IPR Pharma

INTELLECTUAL PROPERTY
RIGHTS OF PHARMACEUTICALS
Presented by-
HEMANGA HAZARIKA
M. Pharm 2nd Semester
Roll no- MP/13/02 Dept. of Pharmaceutics
Girijananda Chowdhury Institute of Pharmaceutical Science, Azara, Guwahati-17

INTRODUCTION
According to the WIPO, “IP refers to creation
of the mind, inventions, literary and artistic
works and symbols, names, images and
designs used in commerce”
Divided into two categories
1) Copyright
2) Industrial property
Tuesday, April 29, 2014
Girijananda Chowdhury Institute of
Pharmaceutical Science, Azara, Guwahati-17
2

THE LEGISLATION COVERING IP IN
INDIA ARE
Copyright: The Copyright Act of 1957
Last amended in 1994
Design: The Design Act 1911
IT: The Information Technology Act 2000
Patent: The patent Act 1970(Changes bought
in 1994)
Trademark: The Trade Merchandise Mark Act
1958
Communication: Communication Bill 2000
Pharmaceutical Science, Azara, Guwahati 17
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COPYRIGHT- IN INTERNATIONAL CONTEXT
Berne convention(1886)
Universal Copyright Convention(UCC )(1952)
Paris revision in 1971
World Intellectual Property
Organization(WIPO)
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COPYRIGHT- IN INDIAN CONTEXT
Copyright in 1847 was passed by the Governor
General of India
In 1911 the law of copyright was codified in
England
The Governor General of India enacted the Indian
copyright Act of 1914 to make some modification
to the whole of the 1911 Act
Copyright Act 1914 was again modified after
independence which in force even today was
passed in the Indian Parliament in 1957
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INDUSTRIAL PROPERTY
Patents
Trademarks
Industrial designs
Geographic indication of source
7

PATENTS
The first congress adopted a Patent Act in
1790 in the US
The first patent was issued under this Act on
July 1790; to Samuel Hopkins of Vermont for a
potash production technique
The first legislation in India relating to patent
was the Act of 1856
In 1888 new legislation was introduced
8

ADVANTAGES OF PATENTING
Incentives to individual
Encourage innovation
Inspiration for the future generation
Gets the benefits of the research
Patented products useful to a number of
people become available to the public
9

FILING OF PATENT APPLICATION WITH
INDIAN PATENT OFFICE
 Covering indicating the list of documents
 Application for grant of patent in Form 1
 Complete specification in Form 2, comprising
Description
Claims
Drawings
Abstract
 Statement and undertaking in Form 3
 Power of Attorney in Form 26(in original)
 Declaration of inventorship in Form 5
 Certified true copy of the Priority document
 Requisite statutory fees
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NON PATENTABLE INVENTIONS
Contrary to public order
The mere discovery of a scientific principle
Obtained by a mere admixture
Method of agriculture or horticulture
Surgical technique for hand surgery
Atomic energy
Living thing and non-living things occurring in
nature
Mathematical or business methods
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pharmaceutical Science, Azara, Guwahati-17
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pharmaceutical Science, Azara, Guwahati-17
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PATENT FACILITATOR CENTERS IN
INDIA
Technology Information, Forecasting &
Assessment Council (TIFAC), New Delhi
Intellectual Property Management (IPM)
Division, CSIR, New Delhi
National Research Development Corporation
(NRDC), New Delhi
Patent Information System (PIS), Nagpur
National Information Centre, New Delhi
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PATENT-IMPACT ON PHARMACEUTICAL
INDUSTRY
BAD
 Competition from
MNCs
 Litigation
 Price rise
GOOD
 Growth of Pharma Ind.
 More resources would
be devoted to basic
research
 Global research
industry
 Outsource
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RECENT PATENT DISPUTES AND
LITIGATIONS IN INDIA
 Patent application for Imatinib mesylate (Gleevec) was
rejected by Patent office and also by IPAB
 A Compulsory License has recently been granted to
Sorafinib of Natco against Naxaver of Bayer, who has
been granted a patent in India
 Bayer has been found by Controller General of Patents
to have:
 Not made the medicine available in sufficient quantities to patient
 Priced the medicine exorbitantly (Rs. 2,80,000/- as against Rs.
8,800/- of Natco)
 Not worked in the territory of India
 In the meantime, Cipla has reduced the price below
that of Natco
pharmaceutical Science, Azara, Guwahati-
17
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E.g. of selected Indian process patents
on novel drug delivery systems
Indian patent number Title of the patent
189017 A method for preparing sustained release microparticles
187188 A method of producing sterile ophthalmic gel drop
preparation
182866 A method of preparing sustained release excipient
178710 A process for producing oral sustained release opioid
formulation
178449 A process for making transdermal device for
controlled/regulated administration
184719 Implant injection device
186948 A process for preparation of controlled release formulations
of nimesulide
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TRADEMARK
Legislation is the Trademark Act 1994
Certification marks are given for compliance
with defined standards (eg. ISO 9000)
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DESIGN
Essential requirements for the registration of
design-
New, original and not previously published or
used in any country
Applicable to any industrial process
Features should be judged solely by the eye
Should not include any trademark or artistic work
Distinguishable from any known design
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GEOGRAPHICAL INDICATION
India as a member of WTO enacted the
Geographical Indication of Goods Act 1999 has
come into force wef 15th Sept 2003
Geographical indications ensures that none other
than those regd. As authorized uses are allowed
to use popular product name
Darjeeling tea become the first GI tagged product
in India in 2004-05
Since then by 2010. 132 had been added to the
list
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CONCLUSION
There has been a growth in patent activities in
India after TRIPS existence
India’s leading drug companies, they couldn't
survive as global players without significant R&D
capabilities
Considerable improvement in research
investment has been observed after
implementation of TRIPS of WTO
There is an urgent need for SMEs to develop a
collaborate research culture with public and
privately funded research orgs for their survival
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REFERENCES
1) Bedi Neena et al. Patenting and R&D in Indian Pharmaceutical
Industry: Post- TRIPS Scenario. Journal of Intellectual Property
Rights; Vol 18, March 2013, pp 105-110
2) Janodia D. Manthan et al. Impact of Patents in Pharma Industry’s
Competency: A viewpoint of Pharmaceutical Companies of India;
Journal of Intellectual Property Rights; Vol 14, September
2009, pp 432-436
3) Nair G. Gopakumar . Intellectual Property Rights in Pharma
Industry. Pharma Times; Vol 44, July 2012, pp 31-43
4) Kulkarni Suhas et al. Analysis of Patent Filing Procedure in India.
Pharma Times; Vol 44, July 2012, pp 23-26
5) Prabu S. Lakshmana et al. Intellectual Property Rights and its
Development in India; Pharma Times; Vol 44, July 2012, pp 19-22
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