Unit 1

WHAT IS INTELLECTUAL PROPERTY?

The term property means a movable or an immovable material that a person possesses and then
comes the ownership issue, which determines the owner of a given property. The property from
times immemorial deals with land, house, shop, buildings, vehicles, money, shares, funds,
jewelleries, etc. and which has potential value. This ownership and property issues gives a sort
of social value to the owner and the concerned person may prove that he is rich or holds
property of significant worth. The social fabric which keeps us intertwined has given immense
importance to this kind of property issues and also to disputes arising out of legal domain. The
property relates to either a ‘brick and mortar economy’ which deals with land, buildings,
money, vehicles, etc. or to a knowledge economy. The knowledge based economy is at the
centre stage in the last few decades, when the developed nations and the developing ones have
started giving prime importance to the applicability arising out of them[1]. This has given rise
to the idea based economy directly emanating from the creation of human mind. Thus, a new
domain termed ‘Intellectual property’ was envisaged and which later became integral to the
world economy.
Intellectual property is the property that is the outcome of any human mind. It is the creation
having usefulness by the idea generated by human intellect. A child learns alphabets, numerals,
languages in his/her initial days and later during school/college goes a step higher to learn the
basics of education. After the basic education, he/she learns the art of expression or rather
application of knowledge. This all signifies the importance of human brain or intellect and the
creation thus arising from his brain is known as ‘Intellectual property. The information is being
added day by day and so the knowledge is expanding further. The ‘Intellectual property’ thus
becomes the dynamic area due to the emergence of new knowledge, technologies and human
ingenuity[2]. Invention is to bring something new to the society by the use of science and
technology. When profitability meets invention, it is known as innovation. In 1911, Joseph
Schumpeter propounded a theory which emphasized innovation and entrepreneurship.
According to this theory, invention bears no relevance until economic benefit is involved.
Schumpeter realized that economy of any country is by the process of ‘creative destruction’ i.e.,
new innovation replace earlier inferior technologies for yielding better products and
technologies[3,4]. Thus, knowledge economy is the buzzword today and depends more on the
advances in science and technology, in the present scenario. The advances in science and
technology subsequently depend upon the respect for intellectual property rights (IPRs). Thus,
the technological progress of any country is reflected by the rise in its economy.
INTELLECTUAL PROPERTY IN THE KNOWLEDGE ERA: The present age is the time
of knowledge based economy where a country’s economic growth is governed by the
knowledge accumulation and the human capital enriched with scientific training. According to
Paul. M. Romer, the economic growth is dependent on (i) investment in research and
development (ii) investment in human resource development (HRD)[5]. Both the types of
investment must have profit at their centre stage, which ultimately ignites the human intellect to
evolve further and thus the new technology is born. This new technology lives until another
superior technology developed by the research and development team of the country is born.
But, this technological change or the technological course of action is possible only by the
conducive environment, policy and decision making component of that particular country. This
technological progress attracts the foreign direct investment (FDI) and there is influx of
investment in addition to technology and skilled people[6].
INTELLECTUAL PROPERTY RIGHTS
The ‘brick and mortar economy’ has some rights associated to it and is useful for the person
who has such property. The right conferred to the property, arising out of human intellect is
known as ‘Intellectual property rights or IPR[9]. The importance of intellectual property in
India is well ascertained by the fact that India ratified the Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS) administered by World Trade Organization (WTO)[10].
This was negotiated in the Uruguay round of the General Agreement on Tariffs and trade
(GATT). WTO sets minimum standard for many different kinds of intellectual property rights
to promote protection of intellectual property rights without any impediments to trade, across
the globe.
The intellectual property has the following classification (Fig. 2)
1. Copyright
2. Industrial property
The copyright is used to protect the intellectual output of an author in the field of literature, etc.
With the copyright are some related rights also which protect the performances of people in the
area of art and literature. Industrial property is a collective term given to the rights associated
with patent, trademarks, industrial designs and geographical indications. According to the trade-
related intellectual property rights (TRIPS) agreement of the world trade organization (WTO),
there are seven categories of intellectual property which are as follows:
(a) Copyrights and related rights
(b) Trademarks, trade names and service marks
(c) Industrial designs
(d) Patents
(e) Layout designs of integrated circuits
(f) Geographical indications
(g) Undisclosed information.

PATENTS The knowledge economy gets boosted by the new inventions and innovations. Any
new invention which was time and money intensive, needs to be rewarded by financial security.
The widely opted method is by patents. A patent is a techno-legal document which clearly
describes an invention and is issued by the office of the Controller General of Patents, Designs
& Trade Marks[12]. It sets out legal framework by which the invention can be exploited after
being permitted by the owner. Patent rights are territorial in nature and generally, the exclusive
rights are applicable only in the country where a patent has been granted, in accordance to the
law of that country. The term of patent is for twenty years. There are many advantages and
disadvantages of patent. These are as following:
8.1. Innovation
Patents directly promotes innovation Funds flow for R & D Corporates and companies get
monetary benefits by the exploitation of successful patents; Become fancy of new markets.
8.2. Economy
Companies that use intellectual property rights out market other competitors; Patents increase
market value; IPR helps small and medium-sized enterprises (SMEs) to grow better, Generates
tax revenues; Promotes foreign direct investment (FDI); Technology transfer is facilitated and
Ultimately generates newer employment avenues.
8.3. Society and IPR
New and innovative products keep on flooding the market regularly. IPR provides solution to
many problems of society. Consumers are always served with fancy and economical products
due to IP of R&D. Consumers are alert and get protected from cheap, inferior and dangerous
counterfeits due to enforcement of IP rights.
8.4. The Cons of Patent
The disadvantage of patent is the cost associated with it and the legal responsibility to possess
it.
8.5. Cost
To hold any patents is not cheap and costs more. Even to keep a patent alive requires annual
renewal and maintenance fees. Failure to pay these fees results in the expiry of the granted
patent.
8.6. Liability
Any person having the patent is susceptible to the lawsuits by the competitor or by the person
who thinks the said patent is a violation of his/her own patent. Hence, the drawback of any
patent is the lawsuits that are associated with it. In case of infringement the owner has to get
bothered. The owner is responsible for the enforcement of patent rights and must bear the cost
associated with it. Even after careful application the patent may not be granted and even after
getting the patent, money will not come automatically. The owner has to either set up
manufacturing unit or license it to others and earn royalty. So, there is a responsibility right
from the R & D to the patent successfully granted over the shoulders of the owner. Our country
follows the Indian Patent Act, 1970 which was amended from time to time to become TRIPS
compliant[13]. The most recent amendment was made in 2014 by the patents (Amendment)
Rules 2014[14]. During this tenure, India also became member of the Paris Convention, Patent
Cooperation Treaty and Budapest Treaty.
8.7. Conditions of Patentability
Any researcher’s outcome in a form of invention must be based on several criteria, to qualify
for patent protection. These are industrial application (usefulness), novelty, and inventive step.
8.8. Industrial Applicability
It is defined as utility and the invention must have practical implications. The invention must
be possible to be performed by the person on an industrial level. It must be useful.
8.9. Novelty
A fundamental and very important prerequisite is being new. To prove what is new is difficult
but to prove its absence is easy and that is a condition of patentability. “Prior art” means the
knowledge either written or oral that exists prior to filing of the patent document[12]. Any
invention is new if it does not form part of prior art. The novelty is killed by the following
means. (a) Published articles, e-content, etc. (b) Oral disclosures including lectures, radio
broadcast, etc. (c) Disclosure by use, means the public is aware about it.
8.10. Inventive Step
This is known as non-obviousness and implies that whether the invention is obvious to a person
having ordinary skill (not the best expert) in the art. The inventive step is destroyed if a person
can easily spell out the outcome by just reading the detailed protocol given in the patent
document. To qualify for patent protection the invention must fall within the scope of
patentable subject matter[15]. The TRIPS agreement has specified members to exclude those
inventions which are contrary to public order and morality. There are some fields of technology
which may be excluded from the scope of patentable subject matter and are: (a) Already
existing natural materials (b) Plant varieties (c) Animal varieties (d) Theories or mathematical
models (e) Scheme, rule, methods, etc. (f) Diagnostic methods or methods for treatment of
animals or humans, etc.
8.11. Rights of a Patent Holder There are several rights associated with the patent holder.
They are: (a) Right to exclude others from making, selling, using the invention. (b) Right to sell,
use, etc. (c) Right to assign or license (d) To protect against infringement.
CLASSIFICATION OF PATENTS
To make searching easier, every patent is classified using a defined scheme. A classification
scheme is a system of codes that groups inventions according to technical area, which means
similar inventions are grouped under the same classification.

 International Patent Classification (IPC)

The International Patent Classification (IPC), established by the Strasbourg Agreement

1971, provides for a hierarchical system of language independent symbols for the
classification of patents and utility models according to the different areas of technology
to which they pertain.

 US Patent Classification System (USPC)

The USPC is a system for organizing all U.S. patent documents and many other technical
documents based on common subject matter. The system contains 450 classes and
150,000 subclasses.

 Cooperative Patent Classification (CPC)

The Cooperative Patent Classification (CPC) effort is a joint partnership between the
United States Patent and Trademark Office (USPTO) and the European Patent Office
(EPO) where the Offices have agreed to harmonize their existing classification systems
(European Classification (ECLA) and United States Patent Classification (USPC)
respectively) and migrate towards a common classification scheme.

India Patent Types

In India, patents can, depending on their priority argument, be categorised into three groups, 
Ordinary patent application
Conventional patent application
PCT national phase patent application
Ordinary Patent Application
Ordinary patent requests with provisional or full specifications can be filed in India.
Furthermore, the fact that it does not claim a preference from any other application is distinctive
from other patents. The specification is a declaration of technical disclosure allowing the
normal qualified person to carry out an invention. Moreover, it starts with the name of the
invention and includes the invention area, state of the art, invention purpose, overview,
comprehensive invention description, sketches, and statements, along with a summary of the
invention. The abstract contains a short description. Further, the full specification must
preceded within 12 months by a provisional submission. 
Convention Patent Application
In India, the priority of a convention application shall be asserted and shall be filed with a
complete specification within 12 months from the priority date.
PCT National Phase Patent Application
PCT’s National Step Patent Request must lodge with India in accordance with the complete
English requirements after a PCT application that file at WIPO and within 31 months of the
priority date. In the course of 31 months from the date of earliest priority, or within 3 months
after a request made by the controller, the English translation of the priority documents should
be filed. Further, if WIPO does not issue PCT/IB/304, the certified copy must be filed with
priorities within 31 months of the earliest priority date. 

Patentability criteria
Sections 3 and 4 of the Indian Patents Act, 1970 specifically state the inventions that can not be
patenteted. The patentability of an invention is determined by its ability to meet the criteria.
According to Section 2(j) of the Indian Patent Act, 1970 an invention means “a new product or
process involving an inventive step and capable of industrial application“, such invention
protected under the patent law refers to patented.
The following criteria determine the patentability of invention in India:
1. Patentable subject matter:
The foremost consideration is to determine whether the invention relates to a patentable subject-
matter. Sections 3 and 4 of the Patents Act list out non-patentable subject matter. As long as the
invention does not fall under any provision of Sections 3 or 4, it means it has patentable subject
matter (subject to the satisfaction of the other criteria).
2. Novelty:
Novelty is an important criterion in determining the patentability of an invention. novelty or
new invention is defined under Section 2(l) of the Patents Act as “any invention or technology
which has not been anticipated by publication in any document or used in the country or
elsewhere in the world before the date of filing of patent application with complete
specification, i.e., the subject matter has not fallen in public domain or that it does not form part
of the state of the art”.
Simply put, the novelty requirement basically states that an invention should never have been
published in the public domain. It must be new with no same or similar prior arts.
3. Inventive step or Non-Obviousness:
Inventive step is defined under Section 2(ja) of the Patents Act as “a feature of an invention that
involves technical advance as compared to the existing knowledge or having economic
significance or both and that makes the invention not obvious to a person skilled in the art”.
This means that the invention must not be obvious to a person skilled in the same field as the
invention relates to. It must be inventive and not obvious to a person skilled in the same field.
4. Capable of Industrial Application:
Industrial applicability is defined under Section 2(ac) of the Patents Act as “the invention is
capable of being made or used in an industry”. This essentially means that the invention cannot
exist in the abstract. It must be capable of being applied in any industry, which means that the
invention must have practical utility in order to be patentable.

TRADEMARKS, TRADE NAMES AND SERVICE MARKS Simply a word or a combination

of words, letters, and numbers constitutes a trademark. Trademarks also consist of drawings,
symbols, threedimensional features (shape) and non-visible signs such as sounds and fragrances
which are used as distinguishing features. Trademarks are distinctive symbols that aid the
consumers to decide what to buy and abstain for. These are commercial source indicators that
spot certain goods or services produced by a specific enterprise. Trademarks are important
when customers and producers are far away from one another[11]. At the national level,
protection can be obtained by registration simply by filing an application for registration at the
trademark office and subsequently paying the fees. But two options are there at international
level: either to file a trademark application with the trademark office of each country or by
WIPO’s Madrid system. The registration of a trademark is at the trademark office and shall be
for a period of ten years. The term may be renewed from time to time for an unlimited period.

COPYRIGHTS AND RELATED RIGHTS Expression of any idea in its original form can be
protected by copyright. The protection extends only to expressions but not to ideas, procedures,
methods of operation or mathematical concepts. For a number of objects like logos, title and
slogans copyright may or may not be available depending on whether they have any sufficient
authorship. Copyright gives two types of rights to the holder which are as follows:
Economic rights: By this the owner derives financial reward from the use of his/her own works
by others.
Moral rights: By this the non-economic interests of the author gets protected. Copyright gives
economic rights to creators of original literary and artistic works, including the right to
reproduce the work, make copies, adaptation, and translation to display the work publicly. As
artists and creators have developed new forms of expression, these categories have expanded to
include them. According to the Berne convention 1886, copyright protection covers the life of
the author plus fifty years. According to the Berne convention, the protection by copyright is as
soon as they exist and no formal registration is needed[11]. WIPO administers following
copyrightrelated treaties:  Berne Convention for the protection of literary and artistic works. 
Brussels Convention relating to the distribution of program-carrying signals transmitted by
satellite.  Geneva convention for the protection of producers of phonograms against
unauthorized use.  Marrakesh treaty to facilitate access to published works for visually
impaired persons.  Rome Convention for the protection of performers, producers of
phonograms and broadcasting organizations.  WIPO Copyright Treaty (WCT).  WIPO
Performances and Phonograms Treaty (WPPT).  Beijing treaty on audiovisual performances.

Idea-expression dichotomy:The idea-expression dichotomy was formulated to ensure that the

manifestation of an idea (i.e. an expression) is protected rather than the idea itself. The doctrine
has been widely used in the United States and is not really alien to Indian jurisprudence. Courts
have repeatedly opined that ideas per se are not copyrightable; only the expression of an idea is
copyrightable. An idea is the formulation of thought on a particular subject whereas an
expression constitutes the implementation of the said idea. While many persons may
individually arrive at the same idea, they can claim copyright only in the form of an expression
to this idea. Such expression must be a specific, particular arrangement of words, designs or
other forms. Thus, such a doctrine allows for several expressions to be available for the same
idea.The earliest case regarding the idea-expression dichotomy is the U.S. Supreme Court
decision of Baker v. Selden, which concerned the copyright over an account book. Selden had
written a book which described an improved system of book keeping by a particular
arrangement of columns and headings which made the ledger book easier to read. Baker
accomplished a similar result, but using a different means of arrangement of columns and
headings. The court held that while a copyright may exist over the publishing and sale of a
book, it does not extend to the ideas and “art” illustrated in the book. The U.S. Supreme Court
created a clear description between an idea and its expression, the primary reason being that
otherwise, it would result in providing an undue scope of monopoly to the copyright holder and
would amount to anti-competitive practice.

Industrial designs: Industrial design is the ornamental aspect of an article and may be a two
dimensional or three dimensional features. Industrial designs help in making any product or
item more beautiful and appealing. This increases the commercial viability of the product and in
increasing its market potentiality[11]. To protect industrial design, limited protection is by
“unregistered industrial designs” and is also protected under patent law as design patents. They
also get protected under copyright law, as works of art, depending on the national law and the
kind of design. The term of a registered industrial design is 15 years.

GEOGRAPHICAL INDICATIONS When any material or product has any quality or reputation
that is only due to its place of origin, it is protected by Geographical Indications (GI). The
specificity is by the specific climate, soil, or method of production. These goods are different
and hold good reputation. For e.g., alphonso mangoes, darjeeling tea, banarasi sarees, etc. GI
are mostly used for agricultural products, food, wine and alcoholic beverages can be used by
producers and growers of the particular region. The registration of GI is for a period of ten years
and may be renewed for an unlimited period[12]. There are many ways to protect a
geographical indication viz.  Sui generis systems  By the use of collective or certification
marks  Administrative product approval schemes Both modes of protection, namely sui generis
systems and collective or certification mark systems have some common features, and they set
up rights for collective use by those persons who have common defined standards.

Traditional Knowledge
Traditional knowledge (TK) is knowledge, know-how, skills and practices that are developed,
sustained and passed on from generation to generation within a community, often forming part
of its cultural or spiritual identity.TK in the narrow sense refers to knowledge as such, in
particular the knowledge resulting from intellectual activity in a traditional context, and
includes know-how, practices, skills, and innovations.
Traditional knowledge can be found in a wide variety of contexts, including: agricultural,
scientific, technical, ecological and medicinal knowledge as well as biodiversity-related
knowledge..Innovations based on TK may benefit from patent, trademark, and geographical
indication protection, or be protected as a trade secret or confidential information. However,
traditional knowledge as such - knowledge that has ancient roots and is often oral - is not
protected by conventional intellectual property (IP) systems.
While the policy issues concerning TK are broad and diverse, the IP issues break down into two
key themes:
Defensive protection
Defensive protection refers to a set of strategies to ensure that third parties do not gain
illegitimate or unfounded IP rights over TK. These measures include the amendment of WIPO-
administered patent systems (the International Patent Classification system and the Patent
Cooperation Treaty Minimum Documentation). Some countries and communities are also
developing TK databases that may be used as evidence of prior art to defeat a claim to a patent
on such TK. WIPO has developed a toolkit to provide practical assistance to TK holders on
documenting TK.
Positive protection
Two aspects of positive protection of TK by IP rights are being explored:
Preventing unauthorized use, and
Active exploitation of TK by the originating community itself.
UNIT 2

What Is the General Agreement on Tariffs and Trade (GATT)?

The General Agreement on Tariffs and Trade (GATT), signed on October 30, 1947, by 23
countries, was a legal agreement minimizing barriers to international trade by eliminating or
reducing quotas, tariffs, and subsidies while preserving significant regulations. 1 The GATT
was intended to boost economic recovery after World War II through reconstructing and
liberalizing global trade.
The GATT went into effect on January 1, 1948. 2 Since that beginning it has been refined,
eventually leading to the creation of the World Trade Organization (WTO) on January 1, 1995,
which absorbed and extended it. 3 By this time 125 nations were signatories to its agreements,
which covered about 90% of global trade.4
The Council for Trade in Goods (Goods Council) is responsible for the GATT and consists of
representatives from all WTO member countries. As of September 2020, the chair of the
Goods Council is Swedish Ambassador Mikael Anzén. 5 The council has 10 committees that
address subjects including market access, agriculture, subsidies, and anti-dumping measures.6
KEY TAKEAWAYS
The General Agreement on Tariffs and Trade (GATT) was signed by 23 countries in October
1947, after World War II, and became law on Jan. 1, 1948.
The purpose of the General Agreement on Tariffs and Trade (GATT) was to make
international trade easier.
The General Agreement on Tariffs and Trade (GATT) held eight rounds in total from April
1947 to December 1993, each with significant achievements and outcomes. 7
In 1995, the General Agreement on Tariffs and Trade (GATT) was absorbed into the World
Trade Organization (WTO), which extended it.
One of the key achievements of the GATT was that of trade without discrimination. Every
signatory member of the GATT was to be treated as equal to any other. 8 This is known as
the most-favored-nation principle, and it has been carried through into the WTO. 9 A practical
outcome of this was that once a country had negotiated a tariff cut with some other countries
(usually its most important trading partners), this same cut would automatically apply to all
GATT signatories. Escape clauses did exist, whereby countries could negotiate exceptions if
their domestic producers would be particularly harmed by tariff cuts. 1 0
Most nations adopted the most-favored-nation principle in setting tariffs, which largely
replaced quotas. Tariffs (preferable to quotas but still a trade barrier) were in turn cut steadily
in rounds of successive negotiations.
History of the General Agreement on Tariffs and Trade (GATT)
The GATT held eight rounds of meetings between April 1947 and December 1993. Each of the
conferences had significant achievements and outcomes.
The first meeting was in Geneva, Switzerland, and included 23 countries. The focus in this
opening conference was on tariffs. The members established tax concessions touching over
US$10 billion of trade around the globe.7
The second series of meetings began in April 1949 and were held in Annecy, France. Again,
tariffs were the primary topic. Thirteen countries were at the second meeting, and they
accomplished an additional 5,000 tax concessions reducing tariffs. 7 1 1
Starting in September 1950 the third series of GATT meetings occurred in Torquay, England.
This time 38 countries were involved, and almost 9,000 tariff concessions passed, reducing tax
levels by as much as 25%.1 1

Japan became involved in the GATT for the first time in 1956 at the fourth meeting along with
25 other countries.1 2 The meeting was in Geneva, Switzerland, and again the committee
reduced worldwide tariffs, this time by US$2.5 billion. 7
This series of meetings and reduced tariffs would continue, adding new GATT provisions in
the process. The average tariff rate fell from around 22%, when the GATT was first signed in
Geneva in 1947, to around 5% by the end of the Uruguay Round, concluded in 1993, which
also negotiated the creation of the WTO.1 3
In 1964 the GATT began to work toward curbing predatory pricing policies. These policies are
known as dumping. As the years have passed, the countries have continued to attack global
issues, including addressing agriculture disputes and working to protect intellectual property.

The TRIPS Agreement

The TRIPS Agreement, which came into effect on 1 January 1995, is to date the most
comprehensive multilateral agreement on intellectual property.
The areas of intellectual property that it covers are: copyright and related rights (i.e. the rights
of performers, producers of sound recordings and broadcasting
organizations); trademarks including service marks; geographical indications including
appellations of origin; industrial designs; patents including the protection of new varieties of
plants; the layout-designs of integrated circuits; and undisclosed information including trade
secrets and test data.
The three main features of the Agreement are:
Standards. In respect of each of the main areas of intellectual property covered by the TRIPS
Agreement, the Agreement sets out the minimum standards of protection to be provided by each
Member. Each of the main elements of protection is defined, namely the subject-matter to be
protected, the rights to be conferred and permissible exceptions to those rights, and the
minimum duration of protection. The Agreement sets these standards by requiring, first, that the
substantive obligations of the main conventions of the WIPO, the Paris Convention for the
Protection of Industrial Property (Paris Convention) and the Berne Convention for the
Protection of Literary and Artistic Works (Berne Convention) in their most recent versions,
must be complied with. With the exception of the provisions of the Berne Convention on moral
rights, all the main substantive provisions of these conventions are incorporated by reference
and thus become obligations under the TRIPS Agreement between TRIPS Member countries.
The relevant provisions are to be found in Articles 2.1 and 9.1 of the TRIPS Agreement, which
relate, respectively, to the Paris Convention and to the Berne Convention. Secondly, the TRIPS
Agreement adds a substantial number of additional obligations on matters where the pre-
existing conventions are silent or were seen as being inadequate. The TRIPS Agreement is thus
sometimes referred to as a Berne and Paris-plus agreement.
Enforcement. The second main set of provisions deals with domestic procedures and remedies
for the enforcement of intellectual property rights. The Agreement lays down certain general
principles applicable to all IPR enforcement procedures. In addition, it contains provisions on
civil and administrative procedures and remedies, provisional measures, special requirements
related to border measures and criminal procedures, which specify, in a certain amount of
detail, the procedures and remedies that must be available so that right holders can effectively
enforce their rights.
Dispute settlement. The Agreement makes disputes between WTO Members about the respect
of the TRIPS obligations subject to the WTO's dispute settlement procedures.
In addition the Agreement provides for certain basic principles, such as national and most-
favoured-nation treatment, and some general rules to ensure that procedural difficulties in
acquiring or maintaining IPRs do not nullify the substantive benefits that should flow from the
Agreement. The obligations under the Agreement will apply equally to all Member countries,
but developing countries will have a longer period to phase them in. Special transition
arrangements operate in the situation where a developing country does not presently provide
product patent protection in the area of pharmaceuticals.
The TRIPS Agreement is a minimum standards agreement, which allows Members to provide
more extensive protection of intellectual property if they so wish. Members are left free to
determine the appropriate method of implementing the provisions of the Agreement within their
own legal system and practice.

World Trade Organization (WTO

The World Trade Organization (WTO) is an intergovernmental organization that regulates
and facilitates international trade between nations.[6] Governments use the organization to
establish, revise, and enforce the rules that govern international trade. [6] It officially commenced
operations on 1 January 1995, pursuant to the 1994 Marrakesh Agreement, thus replacing
the General Agreement on Tariffs and Trade (GATT) that had been established in 1948. The
WTO is the world's largest international economic organization, with 164 member states
representing over 98% of global trade and global GDP.[7][8][9]
The WTO facilitates trade in goods, services and intellectual property among participating
countries by providing a framework for negotiating trade agreements, which usually aim to
reduce or eliminate tariffs, quotas, and other restrictions; these agreements are signed by
representatives of member governments[10]: fol.9–10  and ratified by their legislatures.[11] The WTO
also administers independent dispute resolution for enforcing participants' adherence to trade
agreements and resolving trade-related disputes. [12] The organization prohibits discrimination
between trading partners, but provides exceptions for environmental protection, national
security, and other important goals.[12]
The WTO is headquartered in Geneva, Switzerland.[13] Its top decision-making body is the
Ministerial Conference, which is composed of all member states and usually convenes
biennially; consensus is emphasized in all decisions. [14] Day-to-day functions are handled by the
General Council, made up of representatives from all members. [15] A Secretariat of over 600
personnel, led by the Director-General and four deputies, provides administrative, professional,
and technical services.[16] The WTO's annual budget is roughly 220 million USD, which is
contributed by members based on their proportion of international trade.[17]
Studies show the WTO has boosted trade and reduced trade barriers. [18][19][12][20][6] It has also
influenced trade agreement generally; a 2017 analysis found that the vast majority
of preferential trade agreements (PTAs) up to that point explicitly reference the WTO, with
substantial portions of text copied from WTO agreements. [21] Goal 10 of the United
Nations Sustainable Development Goals also referenced WTO agreements as instruments of
reducing inequality.[22] However, critics contend that the benefits of WTO-facilitated free trade
are not shared equally, citing the outcomes of negotiations and data showing a continually
widening gap between rich and poor nations.

Post TRIPS Scenarios

Later consequences of changes in trips on any sector. Before and after situations.
E.g.- The British law provided highest degree of protection to the pharmaceutical industry;
however this also led to very high prices of medicines in India. To provide cheap medicine and
to promote Indian pharmaceutical Industry, Indian Patent Act (1970) was implemented in India
it allowed process patent for pharmaceutical Industry. The law was later amended to fulfill the
mandatory requirements of WTO and TRIPS. The changes in law caused paradigm shift in the
business of Indian pharmaceutical industry. The present paper is an attempt to find how the
change in law has impacted the Indian pharmaceutical industry. The present paper is based on
Secondary data taken from annual reports of pharmaceutical Industries Aurbindo, Cipla, Lupin,
Ranbaxy, Dabur. The technique of GAP analysis has been used to compare the financial
position of Indian pharmaceutical companies in PRE TRIPS period and POST TRIPS period.
SPSS package has also been used to analyze the data. The results of the study indicate that there
is overall improvement in financial position of Indian pharmaceutical companies in POST
TRIPS period. The improvement is due to more spending in R&D activities and strengthening
of their core competencies. The study provides an insight to the position of Indian
pharmaceutical industry in the present legal scenario.
Madrid Agreement for the Repression of False or Deceptive Indications of Source on Goods
(1891)
According to this Agreement, all goods bearing a false or deceptive indication of source, by
which one of the Contracting States, or a place situated therein, is directly or indirectly
indicated as being the country or place of origin, must be seized on importation, or such
importation must be prohibited, or other actions and sanctions must be applied in connection
with such importation.
The Agreement provides for the cases and the manner in which seizure may be requested and
effected. It prohibits the use, in connection with the sale, display or offering for sale of any
goods, of all indications in the nature of publicity capable of deceiving the public as to the
source of the goods. It is reserved to the courts of each Contracting State to decide which
appellations (other than regional appellations concerning the source of products of the vine) do
not, on account of their generic character, come within the scope of the Agreement. The
Agreement does not provide for the establishment of a Union, governing body or budget.
The Agreement, concluded in 1891, was revised at Washington in 1911, at The Hague in 1925,
at London in 1934, at Lisbon in 1958 and at Stockholm in 1967.
The Agreement is open to States party to the Paris Convention for the Protection of Industrial
Property (1883). Instruments of ratification or accession must be deposited with the Director
General of WIPO.
The Hague Agreement Concerning the International Registration of Industrial Designs
(1925)
Two Acts of the Hague Agreement are currently in operation – the 1999 Act and the 1960 Act.
In September 2009, it was decided to freeze the application of the 1934 Act of the Hague
Agreement, thus simplifying and streamlining overall administration of the international design
registration system.
An international design registration may be obtained only by a natural person or legal entity
having a connection – through establishment, domicile, nationality or, under the 1999 Act,
habitual residence – with a Contracting Party to either of the two Acts.
The Hague Agreement allows applicants to register an industrial design by filing a single
application with the International Bureau of WIPO, enabling design owners to protect their
designs with minimum formalities in multiple countries or regions. The Hague Agreement also
simplifies the management of an industrial design registration, since it is possible to record
subsequent changes and to renew the international registration through a single procedural step.
An international application may be governed by the 1999 Act, the 1960 Act or both, depending
on the Contracting Party with which the applicant has the connection described above (hereafter
referred to as "Contracting Party of origin").
International design applications may be filed with the International Bureau of WIPO, either
directly or through the industrial property office of the Contracting Party of origin if the law of
that Contracting Party so permits or requires. In practice, however, virtually all international
applications are filed directly with the International Bureau, and the majority are filed using the
electronic filing interface on WIPO's website.
International applications may include up to 100 designs, provided they all belong to the same
class of the International Classification for Industrial Designs (Locarno Classification).
Applicants may choose to file an application in English, French or Spanish. International
applications must contain one or several reproductions of the industrial design(s) and must
designate at least one Contracting Party.
International registrations are published in the International Designs Bulletin, issued weekly
online. Depending on the Contracting Parties designated, applicants may request that the
publication be deferred by a period not exceeding 30 months from the date of the international
registration or, if priority is claimed, from the priority date.
Each Contracting Party designated by the applicant may refuse protection within 6 months, or
possibly 12 months under the 1999 Act, from the date of publication of the international
registration. Refusal of protection can only be based on requirements of the domestic law other
than the formalities and administrative acts to be accomplished under the domestic law by the
office of the Contracting Party that refuses protection.
If no refusal is notified by a given designated Contracting Party within the prescribed time limit
(or if such refusal has subsequently been withdrawn), the international registration has effect as
a grant of protection in that Contracting Party, under the law of that Contracting Party.
The term of protection is five years, renewable for at least one five-year period under the 1960
Act, or two such periods under the 1999 Act. If the legislation of a Contracting Party provides
for a longer term of protection, protection of the same duration shall, on the basis of the
international registration and its renewals, be granted in that Contracting Party to designs that
have been the subject of an international registration. To facilitate access to the Hague system
for design creators from least developed countries (LDCs), the fees for an international
application are, in their case, reduced to 10 per cent of the prescribed amounts.
The 1934 Act
The application of the 1934 Act was frozen as of January 1, 2010, meaning that no new
registration or designation under the 1934 Act could be entered in the International Register as
of that date. However, the renewal of existing designations under the 1934 Act and the
recording in the International Register of any change affecting such designations will continue
to be possible up to the maximum duration of protection under the 1934 Act (15 years).
General
The WIPO Secretariat publishes a Guide to the International Registration of Industrial
Designs for users of the Hague system.
The Hague Agreement, concluded in 1925, was revised at London in 1934 and at The Hague in
1960. It was completed by an Additional Act signed at Monaco in 1961 and by a
Complementary Act signed at Stockholm in 1967, which was amended in 1979. As noted
above, a further Act was adopted at Geneva in 1999.
The Hague Agreement created a Union, which, since 1970, has had an Assembly. Every
member of the Union that has adhered to the Complementary Act of Stockholm is a member of
the Assembly. Among the most important tasks of the Assembly are the adoption of the biennial
program and budget of the Union and the adoption and modification of the implementing
regulations, including the fixing of the fees connected with the use of the Hague system.
The 1999 Act of the Agreement is open to any WIPO Member State and to certain
intergovernmental organizations. Instruments of ratification or accession must be deposited
with the Director General of WIPO. While the 1960 Act remains open to States party to the
Paris Convention for the Protection of Industrial Property (1883), it is the more advantageous
1999 Act that governments of prospective Contracting Parties are encouraged to join.
the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the
Purposes of Patent Procedure (1977)
The main feature of the Treaty is that a contracting State which allows or requires the deposit of
microorganisms for the purposes of patent procedure must recognize, for such purposes, the
deposit of a microorganism with any “international depositary authority”, irrespective of
whether such authority is on or outside the territory of the said State.
Disclosure of the invention is a requirement for the grant of patents. Normally, an invention is
disclosed by means of a written description. Where an invention involves a microorganism or
the use of a microorganism, disclosure is not possible in writing but can only be effected by the
deposit, with a specialized institution, of a sample of the microorganism. In practice, the term
“microorganism” is interpreted in a broad sense, covering biological material the deposit of
which is necessary for the purposes of disclosure, in particular regarding inventions relating to
the food and pharmaceutical fields.
It is in order to eliminate the need to deposit in each country in which protection is sought, that
the Treaty provides that the deposit of a microorganism with any "international depositary
authority" suffices for the purposes of patent procedure before the national patent offices of all
of the contracting States and before any regional patent office (if such a regional office declares
that it recognizes the effects of the Treaty). The European Patent Office (EPO), the Eurasian
Patent Organization (EAPO) and the African Regional Intellectual Property
Organization (ARIPO) have made such declarations.
What the Treaty calls an "international depositary authority" is a scientific institution - typically
a "culture collection" - which is capable of storing microorganisms. Such an institution acquires
the status of "international depositary authority" through the furnishing by the contracting State
in the territory of which it is located of assurances to the Director General of WIPO to the effect
that the said institution complies and will continue to comply with certain requirements of the
Treaty.
On July 28, 2020 there were 48 such authorities: seven in the United Kingdom, four in the
Republic of Korea, three in China, India, Italy and the United States of America, two each in
Australia, Japan, Poland, the Russian Federation and Spain, and one each in Belgium, Bulgaria,
Canada, Chile, the Czech Republic, Finland, France, Germany, Hungary, Latvia, Mexico,
Morocco, the Netherlands, Slovakia and Switzerland.
The Treaty makes the patent system of the contracting State more attractive because it is
primarily advantageous to the depositor if he is an applicant for patents in several contracting
States; the deposit of a microorganism under the procedures provided for in the Treaty will save
him money and increase his security. It will save him money because, instead of depositing the
microorganism in each and every contracting State in which he files a patent application
referring to that microorganism, he will deposit it only once, with one depositary authority. The
Treaty increases the security of the depositor because it establishes a uniform system of deposit,
recognition and furnishing of samples of microorganisms.
The Treaty does not provide for the institution of a budget but it does create a Union and an
Assembly whose members are the States which are party to the Treaty. The main task of the
Assembly is the amendment of the Regulations issued under the Treaty. No State can be
requested to pay contributions to the International Bureau of WIPO on account of its
membership in the Budapest Union or to establish an "international depositary authority".
The Budapest Treaty was concluded in 1977.
The Treaty is open to States party to the Paris Convention for the Protection of Industrial
Property (1883). Instruments of ratification or accession must be deposited with the Director
General of WIPO.

The Patents Act 1970

The Patents Act 1970, along with the Patents Rules 1972, came into force on 20 th April 1972,
replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the
recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala
Ayyangar. One of the recommendations was the allowance of only process patents with regard
to inventions relating to drugs, medicines, food and chemicals.
Later, India became signatory to many international arrangements with an objective of
strengthening its patent law and coming in league with the modern world. One of the significant
steps towards achieving this objective was becoming the member of the Trade Related
Intellectual Property Rights (TRIPS) system.
Significantly, India also became signatory of the Paris Convention and the Patent Cooperation
Treaty on 7th December 1998 and thereafter signed the Budapest Treaty on 17th December 2001.
Amendments
This Act remained in force for about 24 years without any change till December 1994. An
ordinance effecting certain changes in the Act was issued on 31 st December 1994, which
ceased to operate after six months. Subsequently, another ordinance was issued in 1999. This
ordinance was subsequently replaced by t he Patents (Amendment) Act, 1999 that was brought
into force retrospectively from 1 st January, 1995. The amended Act provided for filing of
applications for product patents in the areas of drugs, pharmaceuticals and agro chemicals
though such patents were not allowed. However, such applications were to be examined only
after 31-12-2004. Meanwhile, the applicants could be allowed Exclusive Marketing Rights
(EMR) to sell or distribute these products in India, subject to fulfilment of certain conditions.
The second amendment to the 1970 Act was made through the Patents (Amendment) Act, 2002
(Act 38 0f 2002). This Act came into force on 20 th May 2003 with the introduction of the new
Patent Rules, 2003 by replacing the earlier Patents Rules, 1972
The third amendment to the Patents Act 1970 was introduced through the Patents (Amendment)
Ordinance, 2004 w.e.f. 1 st January, 2005. This Ordinance was later replaced by the Patents
(Amendment) Act 2005 (Act 15 Of 2005 ) on 4 th April, 2005 which was brought into force
from 1-1-2005.

International framework for the protection of ip (utility)

The Paris Convention
The WTO TRIPS Agreement
Free Trade-, Economic Partnership-, and International Investment Agreements

Creativity and innovation have been a constant in growth and development of any knowledge
economy. There is an abundance of creative and innovative energies flowing in India. The
evolution of the film and music industry; the contribution of the Indian pharmaceutical sector in
enabling access to affordable medicines globally and its transformation to being the pharmacy
of the world; a strong and dynamic software industry; a considerably diverse handicraft and
textile industry; richness and versatility of the Indian systems of medicines such as Ayurveda,
Unani, Siddha and Yoga; the advances made in the Indian space programme and the pioneering
role of our scientists in keeping it cost effective; these are but a few examples of these energies.
While India has always been an innovative society, much of the intellectual property (IP)
created remains unprotected both on account of lack of awareness and the perception that IP
protection is either not required or that the process to obtain it is unnecessarily complicated. The
rationale for the National IPR Policy lies in the need to create awareness about the importance
of intellectual property rights (IPRs) as a marketable financial asset and economic tool. India
has robust IP laws and a strong IP jurisprudence. The legal framework does reflect the
underlying policy orientation and national priorities, which have evolved over time, taking into
account development needs and international commitments. An all-encompassing IPR Policy
will promote a holistic and conducive ecosystem to catalyse the full potential of intellectual
property for India’s economic growth and socio-cultural development, while protecting public
interest. Such a policy will nurture the IP culture, guiding and enabling all creators and
inventors to realize their potential for generating, protecting and utilizing IPRs which would
contribute to wealth creation, employment opportunities and business development. This policy
shall weave in the strengths of the Government, research and development organizations,
educational institutions, corporate entities including MSMEs, start-ups and other stakeholders in
the creation of an innovationconducive environment. It will complement the strengths of our
substantive laws with transparent, predictable and efficient administrative and procedural
mechanisms as also well-informed adjudicatory structure.
OVERVIEW The concrete measures taken by the Government in the last two decades in
consonance with national development priorities and in conformity with international treaties,
conventions and agreements to which India is a party has created and established a TRIPS
compliant, robust, equitable and dynamic IPR regime. The continuous and unending
improvements alongwith the sweeping and far-sighted changes at the legislative and
administrative levels has resulted in strengthening the administration, management and
enforcement of IPRs. The statutes governing different kinds of IPRs in India are Patents Act,
1970; Trade Marks Act, 1999; Designs Act, 2000; Geographical Indications of Goods
(Registration and Protection) Act, 1999; Copyright Act, 1957; Protection of Plant Varieties and
Farmers’ Rights Act, 2001; Semiconductor Integrated Circuits Layout-Design Act, 2000 and
Biological Diversity Act, 2002. The Department for Promotion of Industry and Internal Trade
(DPIIT) is entrusted with matters concerning the specialised UN agency on IPRs, the World
Intellectual Property Organisation (WIPO), including coordination with other concerned
Ministries or Departments. The Controller General of Patents, Designs and Trade Marks
(CGPDTM) under the Department for Promotion of Industry and Internal Trade, Ministry of
Commerce and Industry is entrusted with the responsibility of administering the laws relating to
Patents, Designs, Trade Marks and Geographical Indications within the territory of India. The
CGPDTM presently functions through Patent Offices at four locations (Chennai, Delhi,
Kolkata, and Mumbai), Trademarks Offices at five locations (Ahmedabad, Chennai, Delhi,
Kolkata and Mumbai), a Geographical Indications Registry at Chennai and a Designs Wing at
Kolkata. The Office of CGPDTM is also in charge of the Rajiv Gandhi National Institute of
Intellectual Property Management at Nagpur. Copyrights were administered by the Ministry of
Human Resource Development. The Copyright Act is comprehensive and with the recent
amendments, the rights of creators have been strengthened. The Protection of Plant Varieties
and Farmers’ Rights Act, 2001 is a sui generis legislation in India providing protection for plant
varieties and rights of farmers and is under the aegis of the Ministry of Agriculture. The
Department of Information Technology was responsible for Semiconductor Integrated Circuits
Layout-designs; the first registration under the Semiconductor Integrated Circuits Layout-
Design Act was granted in October 2014. The preservation of biological diversity in India is
under the Ministry of Environment and Forests; the Biological Diversity Act 2002 provides
mechanism for regulating access and ensuring fair and equitable sharing of benefits arising out
of the use of biological resources and associated traditional knowledge. India has always been
conscious of its obligations in the international arena, and has acceded to a number of
international conventions to further the cause of IPRs globally. India was the first country to
ratify the Marrakesh Treaty 2013 for Access to Published Works by visually impaired persons.
The accession to the Madrid Protocol in 2013 is a step towards global alignment for proprietors
of marks. The Indian Patent Office has been recognized as an International Search Authority
and an International Preliminary Examination Authority. The IPR regime in India has adequate
safeguards in the form of judicial review and appellate provisions. Indian courts have
consistently enforced IPRs, with judgements clearly expressing the intent and purpose of our
laws. The Intellectual Property Appellate Board hears appeals arising from the decisions of
Controllers of Patents as also Registrars of Trade Marks and GIs. In a slew of initiatives, the IP
offices under the CGPDTM have been modernized and there is a perceptible change for the
better. Conscious efforts have been made to develop a robust e-service delivery system,
including real-time public dissemination of dynamic IP knowledge through e-enabled
innovative tools.

The World Intellectual Property Organization 

(WIPO; French: Organisation mondiale de la propriété intellectuelle (OMPI)) it is one of
the 15 specialized agencies of the United Nations (UN).[1][2][notes 1] Pursuant to the
1967 Convention Establishing the World Intellectual Property Organization, WIPO was created
to promote and protect intellectual property (IP) across the world by cooperating with countries
as well as international organizations.[5] It began operations on 26 April 1970 when the
convention entered into force. The current Director General is Singaporean Daren Tang, former
head of the Intellectual Property Office of Singapore, who began his term on 1 October 2020.[6]
WIPO's activities include hosting forums to discuss and shape international IP rules and
policies, providing global services that register and protect IP in different countries, resolving
transboundary IP disputes, helping connect IP systems through uniform standards and
infrastructure, and serving as a general reference database on all IP matters; this includes
providing reports and statistics on the state of IP protection or innovation both globally and in
specific countries.[7] WIPO also works with governments, nongovernmental organizations
(NGOs), and individuals to utilize IP for socioeconomic development.
WIPO administers 26 international treaties that concern a wide variety of intellectual property
issues, ranging from the protection of audiovisual works to establishing international patent
classification.[8] It is governed by the General Assembly and the Coordination Committee,
which together set policy and serve as the main decision making bodies. The General Assembly
also elects WIPO's chief administrator, the Director General, currently Daren Tang of
Singapore, who took office on 1 October 2020.[9] WIPO is administered by a Secretariat that
helps carry out its day-to-day activities.
Headquartered in Geneva, Switzerland, WIPO has "external offices" around the world,
including in Algiers (Algeria); Rio de Janeiro (Brazil); Beijing (China), Tokyo (Japan); Abuja
(Nigeria); Moscow (Russia); and Singapore (Singapore).[10] Unlike most UN organizations,
WIPO does not rely heavily on assessed or voluntary contributions from member states; 95
percent of its budget comes from fees related to its global services.[11]
WIPO currently has 193 member states,[12] including 190 UN member states and the Cook
Islands, Holy See and Niue; Palestine has permanent observer status.[13] The only non-members,
among the countries recognised by the UN are the Federated States of
Micronesia, Palau and South Sudan.
 UNIT 3
Discovery and Invention
It is essential to know the differences between the two. The invention can simply be defined as
the creation of something new through one’s knowledge, hard work, and skills. Unlike
discovery, the invention is the fabrication of something new entirely that can have its own uses
and functions in the modern world. Understanding the history of transportation will give you a
key insight into the stages of invention.

Difference between Discovery and Invention

Discovery
The act of finding or exploring something new that
has not been found before is termed as Discovery.
Discoveries are usually natural occurrences and are
usually present until discovered by somebody.
Discovery involves the process of exploration of
the world around us.
Discovery cannot be patented.
Discoveries usually occur by accident.
Invention
The act of creation or designing of an object or a
service that has not been found before is termed
as an invention.
Inventions are man-made or scientific
occurrences of objects that exist due to the
willpower and creation of human beings.
The invention involves the process of
experimentation.
An invention can be patented by its creator.
Inventions usually occur in the process of
creation.

Definition of Prior Art for Patent Inventions

Prior art is the term given to information (patents, periodical articles, newspaper articles,
brochures, actual goods) that has been publicly disclosed prior to the filing date of the patent. It
is this entire body of work that forms the backdrop of the analysis of novelty and non-
obviousness of an invention. Essentially prior art answers the question of what was already
invented prior to the invention that has been submitted or the invention that has been
discovered. Has the invention already been invented by someone else in the world? Is the
invention, while new to the inventor, actually something that was invented many years ago by
someone else? The answer to this question is found in the prior art. That is, if reliable and
acceptable documentation can be found that someone else in the world already invented the
invention, then the invention is not entitled to a patent. Consequently, prior art encompasses
everything that came before. Prior art is not limited to other United States patents, but includes
virtually any publicly available information including patents and published patent application
from any country in the world, academic papers and publications, trade and specialty journals
and magazines, on line resources, brochures, sales material, and actual physical specimens.
Such prior art can be in any language, and does not have borders. 

You can think of prior art as being the entire body of knowledge in a field prior to the invention.
A prior publication that is publicly available can be from anywhere in the world qualifies as
prior art. For example, a published magazine article in Belize, a patent issued in Guyana, a
review of a device sold in the Philippines, a device used in the United States. This is an
overwhelming amount of data, that, if one was to exhaustively search the entirety of the prior
art, would be cost prohibitive. Imagine having a search firm search worldwide patents
(including patents in countries where there is no on-line access), searching worldwide libraries
and universities could cost in excess of six figures. The searching of prior art is typically a
sliding scale, a search of worldwide on-line databases, has a wide scope and a relatively low
cost. Thus, having some searching can be cost effective, however, increases in searching, tends
to produce diminishing returns. As the search continues, the additional searching tends to have a
smaller scope and a greater cost. Thus, it is often suggested that a search of the USPTO, or a
search of worldwide on-line databases, along with Internet searches, will tend to strike a good
balance between cost and efficacy. So, then the question is when are searches around the world
undertaken. There are many circumstances where increased searching is warranted is where the
benefit outweighs the cost. Such situations include, for example, the invalidating of a patent
before the Patent Trial and Appeal Board, where the value of the market vastly exceeds the cost
of a search. Similarly, if there is an accusation of infringement, with a very large potential
liability, it is often of great value to overturn every stone so to speak to find any prior art that
may limit or invalidate a patent. Certain freedom to operate opinions over valuable markets
likewise may demand that such searching is undertaken.

INNOVATION AND R & D In our day to day life, we come across many things which tickles
our brain and later some new technology comes up which subsequently gets redesigned and
modulated to get a better result. This invention leads to innovation when the creative mind has
intellectually generated a solution to an existing problem. Eons ago, the human race has
produced a solution to the problem encountered from food, shelter to everything that was
essential for survival in uninhabited land, during the development of civilization[7]. Our
forefathers have not seen any rampant and sweeping changes in the technology development
during their tenure, but now in our life span, we have encountered many things and most of
them have even become obsolete. This visible and technology driven change in the scientific
discipline is due to the knowledge and professional skills acquired and updated across the
educational curriculum during the lifetime of an individual. The human resource potential of
any country depends upon the educational framework offered during school and University
level to the students. These students further by their creative and curious mind contribute to the
research and development (R & D), which culminates in any good invention. The success of
any invention instigates other researcher whose creativity and ingenuity gets the shape of
further new innovation. The new product that enters the market survives the market heat and
earns profit. This profit gives inspirational effect to the competitors and the technology ball
starts rolling. It gets speed over the time due to a cycle, as shown in Fig. 1. Thus profit motive
and financial incentive exerts a driving force for the rise in economy. The economic growth of
any country gets affected by the accumulation of technological knowledge rather than capital or
labor. The last decade has witnessed comprehensive economic changes across the globe. The
developing countries like India, has undergone a major paradigm shift in the science and
technology field by its R & D potential[8]

BIOTECHNOLOGY
Bull, Holt and Lilly (1982) defined biotechnology as the application of
scientific and engineering principles to the processing of materials by
biological agents to provide goods and services”. Here biological agents are
microbes, plants, animals or parts thereof and materials include both organic
and inorganic materials[20].
The Egyptians in early days used yeast in bread and wine making, so
‘biotechnology’ is not a new field and still today, we use microbes to produce
many industrially beneficial products. In the 18th and 19th centuries i.e., age
of engineering, the society was benefitted by the industrial revolution such
as steam engine. Later in the 20th century, benefits of chemistry was seen whose products and
medicines made our lives more safe and comfortable.
Currently, the biotechnology revolution is around the corner and one of
the key areas in the intellectual property rights. Biotechnological inventions
can be classified in many categories which relate to biological materials or
parts thereof. ‘Bio’ is a Greek word meaning ‘life’ and ‘technology’ is the
branch of knowledge that deals with the use of technical means.
‘Biotechnology’ exploits the living organisms for the benefit of industry,
technology, medicine or agriculture. It involves the biological molecules
like DNA, RNA and proteins for the development of new and useful varieties.
The biotechnology based inventions are industrially important and involves
genetic engineering to produce transgenics, e.g., genetically engineered
pharmaceutically important human insulin and genetically modified plants
resistant to disease and pests, etc.
Biotechnology based inventions also need strong IPR protection due to
the time, money and knowledge being invested. The law of IP protection
applies to the biotechnology driven areas also but the inventions must be
within the ambit of ‘patentable subject matter[21].

PATENTING OF BIOTECHNOLOGICAL INVENTIONS Protection of biological inventions

is sometimes debatable as it involves live organisms to be used directly or it involves the usage
of their parts. French scientist Louis Pasteur got US patent for yeast as an article of industrial
utility. Still, protecting microorganisms by IP laws was considered to be in nascent stage. Prof.
A.M. Chakraborty, genetically engineered a Pseudomonas bacterium containing four plasmids
and capable to degrade oil spillage in water bodies[22]. Initially the invention was rejected on
the grounds of ‘non-patentable subject matter’, but the Supreme Court ruled in favor of Prof.
Chakraborty’s claims, thus opening new doors for other global patent office like EPO
(European Patent Office), JPO (Japanese Patent Office) etc. Indian patent office also allows
protection of new microbial strains. The problem faced while carrying out the patentable
inventions is the physical presence of the said ‘new microbial strain’. So, the inventor has to
deposit the strain in the culture collection centre, according to the Budapest Treaty and
IMTECH, Chandigarh, India is a recognized deposition centre in India. Plants and animals
except microbes are not patentable but the plants that have an additional value and any effect of
genetic engineering can be allowed for patenting under strict criteria[23]. The protection of
plant varieties is either by patents or by sui generis system or combination thereof. In India,
PPVFRA Act 2001 (Plant Variety Protection and Farmer’s Right) frames law for protection of
plant varieties. Philip Leder and Timothy Stewart developed ‘Harvard Mouse’ which was
granted patent for biotechnology and genetic engineering invention. Indian Patents Act has
excluded plant and animals from patentability[24]. The treatment method for human beings is
also not patentable in India. The modified body parts may be considered for patentability, if
they qualify the requirements[25]. A mere DNA sequence does not contain any technical
information and does not fall under the purview of patents[26]. However, DNA sequence or a
partial sequence technically produced may be a patentable invention[27]. The isolation of DNA,
RNA and proteins in pure form has tremendous commercial value for the fast growing
biotechnology based industries. The biological materials like DNA, RNA, Plasmids, and
Proteins are patentable if they are isolated and separated from the naturally occurring
substances already associated with it inside the cell. Expressed sequence tags (ESTs) are
portions of a gene which are used in multiple ways and the patentability of ESTs may be
challenged in ways like (i) they are obvious and doesn’t have any inventive step (ii) getting full
length gene sequence is not easy (iii) potential uses of ESTs is hypothetical without true
biological information[28]. The new area of bioinformatics deals with the data generated by the
genomics explosion, databases, software etc. and these need to be protected. Biotechnology is a
fast growing industry and involves live organisms both plant and animals, but there are many
inventions which fall in the category which are non-patentable viz.[29]: (i) Processes for
cloning human beings. (ii) Processes for modifying the germ-line genetic identity of human
beings. (iii) Uses of human embryos for commercial purposes. (iv) Processes for modifying the
genetic identity of animals which are likely to cause them. Suffering without any substantial
medical benefit to man or animal, and also animals resulting from such processes.
LEGAL ISSUES IN BIOTECHNOLOGY INVENTIONS There are obstacles being faced in
other areas of science and technology while patenting and applying IPRs. In the biotechnology
domain, there exists a higher degree of complexity and there are several legal issues[29]: (i)
Discovery is a mere finding of the subject matter and invention is a solution to a technical
problem. So, there is lot of argument as to whether the patentable subject matter is a mere
discovery or an invention. (ii) Whenever any life form is used for research and a new variety is
made or tailored according to need, then the issue of ethics crops up. The debate revolves
around the legalities involved in it. So, the issue must be in sync with public order and morality.
(iii) Inanimate vs. animate: The TRIPS agreement gave directions to protect the subject matter
by many instruments of IPR but they all were for inanimate objects. When biotechnology
became the focus of IP protection, the problem of life form and animate objects came into
picture[30]. Thus, it poses an obstacle when seeking protection. (iv) The office of the
trademarks and patent requires full disclosure of the invention so that the person exploiting that
invention must get the same results. But, this is not possible in the inventions related to
biotechnology. Hence, Budapest treaty was signed by the signatory members to deposit the
microbes and other life forms. The foregoing discussion sheds light on the need of IP protection
in biotechnology related inventions and the barriers encountered. A biotech related invention is
taken as any other invention and is protected according to the set rules in Article 27.1, 27.2,
27.3 of the TRIPS agreement.
Different Categories of Instruments to Protect a Biotechnology IP
There are different ways by which the biotechnology inventions may be
protected:
Patents: Any invention which qualifies the basic criteria of patentability
may be given patent protection. This invention enjoys the benefits of all
the rights given to a patent holder.
Copyright: The lab records, data book displaying the crude results and
protocols of any research experiments is given the copyright protection.
Trademark: If any name is given to mark the product, then the mark
can be legally protected by a trademark.
Trade secret: When any information has to be kept confidential and
needs protection, then it can be protected by a trade secret.
Geographical indications: This is a method of protection which finds
use in many life science industry sectors as this relates the subject matter
to the unique geographical locations.
In the context of biotechnology inventions, there are few cases where
the defense in patent law must be given protection. These are as mentioned
below: (i) Purely for academic purpose: Since the aim of patenting and protection
of IP is for technological development of a country[32], the researchers
and people working in the R & D institutions must not live in
apprehensions of any inadvertent infringement of protected inventions
while working. So, the defense in favor of experiment and R & D is
must.
(ii) Farmer’s rights: The multinational companies bring some of the best
and elite cultivars which give high yields by their efficient R & D
department. Since, they have invested great deal of time and money,
the invention must be protected by any IP instruments. This doesn’t
allow the farmers to breed the seeds obtained from the mother plant[33].
Moreover, the condition worsens if the seeds are not viable due to
some genetic engineering technology like ‘Terminator gene
technology’. From ages, the farmers cultivate, harvest and preserve
seeds for future use and this is in accordance to the International
Union for the Protection of New Varieties of Plants (UPOV) convention.
So, the farmers’ rights and interest must be protected, in the era of
biotechnology inventions.
(iii) Innocent bystanders case: In the age of genetically modified organisms
(GMOs), the patented life form reproduces unlike mechanical
inventions. Even after due care, the farmer growing his normal variety
of plants near to patented variety, gets the seed of patented variety
and unknowingly starts growing in the field. Here the farmer is termed
as’innocent bystander’. This may also be the case if any mutation
produces the phenotype which resembles that of patented variety[34].
In both the cases, the farmer must not be held guilty of infringement.

Voluntary Licensing
Issuing compulsory licensing always end with
political rhetoric and threat of trade retaliation and
investment red flags.24 The grant of first compulsory
license in India met with lot of resistance and litigation
in various forums and took seven years to get the final
verdict from the Supreme Court of India. Some
activists argue that multinational companies should
provide unconditional voluntary license (VL) to
countries those who cannot afford the cost of patented
medicines. The voluntary licenses can be granted to
international organizations like WHO for nominal
royalty payments which can be later paid by the
respective governments who use the drug in question.
The massive production can be given to generic
producers and imported into needful countries.
The advantages of granting such license can be
summarized as follows:
1 The negotiations can be done directly without
any litigation or time consuming process.
2 This could reduce the time for issuing CL and
consequent litigation.
3 This will enable transfer of technology and
economic development in developing countries.
4 It is not threatening the rights of the pharma
companies rather the companies get a good
name for helping the developing and least
developed countries. Voluntary Licensing
Issuing compulsory licensing always end with
political rhetoric and threat of trade retaliation and
investment red flags.24 The grant of first compulsory
license in India met with lot of resistance and litigation
in various forums and took seven years to get the final
verdict from the Supreme Court of India. Some
activists argue that multinational companies should
provide unconditional voluntary license (VL) to
countries those who cannot afford the cost of patented
 medicines. The voluntary licenses can be granted to
international organizations like WHO for nominal
royalty payments which can be later paid by the
respective governments who use the drug in question.
The massive production can be given to generic
producers and imported into needful countries.
The advantages of granting such license can be
summarized as follows:
1 The negotiations can be done directly without
any litigation or time consuming process.
2 This could reduce the time for issuing CL and
consequent litigation.
3 This will enable transfer of technology and
economic development in developing countries.
4 It is not threatening the rights of the pharma
companies rather the companies get a good
name for helping the developing and least
developed countries.

 Patent Infringement
A patent granted under the Indian Patents Act 1970, confers exclusive rights to the patentee to prevent
third parties from making, using, offering for sale, selling or importing the patented invention for the
purpose of using, selling and offering for sale in India without the consent of the patentee until the expiry
of the said patent1. This prevents third parties from commercially exploiting the patented invention till
the time the said patent is in force. Any use of the patented invention without the appropriate consent of
patentee shall be considered as an act of infringement. The act of infringement can lead the infringer to
trouble as the infringer can be sued by the patentee for infringement with demands for monetary
compensation.

It is evident that the research conducted for inventions is based on prior work carried out in the
particular field of art. In the conditions when the carried out prior work is patented, the researcher
cannot wait until the patent is in force for the carried prior work as it can have detrimental implications
on the research and development in the particular field of art. Therefore, there is a need for very clear
understanding about what activities are deemed as infringement and what are the exemptions available.

Activities considered infringing activities

The Patents Act, 1970, does not exactly list down activities which would be considered infringing the
patent rights assigned to the patentee. Having said that, Section 48 of the Act confers exclusive rights to
the patentee to prevent third parties from making, using, offering for sale, selling or importing the
patented invention for the purpose of using, selling and offering for sale in India without the consent of
the patentee. Therefore, one can presume that any act of a third party which violates the rights conferred
upon the patentee, shall be considered an act of infringement.

However, third parties can use patented inventions for commercial gains either by getting a license from
the patentee or getting his/her appropriate consent for a specific use. Any commercial use of the
patented invention without the consent of the patentee shall amount to an act of infringement.
Activities considered non-infringing activities
The Patents Act 1970, in Sections 47, 49 and 107A defines certain activities related to the patented
invention which are not considered as infringing activities. They can be called the statutory exemptions to
infringement. The statutory exemptions to infringement are defined as follows:

Government Use
The provisions of Section 47 of the Patents Act, 1970, lays down certain conditions to the grant of
patents. The use of inventions by the government is one of the defined statutory exemptions to
infringement. Under the ambit of Section 47, government can use an invention any time after filing of the
patent application or after the grant of the patent rights to the patentee2. Government can also authorize
any person in writing, for using an invention, for the purpose of government's own use of the invention.
Government can also make or import a patented invention for its own use. Further, the Bombay High
Court has discussed the scope of government use under the ambit of Section 47 in Garware Waall Ropes
Ltd vs A.I. Chopra, Engineers and Contractors.

Moreover, Section 99 to Section 103 of the Indian Patents Act, 1970, defines the meaning of use of
invention by the government3 and the conditions4 for such use.

Exemptions for Research and Development

The Section 47(3) of the Patents Act, 1970, lays down provisions for the use of the patented invention, by
any person, for the purpose of only experiment or research including the imparting of instructions to
pupils5. This provision sets the ground for the research and development of the field of art in which the
patent is granted. The scientific researchers can use the patented invention for carrying out researches
for the development of science and greater good of the society. The provision also enables educational
use of the patented invention for enlightening the students about the particular state of the art.

However, selling of the patented products for experimental purpose shall not fall under the ambit of this
statutory exemption and shall be considered an act of infringement and the person selling the product
for the monetary gain shall be considered an infringer. Moreover, use of the pirated article for the
purpose of experiment or imparting instructions to pupil shall be considered an act of infringement.

Supply of Medicinal Drug to Medical institutions by Government

Section 47(4) of the Patents Act, 1970, permits the government to import the patented medicine or drug
for the purpose merely of its own use or distribute the patented medicine or drug in dispensaries,
hospitals or other medical institutions notified in the official gazette of the government 6. This provision
enables the government to establish the balance between the public interest of access to healthcare and
the exclusive rights granted to the patentee. However, use of patented medicines for monetary gains
without the consent of the patentee shall amount to an act of infringement.

Patented Invention used on Foreign Vessels

Section 49 of the Patents Act, 1970, lays down provisions that it shall not be considered as an act of
infringement if a foreign vessel which is using a patented invention comes to India, temporarily or
accidentally7. This prevents the condition of accidental infringement of patent rights by the foreign vessel
having a patented invention on-board. However, there shall be no commercial intentions for the use of
patented invention in India.
Bolar Exemptions and Parallel Imports
Section 107A of the Patents Act, 1970, lays down the statutory exemptions similar to Bolar Exemptions.
The provisions of the section allow the use of patented invention for the purpose of development and
submission of information required under any law in India8. Moreover, the provisions of this section also
allow importation of patented products by any person from a person who is duly authorised under the
law to produce and sell the product9. These provisions enable the generic pharmaceutical companies to
research the bioequivalence of the patented active pharmaceutical compounds and helps them in
development of the generic drugs which can be marketed after the expiry of the patent of the drug.
Further, the provision of parallel import helps in regulating the pricing of the patented product and avoid
misuse of the patent rights by the patentee.

Conclusion
The patent system provides exclusive rights to the patentee for his commercial gains for a fixed period of
time. However, it is of prime importance to understand the fact that research and development in the
field of art should not be hindered due to granted patents in that particular field of art. For this purpose,
it is important for the researchers to gain knowledge on patent infringing activities and non-infringing
activities.

Legal Remedies against IP Infringements.

TRIPS Agreement national implementation

Civil remedies

Injunctions

Damages

Other Remedies

Indemnification of Defendant

Criminal sanctions

Remedies not contemplated by TRIPS

1. Civil remedies: Injunctions (Art. 44)

Judicial Authorities shall have the authority to order a party to

desist from an infringement, i.a., to prevent the

commercialization of imported infringing goods;

exception allowed for goods acquired in good faith.

New Copyright Law, Art. 93:

Injunction to prohibit the continuation of the infringement

Recurring penalty payment, if need be

Available against intermediaries as well

2. Civil Remedies: Damages (Art. 45)

Adequate compensation for the injury suffered by the right

holder because of the infringer who knew, or should have

known, that he was engaged in an infringing activity ;

exception: judicial authorities may order recovery of profits

and/or payment of pre-established damages “even” for the

“good-faith” infringer.

New Copyright Law, Art. 94; “all appropriate aspects” including

lost profits + any unfair profits made by the infringer + “in

appropriate cases, elements other than economic factors

” OR

lump-sum: royalties/fees which would have been due X 2. Judicial expenses, which may include attorney’s
fees – NCL: Art.

95

4. Indemnification of Defendant (Art. 48)

Measures not justified + abuse of procedure

Defendant’s expenses, that may include appropriate attorney’s fees.

5. Criminal sanctions (Art. 61)

Criminal procedures and penalties mandatory at least in cases of

wilful TM counterfeiting or copyright piracy on a commercial scale. Remedies should include:

Imprisonment and/or monetary fines

sufficient to provide a deterrent;

consistently with the level of penalties for crimes of a

corresponding gravity.

In appropriate cases, seizure, forfeiture and destruction of the

infringing goods / any materials and implements used for the

commission of the offence.

6. Remedies outside TRIPS

E.g.: Publication of the judgment

New Copyright Law, Art. 96: “The Court may order, at the

request of the applicant and at the expense of the infringer,

appropriate measures for the dissemination of the information

concerning the decision including the publication of such

decision, in whole or in part, in the mass media; in the same

circumstances, the court may order supplementary publication

measures in accordance with the special requirements of the

case, including high publicity”.

6. Remedies outside TRIPS

E.g.: Publication of the judgment

New Copyright Law, Art. 96: “The Court may order, at the

request of the applicant and at the expense of the infringer,

appropriate measures for the dissemination of the information

concerning the decision including the publication of such

decision, in whole or in part, in the mass media; in the same

circumstances, the court may order supplementary publication

measures in accordance with the special requirements of the

case, including high publicity”.