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BY:- ATUL H KATEGAONKAR

M.PHARM. SECOND SEM.2007-08

GUIDED BY:-
Prof. SWATI JAGDALE.
ASST.PROFESSOR IN PHARMACEUTICS

MAEER’s
MAHARASHTRA INSTITUTE
OF PHARMACY
KOTHRUD,PUNE-38

Nov 28, 2009 PHARMA PATENT 1


Contents
 INDIAN PHARMACEUTICAL INDUSTRY.

 PHARMACEUTICAL INDUSTRY AND INDIAN PATENT SYSTEM.

 TRIPS.

 INTELLECTUAL PROPERTY.

 MODES OF PROTECTING INTELLECTUAL PROPERTY.

 INVENTION.

 PHARMA PATENT.

 INFRINGMENT.

 CASE STUDIES.

 CONCLUSION.

 BIBLIOGRAPHY.

Nov 28, 2009 PHARMA PATENT 2


Indian Pharmaceutical
Industry
Global Pharmaceutical market estimated
at US$ 600 bn plus

About 60% from exports to about 65


countries.

Pharmaceutical
Pharmaceutical In terms of market ranking India ranks
Industry 4th in Volume terms, 13th in Value terms
Industry & 8th in Manufacturing capabilities terms
in the world

3000 API units; 5000 Formulation units &


2000other units (intermediates,etc.).

Represents less than TWO


percent of the global pharmaceutical industry

Nov 28, 2009 PHARMA PATENT 3


PHARMACEUTICAL INDUSTRY AND INDIAN PATENT
SYSTEM.


First Indian Patent Act 1856

Patents and Design Act 1911 -Product-patents for drugs and medicines
 Strong intellectual property laws
 MNCs enjoyed a complete monopoly and charged high prices

Dominated the Indian drug market

Controlling 80% of the market

“India ranks amongst the highest priced nations of the world “

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 Indian Patents Act, 1970 was a response to the Patents Act, 1911.

Salient Features
 Only process patents for food,
pharmaceuticals and chemical
products.

 Product and process patents in all other


areas

 Term of patent – variable (7 / 14 years)

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 As on date, India is fully in compliance with its international
obligations under the TRIPs Agreement.

 The Patents Act 1970 3 amendments 1999, 2002 & 2005.

 The III Amendment in 2005 has major implications on-


 Introduction of product patent protection for food, pharmaceutical
and chemical inventions.
 Examination The “mail box” applications, from January 01, 2005
mail box facility to accept product patent applications

Nov 28, 2009 PHARMA PATENT 6


Results of Changes in the Patent
System

 Pharma industry – 10 billion dollar industry

 Size of drug industry


About 20,000 manufacturing units providing
employment to approximately 33 Lakhs people
 Ranked 4th in terms of volume and 13th in terms of
value world wide

 India is one of the top five manufacturers of bulk


drugs and among top 20 pharmaceutical exporters

 R&D expenditure over Rs.1000 crores


Nov 28, 2009 PHARMA PATENT 7
TRIPS (Trade Related Aspects of Intellectual Property Rights)

-International agreement administered by the World Trade Organization (WTO)


that sets down minimum standards for many forms of intellectual property (IP)
regulation.

- It was negotiated at the end of the Uruguay Round of the


General Agreement on Tariffs and Trade (GATT) in 1994.

“To promote access to medicines for all."

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Indian Patent Act of 1970 TRIPS
Only process not product patents in Process and product patents in almost
food, medicines, chemicals all fields of technology

Term of patents 14 years; 5-7 in Term of patents 20 years


chemicals, drugs

Compulsory licensing Limited compulsory licensing

Several areas excluded from patents Almost all fields of technology


(method of agriculture, any process for patentable.
medicinal surgical or other treatment of
humans, or similar treatment of animals
and plants to render them free of disease
or increase economic value of products)

Government allowed to use patented Very limited scope for governments to


invention to prevent scarcity (rare) use patented inventions

Nov 28, 2009 PHARMA PATENT 9


What is Intellectual Property ?

Intellectual property Rights refers to the Right of any party


to safeguard & legally prevent others from using an original
brand, trade secrets or inventions.

THE IPR CYCLE

Creation

Exploitation Protection

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MODES OF PROTECTING INTELLECTUAL PROPERTY.
Instruments Protection
Patents Protectinventions which are novel, non-obvious
and have commercial application
Copyrights Protects creative output such as words, music, art,
etc.
Trademarks ™ Protects signs or marks which distinguish product
or services
Geographical Protection of goods that can be identified to a
Indications particular territory, region or country

Traditional e.g.therapeutic benefits of turmeric, neem, etc.,


Knowledge agricultural practices, genetic resources

Design Rights Protection of external appearance of products

Nov 28, 2009 PHARMA PATENT 11


MODES OF PROTECTING INTELLECTUAL PROPERTY.
contd….
Instruments Examples No. of Years of Protection

Patents New Chemical Entity, Novel Drug Generally 20 years;


Delivery System (NDDS), etc. in some countries 14 years
Also process patent

Copyrights Literary article/book, computer Not less than 50 years


software, Research Papers

Trademarks Logos, marks, etc. e.g. Initially for 7 years can be


renewed perpetually
Geographical Scotch Whisky,Basmati rice, Initially for 10 years can be
Indications Darjiling Tea renewed from time to time

Design Rights Coca Cola bottle shape Initially for 10 years, can be
renewed for further 10 years

Nov 28, 2009 PHARMA PATENT 12


 Core, IP generating departments in pharma.
 Drug discovery & development
 Drug delivery
 Formulation
 Pharma research
 Chemical research
 Herbal research
 Biotechnology

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Inventio
n
Invention means-
A new product or process involving an Inventive Step
and capable of Industrial application

 An invention is considered to be new, if it does not


form a part of the state of the art
 Capable of industrial application means- invention is
capable of being made or used in any kind of industry
 Inventive Step means a feature of an invention that
involves an technical advance as compared to the
existing knowledge or having economic significance or
both and that makes the invention not obvious to a
person skilled in the art

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Patent :-
 A patent for an invention is granted by the Government
to the inventor, giving the inventor the right to stop
others from making, using or selling the invention without
the permission of the inventor for a limited period

Need for Patent System


 Legal protection for newly developed product & processes.
 To ensure commercial returns to the inventor for time & money spend
in generating a new product.
 Provides an inducement to invest in R & D
 “Research is the heart of the Pharma.”
 Stimulant for Economic growth.

Nov 28, 2009 PHARMA PATENT 15


INVENTIONS – NOT
PATENTABLE

“Not Everything is Patentable”

 B) Primary or intended use or commercial exploitation of


which could be contrary to Public order or morality or which
causes serious prejudice to human, animal or plant life or
health or to the environment .
e.g.
 Device for house-breaking,

 Biological warfare material or a device,

 Embryonic stem cell,

 Terminator gene technology,

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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

e.g.
 Archimedes Principle.
 Bohr’s Postulates etc as such – not patentable ,
 However, An apparatus/method for technological
application may be patentable

Nov 28, 2009 PHARMA PATENT 17


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 OR
 The 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.

3 d : Explanation :
For 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.

 e.g. New use of Aspirin in heart ailments,

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E) A substance obtained by mere admixture resulting only in the
aggregation of the properties of the components thereof or a
process for producing such substance
e.g. Not patentable-
1) Paracetamol (Antipyretic) +Brufen (analgesic)
= A drug (antipyretic & analgesic)
2) A mixture of sugar and some colorants in water to
produce a soft drink is mere admixture
But, a mixture resulting into synergistic properties of mixture of
ingredients however, may be patentable
e.g. Soap, Detergents,lubricants etc

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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

e.g.
 Removal of cancer tumor
 Removal of dental plaque and carries,
 Surgical processes, any process relating to therapy,
 Method of vaccination
However ,
 Method performed on tissues or fluids permanently removed from
the body
 Surgical,therapeutic or diagnostic Apparatus or instrument
are not excluded from patentability

Nov 28, 2009 PHARMA PATENT 20


 j) Plants & animals in whole or any part thereof other than micro-
organisms, but including seeds, varieties and species and
essentially biological process for production or propagation of plants
& animals
e.g.

 Clones and new varieties of plants:


Not patentable

 Microorganisms:
Not patentable

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 PRODUCT WITHIN THE SCOPE OF
PRODUCT PATENTS
“ANYTHING UNDER THE SUN MADE BY MAN”

 New drug molecules,


 Pharmaceutical preparations
 Synergistic combinations
 Combination of a new chemical entity with a known
component
 Agrochemicals
 New chemical products
 New products resulting through bio-technological,
microbiological or biochemical processes
 Genetically modified Micro-organisms/DNA sequence.

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PATENT GRANT PROCEDURE
Filing of patent application

Early Publication Publication after 18 months

Opposition By Third Party


Representation (Pre Grant Opposition)
Request for examination (Form 18
with fees)

Examination: Grant or Refusal

Publication of Grant of patent

Opposition to the patent


(Post Grant Opposition)

Decision By Controller

Nov 28, 2009 PHARMA PATENT 23


PUBLICATION OF INVENTION

Promptly after 18 month from priority date


Early publication Possible on request

In Patent Office journal/ ipindia.nic.in

No publication of Applications for which-


 Complete specification not filed

What is published ?
Priority details

Applicants details

Abstract

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DOCUMENTS
REQUIRED
 Application Form 1 in Duplicate with Fees.
 Provisional or complete specification along with
 Drawings, if any, in Duplicate.
 Abstract in Duplicate
 Declaration as to Inventorship (If provisional specification is filed first
or, in case of convention application) along with Complete Specification
or within one month in F/ 5
 For Convention Application- A certified copy of Complete
Specification filed in the convention country
 Power of Attorney- If filed through a Patent Attorney
 Information regarding foreign filing (u/s 8)
 Statement and undertaking regarding foreign filing in Form 3 in
duplicate.

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CONTENTS OF COMPLETE SPECIFICATION
 It is a Techno-legal document

 Title of Invention along with form 2


 Field of Invention.
 Use of Invention
 Prior Art and its drawbacks .
 Problem to be solved.
 Object of Invention(may be more than one)
 General statement of invention
 Detailed Description of Invention[ with reference. to drawings
 Best method /example of working of the invention
known to the applicant
 Statement of claims.
 Signature with date
 Drawings
 Abstract

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LIFE OF A PATENT

 EUROPE :
20 years from date of filing.
 USA

- Before GATT (June 08, 1995):


20 years from date of filing or
17 years from date of grant
- After GATT: 20 Years from date of filing.

 INDIA

Till May,2003
(a) Pharmaceuticals / Food 7 years from date of filing,
(b) others like engineering etc 14 years from date of filing
- After May, 2003: 20 years from filing date.

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A typical product life cycle

100
Growth

50

0
10 20 30 40
Year
Proprietary Generic Commodity

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Nov 28, 2009 PHARMA PATENT 29
Patent Applications
1999-2007
32000

30000
28882
28000

26000
24415
24000

22000

20000

18000
17466
16000

14000
12613
12000
11466
10592
10000
8503
8000

6000
4824
4000

2000

0
1999- 2000-01 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07
2000
Nov 28, 2009 PHARMA PATENT 30
2007 14

2008 10

Year & No. Of


2009 6
Drugs Going Off
2010 9
patent
2011 10

Anti-cancer drugs scheduled to lose their


patent protection are:

Nov 28, 2009 PHARMA PATENT 31


STATUS IN
2008
 Countries in the world :
200

 Countries having patent laws :


157

 Country members of Patent Cooperation Treaty :


130

Nov 28, 2009 PHARMA PATENT 32


INFRINGEMENT

A patent provides the proprietor of that patent with the right to


exclude others from utilizing the invention claimed in that
patent.
Should a person utilize that invention, without the permission
of the patent proprietor, they may infringe that patent.

Nov 28, 2009 PHARMA PATENT 33


CASE STUDIES

Nov 28, 2009 PHARMA PATENT 34


1) REVOCATION OF TURMERIC PATENT

 U.S. Patent 5401540 granted to University of


Mississippi by USPTO for Turmeric Wound Healing
Properties - 1995.
 CSIR requested for re-examination giving 32
references from Ancient Indian Literature (e.g.
Ayurvedic Pharmacopoeia, The Wealth of India,
Indian Home Remedies, etc.) – 1996.
 CSIR proved that use of turmeric is not novel and it
is prior knowledge.
 Based on CSIR representation USPTO revokes
Turmeric Patent – 1998.

Nov 28, 2009 PHARMA PATENT 35


2) Tarceva case-
 Roche Vs Cipla Mar 20, 2008

Patent case: HC declines to restrain Cipla

Making, selling generic version of Roche’s Tarceva (lung-cancer drug)

Nov 28, 2009 PHARMA PATENT 36


CONCLUSION

The only thing that keeps us alive


is our brilliance
The only thing protecting our brilliance
is our patents
Edwin H. Land, 1976

Nov 28, 2009 PHARMA PATENT 37


BIBLIOGRAPHY
 Malik K A, Zafar Y. IPR in plant biotech,Asian Biotechnology &
Development Review. 2005;(8);7-43.
 Narayan S. Drug IPR where India must not 'trip'. BusinessLine.2007;(24);8.
 Dhar B, Gopakumar K.M. Post-2005 TRIPS scenario in patent protection
in the pharmaceutical sector: The case of the generic pharmaceutical
industry in India 2006;8.
 Dr.Kuchekar B S,Khadatare A M,Itkar S C, Forensic Pharmacy,Nirali
Prakashan.2005;(5);15.1-16.8.
 Subbaram N ,What everyone should know about PATENTS?,Pharma Book
Syndicate.2007;1-192.
 Ashiya M, TRIPS and Pharmaceutical Industry Impact on Developing
Countries,The Icfai University Press.2007(1);1-230.
 Chakaraborty S,New patent Regime,Lessons for indian Pharma,
Countries,The Icfai University Press.2006(1); 1-242.

Nov 28, 2009 PHARMA PATENT 38


 The Patent Act, 1970, Office of the Controller General of Patents, Designs,
and Trademarks, Government of India.
 “India’s new product patent law: challenges and opportunities for local drug
makers,” Pharma Market Letter, Dec. 6,2004. The Indian Pharmaceutical
Industry: Collaboration for Growth, KPMG, 2006
 TOI PUNE JUNE 14,2008.
 Business Daily from THE HINDU group of publications
Wednesday, Apr 16, 2008

 Business Daily from THE HINDU group of publications


Sunday, Sep 23, 2007
 Business Daily from THE HINDU group of publications
Wednesday, Apr 04, 2007

 http://en.wikipedia.org/wiki/Agreement_on_Trade-Related_Aspects_of_Intelle
 http://www.iprsonline.org/unctadictsd/description.htm
 http://www.uspto.gov/web/offices/ac/ido/o eip/taf/asgstca/inx_stc.htm

Nov 28, 2009 PHARMA PATENT 39


E-mail :- atul_kategaonkar@rediffmail.com

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