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 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

  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 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)”.

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