Post on 21-Feb-2017
INTELLECTUAL PROPERTY RIGHTS
& STEPS IN PATENT GRANTING
DR.M.V.NAGABHUSHANAMPROFESSOR & HEAD OF THE DEAPRTMENT
DEPARTMENT OF PHARM. MANAGEMENT & REGULATORY AFFAIRSHINDU COLLEGE OF PHARMACY, GUNTUR A.P.
Industry size : 25.8 Bn USDExports : 13.2 Bn USD
Imports: 3.52 Billion USDIndustry is growing @ 20% p.a
Domestic Market 2011-2012: 12.6 Bn USD
4th Largest in world in terms of Volume & ranks 13th in terms of ValueExport of Biotech products & Biopharmaceuticals ~US $1.36 BnExport of Vaccines- US $507.9 million (US $ 42 Bn by year 2015)
Manufacturing Facilities 172 US FDA ApprovedIndia Stood First Globally with 2759 DMF filling Out of 7886 DMFs
US Pharmacopoeia has office in Hyderabad, IndiaUSFDA has country office in Delhi, Mumbai
9,000 manufacturing units in the country600,000 Retail & Wholesale Shops in India
153 EDQM certified facilities; 6th largest supplier of HIV drugs after Germany
Drugs from India are exported to more than 200 countriesVaccines from India are exported to more than 151 countries
Emerging markets India and China will figure in the top 10
pharma markets of the world by 2015, an Ernst & Young
report has said. The report has identified India as the
preferred choice for outsourcing in the area of late stage drug
discovery, shared services and complex manufacturing while
China has been the preferred market for building blocks and
intermediates.
PHARMA MANAGEMENT & REGULATORY AFFAIRS
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.
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CATEGORIES OF INTELLECTUAL PROPERTY
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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.
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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.PHARMA MANAGEMENT & REGULATORY AFFAIRS
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
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.
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PatentTrademark
Copyright
Design Registration
Trade Secret
Geographical Indications
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INTELLECTUAL PROPERTY
INDUSTRIAL PROPERTY + COPY RIGHT
PATENTS DESIGNS TRADEMARKS Geographical Indications
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Duration of Intellectual Property Rights in a nutshell
• Term of every patent will be 20 years from the date of filing of patent application,
• irrespective of whether it is filed with provisional or complete specification. Date of
• patent is the date on which the application for patent is filed.
• 2) Term of every trademark registration is 10 years from the date of making of the
• application which is deemed to be the date of registration.
• 3) Copyright generally lasts for a period of sixty years.PHARMA MANAGEMENT & REGULATORY AFFAIRS
Duration of Intellectual Property Rights in a nutshell
• 4) The registration of a geographical indication is valid for a period of 10 years.
• 5) The duration of registration of Chip Layout Design is for a period of 10 years counted
• from the date of filing an application for registration or from the date of first commercial
• exploitation anywhere in India or in any convention country or country specified by
• Government of India whichever is earlier.• 6) The duration of protection of registered varieties is different for
different crops namely• 18 years for trees and vines, 15 years for other crops and extant
varieties.
Global Intellectual Property Trends
• With over 3 million applications filed per year,
trademark protection is the most sought after
form of IP worldwide
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Intellectual Property Trends – India
• During 2009-10, 34,287 patent applications were
filed, 6069 examined and 6168 patents granted.
The number of applications filed by the Indian
applicants was 7044.
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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.
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• Pfizer’s cough and cold syrup Corex is a leading brand in India with sales of $35.53 million (Rs 167 crore)
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•
• 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.
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• Phensedyl cough and cold syrup from Piramal
Healthcare is the third leading brand in India and it
registered a growth of over 50 percent.
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• 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.
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•
• Franco- Indian Pharma’s anaemia drug Dexorange, Pfizer’s cough and cold syrup Corex have registered a doubledigit growth.
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Introduction• 1856 - George Alfred DePenning, a civil engineer, is
supposed to have made the first application for a patent in India for his invention –
"An Efficient Punkah Pulling Machine" . • March 3- Petition to the Government of India for grant of
exclusive privileges for his inventions.• Sept. 2 – Submission of Specifications for his invention
along with drawings to illustrate its working.• These were accepted and the invention was granted the first ever Intellectual Property protection in India.
Department of Pharmaceutical Management And Regulatory Affairs
History of Patent Law
Department of Pharmaceutical Management And Regulatory Affairs
YEAR
ACTS
1856
THE ACT VI OF 1856 ON PROTECTION OF INVENTIONS BASED ON THE BRITISH PATENT LAW OF 1852. CERTAIN EXCLUSIVE PRIVILEGES GRANTED TO INVENTORS OF NEW MANUFACTURERS FOR A PERIOD OF 14 YEARS.
1859THE ACT MODIFIED AS ACT XV; PATENT MONOPOLIES CALLED EXCLUSIVE PRIVILEGES (MAKING. SELLING AND USING INVENTIONS IN INDIA AND AUTHORIZING OTHERS TO DO SO FOR 14 YEARS FROM DATE OF FILING SPECIFICATION).
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• 1872 THE PATENTS & DESIGNS PROTECTION ACT.• 1883 THE PROTECTION OF INVENTIONS ACT.• 1888 CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT.• 1911 THE INDIAN PATENTS & DESIGNS ACT.• 1972 THE PATENTS ACT (ACT 39 OF 1970) CAME INTO FORCE ON
20TH APRIL 1972.• 1999 ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT, (1999)
CAME INTO FORCE FROM 01-01-1995.• 2002 THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE
FROM 2OTH MAY 2003• 2005 THE PATENTS (AMENDMENT) ACT 2005 EFFECTIVE FROM Ist
JANUARY 2005
History of Patent Law
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Patent Filing Procedures• Step 1: Filing of Patent Application• Step 2: Publication• Step 3: Opposition (if any)• Pre grant Opposition ; Post grant Opposition• Step 4: Request for Examination• Step 5: First Examination Report• Step 6: Amendment of objections by the applicant• Step 7: Grant of Patent• Step 8: Renewal fees
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HISTORY OF COPYRIGHT LAW 1847
• Copyright law entered India through an enactment.• According to the 1847 enactment, the term of copyright was for the lifetime
of the author + seventy years post-mortem.
Purpose: • Specifically reserves the subsistence of copyright in the author, and his right to
sue for its infringement to the extent available in law other than the 1847 Act.
Registration of copyright with the Home Office was mandatory for the enforcement of rights under the Act.
Department of Pharmaceutical Management And Regulatory Affairs
HISTORY OF COPYRIGHT LAW 1914:• Indian legislature enacted a new Copyright Act with few modifications
• First - Introduced criminal sanctions for copyright infringement (sections7 to 12).
• Second - Modified the scope of the term of copyright; under section 4
Act was continued with minor adaptations and modifications till the 1957 Act was brought into force on 24th January, 1958.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS
COPYRIGHT ENFORCEMENT ADVISORY COUNCIL (CEAC)
• The Government has set up on November 6, 1991 a Copyright Enforcement Advisory Council (CEAC) to review the progress of enforcement of Copyright Act periodically and to advise the Government regarding measures for improving the enforcement of the Act.
Amendments: 1981
1984 1992 1994 1999 2010 2012
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS
HISTORY OF TRADEMARK LAW1940 - The Indian Trademarks Act was passed .
1958 - The Trademark and Merchandise Act, 1958
Purpose:• Enables the registration of trademarks so that the proprietor of the
trademark gets legal right to the exclusive use of the trademark.
Objective: • Easy registration and better protection of trademarks and for prevention
of the use of fraudulent marks on merchandise.
1999 – The Trademark Act 1999
Objective:• To confer the protection to the user of the trademark on his goods and
prescribe conditions on acquisition, and legal remedies for enforcement of trademark rights.DEPARTMENT OF PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS
History of Geographical Indications1999 - Geographical Indications of Goods (Registration and
Protection) Act, 1999
2002 - The Geographical Indications of Goods (Registration and Protection) Rules, 2002
- deal with registration and better protection of geographical indications relating to goods.
Purpose: • Provide legal protection to Indian Geographical Indications which in turn
boost exports.
According to the Act:
The term 'geographical indication' (in relation to goods) means "an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory.
What is a Geographical Indication?• It is an indication• It originates from a definite geographical territory.• It is used to identify agricultural, natural or
manufactured goods• The manufactured goods should be produced or
processed or prepared in that territory.• It should have a special quality or reputation or
other characteristics
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Examples of Geographical Indication
• Solapur Chaddar
• Solapur Terry Towel
• Basmati Rice
• Darjeeling Tea
• Kanchipuram Silk Saree
• Alphanso Mango
• Nagpur OrangePHARMA MANAGEMENT & REGULATORY AFFAIRS
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JURISDICTION OF OFFICES
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Organization Structure – IP Offices
What is Patent?
• Patent is a grant for an invention by the Government to
the inventor in exchange for full disclosure of the
invention. A patent is an exclusive right granted by law to
applicants / assignees to make use of and exploit their
inventions for a limited period of time (generally 20 years
from filing).
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PATENT • A Legal Right• Conferred by the state• To an applicant / inventor• For Disclosing a New
invention• To make, use, sell or license the invention• For a limited period
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PATENTS• As on date, India is fully in compliance with its
international obligations under the TRIPs Agreement.
• The Patents Act 1970 has undergone three amendments – 1999, 2002 & 2005.
• Introduction of product patent protection for food,
pharmaceutical and chemical inventions.
* New amendment effective from January 01, 2005
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PATENTING OF PHARMACEUTICALS• New Chemical Entities• Process for preparing the new chemical entity• Pharmaceutical Intermediates• Pharmaceutical compositions of new
compounds• New pharmaceutical compositions of old
compounds• Process for preparing new compositions• First pharmaceutical use of a known compound• Second or new pharmaceutical use of a known
compound.PHARMA MANAGEMENT & REGULATORY AFFAIRS
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CRITERIA FOR GRANTING A PATENT• New (Novelty)
i.e invention must be new and not known earlier.• Useful (Capable of Industrial application)
i.e. invention must work and should not be only theoretical
• Unobvious (Involve an inventive step)i.e. must involve some effort on part of inventor
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WHAT CANNOT BE PATENTED• According to Indian Patent Act 1970,following inventions
are not patentable
• Invention which is contrary to well established natural laws
• Primary use of invention is injurious to public health
• Mere discovery of scientific principle or the formulation of an abstract theory
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Arrangement or rearrangement or duplication of known devices
A method of agriculture or horticulture
Any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for similar treatment of animals or plants
A presentation of information
A mathematical or business method or a computer programme or algorithms
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WHAT CANNOT BE PATENTED
Office Territorial Jurisdiction
• Patent Office Branch, Mumbai• The States of Maharashtra, Gujarat, Madhya
Pradesh,• Goa and Chhattisgarh and the Union Territories of• Daman and Diu & Dadra and Nagar Haveli• Patent Office Branch, Chennai• The States of Andhra Pradesh, Karnataka, Kerala,
Tamil• Nadu and the Union Territories of Pondicherry and• Lakshadweep.PHARMA MANAGEMENT & REGULATORY AFFAIRS
Office Territorial Jurisdiction• Patent Office Branch, New Delhi• The States of Haryana, Himachal Pradesh, Jammu
and• Kashmir, Punjab, Rajasthan, Uttar Pradesh,
Uttaranchal,• Delhi and the Union Territory of Chandigarh.• Patent Office, Kolkata The rest of India
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LICENSING AND THE GOVERNMENTOr
How to negotiate a successful partnership.
Pharma Management & Regulatory AffairsPHARMA MANAGEMENT & REGULATORY AFFAIRS
What is a License?
• A contract between licensor and licensee.
• Licensor grants to licensee the right to practice the technology claimed in the licensed patent
• Licensor agrees not to sue licensee for infringing licensor’s patent
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Types Of Patent Applications• 1) Ordinary Application• 2) Application for Patent of Addition (granted for
Improvement or Modification of the• already patented invention, for an unexpired term of the
main patent).• 3) Divisional Application (in case of plurality of inventions
disclosed in the main• application).• 4) Convention application, claiming priority date on the
basis of filing in Convention• Countries.• 5) National Phase Application under PCT.
How is a patent obtained?• File an application for patent With one of the patent offices based on
territorial jurisdiction of the place of office or residence of the applicant /agent
• Pay the required fee• Information concerning application form and details of fee available at• www.ipindia.nic.in• Guidelines for applicants also available on this website• The Patent Office then Conducts searches to ascertain the prerequisites• - Publishes the application• - Conducts in-depth examination• - Raises objection to the application• - Grants the patentPHARMA MANAGEMENT & REGULATORY AFFAIRS
Patent Grant Procedure Filing of patent application
Publication after 18 months
Pre Grant Opposition /Representation by any person. Request for examination
Examination: Grant or Refusal
Publication of Grant of patent
Post Grant Opposition to grant of patent (Constitution of Opposition Board)
Early Publication
Decision By Controller
Who can apply for Patent?
• The inventor may make an application, either alone or jointly with another, or his/their assignee
• or legal representative of any deceased inventor or his assignee.
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Specifications• Provisional Application for patent may be accompanied by the
provisional specification. It should contain the description of invention with drawing, if required. It is not necessary to include Claim. However, the complete specification should be fairly based on the matter disclosed in the provisional specification and should be filed within 12 months.
• If the complete specification is not filed within 12 months the application is deemed to have been abandoned. Usually a provisional specification is filed to establish priority of the invention in case the disclosed invention is only at a conceptual stage and a delay is expected in submitting full and specific description of the invention. Although, a patent application accompanied with provisional specification does not confer any legal patent rights to the applicants, it is, however, a very important document to establish the earliest ownership of an invention. specification
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Complete specification• The complete specification is an essential document in the
filing of patent application along with the drawing to be attached according to the necessity. Complete specification should fully describe the invention with reference to drawing, if required, disclosing the best method known to the applicant and end with Claim/Claims defining the scope of protection sought.. The specification must be written in such a manner that person of ordinary skill in the relevant field, to which the invention pertains, can understand the invention.
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• Normally, it should contain the following matter-• Title of invention,• 2) Field of invention,• 3) Background of invention with regard to the drawback associated
with known art,• 4) Object of invention,• 5) Statement of invention,• 6) A summary of invention,• 53• 7) A brief description of the accompanying drawing,• 8) Detailed description of the invention with reference to
drawing/examples,• 9) Claim(s),
Complete specification
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What is e-Filing?
• E-filing is a service provided by the Intellectual Property Office, India in order to enable
• customers to apply for a patent on-line allowing from the User’s browser for the User to:
• • Complete an electronic application form • Provide the associated attachments • Complete
• the necessary payment details
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COPY RIGHT
• Copy right is a exclusive right which an author acquires for
his work of literary or artistic nature such as book, a
painting, a sculpture, a photograph, a motion picture..etc
• It is a right to print, multiple, publish or sell a work.
Pharma Management & Regulatory AffairsPHARMA MANAGEMENT & REGULATORY AFFAIRS
COPYRIGHT
• The economic right given to creators of literary and artistic works.
• Includes the rights to: Reproduce the work Make copies Perform or display the work publicly
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Copyright holders have the right to……stop other parties from… 1. Making copies of the work. 2. Making changes to the work or creating new works
based on the original work. 3. Distributing the work. 4. Publishing the work. 5. Licensing the work to others.6. Otherwise exploiting the work.
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Duration of copy right protection• Original literary, dramatic, artistic or musical
works: the life time of the author + period of 70 yrs from the end of the year in which the author dies
• Computer generated works: 50 yrs from the date of creation of work.
• Sound recordings: 50 yrs from the end of year in which it was made or published.
• Broadcasts: 50 yrs from the end of year of broadcast
• Typographical arrangement of published editions: 25 yrs from the year of 1st publication
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WHAT IS A VALID COPYRIGHT NOTICE?• A copyright should contain:1. The word “Copyright”2. A “c” in a circle (©)3. The date of publication, AND4. The name of either the author or the owner of all
the rights5. “All Rights Reserved”• EXAMPLE: A Year in Provence. Copyright © 1989
by Peter Mayle. All Rights Reserved.
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HOW TO REGISTER YOUR WORK
• Registering a copyright is a simple process:– Fill out the appropriate form for the type of work you are
registering.– Enclose a deposit of one or two samples of the work
(depending on what type of work it is)– Pay the fee per registration (if you are registering several
works that are part of one series, you may register the works together as a group registration).
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TRADEMARK• Trademarks are commercial source indicators, distinctive
signs that identify certain goods or services produced or provided by a specific person or enterprise.
• Trademark helps consumers to identify and purchase a product or service based on whether its specific characteristics and quality – as indicated by its unique trademark – meet their needs
• Must prosecute infringement of trademark or risk losing the mark yourself!!
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What is Trademark?
• A trade mark (popularly known as brand name) in layman’s language is a visual symbol which
• may be a word signature, name, device, label, numerals or combination of colours used by one
• undertaking on goods or services or other articles of commerce to distinguish it from other
• similar goods or services originating from a different undertaking.
Key Features of Trademark
• · Trademark must be Distinctive• · Trademark must be used in Commerce
What is Trademark?• The selected mark should be capable of being represented graphically
(that is in the paper• form).• · It should be capable of distinguishing the goods or services of one
undertaking from• those of others.• · It should be used or proposed to be used mark in relation to goods or
services for the• purpose of indicating or so as to indicate a connection in the course of
trade between the• goods or services and some person have the right to use the mark with
or without identity• of that person.
Types of Trademark
• Trademark,• · Servicemark,• · Collectivemark,• · Certification Mark
Functions of Trademark
• Trademark performs four functions –• · It identifies the goods / or services and its
origin;• · It guarantees its unchanged quality;• · It advertises the goods/services;• · It creates an image for the goods/ services.
MARKS
• Trademarks® , ™– A trademark identifies tangible good or product of a company or individual.
• Servicemarks ®, SM
– A service mark identifies the service s of a provider. Marks used by a company can
function as both.
• Trade names
– Once a trade name was used to denote any mark descriptive of a good or service.
– Today, it is a company business name.
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An Example of Copyright AND Trademark
• The gold-colored top of the New York Life building is in the public domain and anyone can photograph it.
• However, that image also functions as a trademark for the New York Life Company, and a competing company could not use the image as a representation of their company’s goods or services..
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TRADE SECRETS
• Any information that may be used in the operation of a business and that is sufficiently valuable to afford an actual or potential economic advantage.
• Examples: Formula for Coca-Cola; compilations of information that provides a competitive advantage (customer databases), advertising strategies
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Geographical indications•An indication used to identify agricultural, natural or manufactured goods originating from a definite territory in India.•It should have a special quality or characteristics or reputation based upon the climatic or production characteristics unique to the geographical location.•Examples of Geographical Indications in India are Darjeeling Tea, Kanchipuram Silk Saree, Alphonso Mango, Nagpur Orange, Kolhapuri Chappal, Bikaneri Bhujia, etc.
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• The registration of a Geographical Indication is for a period of ten years.
• Renewal is possible for further periods of 10 years each.
• A trade mark is a sign which is used in the course of trade and it distinguishes goods or services of one enterprise from those of other enterprises.
• Geographical Indication is used to identify goods having special characteristics originating from a definite geographical territory.
Geographical indications
Legislative Framework of IP Administration
CONTROLLER GENERAL OF PATENTS, DESIGNS AND TRADEMARKS
(CGPDTM)
T M REGISTRY
DESIGN OFFICE
G.I. REGISTRY
Head OfficeKOLKATA
BranchDELHI
BranchCHENNAI
BranchMUMBAI
Head OfficeMUMBAI
DELHI
KOLKATA
CHENNAI
A’BAD
IPTI ,NIIPM, P.I.S. Nagpur
KOLKATA
PATENT OFFICE
CHENNAI
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Law and Regulations
• Patents Act, 1970– Amended in
• 1999• 2002• 2005
• Patents Rules, 2003– Amended in
• 2005• 2006
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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
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Patent Law - 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
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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
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Scope of Patentability Under The Patents Act
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What is an Invention?
“Invention” means a new product or process involving an inventive step and capable of industrial application
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Patentable subject matterInvention must
* Relates to a process or product or both
* Be new (novel)
* Involves an inventive step
* Be capable of industrial application
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“New” means
Invention must not bePublished in India or elsewhere
In prior public knowledge or prior public use with in India
Claimed before in any specification in India
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Inventive stepA feature of an invention that
• Involves technical advance as compared to the existing knowledge or
• Have economic significance or both and
* Makes the invention not obvious to a person skilled in the art
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Industrial application means
Invention is capable of being made or used in any kind of
industry
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Section 3 exclusionsSection 3(a) • Frivolous inventions• Inventions contrary to well established natural
laws
Examples Machine that gives more than 100% performance Perpetual machine
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Section 3 exclusionsSection 3(b)
Commercial exploitation or primary use of inventions, which isContrary to
public order or Morality
Examples– Gambling machine, – Device for house-breaking ,
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Section 3 exclusionsSection 3(b) Commercial exploitation or primary use of inventions , which
Causes serious Prejudice to health or human, animal, plant life or to the environment
Examples Biological warfare material or device,
weapons of mass destruction Terminator gene technology, Embryonic stem cell
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Checks and Balances Section 3(b)Excludes patents on
• GMOs – exploitation of which could be contrary public order or morality or prejudicial to human, animal or plant life or health or to the environment
Effect : Only genetically modified micro-organisms (GMOs) which do not fall under section 3 (b) are patentable.
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Section 3 exclusions Section 3 ( c )• Mere Discovery of a Scientific Principle or• formulation of an Abstract Theory or• discovery of any living thing or • discovery of non–living substance occurring in nature
ExamplesNewton’s Laws Superconducting Phenomenon as such Property of certain material to withstand mechanical shockDiscovery of micro-organism Discovery of natural gas or a mineral
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Checks and Balances Section 3(c)Excludes patents on
•Naturally occurring Micro-organisms
Effect Genetically modified microorganisms (GMOs) are however, patentable.
Section 3 exclusions
Section3 (d) The mere discovery of a new form of
a known substance which does not result in the enhancement of the known efficacy of that substance
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Section 3 exclusionsSection3 (d) ExplanationFor the purposes of this clause,• salts, esters, ethers, polymorphs, • metabolites, pure form, particle size,• isomers, mixture of isomers, • complexes, combinations and other derivatives of known
substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
Examples– Crystalline forms of known substance
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Checks and BalancesSection 3 (d) Explanation
Effect Salts, esters, ethers, polymorphs, metabolite, pure
forms, particle size, isomers, complexes, combinations and derivatives of a known substance with enhanced efficacy are patentable
Section 3 exclusionsSection3 (d)
Mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus, unless such known process results in a new product or employs at least one new reactant.
Examples– New use of Aspirin for heart ailments,– Mere new uses of Neem
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Section 3 exclusions
Section 3(e)Substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance
Examples Combiflam [Paracetamol (Antipyretic) + Brufen (analgesic)] Solution of sugar and color additives in water to form a soft drink
However,A mixture resulting into synergistic properties of mixture of ingredients however, may be patentable - Soap, Detergents, lubricants etc
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Checks and Balances Section 3 ( e )
Effect Substance obtained by mere admixture resulting
only in the aggregation of the properties of the components thereof or
a process for producing such substanceare not patentable
However Synergistic formulations are patentable
Section 3 exclusions
Section 3 ( f )Mere arrangement or re-arrangement or duplication of known devices, each functioning independently of one another in a known way
ExamplesA Bucket fitted with torch,An Umbrella with fanA Clock and radio in a single cabinetA flour-mill provided with sieving
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Section 3(h) Method of Agriculture or Horticulture
ExamplesCultivation of algae , Producing new form of a known plant, Preparation of an improved soil
However, Agricultural Equipments are patentable
Section 3 exclusions
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Section 3(i) Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products
Examples Removal of cancer tumor Removal of dental plaque and carries Surgical processes Processes relating to therapy Method of vaccination, Blood transfusion
Section 3 exclusions
However ,Treatment performed on tissues or fluids permanently removed from the body Surgical,therapeutic or diagnostic Apparatus or instrumentsare patentable PHARMA MANAGEMENT & REGULATORY AFFAIRS
Section3 exclusions
Section 3(j) Plants & animals in whole or any part
thereof other than micro- organisms, but including seeds, varieties an d species and essentially biological process for production or propagation of plants & animals
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Section 3 exclusionsSection 3(j)• Plants & animals in whole• Parts of plants & animals• Seeds• Varieties & species• Essentially biological processes for
propagation or production of the animals & plants
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Checks and Balances Section 3(j)Excludes patents on • Plants and animals in whole or any parts thereof,
…… including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals
Examples– Clones and new varieties of plants– A process for production of plants or animals if
it consists entirely of natural phenomena such as crossing or selection
– Essentially biological Process
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Section 3(k) * mathematical method or * business method or * algorithms or * computer programme per se
Examples– Computer program by itself or as a record on a carrier
However – New calculating machine – combination of hardware and software is patentable
Section 3 exclusions
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Section 3(l) A literary,dramatic, musical or artistic work or any other aesthetic creation including cinematographic work and television productions These subject-matters fall under the copyright protection
Section 3 exclusions
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Section 3(m) A mere scheme or rule or method of performing mental act or method of playing game
Examples•Scheme for learning a language •Method for solving a crossword puzzle, •Method of learning a language •Method of teaching /learning
However,•Novel apparatus for playing game or carrying out a scheme is patentable
Section 3 exclusions
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Section 3 (n)Presentation of information
Examples Any manner or method of expressing information
whether by spoken words Visual displaysymbolsdiagrams
Information recorded on a carrier
Section 3 exclusions
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Section 3 (o)Topography of integrated circuits.
ExamplesMask works - circuits layout
Section 3 exclusions
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Section 3 (p)Inventions which are Traditional Knowledge or an aggregation or duplication of known properties of traditionally known component or components
ExamplesTraditional Knowledge already in public domain- Wound healing property of Haldi
However, Any value-addition using Traditional Knowledge leading to a new process or product ,which is novel with inventive step and industrial applicability, gExtraction of Azadirachtin from Neem
can be patented
Section 3 exclusions
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Section 4Inventions falling within Section 20(1) of the Atomic Energy Act, 1962 are not patentable
EffectInventions relating to compounds of Uranium, Beryllium, Thorium, Plutonium, Radium, Graphite, Lithium and more as notified by Central Govt. from time to time.
Non Patentable inventions
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Stages from filing to grant of a patent
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Obtaining a patent
• File an application for patent– With one of the patent offices based on territorial
jurisdiction of the place of office or residence of the applicant /agent
– Pay the required fee• Information concerning application form and details
of fee available at www.ipindia.nic.in • Guidelines for applicants also available on this
website
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Formality Check
• An Examiner checks the formal requirements before accepting the application and the fee – this is done immediately
• Issue of application number and the cash receipt – this is done the same day
• In case of receipt of application by post, cash receipt, application number is sent by post within 2-3 days
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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
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Request for Examination
• Application is examined on request• Request for examination can be made either
by the applicant or by a third party• A period of 48 months, from the date of filing,
is available for making request for examination
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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 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
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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
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Pre-grant Opposition
• After publication, an opposition can be filed within a period of 6 months
• Opportunity of hearing the opponent is also available
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Examination of Pre-grant Opposition
• Opposition (documents) is sent to the applicant
• A period of 3 months is allowed for receipt of response
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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
STAGES - FILING TO GRANT OF PATENT
PUBLICATION OF APPLICATION
REQUEST FOR EXAMINATION
GRANT OF PATENT
3rd Party Representation
Revocation/Amendment
OPPOSITION
• PROMPTLY AFTER 18 MONTHS FROM P.D.
• WITHIN 48 MONTHS FROM F.D.
• ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS
• IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS
• WITHIN 12 MONTHS
FILING OF APPLICATIONPROVNL. / COMPLETE
Decision of Controller
EXAMINATION-ISSUE OF FER
Appeal
Appellate BoardPHARMA MANAGEMENT & REGULATORY AFFAIRS
Renewal Fee
• To be paid within 3+6 months from date of recording in the register [sec 142 (4) ]
• 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
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Indian Drug Regulatory System: Government of India
Ministry of Health & Family Welfare
DGHS
Central Drugs Standard Control
Organization (CDSCO)
Ministry of Science & Technology
Indian Council of Medical Research(ICMR)
Council of Scientific & Industrial Research
(CSIR)
BARC(Radioactive)
Ministry of Chemicals & Petrochemicals
National Pharmaceutical
Pricing Authority (NPPA)
Department of Chemical &
Petrochemicals (DCP)
Department of Pharmaceuticals
Ministry of Commerce &
Industry
Patent Office
Dept. of Commerce &
Pharmexil
Controller General of
Patent
DGFT
Ministry of Environment &
Forest
GEAC-[Genetic Engineering
Approval Committee]
Department of Biotechnology
r-DNA Advisory Committee
Review Committee
Genetic Manipulation
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Regulatory/Apex/Committee Functions
CDSCO Central Drugs Standard Control Organization (1948)
Laying down standards, Clearance of new drugs, CLAA items, Banning Drugs, Clinical Trails etc.
ICMR Indian Council of Medical Research (1911)
Formulates, Coordinates and Promotes biomedical research & Ethical Principles
GEAC Genetic Engineering Approval Committee (1989)
Manufacture, Use, Import of Hazards Microorganisms/Genetically Engineered Organisms or Cells
DBT Department of Biotechnology (1986) It promote transgenic research, molecular biology of human genetic disorders, brain research, and commercialization of diagnostic kits and vaccines for communicable diseases
AERB Atomic Energy Review Board (1983) Promotes Radio therapy & Research, Safety review for Gamma Irradiators (Devices)
BARC Bhabha Atomic Research Centre (1967)
Promotes Isotopes application in Medicine & also monitoring usage of radioactive materials
DTAB Drug Technical Advisory Board (1950) To advise Central & State Govt. on Technical Matters arising out of the Drugs & Cosmetics
RCGM Review Committee on Genetic Manipulation (1989)
No Objection Certificate for Clinical Trial & also r-DNA strains,
DCC Drug Consultative Committee (since 1951)
Advisory Committee to DTAB and Central & State Govt. for uniform implementation of Various provisions of the ActPHARMA MANAGEMENT & REGULATORY AFFAIRS
Introduction to Ministry of Health & Family Welfare (MOH&FW)
• MOH&FW comprises 04 departments each of which is headed by a Secretary to the Govt. of India – Department of Health & Family welfare – Department of AYUSH – Department of Health Research – Department of AIDS Control
• CDSCO is a separate division comes under DGHS, headed by DCG(I)
• Public health is one of the major objectives of Govt. of India and to achieve this it is important that drugs/vaccines are available to the public are Quality, Safety, Purity and Efficacious.
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153
Snapshot - Indian Pharmaceutical Industry
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Goa
New Delhi
Chennai
CDSCO North Zone (Ghaziabad)
Kolkata.
CDSCO West Zone (Mumbai)
CDSCO South Zone (Chennai)
CDSCO East Zone (Kolkata)
CDSCO, HQ
• HyderabadAhmedabad
*New Zonal Offices : 2 (Ahmedabad & Hyderabad)*Sub- Zonal Office : 3*Port Offices/Airports : 11*Central Laboratories : 6
35 SLAs= 29 States+ 6 UTs
Bengaluru
Geographical Location of CDSCO
Chandigarh
J&KHQ
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Functions of CDSCOApproval of new drugs and clinical trials
Import Registration and Licensing
License approving of Blood Banks, LVPs, Vaccines, r-DNAproducts & some Medical Devices (CLAA Scheme)
Amendment to D &C Act and Rules
Banning of drugs and cosmetics
Grant of Test License, Personal License, NOCs for Export
Testing of New Drugs
156PHARMA MANAGEMENT & REGULATORY AFFAIRS
Functions of State Licensing Authorities
Licensing of Manufacturing Site for Drugs including API and Finished Formulation
Licensing of Establishment for sale or distribution of Drugs
Approval of Drug Testing Laboratories
Monitoring of Quality of Drugs and Cosmetics marketed in the country
Investigation and prosecution in respect of contravention of legal provision
Recall of sub-standard drugs
157PHARMA MANAGEMENT & REGULATORY AFFAIRS
Principles of GLP and Regulatory requirements
Objectives of GLP • GLP makes sure that the data submitted are a true
reflection of the results that are obtained during the study.• GLP also makes sure that data is traceable.• Promotes international acceptance of tests.
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What is GLP?• Good Laboratory Practice (GLP) deals with the organization, process and conditions under which
laboratory studies are planned, performed, monitored, recorded, reported & archived. GLP practices are intended to promote the quality and validity of test data (part 58 CFR 21). OR
• GLP is a quality system concerned with the organizational process and the conditions under which non clinical health & environmental safety studies are planned, performed, monitored, recorded, archived & reported. (Ref. Jurg P. Seiler-Switzerland, GLP, 2nd edition by Springer publication, 2005, Page 61).
• Schedule L-I regulations and guidelines have a significant impact on the daily operation of an analytical laboratory.
• GLP is a regulation. It is not only good analytical practice. Good analytical practice is important, but it is not enough. For example, the laboratory must have a specific organizational structure and procedures to perform and document laboratory work. The objective is not only quality of data but also traceability and integrity of data. But the biggest difference between GLP and Non-GLP work is the type and amount of documentation.
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Pharmaceutical product Submitted to regulatory authority
Verification
Repetition of experiment or Reconstruction of all activities activities (Direct confirmation) (Indirect confirmation)
Judgment taken Accept / Reject
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GLP Concerns as Per WHO TRS 957 2010 Guidelines
Part 1 Management and infrastructure
• Organization and management• Quality management system• Control of documentation• Records• Data-processing equipment• Personnel• Premises• Equipment, instruments and
other devices• Contracts
Part 2 Materials, equipment, instruments
and other devices• Reagents• Reference substances
and reference materials• Calibration, verifi cation
of performance and• qualification of
equipment, instruments and other devices
• Traceability
Part 3 Working procedures
• Incoming samples• Analytical
worksheet• Validation of
analytical procedures
• Testing• Evaluation of test
results• Certificate of
analysis• Retained samples
Part 4Safety
• General rules
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GLP Concerns as Per Schedule L1 (Rule 74, 78 & 150E), Drugs & Cosmetics Act 1940
GLP
Internal Quality System Audits
General Requirements Premises
Personal
Equipments
Chemicals and Reagents
Quality SystemMicrobiological Cultures
Reference Materials
Maintenance, Calibration, and
Validation of Equipments
Good House Keeping and SafetyManagement Review
Standard Operating Procedures
Protocols and Specifications Archive
Raw Data
Storage and Archival
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Intellectual Property & the Pharma Industry - Introducing Marty the Medicine.mp4PHARMA MANAGEMENT & REGULATORY AFFAIRS
Intellectual property rights and their effects on essential commodities.mp4
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Intellectual Property Rights-An introduction.mp4
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