Professional Documents
Culture Documents
1. INTRODUCTION
Intellectual Property:
Intellectual Property (IP) is a class of property emanating primarily from the activities of
the human intellect. Human beings are distinguished from animals by the intellectual
faculty endowed by the Almighty. The human beings are thus, elevated themselves to the
present civilized state solely due to the exercise of such intellectual faculty. It is common
that any property, moveable or immovable is to be legally protected in order to prevent it
from stealing. Similarly the rights in the intellectual property created need also to be
protected to prevent it from infringement; the property, which is created by the human
intellect. In other words, intellectual property relates to information, which can be
incorporated in tangible objects and reproduced in different locations.
Examples: Patents, Designs, Trade Marks, Copyrights. Geographical indications etc.
Like the movable and immovable property, intellectual property is also governed by the
law of the country which is for the time being in force, namely Law of Intellectual
Property Rights.
In short, patents are for new inventions, which are solutions to scientific and technical
problems. Industrial designs are esthetic creations determining the appearance of
industrial products. Trademarks are useful for the consumer for the identification of the
manufacturer to fee products. Copyrights are the rights in literary, artistic, software, etc.
2. HISTORY
The earliest use of the term "intellectual property" appears to be an October 1845
Massachusetts Circuit Court ruling in the patent case Davoll et al. v. Brown. in which
Justice Charles L. Woodbury wrote that "only in this way can we protect intellectual
property, the labors of the mind, productions and interests as much a man's own...as the
wheat he cultivates, or the flocks he rears." (1 Woodb. & M. 53, 3 West.L.J. 151, 7 F.Cas.
197, No. 3662, 2 Robb.Pat.Cas. 303, Merw.Pat.Inv. 414). But the statement that
"discoveries are...property" goes back earlier. Section 1 of the French law of 1791 stated
"All new discoveries are the property of the author; to assure the inventor the property
and temporary enjoyment of his discovery, there shall be delivered to him a patent for
five, ten or fifteen years".
In Europe, French author A. Nion mentioned "propriété intellectuelle" in his Droits civils
des auteurs, artistes et inventeurs, published in 1846.
The term's widespread popularity is a much more modern phenomenon. It was very
uncommon until the 1967 establishment of the World Intellectual Property Organization,
which actively tried to promote the term. Still, it was rarely used without scare quotes
until about the time of the passage of the Bayh-Dole Act in 1980.
The concept's origins can potentially be traced back further. Jewish law includes several
considerations whose effects are similar to those of modern intellectual property laws,
though the notion of intellectual creations as "property" does not seem to exist. The
Talmud contains the first known example of codifying a prohibition against the stealing
of ideas, which is further discussed in the Shulchan Aruch.
However, the legal system of most of the Western world does not have provisions for
intellectual property and the laws the term encompasses are justified on more constrained
grounds. The term does not occur in the United States Copyright Statutes, except in
certain footnotes citing the titles of certain Bills. The term used in the statutes and in the
Constitution is "exclusive rights".
There are various forms of IPR. The Trade Related Aspects of Intellectual Property
Rights (Knows as TRIPS) which are recognized by the Agreement of the Word Trade
Organization (WTO), are the following:
Patents, Designs, Trade Marks, Copyrights, Geographical Indications, Integrated circuits
and Trade secrets. In addition to these forms, there are many other forms like Utility
model Plant variety protection etc. Out of these, Patents, Designs Trade marks and
Copyright are the most important and common forms of IRP.
Patents:
Patents are legal rights granted for new inventions employing scientific and technical
knowledge. A patent confers on its holder the excusive right for a limited period (usually
called “term”) the rights to the new inventions disclosed. The subject of Patent, which
involves scientific and legal issues, is relatively complicated as compared with the other
species of intellectual property like designs, trademarks and copyrights. Moreover the
grant of patent rights has to strike a balance between different conflicting interests such
as : between keeping valuable technical information as trade secrets and disclosing such
information, between public and private interests of the inventor/industry, between
exclusive rights and promoting competition and particularly in developing countries,
between the interests of indigenous industry and transnational corporations.
In India, currently, the Patents Act 70 and the corresponding Rules 1972 govern the grant
of patents. Recently the Indian Parliament has passed an Act for the comprehensive
amendment of the Patents Act 70. Rules under the modified Act have been notified and
are currently in the finalization stage. The modified Act and the Rules are expected to be
brought into force in the near future. {Refer the Annex for the copies of the modified
Patents (Amendment) Ordinance 2004 Act and the amended Rules, which have been
brought into force w.e.f. 1.1.2005}
Industrial Designs:
A design is an idea or conception as to features of shape, configuration pattern or
ornament applied to an article. A design can be either two or three-dimensional. In short a
design in order to secure legal protection must consist of a shape which is three-
dimensional or of a pattern which is two-dimensional and that the shape or pattern must
be applied to an article or articles. The main criteria for securing protection for a design
are novelty and originality of the design.
Trade Marks:
A trade mark is a visual symbol in the form of a word, device, or a label applied to an
article of manufacture of commerce with a view to indicate the purchasing members of
the public about the origin of the manufacture of the goods affixed with that mark, It
distinguishes such goods from the goods manufactured by others in the trade. In other
words, a trademark enables a customer to distinguish the products of one manufacturer
from that of others. When properly advertised, the mark becomes an effective instrument
to attract customers and by its proper use, the trademark acquires good will to the
customers. A trade mark, through its widespread and extensive use in public, becomes
popular and eventually results in acquiring an exclusive right on the mark which can be
legally enforced by the owner of the mark. The main criteria for securing a trademark
registration are its originality.
Copyrights:
Copyright is basically the right to copy and make use of literary, dramatic, musical,
artistic works, cinematographic films, records and broadcast. Copyright is a proprietary
right and comes into existence as soon as the work is created. In early days the concept of
copyright had its origin under the Common Law. Subsequently it came to be governed by
the statutory laws of each country. The main criteria for the copyright registration are its
originality.
India has opted for the second category namely suits generic system. Accordingly Indian
Parliament has passed the “Protection of Plant Varieties and Farmers Rights Act 2001”.
The Rules for this legislation is being framed and it is expected that this legislation will
be brought into force soon.
Geographical Indications:
Geographical Indications are indications, which identify a good as originating in the
territory of a country or a region or locality in that territory where a given quality,
reputation or other characteristic of the goods is essentially attributable to its
geographical origin. The TRIPS agreement requires the member countries to enact
legislation for the protection of Geographical indications. An office for the registration of
the Geographical indication in India has been opened at Chenni. The legislation has
been brought into force. It is under the Office of the Controller General of Patents,
Designs & Trade Marks and the office where the application for registration has to be
filed is at Chennai at Guna Complex. Teynampet, Channai.
Utility Models:
Utility models involve some of the inventions in the mechanical field. There fore the
object of utility models are sometimes described as devices for useful objects. This type
of inventions is also referred to as “petty inventions”. As the name suggests, the degree of
inventive step required for the inventions to be protected by patents. The maximum term
of protection under this category of inventions is generally shorter than that available in
the case of patents. The examination procedure for securing the rights is short and the
cost very low. The Utility Model system facilitates creating a culture of creativeness and
builds up the mind for enhancing creativity (inventing).
According to the TRIPS provisions, all member countries should provide protection for
new microorganisms. Accordingly in the Patent Amendment Act (2002), which was
brought into force in May 2003t provides protection for new microorganisms.
Jurisdiction for the enforcement of the legal rights accrued under Intellectual
Property:
The jurisdiction for the enforcement of the legal rights accrued under Intellectual
Property under the appropriate legislation is within the boundaries of the country, which
grants such rights, and not outside. In other words, the legal rights in Intellectual Property
secured in one country cannot be enforced in another country or countries. This means,
for example, the rights secured by the grant of a patent in India can be enforced only in
India and not outside. Similarly the rights secured by the grant of a patent in USA can be
enforced only in USA and not outside.
The above situation will also prevail under the WTO agreement. In short TRIPS
provisions of WTO Agreement do not also envisage one patent, which will be valid in all
the WTO member countries. But there is an exception to the above situation. That is
regarding the Copyright. In the case of Copy right, as per the Berne Convention, the
rights protected under the Copyright law in a member country is enforceable in other
member country or countries. For example, the copyright protected in India will be
enforceable in other Bern member country like USA and vice versa.
Perhaps no other subject has evoked so much attention all over the world particularly in
the developing country like India. As the Intellectual Property Rights (IPR) consequent to
the coming into force of the WTO Agreement incorporating the trade related aspects of
intellectual Property Rights (TRIPS) and the establishment of Worlds Trade Organization
(WTO)
In the Indian context, integration of its economy with the global economy is gaining
momentum. This process will not be complete unless the research and development is
also integrated with global research and development.
The potential knowledge as a creator wealth is gaining currency all around the world. But
only knowledge that is protected or protectable can have the potential of wealth creation
the inclusion of intellectual Property Rights in the form of Trade Related aspects of
Intellectual Property Rights is an indication of this realization. Integration at a global
level will require paying urgent attention to enhance he levels of innovations and
creativity substantially. Innovation is as defining trait of successful organization.
The success of companies such as 3M Corporation in USA, Pfizer, Sony, and IBM etc. is
some examples, which substantiate the above situation. After the Second World War
Japan has transformed itself into one of the economic giants in the world taking
advantage of the IPR system especially patent system. The same reasons can also be
attributed for the companies in China and Korea becoming powerhouses of innovations.
The benefits of IP system are therefore, explained with reference to Patent system.
However it should be kept in mind that similar benefits are also there in other species of
IP. Patents are very useful as they can be utilized as devices to advance knowledge and to
bring new knowledge eventually into the public domain. As instruments of
competitiveness by the enterprises against potential or actual competitors and by the
governments in their bid to strengthen their own countries against foreigners. Patents
encourage inventive activities in a country. A patent system contributes to the stimulation
of inventions in the following ways. Rights accrued to work the invention covered in a
patent for a limited period of time provides an important incentive for inventive and
innovative activities. If the inventions, which are the fruits of R&D, are not protected by
patents, they would be available for free exploitation by anyone, including those who
have not invested in R & D. The inventive organization and the personnel, under these
circumstances, will be placed in a disadvantageous position.
A Patent System of rewarding the inventor and / or the patentee is based on the idea that
the grant of monopoly will automatically secure to him a reward which is commensurate
with the value of the intellectual input provided and the investment made for the
development of the invention. In theory, if the invention is good commercially the
inventor should be able to exploit it or sell the patent, thereby making profit. If on the
other hand, it is not commercially good, he would receive nothing. In practice even if the
invention is not good, owing to the factors beyond the control of the inventor, the
inventor might not be able to make a profit out of his patent. On the other hand, in certain
other cases the reward of the inventor obtained for his invention might be out of all
proportions. But the desire for economic reward is undoubtedly an important factor for
activating and stimulating creative activities. If the patentee has no financial resources to
work the invention commercially, he can grant license or assign the rights in the patent to
others for its commercialization and obtain financial reward.
Securing patents will help the inventor (patentee) to develop the know how to make it
commercially viable with the assistance of a third party, if required, with the legal
protection on the invention. Such a position protects the inventor from unfair
competition. Securing a patent would enable the inventor to establish an official record of
the inventor ship. In order to obtain patent, the invention has to be disclosed in detail in
the patent document (specification). The patent law also stipulates that the invention
should not be made open to public fore the date of filing of the application for patent.
Therefore in most cases, the information contained in a patent document is the first
available information on the particular subject, which is not available from any other
source, Therefore, the patent documents are richest, latest and unique source of
technological information in the world. The information contained in the patent
documents published anywhere in the world can be freely used for R & D purposes at any
point of time anywhere in the world, including the country which has granted the patent
and where it is still in force. Such a use will not constitute an infringement. A patent,
which has lapsed, become public property and therefore can also be commercially
utilized by any person interested. Thus the patent system enables the dissemination of
valuable technological information to the benefit of the society. The inventor (patentee)
can secure a patent for the invention developed and if desired make the said protected
invention to the public and / or interested person freely for exploitation without
demanding any benefits. In such a situation, if somebody misuses or abuses the rights in
the patent, the inventor (patentee) can initiate legal proceedings for preventing such
misuse or abuse. On the other hand if such protection has not been secured, then the
inventor will remain as a silent spectator for the abuse or misuse of the invention.
IPR has an important role in both in R&D and in the transfer of Technology. When IP is
generated and consequently wealth is generated by the commercialization or otherwise of
the IP, the sharing of the generated wealth will depend upon the intellectual contributions
made for the generation of the IP. Therefore, in undertaking R&D entering into any
collaboration and in the transfer of technology, the IPR will be an important component.
It may be observed in many of the agreements, which are being executed, in the recent
times, there is Clause indicating the ownership, sharing and other related issues relating
to IPR.
6. PATENT SYSTEM
Patent:
Patent is a grant (in the form of a document) by the Government given for disclosing a
new invention by an inventor or a group of inventors or an applicant. Once the patent is
issued it gives to the inventor or the applicant as the case may be, the exclusive rights to
sell, manufacture and use the invention disclosed in the patent. The legal exclusive right
in the patent can be exercised by the inventor / applicant in the country, which grants the
right. This right can be exercised only for a limited period of time, normally known as
term of the patent. On the expiry of the term the invention becomes public property.
The Patent Act, 1970 came into force on the 20th April, 1972 and extends to the whole of
India. This Act was amended in March, 1999 and June, 2002 to meet India's obligation
under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS),
which forms part of the agreement establishing the Word Trade Organization (WTO). The
amendments primarily focused on the obligations which came into force from 1st
January, 2000 (in respect of amendments notified in June, 2002). The first amendment to
the Patents Act introduced a transitional facility ('mail box') from 1st January, 1995 to
receive and hold product patent application in the fields of pharmaceuticals and
agricultural chemicals till January, 2005 and also for grant of exclusive marketing rights
(EMRs) for a period of five years till the product patent is granted or patent application is
rejected, whichever is earlier. The Patents Rules, 2003 came into force on the 20th May,
2003 and the Patents (Amendment) Act, 2005 became effective from 1st January, 2005
The Patents (Amendment) Ordinance, 2004 stands repealed.
The fact that patent documents are open to the public and are freely exchanged,
distinguish the patent system form other proprietary rights relating to technical subject
matter such as trade secrets and know-how. There is a school of thought, which believes
that the patent system prevents dissemination of free scientific information, as was the
practice earlier. In this context, it is to be noted that the patent system only assists in free
exchange of scientific information. By securing patents, it is not mandatory that the
patentee should charge any fees for commercializing the invention disclosed therein. An
inventor can make available the invention developed to those interested for
commercialization without charging any fees therefore. In such a situation, if somebody
misuses or abuses the rights in the patent, the inventor (patentee) can initiate legal
proceedings for preventing such misuse or abuse. On the other hand, if such protection
has not been secured, than, the inventor will remain as a silent spectator for the abuse or
misuse of the invention.
One of the important objectives of the patents system is to disseminate the information
disclosed in the patent as early as possible. In the context, it should be noted that many
countries in the world publish the contents of patent document (Called patent
specification) on the expiry of 18 months from the date of filing or the priority date,
whichever date is earlier. The main objective of this publication is to make available the
information to the interested public early, instead of keeping the information confidential
for a long time. Consequent on the patent system getting popular day by day and the
examination of the patent documents getting complicated due to the high technologies
involved, the publication of the patent documents are, currently, getting very much
delayed. To avoid such a situation only, the early publication of the information contained
in patent applications has been adopted globally. In this context, it should also to be noted
that India has also adopted the procedure of such publication after 18 months, as a
provision to this effect has been incorporated in the Patent (Amendment) Act 2002 and
has been brought into force from May 2003.
The Patent system reward the competitive, creative drive with temporary limited,
exclusive rights, in return for the cooperation of an inventor in teaching the rest of the
society how to use his or her findings (Inventions) for all time thereafter. This philosophy
of the patent system should be kept in mind in order to appreciate, and understand the
patent system effectively.
India, the fees prescribed under the Patents Rules 2003, which were recently modified
and brought into force with effect from 1-1-2005, have substantially enhanced the fees
for various proceedings under the Patents Act and Rules. But the fees, thought may not be
affordable for Indian applicants especially the individuals and non profit making
organizations/institutions, are still less as compared to those prevailing in the foreign
countries.
It should be noted that the expenses connected with securing patents and maintenance are
spread over a period of several months of to a few years. In short, to get a patent it cost
some money. But by employing right development strategy and aggressive marketing of
the invention, one would have sufficient cash flow before one need to pay the legal costs.
If the invention protected is very good commercially, the expenses incurred for securing a
patent for the said invention as well as its maintenance will be negligible as compared to
the commercial benefit that will be accrued to the patentee from the patented invention.
Patent pending:
It means that the patent office has received a patent application disclosing a new
invention. Only on or after the date of filing the application can the words “patent
pending”(sometimes also referred to as “patent applied for”) be used. It is illegal to
mention “patent pending” or “patent applied for” before filing an application in the Patent
Officer. Such mentioning amount to fraud and will attract penalties prescribed in the
Patent Act.
• If any one of the above-mentioned criteria is not fulfilled, such an invention will
not be patentable subject matter. In some countries, the patent law excludes
certain specific kinds if invention from being patentable even thought the
invention satisfy all the above-mentioned criteria for patentability, examples:
inventions relating to nuclear transformation, treatment of human beings, plants
and animals etc. Such categories of inventions are stipulated in the patent
legislation of the country concerned.
The novelty of the invention is determined taking into consideration the knowledge
available anywhere in the world in the relevant field at the time of filing the application
for patent. In other words, the invention should not be publicly known anywhere in the
world on the date of filing the application for patent. The disclosure of the invention to
the public by the inventor himself before filing the application for a patent by publication
or otherwise would destroy the novelty of the invention (except under certain
circumstances – See Section 31 of the Patents Act) and would stand in the way of
securing patent for the said invention subsequently. Therefore, if an invention has to be
legally protected by patents, it should not be made open to public by its publication or
otherwise, before filing the application for patent accompanied with complete
specification.
In other words, an invention cannot be patented, if
• The invention was known in any part of they would on the day of filing the
application for patent.
• It was previously described in an article and published anywhere in they would.
The publication of the inventor himself / herself will adversely affect the patent
grant.
• It was previously patented elsewhere.
• The difference between the invention to be protected and the previous patent (or
publicly know product or process etc.) is such that it would have been obvious to
a person skilled in the art. For example, merely changing the size or color will not
be patentable.
Mosaic of citations:
It is emphasized that the novelty of the invention will be destroyed only if invention is
publicly known is a singe document. In other words, if full information in respect of an
invention cannot be derived from a single prior art published document, the novelty of
the invention will not be destroyed by virtue of such disclosure. In other words, mosaic of
citations for attacking the novelty of an invention is not permitted. In other words, the test
for novelty is that each and every limitation of the invention claimed must be present in
the single prior art document as such.
There is a school of thought, which believes that the patent system prevents
dissemination of free scientific information, as was the practice earlier, in this context, it
is to be noted that the patent system only assists in free exchange of scientific
information. By securing patents, it is not mandatory that the patentee should charge any
fees make available the invention developed to those interested for commercialization
without charging any fees there for. In such a situation, if somebody misuses or abuses
the rights in the patent, the inventor (patentee) can initiate legal proceedings for
preventing such misuse or abuse. On the other hand, if such protection has not been
secured, then, the inventor will remain as a silent spectator for the abuse or misuse of the
invention.
One of the important objectives of the patent system is to disseminate the information
disclosed in a patent as early as possible. In this context it should be noted that many
countries in the world publish the contents of patent documents (Called patent
specification) on the expiry of 18 months from the date of filing or the priority date
whichever date is earlier. The main objective of this publication is to make available the
information to be interested public early instead of keeping the information confidential
for a long time. Consequent on the patent system getting popular day by day and the
examination of the patent documents getting complicated due to the high technologies
involved, the publication of the patent documents are, currently, getting very much
delayed. To avoid such a situation only the early publication system has been adopted. In
this context, it should also to be noted that India has also adopted the procedure of
publication after 18 months as a provision to this effect has been incorporated in the
Patent (Amendment) Act. 2002.
It should be noted that there is no such grace period provided under the Indian Patents
Act, except for making conventional application claiming priority based on a basic
application filed under international agreements such as Paris Convention. PCT (Patent
Cooperation Treaty) and WTO.
to be deferred till all such applications have been filed. But in certain countries, by virtue
being Convention countries and those which are members of the Paris Convention there
is a grace period of 12 months for filing the corresponding application in the member
countries, based on the first filing in the base country.
The inventions, which are patentable under the Indian Patents Act:
The patentable inventions under the Indian Patent Act, as applied to process, method, art
or manner of manufacture should be regarded as an artificial process or operation of an
industrial nature wherein certain starting materials has been subjected to the process or
operation to convert the starting material in such a manner to produce a new and useful
article or substance which is tangible. If the starting material remains unaltered by the
process and said product also remains the same as the starting material, than, the process
may not constitute an invention for the purposes of patentability.
It is to be noted that if the alternate process developed is very efficient and the product is
very useful having good commercial potential, the patent holders for the respective
inventions can come together and have a joint agreement (cross licensing) and bring the
product to the market and share the profits amongst themselves, Such an exercise will
benefit the society in getting the fruits of the research work. Such a situation instead of
hampering R&D in developing alternative processes for a product under the product
patent regime will enhance such development activities.
The term “process” means a process, art, or method. A process may also be defined as
one or more steps or acts performed on materials to produce a result. A process should be
regarded as an artificial process or operation of an industrial nature where in certain
starting materials are subjected to the process or operation to convert the starting material
in such a manner to produce a new and useful article or substance, which is tangible.
If the starting material remains unaltered by the process and the resulting product also
remains the same as the starting material, then, the process may not be an invention for
the purpose of patentability. It is an invention if the process requires some ingenuity or
inventive step.
A product/article would include any new product or thing made by the process defined
above by the industry or man. A “composition of matter” is that formed by the synergistic
mixture of two or more ingredients resulting in a composition having properties different
to that of the ingredients used.
The main criteria for obtaining patents abroad are the same as in India, namely novelty,
inventive step and utility. The degree of protection possible in various countries may
differ from country to country and is stipulated in the patent legislation of the country
concerned. But the criteria of patentability are same in all the countries.
Filing processing and maintaining patents in foreign countries is very expensive.
Therefore the invention to be protected abroad and the countries where the protection is
desired have to be judicially determined considering tenter-alia the following additional
criteria. Justification for securing patents abroad and consideration for selecting the
country (ies.)
According to the Indian Patents Act, three types of patents can be secured. These are
1. Ordinary patent
2. A patent of addition and
3. A patent granted under Convention Agreement.
1. Ordinary Patent:
An ordinary patent is a patent granted based on an ordinary application made for patent.
2. Patent of addition:
A patent of addition is a patent secured for an improvement or modification of an
invention for which invention; a patent has already been applied for or granted. A patent
of addition remains in forced only as long as the patent for the main invention remains in
force. No renewal fees have to be paid for maintaining a patent of addition.
In case the main patent is revoked, the patent of addition may be made an independent
patent by the authority ordering the revocation of the main patent. Such an independent
patent can continue thereafter for the unexpired term of the main patent subject to the
payment of the renewal fees.
An application for a patent for an invention may be made by any one of the following
persons either alone or jointly with any other person-
• Any person claiming to be the true and first inventor of the invention;
• Any person being the assignee of the person claiming to be the true and first
inventor in respect of the right to make such an application;
• The legal representative of any deceased person who immediately before his
death was entitled to make such an application.
Every application for a patent shall be for one invention only and shall be made in the
prescribed from and filed in the patent office. Every application shall state that the
applicant is in possession of the invention and shall name the person claiming to be the
true and first inventor; and where the person so claiming is not the applicant or one of the
applicants, the application shall contain a declaration that the applicant believes the
person so named to be the true and first inventor. A provisional or a complete
specification shall accompany every application.
An Indian resident can file application for patent at the appropriate Patent Office under
whose jurisdiction he resides or has his principal place of business. For non-residents, the
address for service in India or principal where application for patent can be filed. Where
an applicant for a patent under this Actins prosecuting an application for a patent in any
country outside India in respect of the same or substantially the same invention, he shall
file along with his application - (a) a statement settling detailed particulars of such
application; and (b) an undertaking that he would keep the Controller informed of
detailed particulars as required. The Controller may also ask similar information from an
application for a patent.
Contents of specification:
Every specification, whether provisional or complete, shall describe the invention and
shall begin with a title sufficiently indicating the subject matter to which the invention
relates. The Controller may require the drawings to be supplied with any provisional or
complete specification, which shall form part of the respective specification. In any
particular case the Controller may require that a model supplement an application or
sample of anything illustrated in the invention but such sample or model shall not be
deemed to form part of the specification. Every complete specification shall -
• Fully and particularly describe the invention and its operation or use and the
method by which it is to be performed;
• Disclose the best method of performing the invention which is known to the
application and for which he is entitled to claim protection; and
• End with a claim or claims defining the scope of the invention for which
protection is claimed.
The publication of every application shall include the particulars of the date and number
of application, name and address of the applicant and an abstract.
An application for a patent shall not be examined unless the applicant or any other
interested person makes a request for such examination within the prescribed period
otherwise the application is treated as withdrawn. When a request for examination has
been made the application, the specification and other related the Controller to an
examiner for making a report refers documents. The examiner shall make investigation
and summit the report to the Controller who may accept the same and proceed further or
make necessary orders otherwise.
The grant of a patent under this Act shall be subject to the condition that -
• Any machine, apparatus or other article in respect of which the patent is granted
or any article made by using a process in respect of which the patent is granted,
may be imported or made by or on behalf of the Government for the purpose
merely of hats own;
• Any process in respect of which the patent is granted may be used by or on behalf
the Government for the purpose merely of its own;
• Any machine, apparatus or other article in respect of which the patent is granted
or may article made by using a process in respect of which the patent is granted,
may be made or used, and any process in respect of which the patent is granted
may be used, by any person, for the purpose merely of experiment of research
including the imputing of instruction to pupils;
• And in the case of a patent in respect of any medicine or drug, the medicine or
drug may be imported by the Government for the purpose merely of its own use
or for distribution in any dispensary, hospital or other medical institutes
maintained by or on behalf or the Government or any other dispensary, hospital or
other medical institution which the Central Government may, having regard to the
public service that such dispensary, hospital or medical institution render, specify
in this behalf by notification in the Original Gazette.
Patent specification:
The invention for which legal (Patent) protection is desired is disclosed in a patent
document commonly called specification – A patent specification should always
accompany an application for patent. The legal rights in a patent are based on the
disclosure made in the specification. A patent specification is a scientific cum legal
document. A scientific document because. It discloses the scientific and technical
information about the invention, which is to be protected. A legal document because the
contents of the specification are susceptible to interpretation by courts of law if and when
a legal dispute arises. It is therefore important that the disclosure made in this document
is diligently made.
Different types of patent specification:
There are two types of patent specification
(i) Provisional specification and
(ii) Complete specification.
As stated above the application for patent should always be accompanied with a
provisional or complete specification. Without such a specification the application will
not be received by the Patent office.
It may also be noted that if the application is a Convention application, the specification,
which should accompany the application, should always be a Complete Specification and
not a provisional specification.
Provisional Specification:
A provisional specification discloses only the nature of the invention and helps to
establish the identity of the invention and registers the earliest authorship of an invention
in the Patent Office, on first cum first basis. If is a document of record and no amendment
by way of additional of new matter will allow.
Patent search:
The patents are classified under the National Patent Systems of every country (line Indian
Patent Classification System, Us Patent Classification System etc) as well as under an
International Patent Classification System (IPC). The IPC classification system classifies
the entire S&T into 8 main headings. Each heading is further classified minutely into
about 95000 sub headings. These are available through various websites. For example
one may refer to USPTO website as well as the Website of WIPO (World Intellectual
Property Organization).
Provisional & Complete Specifications:
The provisional specification is not a rough draft of the complete specification. In
particular, the provisional specification does not contain the statement of claims defining
the scope of protection sought for. The complete specification, which is filed after the
provisional specification, does not also replace the provisional specification. Provisional
and Complete specification are permanent and independent documents. It is also to be
noted that the provisional specification although do not contain the full details of the
invention, should contain the details as to the prior art on the subject, objectives of the
invention disclosed the principle by which the inventions is being developed, a brief
description of the invention and the expected advantages.
If the applicant mentions a biological material in the specification which may not be
described in such a way as to satisfy the requirements of fully and particularly describe
the invention and its operation or use and the method of performing the invention which
is known to the application and for which he is entitled to claim protection, and if such a
material is not available to the public, the application shall be completed by depositing
the material to an authorized depository institutions as may be notified by the Central
Government in the Official Gazette by fulfilling the following conditions :
In addition, the description in a complete specification should be in intelligible language
(i) to indicate clearly what the invention is so that others know what the monopoly is, that
is granted to the patentee and (ii) in what manner the patented invention is to be
performed so that others may learn from the specification how practically to avail
themselves of the patented invention, when the patent is lapsed or expired and become a
public property. It is not necessary, however that such a person should be able to carry out
the invention without trails or experiment but the degree of experiment required should
not amount to the exercise of inventive ingenuity. A useful test to decide the permissible
limit of experiments is in asking whether anything new has to be found out by a person of
reasonable competent in order to succeed in working the invention disclosed in the
specification. If the answer is yes, the description in the specification is not sufficient. On
the other hand, if the answer is no, then, the description in the specification is sufficient.
The specification – both provisional and complete – must be drafted with the utmost care
and good faith. If must not contain nay false representation or misrepresentation of the
invention or any material part of it, or otherwise mislead the public. The specification
must not be drafted in ambiguous language. It must be clear and concise, as the nature of
the subject will admit. The specification must be intelligible to an ordinary workman
possessing the ordinary skill and knowledge of that branch of the field to which the
invention relates. It is not required to describe the invention and the manner in which it is
to be performed so fully as to instruct persons wholly ignorant on the subject matter.
The specification must describe the best mode known to the patentee of performing the
invention and all the knowledge relating thereto, including that, which he may have
acquired during the period of provisional protection prior to the date of filing the
complete specification
If the specification describes anything, which is not new, it must clearly distinguish that
which is old from which is new and claim only the latter. All information regarding the
modifications / improvements, if any, which fall within the scope of the claim should be
included in the description.
If the applicant does not disclose all the above said information in the complete
specification or include any information, which may mislead the public or gives false
information about the invention, Controller may not grant a patent. In the vent a patent
was granted based on such information the patent would be held invalid and liable to be
revoked.
Since additional fees for each additional page in excess of 10 have to be paid, the
specifications have to be diligently drafted to avoid heavy expenses without
compromising the legal rights, which can be secured.
Statement of Claims:
As explained above one of the mandatory requirements of the complete specification is
that it should end with a statement of claims defining the invention for which legal
protection is sought. The novel part [s] of the invention described in the complete
specification is distinguished from the prior art in the statement of claims, which as stated
above, define and determine the scope of legal protection sought for.
Publication of the filing of the application in the Patent Office Journal, which is a weekly
publication. In this publication only name of the applicant, title of the application and the
number and date allotted to the application are notified. No other information will be
available to the public.
Publication of the application for patents in the Journal, except those on which secrecy
direction is given under Section 35, on the expiry of 18 months from the date of filing or
the priority date whichever is earlier. This publication includes the date of the application
number, name and address of the applicant and an abstract. Consequent on this
publication any interested public can get the copies of the full text of the patent
specification from the appropriate office of the Patent office by paying the prescribed
copying charges.
Withdrawal of the application if the application if so desires. For such withdrawal the
request in the prescribed manner has to be made before three months form the date of
expiry of 18 months from the date of filing or the priority date whichever is earlier.
If the applicant or interested party desired to get the application examined making a
request there for in the prescribed manner within the stipulated period at the appropriate
office of the Patent Office. Overcoming the official requirements. If any, raised by the
Patent Office and placing the application in order within the prescribed period.
Grant of a patent immediately on placing the application in order and publication of the
grant. Filing opposition by any interested party within 12 months from the date of grant
renewal of patents for keeping them in force.
Rights of patentees:
A patent granted under this Act shall confer upon the patentee -
where the subject matter of a patent is a product, the exclusive right to prevent third
parties, who do not have his consent, from the act of making, using, offering for sale,
selling or importing for those purposes the product obtained by that process in India
where the subject natters of a patent is a process, the exclusive right to prevent third
parties, who do not have his consent, from the act of using that process, and from the
actor using, offering for sale, selling or importing for those purposes the product obtained
by that process in India. Patent rights are not infringed when used on foreign vessels, etc.
temporarily or accidentally in India
Rights of co-owners of patents:
Each of the co-owners of a patent shall be entitled, unless an agreement to the contrary is
in force, to an equal undivided share in the patent. Where two or more persons are
registered as grantee or proprietor of a patent, then, unless an agreement to the country is
in force, each of those persons shall be entitled to the rights conferred for his own benefit
without accounting to the other person/persons. Where two or more persons are registered
as grantee or proprietor of a patent shall not be assigned by one of such persons except
with the consent of the other person/persons. Where a patented article is sold by one of
two or more persons registered as grantee or proprietor of a patent, the purchaser and any
person claiming thought him shall be entitled to deal with the article in the same manner
as if the article had been sold by a sole patentee.
Term of patent:
The term of every patent granted after the commencement of the Patents (Amendment)
Act. 2002, and the term of every patent which has not expired and has not cased to have
effect, on the date of such the application for the patent. A patent shall case to have effect
notwithstanding anything therein or in this Act for non-payment of renewal fee. On
cassation of the patent right due to non-payment of renewal fee or on expiry to the term
of patent, the subject natters covered by the said patent shall not be entitled to any
protection.
Patents of addition:
"Patent of addition" means a patent granted in accordance with section 54; a patent of
addition shall not be granted before grant of the patent for the 'main invention.'
A patent shall not be granted as a patent of addition unless the date of filing of the
application was the same as or later than the date of filing of the application in respect of
the main invention. A patent of addition shall be granted for a term equal to that of the
patent for the main invention, or so much thereof as has not expired, and shall remain in
force during that term or until the previous caser of the patent for the main inventing and
no longer. The grant of a patent of addition shall not be effused, and a patent granted as a
patent of addition shall not be revoked or invalidated, on the ground only that the
invention claimed in the complete specification does not involve any inventive step
having regard to any publication or use of (a) the main invention described in the
complete specification relating thereto; or (b) any improvement in or modification of the
main invention described in the complete specification of a patent of addition to the
patent for the main invention or of an application for such a patent of addition, and the
validity of a patent of addition shall not be questioned on the ground that the invention
ought to have been subject of an independent patent.
on which the patent ceased to have effect and the date of publication of the application
for restoration of the patent.
Surrender of patents:
A patentee may offer to surrender his patent by giving notice in the prescribed manner to
the Controller. This Controller shall then publish the offer of surrender and notify every
interested person whose name appears in the register. After hearing the patentee and any
opponent if the Controller is satisfied that the patent may be surrendered, he may by order
revoke the patent in question.
Revocation of patents:
A patent, whether granted before or after the commencement of this Act may be revoked
by the Appellate Board / High Court on any one of the following grounds. :-
that the invention, so far as claimed in any claim of the complete specification, was
claimed in a valid claim of earlier priority date contained in the complete specification of
another patent granted in India that the patent was granted on the application of a person
not entitled to apply therefore; that the patent was obtained wrongfully in contravention
of the rights of the petitioner or any person under or thought whom he claims that the
subject of any claim of the complete specification is
(i) not an invention within the meaning of this Act;
(ii) is not new;
(iii) is obvious or does not involve any inventive step;
(iv) is not useful;
(v) does not sufficiently and fairly describe the invention and the method by
which it is to be performed;
(vi) is not patentable under this Act;
(vii) was anticipated having regard to the knowledge available within any local or
indigenous community in India or elsewhere;
For want of sufficient disclosure where any claim of complete specification is not fairly
based on the matter disclosed in the specification. That the patent was obtained on a false
suggestion or representation that the applicant contravened any direction for secrecy
passed under section 35 or made or caused to be made an application for the grant of a
patent outside India in contravention of section 39; That leave to amend complete
specification was obtained by fraud that the complete specification does not disclose or
wrongly mentions the source or geographical origin of biological material used for the
invention; At any time after grant of a patent, the Central Government may direct the
Controller to revoke a patent for an invention relating to atomic energy. However the
Controller may allow the patentee to amend the complete specification in such manner as
he considers necessary instead of revoking the patent.
A patent can also be revoked in public interest. The Central Government can revoke a
patent if it is of opinion that a patent or the mode in which it is exercised is mischievous
to the State or generally prejudicial to the public.
Register of patents:
A register of patents is kept at the patent office in which are entered -
The names and addresses of the grantees of patents, notification of assignments, and of
transmissions of patents, of licenses under patents, and Particulars of such matters
affecting the validity or proprietorship of patents as may be prescribed.
The register shall be kept under the control and management of the Controller, subject to
the superintendence and direction of the Central Government. The register of patents or
any part thereof can be kept in computer floppies, diskettes or any other electronic from
subject to prescribed safeguards. The Appellate Board may, on the application of any
aggrieved person, make such order for the making, variation or deletion, of any entry
therein as it may think fit. The register shall be prima falsie evidence of any matters
entered therein. A petition for revocation of a patent can be filed anytime during the
period the patent is in force. But it would be advisable to initiate the proceedings as early
as possible term.
When the legal rights in a valid patent is used commercially without the authorization of
the Patentee it amounts to the infringement of the legal rights of the patentee. It should be
born in mind that patent is a property (intellectual property) and the patent has all the
legal rights on the invention covered by the patent. Therefore if any person violates such
rights the patentee has all the rights to institute infringement proceedings to stop the
unauthorized commercial use as well as to clam appropriate damages for the
unauthorized use already affected.
The suits for a declaration as to non-infringement or for any relief in cases of groundless
threats in infringement or for infringement of a patent have to be filed in a count not
inferior to a district court which has jurisdiction to try the suit. This is subject to the
condition that where the defendant makes a counter claim for revocation of the patent,
then, along with the counter claim, the suit will be transferred to the High Court for
decision.
In a suit for infringement of a patent, where the subject matter of the patent is a process
for obtaining a product, the court may direct the defendant to prove that the process used
by him to obtain the product, identical to the product of the patented process, is different
from the patented process if.
• The subject matter of the patent is a process for obtaining a new product or.
• There is substantial likelihood that the identical product is made by the process,
and the patentee or a person deriving title or interest in the patent from him.- has
been unable through reasonable efforts to determine the process actually used.
This is subject to the condition that the patentee or a person deriving title or interest in the
patent from him, first proves that the product is identical to the product directly obtained
by the patented process. In considering whether a party has discharged the burden
imposed upon him as explained above, the court shall not require him to disclose any
manufacturing or commercial secrets, if it appears to the court that it would be
unreasonable to do so.
The validity of a claim of the patent specification of a patent shall not be called in
question in a suit for a declaration of non-infringement. Accordingly, the making or
refusal of such declaration in the case of a patent shall not be deemed to imply that the
patent is valid or invalid.
A suit for declaration for non-infringement may be filed at any time after the publication
of the grant of a patent on the application in the Patent Office journal. The suit has to be
filed at any court, which is not inferior to a district court. The suit has to be filed at any
court, which is not inferior to a district count. If the suit involves counter clam for
revocation if the patent, the entire matter has to be transferred to the High Court.
In normal cases a suit for infringement can be filed after the publication of the grant of
the patent. The damages if the suit is successful can be claimed from the date of
publication under Section 11 A of the Act or the date of infringement whichever date is
earlier. But in the case of application filed before 1.1.2005 containing claims for the
products in the field of pharmaceutical or Agricultural chemical products (which are
termed as “Mail Box or WTO” applications, though the suit for infringement can be filed
after the publication of the grant of the patent, the damages, if the suit is successful, can
be claimed from the date of publication of the grant of a patent on the application or the
date of infringement whichever is earlier.)
of a patent and the person aggrieved thereby may bring a suit against him praying for the
following relief namely.
A declaration to the effect that the threats are unjustifiable. An injunction against the
continuance of the threats; and such damages, if any, as he has sustained thereby. If in
such a suit the defendant proves that the acts in respect of which the proceedings were
threatened constitute or if done would constitute an infringement of a patent or rights
arising from the publication of a complete specification in respect of a claim of the
specification not shown by the plaintiff to be invalid, the Court may grant to the plaintiff
all or any of the relieves prayed for.
Introduction:
TRIPs, the intellectual property component of the Uruguay round GATT Treaty, gave rise
to an acrimonious debate between the developed countries and less developed countries
(LDCs). On one side, business interests in the developed world claimed large losses from
the imitation and use of their innovations in LDCs. They also asserted that establishing
strong intellectual property rights would actually benefit the developing countries by
encouraging foreign investment, the transfer of technology and greater domestic research
and development (R&D). On the other side, LDC governments adamantly opposed this
view, worrying about the higher prices that stronger intellectual property rights would
entail and about the harm that their introduction might cause to infant high tech
industries.
No country was more actively involved in opposing this component of the GATT
agreement than India and no part of TRIPs was, and continues to be, more sensitive than
the proposal to require product patents for pharmaceutical innovations. The national
sentiment on this issue is well captured in an often quoted statement made by Indira
Gandhi at the World Health Assembly in 1982: "The idea of a better-ordered world is one
in which medical discoveries will be free of patents and there will be no profiteering from
life and death."
What is striking about the original TRIPs debate and the continuing discussions about
pharmaceutical product patents is the divergence between the strength of the claims made
by both side and the weakness of the empirical foundations for those claims. Now that the
treaty has been signed and most of the developing world is committed to introducing
pharmaceutical product patents by the year 2004, not only do we not know how much this
may affect their welfare, we do not even know the direction of the effect. This ignorance
has political implications. India, for example, agreed to this aspect of the treaty much
against her will, believing it to be harmful to her interests. As a result, the implementing
legislation is currently on the shelf, unable to get through parliament. If it could be
shown, empirically, that product patents, in fact, conveyed some benefits to the country, it
would increase the local political will both to pass legislation and to enforce patentee
rights with greater enthusiasm. If, on the other hand, it could be shown that the net effect
of this part of World Trade Organization (WTO) membership will be, in fact, very costly
to the developing countries, it would put them in a stronger position from which to argue
that they should receive concessions on other fronts in future international negotiations.
Apart from the immediate interest in the effects of this particular policy change, the sheer
size of the change, together with the fact that it was, essentially, imposed from without,
makes it a rare opportunity to examine the economic effects of granting patent rights. In
the aftermath of the signing of the GATT treaty, we are in a situation where a large part of
the world is moving from no protection to full-fledged twenty year protection of
intellectual property rights in the one area where, it is thought, patents really matter:
pharmaceuticals. Further, unlike the historical introduction of pharmaceutical product
patents in much of the developed world the group of countries, which will be newly
granting rights in product innovations have distinctly different demands for drugs than
those, which currently grant such rights. Thus, there is some hope for detecting incentive
effects in the pattern of R&D spending.
This paper focuses on India. After a brief history, it sets out in Section III the various
ways in which the introduction of product patents for pharmaceuticals may, in theory,
benefit or hurt the country. In the sections, which follow, it brings together information
from a variety of sources to assess what can be expected, now, about the importance of
each of these various potential effects. While firm conclusions must await further analysis
as the treaty requirements are implemented, the paper gives some indication of where one
might or might not expect to see change occurring. I obtained much of the information
presented in this study while on leave in India from September 1996, to March 1997.
Over the six months I was able to interview a wide range of people. Executives from
Indian firms and the subsidiaries of multinational corporations (MNCs) were very
generous with their time, and also allowed me to tour their R&D facilities. Industry group
representatives from the Organization of Pharmaceutical Producers of India and the
Indian Drug Manufacturers' Association, as well as members of the National Working
Group on Patent Laws, provided a great deal of documented information and as well as
insight on the current and historical situation. Attendance at a conference held by the
Forum of Parliamentarians on Intellectual Property, a meeting of the U.S.-Indian
Business Forum, and a gathering of Indian medical professionals, scientists, and
government representatives sponsored by Pfizer was invaluable for getting a sense of the
domestic and international political aspects of the policy change. Details of the
administrative, regulatory and enforcement issues were gained from interviews with the
Drug Controller General, the head of the Chemists' Association and a number of Indian
patent attorneys. The Delhi branch of the Indian Patent Office, the Export Promotion
Agency (CHEMEXCIL) and the Department of Science and Technology also provided
information.
Pharmaceutical product innovations, as well as those for food and agrochemicals, became
unpatentable, allowing innovations patented elsewhere to be freely copied and marketed
in India. The statutory term was shortened to 5 to 7 years on pharmaceutical process
patents and automatic licensing was put in place. As a result, the number of patents
granted per year fell by three-quarters over the following decade, from 3,923 in 1970-71
(of which 629 were to Indian applicants, 3,294 to foreign applicants) down to 1,019 in
1980-81 (349 Indian, 670 foreign) (OPPI, 1996a). Although all inventors were affected
by the weakened patent regime, it is clear that foreigners, in particular, no longer found
taking out a patent in India worthwhile. Other aspects of the policy package set up to
encourage the domestic production of pharmaceuticals included restrictions on the import
of finished formulations, high tariff rates, ratio requirements (where imports of bulk
drugs had to be matched by purchases from domestic sources at a fixed ratio) and equity
ceilings on foreign participation. Further, the strict price control regulation which was
introduced with the 1970 Drugs Price Control Order, while making the production of
pharmaceuticals less profitable for all firms selling in the Indian market, made it
relatively less interesting for foreign firms with market options elsewhere. Thus even the
price control regime probably contributed to the shift towards a greater share of
production being met by Indian firms. Supported by this regulatory environment, by
1991, Indian firms accounted for 70% of the bulk drugs and 80% of formulations
produced in the country (Hamied, 1993). Of the top ten firms by 1996 pharmaceutical
sales, six are now Indian firms rather than the subsidiaries of foreign multinationals.
Domestic firms now produce about 350 of the 500 bulk drugs consumed in the country
(Government of India, 1994a). Employment in the pharmaceutical sector was estimated
to have reached almost half a million by 1995 (OPPI, 1996b).
The World Trade Organization (WTO) and its predecessor, the General Agreement on
Tariffs and Trade (GATT) have been enormously successful over the last 50 years at
reducing tariff and other trade barriers among an ever-increasing number of countries.
The predecessor to the WTO began in 1947 with only 23 members; today it has 146
members, comprising approximately 97 percent of world trade. Although the WTO,
established in 1995, is relatively young for an international institution, it has its origins in
the Bretton Woods Conference at the end of World War II. At this conference, finance
ministers from the Allied nations gathered to discuss the failings of World War Is
Versailles Treaty and the creation of a new international monetary system that would
support postwar reconstruction, economic stability, and peace. The Bretton Woods
Conference produced two of the most important international economic institutions of the
postwar period: the International Monetary Fund (IMF) and the International Bank for
Reconstruction and Development (the World Bank). Recognizing that the beggar-thy-
neighbor tariff policies of the 1930s had contributed to the environment that led to war,
ministers discussed the need for a third postwar institution, the International Trade
Organization (ITO), but left the problem of designing it to their colleagues in government
ministries with responsibility for trade. By the late 1940s, representatives of the American
government had met several times with representatives of other major nations to design a
postwar international trading system that would parallel the international monetary
system. These meetings had two objectives:
1) To draft a charter for the ITO and 2) to negotiate the substance of an ITO agreement,
specifically, rules governing international trade and reductions in tariffs. Although a
charter was drafted, the ITO never came into being. By 1948, support for yet another
international organization had waned in the U.S. Congress. Without American
participation, the institution would have been greatly weakened and, in the event, the
effort to create an organization to manage problems relating to international trade was
abandoned. However, although the U.S. Congress would not support another
international institution, in 1945 it had given the U.S. president the authority to negotiate
a treaty governing international trade by extending the 1934 Reciprocal Trade
Agreements Act. This led to the establishment of the General Agreement on Tariffs and
Trade (GATT) in 1947—a treaty whereby 23 member countries agreed to a set of rules to
govern trade with one another and maintained reduced import tariffs for other members.4
The GATT treaty did not provide for a formal institution, but a small GATT Secretariat,
with a limited institutional apparatus, was eventually headquartered in Geneva to
administer various problems and complaints that might arise among members. Over the
next 40 years, GATT grew in membership and in its success at reducing barriers to trade.
GATT members regularly met in what came to be known as negotiating rounds. These
rounds were primarily focused on negotiating further reductions in the maximum tariffs
that countries could impose on imports from other GATT members. The success of these
rounds is evident. Tariffs on manufactured products fell from a trade-weighted average of
roughly 35 percent before the creation of GATT in 1947 to about 6.4 percent at the start
of the Uruguay Round in 1986.5 Over the same time period, the volume of trade among
GATT members surged: In 2000 the volume of trade among WTO members stood at 25
times its 1950 volume. This growth in the volume of trade is impressive and appears to
have accelerated in recent decades. Comparing the growth of world GDP, expressed as an
index number, to the growth of the volume of trade among GATT/ WTO members, also
expressed as an index number, while trade grew more slowly than world GDP in the early
years of the GATT/WTO, in recent years it has outpaced GDP growth. Despite this
success, by the 1980s several problems had surfaced with the GATT apparatus. Firstly,
the dispute resolution mechanism of GATT was not functioning as effectively as had been
hoped. Countries with longstanding disagreements were unable to reach any sort of
resolution on a number of issues, ranging from government subsidies for exports to
regulations regarding foreign direct investment. Secondly, a number of commodities,
most importantly, agricultural products and textiles, were widely exempt from GATT
disciplines. Thirdly, it was widely believed that certain forms of administered trade
protection—antidumping duties, voluntary export restraints, and countervailing duties—
were restricting trade and distorting trade patterns in many important sectors. Fourthly,
trade in services was expanding rapidly and GATT had no rules regarding trade in
services. Fifthly, countries that produced intellectual property —movies, computer
programs, patented pharmaceuticals—were becoming increasingly frustrated by the lack
of intellectual property protection in many developing nations. Lastly, the rules regarding
trade-related investment measures
—for example, domestic purchase requirements for plants built from foreign direct
investment—were hotly disputed. To address these problems, a new round of trade
negotiations—the Uruguay Round—was launched in 1986.
The goals of the Uruguay Round were far more ambitious than in previous rounds. It
sought to introduce major reforms into how the world trading system would function. The
treaty negotiated during the Uruguay Round,
the GATT treaty of 1994, established the WTO—the international institution to govern
trade that was first visualized by the attendees of the Bretton Woods Conference 50 years
earlier. The new GATT treaty provided for an entirely new and different dispute
resolution mechanism to eliminate the gridlock of the old system. Furthermore, the
Uruguay Round expanded GATT’s authority to new areas—agreements regarding trade in
textiles, agriculture, services, and intellectual property were major achievements. Finally,
new sets of rules regarding administered protection came into effect with the creation of
the WTO in 1995.
14. CONCLUSION
From the study of the above project it can be concluded that, The Intellectual Property
Rights & Patents plays an important role in protecting the rights of an inventor or a
company. The rights conferred give creators an exclusive right over the use of their
creations for a specified period of time. In pharmaceutical context these are required to
protect inventions such as new drug entity (NDE). The protection of data exclusivity is
also becoming a focus for more attention.
It also be concluded that in the process of preparing a new chemical entity (NCE) for
regulatory approval, a pharmaceutical company conducts a massive array of laboratory,
animal, and human trials. The data so obtained are the property of the company
developing them but the patent rights that protect the NCE do not protect the data. In the
normal course of events, the licensing process requires that much of these data be turned
over to the regulatory body that provides the final approval to market the drug.
The introduction of product patents will contribute to more R&D being done in India.
Although strong intellectual property rights are important to MNCs in deciding where to
locate R&D facilities, given the centralized nature of R&D and fact that costs are not the
paramount concern there does not seem to be any compelling reason for them to locate in
India even after product patents are available. Further, a number of MNCs are already
increasing their use of local subsidiaries to do development work. Although stronger
intellectual property rights may make the Indian environment more appealing to MNCs
as a location for R&D, it is unlikely that product patents will make a dramatic difference
to their choices.
15. REFERENCES