Introduction to Intellectual Property
Right
Sayali C. Kore1*,
Shital T. Jadhav1, Amruta
S. Kadam1, Sushila D. Chavan1
1Lecturer, College of Pharmacy (D. Pharm)
Degaon, Satara, (MH) India-
415 004.
*Corresponding
Author E-mail: saylikore123@gmail.com
ABSTRACT:
Intellectual
property rights are like any other property right. Intellectual property (IP)
pertains to any original creation of the human intellect such as artistic,
literary, technical, or scientific creation. We encounter intellectual property
at every step of our life today. Intellectual property (IP) pertains to any
original creation of the human intellect such as artistic, literary, technical,
or scientific creation. Intellectual property rights (IPR) refers to the legal
rights given to the inventor or creator to protect his invention or creation
for a certain period of time1These legal rights confer an exclusive right to
the inventor/creator or his assignee to fully utilize his invention/creation
for a given period of time. It is very well settled that IP play a vital role
in the modern economy. Present review furnishes a brief overview of IPR with
special emphasis on pharmaceuticals. There are several compelling reasons to
promote and protect intellectual property.
KEY WORDS: IPR- intellectual propery right, patent.
INTRODUCTION:
Intellectual Property refers to
creation of mind i.e. inventions,
industrial designs for article, literary and artistic work, symbols etc. used
in commerce.
Intellectual property rights are like any
other property right. Intellectual property (IP) pertains to any original
creation of the human intellect such as artistic, literary, technical, or
scientific creation. We encounter intellectual property at every step of our
life today.
The design on the bed sheet and the pillow covers, the bed and other
items of furniture in the house, the cereals for breakfast, the pasteurized
milk in tetra pack, the soft drinks and their bottles, the television, the
personal computer, the gas stove, the microwave oven, the refrigerator, the
vehicles, the weighing machine, the books, the films, the music cassettes, the
tiles, the paints, and practically everything we use is the product of man’s
ingenuity, knowledge and skill, besides labor and capital; and it falls under
some kind of intellectual property that had to be respected before the item
could be lawfully manufactured. In
this Unit we will discuss the basic concept behind the intellectual property
rights and their rationale. These are different types of IP rights like
copyright, trademarks, patents, industrial designs etc. Understanding of this
classification and identifying different rights is very important.1
They allow creators, or owners, of patents, trademarks or copyrighted
works to benefit from their own work or investment in a creation these rights
are outlined in Article 27 of the Universal Declaration of Human Rights, which
provides for the right to benefit from the protection of moral and material
interests resulting from authorship of scientific, literary or artistic
productions. The importance of intellectual property was first recognized in
the Paris Convention for the Protection of Industrial Property (1883) and the
Berne Convention for the Protection of Literary and Artistic Works (1886). Both
treaties are administered by the World Intellectual Property Organization
(WIPO).6
Intellectual property (IP) pertains to any original creation of the
human intellect such as artistic, literary, technical, or scientific creation.
Intellectual property rights (IPR) refers to the legal rights given to the
inventor or creator to protect his invention or creation for a certain period
of time1These legal rights confer an exclusive right to the
inventor/creator or his assignee to fully utilize his invention/creation for a
given period of time. It is very well settled that IP play a vital role in the
modern economy. It has also been conclusively established that the intellectual
labor associated with the innovation should be given due importance so that
public good emanates from it. There has been a
quantum jump in research and development (R and D) costs with an
associated jump in investments required for putting a new technology in the
market place2The stakes of the developers of technology have become
very high, and hence, the need to protect the knowledge from unlawful use has
become expedient, at least for a period, that would ensure recovery of the R
and D and other associated costs and adequate profits for continuous investments
in R and D. IPR is a strong tool, to protect investments, time, money, effort
invested by the inventor/creator of an IP, since it grants the inventor/creator
an exclusive right for a certain period of time for use of his
invention/creation. Thus IPR, in this way aids the economic development of a
country by promoting healthy competition and encouraging industrial development
and economic growth. Present review furnishes a brief overview of IPR with
special emphasis on pharmaceuticals. There are several compelling reasons to
promote and protect intellectual
property. First, the progress and well-being of humanity rest on its
capacity to create and invent new works in the areas of technology and culture.
Second, the legal protection of new creations encourages the commitment of
additional resources for further innovation. Third, the promotion and
protection of intellectual property spurs economic growth, creates new jobs and
industries, and enhances the quality and enjoyment of life. An efficient and
equitable intellectual property system can help all countries to realize
intellectual property’s potential as a catalyst for economic development and
social and cultural well-being. The
intellectual property system helps strike a balance between the interests of
innovators and the public interest, providing an environment in which
creativity and invention can flourish, for the benefit of all.
For the average person benefit of Intellectual property rights reward creativity and
human endeavor, which fuel the progress of humankind. Some examples: The
multibillion dollar film, recording, publishing and software industries – which
bring pleasure to millions of people worldwide – would not exist without
copyright protection. Without the rewards provided by the patent system,
researchers and inventors would have little incentive to continue producing
better and more efficient products for consumers. Consumers would have no means
to confidently buy products or services without reliable, international
trademark protection and enforcement mechanisms to discourage counterfeiting
and piracy.6
Intellectual property is divided into
two categories: industrial property, which
includes inventions (patents), trademarks, industrial designs, and geographic indications of source: and Copyright, which includes literary
and artistic works such as novels, poems, plays, films and musical works etc.
According to the TRIPS Agreement, the
intellectual property has been classified into-Patents, Industrial Designs, Trade Marks, Copyright, Geographical Indications,
Layout Designs of Integrated Circuits, Protection of
Undisclosed Information/Trade Secrets.
Different IP Rights vary in the protection they provide.
History:
The laws and administrative procedures relating to IPR have their roots
in Europe. The trend of granting patents started in the fourteenth century. In
comparison to other European countries, in some matters England was
technologically advanced and used to attract artisans from elsewhere, on
special terms. The first known copyrights appeared in Italy. Venice can be
considered the cradle of IP system as most legal thinking in this area was done
here; laws and systems were made here for the first time in the world, and
other countries followed in due course.4 Patent act in India is more
than 150 years old. The inaugural one is the 1856 Act, which is based on the
British patent system and it has provided the patent term of 14 years followed
by numerous acts and amendments.1
Objectives:
After studying this unit, you should be able to:
To appreciate the concept of intellectual property (IP) vis-à-vis
physical property;
To recognize the different kinds of intellectual property;
To appreciate the rationale behind IP, and the underlying premises;
To understand how a balance is sought to be achieved between the rights
of the owner of IP on one hand and the rights of other individuals and the
society in general on the other; and
To know the position of IP under the constitution of
India.
The concept of intellectual property 8:
1.1 Intellectual property, very broadly, means the legal rights which
result from intellectual activity in the industrial, scientific, literary and
artistic fields. Countries have laws to protect intellectual property for two
main reasons. One is to give statutory expression to the moral and economic
rights of creators in their creations and the rights of the public in access to
those creations. The second is to promote, as a deliberate act of Government
policy, creativity and the dissemination and application of its results and to
encourage fair trading which would contribute to economic and social
development.
1.2 Generally speaking, intellectual property law aims at safeguarding
creators and other producers of intellectual goods and services by granting
them certain time-limited rights to control the use made of those productions.
Those rights do not apply to the physical object in which the creation may be
embodied but instead to the intellectual creation as such. Intellectual
property is traditionally divided into two branches, “industrial property” and
“copyright.”
1.3 The Convention Establishing the World Intellectual Property
Organization (WIPO), concluded in Stockholm on July 14, 1967 (Article 2(viii))
provides that “intellectual property shall include rights relating to:
- Literary, artistic and scientific works,
- Performances of performing artists, phonograms and broadcasts,
- Inventions in all fields of human endeavor,
- Scientific discoveries,
- Industrial designs,
- Trademarks, service marks and commercial names and designations,
- Protection against unfair competition,
and all
other rights resulting from intellectual activity in the industrial,
scientific, literary or artistic fields.”
World intellecyual
property organization 6
Established in 1970, the World Intellectual Property Organization
(WIPO) is an international organization dedicated to helping ensure that the
rights of and owners of intellectual property are protected worldwide, and that
inventors and authors are therefore recognized and rewarded for their
ingenuity. This international protection acts as a spur to human creativity,
pushing back the limits of science and technology and enriching the world of
literature and the arts. By providing a stable environment for marketing
products protected by intellectual property, it also oils the wheels of
international trade. WIPO works closely with its Member States and other
constituents to ensure the intellectual property system remains a supple and
adaptable tool for prosperity and well-being, crafted to help realize the full
potential of created works for present and future generations.
WIPO promote the protection of intellectual property
such As part of the United Nations
system of specialized agencies, WIPO serves as a forum for its Member States to
establish and harmonize rules and practices for the protection of intellectual
property rights. WIPO also services global registration systems for trademarks,
industrial designs and appellations of origin, and a global filing system for
patents. These systems are under regular review by WIPO’s Member States and
other stakeholders to determine how they can be improved to better serve the
needs of users and potential users. Many industrialized nations have
intellectual property protection systems that are centuries old. Among newer or
developing countries, however, many are in the process of building up their
patent, trademark and copyright legal frameworks and intellectual property
systems. With the increasing globalization of trade and rapid changes in technological
innovation, WIPO plays a key role in helping these systems to evolve through
treaty negotiation; legal and technical assistance; and training in various
forms, including in the area of enforcement. WIPO works with its Member States
to make available information on intellectual property and outreach tools for a
range of audiences – from the grassroots level through to the business sector
and policymakers – to ensure its benefits are well recognized, properly
understood and accessible to all.
WIPO is funded:
WIPO is a largely self-financed organization, generating more than 90
percent of its annual budget through its widely used international registration
and filing systems, as well as through its publications and arbitration and
mediation services. The remaining funds come from contributions by Member
States.
Types of intellectual property right1,6,7
IP
has been generally divided into two main categories viz., (a) Industrial
Property, (b) Copyright.
Industrial
property consists of rights relating to inventions,
trademarks, industrial designs and appellation of origin.
The TRIPS Agreement of the WTO
recognises following types of intellectual property rights (IPRs)
1
Patents
A patent is a statutory right granted for a limited period to
an inventor in respect of an invention to exclude any other person from
manufacturing, using or selling the patented product or from using the patented
process, without due permission. Under the TRIPS Agreement of the WTO,
inventions in all fields of technology - whether products or processes
- are patentable if
they meet the criteria of novelty,
involve an inventive step and
are capable of industrial application.
Patents are one of the oldest forms of IP protection. The patent system started
in the 1700s. The aim of the patent system is to encourage economic and
technological development by rewarding intellectual creativity.
2
Copyright and
Related Rights
Copyright is granted in
respect of original literary, musical, artistic or audio-visual works – the
creations of authors, playwrights, composers, artists and filmmakers. The rights under copyright include: rights
of reproduction, communication to the public, adaptation and translation of
work. Copyright is now spoken together with the related or neighbouring
rights as one category. Though originality in expression is a requirement for
copyright, the quality of the work is not an issue at all. It is to be noted that, though the copyright
subsists in works, which are the creation of ideas, it is not the idea that the
copyright protects, but merely the expression of the idea as fixed in a
particular work. If an author thinks up
the plot of a story, it is not the idea of the plot that is entitled for
protection under a copyright but only the written form of the story flowing
from the idea. Any other person can come up with a differently written story on
the same idea and have a valid claim for a copyright over it. If a painter has
a copyright in a painting, which depicts sunrise, no one else can legally copy
that painting without his permission. However, there is no copyright in the
idea of sunrise and anybody is free to paint sunrise as per his or her own
imagination, and everyone will be entitled to copyright in one’s own
creation. The copyright is in the
painting, not in the idea of sunrise.
Copyright is an inherent right that commences since the completion of the work
as an expression of the idea. Copyright comes with the doctrine of fair use, which includes use of the
work for purposes of criticism, comment, news reporting, teaching and
education, scholarship and research. Fair use does not constitute infringement.
We may also remember that unlike patents or registered designs, copyright
confers no monopoly rights. In fact if two persons can produce precisely
similar work demonstrably working independently of each other, each one will
have the legal right to his or her own creation.
3
Industrial Designs6
An industrial design is the ornamental or aesthetic aspect of an
article; it may consist of three-dimensional features such as shape or surface,
or of two-dimensional features such as patterns, lines or colour. The design
serves as a tool for product differentiation and lures customers by enhanced
visual appeal. It becomes a kind of IP to be protected. Industrial designs are
applied to a wide variety of products of industry or handicraft: watches,
jewellery, fashion and other luxury items, industrial and medical implements,
house ware, furniture, electrical appliances, vehicles and architectural
structures, textile designs, toys etc.
An industrial design is distinguished
from trade mark primarily because it is constituted by the appearance of a
product, which is not necessarily distinctive. A trade mark is necessarily to
be distinctive to serve as a sign for product differentiation. The functions of, and the justification for
protecting industrial designs and trade marks are
quite different. Designs must relate to the appearance of the object which is
not determined by technical or functional necessity. Design enhances the visual appeal and adds to
the commercial value of the product; it also facilitates the marketing and
commercialisation of the product. For registration, a design needs to be new
and original, though the notion of these qualities may vary from country to country. In certain conditions, an industrial design
can be protected under copyright law or the law against unfair competition.
4
Trademarks, Trade
names and Service marks:
Trademarks and service
marks are distinctive symbols that help the consumer to distinguish
between competing goods or services and are a major part of the goodwill a
company enjoys in the trade. A trade name is the name of an enterprise, which
also individualises the enterprise in the minds of the customers. They are
therefore protected as IP. Thus a trade mark is a sign that individualises the
goods of a given enterprise and distinguishes them from the goods of its
competitors. You may be quite familiar with the distinctive marks of Pepsi-Cola
and Coca-Cola Companies. Similarly in passenger cars a characteristic star
enclosed in a circle, or a characteristic treelike T, enclosed in an ellipse,
displayed in the front and the rear of a vehicle immediately proclaims that the
first vehicle is from the Mercedes and the second one is from the Tatas stable. Trademarks invariably come to symbolise
quality of goods or services in the customer’s mind. However, there is no
requirement in law that a trade mark has to meet any quality standards. If
quality is not maintained, customers will shift to another brand.
A trade mark is required to be
distinctive and not deceptive. If you market goods of fake leather under the
trade mark ‘Realeather’ you will be taken in by a
deceptive trademark.A trademark is a
recognizable sign, design or
expression which identifies products or services of a particular source from those of
others.
5
Geographical
Indications:
Geographical
indications (GI) is a sign used on goods that have a specific geographical origin
and possess qualities or a reputation that is solely due to the place of
origin. Such goods enjoy an advantage over competing goods solely because of
their geographical origin, which thus becomes a kind of IP and is protected. A
GI is different from a trade mark. A trade mark is a sign that distinguishes
the product and services of an enterprise from those of another. The owner of a
trade mark is entitled to exclude others from using the trade mark. A GI merely
tells that a product is produced in a certain place and has certain
characteristics which are due to the place of production. All producers who
make their products in a place designated by the GI and share the same
qualities can use it. The Paris Convention uses two terms in the context
of geographical indication: appellation of origin and indication of source.
Indication of source on a product merely indicates that the product originates
in the place indicated. Appellation of origin indicates not only the place of
origin but also the essential quality link between the product and the area of
its origin; e.g. Kolhapuri chappals
from Kolhapur, India.5, 6
6
Layout Designs of
Integrated Circuits; or Topography:
Layout
design (of integrated circuits is a
relatively new area in IP, which has appeared with computer technology and has
acquired importance as the technology makes rapid advances. The programming
instructions on a computer chip are implemented through a circuitry printed on
semiconductor materials. The design of circuitry on the chip requires great
investment of knowledge, skills and capital and it needs to be protected as IP.
The right in topography aims to prevent copying of the layout design but
reverse engineering to come up with improved design is regarded as fair. It may also be noted that, while for claiming
a patent, an invention is required to meet the criteria both of novelty and
non-obviousness, a layout design is only required to be original. Protection of
layout design confers no monopoly right. Independent development of a design,
identical with a protected design is permitted.
Semiconductor Integrated Circuit means a
product having transistors and other circuitry elements, which are inseparably
formed on a semiconductor material or an insulating material or inside the
semiconductor material and designed to perform an electronic circuitry
function. The aim of the Semiconductor Integrated Circuits Layout-Design Act
2000 is to provide protection of Intellectual Property Right (IPR) in the area
of Semiconductor Integrated Circuit Layout Designs and for matters connected
therewith or incidental thereto. The main focus of SICLD Act is to provide for
routes and mechanism for protection of IPR in Chip Layout Designs created and
matters related to it. The SICLD Act empowers the registered proprietor of the
layout-design an inherent right to use the layout-design, commercially exploit
it and obtain relief in respect of any infringement. The initial term of
registration is for 10 years; thereafter it may be renewed from time to time. Department of Information
Technology. Ministry of Communications and Information Technology is the
administrative ministry looking after its registration and other
matters.1, 2, 3
7 Trade Secrets:
It may be confidential business
information that provides an enterprise a competitive edge may be considered a
trade secret. Usually these are manufacturing or industrial secrets and
commercial secrets. These include sales methods, distribution methods, consumer
profiles, advertising strategies, lists of suppliers and clients, and 5
manufacturing processes. Contrary to patents, trade secrets are protected
without registration. A trade secret can be protected for an unlimited period
of time but a substantial element of secrecy must exist, so that, except by the
use of improper means, there would be difficulty in acquiring the information.
Considering the vast availability of traditional knowledge in the country the
protection under this will be very crucial in reaping benefits from such type
of knowledge. The Trades secret, traditional knowledge are also interlinked /
associated with the geographical indications.1, 2
8 Protection of New Plant Variety:
The objective of this act is to recognize the role of farmers as
cultivators and conservers and the contribution of traditional, rural and
tribal communities to the country’s agro biodiversity by rewarding them for
their contribution and to stimulate investment for R and D for the development
new plant varieties to facilitate the growth of the seed industry. The Plant
Variety Protection and Farmers Rights act 2001 was enacted in India to protect
the New Plant Variety; the act has come into force on 30.10.2005 through
Authority. Initially 12 crop species have been identified for regt. i.e. Rice,
Wheat, Maize, Sorghum, Pearl millet, Chickpea, Green gram, Black gram, Lentil,
Kidney bean etc. India has opted for sui- generic system instead of patents for
protecting new plant variety. Department Agriculture and Cooperation is the
administrative ministry looking after its registration and other matters. 1,
2
Laws protecting IPRS’ in India
The patents act-1970
Protects
inventions. The amended Act
effecting the latest amendment of 2005 has been brought into force with
retrospective effect from January 1, 2005.
The designs act-2000
For protection of designs
such as shapes, configuration, pattern, ornamentation or composition of lines
applied to articles in two or three dimensions
The copyright act-1957
Protects,
literary artistic, musical, dramatic works, cinematographic films and sound
recordings. Amended to include
computer software programmes as literary work
The trade marks act 1999
For marks
relating to trade and services.
This Act has been comprehensively amended in 1999 and has come into force on
September 15, 2003
Plant variety protection act-2000
For protection of plant
varieties
The Semiconductor Integrated
Circuits Layout Design Bill 1999 has been introduced in RajaSabha.
An overview on patent6
A patent grants
an inventor exclusive rights to make, use, sell, and import
an invention
for a limited period of time, in exchange for the public disclosure of the
invention. An invention is a solution to a specific technological problem,
which may be a product or a process. A patent is an exclusive right granted for
an invention –a product or process that provides a new way of doing something,
or that offers a new technical solution to a problem. A patent provides patent owners with protection for their
inventions. Protection is granted for a limited period,
generally 20 years.17A patent is awarded for an invention, which
satisfies the criteria of global novelty, non-obviousness, and industrial or
commercial application. Patents can be granted for products and processes. As
per the Indian Patent Act 1970, the term of a patent was 14 years from the date
of filing except for processes for preparing drugs and food items for which the
term was 7 years from the date of the filing or 5 years from the date of the
patent, whichever is earlier. No product patents were granted for drugs and
food items. A copyright generated in a member country of the Berne Convention
is automatically protected in all the member countries, without any need for
registration. India is a signatory to the Berne Convention and has a very good
copyright legislation comparable to that of any country. However, the copyright
will not be automatically available in countries that are not the members of
the Berne Convention. Therefore, copyright may not be considered a territorial
right in the strict sense. Like any other property IPR can be transferred,
sold, or gifted.
Patents are necessary for provide incentives to individuals by recognizing
their creativity and offering the possibility of material reward for their
marketable inventions. These incentives encourage innovation, which in turn
enhances the quality of human life.
Patent protection means an
invention cannot be commercially made, used, distributed or sold without the
patent owner’s consent. Patent rights are usually enforced in courts that, in
most systems, hold the authority to stop patent infringement. Conversely, a
court can also declare a patent invalid upon a successful challenge by a third
party.
Fig 1 Patent Procedure in General
A patent owner has the right to decide who may – or may not –use the
patented invention for the period during which it is protected. Patent owners
may give permission to, or license, other parties to use their inventions on
mutually agreed terms. Owners may also sell their invention rights to someone
else, who then becomes the new owner of the patent. Once a patent expires,
protection ends and the invention enter the public domain. This is also known
as becoming off patent, meaning the owner no longer holds exclusive rights to
the invention, and it becomes available for commercial exploitation by others.
Role of patents play in everyday life Patented inventions have pervaded every aspect of
human life, from electric lighting (patents held by Edison and Swan) and sewing
machines (patents held by Howe and Singer), to magnetic resonance imaging (MRI)
(patents held by Damadian) and the I Phone (patents held by Apple).
In return for patent protection, all patent owners are obliged to
publicly disclose information on their inventions in order to enrich the total
body of technical knowledge in the world. This ever increasing body of public
Knowledge promotes further creativity and innovation. Patents therefore provide
not only protection for their owners but also valuable information and
inspiration for future generations of researchers and inventors.
How is a patent granted?
The first step in securing a patent is to file a patent application.
The application generally contains the title of the invention, as well as an
indication of its technical field. It must include the background and a description
of the invention, in clear language and enough detail that an individual with
an average understanding of the field could use or reproduce the invention
.Such descriptions are usually Accompanied by visual
materials –drawings, plans or diagrams – that describe the invention in greater
detail. The application also contains various “claims”, that is, information to
help determine the extent of protection to be granted by the patent.
Time-table for obtaining
patent
Fig
2 Time-Table for obtaining patent
Inventions which can be protected must, in general, fulfill the following conditions to
be protected by a patent. It must be of practical use; it must show an element
of “novelty”, meaning some new characteristic that is not part of the body of
existing knowledge in its particular technical field. That body of existing
knowledge is called “prior art”.The invention must
show an“inventive step” that could not be deduced by
a person with average knowledge of the technical field. Its subject matter must
be accepted as “patentable” under law. In many countries, scientific theories,
mathematical methods, plant or animal varieties, discoveries of natural
substances, commercial methods or methods of medical treatment (as opposed to
medical products) are not generally patentable.
Who grants patents?
Patents are granted by national patent offices or by regional offices
that carry out examination work for a group of countries –for example, the
European Patent Office (EPO) and the African Intellectual Property Organization
(OAPI). Under such regional systems, an applicant requests protection for an
invention in one or more countries, and each country decides whether to offer
patent protection within its borders. The WIPO-administered Patent Cooperation Treaty
(PCT) provides for the filing of a single international patent application that
has the same effect as national applications filed in the designated countries.
An applicant seeking protection may file one application and request protection
in as many signatory states as needed.
Types of patent applications6
a) Ordinary Application
b) Application for Patent of Addition
(granted for Improvement or Modification of the already patented invention, for
an unexpired term of the main patent).
c) Divisional Application (in case of
plurality of inventions disclosed in the main application).
d) Convention application, claiming
priority date on the basis of filing in Convention Countries.
e) National Phase Application under
PCT.
Documents required for filing an
application 6
1) Application form in duplicate
(Form 1).
2) Provisional or complete
specification in duplicate. If the provisional specification is filed, it must
be followed by the complete specification within 12 months.(Form
2).
3) Drawing in duplicate (if
necessary).
4) Abstract of the invention in
duplicate.
5) Information and undertaking
listing the number, filing date and current status of each foreign patent
application in duplicate (Form 3).
6) Priority document (if priority
date is claimed) in convention application, when directed by the Controller.
7) Declaration of inventor-ship where
provisional specification is followed by complete specification or in case of
convention/PCT national phase application (Form 5).
8) Power of attorney (if filed
through Patent Agent).
9) Fee (to be paid in cash/by cheque/by demand draft) (See Schedule I).
(Note: The cheque or demand draft should be payable to the
"Controller of Patents" drawn on any schedule bank at a place where
the appropriate office is situated
4. Benefits of
IPR
The benefits of Intellectual property rights
Businesses with a defined IP strategy:
• Maintain their competitive edge
• Are able to raise funds for development because investors have
confidence that the ideas won’t be stolen
• Are able to protect their innovative ideas, which use new
technologies and design or unique selling points, from exploitation by
unscrupulous traders. Consumers:
• Have confidence that products with trademarks are brand names made to
a certain standard and quality
• Have innovative products to choose from. Creative individuals and
entrepreneurs:
• Have time to develop their innovative ideas
• Reap financial rewards from their ideas
• Are given opportunities to reach personal fulfillment. Society and the
economy benefit from:
• Growth in enterprise and creativity
• Innovation and vibrancy
• Increased and varied employment opportunities
• Reputation for innovation.
Management of intellectual property
in pharmaceutical industries
More than any other technological area,
drugs and pharmaceuticals match the description of globalization and need to
have a strong IP system most closely. Knowing that the cost of introducing a
new drug into the market may cost a company anywhere between $ 300 million to
$1000 million along with all the associated risks at the developmental stage,
no company will like to risk its IP becoming a public property without adequate
returns. Creating, obtaining, protecting, and managing IP must become a
corporate activity in the same manner as the raising of resources and funds.
The knowledge revolution, which we are sure to witness, will demand a special
pedestal for IP and treatment in the overall decision-making process.
Competition in the global pharmaceutical
industry is driven by scientific knowledge rather than manufacturing know-how
and a company's success will be largely dependent on its R and D efforts.
Therefore, investments in R and D in the drug industry are very high as a
percentage of total sales; reports suggest that it could be as much as 15% of
the sale. One of the key issues in this industry is the management of
innovative risks while one strives to gain a competitive advantage over rival
organizations. There is high cost attached to the risk of failure in pharmaceutical
R and D with the development of potential medicines that are unable to meet the
stringent safety standards, being terminated, sometimes after many years of
investment. For those medicines that do clear development hurdles, it takes
about 8-10 years from the date when the compound was first synthesized. As
product patents emerge as the main tools for protecting IP, the drug companies
will have to shift their focus of R and D from development of new processes for
producing known drugs towards development of a new drug molecule and new
chemical entity (NCE). During the 1980s, after a period of successfully
treating many diseases of short-term duration, the R and D focus shifted to
long duration (chronic) diseases. While looking for the global market, one has
to ensure that requirements different regulatory authorities must be satisfied.
It is understood that the documents to be submitted to regulatory authorities
have almost tripled in the last ten years. In addition, regulatory authorities
now take much longer to approve a new drug. Consequently, the period of patent
protection is reduced, resulting in the need of putting in extra efforts to
earn enough profits. The situation may be more severe in the case of drugs
developed through the biotechnology route especially those involving
utilization of genes. It is likely that the industrialized world would soon
start canvassing for longer protection for drugs. It is also possible that many
governments would exercise more and more price control to meet public goals.
This would on one hand emphasize the need for reduced cost of drug development,
production, and marketing, and on the other hand, necessitate planning for
lower profit margins so as to recover costs over a longer period. It is thus
obvious that the drug industry has to wade through many conflicting
requirements. Many different strategies have been evolved during the last 10 to
15 years for cost containment and trade advantage. Some of these are out
sourcing of R and D activity, forming R and D partnerships and establishing
strategic alliances.
REFERANCES:
1.
Introduction To Intellectual Property Right
Available
from: www.wipo.int
2. Introduction
To Intellectual Property Right Available from
http://www.tifac.org.in/do/pfc/pfc.htm
3. The Layout Design for Integrated
Circuits System in India Available from: DIT website link at
http://mit.gov.in/default.aspx?id=322
4. The Protection of New Plant
Variety System in India, Protection of Plant Varieties and Farmers’ Rights
Authority, India (PPV and FR) Available from: http://www.plantauthority.gov.in/
5. Geographical Indication
System in India viewed at website of Geographical Indication Registry, website
at http://ipindia.nic.in/girindia/
6. WIPO Intellectual Property
Rights Handbook, published at 2004,
7. BITS; Pilani,
A Manual On Intellectual Property Rights, published on November 2007, Available
from:
http://www.bitspilani.ac.in/uploads/Patent_ManualOct_25th_07.pdf
8. WIPO Intellectual Property
Rights Handbook, second edition, published on 2004, Available
from: http://www.wipo.int/freepublications/en/intproperty/489/wipo_pub_489.pdf
9. DIP and P website at http://ipindia.nic.in/ipr/patent/patents.htm
Received on 21.11.2015 Accepted
on 10.12.2015
© Asian Pharma Press All
Right Reserved
Asian J. Pharm. Tech. 2015; Vol. 5: Issue 4, Oct. - Dec., Pg 222-230
DOI: 10.5958/2231-5713.2015.00032.X