1. Patent, Intellectual Property and Regulatory Affairs.
Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D
Department of Pharmaceutics
KLE University College of Pharmacy
BELGAUM , Karnataka, India
Cell No:
13 Sept. 2012
KLE College of Pharmacy, Nipani.

2. KLE College of Pharmacy, Nipani.
Contents
Introduction
Intellectual property concept
Intellectual property rights
Patents
Infringement of patents
Patent laws and functions
Application of patent
Rights of patentee
GATT
13 Sept. 2012
KLE College of Pharmacy, Nipani.

3. 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.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

4. 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.”
13 Sept. 2012
KLE College of Pharmacy, Nipani.

5. Intellectual property: the concept
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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KLE College of Pharmacy, Nipani.

6. 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”
13 Sept. 2012
KLE College of Pharmacy, Nipani.

7. 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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KLE College of Pharmacy, Nipani.

8. KLE College of Pharmacy, Nipani.
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.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

9. KLE College of Pharmacy, Nipani.
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.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

10. KLE College of Pharmacy, Nipani.
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.”
13 Sept. 2012
KLE College of Pharmacy, Nipani.

11. KLE College of Pharmacy, Nipani.
Patents
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KLE College of Pharmacy, Nipani.

12. KLE College of Pharmacy, Nipani.
Patents
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KLE College of Pharmacy, Nipani.

13. 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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KLE College of Pharmacy, Nipani.

14. 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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KLE College of Pharmacy, Nipani.

15. Different Types of Patents Issued
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 Queen corn, Better Boy tomatoes
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KLE College of Pharmacy, Nipani.

16. 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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KLE College of Pharmacy, Nipani.

17. 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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KLE College of Pharmacy, Nipani.

18. KLE College of Pharmacy, Nipani.
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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KLE College of Pharmacy, Nipani.

19. What is patentable application
Novelty
Inventive step
Industrially applicable
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KLE College of Pharmacy, Nipani.

20. 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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KLE College of Pharmacy, Nipani.

21. Non-Patentable inventions
(e) 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;
(h) 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 micro-organisms 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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KLE College of Pharmacy, Nipani.

22. 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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KLE College of Pharmacy, Nipani.

23. KLE College of Pharmacy, Nipani.
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.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

24. Complete specification
Title of invention,
Field of invention,
Background of invention with regard to the drawback associated with known art,
Object of invention,
Statement of invention,
A summary of invention,
A brief description of the accompanying drawing,
Detailed description of the invention with reference to drawing/examples,
Claim(s),
Abstract.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

25. KLE College of Pharmacy, Nipani.
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.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

26. KLE College of Pharmacy, Nipani.
GATT
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.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

27. KLE College of Pharmacy, Nipani.
TRIPS
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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KLE College of Pharmacy, Nipani.

28. KLE College of Pharmacy, Nipani.
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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KLE College of Pharmacy, Nipani.

29. KLE College of Pharmacy, Nipani.
References
infringements
Wipo Intellectual Property Handbook: policy, law and Use.
13 Sept. 2012
KLE College of Pharmacy, Nipani.

30. E-mail : nanjwadebk@gmail.com
THANK YOU…
Cell No:
13 Sept. 2012
KLE College of Pharmacy, Nipani.