useful for industry

1. Patent and Related
Issues
Dr. Niteen S. Ahire.
Dept. of Pharmacology
SVNGMC, Yavatmal

2. • INTRODUCTION TO IPR
• PATENT OVERVIEW
• INDIAN PHARMACEUTICAL INDUSTRY
AND PATENT SYSTEM.
• PATENT LAWS IN INDIA
• IMPORTANT PROVISION FOR PUBLIC
HEALTH SAFEGAURDE
• PHARMACEUTICAL CLAIMS FOR PATENT
• INDIAN PATENT SYSTEM FRAME WORK. 2

3. • OBTAINING A PATENT.
• INDIAN PHARMACEUTICAL IN PATENT
ERA.
• CONCLUSION.
• REFERENCES.
3

4. INRODUCTION
Property
• In lay term, property means some material object
belonging to a particular person.
Ownership
• It means the right to possess, use and dispose of
the property.
4

5. Intellectual property
Intellectual property is an intangible creation of
human mind, usually expressed or translated
into a tangible form that is assigned certain
rights of property.

6. IPR:
• “Intellectual Property Rights” are legal rights,
which result from intellectual activity in
industrial, scientific, literary & artistic fields.
• These rights Safeguard creators and other
producers of intellectual goods & services by
granting them certain time-limited rights to
control their use.
6

7. 7

8. 8

9. Major Types of IP
Functional & Technical
Inventions
Patents Act, 1970
Amended
in 1999 & 2005
Purely
Artistic works
Copyright Act,
1957
Amended in1982,
1984, 1992,
1994 & 1999
A symbol, logo, word, sound,
color, design, etc.
Trademark
Act, 1999
Amended in 1994,
1996 & 2000

10. Patent
• A patent is an exclusive right granted for an invention, which is
a product or a process that provides a new way of doing
something, or offers a new technical solution to a problem.
10

11. Trademarks
• A trademark is a distinctive sign that identifies certain goods
or services as those produced or provided by a specific person
or enterprise.
• 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.
11

12. Copyrights
• Copyright is a legal term describing rights given to creators for
their literary and artistic works.
• The kinds of works covered by 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; and advertisements, maps and technical
drawings.
The rights under copyright includes :-
 Right of reproduction
 Communication to the public
 Adaptation of work
 Translation of work
12

13. What is covered by copyright?
Literary Films Dramatic
Musical Sound RecordingArtistic

14. Duration of Copyright
Copyright lasts for-
 Author’s lifetime + 50 years from the end of calendar year in
which the author dies
 50 years for films & sound recordings
 25 years for typographical arrangements of a published
edition
 Copyright protection always expires on December 31 of the
last calendar year of protection

15. Geographical Indications
(GI):
• GI are signs used on goods that have a specific geographical
origin and possess qualities or a reputation that are due to
that place of origin.
• Recently the GIs of goods like Chanderi Sarees, Kullu Shawls,
Darjeeling tea,etc. have been registered.
15

16. Industrial Designs:
• Industrial designs refer to creative activity, which result in the
ornamental or formal appearance of a product, and design
right refers to a novel or original design that is accorded to the
proprietor of a validly registered design.
• Under the TRIPS Agreement, minimum standards of
protection of industrial designs have been provided for.
• As a developing country, India has already amended its
national legislation to provide for these minimal standards.
16

17. Trade Secrets
• It may be confidential business
information that provides an
enterprise a competitive edge may
be considered a trade secret.
• Usually these are manufacturing or
industrial secrets and commercial
secrets.
• These include sales methods,
distribution methods, consumer
profiles, advertising strategies, lists of
suppliers and clients, and
manufacturing processes.
17

18. Layout Design for Integrated
Circuits
• Semiconductor Integrated Circuit means a product having
transistors and other circuitry elements, which are inseparably
formed on a semiconductor material or an insulating material
or inside the semiconductor material and designed to perform
an electronic circuitry function.
18

19. Protection of New Plant
Variety
The objective of this act is-
• to recognize the role of farmers as cultivators and conservers
and the contribution of traditional, rural and tribal
communities to the country’s agro biodiversity by rewarding
them for their contribution
• to stimulate investment for R & D for the development new
plant varieties to facilitate the growth of the seed industry.
19

20. Patent- Overview

21. Patent
• The criteria for patentability require that a product or
manufacturing process fulfills the conditions of
• Novelty
• Inventiveness (Un-obviousness)
• Industrial applicability (or utility)
• Whether a claimed invention meets the tests of novelty and
non-obviousness is determined by comparing it to the body of
previously disclosed information in the same field.
• This information is usually called “prior art.”
• The most commonly used prior art consists of published
patents that have already been issued or published by the
world’s patent offices.
21

22. “New” means….
 Sec. 2(j) Invention
• Any new product or process
• Involves an Inventive Step
• Capable Of Industrial Application
 Sec. 2(j a) Inventive Step – Feature involving
• Technical advancement; or
• Economic significance; or
• Combination of above
• and makes it non obvious to a person skilled in the
art
22

23. Life & Duration
 Term of the patent is 20 years from the date of filling for
all types of inventions
 The date of patent is the date of filing the application for
patent
 The term of the patent is counted from this date

24. Fees For Filing Patent

25. Why I go for getting a patent ??
25

26. 26

27. What Does a Patent look Like?

28. BENIFITS
Biggest source of scientific & technical knowledge
More than 40 million Patent Documents and 1 million
being added every year
Identifies emerging technologies, research areas and business
opportunities
To prevent others from illegally exploiting the invention
Avoids duplication of research and Acts as a stepping Stone
for Scientific Research.
Linking creativity to wealth
28

29. Problems
• Patented products may put excessive
economical burden on its users.
• Majority group of users who can not afford it,
will be refrained from using a newer,
sometimes more beneficial inventions.
Specially in case of medicinal products.
29

30. What are not patentable in India
(under sec 3 of Patent Act 1970) Invention area
- Which is frivolous or contrary to established natural laws
- Which is contrary to public order or morality
- Mere discovery of a scientific principle or the formulation of
an abstract theory or discovery of any living thing or non-
living substance occurring in nature
- Mere discovery of a new form, property or use of a known
substance without any enhancement
- Mere arrangement or re-arrangement or duplication of
known devices each functioning independently of one
another in a known way
30

31. What are not patentable in India
- Substance obtained by a mere admixture resulting only in
the aggregation of the properties of the components thereof
or a process for producing such substance
- Method of agriculture or horticulture
- Process for the medicinal or other treatment of human
beings or animals to render them free of disease
- Mere scheme or rule or method of performing mental act or
method of playing game
- Plants and animals in whole or any part thereof other than
micro-organisms but including seeds, varieties and species and
essentially biological processes for production or propagation
of plants and animals
31

32. What are not patentable in India
-A mathematical or business method or a computer
program per se or algorithms
-A presentation of information
-Topography of integrated circuits
-An invention which in effect, is traditional knowledge or
which is an aggregation or duplication of known properties
of traditionally known component or components
-Relating to atomic energy
32

33. The Pharmaceutical
Industry and the
Patent System

34. Patents and Pharma sector
• The pharmaceutical sector is a major user of the patent system.
• Pharmaceuticals is a research based industry and needs
innovative and creative approach which is the key to generation
of intellectual properties
• Compared to other industries, the balance of rights and
obligations are very delicate in Pharma, since the inventions
need to serve the needs of health care and nutrition of the
community making essential medicines affordable and
accessible to the needy, world over.
34

35. SPECIAL PROBLEMS
I. Since capital investment in the pharmaceutical industry
disproportionately is directed to laboratory research and
clinical trials rather than the manufacture of the final product,
patent exclusivity is the only effective way to protect and
receive a return on that investment.
II. The culture of medical research, however, emphasizes very
early disclosure of inventions
III. a “Buyer Beware” philosophy
IV. Extensions of patent term to compensate for the inability to
market inventions due to safety and efficacy regulation.
V. “Regulatory Exception” / Bolar provision
35

36. From history to present….
International Bureau for the Protection of Intellectual Property
(19th Century)
The World Intellectual Property Organization (1967)
• Headquartered in Geneva
• WIPO is the specialized United Nations Agency that serves as
the secretariat for administration of most of the global
intellectual property treaties.
• It is the principal forum for negotiation of new patent treaties
and the leading provider of technical assistance to developing
countries in the field of intellectual property rights.
• WIPO Currently has 179 member states. 36

37. From history to present….
The World Trade Organization (1994)
• WTO was established in Marrakech following the successful
conclusion of the Uruguay Round of Trade Negotiations.
• The predecessor to the WTO was the General Agreement on
Tariffs and Trade (GATT).
• A key reform of the Uruguay Round was the Agreement on
Trade Related Aspects of Intellectual Property Rights (TRIPS)
codified as an annex to the treaty establishing the WTO.
• After TRIPS Agreement in 1994 many developing countries
that have joined the WTO have obligated themselves to
provide such protection, least developed countries are not
required to meet this obligation until 2016. 37

38. Major requirements of the TRIPS
agreement
• WTO Member States must provide a level of rights equal to those
provided in the major global intellectual property treaties
administered by WIPO
• WTO member states may not discriminate among technologies in
providing patent protection
• WTO member states must provide patent protection for at least 20
years from the date of filing a patent application
• WTO Member States must provide effective judicial enforcement of
intellectual property rights.
• A TRIPS Council was created to coordinate WTO policy in the area of
intellectual property rights and to manage the resolution of disputes
among states on implementation of TRIPS obligations.
38

39. Doha Ministerial Declaration
• Doha Declaration on the TRIPS Agreement and Public
Health was adopted by the WTO Ministerial Conference
of 2001 in Doha on November 14, 2001.
• DOHA Declaration has reiterated-
Access to medicine is a critical factor in poor countries.
TRIPS Agreement has flexibilities. Developing countries
should make use of these flexibilities.
39

40. Patent Laws In India

41. 1856 THE ACT VI OF 1856 ON PROTECTION OF INVENTIONS BASED ON THE BRITISH PATENT LAW OF 1852. CERTAIN
EXCLUSIVE PRIVILEGES GRANTED TO INVENTORS OF NEW MANUFACTURERS FOR A PERIOD OF 14 YEARS.
1859 THE ACT MODIFIED AS ACT XV; PATENT MONOPOLIES CALLED EXCLUSIVE PRIVILEGES (MAKING. SELLING AND
USING INVENTIONS IN INDIA AND AUTHORIZING OTHERS TO DO SO FOR 14 YEARS FROM DATE OF FILING
SPECIFICATION).
1872 The Patterns and Designs Protection Act’ (Act XIII of 1872)
1883 THE PROTECTION OF INVENTIONS ACT.
1888 CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT.
1911 THE INDIAN PATENTS & DESIGNS ACT.
1972 THE PATENTS ACT (ACT 39 OF 1970) CAME INTO FORCE ON 20TH APRIL 1972.
1999 ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT, (1999) CAME INTO FORCE FROM 01-01-1995.
2002 THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE FROM 2OTH MAY 2003
2005 THE PATENTS (AMENDMENT) ACT 2005 EFFECTIVE FROM Ist JANUARY 2005
41

42. Patents Act 1970 – Salient Features
• Only process patents for food, pharmaceuticals
and
chemical products.
• Product and process patents in all other areas
• Term of patent – variable (7 / 14 years)
• Elaborate public interest provisions (License of
right, Government use)
42

43. Patents Act 1970 – How it helped
Indian Pharma Sector
• Allowed Indian companies to legally produce generic
versions of medicines that were under patent elsewhere
• Developed thriving generic drug industry
• Indian drug manufacturers were capable to produce
low-cost drugs.
43

44. TRIPS
This Agreement links intellectual property and trade
issues for the first time and provides a multilateral
mechanism for settling disputes between states.
TRIPS Agreement mandates
• Product Patent
• Term of Patent
• Mailbox Provision
• EMR 44

45. Amendment of the Patent Act
India has made three amendments in its original
Patent Act 1970.
• Ist amendment-1999
• IInd amendment-2002
• IIIrd and Final Amendment-2005
45

46. Ist Amendment-1999
Mailbox provision - “Transitional arrangements”-which
allowed product patent applications to be filed through a
‘mailbox’.
Exclusive Marketing Rights (EMRs) -
Kind of exchange for permission to delay the granting of
product patents until January 1, 2005.
• Novartis for anti-cancer medicine, Gleevec
46

47. IInd amendment-2002
• 20 years term
• Definition of invention
• Reversal of burden of proof
• Modification of compulsory licence provision
• Right of patentee (include importation also)
47

48. IIIrd amendment-2005
• Introduction of product patents in the area of chemicals,
pharmaceuticals, agricultural chemicals and food.
• The Act repealed the Section 5(1) of the Patents Act,
1970, which provided for process patents in this field.
48

49. Indian Patent Act
• Invention, inventive step, pharmaceutical product redefined.
• Clarification on definition of “new entity”
• Inventions Excluded from Patents (Section 3)
• Re-introduction of Product Patents for Drugs, Medicines and
Foods including products of Chemical Reactions
• Reversal of burden of proof
• Patent Term 20 years
• Substantially reduced time-lines
• Enlarged framework for Compulsory Licence
49

50. Important
Provisions For Public
Health Safeguard

51. Important provisions for
public health safeguard
I. Compulsory licensing
II. Parallel Import
III. Pre-grant opposition
IV. “Bolar” Provision/ Research Exception
51

52. Compulsory licensing
• Article 31 of the TRIPS Agreement
• Compulsory licensing is when a government allows
someone else to produce the patented product or
process without the consent of the patent owner.
• The patent owner still has rights over the patent,
including a right to be paid for the authorized copies of
the products.
52

53. Compulsory licensing
• Normally the person or company applying for a licence
has to have tried to negotiate a voluntary licence with
the patent holder on reasonable commercial terms. Only
if that fails can a compulsory licence be issued.
• For “national emergencies”, “other circumstances of
extreme urgency” or “public non-commercial use” (or
“government use”) or anti-competitive practices, there is
no need to try first for a voluntary licence.
53

54. Parallel Import
• Products marketed by the patent owner or with the
patent owner’s permission in one country and imported
into another country without the approval of the patent
owner.
• E.g. In Mozambique 100 units of Bayer's ciprofloxacin
(500mg) costs US$740, but in India Bayer sells the same
drug for US$15 (owing to local generic competition).
Mozambique can import the product from India without
Bayer's consent.
• “Theory of Exhaustion” of intellectual property rights
54

55. Pre-grant opposition
• Opposition prior to grant of Patent can be made on any
ground on which opposition can be made after grant of
Patent.
• Personal hearing will also have to be given at pre-grant
stage to opponent, if requested.
• After examining the opposition and the submissions made
during the hearing, Controller may
• Either reject the opposition and grant the patent
• Or accept the opposition and modify/reject the patent
application
55

56. Bolar Provision
• This allow researchers to use a patented invention for research,
in order to understand the invention more fully.
• Some countries allow manufacturers of generic drugs to use the
patented invention to obtain marketing approval — for example
from public health authorities — without the patent owner’s
permission and before the patent protection expires.
• The generic producers can then market their versions as soon
as the patent expires. This provision is sometimes called the
“regulatory exception”
56

57. Pharmaceutical
Claims For Patent

58. Types of claims
I. Product claims:
i. Pharmaceutical substances:
a. New Chemical Entities;
b. Formulations/Compositions;
c. Combinations/ dosage/dose;
d. New forms of known substance such as:
Salts, Ethers and Esters; Polymorphs;Solvates, including
hydrates;Clahrates;Stereoisomers;Enantiomers;Metabolites and pro-
drugs;Conjugates;Pure forms;Particle size;Isomers and mixtures
thereof;Complexes;Derivatives of known substances; and
ii. Kits
iii. Product-by-process.
58

59. Types of claims
II. Claims for process/method of manufacturing;
III. Claims related to new property, new use of known substance
or use claims, including second indications;
IV. Claims for method of treatment and/or diagnosis of human
beings and animals;
V. Claims related to selection inventions (relating to product and
process)
59

60. Formulations and
compositions
• The same active ingredient may be
presented in formulations,
e.g. as tablets, capsules, ointment
or aqueous solutions for parenteral administration.
• New use of known substance or its new use in a
pharmaceutical composition is not normally patentable.
60

61. Combinations
• Combinations claims are rejected unless the combination
generates a new and non-obvious synergy or distinct
effect.
• If, however, a new and non obvious synergistic effect is
considered a basis for patentability, it should be properly
demonstrated by biological tests and appropriately
disclosed in the patent specifications.
61

62. Dosage/dose
• Some patent applications claim inventions consisting of
the dosage for administration to patients of an existing
product, including pediatric dosages.
• Some countries admit patents on dosages under certain
circumstances. E.g.UK Guidelines allows for the patenting
of a dosage where there is a new medical indication and
the dosage is substantially different
62

63. New forms of known substance
• Salts are normally formed to increase stability
or solubility of the drug & it is
common knowledge in the pharmaceutical
field that salts result in different solubility and, therefore,
in different bioavailability.
• There may be exceptional cases in which new salts present
unexpected advantages in properties as compared to what
is in the prior art.
63

64. Isomers
• Isomers having the same empirical formula but having
structural differences may be considered novel and may
not normally offend “obviousness” as they are structurally
different.
• Stereo Isomers are prima facie obvious. Hence product
patent may not be granted for the enantiomers.
64

65. Metabolites
• A metabolite is unpatentable
since giving the drug to a patient
naturally and inevitably results in
formation of that metabolite.
65

66. Prodrugs
• The inventive aspects of prodrug may be decided based on
the merits of the case.
• However, if there is a marked improvement over the primary
drug, prodrugs may be patentable.
inactive active
66

67. Analogy processes
• Manufacturing processes (often called ‘analogy
processes’)
• Non-novel or obvious pharmaceutical processes,
regardless of whether the starting materials,
intermediaries or the end product are novel or inventive
are not patentable as such.
67

68. Medical use of a product, including
first and second indications
• According to TRIPS Agreement, members should be under
no obligation to grant use claims, including second
indications.
• Claims relating to the use, including the second indication,
of a known pharmaceutical product can be refused, inter
alia, on grounds of lack of novelty and industrial
applicability.
68

69. Method of treatment
• Some patents claim methods of treatment, including
prophylaxis, cure, relief of pain, diagnosis or surgical methods.
• These claims do not cover a product per se, but the way in
which it is used in order to obtain certain effects.
• National patent policies considerably differ on this subject and,
in some cases, adopt a very expansive approach
• Methods of treatment are deemed non patentable where
industrial applicability is required as a condition for
patentability. 69

70. Selection patents
• A “selection patent” is a patent under which a single element
or a small segment within a large known group is “selected”
and independently claimed based on a particular feature not
mentioned in the large group.
• A “selection invention” may be applied for, for instance, when
a range of products characterized as having n-carbon atoms
has been patented, and later on a patent on a specific range
(e.g. C1-C4) is claimed.
• Patent owner may use the selection patent to extend the term
of protection for the selected subset
• Selection patents can be denied when the supposed
advantage is a property shared by all or nearly all the large
group.
70

71. Markush claims
• Often broad (“generic”) patent claims are drafted covering a
family of a large number (sometimes thousands or millions) of
possible compounds.
• They may be used to obtain a wide patent coverage including
a large number of compounds whose properties have not
been tested, but only theoretically inferred from the
equivalence with other compounds within the claim.
• E.g. R1 is selected from phenyl, pyridyl, thiazolyl, thioalkyl,
alkoxyl and methyl; R2-R3 are methyl, tolyl or phenyl… the
compounds are used as a pharmaceutical for increasing the
oxygen intake capability of blood.
71

72. Examination of Markush claims
(i) it discloses all the possible embodiments covered under the
claimed Markush formula;
(ii) such embodiments share a common use or property;
(iii) such possible embodiments share common structure;
(iv) physical and chemical properties of claimed compound are
disclosed;
(v) test conducted for each embodiment is provided;
(vi) at least one process for preparing the compounds is
disclosed when more than one processes are claimed.
72

73. Indian Patent System
- Framework

74. ProtectionOf Intellectual PropertyIn India
(Patents,Designs,TradeMarks&Copyrights)
CONTROLLER GENERAL OF
PATENTS, DESIGNS & TRADE MARKS
REGISTAR OF COPYRIGHT
MINISTRY OF COMMERCE
& INDUSTRY
MINISTRY OF HUMAN
RESOURCE DEVELOPMENT
DEPT. OF EDUCATION
DEPT. OF INDUSTRIAL POLICY &
PROMOTION
74

75. CONTROLLER GENERAL OF PATENTS, DESIGNS
AND TRADEMARKS (CGPDTM)
T M REGISTRY
DESIGN OFFICE
G.I. REGISTRY
Head Office
KOLKATA
Branch
DELHI
Branch
CHENNAI
Branch
MUMBAI
Head Office
MUMBAI
DELHI
KOLKATA
CHENNAI
AHM’BAD
P.I.S. Nagpur
KOLKATA
PATENT OFFICE
CHENNAI
75

76. 76
office Territorial Jurisdiction
Patent Office Branch, Mumbai Maharashtra ,Gujrat ,Madhya Pradesh ,
Goa and Chhattisgarh and the Union
Territories of Daman and Diu & Dadra
and Nagar Haveli.
Patent Office Branch, Chennai AP, Karnataka, kerla , Tamil Nadu , Union
Territories of Pondicherry and
Lakshadweep,
Patent Office Branch , New Delhi Haryana ,Himachal Prades , J&K ,Punjab
,Rajasthan ,UP ,Uttaranchal , Delhi and
Union Territory of Chandigarh
Patent Office , kolkata Rest of India.

77. STAGES- GRANTOFPATENT
.
PUBLICATION OF APPLICATION
PROMPTLY AFTER 18 MONTHS
REQUEST FOR EXAMINATION
WITHIN 48 MONTHS FROM F.D
GRANT OF PATENT
REVOCATION / AMENDMENT
POST GRANT OPPOSITION• WITHIN 12 MONTHS
FILING OF APPLICATION
PROVNL. / COMPLETE
DECISION OF
CONTROLLER
EXAMINATION: GRANT OR REFUSAL
ALL OBJECTIONS TO BE COMPLETED WITHIN 12 MONTHS
APPEAL
APPELLATE BOARD
PRE GRANT OPPOSITION
WITHIN 6 MONTHS
77

78. References
• Guidelines D, Examination F, Patent O, In A, Field T,
Pharmaceuticals O. No Title.
• Inventions not Patentable in India. 1962;
• Heath C. Parallel Imports and International Trade 1.
1996;661(October 1995):1–13.
• Lehman B. The Pharmaceutical Industry and the Patent
System. 2003;1–14.
• Intellectual S, Protection P. Pharmaceutical Patents.
• Services I. PATENT OPPOSITION SYSTEMS IN. 2008;
78

79. Indian
Pharmaceuticals In
Patent Era

80.  The Indian pharmaceutical market (IPM) is valued at 72069
crore INR in 2013 as against 65654 crore INR in 2012.
 It has experienced a slowdown with its growth going down
to 9.8% from 16.6% in 2012.
 R&D expenditure over Rs.1000 crores
 Projected exports of domestic pharma products -
$4 billion by 2010
$6 billion by 2015
Indian pharmaceutical industry
80

81. Advantage To Pharma India
• Abundant scientific and technical manpower, hence strong
intellectual capital
• Large and diverse patient base to conduct international
clinical trials
• US FDA/WHO compliant manufacturing facilities
• Strong base in bulk drugs manufacture
• Entrepreneurial skills
• Cost Competitiveness
81

82.  Indian pharmaceutical companies set to become
innovation driven
 Boost to Research and Development
 Strategies for development:
 Strategic alliances and partnerships
 Joint Ventures and In-licensing deals
 Marketing, Research and Manufacturing tie –ups
 Collaborative partnerships particularly in the area
of research
Future Of Pharma India
82

83. Patent laws helps in protecting the IP and thus preventing
the duplication as well as indiscriminate/ illegal use of it.
It also helps to reimburse the huge investment & thus
promoting more R & D for the advancement of medical
field also betterment of patient care.
But at same time non affording and needy patient
population may not get the benefit for the early advanced
treatment.
With combined approach of pharmaceutical owners and
regulators' from government as well as from public sector,
we may hope to overcome ever-growing concerns of the
effect of patent laws on treatment accessibility to the
patients
83

84. 84

85. References
• Information on intellectual property in the WTO, news and
official records of the activities of the TRIPS Council, and
details of the WTO’s work with other international
organizations in the field, 2014; obtained
fromhttp://www.wto.org/english/tratop_e/trips_e/trips_e.ht
m
• AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL
PROPERTY RIGHTS, 2011 :319–51.
• Ghai D. Patent protection and indian pharmaceutical industry.
2010;3(2):43–8.
• Technology I. CHAPTER I AN OVERIVEW OF INTELLECTUAL
PROPERTY SYSTEM. :5–45. 85

86. 86

87. 87

88. 88

89. 89

90. Filing of Application
• File an application for patent
• With one of the patent offices based on territorial
jurisdiction of the place of office or residence of the
applicant /agent
• Pay the required fee
• Information concerning application form and details of
fee available at www.ipindia.nic.in
• Guidelines for applicants also available on this website
90

91. Formality Check
• An Examiner checks the formal requirements before
accepting the application and the fee – this is done
immediately
• Issue of application number and the cash receipt – this is
done the same day
• In case of receipt of application by post, cash receipt,
application number is sent by post within 2-3 days
91

92. Publication
• Application is kept secret for a period of 18 months from
the date of filing
• In 19th month, the application is published in the official
journal – this journal is made available on the website
weekly
• Applicant has an option to get his application published
before 18 months also
• In that case, application is published within one month of
the request
92

93. Request for Examination
• Application is examined on request
• Request for examination can be made either by the
applicant or by a third party
• A period of 48 months, from the date of filing, is
available for making request for examination
93

94. Examination
• Application is sent to an Examiner within 1 month from
the date of request for examination
• Examiner undertakes examination:
whether the claimed invention is not prohibited for
grant of patent
whether the invention meets the criteria of
patentability
94

95. Issue of FER
• A period of 1 to 3 months is available to Examiner to
submit the report to the Controller
• 1 month’s time available to Controller to check the
Examiner’s report
• First Examination Report (FER) containing gist of the
objections is issued within 6 months from the date of
filing of request
95

96. Response from the Applicant
• 12 months’ time, from the date of issue of FER, is
available to the applicant to meet the objections
• If objections are met, grant of patent is approved by the
Controller – within a period of 1 month
96

97. Pre-grant Opposition
• After publication, an opposition can be filed within a
period of 6 months
• Opportunity of hearing the opponent is also available
• Opposition (documents) is sent to the applicant
• A period of 3 months is allowed for receipt of response
97

98. Grant of a Patent
• A certificate of patent is issued within 7 days
• Grant of patent is published in the official journal
Post grant opposition:
• Within 12 months
98

99. References
• Guidelines D, Examination F, Patent O, In A, Field T,
Pharmaceuticals O. No Title.
• Inventions not Patentable in India. 1962;
• Heath C. Parallel Imports and International Trade 1.
1996;661(October 1995):1–13.
• Lehman B. The Pharmaceutical Industry and the Patent
System. 2003;1–14.
• Intellectual S, Protection P. Pharmaceutical Patents.
• Services I. PATENT OPPOSITION SYSTEMS IN. 2008;
99

100. Obtaining A Patent