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Introduction to
Intellectual Property Rights
Contents as per Syllabus
 Introduction,
 IP laws in India,
 Definitions,
 Geographical Indications,
 Industrial Design,
 Patents,
 Copyright,
 Trademark.
2
Introduction
 WIPO (World Intellectual Property Organization) was established by the WIPO
Convention in 1967.
 The WIPO is a specialized agency of the United Nations.
 It promotes the protection of IP throughout the world. Its headquarters are in Geneva,
Switzerland. Worlds intellectual property day is April 26.
 On World Intellectual Property Day this year, WIPO's focus is on promoting Visionary
Innovation as the key to a secure future.
 Intellectual property (IP) pertains to any original creation of the human intellect such
as artistic, literary, technical, or scientific creation.
3
Introduction
 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.
 IPR is a strong tool, to protect investments, time, money, effort invested by the
inventor/creator of an IP, since it grants the inventor/creator an exclusive right for a
certain period of time for use of his invention/creation.
 Thus IPR, in this way aids the economic development of a country by promoting
healthy competition and encouraging industrial development and economic growth.
4
Definitions
 Invention: Invention means a new product or process involving an inventive step and capable of industrial
application. It is a conception of new ideas.
 Innovation: Innovation is an application adoption of the idea. e.g. it is the process that moves the idea into
market place.
 Patent: A patent is an IPR relating to invention, it is a grant of exclusive right, for a limited period, provided by
the govt. to the patentee, in exchange of full disclosure of his invention, & excluding other from Making, using,
selling, importing the patented product or process.
 Copyright: The rights of the Author of literary & Artistic work are protected by the copyright. For the
minimum period of 50 years after the death of the author.
 Trademark: Can be characterized as protection of distinctive sign or logos and geographical indications (GIs).
5
Definitions
 Distinctive sign: Which distinguish the goods and services of one undertaking from those of the other.
 Geographical Indications (GIs): Which identify the goods as originating in a place where a given characteristic
of goods is essentially attributed to its Geographical origin.
 Novelty: The essential conduction for patentability, that what is claimed is new.
 Absolute Novelty: A system where by any prior publication anywhere, destroys the novelty of a patent.
 Local Novelty: The principle that a patent can be invalidated by prior publication only if the publication was in
the country granting the patent.
 Mixed Novelty: The principle that a patent can be invalidated by prior printed publication anywhere in the
world, but by prior use only in the country granting the patent. Amendment: Alteration made to patent
specification during prosecution or after grant.
6
Definitions
 Compulsory License: A license which government authorities or court force the patentee to grant to
another party.
 Convention Country: A state which is a member of Paris convention for the protection of industrial
property.
 Doha License: A compulsory license granted to allow export of patented pharmaceutical to a developing
country.
 Exclusive Marketing Rights: The right of a person filing a black box application to exclude competitors
until his application is granted or refused, if certain conditions are met.
 Foreign Filing: Filing in countries other than the country of first filing.
7
Intellectual Property Law in India
 There are many big and small intellectual property law firms worldwide, like in India, USA, UK,
Chicago etc, providing qualitative help to inventors and creators of product.
 In India intellectual property rights are safely protected and controlled by well-established
statutory and judicial framework.
 Apart From that, there are many attorneys and law firm of intellectual property in India in
various states.
 Intellectual Property is a property that arises from the human intellect.
 It is a product of human creation. Intellectual Property comprises 2 distinct forms:
 Literary and Artistic Works
 Industrial Property
8
Intellectual Property Law in India
 Literary and Artistic Works:
 They are books, paintings, musical compositions, plays, movies, radio/tv programs,
performances and other artistic works.
 They are Protected by “COPYRIGHT”.
 Industrial Property:
 Industrial Property describes physical matter that is the product of an idea or concept for
commercial purposes.
 They are protected by:
Patented objects,
Trademarks,
Industrial Designs,
Trade Secrets,
Layout-designs,
Geographical Indications.
9
Major Types of IPR
 Functional and Technical Inventions: Patents Act, 1970 Amended in 1999 and 2005.
 Purely Artistic works: Copyright Act, 1957 Amended in 1982, 1984, 1992, 1994 and 1999.
 A symbol, logo, word, sound, colour, design, etc.: Trademark Act, 1999 Amended in 1994, 1996
and 2000.
10
Geographical Indications
Geographical Indications
 GI is a sign used on products that have a specific geographical origin and possess qualities or a
reputation that are due to that origin.
 In order to function as a GI, a sign must identify a product as originating in a given place.
 A GI is a sign used on products that have a specific geographical origin and possess qualities or a
reputation that are due to that origin.
 In order to function as a GI, a sign must identify a product as originating in a given place.
 In addition, the qualities, characteristics or reputation of the product should be essentially due
to the place of origin. Since the qualities depend on the geographical place of production, there is
a clear link between the product and its original place of production.
12
Benefits of Geographical Indication
 It confers legal protection.
 Prevents unauthorized use of a Registered Geographical Indication by others.
 It promotes economic prosperity of producers of goods produced in a geographical territory.
 Boosts the export.
 Can serve as source-identifiers for consumers. Helps the producers develop consumer loyalty.
 Plays a role in consumer decisions, including willingness to pay a higher price for regionally
branded food products.
 For example, geographic location is an important component of wine pricing.
13
Examples of GIs in India
 Basmati rice,
 Mysore silk,
 Mysore sandalwood oil,
 Mysore sandal soap,
 Mysore jasmine,
 Coorg orange,
 Madhubani paintings,
 Darjeeling tea,
 Dharwad pedha,
 Alphonso mango.
14
Examples of GIs in World
 Canadian whisky,
 Swiss watches,
 Florida oranges,
 Champagne,
 Tequilla.
15
16
Geographical Indication in India
 India, as a member of the World Trade Organization (WTO), enacted the Geographical Indications of
Goods (Registration and Protection) Act, 1999 has come into force with effect from 15 Sep. 2003.
 The Central Government of India has established the Geographical Indications Registry with all
India jurisdiction in Chennai.
 The GI Act is being administered by the Controller General of Patents, Designs and Trade Marks ‐
who is the Registrar of Geographical Indications.
 Agreement on Trade-Related Aspects of Intellectual Property Rights (1994).
 Two basic obligations on WTO member governments relating to GIs in the TRIPS agreement.
 Article 22: Prevent misleading the public as to the geographical origin of the good.
 Article 23: prevent the use of a geographical indication identifying wines not originating in the place.
17
Trade Related Intellectual Property Rights (TRIPS)
 TRIPS is an international legal agreement between all the member nations of the World Trade
Organization (WTO).
 It sets down minimum standards for the regulation by national governments of many forms of
intellectual property (IP) as applied to nationals of other WTO member nations.
 TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and
Trade (GATT) in 1994 and is administered by the WTO.
 The TRIPS agreement introduced intellectual property law into the international trading system
for the first time and remains the most comprehensive international agreement on intellectual
property to date.
 In 2001, developing countries, concerned that developed countries were insisting on an overly
narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration.
 The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that
TRIPS can and should be interpreted in light of the goal "to promote access to medicines for all."
18
Status of Geographical Indication
Registrations in India
 Around 65 GI’s of Indian origin have already been registered with the GI Registry.
 These include GI like:
 Darjeeling (tea),
 Pochampalli, Ikat (textiles),
 Chanderi (sarees),
 Kancheepuram silk (textiles),
 Kashmir Pashmina (shawls),
 Kondapalli (toys),
 Mysore (agarbattis).
19
Industrial Design
Industrial Design
 An industrial design (or design patent) is a form of intellectual property protection available for design
innovators in a country.
 It is focused on protecting the visual features of an article, namely its design, shape, pattern or ornament.
 For example, an industrial design could protect an original design or shape of shoes.
 In contrast, a change in the functionality of an article or in the materials used to manufacture an article are
not aspects which are eligible for industrial design protection.
 An industrial design is different from a patent, which aims to protect an improvement in functionality.
 Industrial designs do not protect intangible goods that are not visible to the eye.
21
Industrial Design
 “Industrial design is an applied art whereby the aesthetics and usability of mass-produced products may be
improved for marketability and production. The role of an Industrial Designer is to create and execute
design solutions towards problems of form, usability, user ergonomics, engineering, marketing, brand
development and sales.”
 Industrial Design is concerned with all the human aspects of machine-made products and their relationship
to people and the environment.
 The designer is responsible for these products and their impact on society and nature.
 The designer accounts for the product's human factors engineering, safety, form, color, maintenance and
cost.
 Industrial design deals with consumer products as well as industrial products.
22
History of Industrial Design
 The school of St. Peter, at Lyons was founded about 1750 for the instruction of draftsmen employed in
preparing patterns for the silk manufacture.
 The practical draughtsman's book of industrial design by Jacques-Eugène Armengaud was printed in 1853.
 Robert Lepper helped to establish one of the country's first industrial design degree programs at Carnegie
Institute of Technology.
 The first use of the term "industrial design" is often attributed to the industrial designer Joseph Claude Sinel in
1919 (although he himself denied this in interviews) but the discipline predates 1919 by at least a decade.
 Christopher Dresser is considered the world's first industrial designer.
 Industrial design's origins lie in the industrialization of consumer products.
 Deutscher Werkbund, founded in 1907 and a precursor to the Bauhaus, was a state-sponsored effort to
integrate traditional crafts and industrial mass-production techniques, to put Germany on a competitive
footing with England and the United States.
23
Types of Industrial Design
 Four major design and research activities:
 human behaviour,
 the human-machine interface,
 the environment, and
 the product itself.
 Rights obtained from design:
 A right to forbid others from producing, selling or importing the same products or
products with the same look for a period of 25 years and rights cover nationally.
24
India's Design Act, 2000
 Enacted to consolidate and amend the law relating to protection of design and to
comply with the articles 25 and 26 of TRIPS agreement.
 The new act, (earlier Patent and Design Act, 1911 was repealed by this act), now
defines "design" to mean only the features of shape, configuration, pattern,
ornament, or composition of lines or colours applied to any article, whether in two-
or three dimensional, or in both forms, by any industrial process or means, whether
manual or mechanical or chemical, separate or combined, which in the finished
article appeal to and are judged solely by the eye; but does not include any mode or
principle of construction.
25
Conditions to register a Design
 Condition 1-Novelty: Completely new look on the market prior to filing but could have been shown up
to 12 months before filing.
 Condition 2-Individual character: To have individual character a design: has to differ in various ways
from the designs already known.
26
Purpose to register as Industrial Design
 To have exclusive right,
 Ban others from copying,
 Certificate of ownership,
 Design registration can be used in Court,
 A better license position,
 Design registration gives a broader protection than copyright.
27
Patent
Patent Definition
 A patent describes an invention for which the inventor claims the exclusive right.
 A patent is an exclusive right granted by the government for the commercial exploitation of
invention for a specific period of time Right to prevent the use by a third party.
 Inventions patentable if:
 Any new (novel) or useful,
 Process or method,
 Machine or apparatus,
 Article of manufacture,
 Improvements of any of the above,
 Not obvious,
 Pertains to patentable subject matter.
 Patentable subject Matter:
 Inventions relate to a process or product or both,
 Involves an inventive step,
 Be capable of industrial application,
 A machine.
29
Patent Definition
 Invention must not be- Published in India or elsewhere in prior public knowledge or
prior public use with in India Claimed before in any specification in India.
 Life and Duration of Patent:
 Term of the patent is 20 years from the date of filling for all types of inventions,
 Priority date- first to file,
 The date of patent is the date of filing the application for patent,
 The term of the patent is counted from this date.
30
Advantage of Patenting
 Avoids duplication of research,
 Keeps abreast with latest development in different fields of
technology,
 Helps industry to improve existing technology to produce cheaper &
better product,
 Serves as an indicator of achievements in R & D institutions and
ability of individual researcher,
 Helps to frame business strategy according to new trend of
technology.
31
Importance of patent information
 To researcher/inventor in industry/ R & D organization/university:
 To avoid duplication of research.
 To find ready solutions to technical problems in ongoing research.
 To keep up to date with developments in technology field.
 To industry:
 To improve existing technology.
 To increase production.
 To identify suitable technologies for adaptation.
 To business enterprises:
 To identify new products for marketing.
 To find out patent owners.
 Consultants and planners:
 To advice industry / R&D / financial institutions on issues related to technology.
 To find out a new technology for business.
32
Is a patent granted in one country enforceable
in other country?
 No, there is nothing like a global patent or a world patent. Patent rights
are essentially territorial in nature.
 Granting a patent in one country of the Union does not force other
countries to grant the patent for the same invention.
 The refusal of the patent in one country does not mean that it will be
terminated in all the countries.
33
History of Indian Patent
 1856 : Act IV for the protection of inventions based on the British Patent law of 1852.
 1857 : Act IX.
 1859 : Act XV Patent monopolies called this exclusive privileges.
 1872 : Patent and Design protection Act.
 1911 : The Patent and Design Act.
 1970 : The Indian Patent act (Act 39 of 1970) come into force from 1972.
 1999 : On march 26, 1999 Patent Amendment Act, come into force from 1st Jan. 1995.
 2002 : Patent Amendment Act 2002, come into force from 20th May 2003.
 2005 : Patent Amendment Act 2005, effective from 1st Jan. 2005.
 2006 : Patent Amendment Rule on 5th May 2006.
34
Types of Patent: There are 4 types of patents in general
 A utility patent:
 It is a long, technical document that teaches the public how to use a new machine,
process, or system.
 New technologies like genetic engineering and internet-delivered software are
challenging the boundaries of what kinds of inventions can receive utility patent
protection.
 A utility patent is granted for a new product process machine method of
manufacturing and composition of matter. This category excludes most botanical
creations related to plant and agricultural use.
35
Types of Patent
 A plant patent:
Is just that a patent for a plant.
Plant patents protect new kinds of plants produced by cuttings or other
nonsexual means.
Plant patents generally do not cover genetically modified organisms and focus
more on conventional horticulture.
36
Types of Patent
 A design patent:
 Protects an ornamental design on a useful item.
 The shape of a bottle or the design of a shoe, for example, can be protected by a design patent.
 The document itself is almost entirely made of pictures or drawings of the design on the useful
item.
 Design patents are notoriously difficult to search simply because there are very few words used
in a design patent.
 In recent years, software companies have used design patents to protect elements of user
interfaces and even the shape of touchscreen devices.
 Design patents are granted for any new or original Ornamental design for an article of
manufacture.
 A design patent protects only the appearance of the article and not the article itself.
 An inventor can easily register both a utility patent and a design patent.
37
Types of Patent
 A provisional patent:
Goes hand in glove with a utility patent.
A law allows inventors to file a less formal document that proves the
inventor was in possession of the invention and had adequately figured
out how to make the invention work.
Once that is on file, the invention is patent pending.
If, however, the inventor fails to file a formal utility patent within a year
from filing the provisional patent, he or she will lose this filing date.
38
Scope of Patentability Under the Patents Act
 Invention: As per Section 2(1)(j) “Invention” means a new product or process involving an
inventive step and capable of industrial application.
 Basic criteria of patentability: The 3 basic criteria which any invention must meet in order to
deserve a patent: Novelty, Non-obviousness and Industrial application.
 Patentable subject matter:
 Invention must relate to a Process or Product or both be new (Novel) involves an inventive step
be Capable of industrial application not fall under Section 3 and 4.
 New means an invention must not be Published in India or elsewhere in prior public
knowledge or prior public use with in India, claimed before in any specification in India.
 Inventive step means a feature of an invention that involves technical advance as compared to
the existing knowledge or have economic significance or both and makes the invention not
obvious to a person skilled in the art.
 Industrial application means Invention is capable of being made or used in any kind of
industry.
39
Filing a patent application
 Documents can be filed in the patent office-
✓ through online (e-filing) or www.ipindiaonline.gov.in/online,
✓ through post or
✓ can be submitted by hand.
40
General procedure for obtaining a patent
 Filing of patent application,
 Publication after 18 months,
 Pre-Grant Opposition /Representation by any person,
 Request for examination,
 Examination: Grant or Refusal,
 Publication of Grant of patent,
 Post Grant Opposition to grant of patent,
 Decision by Controller
41
Patent offices in India and their respective
territorial jurisdiction
42
Office Territorial Jurisdiction
Intellectual Property Office, Mumbai Maharashtra, Gujarat, Madhya Pradesh, Goa and
Chhattisgarh and Union Territories of Daman and Diu &
Dadra and Nagar Haveli
Intellectual Property Office, Chennai Andhra Pradesh, Karnataka, Kerala, Tamil Nadu and
Union Territories of Pondicherry and Lakshadweep
Intellectual Property Office, New Delhi Haryana, Himachal Pradesh, Jammu and Kashmir,
Punjab, Rajasthan, Uttar Pradesh, Uttaranchal, Delhi
and the Union Territory of Chandigarh.
Intellectual Property Office, Kolkata The rest of India.
Patent Application Filing Procedure-Process in India
 Filing a patent application in the Indian Patent Office is the first step towards securing a
patent to invention in India.
 To file a patent application, a set of forms has to be submitted to the patent office.
 The forms may be submitted online if an individual have a class 3 digital certificate.
Alternatively, true copies (hard copies) to be sent to the patent office.
 The patent office charges 10% additional fee if applications are filed offline.
 The most important factor in filing a patent application is preparing a patent specification.
 Drafting a patent specification is a highly skilled job, which can be only performed by
persons who have both technical as well as patent law expertise.
 If a person or company is serious about protecting their intellectual property, it is highly
recommended to use the services of professional patent practitioners.
 Indian patent offices are located at Delhi, Kolkata, Mumbai and Chennai.
 The patent application has to be filed in the appropriate office based on company’s location.
43
Patent Application Filing Procedure-Process in India
 On identification of the patent office in which a patent application is to be filed, an overview
of the forms to be submitted.
 To file a patent application, a form 1, form 2, form 3 and form 5 is to be submitted.
 Subsequent to filing these forms with the appropriate fees, a patent application number
from the patent office will be allotted.
 A form 9 (optional) and form 18 along with filing a complete application or after filing a
complete application to be selected to file a patent.
 An Indian Patent Application forms are available online.
 In the table below, the list of forms that have to be submitted and their respective fees is
provided. The provided fee mentioned is for E-filing only.
44
The patent office charges an additional fee of
10% over the fee for applications filed offline
45
Form Title
Patent office Fee (INR) 1$ = ~ 60
INR E-Filing only
Comment
Applicant-
Natural
person/
Start-up
Applicant – other than
natural person
Small
Entity
Others except
small entity
1 Application for Grant of Patent 1600 4000 8000 Mandatory
2 Provisional/Complete Specification No fee* No fee* No fee* Mandatory
3 Statement and Undertaking Under Section 8 No fee No fee No fee Mandatory
5 Declaration as to Inventorship No fee No fee No fee Mandatory
9 Request for Publication 2500 6250 12500 Optional
18 Request for Examination of Application for Patent 4000 10000 20000 Mandatory
* – A fee of 160/400/800/sheet, based on the type of applicant, is applicable for each sheet exceeding 30 sheets in a patent specification.
Further, a fee of INR 320/800/1600/Claim, based on the type of applicant, is applicable for each claim exceeding 10 claims in the patent specification.
Various Forms used in filling patent
 Form 1 : Application for Grant of Patent
 Form 2 : Provisional/Complete Specification
 Form 3 : Statement and Undertaking Under Section 8
 Form 5 : Declaration as to Inventorship
 Form 9 : Request for Publication
 Form 18 : Request for Examination of Application for Patent
46
Patent Infringement
Patent
 A patent is a form of intellectual property.
 A patent gives its owner the right to exclude others from making, using,
selling, and importing an invention for a limited period of time, usually twenty
years.
 The invention includes drug, equipment, composition etc.,
48
Rights of a Patent Holder
 An issued patent gives the patent owner right to prevent others from
 Selling
 Making
 Offering for sale in the country or
 Importing into the country in which a patent is granted.
 Starts from the date of publication and last until the expiry of patent term
49
Patent Infringement
 If any person exercises the exclusive rights of the patent holder without permission
within the country of patent grant and during the patent term.
 A person is liable for infringement if his product or process is same as the patented
invention.
 As claims in a patent define boundaries of the invention claimed, a product or process
patent will be infringing if it falls within the scope of a claim in the patent
 Therefore, understanding the meaning and scope of patent claims is important for
determining infringement
50
Patent Infringement
 Patent infringement is the commission of a prohibited act with respect to a patented
invention without permission from the patent holder.
 It occurs when someone violates the patent rights an inventor has in his invention by making,
using or selling the invention without the patent owner’s permission (or if the patent has
been licensed), in a way not permitted by the license.
 If any person exercises the exclusive rights of the patent holder without permission within
the country of patent grant and during the patent term.
 A person is liable for infringement if his product or process is same as the patented invention.
 As claims in a patent define boundaries of the invention claimed, a product or process patent
will be infringing if it falls within the scope of a claim in the patent.
51
Types of Patent Infringement
 Direct Infringement:
 Occurs when a product is substantially close to any patented product or in a case where the
marketing or commercial use of the invention is carried out without the permission of the
owner of the invention.
 It directly states that the third party has wilfully or intentionally stolen the technology from
the inventor without his prior permission.
 It occurs when someone directly makes, uses or sells the patented invention within the
country. Direct infringement may be literal or equivalence.
52
Types of Direct Infringement
 It can include, manufacture patented technology; use patented technology;
offer patented technology for sale; sell patented technology; import patented
technology; pass off the patented.
 Literal Infringement: If all elements of a claim are literally present in an
patented product or process.
 Equivalence Infringement: If the elements of a product or process differing
from those of claim elements are present by equivalence.
53
Types of Patent Infringement
 Indirect Infringement:
 Occurs when some amount of deceit or accidental infringement happens without any
intension of infringement.
 It refers to the unfair practice that does not give a clear indication that the patent is bought
and sold in the market.
 It occurs, for instance, when a device is claimed in a patent and a third party supplies a
product which can only be reasonably used to make the claimed device.
 Indirect infringement may be induced or contributory.
54
Types of Indirect Infringement
 It can includes sell parts that can only be realistically used for a patented invention;
sell an invention with instructions on using a certain method that infringes on a
method patent; license an invention that is covered by another‘s patent; sell material
components that have been especially made for use in a patented invention and have
no other commercial use.
 Induced Infringement: A middle party (induced infringer) enables (or help,
influence or ‘induce’) a third party (direct infringer) to participate the patented
invention.
 Contributory Infringement: If a party contribute to the infringement of a patent
claim may be held liable.
55
Determining Patent Infringement56
 An act of patent infringement occurs when someone practices each and every element of a patent
claim.
 Patent claims are the numbered paragraphs at the end of patentee.
 To determine if there is infringement, patentee want to compare each segment of each claim to the
device that think is infringing.
 Below is an example of comparing a patent claim to an accused device:
 As shown above, if patentee is able to match up every element of a patent claim to an accused
device, then its proving an infringement.
Class 3 digital certificate
 Class 3 DSC provides the highest level of security and comes with 1 year, 2 year and 3 year
validity.
 A person who already has the specified Digital Signature Certificate (DSC) for any other
application can use the same for e-filing of a patent application and it is not required to
obtain a fresh DSC.
 Class 3 Digital Signature Certificate is used for E tendering (online tender) and E Auction
(online auction) purpose in India.
 Class 3 DSC is more secure and provides highest level of security as compare to Class 2
DSC.
 Class 3 Digital Signature Certificate is issued to individual or organization to authenticate
the identity of vendors while participate in e procurement activities across India.
 Individual User known as Class 3A or Class 3 individual Digital Signature Certificate.
 Company user known as Class 3B or Class 3 organization Digital Signature Certificate.
57
Orange Book
 It is the publication of “Approved Drug Products with Therapeutic Equivalence Evaluations”
by the Food and Drug Administration.
 It is prepared by The Orange Book Staff, Centre for Drug Evaluation and Research.
 It identified drug products on the basis of safety and effectiveness by the Food and Drug
Administration under the Federal Food, Drug, and Cosmetics Act.
 Drugs marketed only on the basis of safety or pre-1938 drugs.
 The list is independent of any current regulatory action against a drug product.
 The main criterion for the inclusion of any product is that the product is the subject of an
application with an effective approval that has not been withdrawn for safety or efficacy
reasons.
 The FDA does not recommend substituting drugs that have not been determined to be
bioequivalent.
 Drugs that are not listed as bioequivalent should not be substituted for each other.
58
Objectives of Orange Book
 To allow review of patterns of access and usage
 To allow discovery of use of unusual privileges
 To supply an additional form of user assurance
 To serve as a deterrent by its existence
 To allow discovery of repeated attempts to bypass protections.
59
Contents of Orange Book
1. Introduction:
 1.1 Content and Exclusion,
 1.2 Therapeutic Equivalence-Related Terms,
 1.3 Statistical Criteria for Bioequivalence,
 1.4 Reference Listed Drug,
 1.5 General Policies and Legal Status,
 1.6 Practitioner/User Responsibilities,
 1.7 Therapeutic Equivalence Evaluations Codes,
 1.8 Description of Special Situations,
 1.9 Therapeutic Equivalence Code Change for a Drug Entity,
 1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product,
 1.11 Discontinued Section,
 1.12 Changes to the Orange Book,
 1.13 Availability of the Edition.
60
2. How to use the drug products lists:
2.1 Key Sections for Using the Drug Product Lists,
2.2 Drug Product Illustration
2.3 Therapeutic Equivalence Evaluations Illustration.
Orange Book: At a glance61
Copyright
What is Copyright?
 Copyright is a legal term describing rights given to creators for their literary and
artistic works.
 Copyright include:
 Literary works such as novels, poems, plays, reference works, newspapers and computer
programs;
 Databases;
 Films, musical compositions, and choreography;
 Artistic works such as paintings, drawings, photographs and sculpture;
 Architecture;
 Advertisements, maps and technical drawings.
63
Objective of Copyright
 Copyright is a monopoly right restraining others from exercising that right
which has been conferred on the owner of copyright.
 It is a negative right meaning thereby that it is prohibitory in nature.
 It is a right to prevent others from copying or reproducing the work.
 The object of copyright is to encourage authors, composers and artists to
create original works by rewarding them the exclusive right for a specific
period to reproduce the works for publishing and selling them to the public.
 The moral basis of copyright law rests in the eighth commandment “Thou
shall not steal”.
64
Is copyright is single right?
 Copyright is not a single right.
 It is a bundle of rights in the same work.
 Example: In the case of a literary work, copyright consists of reproduction in
print media, the right of dramatic and cinematographic versions, the right of
translation, adaptation, abridgement and the right of public performance.
65
Copyright: National Vs International
 The Copyright Act of each country is compliant with most international conventions
and treaties.
 No single “International copyright” for whole world.
 In India, the Copyright Act, 1957 is compliant with these international conventions
and treaties:
 Berne Convention of 1886,
 Universal Copyright Convention of 1951,
 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
66
Indian Copyright Act, 1957
 The Copyright Act 1957 (as amended by the Copyright Amendment Act 2012) governs the subject of copyright
law in India.
 The Act is applicable from 21 January 1958.
 The history of copyright law in India can be traced back to its colonial era under the British Empire.
 The Copyright Act 1957 was the first post-independence copyright legislation in India and the law has been
amended six times since 1957.
 The most recent amendment was in the year 2012, through the Copyright (Amendment) Act 2012.
 India is a member of most of the important international conventions governing the area of copyright law,
including the Berne Convention of 1886 (as modified at Paris in 1971), the Universal Copyright Convention of
1951, the Rome Convention of 1961 and the Agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPS).
 Initially, India was not a member of the WIPO Copyright Treaty (WCT) and the WIPO Performances and
Phonograms Treaty (WPPT) but subsequently entered the treaty in 2013.
67
Amendments in Indian Copyright Act
 First right in India in 1914.
 Now, Indian Copyright Act,1957; w.e.f. 1958.
 Further amendments in 1983, 1984, 1992, 1994, 1999.
 Adopted many English provisions, introduced new ideas and concepts.
 Created Copyright Office and Copyright Board.
 Introduced civil and criminal remedies against infringement
68
Categories of Copyright
(Amendment) Act 2012
 Amendments to rights in artistic works, cinematograph films and sound
recordings,
 WCT and WPPT related amendment to rights,
 Author-friendly amendments on mode of Assignment and Licenses,
 Amendments facilitating Access to Works,
 Strengthening enforcement and protecting against Internet piracy,
 Reform of Copyright Board and other minor amendments.
69
WCT: WIPO Copyright Treaty; WPPT: WIPO Performances and Phonograms Treaty
Indian Perspective on Copyright
 The Copyright Act, 1957 confers copyright protection in the following two forms:
 Economic Rights and
 Moral Rights.
 Economic rights: Several exclusive rights typically attach to the holder of a copyright:
 to produce copies or reproductions of the work and to sell those copies (including, typically,
electronic copies),
 to import or export the work,
 to create derivative works (works that adapt the original work),
 to perform or display the work publicly,
 to sell or assign these rights to others,
 to transmit or display by radio or video.
70
Indian Perspective on Copyright
 Moral rights:
 Right of paternity to claim authorship of work and to prevent all others from claiming
authorship of his work.
 Right of integrity to prevent distortion, mutilation or other alterations of his work, or any
other action in relation to said work, which would be prejudicial to his honour or
reputation.
71
Term of Copyright
 The general rule is that copyright lasts for 60 years.
 It is counted-
From the death of the author for:
Literary,
Dramatic,
Musical,
Artistic work.
From the date of publication for:
Cinematograph films,
Sound recordings,
Photographs,
Posthumous publication,
Works of Government & International organizations.
72
Copyright
Registration
Procedure in India
73
Counterfeiting to Copyright
 Counterfeit mark: The production of certain brand bags by putting a false label, and sold at
low prices.
 Counterfeit products: Copies of articles, similar to the original under a different name
 Infringement "mixed”: Copy for both the model and brand. Ex. Fake Louis Vuitton bags or
Rolex watches for instance.
 Infringement of copyright: Copying or using the work of another creator, without his prior
permission.
 The term "counterfeit" describes fake goods.
 The term "piracy" describes the act of reproducing movies, music, books or other
copyrighted works without permission from the copyright owner.
74
Copyright infringement (Piracy)
 It is the use of works protected by copyright law without permission for a usage where such
permission is required, thereby infringing certain exclusive rights granted to the copyright
holder, such as the right to reproduce, distribute, display or perform the protected work, or
to make derivative works.
 The copyright holder is typically the work's creator, or a publisher or other business to
whom copyright has been assigned.
 Copyright holders routinely invoke legal and technological measures to prevent and penalize
copyright infringement.
 Copyright infringement disputes are usually resolved through direct negotiation, a notice
and take down process, or litigation in civil court.
75
Trademark
Background of Trademark
 Today’s consumers are Brand oriented and therefore, using deceptive name can affect the
market for original brand hugely.
 When the brand value is used without prior approval, the owner looks for the legal
remedies to protect its brand value.
 Stopping non-permitted use of the trademark is equally important as trademark
registration.
 Therefore, the special Act for the protection of trade names is enforced as Trademark Act,
1999 with an aim to provide exclusive right to use the brand name and stop unauthorized
use by any other person including the competitors.
 Hence, to protect the brand name and the value created, the brand name and logo are
registered as a trademark under this Act.
77
Trademark
 A trademark is a word, phrase or a unique symbol, which is used by an individual,
business organization or other legal entity to distinctively identify the source of their
products or services to customers, and to differentiate their products or services from
other entities.
 A registered trademark is designated with encircled R symbol (®).
 The certificate of trademark registration provides exclusive rights to the proprietor to use
the brand name for their business activity falling under the class in which it is registered.
78
Trademark
 A trademark is a distinctive sign that identifies certain goods or services as those
produced or provided by a specific person or enterprise.
 It may be one or a combination of words, letters, and numerals.
 They may consist of drawings, symbols, three- dimensional signs such as the shape
and packaging of goods, audible signs such as music or vocal sounds, fragrances, or
colours used as distinguishing features.
 It provides protection to the owner of the mark by ensuring the exclusive right to use
it to identify goods or services, or to authorize another to use it in return for payment.
79
Trademark
 It helps consumers identify and purchase a product or service because its nature and
quality, indicated by its unique trademark, meets their needs.
 Registration of trademark is prima facie proof of its ownership giving statutory right to the
proprietor.
 Trademark rights may be held in perpetuity.
 The initial term of registration is for 10 years; thereafter it may be renewed from time to
time.
 A trademark (also written trade mark or trade-mark is a type of intellectual property
consisting of a recognizable sign, design, identifies or expression which products or
services of a particular source from those of others, although trademarks used to identify
services are usually called service marks.
80
Designation of Trademark
 A trademark may be designated by the following symbols:
™ (the "trademark symbol", which is the letters "TM" in superscript, for
an unregistered trademark, a mark used to promote or brand goods),
℠ (which is the letters "SM" in superscript, for an unregistered service mark, a
mark used to promote or brand services),
® (the letter "R" surrounded by a circle, for a registered trademark).
81
Infringement of
Trademark & Remedies
 When the exclusive rights of the owner of the registered Trademark are violated, it is said to
be an infringement of Trademark.
 In form of Injunction: The action of an injunction is referred as stopping one person from
doing particular activity or task through the judicial process.
 In form of Damages: Damages refer to the recovery of loss faced by the trademark owner
through the trademark infringement. The monetary value of financial loss or brand
impairment is recovered under this head
 Custody of infringing materials: This remedy suggests that the Court may ask the infringer
to deliver all the goods/products that are labelled with the brand name. Here, the Court may
direct the authorities to withhold the related materials accounts & destruct all such goods.
82
Applied and Registered
Trademark Symbol
 Applied Trademark Symbol-™:
 In India, the owner of the mark can use the symbol next to his/her mark when the application
for trademark registration has been successfully filed with the IP India.
 It is used to represent the fact that registration for the particular trademark is already in the process,
and thus, acts as a warning for infringers.
 Registered Trademark Symbol-®:
 The R symbol represents the fact that the trademark has been successfully registered with the Indian
Trademarks Registry.
 Once the trademark is registered, it gives the owner of the mark exclusive rights to use the mark to
represent his/her goods or services.
 No one else would be able to use the mark without the permission or license of the trademark
proprietor.
 Therefore, the ® symbol warns others about the fact that the trademark has already been registered.
83

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Introduction to intellectual property rights

  • 2. Contents as per Syllabus  Introduction,  IP laws in India,  Definitions,  Geographical Indications,  Industrial Design,  Patents,  Copyright,  Trademark. 2
  • 3. Introduction  WIPO (World Intellectual Property Organization) was established by the WIPO Convention in 1967.  The WIPO is a specialized agency of the United Nations.  It promotes the protection of IP throughout the world. Its headquarters are in Geneva, Switzerland. Worlds intellectual property day is April 26.  On World Intellectual Property Day this year, WIPO's focus is on promoting Visionary Innovation as the key to a secure future.  Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. 3
  • 4. Introduction  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.  IPR is a strong tool, to protect investments, time, money, effort invested by the inventor/creator of an IP, since it grants the inventor/creator an exclusive right for a certain period of time for use of his invention/creation.  Thus IPR, in this way aids the economic development of a country by promoting healthy competition and encouraging industrial development and economic growth. 4
  • 5. Definitions  Invention: Invention means a new product or process involving an inventive step and capable of industrial application. It is a conception of new ideas.  Innovation: Innovation is an application adoption of the idea. e.g. it is the process that moves the idea into market place.  Patent: A patent is an IPR relating to invention, it is a grant of exclusive right, for a limited period, provided by the govt. to the patentee, in exchange of full disclosure of his invention, & excluding other from Making, using, selling, importing the patented product or process.  Copyright: The rights of the Author of literary & Artistic work are protected by the copyright. For the minimum period of 50 years after the death of the author.  Trademark: Can be characterized as protection of distinctive sign or logos and geographical indications (GIs). 5
  • 6. Definitions  Distinctive sign: Which distinguish the goods and services of one undertaking from those of the other.  Geographical Indications (GIs): Which identify the goods as originating in a place where a given characteristic of goods is essentially attributed to its Geographical origin.  Novelty: The essential conduction for patentability, that what is claimed is new.  Absolute Novelty: A system where by any prior publication anywhere, destroys the novelty of a patent.  Local Novelty: The principle that a patent can be invalidated by prior publication only if the publication was in the country granting the patent.  Mixed Novelty: The principle that a patent can be invalidated by prior printed publication anywhere in the world, but by prior use only in the country granting the patent. Amendment: Alteration made to patent specification during prosecution or after grant. 6
  • 7. Definitions  Compulsory License: A license which government authorities or court force the patentee to grant to another party.  Convention Country: A state which is a member of Paris convention for the protection of industrial property.  Doha License: A compulsory license granted to allow export of patented pharmaceutical to a developing country.  Exclusive Marketing Rights: The right of a person filing a black box application to exclude competitors until his application is granted or refused, if certain conditions are met.  Foreign Filing: Filing in countries other than the country of first filing. 7
  • 8. Intellectual Property Law in India  There are many big and small intellectual property law firms worldwide, like in India, USA, UK, Chicago etc, providing qualitative help to inventors and creators of product.  In India intellectual property rights are safely protected and controlled by well-established statutory and judicial framework.  Apart From that, there are many attorneys and law firm of intellectual property in India in various states.  Intellectual Property is a property that arises from the human intellect.  It is a product of human creation. Intellectual Property comprises 2 distinct forms:  Literary and Artistic Works  Industrial Property 8
  • 9. Intellectual Property Law in India  Literary and Artistic Works:  They are books, paintings, musical compositions, plays, movies, radio/tv programs, performances and other artistic works.  They are Protected by “COPYRIGHT”.  Industrial Property:  Industrial Property describes physical matter that is the product of an idea or concept for commercial purposes.  They are protected by: Patented objects, Trademarks, Industrial Designs, Trade Secrets, Layout-designs, Geographical Indications. 9
  • 10. Major Types of IPR  Functional and Technical Inventions: Patents Act, 1970 Amended in 1999 and 2005.  Purely Artistic works: Copyright Act, 1957 Amended in 1982, 1984, 1992, 1994 and 1999.  A symbol, logo, word, sound, colour, design, etc.: Trademark Act, 1999 Amended in 1994, 1996 and 2000. 10
  • 12. Geographical Indications  GI is a sign used on products that have a specific geographical origin and possess qualities or a reputation that are due to that origin.  In order to function as a GI, a sign must identify a product as originating in a given place.  A GI is a sign used on products that have a specific geographical origin and possess qualities or a reputation that are due to that origin.  In order to function as a GI, a sign must identify a product as originating in a given place.  In addition, the qualities, characteristics or reputation of the product should be essentially due to the place of origin. Since the qualities depend on the geographical place of production, there is a clear link between the product and its original place of production. 12
  • 13. Benefits of Geographical Indication  It confers legal protection.  Prevents unauthorized use of a Registered Geographical Indication by others.  It promotes economic prosperity of producers of goods produced in a geographical territory.  Boosts the export.  Can serve as source-identifiers for consumers. Helps the producers develop consumer loyalty.  Plays a role in consumer decisions, including willingness to pay a higher price for regionally branded food products.  For example, geographic location is an important component of wine pricing. 13
  • 14. Examples of GIs in India  Basmati rice,  Mysore silk,  Mysore sandalwood oil,  Mysore sandal soap,  Mysore jasmine,  Coorg orange,  Madhubani paintings,  Darjeeling tea,  Dharwad pedha,  Alphonso mango. 14
  • 15. Examples of GIs in World  Canadian whisky,  Swiss watches,  Florida oranges,  Champagne,  Tequilla. 15
  • 16. 16
  • 17. Geographical Indication in India  India, as a member of the World Trade Organization (WTO), enacted the Geographical Indications of Goods (Registration and Protection) Act, 1999 has come into force with effect from 15 Sep. 2003.  The Central Government of India has established the Geographical Indications Registry with all India jurisdiction in Chennai.  The GI Act is being administered by the Controller General of Patents, Designs and Trade Marks ‐ who is the Registrar of Geographical Indications.  Agreement on Trade-Related Aspects of Intellectual Property Rights (1994).  Two basic obligations on WTO member governments relating to GIs in the TRIPS agreement.  Article 22: Prevent misleading the public as to the geographical origin of the good.  Article 23: prevent the use of a geographical indication identifying wines not originating in the place. 17
  • 18. Trade Related Intellectual Property Rights (TRIPS)  TRIPS is an international legal agreement between all the member nations of the World Trade Organization (WTO).  It sets down minimum standards for the regulation by national governments of many forms of intellectual property (IP) as applied to nationals of other WTO member nations.  TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994 and is administered by the WTO.  The TRIPS agreement introduced intellectual property law into the international trading system for the first time and remains the most comprehensive international agreement on intellectual property to date.  In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration.  The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal "to promote access to medicines for all." 18
  • 19. Status of Geographical Indication Registrations in India  Around 65 GI’s of Indian origin have already been registered with the GI Registry.  These include GI like:  Darjeeling (tea),  Pochampalli, Ikat (textiles),  Chanderi (sarees),  Kancheepuram silk (textiles),  Kashmir Pashmina (shawls),  Kondapalli (toys),  Mysore (agarbattis). 19
  • 21. Industrial Design  An industrial design (or design patent) is a form of intellectual property protection available for design innovators in a country.  It is focused on protecting the visual features of an article, namely its design, shape, pattern or ornament.  For example, an industrial design could protect an original design or shape of shoes.  In contrast, a change in the functionality of an article or in the materials used to manufacture an article are not aspects which are eligible for industrial design protection.  An industrial design is different from a patent, which aims to protect an improvement in functionality.  Industrial designs do not protect intangible goods that are not visible to the eye. 21
  • 22. Industrial Design  “Industrial design is an applied art whereby the aesthetics and usability of mass-produced products may be improved for marketability and production. The role of an Industrial Designer is to create and execute design solutions towards problems of form, usability, user ergonomics, engineering, marketing, brand development and sales.”  Industrial Design is concerned with all the human aspects of machine-made products and their relationship to people and the environment.  The designer is responsible for these products and their impact on society and nature.  The designer accounts for the product's human factors engineering, safety, form, color, maintenance and cost.  Industrial design deals with consumer products as well as industrial products. 22
  • 23. History of Industrial Design  The school of St. Peter, at Lyons was founded about 1750 for the instruction of draftsmen employed in preparing patterns for the silk manufacture.  The practical draughtsman's book of industrial design by Jacques-Eugène Armengaud was printed in 1853.  Robert Lepper helped to establish one of the country's first industrial design degree programs at Carnegie Institute of Technology.  The first use of the term "industrial design" is often attributed to the industrial designer Joseph Claude Sinel in 1919 (although he himself denied this in interviews) but the discipline predates 1919 by at least a decade.  Christopher Dresser is considered the world's first industrial designer.  Industrial design's origins lie in the industrialization of consumer products.  Deutscher Werkbund, founded in 1907 and a precursor to the Bauhaus, was a state-sponsored effort to integrate traditional crafts and industrial mass-production techniques, to put Germany on a competitive footing with England and the United States. 23
  • 24. Types of Industrial Design  Four major design and research activities:  human behaviour,  the human-machine interface,  the environment, and  the product itself.  Rights obtained from design:  A right to forbid others from producing, selling or importing the same products or products with the same look for a period of 25 years and rights cover nationally. 24
  • 25. India's Design Act, 2000  Enacted to consolidate and amend the law relating to protection of design and to comply with the articles 25 and 26 of TRIPS agreement.  The new act, (earlier Patent and Design Act, 1911 was repealed by this act), now defines "design" to mean only the features of shape, configuration, pattern, ornament, or composition of lines or colours applied to any article, whether in two- or three dimensional, or in both forms, by any industrial process or means, whether manual or mechanical or chemical, separate or combined, which in the finished article appeal to and are judged solely by the eye; but does not include any mode or principle of construction. 25
  • 26. Conditions to register a Design  Condition 1-Novelty: Completely new look on the market prior to filing but could have been shown up to 12 months before filing.  Condition 2-Individual character: To have individual character a design: has to differ in various ways from the designs already known. 26
  • 27. Purpose to register as Industrial Design  To have exclusive right,  Ban others from copying,  Certificate of ownership,  Design registration can be used in Court,  A better license position,  Design registration gives a broader protection than copyright. 27
  • 29. Patent Definition  A patent describes an invention for which the inventor claims the exclusive right.  A patent is an exclusive right granted by the government for the commercial exploitation of invention for a specific period of time Right to prevent the use by a third party.  Inventions patentable if:  Any new (novel) or useful,  Process or method,  Machine or apparatus,  Article of manufacture,  Improvements of any of the above,  Not obvious,  Pertains to patentable subject matter.  Patentable subject Matter:  Inventions relate to a process or product or both,  Involves an inventive step,  Be capable of industrial application,  A machine. 29
  • 30. Patent Definition  Invention must not be- Published in India or elsewhere in prior public knowledge or prior public use with in India Claimed before in any specification in India.  Life and Duration of Patent:  Term of the patent is 20 years from the date of filling for all types of inventions,  Priority date- first to file,  The date of patent is the date of filing the application for patent,  The term of the patent is counted from this date. 30
  • 31. Advantage of Patenting  Avoids duplication of research,  Keeps abreast with latest development in different fields of technology,  Helps industry to improve existing technology to produce cheaper & better product,  Serves as an indicator of achievements in R & D institutions and ability of individual researcher,  Helps to frame business strategy according to new trend of technology. 31
  • 32. Importance of patent information  To researcher/inventor in industry/ R & D organization/university:  To avoid duplication of research.  To find ready solutions to technical problems in ongoing research.  To keep up to date with developments in technology field.  To industry:  To improve existing technology.  To increase production.  To identify suitable technologies for adaptation.  To business enterprises:  To identify new products for marketing.  To find out patent owners.  Consultants and planners:  To advice industry / R&D / financial institutions on issues related to technology.  To find out a new technology for business. 32
  • 33. Is a patent granted in one country enforceable in other country?  No, there is nothing like a global patent or a world patent. Patent rights are essentially territorial in nature.  Granting a patent in one country of the Union does not force other countries to grant the patent for the same invention.  The refusal of the patent in one country does not mean that it will be terminated in all the countries. 33
  • 34. History of Indian Patent  1856 : Act IV for the protection of inventions based on the British Patent law of 1852.  1857 : Act IX.  1859 : Act XV Patent monopolies called this exclusive privileges.  1872 : Patent and Design protection Act.  1911 : The Patent and Design Act.  1970 : The Indian Patent act (Act 39 of 1970) come into force from 1972.  1999 : On march 26, 1999 Patent Amendment Act, come into force from 1st Jan. 1995.  2002 : Patent Amendment Act 2002, come into force from 20th May 2003.  2005 : Patent Amendment Act 2005, effective from 1st Jan. 2005.  2006 : Patent Amendment Rule on 5th May 2006. 34
  • 35. Types of Patent: There are 4 types of patents in general  A utility patent:  It is a long, technical document that teaches the public how to use a new machine, process, or system.  New technologies like genetic engineering and internet-delivered software are challenging the boundaries of what kinds of inventions can receive utility patent protection.  A utility patent is granted for a new product process machine method of manufacturing and composition of matter. This category excludes most botanical creations related to plant and agricultural use. 35
  • 36. Types of Patent  A plant patent: Is just that a patent for a plant. Plant patents protect new kinds of plants produced by cuttings or other nonsexual means. Plant patents generally do not cover genetically modified organisms and focus more on conventional horticulture. 36
  • 37. Types of Patent  A design patent:  Protects an ornamental design on a useful item.  The shape of a bottle or the design of a shoe, for example, can be protected by a design patent.  The document itself is almost entirely made of pictures or drawings of the design on the useful item.  Design patents are notoriously difficult to search simply because there are very few words used in a design patent.  In recent years, software companies have used design patents to protect elements of user interfaces and even the shape of touchscreen devices.  Design patents are granted for any new or original Ornamental design for an article of manufacture.  A design patent protects only the appearance of the article and not the article itself.  An inventor can easily register both a utility patent and a design patent. 37
  • 38. Types of Patent  A provisional patent: Goes hand in glove with a utility patent. A law allows inventors to file a less formal document that proves the inventor was in possession of the invention and had adequately figured out how to make the invention work. Once that is on file, the invention is patent pending. If, however, the inventor fails to file a formal utility patent within a year from filing the provisional patent, he or she will lose this filing date. 38
  • 39. Scope of Patentability Under the Patents Act  Invention: As per Section 2(1)(j) “Invention” means a new product or process involving an inventive step and capable of industrial application.  Basic criteria of patentability: The 3 basic criteria which any invention must meet in order to deserve a patent: Novelty, Non-obviousness and Industrial application.  Patentable subject matter:  Invention must relate to a Process or Product or both be new (Novel) involves an inventive step be Capable of industrial application not fall under Section 3 and 4.  New means an invention must not be Published in India or elsewhere in prior public knowledge or prior public use with in India, claimed before in any specification in India.  Inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or have economic significance or both and makes the invention not obvious to a person skilled in the art.  Industrial application means Invention is capable of being made or used in any kind of industry. 39
  • 40. Filing a patent application  Documents can be filed in the patent office- ✓ through online (e-filing) or www.ipindiaonline.gov.in/online, ✓ through post or ✓ can be submitted by hand. 40
  • 41. General procedure for obtaining a patent  Filing of patent application,  Publication after 18 months,  Pre-Grant Opposition /Representation by any person,  Request for examination,  Examination: Grant or Refusal,  Publication of Grant of patent,  Post Grant Opposition to grant of patent,  Decision by Controller 41
  • 42. Patent offices in India and their respective territorial jurisdiction 42 Office Territorial Jurisdiction Intellectual Property Office, Mumbai Maharashtra, Gujarat, Madhya Pradesh, Goa and Chhattisgarh and Union Territories of Daman and Diu & Dadra and Nagar Haveli Intellectual Property Office, Chennai Andhra Pradesh, Karnataka, Kerala, Tamil Nadu and Union Territories of Pondicherry and Lakshadweep Intellectual Property Office, New Delhi Haryana, Himachal Pradesh, Jammu and Kashmir, Punjab, Rajasthan, Uttar Pradesh, Uttaranchal, Delhi and the Union Territory of Chandigarh. Intellectual Property Office, Kolkata The rest of India.
  • 43. Patent Application Filing Procedure-Process in India  Filing a patent application in the Indian Patent Office is the first step towards securing a patent to invention in India.  To file a patent application, a set of forms has to be submitted to the patent office.  The forms may be submitted online if an individual have a class 3 digital certificate. Alternatively, true copies (hard copies) to be sent to the patent office.  The patent office charges 10% additional fee if applications are filed offline.  The most important factor in filing a patent application is preparing a patent specification.  Drafting a patent specification is a highly skilled job, which can be only performed by persons who have both technical as well as patent law expertise.  If a person or company is serious about protecting their intellectual property, it is highly recommended to use the services of professional patent practitioners.  Indian patent offices are located at Delhi, Kolkata, Mumbai and Chennai.  The patent application has to be filed in the appropriate office based on company’s location. 43
  • 44. Patent Application Filing Procedure-Process in India  On identification of the patent office in which a patent application is to be filed, an overview of the forms to be submitted.  To file a patent application, a form 1, form 2, form 3 and form 5 is to be submitted.  Subsequent to filing these forms with the appropriate fees, a patent application number from the patent office will be allotted.  A form 9 (optional) and form 18 along with filing a complete application or after filing a complete application to be selected to file a patent.  An Indian Patent Application forms are available online.  In the table below, the list of forms that have to be submitted and their respective fees is provided. The provided fee mentioned is for E-filing only. 44
  • 45. The patent office charges an additional fee of 10% over the fee for applications filed offline 45 Form Title Patent office Fee (INR) 1$ = ~ 60 INR E-Filing only Comment Applicant- Natural person/ Start-up Applicant – other than natural person Small Entity Others except small entity 1 Application for Grant of Patent 1600 4000 8000 Mandatory 2 Provisional/Complete Specification No fee* No fee* No fee* Mandatory 3 Statement and Undertaking Under Section 8 No fee No fee No fee Mandatory 5 Declaration as to Inventorship No fee No fee No fee Mandatory 9 Request for Publication 2500 6250 12500 Optional 18 Request for Examination of Application for Patent 4000 10000 20000 Mandatory * – A fee of 160/400/800/sheet, based on the type of applicant, is applicable for each sheet exceeding 30 sheets in a patent specification. Further, a fee of INR 320/800/1600/Claim, based on the type of applicant, is applicable for each claim exceeding 10 claims in the patent specification.
  • 46. Various Forms used in filling patent  Form 1 : Application for Grant of Patent  Form 2 : Provisional/Complete Specification  Form 3 : Statement and Undertaking Under Section 8  Form 5 : Declaration as to Inventorship  Form 9 : Request for Publication  Form 18 : Request for Examination of Application for Patent 46
  • 48. Patent  A patent is a form of intellectual property.  A patent gives its owner the right to exclude others from making, using, selling, and importing an invention for a limited period of time, usually twenty years.  The invention includes drug, equipment, composition etc., 48
  • 49. Rights of a Patent Holder  An issued patent gives the patent owner right to prevent others from  Selling  Making  Offering for sale in the country or  Importing into the country in which a patent is granted.  Starts from the date of publication and last until the expiry of patent term 49
  • 50. Patent Infringement  If any person exercises the exclusive rights of the patent holder without permission within the country of patent grant and during the patent term.  A person is liable for infringement if his product or process is same as the patented invention.  As claims in a patent define boundaries of the invention claimed, a product or process patent will be infringing if it falls within the scope of a claim in the patent  Therefore, understanding the meaning and scope of patent claims is important for determining infringement 50
  • 51. Patent Infringement  Patent infringement is the commission of a prohibited act with respect to a patented invention without permission from the patent holder.  It occurs when someone violates the patent rights an inventor has in his invention by making, using or selling the invention without the patent owner’s permission (or if the patent has been licensed), in a way not permitted by the license.  If any person exercises the exclusive rights of the patent holder without permission within the country of patent grant and during the patent term.  A person is liable for infringement if his product or process is same as the patented invention.  As claims in a patent define boundaries of the invention claimed, a product or process patent will be infringing if it falls within the scope of a claim in the patent. 51
  • 52. Types of Patent Infringement  Direct Infringement:  Occurs when a product is substantially close to any patented product or in a case where the marketing or commercial use of the invention is carried out without the permission of the owner of the invention.  It directly states that the third party has wilfully or intentionally stolen the technology from the inventor without his prior permission.  It occurs when someone directly makes, uses or sells the patented invention within the country. Direct infringement may be literal or equivalence. 52
  • 53. Types of Direct Infringement  It can include, manufacture patented technology; use patented technology; offer patented technology for sale; sell patented technology; import patented technology; pass off the patented.  Literal Infringement: If all elements of a claim are literally present in an patented product or process.  Equivalence Infringement: If the elements of a product or process differing from those of claim elements are present by equivalence. 53
  • 54. Types of Patent Infringement  Indirect Infringement:  Occurs when some amount of deceit or accidental infringement happens without any intension of infringement.  It refers to the unfair practice that does not give a clear indication that the patent is bought and sold in the market.  It occurs, for instance, when a device is claimed in a patent and a third party supplies a product which can only be reasonably used to make the claimed device.  Indirect infringement may be induced or contributory. 54
  • 55. Types of Indirect Infringement  It can includes sell parts that can only be realistically used for a patented invention; sell an invention with instructions on using a certain method that infringes on a method patent; license an invention that is covered by another‘s patent; sell material components that have been especially made for use in a patented invention and have no other commercial use.  Induced Infringement: A middle party (induced infringer) enables (or help, influence or ‘induce’) a third party (direct infringer) to participate the patented invention.  Contributory Infringement: If a party contribute to the infringement of a patent claim may be held liable. 55
  • 56. Determining Patent Infringement56  An act of patent infringement occurs when someone practices each and every element of a patent claim.  Patent claims are the numbered paragraphs at the end of patentee.  To determine if there is infringement, patentee want to compare each segment of each claim to the device that think is infringing.  Below is an example of comparing a patent claim to an accused device:  As shown above, if patentee is able to match up every element of a patent claim to an accused device, then its proving an infringement.
  • 57. Class 3 digital certificate  Class 3 DSC provides the highest level of security and comes with 1 year, 2 year and 3 year validity.  A person who already has the specified Digital Signature Certificate (DSC) for any other application can use the same for e-filing of a patent application and it is not required to obtain a fresh DSC.  Class 3 Digital Signature Certificate is used for E tendering (online tender) and E Auction (online auction) purpose in India.  Class 3 DSC is more secure and provides highest level of security as compare to Class 2 DSC.  Class 3 Digital Signature Certificate is issued to individual or organization to authenticate the identity of vendors while participate in e procurement activities across India.  Individual User known as Class 3A or Class 3 individual Digital Signature Certificate.  Company user known as Class 3B or Class 3 organization Digital Signature Certificate. 57
  • 58. Orange Book  It is the publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” by the Food and Drug Administration.  It is prepared by The Orange Book Staff, Centre for Drug Evaluation and Research.  It identified drug products on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetics Act.  Drugs marketed only on the basis of safety or pre-1938 drugs.  The list is independent of any current regulatory action against a drug product.  The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.  The FDA does not recommend substituting drugs that have not been determined to be bioequivalent.  Drugs that are not listed as bioequivalent should not be substituted for each other. 58
  • 59. Objectives of Orange Book  To allow review of patterns of access and usage  To allow discovery of use of unusual privileges  To supply an additional form of user assurance  To serve as a deterrent by its existence  To allow discovery of repeated attempts to bypass protections. 59
  • 60. Contents of Orange Book 1. Introduction:  1.1 Content and Exclusion,  1.2 Therapeutic Equivalence-Related Terms,  1.3 Statistical Criteria for Bioequivalence,  1.4 Reference Listed Drug,  1.5 General Policies and Legal Status,  1.6 Practitioner/User Responsibilities,  1.7 Therapeutic Equivalence Evaluations Codes,  1.8 Description of Special Situations,  1.9 Therapeutic Equivalence Code Change for a Drug Entity,  1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product,  1.11 Discontinued Section,  1.12 Changes to the Orange Book,  1.13 Availability of the Edition. 60 2. How to use the drug products lists: 2.1 Key Sections for Using the Drug Product Lists, 2.2 Drug Product Illustration 2.3 Therapeutic Equivalence Evaluations Illustration.
  • 61. Orange Book: At a glance61
  • 63. What is Copyright?  Copyright is a legal term describing rights given to creators for their literary and artistic works.  Copyright include:  Literary works such as novels, poems, plays, reference works, newspapers and computer programs;  Databases;  Films, musical compositions, and choreography;  Artistic works such as paintings, drawings, photographs and sculpture;  Architecture;  Advertisements, maps and technical drawings. 63
  • 64. Objective of Copyright  Copyright is a monopoly right restraining others from exercising that right which has been conferred on the owner of copyright.  It is a negative right meaning thereby that it is prohibitory in nature.  It is a right to prevent others from copying or reproducing the work.  The object of copyright is to encourage authors, composers and artists to create original works by rewarding them the exclusive right for a specific period to reproduce the works for publishing and selling them to the public.  The moral basis of copyright law rests in the eighth commandment “Thou shall not steal”. 64
  • 65. Is copyright is single right?  Copyright is not a single right.  It is a bundle of rights in the same work.  Example: In the case of a literary work, copyright consists of reproduction in print media, the right of dramatic and cinematographic versions, the right of translation, adaptation, abridgement and the right of public performance. 65
  • 66. Copyright: National Vs International  The Copyright Act of each country is compliant with most international conventions and treaties.  No single “International copyright” for whole world.  In India, the Copyright Act, 1957 is compliant with these international conventions and treaties:  Berne Convention of 1886,  Universal Copyright Convention of 1951,  Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). 66
  • 67. Indian Copyright Act, 1957  The Copyright Act 1957 (as amended by the Copyright Amendment Act 2012) governs the subject of copyright law in India.  The Act is applicable from 21 January 1958.  The history of copyright law in India can be traced back to its colonial era under the British Empire.  The Copyright Act 1957 was the first post-independence copyright legislation in India and the law has been amended six times since 1957.  The most recent amendment was in the year 2012, through the Copyright (Amendment) Act 2012.  India is a member of most of the important international conventions governing the area of copyright law, including the Berne Convention of 1886 (as modified at Paris in 1971), the Universal Copyright Convention of 1951, the Rome Convention of 1961 and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).  Initially, India was not a member of the WIPO Copyright Treaty (WCT) and the WIPO Performances and Phonograms Treaty (WPPT) but subsequently entered the treaty in 2013. 67
  • 68. Amendments in Indian Copyright Act  First right in India in 1914.  Now, Indian Copyright Act,1957; w.e.f. 1958.  Further amendments in 1983, 1984, 1992, 1994, 1999.  Adopted many English provisions, introduced new ideas and concepts.  Created Copyright Office and Copyright Board.  Introduced civil and criminal remedies against infringement 68
  • 69. Categories of Copyright (Amendment) Act 2012  Amendments to rights in artistic works, cinematograph films and sound recordings,  WCT and WPPT related amendment to rights,  Author-friendly amendments on mode of Assignment and Licenses,  Amendments facilitating Access to Works,  Strengthening enforcement and protecting against Internet piracy,  Reform of Copyright Board and other minor amendments. 69 WCT: WIPO Copyright Treaty; WPPT: WIPO Performances and Phonograms Treaty
  • 70. Indian Perspective on Copyright  The Copyright Act, 1957 confers copyright protection in the following two forms:  Economic Rights and  Moral Rights.  Economic rights: Several exclusive rights typically attach to the holder of a copyright:  to produce copies or reproductions of the work and to sell those copies (including, typically, electronic copies),  to import or export the work,  to create derivative works (works that adapt the original work),  to perform or display the work publicly,  to sell or assign these rights to others,  to transmit or display by radio or video. 70
  • 71. Indian Perspective on Copyright  Moral rights:  Right of paternity to claim authorship of work and to prevent all others from claiming authorship of his work.  Right of integrity to prevent distortion, mutilation or other alterations of his work, or any other action in relation to said work, which would be prejudicial to his honour or reputation. 71
  • 72. Term of Copyright  The general rule is that copyright lasts for 60 years.  It is counted- From the death of the author for: Literary, Dramatic, Musical, Artistic work. From the date of publication for: Cinematograph films, Sound recordings, Photographs, Posthumous publication, Works of Government & International organizations. 72
  • 74. Counterfeiting to Copyright  Counterfeit mark: The production of certain brand bags by putting a false label, and sold at low prices.  Counterfeit products: Copies of articles, similar to the original under a different name  Infringement "mixed”: Copy for both the model and brand. Ex. Fake Louis Vuitton bags or Rolex watches for instance.  Infringement of copyright: Copying or using the work of another creator, without his prior permission.  The term "counterfeit" describes fake goods.  The term "piracy" describes the act of reproducing movies, music, books or other copyrighted works without permission from the copyright owner. 74
  • 75. Copyright infringement (Piracy)  It is the use of works protected by copyright law without permission for a usage where such permission is required, thereby infringing certain exclusive rights granted to the copyright holder, such as the right to reproduce, distribute, display or perform the protected work, or to make derivative works.  The copyright holder is typically the work's creator, or a publisher or other business to whom copyright has been assigned.  Copyright holders routinely invoke legal and technological measures to prevent and penalize copyright infringement.  Copyright infringement disputes are usually resolved through direct negotiation, a notice and take down process, or litigation in civil court. 75
  • 77. Background of Trademark  Today’s consumers are Brand oriented and therefore, using deceptive name can affect the market for original brand hugely.  When the brand value is used without prior approval, the owner looks for the legal remedies to protect its brand value.  Stopping non-permitted use of the trademark is equally important as trademark registration.  Therefore, the special Act for the protection of trade names is enforced as Trademark Act, 1999 with an aim to provide exclusive right to use the brand name and stop unauthorized use by any other person including the competitors.  Hence, to protect the brand name and the value created, the brand name and logo are registered as a trademark under this Act. 77
  • 78. Trademark  A trademark is a word, phrase or a unique symbol, which is used by an individual, business organization or other legal entity to distinctively identify the source of their products or services to customers, and to differentiate their products or services from other entities.  A registered trademark is designated with encircled R symbol (®).  The certificate of trademark registration provides exclusive rights to the proprietor to use the brand name for their business activity falling under the class in which it is registered. 78
  • 79. Trademark  A trademark is a distinctive sign that identifies certain goods or services as those produced or provided by a specific person or enterprise.  It may be one or a combination of words, letters, and numerals.  They may consist of drawings, symbols, three- dimensional signs such as the shape and packaging of goods, audible signs such as music or vocal sounds, fragrances, or colours used as distinguishing features.  It provides protection to the owner of the mark by ensuring the exclusive right to use it to identify goods or services, or to authorize another to use it in return for payment. 79
  • 80. Trademark  It helps consumers identify and purchase a product or service because its nature and quality, indicated by its unique trademark, meets their needs.  Registration of trademark is prima facie proof of its ownership giving statutory right to the proprietor.  Trademark rights may be held in perpetuity.  The initial term of registration is for 10 years; thereafter it may be renewed from time to time.  A trademark (also written trade mark or trade-mark is a type of intellectual property consisting of a recognizable sign, design, identifies or expression which products or services of a particular source from those of others, although trademarks used to identify services are usually called service marks. 80
  • 81. Designation of Trademark  A trademark may be designated by the following symbols: ™ (the "trademark symbol", which is the letters "TM" in superscript, for an unregistered trademark, a mark used to promote or brand goods), ℠ (which is the letters "SM" in superscript, for an unregistered service mark, a mark used to promote or brand services), ® (the letter "R" surrounded by a circle, for a registered trademark). 81
  • 82. Infringement of Trademark & Remedies  When the exclusive rights of the owner of the registered Trademark are violated, it is said to be an infringement of Trademark.  In form of Injunction: The action of an injunction is referred as stopping one person from doing particular activity or task through the judicial process.  In form of Damages: Damages refer to the recovery of loss faced by the trademark owner through the trademark infringement. The monetary value of financial loss or brand impairment is recovered under this head  Custody of infringing materials: This remedy suggests that the Court may ask the infringer to deliver all the goods/products that are labelled with the brand name. Here, the Court may direct the authorities to withhold the related materials accounts & destruct all such goods. 82
  • 83. Applied and Registered Trademark Symbol  Applied Trademark Symbol-™:  In India, the owner of the mark can use the symbol next to his/her mark when the application for trademark registration has been successfully filed with the IP India.  It is used to represent the fact that registration for the particular trademark is already in the process, and thus, acts as a warning for infringers.  Registered Trademark Symbol-®:  The R symbol represents the fact that the trademark has been successfully registered with the Indian Trademarks Registry.  Once the trademark is registered, it gives the owner of the mark exclusive rights to use the mark to represent his/her goods or services.  No one else would be able to use the mark without the permission or license of the trademark proprietor.  Therefore, the ® symbol warns others about the fact that the trademark has already been registered. 83