Patents and Design Act, 1970

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 indicat
ions

        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

  1. Copyright and related rights
  2. 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

  1. Title
  2. Technical
    field
  3. Abstract
  4. Background
    and prior act
  5. Claims
  6. Current
    problems/drawbacks/gap
  7. Detailed
    description
  8. Drawings
  9. Experiments/trials/examples
    (including tabular column, if any)
  10. Solutions
    to problem/improvement
  11. 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

       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 re
gistrations 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)”.

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