT VARIETIES AND FARMERS
RIGHTS RULES, 2003:
1) Fees payable on matters conducting tests dependent on
the nature and type of tests subject to maximum of Rs50,000 /entry.
2) Fees payable on form no-PV3 on matters of notice of
opposition Rs-1500.
3) Fees payable on Form no-PV5 on matters of extension
of time Rs-1500/month.
4) Fees for registration of essentially derived varieties in
case of Individual-Rs.5000,Educational-Rs.7000,
Commercial-Rs-10,000
5) Form no-PV6, renewal fee for Individual-Rs.5000,
Educational Rs.7000, Commercial-Rs.10, 000/yr.
6) Form no-PV7, Fees payable on application for benefit
sharing Rs.5000.
7) Form no-PV9, Fees payable on application for
registering as Agent/Licensee Rs.10, 000.
8) Form no-PV10, Fees payable on application for
variation/cancellation of the terms of Registration, for
Individual-Rs.3000, Educational-Rs.5000, and
Commercial-Rs.7000.
9) Form no-PV11, fees payable on notice of Opposition to
Application for variation/cancellation of terms of
Registration Rs.1500.
THE PROTECTION OF PLANT VARIETIES AND FARMERS RIGHTS
REGULATIONS, 2006
PROVISIONS REGARDING DEPOSITS OF SEEDS AND
AUTHORISATION: - The forms shall be executed on a non-judicial
stamp paper and shall confirm to the requirement of Indian Stamp
Act, 1899 for deposition of samples. The form shall be duly attested
by the registered breeder in presence of two witnesses in
accordance with the prescribed rule of registration.
The authorisation instrument shall be duly
signed, registered by the registered breeder and the term of the
authorisation must be clearly specified.
PHARMACEUTICAL INDUSTRY TODAY
Pharmaceutical Industry develops, produces and markets drugs
licensed for use as medication. Pharmaceutical companies are
allowed to deal in genetic and/or brand medications and medical
devices. They are subject to a variety of laws and regulation
regarding the patenting, testing and ensuring efficacy and
marketing of drugs.
INDIAN CONTEXT:
The Government started to encourage the growth of drug
manufacturing by Indian companies in the early 1960s and with the
Patent Act in 1970. The lack of patent protection made the Indian
market undesirable to the MNCs that had dominated the market
and while they streamed out.
Indian companies carved a niche in both the Indian and
world markets with their expertise in reverse engineering new
process for manufacturing drugs at low cost. Although, some of the
large companies have been taken baby steps towards drug
invention, the industry as a whole has been following the business
model until present:
 India’s bio-pharmaceutical industries clocked up 70% growth
with revenues of Rs.137 billion in 2009-10 financial year over
the previous fiscal year.
 Bio-pharmaceutical was the biggest contributor generating
60% of industries growth.
The number of purely pharmaceutical company is
fairly low. Indian pharmaceutical industry is mainly operated
and controlled by foreign companies having subsidiaries in
India.
Due to the Patent Act MNCs represent only 35% of the market
down from the 70% of the 1970s.
In terms of global market India currently hold a
modest 1-2% shares, but it has been growing at approximately
10% per year.
India gained its foothold on the global scene
with its innovation and now it is seeking to become a major
player in this field.
Patent System: Impact on Industries.
Pharmaceutical & Healthcare.
Top 3 Pharmaceutical Companies :
1. Ranbaxy
2. Cipla
3. Dr. Reddy’s Laboratory
Patents
As it expands its core business, the industry is being forced to adapt
its business model to recent changes in the operating environment.
The first and most significant change was the January 1, 2005
enactment of an amendment to India’s patent law that reinstated
product patents for the first time since 1972. The legislation took
effect on the deadline set by the WTO’s Trade-Related Aspects of
Intellectual Property Rights (TRIPS) agreement, which mandated
patent protection on both products and processes for a period of
20 years. Under this new law, India will be forced to recognize not
only new patents but also any patents filed after January 1, 1995.
Indian companies achieved their status in the domestic market by
breaking these product patents, and it is estimated that within the
next few years, they will lose $650 million of the local generics
market to patent-holders.
In the domestic market, this new patent legislation has resulted in
fairly clear segmentation. The multinationals narrowed their focus
onto high-end patients who make up only 12% of the market,
taking advantage of their newly bestowed patent protection.
Meanwhile, Indian firms have chosen to take their existing product
portfolios and target semi-urban and rural populations.
Indian companies are also starting to adapt their product
development processes to the new environment. For years, firms
have made their ways into the global market by researching
generic competitors to patented drugs and following up with
litigation to challenge the patent.
An overview of Ranbaxy’s product development process:
Ranbaxy Laboratories Ltd is a subsidiary company of the Ranbaxy.
Top 3 Molecules produced by Ranbaxy Laboratories Ltd.:
Molecules
Application No.
Valacyclovir US-10/236,729
Simvastatin US-11/386,962
US-12/301,396
Donepezil
Filing Date
6-Sep-2002
22-Mar-2006
18-May-2007
Publication No.
US2006/0223882A1
US2009/0298879A1
2011’s Business of Ranbaxy.
 32 out of 55 DF Filings are approved.
 Emerging market sales $262 Million
Growth 11%; 64% of DF sales
 Developed market sales $145 Million
36% of DF sales
 India: Strong CHC Performance;
Industry wide slow down impacts
Acute growth.
Patent No.
US-6849736
-
Issue Date.
1-Feb-2005
-
14335
5157
13125
4844
6%
Q3 2010


9%
Q3 2011
YTD Sep 2010
YTD Sep 2010
India market continued despite industry-wide slow down in Anti-infectives.
Strong CHC performance; launch of ‘Volini Duos’, India’s first approved two in one pain killer.
An Overview of Cipla’s Product Development Process:
Three Cipla Products:
Products
Levoflox
VC 15
Entavir
Application No.
US 11/038,787
-
Filing Date
21-Jan-2005
22-Jan-1988
23-Feb-2001
Publication No.
US2005-0287108A1
-
Patent No.
US4865906
US6627224
Issue Date.
12-Sep-1989
30-Sep-2003
 Business till 2010.







The company achieved an overall growth of about 8% in turnover during the year.
Domestic growth was steady at 10%
According to ORG-IMS, Cipla remained the leader in the domestic market as on 31 st March,
2010 with a market share of 5.3%.
Sales & other income: - 5713.24 Cr. (2010)
Profit after Tax:- 1081.49 Cr. (2010)
The company is investing about 250 Cr. in new R&D and administration facility.
Patents published (Cipla) in 2005-2008:
I.P.O.
165
U.S.
30
P.C.T.
100
E.P.O.
44
Cipla’s Profit Growth (2005-2010):
14
12
10
8
Profit Before Tax
6
Profit After Tax
4
2
0
2010
2009
## Rs. (1-14) Indicative in Crores.
2008
2007
2006
2005