Intellectual property rights in Malaysia with special reference to Pharmaceutical Industry

1. INTELLECTUALPROPERTY RIGHTS
& PATENT FILING SYSTEMS IN
PHARMACEUTICAL INDUSTRY WITH SPECIAL
REFERENCE TO MALAYSIA
DR.M.V.NAGABHUSHANAM, M.Pharm., Ph.D., M.B.A.
PROFESSOR & HEAD OF THE DEAPRTMENT
DEPARTMENT OF PHARMACEUTICAL REGULATORY AFFAIRS
HINDU COLLEGE OF PHARMACY, GUNTUR- 522 002
ANDHRA PRADESH, INDIA. E Mail: beena.maddi@gmail.com

5. INTELLECTUAL PROPERTY RIGHTS (IPR)
• Intellectual property rights (IPR) can be defined as
the rights given to people over the creation of
their minds. They usually give the creator an
exclusive right over the use of his/her creations for
a certain period of time.
PHARMACEUTICAL REGULATORY AFFAIRS

6. PHARMACEUTICAL REGULATORY AFFAIRS

7. PHARMACEUTICAL REGULATORY AFFAIRS

8. Intellectual Property Rights
Why an individual should know about IPR?
Intellectual Property is crucial for creating a
unique identity for the business. It helps to
differentiate the goods and services of one
company from the other in the market and to
easily promote them to the target customers.
PHARMACEUTICAL REGULATORY AFFAIRS

9. Intellectual property rights are the rights given to
persons over the creations of their minds. They
usually give the creator an exclusive right over the use
of his/her creation for a certain period of time.
PHARMACEUTICAL REGULATORY AFFAIRS

10. Intellectual Property rights
• Intellectual Property rights may be protected at
law in the same way as any other form of property.
Intellectual property laws vary from jurisdiction to
jurisdiction.
PHARMACEUTICAL REGULATORY AFFAIRS

11. What is Intellectual Property?
• Intellectual property is an intangible creation of the
human mind, usually expressed or translated into a
tangible form that is assigned certain rights of property.
Examples of intellectual property include an author's
copyright on a book or article, a distinctive logo design
representing a soft drink company and its products,
unique design elements of a web site, or a patent on
the process to manufacture chewing gum.
PHARMACEUTICAL REGULATORY AFFAIRS

12. The different types of Intellectual Property Rights are:
• i. Patents
• ii. Copyrights
• iii. Trademarks
• iv. Industrial designs
• v.Protection of Integrated Circuits layout design
• vi. Geographical indications of goods
• vii. Biological diversity
• viii. Plant varieties and farmers rights
• ix. Undisclosed information

13. COPYRIGHT
• 1. Writings
• 2. Paintings
• 3. Musical works
• 4. Dramatics works
• 5. Audiovisual works
• 6. Sound recordings
• 7. Photographic works
• 8. Broadcast
• 9. Sculpture
• 10. Drawings
• 11. Architectural works etc.

14. PHARMACEUTICAL REGULATORY AFFAIRS

15. PHARMACEUTICAL REGULATORY AFFAIRS

18. PHARMACEUTICAL REGULATORY AFFAIRS

19. INTELLECTUAL PROPERTY
INDUSTRIAL PROPERTY + COPY RIGHT
PATENTS DESIGNS TRADEMARKS Geographical Indications
PHARMACEUTICAL REGULATORY AFFAIRS

20. PHARMACEUTICAL REGULATORY AFFAIRS

21. PHARMACEUTICAL REGULATORY AFFAIRS

22. PHARMACEUTICAL REGULATORY AFFAIRS

23. PHARMACEUTICAL REGULATORY AFFAIRS

24. The National Pharmaceutical Regulatory Agency (NPRA),
formerly known as the National Pharmaceutical Control
Bureau (NPCB), was set up in October 1978 under the
quality control activity of Pharmacy and Supply
Programme. This institution was established to implement
quality control on pharmaceutical products.
The infrastructure and facilities were designed to meet the
requirements for testing and quality control activities. In
1996, NPRA was given an international recognition by the
World Health Organisation (WHO) as a "WHO
Collaborating Centre for Regulatory Control of
Pharmaceuticals". This recognition is an acknowledgement
from WHO for NPRA's contribution in the field of
regulatory affairs.
PHARMACEUTICAL REGULATORY AFFAIRS

25. PHARMACEUTICAL REGULATORY AFFAIRS

28. PHARMACEUTICAL REGULATORY AFFAIRS

29. PHARMACEUTICAL REGULATORY AFFAIRS

31. PHARMACEUTICAL REGULATORY AFFAIRS

32. PHARMACEUTICAL REGULATORY AFFAIRS

33. PHARMACEUTICAL REGULATORY AFFAIRS

34. PHARMACEUTICAL REGULATORY AFFAIRS

37. PHARMACEUTICAL REGULATORY AFFAIRS

38. PHARMACEUTICAL REGULATORY AFFAIRS

39. VISION MISSION OBJECTIVE
To be an
internationally
renowned
regulatory authority
for medicinal
products and
cosmetics.
To safeguard the
nation’s health
through scientific
excellence in the
regulatory control of
medicinal products
and cosmetics.
To ensure that
therapeutic
substances
approved for the
local market are
safe, effective and of
quality and also to
ensure that cosmetic
products approved
are safe and of
quality.

40. PHARMACEUTICAL REGULATORY AFFAIRS

41. Global Intellectual Property Trends
• With over 3 million applications filed per year,
trademark protection is the most sought after
form of IP worldwide
PHARMACEUTICAL REGULATORY AFFAIRS

42. Intellectual Property Trends
• Out of 34,287 patent applications that were
filed, 6069 examined and 6168 patents granted.
PHARMACEUTICAL REGULATORY AFFAIRS

43. PHARMACEUTICAL REGULATORY AFFAIRS

44. COPYRIGHT
Copyright is a protection given to authors,
copyright owner and performer of their
copyright work and performances as prescribe
under the Copyright Act 1987.
PHARMACEUTICAL REGULATORY AFFAIRS

45. COPYRIGHT
DEFINITION OF COPYRIGHT
Copyright is the exclusive right to control creative works created by the
author, copyright owner and performer for a specific period governed
under the Copyright Act 1987.
WORKS ELIGIBLE FOR COPYRIGHT
literary works;
musical works;
artistic works;
films;
sound recordings;
broadcasts; and
derivative works
PHARMACEUTICAL REGULATORY AFFAIRS

46. COPYRIGHT
DURATION OF COPYRIGHT
Literary, Musical or Artistic Works
Generally, this categories of copyright work reflects to the human
beings which shall subsist during the life of the author plus 50 years
after his death.
Film, Sound Recordings and Performer
This categories of copyright work shall subsist for 50 years from the
work was published, fixed in a fixation for the film and sound recording.
For performer, the copyright work shall subsist from the performances
was perform or fixation in a sound recording.
Broadcasts
For the copyright in broadcasts, it protection occurred in way of
transmission either by wire or wireless means, the period for fifty years
shall be computed from the which the broadcasts was first made.

47. COPYRIGHT
THE RIGHTS OF COPYRIGHT OWNERS
Legal Rights
Author, copyright owner and performer is given an
exclusive right to control under the copyright law.
Legal rights that are given to them includes the rights
to enforce their copyrighted works in cases for
infringement either by civil or criminal action. In
term of criminal prosecution, it is conducted by the
Enforcement Division of Ministry of Domestic Trade,
Cooperative and Consumerism (MTDCC) or Royal
Malaysian Police.

48. COPYRIGHT
Economic Rights
Economic rights that are given to rightholders includes rights of
reproduction, rights of communication to public, rights to perform,
showing or playing to the public, rights of distribution and rights of
commercial rental. This rights can be exercised during the period of
protection governed under Copyright Act 1987. Economic rights allows
the owner of rights to derive financial reward from the use of his works
by the user or commercial purposes. Form of economic rights can be by
way of assignment, licensing and testamentary disposition.
Moral Rights
PHARMACEUTICAL REGULATORY AFFAIRS

49. COPYRIGHT
Paternity Rights
This rights allows the author to claim the originality rights of his or
her creation.
Integrity Rights
This right authorizes the author to prevent any users from
distortion, mutilation or other modifications of his or her works
whereby the result of the modification will significantly alter the
original work and adversely affect the author’s honor or reputation.
PHARMACEUTICAL REGULATORY AFFAIRS

50. COPYRIGHT
COPYRIGHT INFRINGEMENTS
Whoever use any copyrighted works without consent or authorization
from the author, copyright owner and performer, it may constitute an
infringement under Copyright Act 1987. Amongst the act of
infringement includes:
reproduces in any material form, performs, shows or plays or
distributes to the public,
imports any article into Malaysia for the purpose of trade or financial
gains;
PHARMACEUTICAL REGULATORY AFFAIRS

51. COPYRIGHT
makes for sale or rent any infringing copy;
sells, rent or by way of trade, exposes or offers for sale or rent any
infringing copy;
distributes infringing copies;
possesses, otherwise than for his private and domestic use, any
infringing copy;
exhibits in public any infringing copy by way of trade;
makes or has in his possession any contrivance used or intended to be
used for the purpose of making infringing copies
PHARMACEUTICAL REGULATORY AFFAIRS

52. PHARMACEUTICAL REGULATORY AFFAIRS

53. PHARMACEUTICAL REGULATORY AFFAIRS

54. DEFINITION OF TRADE MARK
Trademark means any sign capable of being
represented graphically which is capable of
distinguishing goods or services of one undertaking
from those of other undertakings.
Sign – any letter, word, name, signature,
numeral, device, brand, heading, label, ticket, shape
of goods or their
packaging, color, sound, scent, hologram, positioning,
sequence of motion or any combination thereof.

55. TRADE MARK
Collective Mark – A collective mark shall be a sign
distinguishing the goods or services of members of the
association which is the proprietor of the collective mark from
those of other undertakings.
Certification Mark – A certification mark shall be a sign
indicating that the goods or services in connection with which
it shall be used are certified by the proprietor of the mark in
respect of origin, material, mode of manufacture of goods or
performance of services, quality, accuracy or other
characteristics.

56. NON-REGISTRABLE TRADE MARK
Prohibited Marks
If the use of which is likely to confuse or deceive the public or
contrary to law.
Scandalous or Offensive Matter
If it contains or comprises any scandalous or offensive matter or
would not otherwise be entitled to protection in any court of law.
Prejudicial to the Interest or Security of the Nation
Registrar bears the responsibility of determining the trade
mark, whether it might be prejudicial to the interest or security of
the nation. It may be that a mark contains an inflammatory
statement or words.

57. FUNCTIONS OF TRADE MARK
Origin – A trade mark helps to identify the source and those
linked for the products and services trade in the market.
Choice – A trade mark assists consumers to choose goods and
services with ease.
Quality – Consumers define a certain trade mark for its
known quality.
Marketing – Trade mark play a significant role in promoting.
It’s common for consumers to make purchases based on
continuous effect of advertising.
Economic – Recognized trade mark is a valuable asset. Trade
marks may be licensed or franchised.

58. IMPORTANCE OF TRADE MARK REGISTRATION
Intellectual Proprietary privileges in relation to a trade mark may be established
through actual use in the marketplace and registration provides for:
Exclusive Rights – Registered trade marks owners have exclusive right to use their
marks in trading. They also have the rights to take legal action for infringement
under the Trade Mark Law against others who use their marks without consent. They
can either take civil action or lodge complaints to Enforcement Division for
appropriate actions under the Trade Description Act 1972.
Legal Evidence – Registration certificate issued by Registrar Office is a prima facie
evidence of trade mark ownership. A certificate of registration serves as an
important document to establish the ownership of goods exported to other
countries.

59. What is a Trademark?
Trademark means any sign capable of being represented
graphically which is capable of distinguishing goods or
services of one undertaking from those of other
undertakings.
Sign includes any letter, word, name, signature, numeral
, device, brand, heading, label, ticket, shape of goods or
their packaging, colour, sound, scent, hologram,
positioning, sequence
of motion or any combination thereof.
A Trademark is used as a marketing tool to enable
customers to choose a product or services in the market
place.

60. DURATION OF REGISTRATION
Trade mark registration is valid for ten years
from the date of application and may be
renewed every ten years.

61. INDUSTRIAL DESIGN
An industrial design is the ornamental or aesthetic aspect of
an article. The design may consist of three-dimensional
features such as the shape and configuration of an article, or
two-dimensional features, such as pattern and
ornamentation. The design features must be applied to an
article by any industrial process or means of which the
features in the finished article appeal to eye

62. INDUSTRIAL DESIGN
REGISTRABLE INDUSTRIAL DESIGN
Fulfill the interpretation of Industrial design
New in Malaysia or elsewhere
Not contrary to public order or morality
NON-REGISTRABLE INDUSTRIAL DESIGN
A method or principle of construction
The designs of articles depend upon the appearance of another
article which forms an integral part of the article
It differs only in immaterial details or features
The features of the article are dictated solely by function

63. INDUSTRIAL DESIGN
IMPORTANCE OF INDUSTRIAL DESIGN REGISTRATION
Owner of a registered design has the exclusive right to make, import,
sell or hire out any article to which the design has been applied.
PERIOD OF REGISTRATION
A registered industrial design is given an initial protection period of 5
years from the date of filing.
Extendable for a further four consecutive terms. The maximum
protection period is 25 years.
WHO MAY APPLY?
Author, Company, Individual

64. GEOGRAPHICAL INDICATIONS
A geographical indication (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.

65. PROTECTION OF GEOGRAPHICAL INDICATIONS
Regardless whether or not the geographical indication is
registered as against another geographical indication which,
although literally true as to the country, territory, region or
locality in which the goods originate, falsely represents to
the public that the goods originate in another country,
territory, region or locality.

66. GEOGRAPHICAL INDICATIONS
EXCLUSION FROM PROTECTION OF GEOGRAPHICAL INDICATIONS
Geographical indications which are contrary to public order or morality
or territory of origin; or
Geographical indications which are not or have ceased to be protected
in their country.
Geographical indications which have fallen into disuse in their country
or territory of origin.
RIGHTS OF USE
Only producers carrying on their activity in the geographical area
specified in the Register shall have the right to use a registered
geographical indication in the course of trade.
The right of use be in respect of the products specified in the Register in
a accordance to the qualify, reputation or characteristic specified in the
Register.

67. GEOGRAPHICAL INDICATIONS
PERIOD OF PROTECTION
A registered geographical indication is given ten years of
protection from the date of filling and is renewable for every
ten years.
WHO MAY APPLY?
a person who is carrying on an activity as a producer in the
geographical area specified in the application with respect
to the goods specified in the application, and includes with
respect to the such person a competent authority; or
a trade organization or association.

68. PATENT/UTILITY INNOVATION
A patent is an exclusive right granted for an invention, which
is a product or a process that provides, in general, a new
way of doing something, or offers a new technical solution
to a problem.
A utility innovation is an exclusive right granted for a
"minor" invention which does not require to satisfy the test
of inventiveness as required of a patent.

69. UNDERSTANDING A PATENT
DEFINITION OF 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.

70. PATENTABLE INVENTIONS
New, which means that the invention has not been
publicly disclosed in any form, anywhere in the
world;
Involve an inventive step, that is to say the invention
must not be obvious to someone with knowledge
and experience in the technological field of the
invention; and
Industrially applicable, meaning it can be mass
produced.

71. NON-PATENTABLE INVENTIONS
Discoveries, scientific theories and mathematical methods;
Plant or animal varieties or essentially biological processes for the
production of plants or animals, other than man-made living micro-
organisms, micro-biological processes and the products of such micro-
organism processes;
Schemes, rules or methods for doing business, performing purely
mental acts or playing games;
Methods for the treatment of human or animal body by surgery or
therapy, and diagnostic methods practiced on the human or animal
body.

72. DEFINITION OF UTILITY INNOVATION
A utility innovation is an exclusive right
granted for a “minor” invention which does
not require to satisfy the test of inventiveness
as required of a patent.

73. IMPORTANCE OF PATENT REGISTRATION
* To exploit the patented invention
* To assign or transmit the patent
* To conclude license contracts

74. DURATION OF PATENT
A patent is protected 20 years from the date of filing.
DURATION OF UTILITY INNOVATION
A utility innovation is protected 10 + 5 + 5 years from the date of filing
subject to use.
WHO MAY APPLY?
Any person may make an application for a patent or for a utility
innovation either alone or jointly with another person. The word
“person” is not limited to natural persons and thus also includes, for
example, a company.

75. APPLYING FOR PATENT/UTILITY INNOVATION
ONLINE FILING OF PATENTS:
IP Online Portal provides filing of new Patent application, which
consists of Patent Form 1 to Patent Form 21. Other supporting
documents and forms can be uploaded during the filing process.
Preparation before getting started:
Prepare all documents in digital format, e.g. Priority Data, Form 17,
Form 5 or Form 5A etc.

76. Description and Claims are compulsory documents. They must be
uploaded during the filing.
Separate the specifications into separate files: Claims, Abstract,
Description, Drawings.
Please ensure that your attachments are in these formats: DOC,
PDF and TIF.
If you are an agent, please prepare your Form 17 to be uploaded to IP
Online Portal.
Get your own Digital ID from this link.
Install your digital ID into your PC or save it to your secondary storage
device e.g. thumb drive.
Digital ID must be attached to your application.
Proceed with the payment. Check the fees in Pricing Scheme table.
Print a copy of Patent Form 1 form before you make the payment.
Print your Confirmation page upon successful filing.

77. Filing of An International Application (PCT) :-
Intellectual Property Corporation of Malaysia (MyIPO) As Receiving Office
1. Can I file an international application in Malaysia ?
Yes, any Malaysian national or resident can file an international application in Malaysia at the Intellectual Property
Corporation of Malaysia (MyIPO) as a receiving office.
2. What are the contents of the international application ?
An international application shall contain:
i. a request (Form PCT/RO/101)
ii. a description
iii. one or more claims,
iv. one or more drawings (if any)
v. and an abstract
3. What are the requirements to obtain an international filing date ?
The requirements to obtain an international filing date are as following :
a. The applicant must be a national or a resident of Malaysia,
b. The language of the international application must be in English,
c. The international application must contain :
i. an indication that it is intended as an international application,
ii. a request which has the effect of making all possible designation,
iii. the name of the applicant,
iv. a description of the invention,
v. a claim or claims

78. 4. What are the payable fees ?
The following fees are payable for an international application filed at MyIPO:
Transmittal Fee (MyIPO)
International Filing Fee (International Bureau)
Search Fee (International Searching Authority)
5. Which International Searching Authorities can be specified/chosen by the applicant to
conduct the international search for international application?
a Korean Intellectual Property Office
b. Australian Patent Office
c European Patent Office
d Japan Patent Office
6. Besides MyIPO, is there any other office where a Malaysian national or resident can file
his international application?
A Malaysian national or resident can file his international application with the International
Bureau of WIPO which acts as a receiving office for nationals and residents of all PCT
Contracting States.
7. How can I file my international application (PCT) ?
PCT application can be filed directly to MyIPO HQ and branche offices
Via postal delivery POS LAJU, DHL, FEDERAL EXPRESS, UPS
ePCT-Filing https://pct.wipo.int/LoginForms/epct.jsp
8.

79. Can I get reduction of fees if I file through PCT?
Yes. A Malaysian individual is entitled for 90% reduction of International
Filing Fee.
9. How about reduction of online filing fees?
An applicant will enjoy a reduction on Transmittal fee and International
Filing fee if he files through ePCT. Please refer to the PCT Fee Table on
MyIPO website.
10. If I file an International Application via ePCT can I make payment
via account transfer?
This service is not available for yhe time being. Applicant needs to make
payment over the counter at MyIPO HQ or branch offices (Cash, Cheque
or Credit Card ONLY)
Announcement 2018
Request Form

80. PATENT RENEWAL
Annual fee for patent E-Filing Fee (RM) Manual Fee (RM)
a) for second year after grant of patent
260.00 290.00
b) for third year after grant of patent 330.00 360.00
c) for fourth year after grant of patent 390.00 420.00
d) for fifth year after grant of patent 460.00 490.00
e) form sixth year after grant of patent 520.00 560.00
f) for seventh year after grant of patent 600.00 640.00
g) for eighth year after grant of patent 650.00 690.00

81. PATENT RENEWAL
Annual fee for patent E-Filing Fee (RM) Manual Fee
(RM)
h) for ninth year after grant of patent 720.00 760.00
i) for tenth year after grant of patent 780.00 820.00
j) for eleventh year after grant of patent 850.00 890.00
k)for twelfth year after grant of patent 900.00 940.00
l) for thirteenth year after grant of patent 1050.00 1100.00
m) for fourteenth year after grant of patent 1200.00 1250.00

82. PATENT RENEWAL
Annual fee for patent E-Filing Fee (RM) Manual Fee
(RM)
n) for fifteenth year after grant of patent 1300.00 1350.00
o) for sixteenth year after grant of patent 1600.00 1660.00
p) for seventeenth year after grant of patent 1850.00 1900.00
q) for eighteenth year after grant of patent 2100.00 2200.00
r) for nineteenth year after grant of patent 2400.00 2500.00
s) for twentieth year grant of patent 2600.00 2700.00

90. Origin Function – A trademark indicates the source of goods or
services in the market place.
Choice Function – A trademark facilitates consumers in making choices
of goods or services.
Quality Function – Consumers have preference to choose a particular
trademark for its known quality.
Marketing Function – Trademark act as an effective medium of
advertising for producer in marketing their goods or services.
Economic Function – A trademark which is well known with a quality
or reputation may be licensed or assigned as an economic asset.
WHAT ARE THE FUNCTIONS OF TRADEMARKS?

91. CROCIN
Crocin sells more than 2.50 million pills each day.
That's nearly 30 every second, around-the clock
Internationally Crocin goes by the name Panadol.
Crocin is a more than 40-year-old pain reliever
brand. It was born out of the merger of
GlaxoWellcome and SmithKline Beecham in
December 2000. Crocin – also marketed as Panadol in
more than 80 countries – is the leading
paracetamol brand in India. Over the years GSK has
grown the brand laterally adding a number of
variants

92. •
• Voveran, Novartis India’s flagship pain killer
medicine, is the second leading brand with
sales of $31.63 million (Rs 148.7 crore) with
growth rate of 4 percent.

93. • A human insulin product from Novo Nordisk—
Human Mixtard 30/70 which stands fourth in the
top 10 brands of India has registered a growth of
just three percent, according to ORG-IMS
Research.
PHARMA MANAGEMENT & REGULATORY AFFAIRS

94. • Franco- Indian Pharma’s anaemia drug Dexorange,
Pfizer’s cough and cold syrup Corex have registered
a doubledigit growth.

95. PHARMA MANAGEMENT & REGULATORY AFFAIRS

96. PHARMA MANAGEMENT & REGULATORY AFFAIRS

97. CONCLUSIONS
Intellectual Property Rights (IPRs) have assumed central importance
throughout the world in the recent past. Intellectual property is the
creative work of the human mind.
The main motivation for its protection is to encourage creative
activities. The contribution of intellectual property to industrial and
economic development of a country cannot be exaggerated.
The prosperity achieved by developed nations is the result of
exploitation of their intellectual property.
The protection of intellectual property is also responsible for the
transfer of technology from developed countries to the developing
countries.

98. CONCLUSIONS
Since the role of intellectual property is sine qua non in the industrial
and economic development of a country, it becomes therefore
inevitable to protect it. Yet, at the same time, this branch of law is
necessitated and aims to promote and protect the interest of an
individual to secure a fair value for his intellectual effort or investment
or capital or labour.
However, the recent provisions in TRIPs and the subsequent
judgments by the various courts have expanded the scope of
patentability beyond human imagination and have brought all living
organisms like plants, animals including human beings under the ambit
of Intellectual Property Rights