INTELLECTUAL PROPERTY RIGHTS (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation.

1. INTELLECTUAL PROPERTY RIGHTS
Guided by- Ms. Alka Sonker Mam (Ph.D Research Scholar)
Presented by- Shiv Kumar
M.Pharma 1st year (1st sem)
Pharmaceutical Analysis
Department Of Pharmaceutical Sciences.
Babasaheb Bhimrao Ambedkar University (A Central University) Lucknow,U.P.

2. Content
• INTRODUCTION TO INTELLECTUAL PROPERTY RIGHTS
• TYPES OF INTELLECTUAL PROPERTY RIGHTS
• FACTORS AFFECTING INTELLECTUAL PROPERTY
• INFRINGEMENT OF INTELLECTUAL PROPERTY
• PENALITIES OF IP INFRINGEMENT IN INDIA
• ROLE OF IPR IN PHARMACEUTICAL INDUSTRY

3. • INTELLECTUAL PROPERTY RIGHTS (IPR) have been
defined as ideas, inventions, and creative expressions based
on which there is a public willingness to bestow the status of
property. IPR provide certain exclusive rights to the inventors
or creators of that property, in order to enable them to reap
commercial benefits from their creative efforts or
reputation.
• Intellectual property (IP) pertains to any original creation of
the human intellect such as artistic, literary, technical, or
scientific creation. Intellectual property rights (IPR) refers to
the legal rights given to the inventor or creator to protect his
invention or creation for a certain period of time. These legal
rights confer an exclusive right to the inventor/creator or his
assignee to fully utilize his invention/creation for a given
period of time.

4. TYPES OF INTELLECTUAL PROPERTY RIGHTS

5. PATENT
is an exclusive right granted by the government to the innovators to create,
use, sell, industrial production, and import. It prevent others from doing the
likewise without seeking prior consent, within the boundaries of the nation.
Patent is granted for a new product or a process which involves industrial
applications. All inventions are not patentable. The innovations coming under
section 3 and 4 of the Indian Parliament Act, 1970 are exempted from giving
patent.

6. COPYRIGHTS
A legal right granted to the owner of a literary, artistic or scientific work to make
use of it, is widely known as copyright. The protection authorize others also to
make use of it for reproduction and public demonstration by obtaining prior
permission from the authors. Only the expression of ideas are protected by this
law and these ideas are free to use to all as their own interest. The works such as
literary, dramatic, musical work, computer programs, software, drawings,
paintings, cinematographic films and recordings are cover under copyright.

7. TRADEMARKS
These are distinctive and unique in nature helping to identify the source of
specific products from their competitors in the field. It makes easy for
people to identify the exact one for which they are searching from a range of
similar enterprises. Trademarks may consist of alphabets, numerals,
words/combination of words, symbols, drawings, three dimensional signs
and voice recordings. Even colours and fragrances are being used as
distinguishable trademarks in the industry.

8. • INDUSTRIAL DESIGNS
The aesthetic aspects like pattern, colour or lines of two dimensional or three-
dimensional features of an article are protected under the category of Industrial
Designs. There are no technical factors regarding Industrial Designs. The design should
be novel and not utilised anywhere even outside the country. The known shapes or
pattern experimented on new context which involves any mental activity for
conceptualization maybe considered for granting Industrial Designs. Such articles must
have Independent existence from the designs applied to it. The maximum period of
protection will be of fifteen years in total. At the initial stage, the period will be for ten
years and it tends to be extended for five years duration by paying. The power of
issuing registration is vested with the Controller of Patents and Designs situated at the
Intellectual Property Office, Kolkata.

9. • PROTECTION OF NEW PLANT VARIETIES AND FARMER’S
RIGHTS (PPVFR)
The rights under the Protection of new Plant Varieties and Farmer’s Rights (PPVFR)
cover a wide chain of rights conferred exclusively for specific groups, such as
Breeders’ rights, Researchers’ rights and Farmers’ rights. Breeder will have rights to
cultivate, sell, and market the product. Importing and exporting goods are also
permissible. A researcher can use any of the registered varieties, for research
purpose or conducting experiments. A researcher has to get consent from the
breeder of the initial source of a variety, on experiment, for conducting further
development. In addition, farmers’ interest in being a part of the development of a
plant variety is entitled with the registration and protection. The farmers’ general
works and eligibility to get honours and awards for conservation of plant genetic
resources and wild family of economic plants are also protected by law. The office of
the Registrar of Protection of Plant Varieties and Farmer’s Rights authority in New
Delhi is the authorized registration centre for the protection of all rights for plant
varieties and farmers guaranteed by law. The registration process involves complex
procedures and it varying depends on the type of legal right required.

10. • PROTECTION OF UNDISCLOSED INFORMATION/TRADE SECRETS
The trade secrets of an enterprise provide a competitive edge in business. A trade
secret may refer to a chemical product, a combination of some elements or single
chemical formulae related to the industry. Taking some measures like restricting
access to the information and maintaining non-disclosure agreements among the
employees in the industry are part of protecting trade secrets. There is no specific
legislation in India for protecting undisclosed information. For example, the Coco-Cola
has a trade secret. The formulae for the taste and the combination of Coco-Cola, is
kept as secret in the vault of a bank in Georgia.
GEOGRAPHICAL INDICATIONS
The Geographical Indication is a sign of merchandise possesses some specific qualities
and known in the name of a particular geographical area as its origin and a similar
product may not be available elsewhere satisfying all these characteristics. It is
assigned along with the name of the place from which it is originated. This can be
used for a wide variety of products. Among them agricultural products like Darjeeling
tea, Alphonso mango, Mysore sandel, Pokkali rice, and Nagpur orange are widely
recognised in India and foreign countries. Kancheepuram Silk and Aranmula kannadi
are exceptional and familiar to public as the names of genuine and trustable products
guaranteeing certain qualities. The office of the Registrar of Geographical Indications,
Chennai receives all requests on GI in the country.

11. • LAYOUT DESIGN OF INTEGRATED CIRCUITS
The designing of layout of an integrated circuit is the process involving a two or three
dimensional layout or the topography of an IC. It is also termed as mask work. This
structure consists of elements include transistors, other circuitry elements and lead
wires connecting to them. In order to get protection for semiconductor IC layout
designs, an act came into force in India in the year 2000. In the event, the layout of a
circuit found not original, commercially exploited anywhere in India, inherently not
distinctive or not in a distinguishable form from registered layout design will not be
considered for registration under this act. The period of legal coverage will be of ten
years. The Semiconductor Integrated Circuit Layout Design Registry at New Delhi is the
issuing authority of rights regarding design of Integrated Circuits.

12. • FACTORS AFFECTING INTELLECTUAL PROPERTY
• The strength of patent claims and other IP;
• How much of a competitive advantage the IP brings its
owner;
• The size and profitability of the markets for products
that are protected by the IP (and whether those
products can be brought to market);
• How the IP will be used (e.g., to improve products, as a
barrier to competitive entry, or defensively as a cross
licensing tool); and
• How rich and determined are other parties that may
wish to challenge the IP.

13. FACTORS AFFECTING INTELLECTUAL PROPERTY
Term of market exclusivity - Market exclusivity provided by regulatory approval
- Extensions for pediatric investigation
- Extensions for orphan drugs
Patentability standards - Utility/industrial applicability
- Novelty (and grace periods) Priority rules
Trademarks - Protection of brand names
- Protection of "trade dress"
Copyright - Marketing/training materials
Database protection - Proprietary collections/linking of physical, genomic,
epidemiological data

14. INFRINGEMENT
• Infringement is breach or the contravention of the prescribed
procedure of the law. When a person acts ultravires, it becomes a
breach of law which ultimately results in violation or infringement
of law. Infringement is described as "a crime less serious than a
felony.“
Infringement of Intellectual Property
• The use of intellectual property by a stranger without the prior
consent of the owner is infringement of intellectual property.
• The infringement of Intellectual Properties includes Patent
Infringement, Trademark Infringement, Copyright Infringement,
etc.
Patent Infringement
• A person can use a patented product by seeking permission from
the owner. This permission may typically be granted in the form of
a license. In case of India, the patent infringement proceedings can
be initiated only after the grant of patent. Persons involved in
making, using, selling, distributing, importing or offering any of the
above may be held liable for infringement.

15. TRADE MARK INFRINGEMENT
• It is a violation of exclusive rights attaching to a trademark without
the authorization of the trademark owner or licensees (provided that
such sanction was within the scope of the license). Infringement may
occur when one party, the "infringer", uses a trademark which is
identical or confusingly similar to a trademark owned by other party,
in relation to products or services which are identical or similar to the
products or services which the registration covers.
COPYRIGHT INFRINGEMENT
• Copyright infringement or copy right violation is the unauthorized use
of material that is covered by copyright law, in a manner that violates
one of the copy right owner's exclusive rights, such as the right to
reproduce or perform the copyrighted work, or to make derivative
works. For electronic and audio visual media, unauthorized
reproduction and distribution is occasionally referred to as piracy
• The true test to determine infringement is when a trader, spectator or
viewer after having read or seen both the works should get an
unmistakable impression that the subsequent work appears to be a
copy of the first.

16. • PENALITIES OF IP INFRINGEMENT IN INDIA
Intellectual property Infringement is basically using someone else’s Intellectual property
without the consent of the owner of that Intellectual Property. When a person acts
Ultravires, he is breaching the law. Infringement is “a crime less serious than a felony”.
• IP laws in India are governed and protected under the Patents Act, 1970; Trademarks Act,
1999; Copyrights Act, 1957; Designs Act, 2001 etc. Civil and Criminal remedies mentioned
under these acts are of utmost importance for the IP rights enforcement.
• In this context, the principal function of the judiciary is to provide legal remedies against
infringement of personal and property rights of persons. Infringement of intellectual
property rights is considered as tortious invasion of property.
• The courts in India have the power to grant reliefs in cases pertaining to the violation
and/or infringement of intellectual property rights. The judiciary not only does the
adjudication of the intellectual property matters but it also interprets several IP
statutes for better understanding.
• The various IP laws in India mention the provisions of civil and criminal remedies
for IP rights enforcement. These civil and criminal remedies are distinct and
independent. Also, they can be availed simultaneously.

17. CIVIL REMEDIES
• Upon IP infringement civil remedies can be enforced by filing a suit for
infringement and/or passing off (in case of unregistered trademarks) in the
competent court. Following reliefs of civil nature can be granted:
• 1. Injunction
2. Anton Pillar orders or Ex-parte orders
3. Orders for deliver up/surrender or seize and destroy
4. An award of costs and damages
5. Tracing orders
• An injunction is the prohibition of an action by a party to a lawsuit. If the
plaintiff establishes that the prima facie case is in his favour, an injunction is
granted.
• Anton Pillar orders permit the plaintiff’s counsel to enter the infringer’s
premises and seize evidence of infringement. This order is passed when there is
a serious danger of removal/destruction of the infringing articles. Such an order
is granted on an ex-parte application. Infringing goods are delivered to the
plaintiff or destroyed if the orders of delivery-up and destruction are passed.
• Under tracing remedies, an infringer can be ordered to provide details like from
where he got his supplies of infringing goods. Failure to provide such
information is taken as contempt of court.
• An award of cost and damages are two mutually exclusive remedies. Damages
are granted to compensate the losses incurred by the plaintiff on account of the
defendant’s infringing act, whereas actual amounts of profits are handed over
to the plaintiff as the second measure.

18. • CRIMINAL REMEDIES
• Criminal remedies in India are provided only for Trademarks and
copyrights.
• Section 63 of the Copyright Act, 1957 deals with ‘Offences of
Infringement of copyright or other rights conferred by the act’. It
mentions about imprisonment for a term not less than 6 months which
may extend up to 3 years and fine not less than 50,000 rupees which may
extend up to 2 lakh rupees, as punishment if found guilty in a copyright
infringement case. This term and fine can be increased according to the
provisions of Section 63A of the Copyright Act, 1957.
• Chapter XII of the Trademarks Act, 1999 deals with offences, penalties
and procedures pertaining to trademark infringement. Here on account of
trademark infringement, the punishment can go as high as imprisonment
up to 3 years with or without fine. The fine ranges from 50,000 to 2 lakh
rupees. This term and fine can be increased as per the provisions of the
Section 105 of the Trademarks Act, 1999.
• Indian Patent Act, 1970 also considers falsification of entries in register,
claiming patent rights in an unauthorized way etc. to be punishable
criminal offences. Such penalties are mentioned under Chapter XX of the
Indian Patents Act, 1970.

19. • REMEDIES AVAILABLE FOR INFRINGEMENT
• When there is a violation or an infringement of an intellectual property, it
becomes the sole right of the Intellectual property holder to obtain a
remedy for the infringement of something that he has acquired with a lot
of hard work and tremendous efforts .
Patent Infringement Remedies
• A Suit for Infringement of Patent has to be filed before the District Court
or the High Court (depending on the pecuniary jurisdiction) within whose
territorial jurisdiction the cause of action has arisen.However if the
counter claim for revocation has been filed against the same, only the
High Court has the jurisdiction to entertain the matter.
• The reliefs that a court may grant in a patent infringement suit, would
include an injunction and, at the option of the plaintiff either damages or
an account of profits. The court may also order that the goods which are
found to be infringing and materials and implement, the predominant
use of which is in the creation of infringing goods shall be seized,
forfeited or destroyed, as the court deems fit under the circumstances of
the case without payment of any compensation

20. TRADEMARK INFRINGEMENT REMEDIES
• An owner of a Trademark may commence legal proceedings against a
party which infringes its registration O A Suit for Infringement has to be
filed before the District Court or the High Court (depending on the
pecuniary jurisdiction) within whose territorial jurisdiction the cause of
action has arisen.
• The Criminal Remedies available are that a suit for the above offences
can be filed before the magistrate within whose territorial jurisdiction the
offence is committed or Police can register an FIR and prosecute directly;
(statutory requirement to obtain the Registrar's approval).
COPYRIGHT INFRINGEMENT REMEDIES
• A Suit for Infringement of copyright has to be filed in a District Court or a
High Court (depending on the pecuniary jurisdiction) within whose
territorial jurisdiction the cause of action has arisen.
• There are also Administrative Remedies available to the copyright,
trademark and patent which include ban of import or export of goods
including protection of patents, trademarks and copyrights confiscation of
infringing material by Excise Authorities and delivery to the owner

21. • ROLE OF IP IN PHARMACEUTICAL INDUSTRY
• Intellectual Property is essential for the continued innovation of new
medicines, and holds utmost importance in the pharmaceutical industry,
explained in the points mentioned below.
• PROTECTION OF MEDICAL INVENTION
Once a person or a company has designed or developed a new drug or medical
treatment, they must protect it either by filing a Patent Application or by
keeping it as Trade Secret. However, in the case of trade secrets, a drug can be
reverse-engineered, leading to the invention getting stolen, whereas a patent
offers much more watertight protection.
• DRIVES ECONOMIC GROWTH AND COMPETITIVENESS
Intellectual Property leads to the significant economic growth of a
pharmaceutical company by awarding the sole intellectual property rights to
the inventor of a medication or treatment. All the marketing rights of the
invention lie solely with the inventor with further options of even selling or
licensing it.
• PROTECTION OF CONSUMERS AND FAMILIES
In the pharmaceutical industry, Intellectual Property’s main interest lies in
public safety as it helps the consumers in making the right choice while
selecting a medical product. Intellectual property rights help in ensuring a
standard by assuring quality, which further establishes a reliable and effective
public health infrastructure.

22. • PROTECTION AGAINST POTENTIAL INFRINGERS
Intellectual property rights allow pharmaceutical companies to
take strict actions against counterfeit drugs. Without such rights,
countries across the globe would have a difficult time in ensuring
the safety of their medical inventions.
GENERATE SOLUTIONS TO GLOBAL CHALLENGES
• Promoting innovation is very important but at the same time you
need funding to do it. IPR gives you the right encouragement to
do it. There is a need for developing new drugs and vaccines as
there are new diseases being discovered daily or there is
resistance development by the pathogen.

23. ENCOURAGE INNOVATION AND REWARD ENTREPRENEURS
It is very important that the right push is given for inventors to keep them
motivated. It is also important that they are recognized for their work. IPR
gives them this encouragement. It enables a free flow of information by
enabling a safe environment. When you know it is safe to share your
invention then there is going to be a safe channel for exchange.
• BOTTOM LINE
The pharmaceutical industry should make sincere efforts to manage their IP
Rights rather than just acquiring them from the national or regional IP
Offices. It is a matter of fact that yes; Patent and Trademark Rights are not
of much worth unless they are adequately exploited. Enterprises in the
pharmaceutical industry should extract full value from their IP assets and
medical inventions by taking adequate steps to develop an IP strategy for
dealing with possible infringers. Therefore, enforcement of IP Rights is
crucial to ensure that their intellectual property is respected in the
marketplace.