Introduction to Intellectual Property Right

 

Sayali C. Kore1*, Shital T. Jadhav1, Amruta S. Kadam1, Sushila D. Chavan1

1Lecturer, College of Pharmacy (D. Pharm) Degaon, Satara, (MH) India- 415 004.

*Corresponding Author E-mail: saylikore123@gmail.com

 

ABSTRACT:

Intellectual property rights are like any other property right. Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. We encounter intellectual property at every step of our life today. Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. Intellectual property rights (IPR) refers to the legal rights given to the inventor or creator to protect his invention or creation for a certain period of time1These legal rights confer an exclusive right to the inventor/creator or his assignee to fully utilize his invention/creation for a given period of time. It is very well settled that IP play a vital role in the modern economy. Present review furnishes a brief overview of IPR with special emphasis on pharmaceuticals. There are several compelling reasons to promote and protect intellectual property.

 

KEY WORDS: IPR- intellectual propery right, patent.

 

 


INTRODUCTION:

Intellectual Property refers to creation of mind i.e. inventions, industrial designs for article, literary and artistic work, symbols etc. used in commerce.

 

Intellectual property rights are like any other property right. Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. We encounter intellectual property at every step of our life today.

 

 

The design on the bed sheet and the pillow covers, the bed and other items of furniture in the house, the cereals for breakfast, the pasteurized milk in tetra pack, the soft drinks and their bottles, the television, the personal computer, the gas stove, the microwave oven, the refrigerator, the vehicles, the weighing machine, the books, the films, the music cassettes, the tiles, the paints, and practically everything we use is the product of man’s ingenuity, knowledge and skill, besides labor and capital; and it falls under some kind of intellectual property that had to be respected before the item could be lawfully manufactured.  In this Unit we will discuss the basic concept behind the intellectual property rights and their rationale. These are different types of IP rights like copyright, trademarks, patents, industrial designs etc. Understanding of this classification and identifying different rights is very important.1

 

They allow creators, or owners, of patents, trademarks or copyrighted works to benefit from their own work or investment in a creation these rights are outlined in Article 27 of the Universal Declaration of Human Rights, which provides for the right to benefit from the protection of moral and material interests resulting from authorship of scientific, literary or artistic productions. The importance of intellectual property was first recognized in the Paris Convention for the Protection of Industrial Property (1883) and the Berne Convention for the Protection of Literary and Artistic Works (1886). Both treaties are administered by the World Intellectual Property Organization (WIPO).6

 

Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. Intellectual property rights (IPR) refers to the legal rights given to the inventor or creator to protect his invention or creation for a certain period of time1These legal rights confer an exclusive right to the inventor/creator or his assignee to fully utilize his invention/creation for a given period of time. It is very well settled that IP play a vital role in the modern economy. It has also been conclusively established that the intellectual labor associated with the innovation should be given due importance so that public good emanates from it. There has been a   quantum jump in research and development (R and D) costs with an associated jump in investments required for putting a new technology in the market place2The stakes of the developers of technology have become very high, and hence, the need to protect the knowledge from unlawful use has become expedient, at least for a period, that would ensure recovery of the R and D and other associated costs and adequate profits for continuous investments in R and D. IPR is a strong tool, to protect investments, time, money, effort invested by the inventor/creator of an IP, since it grants the inventor/creator an exclusive right for a certain period of time for use of his invention/creation. Thus IPR, in this way aids the economic development of a country by promoting healthy competition and encouraging industrial development and economic growth. Present review furnishes a brief overview of IPR with special emphasis on pharmaceuticals. There are several compelling reasons to promote and protect intellectual property. First, the progress and well-being of humanity rest on its capacity to create and invent new works in the areas of technology and culture. Second, the legal protection of new creations encourages the commitment of additional resources for further innovation. Third, the promotion and protection of intellectual property spurs economic growth, creates new jobs and industries, and enhances the quality and enjoyment of life. An efficient and equitable intellectual property system can help all countries to realize intellectual property’s potential as a catalyst for economic development and social and cultural well-being. The intellectual property system helps strike a balance between the interests of innovators and the public interest, providing an environment in which creativity and invention can flourish, for the benefit of all.

 

 

For the average person benefit of Intellectual property rights reward creativity and human endeavor, which fuel the progress of humankind. Some examples: The multibillion dollar film, recording, publishing and software industries – which bring pleasure to millions of people worldwide – would not exist without copyright protection. Without the rewards provided by the patent system, researchers and inventors would have little incentive to continue producing better and more efficient products for consumers. Consumers would have no means to confidently buy products or services without reliable, international trademark protection and enforcement mechanisms to discourage counterfeiting and piracy.6

 

Intellectual property is divided into two categories: industrial property, which includes inventions (patents), trademarks, industrial designs, and  geographic indications of source: and Copyright, which includes literary and artistic works such as novels, poems, plays, films and musical works etc. According to the TRIPS Agreement, the intellectual property has been classified into-Patents, Industrial Designs, Trade Marks, Copyright, Geographical Indications, Layout Designs of Integrated Circuits, Protection of Undisclosed Information/Trade Secrets. Different IP Rights vary in the protection they provide.

 

History:

The laws and administrative procedures relating to IPR have their roots in Europe. The trend of granting patents started in the fourteenth century. In comparison to other European countries, in some matters England was technologically advanced and used to attract artisans from elsewhere, on special terms. The first known copyrights appeared in Italy. Venice can be considered the cradle of IP system as most legal thinking in this area was done here; laws and systems were made here for the first time in the world, and other countries followed in due course.4 Patent act in India is more than 150 years old. The inaugural one is the 1856 Act, which is based on the British patent system and it has provided the patent term of 14 years followed by numerous acts and amendments.1

 

Objectives:

After studying this unit, you should be able to:

To appreciate the concept of intellectual property (IP) vis-à-vis physical property;

To recognize the different kinds of intellectual property;

To appreciate the rationale behind IP, and the underlying premises;

To understand how a balance is sought to be achieved between the rights of the owner of IP on one hand and the rights of other individuals and the society in general on the other; and

To know the position of IP under the constitution of India.

 

The concept of intellectual property 8:

1.1 Intellectual property, very broadly, 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.

 

1.2 Generally speaking, 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. Those rights do not apply to the physical object in which the creation may be embodied but instead to the intellectual creation as such. Intellectual property is traditionally divided into two branches, “industrial property” and “copyright.”

 

1.3 The Convention Establishing the World Intellectual Property Organization (WIPO), concluded in Stockholm on July 14, 1967 (Article 2(viii)) 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,

and all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.”

 

World intellecyual property organization 6

Established in 1970, the World Intellectual Property Organization (WIPO) is an international organization dedicated to helping ensure that the rights of and owners of intellectual property are protected worldwide, and that inventors and authors are therefore recognized and rewarded for their ingenuity. This international protection acts as a spur to human creativity, pushing back the limits of science and technology and enriching the world of literature and the arts. By providing a stable environment for marketing products protected by intellectual property, it also oils the wheels of international trade. WIPO works closely with its Member States and other constituents to ensure the intellectual property system remains a supple and adaptable tool for prosperity and well-being, crafted to help realize the full potential of created works for present and future generations.

 

WIPO promote the protection of intellectual property such As part of the United Nations system of specialized agencies, WIPO serves as a forum for its Member States to establish and harmonize rules and practices for the protection of intellectual property rights. WIPO also services global registration systems for trademarks, industrial designs and appellations of origin, and a global filing system for patents. These systems are under regular review by WIPO’s Member States and other stakeholders to determine how they can be improved to better serve the needs of users and potential users. Many industrialized nations have intellectual property protection systems that are centuries old. Among newer or developing countries, however, many are in the process of building up their patent, trademark and copyright legal frameworks and intellectual property systems. With the increasing globalization of trade and rapid changes in technological innovation, WIPO plays a key role in helping these systems to evolve through treaty negotiation; legal and technical assistance; and training in various forms, including in the area of enforcement. WIPO works with its Member States to make available information on intellectual property and outreach tools for a range of audiences – from the grassroots level through to the business sector and policymakers – to ensure its benefits are well recognized, properly understood and accessible to all.

 

WIPO is funded:

WIPO is a largely self-financed organization, generating more than 90 percent of its annual budget through its widely used international registration and filing systems, as well as through its publications and arbitration and mediation services. The remaining funds come from contributions by Member States.

 

Types of intellectual property right1,6,7

IP has been generally divided into two main categories viz., (a) Industrial Property, (b) Copyright.

 

Industrial property consists of rights relating to inventions, trademarks, industrial designs and appellation of origin.

 

The TRIPS Agreement of the WTO recognises following types of intellectual property rights (IPRs)

1      Patents

A patent is a statutory right granted for a limited period to an inventor in respect of an invention to exclude any other person from manufacturing, using or selling the patented product or from using the patented process, without due permission. Under the TRIPS Agreement of the WTO, inventions in all fields of technology - whether products or processes - are patentable if they meet the criteria of novelty, involve an inventive step and are capable of industrial application. Patents are one of the oldest forms of IP protection. The patent system started in the 1700s. The aim of the patent system is to encourage economic and technological development by rewarding intellectual creativity.

 

2      Copyright and Related Rights

Copyright is granted in respect of original literary, musical, artistic or audio-visual works – the creations of authors, playwrights, composers, artists and filmmakers. The rights under copyright include: rights of reproduction, communication to the public, adaptation and translation of work. Copyright is now spoken together with the related or neighbouring rights as one category. Though originality in expression is a requirement for copyright, the quality of the work is not an issue at all.  It is to be noted that, though the copyright subsists in works, which are the creation of ideas, it is not the idea that the copyright protects, but merely the expression of the idea as fixed in a particular work.  If an author thinks up the plot of a story, it is not the idea of the plot that is entitled for protection under a copyright but only the written form of the story flowing from the idea. Any other person can come up with a differently written story on the same idea and have a valid claim for a copyright over it. If a painter has a copyright in a painting, which depicts sunrise, no one else can legally copy that painting without his permission. However, there is no copyright in the idea of sunrise and anybody is free to paint sunrise as per his or her own imagination, and everyone will be entitled to copyright in one’s own creation.  The copyright is in the painting, not in the idea of sunrise. Copyright is an inherent right that commences since the completion of the work as an expression of the idea. Copyright comes with the doctrine of fair use, which includes use of the work for purposes of criticism, comment, news reporting, teaching and education, scholarship and research. Fair use does not constitute infringement. We may also remember that unlike patents or registered designs, copyright confers no monopoly rights. In fact if two persons can produce precisely similar work demonstrably working independently of each other, each one will have the legal right to his or her own creation.

 

3      Industrial Designs6

An industrial design is the ornamental or aesthetic aspect of an article; it may consist of three-dimensional features such as shape or surface, or of two-dimensional features such as patterns, lines or colour. The design serves as a tool for product differentiation and lures customers by enhanced visual appeal. It becomes a kind of IP to be protected. Industrial designs are applied to a wide variety of products of industry or handicraft: watches, jewellery, fashion and other luxury items, industrial and medical implements, house ware, furniture, electrical appliances, vehicles and architectural structures, textile designs, toys etc.

 

An industrial design is distinguished from trade mark primarily because it is constituted by the appearance of a product, which is not necessarily distinctive. A trade mark is necessarily to be distinctive to serve as a sign for product differentiation.  The functions of, and the justification for protecting industrial designs and trade marks are quite different. Designs must relate to the appearance of the object which is not determined by technical or functional necessity.  Design enhances the visual appeal and adds to the commercial value of the product; it also facilitates the marketing and commercialisation of the product. For registration, a design needs to be new and original, though the notion of these qualities may vary from country to country.  In certain conditions, an industrial design can be protected under copyright law or the law against unfair competition.

 

4      Trademarks, Trade names and Service marks:

Trademarks and service marks are distinctive symbols that help the consumer to distinguish between competing goods or services and are a major part of the goodwill a company enjoys in the trade. A trade name is the name of an enterprise, which also individualises the enterprise in the minds of the customers. They are therefore protected as IP. Thus a trade mark is a sign that individualises the goods of a given enterprise and distinguishes them from the goods of its competitors. You may be quite familiar with the distinctive marks of Pepsi-Cola and Coca-Cola Companies. Similarly in passenger cars a characteristic star enclosed in a circle, or a characteristic treelike T, enclosed in an ellipse, displayed in the front and the rear of a vehicle immediately proclaims that the first vehicle is from the Mercedes and the second one is from the Tatas stable. Trademarks invariably come to symbolise quality of goods or services in the customer’s mind. However, there is no requirement in law that a trade mark has to meet any quality standards. If quality is not maintained, customers will shift to another brand.

 

A trade mark is required to be distinctive and not deceptive. If you market goods of fake leather under the trade mark ‘Realeather’ you will be taken in by a deceptive trademark.A trademark is a recognizable sign, design or expression which identifies products or services of a particular source from those of others.

 

5      Geographical Indications:

Geographical indications (GI) is a sign used on goods that have a specific geographical origin and possess qualities or a reputation that is solely due to the place of origin. Such goods enjoy an advantage over competing goods solely because of their geographical origin, which thus becomes a kind of IP and is protected. A GI is different from a trade mark. A trade mark is a sign that distinguishes the product and services of an enterprise from those of another. The owner of a trade mark is entitled to exclude others from using the trade mark. A GI merely tells that a product is produced in a certain place and has certain characteristics which are due to the place of production. All producers who make their products in a place designated by the GI and share the same qualities can use it.  The Paris Convention uses two terms in the context of geographical indication: appellation of origin and indication of source. Indication of source on a product merely indicates that the product originates in the place indicated. Appellation of origin indicates not only the place of origin but also the essential quality link between the product and the area of its origin; e.g. Kolhapuri chappals from Kolhapur, India.5, 6

 

6      Layout Designs of Integrated Circuits; or Topography:

Layout design (of integrated circuits is a relatively new area in IP, which has appeared with computer technology and has acquired importance as the technology makes rapid advances. The programming instructions on a computer chip are implemented through a circuitry printed on semiconductor materials. The design of circuitry on the chip requires great investment of knowledge, skills and capital and it needs to be protected as IP. The right in topography aims to prevent copying of the layout design but reverse engineering to come up with improved design is regarded as fair.  It may also be noted that, while for claiming a patent, an invention is required to meet the criteria both of novelty and non-obviousness, a layout design is only required to be original. Protection of layout design confers no monopoly right. Independent development of a design, identical with a protected design is permitted.

 

Semiconductor Integrated Circuit means a product having transistors and other circuitry elements, which are inseparably formed on a semiconductor material or an insulating material or inside the semiconductor material and designed to perform an electronic circuitry function. The aim of the Semiconductor Integrated Circuits Layout-Design Act 2000 is to provide protection of Intellectual Property Right (IPR) in the area of Semiconductor Integrated Circuit Layout Designs and for matters connected therewith or incidental thereto. The main focus of SICLD Act is to provide for routes and mechanism for protection of IPR in Chip Layout Designs created and matters related to it. The SICLD Act empowers the registered proprietor of the layout-design an inherent right to use the layout-design, commercially exploit it and obtain relief in respect of any infringement. The initial term of registration is for 10 years; thereafter it may be renewed from time to time. Department of Information Technology. Ministry of Communications and Information Technology is the administrative ministry looking after its registration and other matters.1, 2, 3

 

7 Trade Secrets:

It may be confidential business information that provides an enterprise a competitive edge may be considered a trade secret. Usually these are manufacturing or industrial secrets and commercial secrets. These include sales methods, distribution methods, consumer profiles, advertising strategies, lists of suppliers and clients, and 5 manufacturing processes. Contrary to patents, trade secrets are protected without registration. A trade secret can be protected for an unlimited period of time but a substantial element of secrecy must exist, so that, except by the use of improper means, there would be difficulty in acquiring the information. Considering the vast availability of traditional knowledge in the country the protection under this will be very crucial in reaping benefits from such type of knowledge. The Trades secret, traditional knowledge are also interlinked / associated with the geographical indications.1, 2

 

8 Protection of New Plant Variety:

The objective of this act is to recognize the role of farmers as cultivators and conservers and the contribution of traditional, rural and tribal communities to the country’s agro biodiversity by rewarding them for their contribution and to stimulate investment for R and D for the development new plant varieties to facilitate the growth of the seed industry. The Plant Variety Protection and Farmers Rights act 2001 was enacted in India to protect the New Plant Variety; the act has come into force on 30.10.2005 through Authority. Initially 12 crop species have been identified for regt. i.e. Rice, Wheat, Maize, Sorghum, Pearl millet, Chickpea, Green gram, Black gram, Lentil, Kidney bean etc. India has opted for sui- generic system instead of patents for protecting new plant variety. Department Agriculture and Cooperation is the administrative ministry looking after its registration and other matters. 1, 2

 

Laws protecting IPRS’ in India

The patents act-1970

Protects inventions. The amended Act effecting the latest amendment of 2005 has been brought into force with retrospective effect from January 1, 2005.

 

The designs act-2000

For protection of designs such as shapes, configuration, pattern, ornamentation or composition of lines applied to articles in two or three dimensions

The copyright act-1957

Protects, literary artistic, musical, dramatic works, cinematographic films and sound recordings. Amended to include computer software programmes as literary work

The trade marks act 1999

For marks relating to trade and services. This Act has been comprehensively amended in 1999 and has come into force on September 15, 2003

Plant variety protection act-2000

For protection of plant varieties

The Semiconductor Integrated Circuits Layout Design Bill 1999 has been introduced in RajaSabha.

 

An overview on patent6

A patent grants an inventor exclusive rights to make, use, sell, and import an invention for a limited period of time, in exchange for the public disclosure of the invention. An invention is a solution to a specific technological problem, which may be a product or a process. A patent is an exclusive right granted for an invention –a product or process that provides a new way of doing something, or that offers a new technical solution to a problem. A patent provides patent owners with protection for their inventions. Protection is granted for a limited period, generally 20 years.17A patent is awarded for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial or commercial application. Patents can be granted for products and processes. As per the Indian Patent Act 1970, the term of a patent was 14 years from the date of filing except for processes for preparing drugs and food items for which the term was 7 years from the date of the filing or 5 years from the date of the patent, whichever is earlier. No product patents were granted for drugs and food items. A copyright generated in a member country of the Berne Convention is automatically protected in all the member countries, without any need for registration. India is a signatory to the Berne Convention and has a very good copyright legislation comparable to that of any country. However, the copyright will not be automatically available in countries that are not the members of the Berne Convention. Therefore, copyright may not be considered a territorial right in the strict sense. Like any other property IPR can be transferred, sold, or gifted.

 

Patents are necessary for provide incentives to individuals by recognizing their creativity and offering the possibility of material reward for their marketable inventions. These incentives encourage innovation, which in turn enhances the quality of human life.

 

Patent protection means an invention cannot be commercially made, used, distributed or sold without the patent owner’s consent. Patent rights are usually enforced in courts that, in most systems, hold the authority to stop patent infringement. Conversely, a court can also declare a patent invalid upon a successful challenge by a third party.


 

Fig  1  Patent Procedure in General

 


 

A patent owner has the right to decide who may – or may not –use the patented invention for the period during which it is protected. Patent owners may give permission to, or license, other parties to use their inventions on mutually agreed terms. Owners may also sell their invention rights to someone else, who then becomes the new owner of the patent. Once a patent expires, protection ends and the invention enter the public domain. This is also known as becoming off patent, meaning the owner no longer holds exclusive rights to the invention, and it becomes available for commercial exploitation by others.

 

Role of patents play in everyday life Patented inventions have pervaded every aspect of human life, from electric lighting (patents held by Edison and Swan) and sewing machines (patents held by Howe and Singer), to magnetic resonance imaging (MRI) (patents held by Damadian) and the  I Phone (patents held by Apple).

 

In return for patent protection, all patent owners are obliged to publicly disclose information on their inventions in order to enrich the total body of technical knowledge in the world. This ever increasing body of public Knowledge promotes further creativity and innovation. Patents therefore provide not only protection for their owners but also valuable information and inspiration for future generations of researchers and inventors.

 

How is a patent granted?

The first step in securing a patent is to file a patent application. The application generally contains the title of the invention, as well as an indication of its technical field. It must include the background and a description of the invention, in clear language and enough detail that an individual with an average understanding of the field could use or reproduce the invention .Such descriptions are usually Accompanied by visual materials –drawings, plans or diagrams – that describe the invention in greater detail. The application also contains various “claims”, that is, information to help determine the extent of protection to be granted by the patent.


 

Time-table for obtaining patent

 

Fig 2   Time-Table for obtaining patent


 

Inventions which can be protected must, in general, fulfill the following conditions to be protected by a patent. It must be of practical use; it must show an element of “novelty”, meaning some new characteristic that is not part of the body of existing knowledge in its particular technical field. That body of existing knowledge is called “prior art”.The invention must show an“inventive step” that could not be deduced by a person with average knowledge of the technical field. Its subject matter must be accepted as “patentable” under law. In many countries, scientific theories, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods or methods of medical treatment (as opposed to medical products) are not generally patentable.

 

Who grants patents?

Patents are granted by national patent offices or by regional offices that carry out examination work for a group of countries –for example, the European Patent Office (EPO) and the African Intellectual Property Organization (OAPI). Under such regional systems, an applicant requests protection for an invention in one or more countries, and each country decides 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 that 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.

 

Types of patent applications6

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.

 

Documents required for filing an application 6

1) Application form in duplicate (Form 1).

2) Provisional or complete specification in duplicate. If the provisional specification is filed, it must be followed by the complete specification within 12 months.(Form 2).

3) Drawing in duplicate (if necessary).

4) Abstract of the invention in duplicate.

5) Information and undertaking listing the number, filing date and current status of each foreign patent application in duplicate (Form 3).

6) Priority document (if priority date is claimed) in convention application, when directed by the Controller.

7) Declaration of inventor-ship where provisional specification is followed by complete specification or in case of convention/PCT national phase application (Form 5).

8) Power of attorney (if filed through Patent Agent).

9) Fee (to be paid in cash/by cheque/by demand draft) (See Schedule I).

(Note: The cheque or demand draft should be payable to the "Controller of Patents" drawn on any schedule bank at a place where the appropriate office is situated

 

4.  Benefits  of  IPR 

The benefits of Intellectual property rights

Businesses with a defined IP strategy:

• Maintain their competitive edge

• Are able to raise funds for development because investors have confidence that the ideas won’t be stolen

• Are able to protect their innovative ideas, which use new technologies and design or unique selling points, from exploitation by unscrupulous traders. Consumers:

• Have confidence that products with trademarks are brand names made to a certain standard and quality

• Have innovative products to choose from. Creative individuals and entrepreneurs:

• Have time to develop their innovative ideas

• Reap financial rewards from their ideas

• Are given opportunities to reach personal fulfillment. Society and the economy benefit  from:

• Growth in enterprise and creativity

• Innovation and vibrancy

• Increased and varied employment opportunities

• Reputation for innovation.

 

Management of intellectual property in pharmaceutical industries 

More than any other technological area, drugs and pharmaceuticals match the description of globalization and need to have a strong IP system most closely. Knowing that the cost of introducing a new drug into the market may cost a company anywhere between $ 300 million to $1000 million along with all the associated risks at the developmental stage, no company will like to risk its IP becoming a public property without adequate returns. Creating, obtaining, protecting, and managing IP must become a corporate activity in the same manner as the raising of resources and funds. The knowledge revolution, which we are sure to witness, will demand a special pedestal for IP and treatment in the overall decision-making process.

 

Competition in the global pharmaceutical industry is driven by scientific knowledge rather than manufacturing know-how and a company's success will be largely dependent on its R and D efforts. Therefore, investments in R and D in the drug industry are very high as a percentage of total sales; reports suggest that it could be as much as 15% of the sale. One of the key issues in this industry is the management of innovative risks while one strives to gain a competitive advantage over rival organizations. There is high cost attached to the risk of failure in pharmaceutical R and D with the development of potential medicines that are unable to meet the stringent safety standards, being terminated, sometimes after many years of investment. For those medicines that do clear development hurdles, it takes about 8-10 years from the date when the compound was first synthesized. As product patents emerge as the main tools for protecting IP, the drug companies will have to shift their focus of R and D from development of new processes for producing known drugs towards development of a new drug molecule and new chemical entity (NCE). During the 1980s, after a period of successfully treating many diseases of short-term duration, the R and D focus shifted to long duration (chronic) diseases. While looking for the global market, one has to ensure that requirements different regulatory authorities must be satisfied. It is understood that the documents to be submitted to regulatory authorities have almost tripled in the last ten years. In addition, regulatory authorities now take much longer to approve a new drug. Consequently, the period of patent protection is reduced, resulting in the need of putting in extra efforts to earn enough profits. The situation may be more severe in the case of drugs developed through the biotechnology route especially those involving utilization of genes. It is likely that the industrialized world would soon start canvassing for longer protection for drugs. It is also possible that many governments would exercise more and more price control to meet public goals. This would on one hand emphasize the need for reduced cost of drug development, production, and marketing, and on the other hand, necessitate planning for lower profit margins so as to recover costs over a longer period. It is thus obvious that the drug industry has to wade through many conflicting requirements. Many different strategies have been evolved during the last 10 to 15 years for cost containment and trade advantage. Some of these are out sourcing of R and D activity, forming R and D partnerships and establishing strategic alliances.

 

REFERANCES:

1.     Introduction To Intellectual Property Right Available from: www.wipo.int

2.     Introduction To Intellectual Property Right Available from http://www.tifac.org.in/do/pfc/pfc.htm

3.     The Layout Design for Integrated Circuits System in India Available from: DIT website link at http://mit.gov.in/default.aspx?id=322

4.     The Protection of New Plant Variety System in India, Protection of Plant Varieties and Farmers’ Rights Authority, India (PPV and FR) Available from:  http://www.plantauthority.gov.in/

5.     Geographical Indication System in India viewed at website of Geographical Indication Registry, website at http://ipindia.nic.in/girindia/

6.     WIPO Intellectual Property Rights Handbook, published at 2004,

7.     BITS; Pilani, A Manual On Intellectual Property Rights, published on November 2007, Available from:  http://www.bitspilani.ac.in/uploads/Patent_ManualOct_25th_07.pdf

8.     WIPO Intellectual Property Rights Handbook, second edition, published on 2004, Available from:  http://www.wipo.int/freepublications/en/intproperty/489/wipo_pub_489.pdf

9.       DIP and P website at http://ipindia.nic.in/ipr/patent/patents.htm

 

 

 

Received on 21.11.2015          Accepted on 10.12.2015        

© Asian Pharma Press All Right Reserved

Asian J. Pharm. Tech.  2015; Vol. 5: Issue 4, Oct. - Dec., Pg 222-230

DOI: 10.5958/2231-5713.2015.00032.X