Transcript Patent, Intellectual Property and Regulatory Affairs. Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph.

Patent, Intellectual Property and
Regulatory Affairs.
Prof. Dr. Basavaraj K. Nanjwade
M. Pharm., Ph. D
Department of Pharmaceutics
KLE University College of Pharmacy
BELGAUM-590010, Karnataka, India
Cell No: 00919742431000
E-mail : [email protected]
13 Sept. 2012
KLE College of Pharmacy, Nipani.
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Contents
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Introduction
Intellectual property concept
Intellectual property rights
Patents
Infringement of patents
Patent laws and functions
Application of patent
Rights of patentee
GATT
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Intellectual property: the concept
• It means the legal rights which result from
intellectual activity in the industrial, scientific,
literary and artistic fields.
• Countries have laws to protect intellectual
property for two main reasons :
– One is to give statutory expression to the moral and
economic rights of creators in their creations and the rights
of the public in access to those creations.
– The second is to promote, as a deliberate act of
Government policy, creativity and the dissemination and
application of its results and to encourage fair trading
which would contribute to economic and social
development.
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Intellectual property: the concept
• Intellectual property law aims at safeguarding
creators and other producers of intellectual goods and
services by granting them certain time-limited rights
to control the use made of those productions.
• Intellectual property is traditionally divided into two
branches, “industrial property” and “copyright.”
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Intellectual property: the concept
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The Convention Establishing the World Intellectual
Property Organization (WIPO), concluded in
Stockholm provides that “intellectual property shall
include rights relating to:
Literary, artistic and scientific works,
Performances of performing artists, phonograms and
broadcasts,
Inventions in all fields of human endeavor,
Scientific discoveries,
Industrial designs,
Trademarks, service marks and commercial names and
designations,
Protection against unfair competition,
All other rights resulting from intellectual activity in
the industrial, scientific, literary or artistic fields.”
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Intellectual property: the concept
• The expression “industrial property” covers
inventions and industrial designs.
• Simply stated, inventions are new solutions to
technical problems and industrial designs are
aesthetic creations determining the appearance of
industrial products.
• In addition, industrial property includes trademarks,
service marks, commercial names and designations,
including indications of source and appellations of
origin, and protection against unfair competition.
• The Geneva Treaty on the International Recording of
Scientific Discoveries defines a scientific discovery
as “the recognition of phenomena, properties or laws
of the material universe not hitherto recognized and
capable of verification”
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Intellectual property: the concept
• Intellectual property rights are limited territorially; they
exist and can be exercised only within the jurisdiction
of the country or countries under whose laws they are
granted.
• Moreover, with growing similarity in the approach and
procedures governing intellectual property matters in
various countries, it makes eminent sense to simplify
practice through international standardization and
mutual recognition of rights and duties among nations.
• Therefore, governments have negotiated and adopted
multilateral treaties in the various fields of intellectual
property, each of which establishes a “Union” of
countries which agree to grant to nationals of other
countries of the Union the same protection as they grant
to their own, as well as to follow certain common rules,
standards and practices.
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Patents
• A patent is an exclusive right granted for an
invention, which is a product or a process that
provides a new way of doing something, or offers a
new technical solution to a problem.
• A patent provides protection for the invention to the
owner of the patent. The protection is granted for a
limited period, generally 20 years.
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Patents
• Patents are one of the main tools used by companies,
organizations, and individuals to protect designs and
inventions (sometimes called “intellectual property”).
• Patent writers try to strike a balance between
providing enough information for the patent to be
approved by the granting agency, and not disclosing
too many details to potential competitors.
• Patents that contain information about chemical
compounds may not have detailed syntheses, spectral
information, or other data.
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Patents
• A patent is granted by a national patent office or by a regional
office that does the work for a number of countries.
• E.g. US Patent and Trademark Organisation, European Patent
Office and the African Regional Industrial Property
Organization.
• Under such regional systems, an applicant requests protection
for the invention in one or more countries, and each country
decides as to whether to offer patent protection within its
borders.
• The WIPO-administered Patent Cooperation Treaty (PCT)
provides for the filing of a single international patent
application which has the same effect as national applications
filed in the designated countries.
• An applicant seeking protection may file one application and
request protection in as many signatory states as needed.”
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Patents
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Patents
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Infringement of patent
• The word "infringement" means an encroachment
upon the domain belonging to a patentee that is
described by the claims of her/his patent. If a
patent is analogized to real property, the claims
correspond to the boundary recited in the deed.
Invasion of the boundary of a landowner's real
estate is called trespass, while invasion of a
patentee's claims is called infringement.
• Patent infringement consists of the unauthorized
making, using, offering for sale or selling any
patented invention within the United States or
United States Territories, or importing into the
United States of any patented invention during the
term of the patent.
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Infringement of patent
• When patent infringement happens, the patentee may
sue for relief in the appropriate Federal court. The
patentee may ask the court for an injunction to
prevent the continuation of the patent infringement
and may also ask the court for an award of damages
because of the patent infringement.
• Suits for infringement of patents follow the rules of
procedure of the Federal courts. From the decision of
the district court, there is an appeal to the Court of
Appeals for the Federal Circuit. The Supreme Court
may thereafter take a case by writ of certiorari.
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Different Types of Patents Issued
1. Utility patents may be granted to anyone who
invents a useful process, a machine, an article of
manufacture, or a composition of matter. Examples:
fiber optics, computer hardware, or medications.
Utility patent can be provisional or non-provisional.
2. Design patents may be granted to anyone who invents
a new, original, and ornamental design for an article
of manufacture. Examples: the look of an athletic
shoe, a bicycle helmet.
3. Plant patents may be granted to anyone who invents
or discovers and asexually reproduces any distinct
and new variety of plants. Examples: Hybrid tea
roses, Silver QueenKLEcorn,
Better Boy tomatoes
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Different Types of Patents Issued
• In general, a utility patent protects the way an article
is used and works, while a design patent protects the
way an article looks. Both design and utility patents
may be obtained on for the article if it is inventive in
both its utility and its ornamental appearance.
• Utility applications can be provisional or
nonprovisional. A provisional application is a very
simple patent application which includes only a
description of the invention. A nonprovisional
application is the full patent application that includes
oaths, drawings, and claims. You still have to file a
nonprovisional application within one year of filing
your provisional application.
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Patent laws and functions
• Patent law specifies the rules for patents. The
governing authorities administers all patent laws
relating to the granting of patents and various
other provisions relating to patents.
• They examine applications and grant patents
when applicants are entitled to them.
• They publish and distribute all patent information
including: recording assignments of patents,
maintaining search files in their working country
and foreign patents, maintaining a search room
for public use in examining issued patents and
records, and suppling copies of patents and
official records to the public.
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Application of Patent
a) Ordinary Application
b) Application for Patent of Addition (granted for
Improvement or Modification of the already patented
invention, for an unexpired term of the main patent).
c) Divisional Application (in case of plurality of
inventions disclosed in the main application).
d) Convention application , claiming priority date on the
basis of filing in Convention Countries.
e) National Phase Application under PCT.
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What is patentable application
• Novelty
• Inventive step
• Industrially applicable
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Non-Patentable inventions
(a) frivolous or which claims anything obviously contrary to well
established natural laws;
(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;
(c) the mere discovery of a scientific principle or the formulation of an
abstract theory (or discovery of any living thing or non-living
substances occurring in nature);
(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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Non-Patentable inventions
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mere admixture resulting only in the aggregation of the properties of
the components thereof or a process for producing such substance;
(f) the mere arrangement or re-arrangement or duplication of known
devices each functioning independently of one another in a known
way;
(g) a method of agriculture or horticulture;
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any process for the medicinal, surgical, curative,
prophylactic,diagnostic, therapeutic or other treatment of human
beings
(i) plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially
biological processes for production or propagation of plants and
animals;
(j) a mathematical or business method or a computer programme per se
or algorithms;
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Non-Patentable inventions
(k) a literary, dramatic, musical or artistic work or any other aesthetic
creation whatsoever including cinematographic works and television
productions;
(I) scheme or rule or method of performing mental act or method of
playing game;
(m) a presentation of information;
(n) topography of integrated circuits;
(o) an invention which in effect, is traditional knowledge or which is an
aggregation or duplication of known properties of traditionally
known component or components.
(p) Inventions relating to atomic energy and the inventions prejudicial
to the interest of security of India.
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Rights of patentee
• Where a patent covers a product, the grant of patent gives
the patentee the exclusive right to prevent others from
performing, without authorisation, the act of making, using,
offering for sale, selling or importing that product for the
above purpose.
• Where a patent covers a process, the patentee has the
exclusive right to exclude others from performing, without
his authorisation, the act of using that process, using and
offering for sale, selling or importing for those purposes, the
product obtained directly by that process in India. These
rights created by statute are circumscribed by various
conditions and limitations as provided in the Patents Act,
1970 as amended by The Patents (amendment) Act, 2002.
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Complete specification
1) 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,
7) A brief description of the accompanying drawing,
8) Detailed description of the invention with reference
to drawing/examples,
9) Claim(s),
10) Abstract.
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GATT
• General Agreement on Tariffs and Trade.
• In 1947 India signed the GATT.
• Designed to provide international free trade within
member states.
• Regulation and Reducing tariffs on traded goods.
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GATT
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To encourage trade.
To export indigenous products.
Purchase goods needed for domestic market.
The biggest advancement in international trade
liberalisation through multilateral negotiations.
• To provide stable and predictable international trade
system.
• Mediator in settling the disputes regarding trade
through frequent negotiations, reduction in tariffs
expanding world trade.
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TRIPS
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Trade related intellectual property rights
Supply of medicines in the market
Prices of the medicines
Fresh investment in drug industry
National health care programme
Development of national drug industry
National R & D efforts
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TRIMS
• Trade Related Investment Measurements
• Main objective was to revive the economy in
developing countries.
• It was a negotiation to GATT.
• It was to control and scrutinize.
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References
• http://www.patentoffice.nic.in/ipr
• http://www.wipo.int/treaties
• http://www.google.com/-about.com/ infringements
• Wipo Intellectual Property Handbook: policy, law and
Use.
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THANK YOU…
Cell No: 00919742431000
E-mail : [email protected]
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