Patents and
Design Act, 1970
Contents
• A
brief discussion on intellectual property rights (IPRs), which includes
industrial properties such as Patents, Trademarks, Industrial designs,
Geographical Indications, Trade secrets and copyrights
• Types
of patents and procedure for filing of patents with reference to drugs and
pharmaceuticals in India
Intended Learning Outcomes
At the
end of this lecture, the student will be able to:
• Explain the need for Intellectual
Property rights
• Distinguish between different IPRs
• Discuss about patents
• Describe the features of patents
• Discuss about the salient features
of Indian Patent Act 1970
• Describe the changes made in the Patent act
following GATT agreement
• Explain the steps involved in filing
of a patent
• Describe
the details to be included in the specifications of patent
• Explain
the importance of trademarks
• Distinguish between different marks
• Explain the importance of
trade secrets and industrial designs
• Explain the importance of
Geographical indications
• Identify the products with a GI tag
Intellectual Property Rights
(IPRs)
• They
are rights recognized by the TRIPS agreement and governed by the WTO
• They
are developed to protect creative people who have disclosed their
inventions/ creations for the benefit on mankind
• IPRs aim at safe guarding creators
and other producers of intellectual goods and services by granting them time
limited rights to control their use
Types of IPRs
IPRs are divided into 2 main areas
- Copyright and related rights
- Industrial property
(a) Trademarks
(b) Geographical Indications
(c) Patents
(d) Industrial designs
(e) Trade secrets
Legislative Framework of IP Administration
Department of IP covers
The
Patents Act, 1970 (as amended in 2005)
The
Patents Rules, 2003 (as amended in 2006)
The
Designs Act, 2000
The
Designs Rules, 2001 (as amended in 2008)
The Trade Marks Act 1999
The
Trade Marks Rules 2002
The
Geographical Indications of Goods (Registration & Protection) Act, 1999
The
Geographical Indications of Goods (Registration & Protection) Rules, 2002,
Department of Education covers
The
Copyrights Act 1957 (amended in 1999)
Copyrights and Related rights
–
Also protected are the rights of performers
(actors, singers , musicians), producers of phonograms (sound recordings) and
broadcasting organizations
–
The social purpose of protection of copyright is
to encourage and reward creative work
–
Copyright is valid as long as the creator lives +
60 years after his death
–
Copyright is recognized internationally and does
not require frequent renewal
–
The creators often sell the rights
of their works to potential individuals or companies best able to market such
works in return for payment as royalty
Patent
• Is
a legal protection for an invention
• It
is a written document , which is a protection given by the government to an
inventor for his/ her invention for a limited term
• Ensures protection for the invention to the
original owner of the patent. The protection is granted for 20 years
• The
inventor should not disclose his invention prior to filing a patent application
• Once
the patent is granted the patented invention cannot be commercially produced,
used, distributed or marketed without the owner’s consent
• A patent owner has to decide the class of
people who can avail the patented invention for the stated period of protection
• The
patent owner may give permission to, or license, other parties to use the
invention
• The patent owner may also sell the right to
someone else for monetary gain or for better social cause, who will then become
the new owner of the patent
• Once
a patent expires, the protection ends, and the invention will be deemed as a
public property (public domain)
• Patents not only offer legal protection to the
owner, but also serve as a source of valuable information to researchers and
inventors
• Source of inspiration for future generations
of scientists
• A
patent is granted for an invention
• An
invention is idea of making a new useful article, method or substance
• A
patent once granted for an invention, it becomes an intellectual property which
remains for a specific period of time.
Conditions of Patentability
Patent is granted only for those inventions which have
• Novelty (newness)
• Utility (usefulness) / Industrial
applicability
• Involves an inventive step
• Non-Obviousness (not just the next step)
• Disclosure (enabling)
“Novelty” or “New” means
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
A feature of an invention that
involves
technical advance as compared to the existing knowledge or
have
economic significance or both
makes the
invention not obvious to a person skilled in the art
What is utility?
• Must be operable to perform intended
function
– must work
• Must
be directed to useful function
– must have a use
Industrial application
Invention is capable of being made or used in any kind of
industry
What is non-obvious?
• The
subject matter of the invention as a whole must not be obvious at the time the
invention was made to a person having ordinary skill in the art to which the
subject matter of the invention pertains
• Requirement
is to avoid granting patents for inventions which only follow from
“normal product design and development“
• The
diffrence between the existing prior art and the invention must be sufficiently
great to deserve a patent
PATENTS ACT 1970
• At
the time of independence, India’s pharma market was dominated by MNCs that
controlled a large share of market mainly through imports
• Approx.
99% of all pharma products protected by patents were held by foreign companies
and domestic Indian prices were highest in the world
• Due
to lack of competition, drugs were sold
at high prices in India
• The
Indian Pharma market remained import dependent through the 1960s until the
Govt. initiated policies stressing self reliance through local production
• The
Govt. of India funded 5 state owned pharma companies
• To
end the dominance of MNCs, the govt. enacted a series of policies
• Introduced
the Patents act 1970
• The
act scraped the product patent which was followed by foreign countries
• An
MNC inventing a new drug could at best patent the process of manufacturing it,
provided it was new
• Only
1 method or process for a drug could be patented
• Post
enactment of the Patents act, indigenous firms grew in size and started
producing drugs which were imported till then.
• By
1972, over 100 drugs were produced in India
• Firms
like Ranbaxy and Cipla grew rapidly when compared to MNCs like Glaxo, Pfizer,
Sandoz, Boots, Smithkline and French
• The
favourable environment attracted entry of new firms
-Sun Pharma in 1983
-Dr.
Reddy in 1984
-Aurobindo
in 1986
-Morpen
lab in 1984
-Orchid
chemicals in 1992
• The Indian firms focused on Reverse
Engineering oriented R&D
• Advantages of this includes the
shortening of the time lag between introduction in the global market by the inventor and marketing of the same drug in the Indian
market
Features of Patents Act 1970
• Included Product patent
and Process patent
• PRODUCT PATENT is for all inventions
except food, pharmaceuticals, substances produced by chemical processes and
agrochemicals
• PROCESS
PATENT is for food, pharmaceuticals, substances produced by chemical
processes and agrochemicals
• This
could help other competitors to find new, improved, advanced and economical
processes for producing the same product
• It
disallows monopoly
• India provided patent
protection only for 14 years
• In
case of food, pharmaceuticals, chemicals and agrochemicals, the patent period
is only 5 yrs from the date of sealing or 7 yrs from the date of filing
whichever is earlier
(Note:
Date of filing is
the date on which complete specification is submitted and date of sealing is
the date when the patent is sealed by the controller and the entry is made in
the register of Patents at the head office in Kolkata)
• The act also provided for Compulsory
Working Of A Patent
• The
patented product had to be manufactured in India
• The
patentee cannot hold a patent in India and import the product from another
country thereby compelling the Indian customer to pay a higher price
• The act also provided for Compulsory
Licensing Of A Patent
• In
case of non-working of a patent (if a patent holder does not commercialize the
invention), the act provides that after
3 years of sealing the patent, any other person can apply for compulsory
licensing on the grounds of public benefit
Patent amendment 2005
• The
WTO (comprising 123 nations) come into existence on 1st Jan 1995,
replacing GATT which had commenced in 1948.
• One of the agreements negotiated under
WTO was TRIPS
• India
being a member of WTO , automatically became a signatory to TRIPS
• TRIPS
provided a 3 stage frame for countries such as India which did not grant
product patent in pharmaceuticals
• Provisions
had to be applied by Jan 1, 1996
• Transition
period of 4 years till Jan 1, 2000 to comply with other obligations of
TRIPS such as rights of the patentee, term of patent, compulsory licensing etc.
• Additional
period of 5 yrs till Jan1, 2005 for developing countries like India to
introduce full product patent protection in all fields
• Least
developed countries got a transition period of 10 years from the date of
application, till Jan 1, 2006
• India
amended its patent law on 22nd March 2005 and reintroduced product
patent for pharmaceuticals, food and chemicals
• Reverse engineering or copying of patented
drugs was made illegal
• This
encouraged many foreign pharma companies to invest in the Indian market
• All
Indian firms were forced to enhance R& D activities and investments
Law and Regulations
• Patents
Act, 1970
– Amended
in
• 1999
• 2002
• 2005
• Patents
Rules, 2003
– Amended
in
• 2005
• 2006
Legislative
Measures –Patents
• From
1.1.1995
– Mail-Box
for pharmaceutical and agrochemicals products
– Exclusive
Marketing Rights
• From
1.1.2000
– Patent
term increased to 20 years
– Definition
of invention – inclusion of inventive step
– Reversal
of burden of proof – on the infringer
– Mandatory
compulsory licence provision for food, drugs and chemicals removed
– Right
of patentee (importation also included)
• From
1.1.2005
– Product
patents for food, chemical and pharmaceutical
We have met our international commitments
Patent Law 2005- Salient Features
• Both
product and process patent provided
• Term
of patent – 20 years
• Examination
on request
• Both
pre-grant and post-grant opposition
• Fast
track mechanism for disposal of appeals
• Provision
for protection of bio-diversity and traditional knowledge
• Publication
of applications after 18 months with facility for early publication
• Substantially
reduced time-lines
Safeguards in the Patent Law
• Compulsory
license to ensure availability of drugs at reasonable prices
• Provision
to deal with public health emergency
• Revocation
of patent in public interest and also on security considerations
Stages from filing to grant of a patent
Filing of a patent
• For
filing of a patent – understand the requirements of patent
• All
the criteria must be fulfilled
• Missing
any one of the criterion may make the patent non- workable
• To
ensure compliance, a thorough literature search needs to be carried out using
various patent databases
• When
satisfied, a drafted patent application is to be submitted to the patent
offices concerned
• An
application consists of 5 forms
• Form
1, Form 2, Form3, Form 5 and Form 18
• Form
1, Form 2, Form3, Form 5 are to submitted in duplicate along with the
prescribed fee to the patent office
• Form
18 is to be submitted 18 months after the date of submission of patent
application
Form 1– details about
– applicant
–
inventor
– title of invention
– particulars related to Patent
Cooperation treaty (PCT)
-declaration by inventor
Form 2– is the “heart of patent application”
–
detailed description of invention- with drawings and examples
COMPLETE SPECIFICATION
- Title
- Technical
field - Abstract
- Background
and prior act - Claims
- Current
problems/drawbacks/gap - Detailed
description - Drawings
- Experiments/trials/examples
(including tabular column, if any) - Solutions
to problem/improvement - Summary
of invention
Form 3–
– statement and undertaking by the
applicant
– disclose information regarding corresponding applications filed in
other countries.
– Form 3 (u/s 8): information regarding corresponding
applications at the time of filing the Indian application or within 6 months
from the date of filing the application in India.
– Keep the Controller of Patents informed of every other application filed
outside India subsequent to the filing of the Indian application
-Furnish details regarding the prosecution of corresponding applications
in other countries, if the Controller so requires
Form 4–
PURPOSE: For request for extension of time to:
1. pay renewal fees [u/s 53(2), 142(4) & rule 80(1A)];
2. to file Form 5 [rule 13(6)]
3. Application for review of decisions or setting aside of orders of the
Controller [rule 130]
•
FEES: 300/1200 – per month of time
•
To be filled in with all the details and requisite
fees and executed and filed in hard copy before the CoP in the IPO of
appropriate jurisdiction.
Form 5-
– declaration of the inventor
claiming for inventorship
– Fees: 1000 for individuals/ 4000
for corporates and organizations
Form 13- CHANGES
PURPOSE: On application for amendment of application for
patent/CS/other related documents u/s 57.
FEES: before
grant: 500/1,000
after grant: 1,000/4,000
for change of name/address/nationality/address
for service: 200/800.
To be filed in with all the details and requisite fees and
executed and filed in hard copy before the CoP in the IPO of appropriate
jurisdiction.
Ø On
submission of the application form, a receipt bearing the application number
and date of filing will be issued by the patent office
Ø In
case sufficient information relating to the work is not availabe, a Provisional
Patent application may be filed in
the same format along with the fees
Ø After
generating data- a complete application may be filed
Ø Provisional
Specification
–
To
establish PRIORITY DATE / establish early ownership
–
To
pre-empt others
Ø Complete
Specification
–
To be
filed within 12 months of filing of Provisional Application
Ø After
filing the patent , publication and the process of examination will start
Ø The
application will be sent to an expert in the particular field of invention
Ø The
expert verifies the claim of the application and gives his/her opinion in
writing to the patent office
Ø Any
clarifications raised by the expert needs to be justified by the applicant
Ø If
the replies are satisfactory, patent will be granted
Ø The
patent will be valid for 20 years
Ø Normally
it takes 2-3 years to get a patent in India
Renewal Fee
• To
be paid within 3+6 months from date of recording in the register
• No
fee for 1st and 2nd
year
• Renewal
fee, on yearly basis, is required to be
paid for 3rd to 20th for keeping the patent in force
• Delay
upto six months from due date permissible on payment of fee for
extension of time
• Patent
lapses if renewal fee is not paid within the prescribed period
Patent of addition
• An inventor who makes an improvement in the
invention that was not disclosed in the original patent is entitled to file
Patent of Addition
• This
is applicable only after the grant of the main patent
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
Form 18- Request for Examination (RFE)
• The application shall be taken up
for examination only when a request for the examination has been filed using
Form 18.
• The request can be made by either
the applicant or by any other interested person.
• (RFE) can be filed by either the
applicant or by interested person within a period of 48 months from the date of
priority or date of filing, whichever is earlier.
• The application is deemed to have
been withdrawn on the non-submission of request for examination within the
prescribed period
• Fee:
2500 for individuals/ 10,000 for corporates and organizations
Examination
• Application
is sent to an Examiner within 1 month from the date of request for
examination
• Examiner
undertakes examination w.r.t.
– whether
the claimed invention is not prohibited for grant of patent
– whether
the invention meets the criteria of patentability
Issue of First Examination Report (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 vet
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
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
Pre-grant Opposition
• After
publication, an opposition can be filed within a period of 6 months
• Opportunity
of hearing the opponent is also available
Examination of Pre-grant Opposition
• Opposition
(documents) is sent to the applicant
• A
period of 3 months is allowed for receipt of response
Consideration of Pre-grant Opposition
• 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
• This
is to be done within a period of 1 month from the date of completion of
opposition proceedings
Grant of a Patent
• A
certificate of patent is issued within 7 days
• Grant
of patent is published in the official journal
International Patents
• PCT
permits easy exchange of technical information between various countries
• If
an inventor does not wish for filing a patent in multiple countries and is
interested in filing in only 1 or 2 countries, he can do so by filing the
patent individually
• Patents
are valid only in the country where they are filed and not anywhere else
• So
it can be freely copied by others in various parts of the world without any
binding or permission from the original inventor
• To
avoid this, an international patent application should be filed
• Inventor
can make use of PCT (Patent cooperation Treaty) to protect the patent rights in
multiple countries
• PCT
introduced the concept of single international application for an invention
that is valid in PCT member countries(146 members)
Industrial Designs
- Protects
the artistic aspect (namely, texture, pattern, shape) of an object instead
of the technical features - The term of protection (amount
to at least 10 years) - ‘Amount to’ allow the term to be divided
into two periods (for example two periods of five years) - The third party is prohibited
from making, selling or importing articles bearing a design which is a
copy of the protected design, when such acts are undertaken for commercial
purposes - Exception: optional mandate, if
introduced then such exceptions do not unreasonably conflict with
the normal exploitation of protected industrial designs and do not
unreasonably prejudice the legitimate interests of the owner of the
protected design
Layout-designs
of integrated circuits
- It refers to mask works
(topographies) of the integrated circuits, the stencils used to etch or
encode an electrical circuit on a semiconductor chip - Protection conferred to
“original” layout-design/topographies
- Exclusive
rights include the right of reproduction and the right of importation,
sale and other distribution for commercial purposes - The term of protection (ten
years form the date of first commercial exploitation)
Trade secrets
•
It includes bits of knowledge or ingenuity that
can be patentable but for reasons best known to the keeper of the secret, are
not imparted to the general public
•
The secret can give the business an economic
advantage over competitors
•
As long as the secret is kept a secret , its use
can be exclusive for an indefinite period
•
Not limited by time
•
No registration costs
•
The expensive patent application process is
avoided
Protection of New Plant Variety and Plant Breeder’s Right
• Role
of farmers and the contribution of traditional, rural and tribal communities to
the country’s agro biodiversity were recognized by this right
• It
stimulates investment for R&D for the development new plant varieties in
order to facilitate the growth of the seed industry
• The
Plant Variety Protection and Farmers Rights Act 2001 was enacted in India to
mainly protect the New Plant Variety
Trademark
“A sign distinguishing goods or services produced or sold by
one enterprise (from those of other enterprises)”.
- Trademark protects any word,
name, logo, symbol or colour used
to identify, distinguish or indicate the source of goods or services
- The purpose is to safeguard the
integrity of products and to prevent product confusion and unfair
competition - The term of protection extends
for 20 years and can be renewed forever as long as they are being used in
the business
Functions
of trade mark
- To identify the goods and their
origin - To serve as a guarantee of
unchanged quality of the goods - It acts as a marketing and
advertising device
Genericized
Trademark
- Trademark may be rendered
invalid if it is not used at all or if it is not used properly - It becomes a common name for
the general class of product or service - Such a trademark is called a
Genericized trademark
Eg. Aspirin, Cellophane, Zipper,
Escalator, Thermos
- Xerox and Band aid have come
close to genericization, but rescued by aggressive corrective campaign
Types of Trademarks?
• Trade
marks: to distinguish goods
• Service
marks: to distinguish services
• Collective
marks: to distinguish goods or services by members of an association
• Certification
marks
Geographical Indication
• A geographical
indication (GI) is a name or sign used on certain products which
corresponds to a specific geographical location or origin (e.g. a town, region,
or country)
- GIs are denominations that
identify a good as originating in a region or locality, where the
reputation and quality of good is essentially attributable to its
geographical origin - TRIPS prohibits the use of GIs
in such a way as to cause deception and provides for injunctive relief,
refusal of trademark registration, etc - The term of protection is for
10 years
Why GI is to be protected ?
• Denote
quality and origin of products
• Good
reputation for the product
• Preventing
the product from generic products
• Protecting
the domestic market from competitors
• Preserves
Traditional Knowledge (TK) and Traditional Cultural Expressions (TCEs)
Advantages of GI:
• Legal
protection and preventing from unauthorized use
• Benefits
for farmers and local producers
• Boost
the rural development
• Reduces
unfair practices of trade
• Preserving local culture and resources
• Provides
complete information to consumers
Categories of GI (Class of goods)
• Agricultural
goods
• Handicrafts
• Manufactured
goods
• Food
stuffs
• Natural
goods
GIs
Registry of India- 272 registrations till date
State wise list of GIs
• Karnataka-
28
• Kerala-
20
• Tamil
Nadu- 24
• UP-
21
• Odisha-
15
• AP-
12
• Telangana-
11
• Rajasthan-
11
• Maharasthra-
10
• West
Bengal-8
• Gujarat-
8
• Nagaland-
7
• MP-
6
• Chattisgarh-
5
• J&
K- 5
• Bihar-
4
• HP-4
• Manipur-
3
• Assam-
3
• Punjab-
1
• Haryana-
1
• Goa-1
Protection
of GI internationally
·
Paris
Convention (1883):False indication
·
Madrid Agreement (1891) :False and deceptive
indication
·
Lisbon Agreement (1958):Define appellation of
origin
·
TRIPS Agreement (1994) :First International
treaty bound to protect GIs and to enforce its application
Who can apply for the registration of a geographical
indication?
• Any
association of persons, producers, organization or authority established by or
under the law.
• Registered
proprietor
• Authorized
user
• Producer
Contents of the Application
• Every
application for the registration must contain-
A
statement as to how the GIs serves to designate goods as originating from the
concerned territory of the country/region/locality in the country
• The class of goods to which the GI shall apply
• The Geographical map of the country, region or
locality in the country in which the goods originate or are being manufactured.
• The
particulars regarding the appearance of the GIs as to whether it comprises of
the
ü words
or figurative elements or both.
ü Mechanism
to ensure quality, standards, uniqueness
ü Special
human skills
ü Name
and address of the associations
ü Inspection
structure for maintaining quality
ü Protection
measures for eliminating infringement
TRADITIONAL KNOWLEDGE (TK)
Traditional Knowledge and Intellectual Property
• The
current international system for protecting intellectual property was fashioned
during the age of industrialization in the West and developed subsequently in
line with the perceived needs of technologically advanced societies
• However, in recent years, indigenous peoples,
local communities, and governments, mainly in developing countries, have
demanded equivalent protection for traditional knowledge systems
• In
2000, WIPO members established an Intergovernmental Committee on
Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC),
and in 2009 they agreed to develop an international legal instrument (or
instruments) that would give traditional knowledge, genetic resources and
traditional cultural expressions (folklore) effective protection
Traditional Knowledge
• Traditional
knowledge is a living body of knowledge
that is developed, sustained and passed on from generation to generation within
a community, often forming part of its cultural or spiritual identity
• Knowledge
has ancient roots and is often informal and oral
• As such, it is not easily protected by the
current intellectual property system, which typically grants protection for a
limited period to inventions and original works by named individuals or
companies
Summary
·
Patent is an intellectual property rights for
protecting the rights of inventors
·
Patent is given for an Invention
·
Invention must
-Be new
(novel)
-Involves
an inventive step
-Non
obvious
-Be
capable of industrial application
• Patents
act 1970 had both product and process patents
• The
act was modified as a result of GATT
• India
had to respect product patent in all fields
• Uniform
patent duration of 20 yrs
• The
patent is filed at the earliest as provisional
• Provisional
Specification is given to
–
To
establish PRIORITY DATE / establish early ownership
–
To pre-empt
others
·
Complete Specification is to be filed
within 12 months of filing of Provisional Application
·
The steps involved are Filing of patent
applictaion, formality check, request for examination, examination, Issue of
first examination report, pre grant oppposition, examination of pre grant
opposition and grant of patent
- Industrial design
protects the artistic aspect (namely, texture, pattern, shape) of an
object instead of the technical features - Copyright grants
exclusive rights to the creator of original scientific, artistic and
literary works - A sign distinguishing
goods or services produced or sold by one enterprise (from those of other
enterprises)”.
