IPR Notes
IPR Notes
In other words, we can say that the legal rights prohibit all others from using the
Intellectual Property for commercial purposes without the prior consent of the IP rights
holder. IP rights include trade secrets, utility models, patents, trademarks, geographical
indications, industrial design, layout design of integrated circuits, copyright and related
rights, and new varieties of plants. It is very well settled that IP plays an important role
in the modern economy.
There are many types of intellectual property protection. A patent is a recognition for an
invention that satisfies the criteria of global innovation, and industrial application. IPR is
essential for better identification, planning, commercialization, rendering, and thus the
preservation of inventions or creativity. Each industry should develop its speciality based
on its IPR policies, management style, strategies, and so on. Currently, the
pharmaceutical industry has an emerging IPR strategy, which needs better focus and
outlook in the coming era.
IPR is a strong tool, to protect the investment, time, money, and effort invested by the
inventor/creator of the IP, as it gives the inventor/creator an exclusive right for a certain
period of time for the use of its invention/creation. Thus, IPR affects the economic
development of a country by promoting healthy competition and encouraging industrial
growth and economic growth. The present review presents a brief description of IPR with
particular emphasis on pharmaceuticals.
Intellectual Property can be defined as inventions of the mind, innovations, literary and
artistic work, symbols, names and images used in commerce. The objective of
intellectual property protection is to encourage the creativity of the human mind for the
benefit of all and to ensure that the benefits arising from exploiting a creation benefit the
creator. This will encourage creative activity and give investors a reasonable return on
their investment in research and development.
IP empowers individuals, enterprises, or other entities to exclude others from the use of
their creations. Intellectual Property empowers individuals, enterprises, or other entities
to exclude others from the use of their creations without their consent.
The intellectual property right is a kind of legal right that protects a person’s artistic
works, literary works, inventions or discoveries or a symbol or design for a specific
period of time. Intellectual property owners are given certain rights by which they can
enjoy their Property without any disturbances and prevent others from using them,
although these rights are also called monopoly rights of exploitation, they are limited in
geographical range, time and scope.
As a result, intellectual property rights can have a direct and substantial impact on
industry and business, as the owners of IPRs one can enforce such rights and can stop
the manufacture, use, or sale of a product to the public. IP protection encourages
publication, distribution, and disclosure of the creation to the public, rather than keeping
it a secret and to encourage commercial enterprises to select creative works for
exploitation.
Intangible Rights over Tangible Property: The main Property that distinguishes
IP from other forms of Property is its intangibility. While there are many
important differences between different forms of IP, one factor they share is
that they establish property protection over intangible things such as ideas,
inventions, signs and information whereas intangible assets and close
relationships are a tangible object. In which they are embedded. It allows
creators or owners to benefit from their works when they are used
commercially.
Right to sue: In the language of the law, IP is an asset that can be owned and
dealt with. Most forms of IP are contested in rights of action that are enforced
only by legal action and by those who have rights. IP is a property right and
can, therefore, be inherited, bought, gifted, sold, licensed, entrusted or
pledged. The holder of an IPR owner has a type of Property that he can use
the way he likes subject to certain conditions and takes legal action against
the person who without his consent used his invention and can receive
compensation against real Property.
Rights and Duties: IP gives rise not only to property rights but also duties.
The owner of the IP has the right to perform certain functions in relation to his
work/product. He has the exclusive right to produce the work, make copies of
the work, market work, etc. There is also a negative right to prevent third
parties from exercising their statutory rights.
The scope of IP rights is broad; two classification modes are used to determine whether
IP is copyright or Industrial Property. Industrial properties include patents or inventions,
trademarks, trade names, biodiversity, plant breeding rights and other commercial
interests. A patent gives its holder the exclusive right to use the Intellectual Property for
the purposes of making money from the invention.
Even music and audio-visual works are covered by copyright laws. The duration of
copyright protection exists 60 years after the death of the creator. In other words, an
author’s book is copyrighted for his entire life and then 60 years after his death. Unlike
patent laws, there is no requirement of the administrative process in copyright laws.
There are several reasons for promoting and protecting intellectual property. Some of
them are:
1. Progress and the good of humanity remain in the ability to create and invent
new works in the field of technology and culture.
The subject of intellectual property is very broad. There are many different forms of
rights that together make up intellectual property. IP can be basically divided into two
categories, that is, industrial Property and intellectual property. Traditionally, many IPRs
were collectively known as industrial assets.
It mainly consisted of patents, trademarks, and designs. Now, the protection of industrial
property extends to utility models, service marks, trade names, passes, signs of source
or origin, including geographical indications, and the suppression of unfair competition. It
can be said that the term ‘industrial property” is the predecessor of ‘intellectual
property”.
Copyright law deals with the protection and exploitation of the expression of ideas in a
tangible form. Copyright has evolved over many centuries with respect to changing ideas
about creativity and new means of communication and media. In the modern world, the
law of copyright provides not only a legal framework for the protection of the traditional
beneficiaries of copyright, the individual writer, composer or artist, but also the
publication required for the creation of work by major cultural industries, film; Broadcast
and recording industry; And computer and software industries.
It resides in literary, dramatic, musical and artistic works in ”original’ cinematic films,
and in sound recordings set in a concrete medium. To be protected as the copyright, the
idea must be expressed in original form. Copyright acknowledges both the economic and
moral rights of the owner. The right to copyright is, by the principle of fair use, a
privilege for others, without the copyright owner’s permission to use copyrighted
material. By the application of the doctrine of fair use, the law of copyright balances
private and public interests.
Patent law recognizes the exclusive right of a patent holder to derive commercial
benefits from his invention. A patent is a special right granted to the owner of an
invention to the manufacture, use, and market the invention, provided that the invention
meets certain conditions laid down in law. Exclusive right means that no person can
manufacture, use, or market an invention without the consent of the patent holder. This
exclusive right to patent is for a limited time only.
To qualify for patent protection, an invention must fall within the scope of the patentable
subject and satisfy the three statutory requirements of innovation, inventive step, and
industrial application. As long as the patent applicant is the first to invent the claimed
invention, the novelty and necessity are by and large satisfied. Novelty can be inferred
by prior publication or prior use. Mere discovery ‘can’t be considered as an invention.
Patents are not allowed for any idea or principle.
The purpose of patent law is to encourage scientific research, new technology, and
industrial progress. The economic value of patent information is that it provides technical
information to the industry that can be used for commercial purposes. If there is no
protection, then there may be enough incentive to take a free ride at another person’s
investment. This ability of free-riding reduces the incentive to invent something new
because the inventor may not feel motivated to invent due to lack of incentives.
A trademark is a badge of origin. It is a specific sign used to make the source of goods
and services public in relation to goods and services and to distinguish goods and
services from other entities. This establishes a link between the proprietor and the
product. It portrays the nature and quality of a product. The essential function of a
trademark is to indicate the origin of the goods to which it is attached or in relation to
which it is used. It identifies the product, guarantees quality and helps advertise the
product. The trademark is also the objective symbol of goodwill that a business has
created.
Any sign or any combination thereof, capable of distinguishing the goods or services of
another undertaking, is capable of creating a trademark. It can be a combination of a
name, word, phrase, logo, symbol, design, image, shape, colour, personal name, letter,
number, figurative element and colour, as well as any combination representing a graph.
Trademark registration may be indefinitely renewable.
Geographical indication
It performs three functions. First, they identify the goods as origin of a particular region
or that region or locality; Secondly, they suggest to consumers that goods come from a
region where a given quality, reputation, or other characteristics of the goods are
essentially attributed to their geographic origin, and third, they promote the goods of
producers of a particular region. They suggest the consumer that the goods come from
this area where a given quality, reputation or other characteristics of goods are
essentially attributable to the geographic region.
It is necessary that the product obtains its qualities and reputation from that place.
Since those properties depend on the geographic location of production, a specific link
exists between the products and the place of origin. Geographical Indications are
protected under the Geographical Indication of Goods (Registration and Protection) Act,
1999.
Industrial design
It is one of the forms of IPR that protects the visual design of the object which is not
purely utilized. It consists of the creation of features of shape, configuration, pattern,
ornamentation or composition of lines or colours applied to any article in two or three-
dimensional form or combination of one or more features. Design protection deals with
the outer appearance of an article, including decoration, lines, colours, shape, texture
and materials. It may consist of three-dimensional features such as colours, shapes and
shape of an article or two-dimensional features such as shapes or surface textures or
other combinations.
Plant variety
A new variety of plant breeder is protected by the State. To be eligible for plant diversity
protection, diversity must be novel, distinct and similar to existing varieties and its
essential characteristics under the Plant Protection and Protection Act, 2001 should be
uniform and stable. A plant breeder is given a license or special right to do the following
in relation to different types of promotional material:
The enactment of the Protection of Plant Varieties and ‘Farmers’ Rights Act 2001 is an
outcome of the India’sIndia’s obligation which arose from article 27(3)(b) of the TRIPs
Agreement of 2001 which obliges members to protect plant varieties either by patents or
by effective sui generic system or by any combination thereof India declined to protect
plant varieties by a sui generis law, i.e. the Plant Varieties Act.
There are many benefits of acquiring intellectual property rights. For example, protecting
your IP may result in:
1. The increased market value of your business – IP can generate income for
your business through licensing, selling or commercializing protected products
or services. This, in turn, can improve your stock market or increase your
profit. In the case of a sale, merger or acquisition, registered and protected IP
assets can increase the value of your business.
2. Convert ideas into profitable assets – IP can help to convert creative ideas
into commercially successful products and services. For example, licensing
your patent or copyright can result in a steady stream of royalties and
additional income that can result in profitable assets.
“Sui Generis” stands for its own kind and includes a set of laws which are nationally
recognized and ways of extending plant variety protection other than through patents.
TRIPs themselves do not define what the meaning of Sui Generis is or should be. One of
the main purposes of the sui generis protection is that the exclusive monopoly granted
by the State should enable the real owners of traditional knowledge to be adequately
compensated for their contribution. It also refers to a law that can protect images
contained in construction, inventions, models, drawings, designs, innovations, figures,
emblems, petroglyphs, art, music, history and another traditional artistic feeling.
One of the main objectives of Sui generis protection granted by that exclusive monopoly
of the State should enable traditional ‘owner’s knowledge for adequate compensation of
their contribution towards economic growth. In general, it refers to a particular form of
protection, a form that is specifically adapted to a specific subject or specific
circumstances, which is specifically made for specific needs, priorities, and reality.
The need to Develop a suitable regime in the case of IPR to include traditional medicine
adequate measures for ‘sharing profit”. Codified System and measures of Traditional
Medicines are TKDL(Traditional Knowledge Digital Library) like databases is expected to
play a major role in preventing for bio-theft but non-codified.
Such as regulation of traditional medicine folklore practices, tribal practices etc. New
rules are urgently needed for creating patented ‘and Sui generis” system for the
preservation and promotion of our traditional knowledge Like some national-level
programs initiated by the National Innovation Foundation to enable non-traditional
traditional medical practices Identified, documented, standardized and better used for
therapeutic benefits as well as ailing mankind.
UPOV
The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental
organization that was established in 1961 and is based in Geneva, Switzerland. The purpose of
UPOV is to provide and promote an effective system of plant variety protection, with the aim of
encouraging the development of new varieties of plants, for the benefit of society.
The UPOV Convention provides a consistent and harmonized intellectual property framework at the
international level, for which countries and intergovernmental organizations can adhere to. In order to
become a member, a country or intergovernmental organization must have a domestic Plant
Breeders’ Rights (PBR) or Plant Variety Protection (PVP) law that meets the minimum requirements
of the UPOV Convention. At present, (2014) there are 70 countries and 2 inter-governmental
organizations that are members of UPOV, but this changes over time as more countries become
signatories:
It is important to provide a mechanism for protecting plant varieties, because plant breeding is a time
consuming, expensive, and resource intensive activity. However, plants can easily and quickly be
reproduced, sometimes without permission of the breeder or without fairly compensating him/her for
their investment and effort. Successful breeding requires great skill and knowledge, as well as,
specialized equipment (for example, greenhouses, growth chambers and laboratories).
Often it can take many years to bred a successful plant variety (7 to 15 years depending on the
species), but not all new varieties will be successfully adopted in the marketplace. As such, a breeder
is taking a risk when developing a new variety, but if successful, the benefits to farmers and society
can be enormous. A UPOV based PBR/PVP law, makes it possible for a breeder to protect his/her
variety in the marketplace and receive a return on his/her investment, as well as, encourage
reinvestment plant breeding.
The breeder’s “right” means that authorization is required from the breeder to propagate the variety for
commercial purposes. The UPOV Convention specifies the acts that require the breeder’s
authorization in respect of the use propagating material (e.g. seed) of a protected variety and, under
certain conditions, in respect of the harvested material (e.g. grain or fruit). UPOV members may also
decide to extend protection to products made directly from harvested material, under certain
conditions.
In order to obtain protection for a new variety, the breeder needs to file an application with
each national PBR or PVP Office in the specific region or country in which he/she plans to release
that variety:
For a plant variety to be eligible for protection there are some basic criteria that the breeder must
meet. These four fundamental criteria are applied consistently across all UPOV member countries
and organizations. According to the 1991 Act of the UPOV Convention, the breeder’s right shall be
granted where the variety is:
(i) new,
(ii) distinct,
(iv) stable.
Newness or novelty: In order for a variety to be considered “new”, the propagating or harvested
material of that variety cannot have been sold in the country of filing for over 1 year. Additionally, the
propagating or harvested material of that variety cannot have been sold in another UPOV member
country for over 6 years in the case of trees and vines, and 4 years for all other plant species. A
specified time limit is set for seeking protection in various UPOV member countries so the breeder
does not prolong the length of time he/she can benefit from protection beyond a reasonable time
frame by delaying protection in various countries. Also, the difference in set time frames, 4 years for
all plant species except trees and vines which are 6 years, acknowledges the slower growth and
multiplication of these types of plants.
Distinctness: Another condition of protection is that the applicant must demonstrate that the variety is
“distinct”, meaning it must be clearly distinguishable from all other varieties of common knowledge at
the time of filing the application. In order to establish “distinctness” of a plant variety it is usually
necessary to carry out various tests whereby the candidate variety seeking protection is grown along
with other similar reference varieties for comparative purposes. In order to establish that the candidate
variety is in fact “distinct” it must differ from the other varieties in at least one “clearly distinguishable”
characteristic. The characteristic(s) of interest used to establish distinctness can be either qualitative
(observable) or quantitative (measurable) in nature. It is important to emphasize, it must be shown
that the candidate variety differs from other varieties by at least one clearly distinguishable
characteristic in order to meet the criteria of being “distinct”. The UPOV Office provides guidance on
how “distinctiveness” can be assessed based on phenotypic/morphological characteristics for various
plant species and crop kinds:
Uniformity: The plant variety seeking protection must also be deemed to be “uniform” (or sufficiently
uniform in its relevant characteristics) in order to be eligible for protection. This means that
propagating material of the variety must be homogeneous in appearance, and if there is variation in
the expression of characteristics or off-types, the occurrences must be within acceptable
tolerances/standards for that particular species or crop kind. The UPOV Office provides guidance on
the acceptable tolerances for variances in the expression of characteristics or presence of off-types,
based on the specific plant species or crop kind being assessed.
Stability: The plant variety must remain stable in its relevant characteristics so that it remains
unchanged after repeated cycles of propagation.
In addition to providing a mechanism for protecting varieties arising from plant breeding, the UPOV
Convention spells out special considerations for three specific types of varieties, namely:
Under the UPOV 1991 Convention, if a breeder satisfies all the conditions for protection for their new
plant variety, they are granted exclusive rights to do the following acts in respect of the propagating
material of that protected variety:
(v) exporting,
(vi) importing,
(vii) stocking for any of the purposes mentioned in (i) to (vi), above.
The UPOV 1991 Convention contains key exemptions to the “breeder’s right” intended to balance
interests and ensure benefit sharing. The mandatory exemptions to the breeder’s right include:
Acts done privately and for non-commercial purposes: This provision allows amateur gardeners to use
propagating material for use in their own garden without seeking authorization so long act is private
and non-commercial. Additionally, a farmer can propagate a protected variety to be used exclusively
for the production of a food crop to be consumed entirely by that farmer and his/her dependents (i.e.
subsistence farming).
Acts done for experimental purposes: The breeder’s right does not extend to the use of a protected
variety for experimental purposes. This means that a researcher or scientist can conduct studies on a
protected variety, and publish results of those investigations, without seeking authorization from the
right’s holder. This is an important provision which encourages contribution to the body of scientific
knowledge about various plant varieties.
Acts done for the purpose of breeding other varieties: This is a fundamental element of the UPOV
system, ensuring that no restrictions can be placed on protected varieties for the purpose of breeding
new plant varieties. This means that breeders can always use protected varieties in their breeding
program to contribute to developing improved varieties which benefit farmers and society in general.
Farmer’s Privilege: The UPOV Convention contains an optional provision which allows member
countries to further restrict the breeder’s right, permitting farmers to use propagating material obtained
from their own holdings, to subsequently grow crops. This exemption to the breeder’s right is often
known as the “farmer’s privilege”.
In 2005 the International Union for the Protection of New Varieties of Plants (UPOV) published a study
entitled “UPOV Report on the Impact of Plant Variety Protection” which examined the benefits on
several countries that implemented domestic laws based on the UPOV framework.
b) Improvement of varieties
What is WIPO?
WIPO is the global forum (IP) services, policy, information and cooperation. We are a self-funding
agency of, with 193 member states.
Our mission is to lead the development of a balanced and effective international IP system that
enables innovation and creativity for the benefit of all. Our mandate, governing bodies and procedures
are set out in, which established WIPO in 1967
We help governments, businesses and society realize the benefits of IP.
We provide:
Each WIPO division, led by its Director, is responsible for specific programs to achieve our
nine and objectives:
WIPO Activities by unit
Report to DG the WIPO assembelies
WIPO – Making IP W ork (a quick introduction to WIPO and what we do)
(WTO), established to supervise and liberalize world trade. The WTO is the successor to
the (GATT), which was created in 1947 in the expectation that it would soon be replaced by a
specialized agency of the (UN) to be called the International Trade Organization (ITO). Although
the ITO never materialized, the GATT proved remarkably successful in liberalizing world trade
over the next five decades. By the late 1980s there were calls for a stronger multilateral
organization to monitor trade and resolve trade disputes. Following the completion of the
Uruguay Round (1986–94) of multilateral trade negotiations, the WTO began operations on
January 1, 1995.
The WTO has six key objectives: (1) to set and enforce rules for international trade, (2) to provide a
forum for negotiating and monitoring further trade liberalization, (3) to resolve trade disputes, (4) to
increase the transparency of decision-making processes, (5) to cooperate with other major
international economic institutions involved in global economic management, and (6) to help
developing countries benefit fully from the global trading system. Although shared by the GATT, in
practice these goals have been pursued more comprehensively by the WTO.
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.
Understanding the General Agreement on Tariffs and Trade (GATT)
The GATT was created to form rules to end or restrict the most costly and undesirable features of
the prewar protectionist period, namely quantitative trade barriers such as trade controls and quotas.
The agreement also provided a system to arbitrate commercial disputes among nations, and the
framework enabled a number of multilateral negotiations for the reduction of tariff barriers. The GATT
was regarded as a significant success in the postwar years.
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.
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
The TRIPS Agreement, which came into effect on 1 January 1995, is to date the most comprehensive
multilateral agreement on intellectual property.
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.
The Patent Cooperation Treaty (PCT) is an international treaty administered by the World Intellectual
Property Organization (WIPO). The PCT System makes it possible to seek patent protection for an
invention simultaneously in a large number of countries by filing a single “international” patent
application instead of filing several separate national or regional patent applications. The PCT System
comprises 151 Contracting states (September 2016).
The granting of patents remains under the national or regional legislation of the national or regional
patent offices. It is called the “national phase”.
In the national phase, each patent office is responsible for processing the application in accordance
with its national patent laws, and for deciding whether to grant patent protection. The time required for
that processing varies across patent offices.
Defendant contended that the Plaintiff was not manufacturing the drug
locally and imported only limited quantities through a licensee.
Plaintiff then filed a case before the Delhi HC claiming patent infringement
and damages.
Court Decision
Delhi High court barred the Defendant from making or selling generic copy
of the Plaintiffs drug by granting temporary injunction to the Plaintiff.
The HC observed that Plaintiff had a strong prima facie case and as the
validity of the patent is not seriously questioned, there is a clear way out to
grant injunction.
Defendant had previously also stated that there was a shortage of the drug
and inadequacy thereof. However, the HC observed that the Defendant
failed to provide any proof or figures for such claims.
In 2017, Cipla filed an appeal against this order. However, the appeal was dismissed on
similar grounds. The 2017 Appeal further divided into the implications of a drug being
imported and whether the extent of imports was sufficient to meet the demands in
India.
TRADEMARK INFRIGNENT
Hindustan Unilever Limited v. Utkarsh Somani & Anr. [GA No. 297 of 2019 with CS No. 21 of 2019]
Hindustan Unilever (HUL) filed a suit before the Calcutta High Court requesting for a permanent
injunction to restrain Utkarsh Somani from using the trademarks “LIKEBOY” and “LOVEBOY” for
selling and distributing soaps which are deceptively similar to HUL’s registered trademark LIFEBUOY
and also for bearing a similar trade design, color scheme and packaging labels as that of
LIFEBUOY’s. The Court upon reviewing the evidence and the submissions was, prima facie, satisfied
that the products sold by Utkarsh are infringing HUL’s registered trademark and trade dress. The
Court, therefore, passed an interim injunction in favour of HUL restraining Utkarsh from using the
infringing trademarks. The Court further, has appointed a Special Officer to visit Utkarsh’s godown
and outlet and to seize the infringing goods.
COPYRIGHR INFRIGMENT
INDUSTRIAL DESIGNS
SCIL claimed that the business model of YouTube allows, encourages and profits from use of copyrighted work uploaded on
the website without obtaining any license or permission from the rightful copyright owners and without paying them any
royalty. The High Court passed the order against YouTube and Google restraining them from reproducing, adapting,
distributing, communicating, transmitting, disseminating or displaying on their websites any audio-visual works which is in
the exclusive ownership of SCIL.
Biopiracy
‘Biopiracy’ is an emergent term used to name illegal or improper appropriation of traditional
knowledge and biological materials the fight against biopiracy, the preservation of
biodiversity and the need for sustainable practices hence constitute one of the major
challenges for the twenty-first century . “Natural” space of India is described through its
biodiversity; a biodiversity which can be appreciated but also exploited. Bioprospecting turns
into biopiracy. Vandana Shiva interpreted that, biopiracy is a phenomenon of claiming
property rights to biodiversity and its products through intellectual property rights regimes
and patents based on indigenous and traditional knowledge
6.1 Categories of biopiracy
7. Bioprospecting
The emergence of the discourse of ‘Bioprospecting’ was discussed in (in the late 1980s or
early 1990s) for the search of biological resources that can help to contribute for the
conservation as well as the discovery of beneficial products [42]. Bioprospecting is defined as
‘the search for biodiversity, for valuable genetic and biochemical information found in wild
animals, plants or microbial organisms’ for product development as a purely scientific and
commercial endeavor [Bioprospecting is the exploration of biodiversity for new biological
resources of social and economic value. It is carried out by a wide variety of industries, the
best known being the pharmaceutical industry, but also by a variety of branches of
agriculture, manufacturing, engineering, construction and many others [44]. The
bioprospecting concept is based on recognition of the importance of natural product
discovery for the development of new crops and medicines, often based on traditional
knowledge . Pharmaceutical bioprospecting has been sharply criticized for what has become
known as ‘biopiracy’ in which large international pharmaceutical corporations make use of
local medicinal knowledge without acknowledging that it is indigenous intellectual property
However, bioprospecting has received more attention in recent years due to the increasing
awareness that new drugs will be urgently needed in the near future, either to cure currently
incurable diseases affecting an increasing global population or replacing increasingly
ineffective drugs to treat health problems. Bioprospecting can impact any industry that
depends (wholly or partly) on accessing, sourcing, processing, or production of genetic
resources to develop commercially viable products for the world market
An example of bioprospecting that has been cited as a success story of benefit sharing is the
Kani model of access and benefit sharing (ABS). Trichopus zeylanicus known as
‘Arogyapacha’ used to treat fatigue and stress by the Kani tribe, inhabiting from Southern
Western Ghat region of Kerala State in India (Figure 2). The lead provided by this tribal
community has led to the development of a scientifically validated drug “Jeevani” by the
Tropical Botanic Garden and Research Institute (TBGRI). While transferring the technology
for production of the drug to the pharmaceutical firm, TBGRI agreed to share the license fee
and royalty with the tribal community on a fifty-fifty basis. This is the first benefit sharing
model in the world. However Kani case has criticized for whether the commercialization got
informed consent from tribal community and sharing financial benefits equitably. This
benefit-sharing model have been criticized for not yielding the desired the results
Vision
Conservation and sustainable use of India’s rich biodiversity and associated
knowledge with people’s participation, ensuring the process of benefit sharing for
the well-being of present and future generations.
Mission
Ensure effective implementation of Biological Diversity Act, 2002 and the Biological
Diversity Rules, 2004, for conservation of biodiversity, sustainable use of its
components and fair and equitable sharing of benefits arising out of utilization of
genetic resources.
Mandate
Reaffirm the sovereign rights over the bio-resources of India and contribute towards
Provide policy and support relating to conservation, sustainable use of its components and
resources and for reaching the stakeholders and ensuring fair and equitable benefit sharing in
Take measures to oppose the grant of intellectual property rights to persons in other countries
or any biological resources of India or knowledge associated with such biological resources of Indian
origin.
Advise the State Governments concerning their area specific biodiversity, and in notifying
Heritage Sites and also suggest measures for their management and sustainable use.
(BMC) for preparing People’s Biodiversity Registers (PBR) in the areas falling under their respective
jurisdiction.
Perform such other functions as may be necessary to implement the provisions of Biological
Traditional Knowledge Digital Library has overcome the language and format barrier by
systematically and scientifically converting and structuring the available contents of the
ancient texts on Indian Systems of Medicines i.e. Ayurveda, Siddha, Unani and Sowa
Rigpa as well as Yoga, into five international languages, namely, English, Japanese,
French, German and Spanish, with the help of information technology tools and an
innovative classification system - Traditional Knowledge Resource Classification (TKRC).
As on date, more than 3.6 lakh formulations/ practices have been transcribed into the
TKDL database.
TKRC has structured and classified the Indian Traditional Medicine System into several
thousand subgroups for Ayurveda, Unani, Siddha and Yoga. TKRC enabled incorporation
of about 200 sub-groups under A61K 36/00 in International Patent Classification instead
of few sub-groups earlier available on medicinal plants under A61K 35/00, thus
enhancing the quality of search and examination of priorart with respect to patent
applications field in the area of traditional knowledge.
TKDL has also set international specifications and standards for setting up of TK
databases based on TKDL specifications. This was adopted in 2003 by the Committee in
fifth session of the Intergovernmental Committee (IGC) of WIPO on Intellectual Property
and Genetic Resources, Traditional Knowledge and Expression of folklore.
TKDL technology integrates diverse disciplines and languages such as Ayurveda, Unani,
Siddha, Yoga, Sanskrit, Arabic, Urdu, Persian, Tamil, English, Japanese, Spanish, French,
German, modern science & modern medicine. Currently, TKDL is based on booksIndian
Systems of Medicine, which are available in open domain and can be sourced by any
individual/organization at national/international level. TKDL acts as a bridge between
these books (priorart) and International patent examiners.
In addition, pre-grant oppositions are being filed at various International Patent Offices,
along with prior-art evidences from TKDL. Significant impact has already been realized.
So far more than 230 patent applications have either been set aside/ withdrawn/
amended, based on the prior art evidences present in the TKDL database without any
cost and in few weeks/months of time, whereas APEDA had to spend about seven crores
towards legal fee only for getting few claims of Basmati rice patent revoked.
TKDL is proving to be an effective deterrent against bio-piracy and has been recognized
internationally as a unique effort. TKDL has set a benchmark in TK protection around the
world, particularly in TK-rich countries, by demonstrating the advantages of proactive
action and the power of strong deterrence. The key here is preventing the grant of wrong
patents by ensuring access to TK related prior art for patent examiners without
restricting the use of traditional knowledge.
1. Risk Analysis: The foundation of any safety program is the use of control measures
appropriate for the risk posed by the activities and the agents in use. The process of
analyzing and determining the risk associated with recombinant DNA work is called as
Risk analysis. The principle behind biosafety regulations is to minimize the risk to human
health and safety, and the conservation of environment including safe handling of
hazardous material. Risk analysis consists of three components: risk assessment, risk
management and risk communication. Risk Assessment: Estimation and determination of
risk associated with the handling and production of a recombinant DNA molecule. Risk
Management: The process of analyzing possible prevention measures to minimize the
risk and designing policies accordingly including implementation of them. Risk
Communication: The exchange of information and opinions on risk management between
academic parties, industry, consumers and policy makers.
2. 12. Risk Assessment: The biosafety level is determined based on the risk associated with
the work. The principle investigator is responsible for implementing the necessary safety
requirements in his/her laboratory. Risk assessment process accounts the following
criteria to determine biosafety level: i. Pathogenicity – The ability of an organism to cause
disease in human system. ii. Virulence – The severity of the disease (lethal/non lethal,
availability of cure etc) in a healthy adult. iii. Proliferation – the subsequent multiplication,
genetic reconstruction, growth, transport, modification and die-off of these micro-
organisms in the environment, including possible transfer of genetic material to other
micro- organisms. iv. Transmission route – The possible route of transmission (mucous
membrane, inhalation etc) to establish the disease in human or other organism. v.
Infectious dose (ID) – The amount of infectious agent required to cause disease in
healthy human. vi. Antibiotic/disinfectant resistance – The resistance acquired by the
infectious agent to available antibiotic/disinfectant.
3. 13. The risk associated with recombinant DNA technology can be categorized under
different headings based on their implication on different platforms.
4. 14. General Scientific Considerations- A. Characteristics of Donor and Recipient
Organisms • Taxonomy, identification, source and culture • Genetic characteristics of
donor and recipient organisms • Pathogenic and physiological traits of donor and
recipient organisms B. Properties of the modified/engineered organism C. Description of
(a) modification, (b) nature, function and source of the insert, (c) vector construction, (d)
transfer into host, (e) stability of insert, (f) frequency of mobilization, (g) rate and level of
expression, and (h) Influence of the recipient organism on the activity of the foreign
protein.
Intellectual property management (IP) is a system that manages intangible creations of the human
intellect and primarily encompasses copyrights, patents, and trademarks. It also includes other types
of rights, including publicity rights, and rights against unfair competition.
Intellectual property rights management / intelligent property rights strategy (IPR strategy) is a
strategy for managing a company’s intellectual property rights portfolio. It also covers the following
intellectual property rights such as patent, trademark protection, design protection, and copyright.
The law and administrative procedures relating to Intellectual Property Rights have their roots in
Europe. The trend of granting patents and trademarks started in the fourteenth century.
The term intellectual property rights strategy management is sometimes used as an overarching
strategy for managing the company’s intangible asset, for example, the name of the company, a
service, the logotype, music, computer programs, internal manuals, and working methods, business
concept, etc.…
An intellectual property rights strategy helps the entrepreneur to manage these intangible assets
professionally, to maximize the commercial benefits. IPR covers the questions such as, which type of
patent can be licensed out or sold, what kind of patent should be purchased, other ways to use the
intellectual properties rights, and how to commercialize them and make money.
A good intellectual property rights management should include both an analysis of competitors and an
analysis of risks and take into account the company’s long-term commercial objectives.
Bearing this in mind, it is of the utmost importance to undertake a previous effective intellectual
property conformity compliance, thus protecting your business against litigation, lost profits and a
damaged reputation.
Here are some examples of behaviors or situations that should be taken into account.
2.2. Carefully draw the line between competition and anti-competitive behavior
Everybody knows that fierce competition may lead to marketing exaggerations and distortions.
Marketing departments use several means/methods to appeal to the clients and/or customers, and
these means may sometimes exceed what is legally accepted.
In terms of intellectual property rights, there is a tendency today to use well-known trademarks without
obtaining prior consent. Even where the business activity is not related to the company concerned,
since there is no authorization this is considered an illegal use of a trademark. It does not matter if you
did not intend to damage the trademark. Any use without consent of a well-known trademark should
be considered unlawful.
Another issue is the use of comparative advertisement. Despite not being illegal, no company may
use this strategy to take undue advantage of the reputation of a trademark, trade name or other
distinctive sign of a competitor or the designation of origin of competing products.
Copyright Ownership
Generally speaking, the creator or originator of an idea, work, or novel invention is presumed to own
the copyright to their creations. However, if the work was created as a part of a work-made-for-hire
agreement, or in an employer-employee agreement, the copyright belongs to the employer. On the
other hand, contractors (and not the party that employs them) retain ownership of the copyright of
the works they create unless there's an agreement in place to assign the works to the employing
party.
Patent Ownership
Like a copyright, the creator or originator of an idea, work, or novel invention is presumed to own the
patent to their creations. In the United States, an inventor or multiple inventors must apply for a
patent. Ownership can then be assigned to a corporate entity afterward. Patent ownership can also be
transferred to assignees and successors who then become proprietors of the patent. This makes
patents a liquid property. Patents are often sold by inventors to third parties, who then become
proprietors of the patent and can exclude others from exploiting such inventions.
3. Trade Secrets
What is a trade secret?
Similar to copyright and patent ownership, a trade secret is generally owned by the creator or
creators, if they are employees, the trade secret is owned by the employer. Typically, trade secret
arrangements are clarified through the use of non-disclosure agreements (NDAs), or confidentiality
agreements.
Under an intellectual property assignment agreement, you permanently transfer some or all IP rights
to the assignee in exchange for a specified sum. Essentially, you sell the rights to a third party the
same way that you could sell physical property for a permanent transfer. Generally, you relinquish all
control, involvement, and claim on the intellectual property rights transferred.
Under an intellectual property licensing agreement (also known as an intellectual property license or
an intellectual property license agreement), you retain ownership of your patent, copyright, or
trademark, but you give another party permission to use some or all of your intellectual property rights
for a specific amount of time for a fee or royalty. These intellectual property contracts typically specify
termination dates and procedures.
There are several types of intellectual property licenses embodied in a typical intellectual property
agreement. The following three are the most common:
Exclusive License. You agree not to grant any other licenses of the invention and rights
concerned, as well as not to use the technology yourself.
Sole License. You agree not to grant any other licenses of the invention and rights
concerned, but you can use such rights yourself.
Non-Exclusive License. You agree to give the licensee certain rights, but you also reserve
the right to grant licenses of the invention and rights concerned to third parties or to use them
yourself.
Collaborative research thus takes on a meaning that is somewhere in between these two extremes. It
can be defined as including projects where researchers work together throughout a large part of the
duration of a project, or who make a substantial contribution. Collaborators can include people who
are responsible for a main part of the research. A study published in Research Policy provides further
analysis into the definition of collaborative research.
Institutional Context
Research can be represented by the number of administrative units involved. A simple group involves
multiple researchers from the same
administrative unit. A simple group could be a collaboration among Rice researchers. A complex
group involves multiple researchers from different administrative units. The collaboration between
Rice and Baylor represents a complex group. A multi-sector group involves researchers from multiple
sectors, which can include government, industry, and community.
Disciplinarity
Heterogeneous research can be multidisciplinary, interdisciplinary, and transdisciplinary.
Unidisciplinary research can be considered collaborative if occurs between multiple administrative
units. Multidisciplinary research occurs when researchers from different disciplines work separately in
their own discipline to solve a joint problem. Interdisciplinary research occurs when researchers work
together to solve a problem but still focus on their own disciplines. Transdisciplinary research occurs
when researchers work together using a shared conceptual framework.