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INTELLECTUAL PROPERTY RIGHTS

1. INTRODUCTION Intellectual Property: Intellectual Property (IP) is a class of property emanating primarily from the activities of the human intellect. Human beings are distinguished from animals by the intellectual faculty endowed by the Almighty. The human beings are thus, elevated themselves to the present civilized state solely due to the exercise of such intellectual faculty. It is common that any property, moveable or immovable is to be legally protected in order to prevent it from stealing. Similarly the rights in the intellectual property created need also to be protected to prevent it from infringement; the property, which is created by the human intellect. In other words, intellectual property relates to information, which can be incorporated in tangible objects and reproduced in different locations. Examples: Patents, Designs, Trade Marks, Copyrights. Geographical indications etc. Like the movable and immovable property, intellectual property is also governed by the law of the country which is for the time being in force, namely Law of Intellectual Property Rights. In short, patents are for new inventions, which are solutions to scientific and technical problems. Industrial designs are esthetic creations determining the appearance of industrial products. Trademarks are useful for the consumer for the identification of the manufacturer to fee products. Copyrights are the rights in literary, artistic, software, etc.

Intellectual Property Rights (IPR): The legal rights in the intellectual property generated are termed as intellectual property rights commonly as “IPR” in short. Protection of the legal rights of the intellectual property, especially by way of patents has come to be recognized in the modern times as an important tool, not only to promote inventiveness but also to ensure adequate returns to the investments made. IPR has also become important for the technological. Industrial and Economic Development of a country. V.N.S. INSTITUTE OF PHARMACY, BHOPAL

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As compared to the rights in goods Intellectual Property rights (IPR) as s system of rights, is a relatively new comer. It is to be noted IPR is concerned with the subject “technology” which is not tangible. Considering the role technology played in the modern highly competitive words, the subject of IPR demands much more and careful attention and requires to be understood by many people in different cross sections of the society. Just as ownership and transactions in other forms of property is governed by law, so is the case with IPR. Thus, specific laws to protect IPR in a country are enacted based on the degree of balancing the conflicting interests explained above. The degree of balance to be maintained varies from country to country and in the same country from time to time, depending upon the state of development of the country. It is to be noted that justification of the enforcement of the rights accrued is confined to the country which grant such rights and cannot be extended beyond the territory of the said country.

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2. HISTORY The earliest use of the term "intellectual property" appears to be an October 1845 Massachusetts Circuit Court ruling in the patent case Davoll et al. v. Brown. in which Justice Charles L. Woodbury wrote that "only in this way can we protect intellectual property, the labors of the mind, productions and interests as much a man's own...as the wheat he cultivates, or the flocks he rears." (1 Woodb. & M. 53, 3 West.L.J. 151, 7 F.Cas. 197, No. 3662, 2 Robb.Pat.Cas. 303, Merw.Pat.Inv. 414). But the statement that "discoveries are...property" goes back earlier. Section 1 of the French law of 1791 stated "All new discoveries are the property of the author; to assure the inventor the property and temporary enjoyment of his discovery, there shall be delivered to him a patent for five, ten or fifteen years". In Europe, French author A. Nion mentioned "propriété intellectuelle" in his Droits civils des auteurs, artistes et inventeurs, published in 1846. The term's widespread popularity is a much more modern phenomenon. It was very uncommon until the 1967 establishment of the World Intellectual Property Organization, which actively tried to promote the term. Still, it was rarely used without scare quotes until about the time of the passage of the Bayh-Dole Act in 1980. The concept's origins can potentially be traced back further. Jewish law includes several considerations whose effects are similar to those of modern intellectual property laws, though the notion of intellectual creations as "property" does not seem to exist. The Talmud contains the first known example of codifying a prohibition against the stealing of ideas, which is further discussed in the Shulchan Aruch. However, the legal system of most of the Western world does not have provisions for intellectual property and the laws the term encompasses are justified on more constrained grounds. The term does not occur in the United States Copyright Statutes, except in certain footnotes citing the titles of certain Bills. The term used in the statutes and in the Constitution is "exclusive rights".

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3. IMPORTANT FORMS OF IPR There are various forms of IPR. The Trade Related Aspects of Intellectual Property Rights (Knows as TRIPS) which are recognized by the Agreement of the Word Trade Organization (WTO), are the following: Patents, Designs, Trade Marks, Copyrights, Geographical Indications, Integrated circuits and Trade secrets. In addition to these forms, there are many other forms like Utility model Plant variety protection etc. Out of these, Patents, Designs Trade marks and Copyright are the most important and common forms of IRP.

Patents: Patents are legal rights granted for new inventions employing scientific and technical knowledge. A patent confers on its holder the excusive right for a limited period (usually called “term”) the rights to the new inventions disclosed. The subject of Patent, which involves scientific and legal issues, is relatively complicated as compared with the other species of intellectual property like designs, trademarks and copyrights. Moreover the grant of patent rights has to strike a balance between different conflicting interests such as : between keeping valuable technical information as trade secrets and disclosing such information, between public and private interests of the inventor/industry, between exclusive rights and promoting competition and particularly in developing countries, between the interests of indigenous industry and transnational corporations. In India, currently, the Patents Act 70 and the corresponding Rules 1972 govern the grant of patents. Recently the Indian Parliament has passed an Act for the comprehensive amendment of the Patents Act 70. Rules under the modified Act have been notified and are currently in the finalization stage. The modified Act and the Rules are expected to be brought into force in the near future. {Refer the Annex for the copies of the modified Patents (Amendment) Ordinance 2004 Act and the amended Rules, which have been brought into force w.e.f. 1.1.2005}

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Industrial Designs: A design is an idea or conception as to features of shape, configuration pattern or ornament applied to an article. A design can be either two or three-dimensional. In short a design in order to secure legal protection must consist of a shape which is threedimensional or of a pattern which is two-dimensional and that the shape or pattern must be applied to an article or articles. The main criteria for securing protection for a design are novelty and originality of the design.

Trade Marks: A trade mark is a visual symbol in the form of a word, device, or a label applied to an article of manufacture of commerce with a view to indicate the purchasing members of the public about the origin of the manufacture of the goods affixed with that mark, It distinguishes such goods from the goods manufactured by others in the trade. In other words, a trademark enables a customer to distinguish the products of one manufacturer from that of others. When properly advertised, the mark becomes an effective instrument to attract customers and by its proper use, the trademark acquires good will to the customers. A trade mark, through its widespread and extensive use in public, becomes popular and eventually results in acquiring an exclusive right on the mark which can be legally enforced by the owner of the mark. The main criteria for securing a trademark registration are its originality.

Copyrights: Copyright is basically the right to copy and make use of literary, dramatic, musical, artistic works, cinematographic films, records and broadcast. Copyright is a proprietary right and comes into existence as soon as the work is created. In early days the concept of copyright had its origin under the Common Law. Subsequently it came to be governed by the statutory laws of each country. The main criteria for the copyright registration are its originality. V.N.S. INSTITUTE OF PHARMACY, BHOPAL

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Plant Variety Protection: In many countries, especially in the developed countries, it is now possible to obtain legal protection for inventions using and / of involving biological materials. For example in USA and in many other industrially developed countries it is possible to obtain legal protection for new plant varieties. TRIPS provisions of WTO Agreement make it mandatory to the member countries to provide protection for the new plant varieties. TRIPS provisions have given the member countries two options for the protection of new plant varieties (i) under the Patent law itself and (ii) By a separate system (called Suit generic system) India has opted for the second category namely suits generic system. Accordingly Indian Parliament has passed the “Protection of Plant Varieties and Farmers Rights Act 2001”. The Rules for this legislation is being framed and it is expected that this legislation will be brought into force soon.

Geographical Indications: Geographical Indications are indications, which identify a good as originating in the territory of a country or a region or locality in that territory where a given quality, reputation or other characteristic of the goods is essentially attributable to its geographical origin. The TRIPS agreement requires the member countries to enact legislation for the protection of Geographical indications. An office for the registration of the Geographical

indication in India has been opened at Chenni. The legislation has

been brought into force. It is under the Office of the Controller General of Patents, Designs & Trade Marks and the office where the application for registration has to be filed is at Chennai at Guna Complex. Teynampet, Channai.

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Utility Models: Utility models involve some of the inventions in the mechanical field. There fore the object of utility models are sometimes described as devices for useful objects. This type of inventions is also referred to as “petty inventions”. As the name suggests, the degree of inventive step required for the inventions to be protected by patents. The maximum term of protection under this category of inventions is generally shorter than that available in the case of patents. The examination procedure for securing the rights is short and the cost very low. The Utility Model system facilitates creating a culture of creativeness and builds up the mind for enhancing creativity (inventing).

Protection for Living Organisms: In the recent times due to the dramatic developments in the ability to select and manipulate genetic materials, interests have been developed in the commercial use of living organisms. When the patent system was evolved many years ago it was the presumption that technology can be developed only using the tools of physics, chemistry and engineering. The possibility of using the tools of biology was not recognized. Further all matters connected with life were presumed to be the property of the almighty God. Human intervention for the development of inventions employing living matters was not given recognition or importance. But during the years consequent on the development of technologies based on tools of biological sciences such as microorganisms to produce industrial products such as alcohol, enzymes, antibiotics resulted in the recognition of such tools and slowly and steadily patents covered the inventions in the areas of biotechnology also. According to the TRIPS provisions, all member countries should provide protection for new microorganisms. Accordingly in the Patent Amendment Act (2002), which was brought into force in May 2003t provides protection for new microorganisms.

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Jurisdiction for the enforcement of the legal rights accrued under Intellectual Property: The jurisdiction for the enforcement of the legal rights accrued under Intellectual Property under the appropriate legislation is within the boundaries of the country, which grants such rights, and not outside. In other words, the legal rights in Intellectual Property secured in one country cannot be enforced in another country or countries. This means, for example, the rights secured by the grant of a patent in India can be enforced only in India and not outside. Similarly the rights secured by the grant of a patent in USA can be enforced only in USA and not outside. The above situation will also prevail under the WTO agreement. In short TRIPS provisions of WTO Agreement do not also envisage one patent, which will be valid in all the WTO member countries. But there is an exception to the above situation. That is regarding the Copyright. In the case of Copy right, as per the Berne Convention, the rights protected under the Copyright law in a member country is enforceable in other member country or countries. For example, the copyright protected in India will be enforceable in other Bern member country like USA and vice versa.

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4. IMPORTANCE & BENEFITS OF IPR Consequent to the establishment of World Trade Organization (WTO) new competitive pressures have come up before many countries including India. To meet the increased challenges coupled with cutthroat competition within and outside India, the country needs innovative technologies. Further more technology is also increasingly becoming a valuable commercial or tradable asset and a dominating factor in determining international competitiveness. Added to this the new WTO Agreement incorporating the provisions of Trade Related Issues of Intellectual Property Rights (TRIPS) has put additional pressures on the country. It is being increasingly acknowledged world over that competitiveness of an enterprise and its ability to capture the market, depend largely on its ability to manage “internal” environment on developing innovative technologies. The development of new technologies and industries not only depend on the ingenuity of the scientists, engineers and other but also on investment particularly on research and development and setting up of new enterprises. The Investment costs in research and development is also increasing rapidly along with the competitiveness. Under the circumstances protection of the innovations resulting from R & D under the appropriate IP legislations gains greater importance in the modern era. Perhaps no other subject has evoked so much attention all over the world particularly in the developing country like India. As the Intellectual Property Rights (IPR) consequent to the coming into force of the WTO Agreement incorporating the trade related aspects of intellectual Property Rights (TRIPS) and the establishment of Worlds Trade Organization (WTO) In the Indian context, integration of its economy with the global economy is gaining momentum. This process will not be complete unless the research and development is also integrated with global research and development.

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The potential knowledge as a creator wealth is gaining currency all around the world. But only knowledge that is protected or protectable can have the potential of wealth creation the inclusion of intellectual Property Rights in the form of Trade Related aspects of Intellectual Property Rights is an indication of this realization. Integration at a global level will require paying urgent attention to enhance he levels of innovations and creativity substantially. Innovation is as defining trait of successful organization. The success of companies such as 3M Corporation in USA, Pfizer, Sony, and IBM etc. is some examples, which substantiate the above situation. After the Second World War Japan has transformed itself into one of the economic giants in the world taking advantage of the IPR system especially patent system. The same reasons can also be attributed for the companies in China and Korea becoming powerhouses of innovations.

Benefits of IP System, especially the Patent system: Amongst the IP system, patents can be said to be the most common, important and complicated one. This is because of its technical-cum-legal nature and the widest and the strongest legal protection one can secure. The benefits of IP system are therefore, explained with reference to Patent system. However it should be kept in mind that similar benefits are also there in other species of IP. Patents are very useful as they can be utilized as devices to advance knowledge and to bring new knowledge eventually into the public domain. As instruments of competitiveness by the enterprises against potential or actual competitors and by the governments in their bid to strengthen their own countries against foreigners. Patents encourage inventive activities in a country. A patent system contributes to the stimulation of inventions in the following ways. Rights accrued to work the invention covered in a patent for a limited period of time provides an important incentive for inventive and innovative activities. If the inventions, which are the fruits of R&D, are not protected by patents, they would be available for free exploitation by anyone, including those who

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have not invested in R & D. The inventive organization and the personnel, under these circumstances, will be placed in a disadvantageous position. A Patent System of rewarding the inventor and / or the patentee is based on the idea that the grant of monopoly will automatically secure to him a reward which is commensurate with the value of the intellectual input provided and the investment made for the development of the invention. In theory, if the invention is good commercially the inventor should be able to exploit it or sell the patent, thereby making profit. If on the other hand, it is not commercially good, he would receive nothing. In practice even if the invention is not good, owing to the factors beyond the control of the inventor, the inventor might not be able to make a profit out of his patent. On the other hand, in certain other cases the reward of the inventor obtained for his invention might be out of all proportions. But the desire for economic reward is undoubtedly an important factor for activating and stimulating creative activities. If the patentee has no financial resources to work the invention commercially, he can grant license or assign the rights in the patent to others for its commercialization and obtain financial reward. Securing patents will help the inventor (patentee) to develop the know how to make it commercially viable with the assistance of a third party, if required, with the legal protection on the invention. Such a position protects the inventor from unfair competition. Securing a patent would enable the inventor to establish an official record of the inventor ship. In order to obtain patent, the invention has to be disclosed in detail in the patent document (specification). The patent law also stipulates that the invention should not be made open to public fore the date of filing of the application for patent. Therefore in most cases, the information contained in a patent document is the first available information on the particular subject, which is not available from any other source, Therefore, the patent documents are richest, latest and unique source of technological information in the world. The information contained in the patent documents published anywhere in the world can be freely used for R & D purposes at any point of time anywhere in the world, including the country which has granted the patent and where it is still in force. Such a use will not constitute an infringement. A patent,

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which has lapsed, become public property and therefore can also be commercially utilized by any person interested. Thus the patent system enables the dissemination of valuable technological information to the benefit of the society. The inventor (patentee) can secure a patent for the invention developed and if desired make the said protected invention to the public and / or interested person freely for exploitation without demanding any benefits. In such a situation, if somebody misuses or abuses the rights in the patent, the inventor (patentee) can initiate legal proceedings for preventing such misuse or abuse. On the other hand if such protection has not been secured, then the inventor will remain as a silent spectator for the abuse or misuse of the invention.

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5. ROLE OF IPR IN R&D AND TRANSFER OF TECHNOLOGY IPR has an important role in both in R&D and in the transfer of Technology. When IP is generated and consequently wealth is generated by the commercialization or otherwise of the IP, the sharing of the generated wealth will depend upon the intellectual contributions made for the generation of the IP. Therefore, in undertaking R&D entering into any collaboration and in the transfer of technology, the IPR will be an important component. It may be observed in many of the agreements, which are being executed, in the recent times, there is Clause indicating the ownership, sharing and other related issues relating to IPR.

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6. PATENT SYSTEM Patent: Patent is a grant (in the form of a document) by the Government given for disclosing a new invention by an inventor or a group of inventors or an applicant. Once the patent is issued it gives to the inventor or the applicant as the case may be, the exclusive rights to sell, manufacture and use the invention disclosed in the patent. The legal exclusive right in the patent can be exercised by the inventor / applicant in the country, which grants the right. This right can be exercised only for a limited period of time, normally known as term of the patent. On the expiry of the term the invention becomes public property.

The Patents Act and Rules: A patent is an intellectual property right relating to inventions and is the grant of exclusive right, for limited period by the Government to the patentee, in exchange of full disclosure of his invention, for excluding others from making, using, selling, importing the patented product or process producing that product for those purposes. The purpose of his system is to encourage inventions by promoting their protection and utilization so as to contribute to the development of industries, which in turn, contributes to the promotion of technological innovation and to the transfer and dissemination of technology. Under the system, patents ensure property rights for the invention for which patent have been granted, which may be extremely valuable to an individual or a company. Patent right is territorial in nature and a patent obtained in one country is not enforceable in other country. The inventors are required to file separate patent application in different countries for obtaining the patent in those countries. The Patent Act, 1970 came into force on the 20th April, 1972 and extends to the whole of India. This Act was amended in March, 1999 and June, 2002 to meet India's obligation under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which forms part of the agreement establishing the Word Trade Organization (WTO). The amendments primarily focused on the obligations which came into force from 1st January, 2000 (in respect of amendments notified in June, 2002). The first amendment to

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the Patents Act introduced a transitional facility ('mail box') from 1st January, 1995 to receive and hold product patent application in the fields of pharmaceuticals and agricultural chemicals till January, 2005 and also for grant of exclusive marketing rights (EMRs) for a period of five years till the product patent is granted or patent application is rejected, whichever is earlier. The Patents Rules, 2003 came into force on the 20th May, 2003 and the Patents (Amendment) Act, 2005 became effective from 1st January, 2005 The Patents (Amendment) Ordinance, 2004 stands repealed.

Rights given by the patents: Patents represent on of the powerful intellectual property rights. These rights can be powerful tools if used effectively and diligently. Patent rights can bring substantial income through the manufacture or licensing of the invention covered on the patent. Patent also represents a long time security. The patents rights provide the rights to the patentee to prevent the third party to use the invention covered in the patent commercially without the permission of the Patentee.

Utilities of the patent system other than securing legal rights: The patent system has the following additional utilities other than securing the legal rights: •

For ascertaining global technological trends in specific areas of interest.

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For identifying possible competitors(s) in the field of interest.

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For determining the strength of possible competitors in a particular filed.

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For identify the experts in a particular field.

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For identifying and selecting entrepreneurs for the transfer of technology.

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For preventing grant of frivolous patent by assisting the Controller of Patents by providing the appropriate and relevant prior art relating to the invention disclosed in a patent specification.

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For enhancing scientific knowledge by using the scientific information contained in published patent documents.

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For identifying unexplored areas and to initiate R&D in such areas.

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For identifying uncovered areas to avoid infringement.

7. BENEFITS OF THE PATENTS SYSTEM The fact that patent documents are open to the public and are freely exchanged, distinguish the patent system form other proprietary rights relating to technical subject matter such as trade secrets and know-how. There is a school of thought, which believes that the patent system prevents dissemination of free scientific information, as was the practice earlier. In this context, it is to be noted that the patent system only assists in free exchange of scientific information. By securing patents, it is not mandatory that the patentee should charge any fees for commercializing the invention disclosed therein. An inventor can make available the invention developed to those interested for commercialization without charging any fees therefore. In such a situation, if somebody misuses or abuses the rights in the patent, the inventor (patentee) can initiate legal proceedings for preventing such misuse or abuse. On the other hand, if such protection has not been secured, than, the inventor will remain as a silent spectator for the abuse or misuse of the invention. One of the important objectives of the patents system is to disseminate the information disclosed in the patent as early as possible. In the context, it should be noted that many countries in the world publish the contents of patent document (Called patent specification) on the expiry of 18 months from the date of filing or the priority date, whichever date is earlier. The main objective of this publication is to make available the information to the interested public early, instead of keeping the information confidential for a long time. Consequent on the patent system getting popular day by day and the examination of the patent documents getting complicated due to the high technologies involved, the publication of the patent documents are, currently, getting very much delayed. To avoid such a situation only, the early publication of the information contained in patent applications has been adopted globally. In this context, it should also to be noted that India has also adopted the procedure of such publication after 18 months, as a provision to this effect has been incorporated in the Patent (Amendment) Act 2002 and has been brought into force from May 2003.

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8. WORKING OF PATENTS & RELATED TERMS The Patent system reward the competitive, creative drive with temporary limited, exclusive rights, in return for the cooperation of an inventor in teaching the rest of the society how to use his or her findings (Inventions) for all time thereafter. This philosophy of the patent system should be kept in mind in order to appreciate, and understand the patent system effectively.

Nature & purpose of the patent system: Regardless of the diversity in detail practice of many patent systems of the world. They all share a common and same fundamental goal. The goal in to provide an incentive to each inventor to disclose his or her findings for the long-term benefit of the society rather than to attempt to profit from the invention in secret. The incentive is a short term right (ranging form 5 to 20 years) depending on the country. Under the TRIPS Agreement of the world Trade Organization (WTO), the term of patents amongst the member countries is at last 20 years from the date of filing.

Cost for getting a patent: Hopefully, until the time of filing the application it will cost you nothing. Nevertheless, there will be some patenting expenses one will have to consider. Very few inventor(s) / applicant (s) is capable of diligently drafting the patent documents, defining the full legal scope of protection. Therefore, any write-up prepared by the inventor(s) or applicant has to e reviewed by a patent professional (attorney). This involves some expenditure. The professional charges of the Patent attorneys very based on the expertise, experience and standing in the profession and is generally not negotiable Then the Patent office (Govt) also charges fees for filing the application and for various other proceedings during the processing of the application. After the patent is granted, if the patent is to be maintained for the term of the patent, annual prescribed renewal fees would have also to be paid. In V.N.S. INSTITUTE OF PHARMACY, BHOPAL

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India, the fees prescribed under the Patents Rules 2003, which were recently modified and brought into force with effect from 1-1-2005, have substantially enhanced the fees for various proceedings under the Patents Act and Rules. But the fees, thought may not be affordable for Indian applicants especially the individuals and non profit making organizations/institutions, are still less as compared to those prevailing in the foreign countries. It should be noted that the expenses connected with securing patents and maintenance are spread over a period of several months of to a few years. In short, to get a patent it cost some money. But by employing right development strategy and aggressive marketing of the invention, one would have sufficient cash flow before one need to pay the legal costs. If the invention protected is very good commercially, the expenses incurred for securing a patent for the said invention as well as its maintenance will be negligible as compared to the commercial benefit that will be accrued to the patentee from the patented invention.

Patent pending: It means that the patent office has received a patent application disclosing a new invention. Only on or after the date of filing the application can the words “patent pending”(sometimes also referred to as “patent applied for”) be used. It is illegal to mention “patent pending” or “patent applied for” before filing an application in the Patent Officer. Such mentioning amount to fraud and will attract penalties prescribed in the Patent Act. The objective of mentioning, “patent pending” or “patent applied for” it a warning notices to others. During the “patent pending” period the inventor or the applicant does not have any legal rights on the invention disclosed in the application to cause a competitor to cease and desist. This is because, only after a patent is granted on the application, the legal rights are accrued on the applicant / inventor. Such legal rights will have retrospective effect from the date of the application or the priority date whichever is earlier.

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Therefore, it would be unwise to any person or organization to pursue commercial utilization of the invention disclosed in an application marked with “patent pending” or “patent applied for”, knowing very well that such commercial use could patent liable for patent infringement after the patent is granted on the application.

Criteria for securing patents: All inventions are not patentable. Generally, patent law requires that for an invention to be patentable the following criteria are to be satisfied. •

The invention mush be new (this means that the invention should not be known anywhere in they would on the date of filing of the application).

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The invention must involve inventive step, that the invention must to be obvious to a person reasonably skilled in the field and

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The invention must be industrially applicable (this means the invention should be useful to the society).

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If any one of the above-mentioned criteria is not fulfilled, such an invention will not be patentable subject matter. In some countries, the patent law excludes certain specific kinds if invention from being patentable even thought the invention satisfy all the above-mentioned criteria for patentability, examples: inventions relating to nuclear transformation, treatment of human beings, plants and animals etc. Such categories of inventions are stipulated in the patent legislation of the country concerned.

Determination of Novelty of an invention:

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The novelty of the invention is determined taking into consideration the knowledge available anywhere in the world in the relevant field at the time of filing the application for patent. In other words, the invention should not be publicly known anywhere in the world on the date of filing the application for patent. The disclosure of the invention to the public by the inventor himself before filing the application for a patent by publication or otherwise would destroy the novelty of the invention (except under certain circumstances – See Section 31 of the Patents Act) and would stand in the way of securing patent for the said invention subsequently. Therefore, if an invention has to be legally protected by patents, it should not be made open to public by its publication or otherwise, before filing the application for patent accompanied with complete specification. In other words, an invention cannot be patented, if •

The invention was known in any part of they would on the day of filing the application for patent.

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It was previously described in an article and published anywhere in they would. The publication of the inventor himself / herself will adversely affect the patent grant.

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It was previously patented elsewhere.

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The difference between the invention to be protected and the previous patent (or publicly know product or process etc.) is such that it would have been obvious to a person skilled in the art. For example, merely changing the size or color will not be patentable.

Mosaic of citations: It is emphasized that the novelty of the invention will be destroyed only if invention is publicly known is a singe document. In other words, if full information in respect of an invention cannot be derived from a single prior art published document, the novelty of the invention will not be destroyed by virtue of such disclosure. In other words, mosaic of citations for attacking the novelty of an invention is not permitted. In other words, the test

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for novelty is that each and every limitation of the invention claimed must be present in the single prior art document as such.

Safeguards to be taken for securing patents for inventions: It is the common experience that due to the ignorance of the patent law requirements, the inventors (applicants) act indiscreetly and jeopardize the chance of obtaining valid patents from their inventions. The common mistakes the inventors (applicants) commit are: Publish the invention in magazines, journals, and newspapers before applying for a patent there of the fact that the patent documents are open to the public and are freely exchanged, distinguish the patent system from other proprietary rights relating to technical subject matter, such as trade secrets and know-how. There is a school of thought, which believes that the patent system prevents dissemination of free scientific information, as was the practice earlier, in this context, it is to be noted that the patent system only assists in free exchange of scientific information. By securing patents, it is not mandatory that the patentee should charge any fees make available the invention developed to those interested for commercialization without charging any fees there for. In such a situation, if somebody misuses or abuses the rights in the patent, the inventor (patentee) can initiate legal proceedings for preventing such misuse or abuse. On the other hand, if such protection has not been secured, then, the inventor will remain as a silent spectator for the abuse or misuse of the invention. One of the important objectives of the patent system is to disseminate the information disclosed in a patent as early as possible. In this context it should be noted that many countries in the world publish the contents of patent documents (Called patent specification) on the expiry of 18 months from the date of filing or the priority date whichever date is earlier. The main objective of this publication is to make available the information to be interested public early instead of keeping the information confidential

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for a long time. Consequent on the patent system getting popular day by day and the examination of the patent documents getting complicated due to the high technologies involved, the publication of the patent documents are, currently, getting very much delayed. To avoid such a situation only the early publication system has been adopted. In this context, it should also to be noted that India has also adopted the procedure of publication after 18 months as a provision to this effect has been incorporated in the Patent (Amendment) Act. 2002.

“One year grace period” for filing in USA: In the United States of America, one an inventor public discloses an invention or offers an invention for sale, he/she must file a provisional or a regular non-provisional application within one year of such publication or offering for sale. If this in not done he/she will forever loose the right to file the application for patent, for the said invention. Some inventors like to use the one-year grace period as part of their marketing/developing strategy. They like to stretch out their budget and delay patent filing for as long as they possibly can. It should be noted that there is no such grace period provided under the Indian Patents Act, except for making conventional application claiming priority based on a basic application filed under international agreements such as Paris Convention. PCT (Patent Cooperation Treaty) and WTO.

Precautions to be taken for securing patents: Do not publish the invention nor make it available to the public before filing the application for patent for the said invention. File the application as early as possible. Due care should be taken that the specification (which is the document disclosing the invention) has been diligently drafted. If the specification is not drafted diligently, there may be a danger in publishing the information immediately after filing the application. If corresponding application has to be filed in other country , then, the publication will have

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to be deferred till all such applications have been filed. But in certain countries, by virtue being Convention countries and those which are members of the Paris Convention there is a grace period of 12 months for filing the corresponding application in the member countries, based on the first filing in the base country.

The inventions, which are patentable under the Indian Patents Act: The patentable inventions under the Indian Patent Act, as applied to process, method, art or manner of manufacture should be regarded as an artificial process or operation of an industrial nature wherein certain starting materials has been subjected to the process or operation to convert the starting material in such a manner to produce a new and useful article or substance which is tangible. If the starting material remains unaltered by the process and said product also remains the same as the starting material, than, the process may not constitute an invention for the purposes of patentability.

Process / Product Patent: The issue relating to protection of a product and the protection of a process is very relevant in the case of inventions in the chemical filed. The basic philosophy behind the grant of a patent for the process for the preparation of a product is that the said product can be manufactured by a totally new and different method. In such cases the patentee has the exclusive right for himself, his agent or licensee to use or exercise the process or method in the country, which grants the patent. In other words, the patentee’s exclusive right is confined only to the method or method of manufacturing the product and not to the product. On the other hand, the grant of a patent for the product, per se, prevents a person in commercially utilizing the process he has developed for the preparation of the product without securing a license from the product patent holder. This is because the moment the person prepares the product by the entirely process developed by him; the person will be infringing the rights of the product patent holder. It is to be noted that a patent can be obtained for the new process if it satisfies the patentability criteria. By the grant of a product patent, the patentee has the right for himself, his agent or licensee to make, use, sell or distribute such a product in the country, which grants the patent.

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It is to be noted that if the alternate process developed is very efficient and the product is very useful having good commercial potential, the patent holders for the respective inventions can come together and have a joint agreement (cross licensing) and bring the product to the market and share the profits amongst themselves, Such an exercise will benefit the society in getting the fruits of the research work. Such a situation instead of hampering R&D in developing alternative processes for a product under the product patent regime will enhance such development activities.

Inventions for which patents can be secured: The invention for which patent can be secured should also fit into one or more categories of patentable subject matter stated below.

(a) Development of

(b) Processes

-

for

the -

New compounds New materials New compositions (Formulations-Synergistic compositions) New compounds

preparation of (c) Improvement

of

an -

New materials New compositions (Formulations-Synergistic compositions) Known compounds

existing process for the production of Known materials Known compositions (d) (e) (f) (g)

Development of Development of Development of Development of

-

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Synergistic compositions New Medical Kit New machine / device Improved machine / device New hardware incorporating a software

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The term “process” means a process, art, or method. A process may also be defined as one or more steps or acts performed on materials to produce a result. A process should be regarded as an artificial process or operation of an industrial nature where in certain starting materials are subjected to the process or operation to convert the starting material in such a manner to produce a new and useful article or substance, which is tangible. If the starting material remains unaltered by the process and the resulting product also remains the same as the starting material, then, the process may not be an invention for the purpose of patentability. It is an invention if the process requires some ingenuity or inventive step. A product/article would include any new product or thing made by the process defined above by the industry or man. A “composition of matter” is that formed by the synergistic mixture of two or more ingredients resulting in a composition having properties different to that of the ingredients used. An improvement by way of an addition, simplification or variation relating to an existing process machine, article / product or composition of matter as explained above is also patentable provided it has novelty, inventive step and utility. The term “machine / device” includes mechanical devices or combinations which perform certain function and produce a certain effect or result. Software per se is not patentable. It is a subject matter for protection under the Copyright Act. But a novel hardware (such as device) incorporating software for the functioning of the hardware is patentable.

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Criteria to be taken into consideration for securing patents abroad: Patents are territorial in nature, meaning that the legal rights in the patents secured for an invention in one country is enforceable only in the country, which grant such rights. This means that if one desires to protect the invention in different countries in the world, that person or his assignee or his legal representative has to file separate application in the countries concerned according to the law and practice followed in the said country. There are few exceptions to this requirement namely European Patent Convention (EPC) The African Regional Industrial Property Convention (OAPI), The African Regional Industrial Property Organization (ARIPO) The Cartage Agreement Legislation on Industrial Property. The main criteria for obtaining patents abroad are the same as in India, namely novelty, inventive step and utility. The degree of protection possible in various countries may differ from country to country and is stipulated in the patent legislation of the country concerned. But the criteria of patentability are same in all the countries. Filing processing and maintaining patents in foreign countries is very expensive. Therefore the invention to be protected abroad and the countries where the protection is desired have to be judicially determined considering tenter-alia the following additional criteria. Justification for securing patents abroad and consideration for selecting the country (ies.)

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9. DIFFERENT TYPES OF PATENTS According to the Indian Patents Act, three types of patents can be secured. These are 1. Ordinary patent 2. A patent of addition and 3. A patent granted under Convention Agreement. 1. Ordinary Patent: An ordinary patent is a patent granted based on an ordinary application made for patent. 2. Patent of addition: A patent of addition is a patent secured for an improvement or modification of an invention for which invention; a patent has already been applied for or granted. A patent of addition remains in forced only as long as the patent for the main invention remains in force. No renewal fees have to be paid for maintaining a patent of addition. In case the main patent is revoked, the patent of addition may be made an independent patent by the authority ordering the revocation of the main patent. Such an independent patent can continue thereafter for the unexpired term of the main patent subject to the payment of the renewal fees. 3. A patent granted under Convention Agreement A patent granted in respect of a convention application filed under Section 135 of the Act, which is based on an application made in a Convention country as notified under Section 133 of the At in respect of the same invention. According to the modified meaning of the term “Convention Country”, it means a country of convention, which is a member of a group of countries or a union of countries or an inter-governmental organization notified as such under sub Section (i) of Section 133 of the Act. The convention application has to be made within 12 months from the date of the first application in a Convention country in respect of that invention.

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10. APPLICATION FOR PATENTS An application for a patent for an invention may be made by any one of the following persons either alone or jointly with any other person•

Any person claiming to be the true and first inventor of the invention;

•

Any person being the assignee of the person claiming to be the true and first inventor in respect of the right to make such an application;

•

The legal representative of any deceased person who immediately before his death was entitled to make such an application.

Every application for a patent shall be for one invention only and shall be made in the prescribed from and filed in the patent office. Every application shall state that the applicant is in possession of the invention and shall name the person claiming to be the true and first inventor; and where the person so claiming is not the applicant or one of the applicants, the application shall contain a declaration that the applicant believes the person so named to be the true and first inventor. A provisional or a complete specification shall accompany every application. An Indian resident can file application for patent at the appropriate Patent Office under whose jurisdiction he resides or has his principal place of business. For non-residents, the address for service in India or principal where application for patent can be filed. Where an applicant for a patent under this Actins prosecuting an application for a patent in any country outside India in respect of the same or substantially the same invention, he shall file along with his application - (a) a statement settling detailed particulars of such application; and (b) an undertaking that he would keep the Controller informed of detailed particulars as required. The Controller may also ask similar information from an application for a patent.

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Flowchart of application procedure:

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Provisional and complete specifications: Where an application for a patent is accompanied by a provisional specification, a complete specification shall be filed within 12 months from the date of filing of the application, failing which the application shall be deemed to be abandoned. Where an application for a patent is accompanied by a specification purporting to be a complete specification, the Controller may, if the applicant so requests within 12 months from the date of filing or the application, direct that such specification shall be treated as a provisional specification and proceed with the application accordingly. Post dating of the patent can be done only to the date of filing of the complete specifications.

Contents of specification: Every specification, whether provisional or complete, shall describe the invention and shall begin with a title sufficiently indicating the subject matter to which the invention relates. The Controller may require the drawings to be supplied with any provisional or complete specification, which shall form part of the respective specification. In any particular case the Controller may require that a model supplement an application or sample of anything illustrated in the invention but such sample or model shall not be deemed to form part of the specification. Every complete specification shall •

Fully and particularly describe the invention and its operation or use and the method by which it is to be performed;

•

Disclose the best method of performing the invention which is known to the application and for which he is entitled to claim protection; and

•

End with a claim or claims defining the scope of the invention for which protection is claimed.

Be accompanied by an abstract to provide technical information on the invention. The controller may amend the abstract for providing better information to third parties. A complete specification filed after a provisional specification may include claims in respect of developments of, or addition to, the invention which was described in the provisional specification, being developments or additions in respect of which the V.N.S. INSTITUTE OF PHARMACY, BHOPAL

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applicant would be entitled under the provisions of section 6 to make a separate application for a patent.

Priority dates of claims of a complete specification: There shall be a priority date for each claim of a complete specification. Where a complete specification is filed in pursuance of a single application and the claim is fairly based on the matter disclosed in the specification, the priority date of the claim shall be the date of filing of the relevant specification. Where the complete specification is filed or preceded within pursuance of two or more applications accompanied by a complete specification and the claim is fairly based on the matter disclosed in the specification, the priority date of the claim shall be the date of filing of the relevant specification. A claim in a complete specification of a patent shall not be invalid by reason only of; (a) the publication or use of the invention so far as clamed in that claim on or after the priority date of such claim; or (b) the grant of another patent which claims the invention. As far as claimed in the first mentioned claim, in a claim of the same of latter priority date. Publication and examination of applications: No application for patent shall ordinarily be open to the public for such period as may be prescribed except when an applicant requests the Controller to publish his application at any time before the expiry of the prescribed period. Every application for a patent shall be published on the expiry of the prescribed period. Every application for a patent shall be published on the expiry of the prescribed period except in cases where the application (a) in which secrecy direction in imposed, (b) has been abandoned, or (c) has been withdrawn three months prior to the specified period. The publication of every application shall include the particulars of the date and number of application, name and address of the applicant and an abstract.

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An application for a patent shall not be examined unless the applicant or any other interested person makes a request for such examination within the prescribed period otherwise the application is treated as withdrawn. When a request for examination has been made the application, the specification and other related the Controller to an examiner for making a report refers documents. The examiner shall make investigation and summit the report to the Controller who may accept the same and proceed further or make necessary orders otherwise. The grant of a patent under this Act shall be subject to the condition that •

Any machine, apparatus or other article in respect of which the patent is granted or any article made by using a process in respect of which the patent is granted, may be imported or made by or on behalf of the Government for the purpose merely of hats own;

•

Any process in respect of which the patent is granted may be used by or on behalf the Government for the purpose merely of its own;

•

Any machine, apparatus or other article in respect of which the patent is granted or may article made by using a process in respect of which the patent is granted, may be made or used, and any process in respect of which the patent is granted may be used, by any person, for the purpose merely of experiment of research including the imputing of instruction to pupils;

•

And in the case of a patent in respect of any medicine or drug, the medicine or drug may be imported by the Government for the purpose merely of its own use or for distribution in any dispensary, hospital or other medical institutes maintained by or on behalf or the Government or any other dispensary, hospital or other medical institution which the Central Government may, having regard to the public service that such dispensary, hospital or medical institution render, specify in this behalf by notification in the Original Gazette.

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Application for a patent under the Indian Patents Act: In India, an application for an ordinary patent for an invention can be filed by any person whether a citizen of India or not, who is: •

Claiming to be the first and true inventor of the invention or his assignee or

•

His assignee or

•

The legal representative of a diseased person, who immediately before his death was entitled to file the application.

•

The application can also be filed by any of the aforesaid persons either alone of jointly with any other person.

•

It is to be noted that Government falls within the meaning of the term “person”. Accordingly the Government can also be an applicant.

True and first inventor: The term true and first inventor (s) means the person(s) has/have developed the invention applying his/their intellectual ability. The naming of all the true and first inventor(s) who has/have contributed intellectually for the development of the invention disclosed in the application for patent is an important criteria to obtain a patent. In fact it is a mandatory requirement.

Patent specification: The invention for which legal (Patent) protection is desired is disclosed in a patent document commonly called specification – A patent specification should always accompany an application for patent. The legal rights in a patent are based on the disclosure made in the specification. A patent specification is a scientific cum legal document. A scientific document because. It discloses the scientific and technical information about the invention, which is to be protected. A legal document because the contents of the specification are susceptible to interpretation by courts of law if and when

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a legal dispute arises. It is therefore important that the disclosure made in this document is diligently made.

Different types of patent specification: There are two types of patent specification (i)

Provisional specification and

(ii)

Complete specification.

As stated above the application for patent should always be accompanied with a provisional or complete specification. Without such a specification the application will not be received by the Patent office. It may also be noted that if the application is a Convention application, the specification, which should accompany the application, should always be a Complete Specification and not a provisional specification.

Provisional Specification: A provisional specification discloses only the nature of the invention and helps to establish the identity of the invention and registers the earliest authorship of an invention in the Patent Office, on first cum first basis. If is a document of record and no amendment by way of additional of new matter will allow.

Prescribed standard format for preparing a specification: The Patent law does not prescribe any standard format for preparing a patent specification – Provisional or Complete. However by common practice and use a format has been established to prepare the specification. It may be noted that there may be many variations of the format given below based on the subject matter as well as the complexity of the invention.

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The general format, which is to be adopted, it the following: The patent specification should begin with a title which should be precise and should clearly indicated the subject to which the invention relates. Then title should be followed with the following details indicated by the sub-headings. •

Field of invention

•

Background of the invention

•

Description of the prior art

•

Draw backs of the prior art

•

Necessity to remove the drawbacks of the prior art

•

Objectives of the invention developed

•

Basic principle based on which the invention is developed

•

Summary of the invention giving the essential new features of the invention.

•

Optional features, if any, of the invention.

•

Detailed description of the invention with reference to the drawing if any.

•

Detailed description in respect of the working of the invention.

•

Working Examples to illustrate and substantiate the Invention.

•

Advantages of the invention

•

Statement of claims defining the legal scope of protection.

•

It should be noted that the information, which should be given in the above, mentioned headings should be substantive to bring out clearly the salient novel features of the invention as compared to the prior art.

Patent search: The patents are classified under the National Patent Systems of every country (line Indian Patent Classification System, Us Patent Classification System etc) as well as under an International Patent Classification System (IPC). The IPC classification system classifies the entire S&T into 8 main headings. Each heading is further classified minutely into

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about 95000 sub headings. These are available through various websites. For example one may refer to USPTO website as well as the Website of WIPO (World Intellectual Property Organization).

Provisional & Complete Specifications: The provisional specification is not a rough draft of the complete specification. In particular, the provisional specification does not contain the statement of claims defining the scope of protection sought for. The complete specification, which is filed after the provisional specification, does not also replace the provisional specification. Provisional and Complete specification are permanent and independent documents. It is also to be noted that the provisional specification although do not contain the full details of the invention, should contain the details as to the prior art on the subject, objectives of the invention disclosed the principle by which the inventions is being developed, a brief description of the invention and the expected advantages.

Details to be included in a complete specification: The complete specification is an important document in respect of a patent. The legal rights on the invention covered in a patent are based on the disclosure made in the complete specification. Accordingly, the complete specification should satisfy the following conditions: •

Fully and particularly describe the invention and its operation or use and the method by which it is to be performed.

•

Disclose the best method of performing the invention, which is known to the application and for which he is entitled to claim protection.

•

End with a claim or claims defining the scope of the invention for which protection is claimed.

•

Be accompanied by an abstract to provide technical information on the invention. The Controller has the power to amend the abstract for providing better information to third parties

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If the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy the requirements of fully and particularly describe the invention and its operation or use and the method of performing the invention which is known to the application and for which he is entitled to claim protection, and if such a material is not available to the public, the application shall be completed by depositing the material to an authorized depository institutions as may be notified by the Central Government in the Official Gazette by fulfilling the following conditions : In addition, the description in a complete specification should be in intelligible language (i) to indicate clearly what the invention is so that others know what the monopoly is, that is granted to the patentee and (ii) in what manner the patented invention is to be performed so that others may learn from the specification how practically to avail themselves of the patented invention, when the patent is lapsed or expired and become a public property. It is not necessary, however that such a person should be able to carry out the invention without trails or experiment but the degree of experiment required should not amount to the exercise of inventive ingenuity. A useful test to decide the permissible limit of experiments is in asking whether anything new has to be found out by a person of reasonable competent in order to succeed in working the invention disclosed in the specification. If the answer is yes, the description in the specification is not sufficient. On the other hand, if the answer is no, then, the description in the specification is sufficient. The specification – both provisional and complete – must be drafted with the utmost care and good faith. If must not contain nay false representation or misrepresentation of the invention or any material part of it, or otherwise mislead the public. The specification must not be drafted in ambiguous language. It must be clear and concise, as the nature of the subject will admit. The specification must be intelligible to an ordinary workman possessing the ordinary skill and knowledge of that branch of the field to which the invention relates. It is not required to describe the invention and the manner in which it is to be performed so fully as to instruct persons wholly ignorant on the subject matter. The specification must describe the best mode known to the patentee of performing the invention and all the knowledge relating thereto, including that, which he may have

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acquired during the period of provisional protection prior to the date of filing the complete specification If the specification describes anything, which is not new, it must clearly distinguish that which is old from which is new and claim only the latter. All information regarding the modifications / improvements, if any, which fall within the scope of the claim should be included in the description. A brief statement of advantages of the invention should be included in the description. The description should contain meanings of all the expressions – scientific or otherwise – used. The description in the complete specification should be given with utmost care and diligent, avoiding false information and / or representation of the invention. If the information in the specification is deliberately withhold or misleading or the vital aspects of the invention are suppressed, the patent even when granted may be held invalid abilities. If the applicant does not disclose all the above said information in the complete specification or include any information, which may mislead the public or gives false information about the invention, Controller may not grant a patent. In the vent a patent was granted based on such information the patent would be held invalid and liable to be revoked. Since additional fees for each additional page in excess of 10 have to be paid, the specifications have to be diligently drafted to avoid heavy expenses without compromising the legal rights, which can be secured.

Statement of Claims: As explained above one of the mandatory requirements of the complete specification is that it should end with a statement of claims defining the invention for which legal protection is sought. The novel part [s] of the invention described in the complete

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specification is distinguished from the prior art in the statement of claims, which as stated above, define and determine the scope of legal protection sought for. Therefore the statement of claim portion of the complete specification is importation, as it is the legal operative part of patent defining the legal rights of the patent. It is to be noted, “A patentee who describes the invention in the body of the specification obtains no legal rights on the invention unless it is claimed in the statement of claims”. In the patent parlor ‘’what is not claimed is disclaimed and forms public property ‘’.

Documents required for filing an application for patents in India: The documents required for filing an application for patent in India are the following: Application Form 1 appropriately modified to suit to the particular requirement. Provisional specification describing the nature of the invention (From 2) or the complete specification describing the essential and complete details or the invention (From 2). The From 2 is the first page of the specification to which pages containing the relevant description of the invention are to be attached. Kindly note that the Form used for Provisional and complete specifications are same, the only reference being in the Preamble. Drawing if necessary, to illustrate the invention should accompany the specification. •

An abstract of the invention.

•

Statement and Undertaking on Form 3 in appropriate cases.

•

The prescribed fees for filing the application.

•

All the above documents are to be filed in duplicate

General procedure for securing patents in India: The following are the successive steps for obtaining a patent if India. Filing an application in the prescribed forms along with the prescribed fees at the appropriate office of the Patent Office.

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Publication of the filing of the application in the Patent Office Journal, which is a weekly publication. In this publication only name of the applicant, title of the application and the number and date allotted to the application are notified. No other information will be available to the public. Publication of the application for patents in the Journal, except those on which secrecy direction is given under Section 35, on the expiry of 18 months from the date of filing or the priority date whichever is earlier. This publication includes the date of the application number, name and address of the applicant and an abstract. Consequent on this publication any interested public can get the copies of the full text of the patent specification from the appropriate office of the Patent office by paying the prescribed copying charges. Withdrawal of the application if the application if so desires. For such withdrawal the request in the prescribed manner has to be made before three months form the date of expiry of 18 months from the date of filing or the priority date whichever is earlier. If the applicant or interested party desired to get the application examined making a request there for in the prescribed manner within the stipulated period at the appropriate office of the Patent Office. Overcoming the official requirements. If any, raised by the Patent Office and placing the application in order within the prescribed period. Grant of a patent immediately on placing the application in order and publication of the grant. Filing opposition by any interested party within 12 months from the date of grant renewal of patents for keeping them in force.

Rights of patentees: A patent granted under this Act shall confer upon the patentee where the subject matter of a patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes the product obtained by that process in India where the subject natters of a patent is a process, the exclusive right to prevent third

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parties, who do not have his consent, from the act of using that process, and from the actor using, offering for sale, selling or importing for those purposes the product obtained by that process in India. Patent rights are not infringed when used on foreign vessels, etc. temporarily or accidentally in India

Rights of co-owners of patents: Each of the co-owners of a patent shall be entitled, unless an agreement to the contrary is in force, to an equal undivided share in the patent. Where two or more persons are registered as grantee or proprietor of a patent, then, unless an agreement to the country is in force, each of those persons shall be entitled to the rights conferred for his own benefit without accounting to the other person/persons. Where two or more persons are registered as grantee or proprietor of a patent shall not be assigned by one of such persons except with the consent of the other person/persons. Where a patented article is sold by one of two or more persons registered as grantee or proprietor of a patent, the purchaser and any person claiming thought him shall be entitled to deal with the article in the same manner as if the article had been sold by a sole patentee.

Term of patent: The term of every patent granted after the commencement of the Patents (Amendment) Act. 2002, and the term of every patent which has not expired and has not cased to have effect, on the date of such the application for the patent. A patent shall case to have effect notwithstanding anything therein or in this Act for non-payment of renewal fee. On cassation of the patent right due to non-payment of renewal fee or on expiry to the term of patent, the subject natters covered by the said patent shall not be entitled to any protection.

Patents of addition: "Patent of addition" means a patent granted in accordance with section 54; a patent of addition shall not be granted before grant of the patent for the 'main invention.'

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Where an application is made in respect of any improvement in or modification of the 'main invention' the Controller may, on the request of the applicant, grant the patent of addition for the improvement or modification as a 'patent of addition'. At the request of the patentee, the Controller may revoke the patent for the improvement or modification and grant to the patentee a patent in addition in respect thereof, bearing the same date as the date of patent so revoked. A patent shall not be granted as a patent of addition unless the date of filing of the application was the same as or later than the date of filing of the application in respect of the main invention. A patent of addition shall be granted for a term equal to that of the patent for the main invention, or so much thereof as has not expired, and shall remain in force during that term or until the previous caser of the patent for the main inventing and no longer. The grant of a patent of addition shall not be effused, and a patent granted as a patent of addition shall not be revoked or invalidated, on the ground only that the invention claimed in the complete specification does not involve any inventive step having regard to any publication or use of (a) the main invention described in the complete specification relating thereto; or (b) any improvement in or modification of the main invention described in the complete specification of a patent of addition to the patent for the main invention or of an application for such a patent of addition, and the validity of a patent of addition shall not be questioned on the ground that the invention ought to have been subject of an independent patent.

Restoration of lapsed patents: Where a patent ceases to have effect due to failure to pay renewal fee, an application for the restoration of the patent can be made with the permission of the Controller within 18 months from the date on which the patent ceased to have effect. If the Controller is prima facie satisfied he shall publish the application and after notice of opposition, if any, is decided in favor of the application, the Controller shall upon payment of the total amount due, restore the patent and any patent of addition which has lapsed. No suit or other proceeding shall lie in respect of an infringement of a patent committed between the date

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on which the patent ceased to have effect and the date of publication of the application for restoration of the patent.

Surrender of patents: A patentee may offer to surrender his patent by giving notice in the prescribed manner to the Controller. This Controller shall then publish the offer of surrender and notify every interested person whose name appears in the register. After hearing the patentee and any opponent if the Controller is satisfied that the patent may be surrendered, he may by order revoke the patent in question.

Revocation of patents: A patent, whether granted before or after the commencement of this Act may be revoked by the Appellate Board / High Court on any one of the following grounds. :that the invention, so far as claimed in any claim of the complete specification, was claimed in a valid claim of earlier priority date contained in the complete specification of another patent granted in India that the patent was granted on the application of a person not entitled to apply therefore; that the patent was obtained wrongfully in contravention of the rights of the petitioner or any person under or thought whom he claims that the subject of any claim of the complete specification is (i)

not an invention within the meaning of this Act;

(ii)

is not new;

(iii)

is obvious or does not involve any inventive step;

(iv)

is not useful;

(v)

does not sufficiently and fairly describe the invention and the method by which it is to be performed;

(vi)

is not patentable under this Act;

(vii)

was anticipated having regard to the knowledge available within any local or indigenous community in India or elsewhere;

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For want of sufficient disclosure where any claim of complete specification is not fairly based on the matter disclosed in the specification. That the patent was obtained on a false suggestion or representation that the applicant contravened any direction for secrecy passed under section 35 or made or caused to be made an application for the grant of a patent outside India in contravention of section 39; That leave to amend complete specification was obtained by fraud that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention; At any time after grant of a patent, the Central Government may direct the Controller to revoke a patent for an invention relating to atomic energy. However the Controller may allow the patentee to amend the complete specification in such manner as he considers necessary instead of revoking the patent. A patent can also be revoked in public interest. The Central Government can revoke a patent if it is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public.

Register of patents: A register of patents is kept at the patent office in which are entered The names and addresses of the grantees of patents, notification of assignments, and of transmissions of patents, of licenses under patents, and Particulars of such matters affecting the validity or proprietorship of patents as may be prescribed. The register shall be kept under the control and management of the Controller, subject to the superintendence and direction of the Central Government. The register of patents or any part thereof can be kept in computer floppies, diskettes or any other electronic from subject to prescribed safeguards. The Appellate Board may, on the application of any aggrieved person, make such order for the making, variation or deletion, of any entry therein as it may think fit. The register shall be prima falsie evidence of any matters entered therein. A petition for revocation of a patent can be filed anytime during the period the patent is in force. But it would be advisable to initiate the proceedings as early as possible term.

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11. INFRINGEMENT OF PATENTS When the legal rights in a valid patent is used commercially without the authorization of the Patentee it amounts to the infringement of the legal rights of the patentee. It should be born in mind that patent is a property (intellectual property) and the patent has all the legal rights on the invention covered by the patent. Therefore if any person violates such rights the patentee has all the rights to institute infringement proceedings to stop the unauthorized commercial use as well as to clam appropriate damages for the unauthorized use already affected. The suits for a declaration as to non-infringement or for any relief in cases of groundless threats in infringement or for infringement of a patent have to be filed in a count not inferior to a district court which has jurisdiction to try the suit. This is subject to the condition that where the defendant makes a counter claim for revocation of the patent, then, along with the counter claim, the suit will be transferred to the High Court for decision. In a suit for infringement of a patent, where the subject matter of the patent is a process for obtaining a product, the court may direct the defendant to prove that the process used by him to obtain the product, identical to the product of the patented process, is different from the patented process if. •

The subject matter of the patent is a process for obtaining a new product or.

•

There is substantial likelihood that the identical product is made by the process, and the patentee or a person deriving title or interest in the patent from him.- has been unable through reasonable efforts to determine the process actually used.

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This is subject to the condition that the patentee or a person deriving title or interest in the patent from him, first proves that the product is identical to the product directly obtained by the patented process. In considering whether a party has discharged the burden imposed upon him as explained above, the court shall not require him to disclose any manufacturing or commercial secrets, if it appears to the court that it would be unreasonable to do so. The validity of a claim of the patent specification of a patent shall not be called in question in a suit for a declaration of non-infringement. Accordingly, the making or refusal of such declaration in the case of a patent shall not be deemed to imply that the patent is valid or invalid. A suit for declaration for non-infringement may be filed at any time after the publication of the grant of a patent on the application in the Patent Office journal. The suit has to be filed at any court, which is not inferior to a district court. The suit has to be filed at any court, which is not inferior to a district count. If the suit involves counter clam for revocation if the patent, the entire matter has to be transferred to the High Court. In normal cases a suit for infringement can be filed after the publication of the grant of the patent. The damages if the suit is successful can be claimed from the date of publication under Section 11 A of the Act or the date of infringement whichever date is earlier. But in the case of application filed before 1.1.2005 containing claims for the products in the field of pharmaceutical or Agricultural chemical products (which are termed as “Mail Box or WTO” applications, though the suit for infringement can be filed after the publication of the grant of the patent, the damages, if the suit is successful, can be claimed from the date of publication of the grant of a patent on the application or the date of infringement whichever is earlier.) Where any person (whether entitled to or interested in a patent or an application for a patent or not) threatens any other person by circulars or advertisement or communication, oral or in writing addressed to that or any other person with proceedings of infringement

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of a patent and the person aggrieved thereby may bring a suit against him praying for the following relief namely. A declaration to the effect that the threats are unjustifiable. An injunction against the continuance of the threats; and such damages, if any, as he has sustained thereby. If in such a suit the defendant proves that the acts in respect of which the proceedings were threatened constitute or if done would constitute an infringement of a patent or rights arising from the publication of a complete specification in respect of a claim of the specification not shown by the plaintiff to be invalid, the Court may grant to the plaintiff all or any of the relieves prayed for. In a suit for infringement of a patent, as a defense, every ground stipulated in Section 64 of the Act for the revocation of a patent is available (see section 64 of the Act). In a suit for infringement of a patent, by making, using or importation of any machine, apparatus, or other article or by using of any process or by the importation, use or distribution of any medicine or drug, it shall be ground for defense that such making, using importation or distribution is in accordance with any one or more of the conditions stipulated in Section 47 of the Act (see section 47 of the Act.) The relief, which a count may grant in any suit for infringement include an injunction (subject to such conditions, if any, as the Court thinks fit) and at the option of the plaintiff either damages or an account of profits.

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12. THE INTRODUCTION OF PHARMACEUTICAL PRODUCT PATENTS IN INDIA Introduction: TRIPs, the intellectual property component of the Uruguay round GATT Treaty, gave rise to an acrimonious debate between the developed countries and less developed countries (LDCs). On one side, business interests in the developed world claimed large losses from the imitation and use of their innovations in LDCs. They also asserted that establishing strong intellectual property rights would actually benefit the developing countries by encouraging foreign investment, the transfer of technology and greater domestic research and development (R&D). On the other side, LDC governments adamantly opposed this view, worrying about the higher prices that stronger intellectual property rights would entail and about the harm that their introduction might cause to infant high tech industries. No country was more actively involved in opposing this component of the GATT agreement than India and no part of TRIPs was, and continues to be, more sensitive than the proposal to require product patents for pharmaceutical innovations. The national sentiment on this issue is well captured in an often quoted statement made by Indira Gandhi at the World Health Assembly in 1982: "The idea of a better-ordered world is one in which medical discoveries will be free of patents and there will be no profiteering from life and death." What is striking about the original TRIPs debate and the continuing discussions about pharmaceutical product patents is the divergence between the strength of the claims made by both side and the weakness of the empirical foundations for those claims. Now that the treaty has been signed and most of the developing world is committed to introducing pharmaceutical product patents by the year 2004, not only do we not know how much this V.N.S. INSTITUTE OF PHARMACY, BHOPAL

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may affect their welfare, we do not even know the direction of the effect. This ignorance has political implications. India, for example, agreed to this aspect of the treaty much against her will, believing it to be harmful to her interests. As a result, the implementing legislation is currently on the shelf, unable to get through parliament. If it could be shown, empirically, that product patents, in fact, conveyed some benefits to the country, it would increase the local political will both to pass legislation and to enforce patentee rights with greater enthusiasm. If, on the other hand, it could be shown that the net effect of this part of World Trade Organization (WTO) membership will be, in fact, very costly to the developing countries, it would put them in a stronger position from which to argue that they should receive concessions on other fronts in future international negotiations. Apart from the immediate interest in the effects of this particular policy change, the sheer size of the change, together with the fact that it was, essentially, imposed from without, makes it a rare opportunity to examine the economic effects of granting patent rights. In the aftermath of the signing of the GATT treaty, we are in a situation where a large part of the world is moving from no protection to full-fledged twenty year protection of intellectual property rights in the one area where, it is thought, patents really matter: pharmaceuticals. Further, unlike the historical introduction of pharmaceutical product patents in much of the developed world the group of countries, which will be newly granting rights in product innovations have distinctly different demands for drugs than those, which currently grant such rights. Thus, there is some hope for detecting incentive effects in the pattern of R&D spending. This paper focuses on India. After a brief history, it sets out in Section III the various ways in which the introduction of product patents for pharmaceuticals may, in theory, benefit or hurt the country. In the sections, which follow, it brings together information from a variety of sources to assess what can be expected, now, about the importance of each of these various potential effects. While firm conclusions must await further analysis as the treaty requirements are implemented, the paper gives some indication of where one might or might not expect to see change occurring. I obtained much of the information presented in this study while on leave in India from September 1996, to March 1997.

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Over the six months I was able to interview a wide range of people. Executives from Indian firms and the subsidiaries of multinational corporations (MNCs) were very generous with their time, and also allowed me to tour their R&D facilities. Industry group representatives from the Organization of Pharmaceutical Producers of India and the Indian Drug Manufacturers' Association, as well as members of the National Working Group on Patent Laws, provided a great deal of documented information and as well as insight on the current and historical situation. Attendance at a conference held by the Forum of Parliamentarians on Intellectual Property, a meeting of the U.S.-Indian Business Forum, and a gathering of Indian medical professionals, scientists, and government representatives sponsored by Pfizer was invaluable for getting a sense of the domestic and international political aspects of the policy change. Details of the administrative, regulatory and enforcement issues were gained from interviews with the Drug Controller General, the head of the Chemists' Association and a number of Indian patent attorneys. The Delhi branch of the Indian Patent Office, the Export Promotion Agency (CHEMEXCIL) and the Department of Science and Technology also provided information.

The Pharmaceutical Industry and the Indian Patent System: In 1970, India put into place a series of policies aimed at moving the country towards self-sufficiency in medicines. At this time, the national sector was very small, estimated at less than 25% of the domestic pharmaceutical market (Redwood, 1994). Of the top ten firms by retail sales, only two were Indian firms and the rest were subsidiaries of multinationals. Much of the country's pharmaceutical consumption was met by imports. An important part of the policy package was the passage of the Patents Act 1970 (effective April, 1972). This legislation greatly weakened intellectual property protection in India, particularly for pharmaceutical innovations. Pharmaceutical product innovations, as well as those for food and agrochemicals, became unpatentable, allowing innovations patented elsewhere to be freely copied and marketed in India. The statutory term was shortened to 5 to 7 years on pharmaceutical process

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patents and automatic licensing was put in place. As a result, the number of patents granted per year fell by three-quarters over the following decade, from 3,923 in 1970-71 (of which 629 were to Indian applicants, 3,294 to foreign applicants) down to 1,019 in 1980-81 (349 Indian, 670 foreign) (OPPI, 1996a). Although all inventors were affected by the weakened patent regime, it is clear that foreigners, in particular, no longer found taking out a patent in India worthwhile. Other aspects of the policy package set up to encourage the domestic production of pharmaceuticals included restrictions on the import of finished formulations, high tariff rates, ratio requirements (where imports of bulk drugs had to be matched by purchases from domestic sources at a fixed ratio) and equity ceilings on foreign participation. Further, the strict price control regulation which was introduced with the 1970 Drugs Price Control Order, while making the production of pharmaceuticals less profitable for all firms selling in the Indian market, made it relatively less interesting for foreign firms with market options elsewhere. Thus even the price control regime probably contributed to the shift towards a greater share of production being met by Indian firms. Supported by this regulatory environment, by 1991, Indian firms accounted for 70% of the bulk drugs and 80% of formulations produced in the country (Hamied, 1993). Of the top ten firms by 1996 pharmaceutical sales, six are now Indian firms rather than the subsidiaries of foreign multinationals. Domestic firms now produce about 350 of the 500 bulk drugs consumed in the country (Government of India, 1994a). Employment in the pharmaceutical sector was estimated to have reached almost half a million by 1995 (OPPI, 1996b).

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13. A BRIEF HISTORY OF THE WTO & GATT The World Trade Organization (WTO) and its predecessor, the General Agreement on Tariffs and Trade (GATT) have been enormously successful over the last 50 years at reducing tariff and other trade barriers among an ever-increasing number of countries. The predecessor to the WTO began in 1947 with only 23 members; today it has 146 members, comprising approximately 97 percent of world trade. Although the WTO, established in 1995, is relatively young for an international institution, it has its origins in the Bretton Woods Conference at the end of World War II. At this conference, finance ministers from the Allied nations gathered to discuss the failings of World War Is Versailles Treaty and the creation of a new international monetary system that would support postwar reconstruction, economic stability, and peace. The Bretton Woods Conference produced two of the most important international economic institutions of the postwar period: the International Monetary Fund (IMF) and the International Bank for Reconstruction and Development (the World Bank). Recognizing that the beggar-thyneighbor tariff policies of the 1930s had contributed to the environment that led to war, ministers discussed the need for a third postwar institution, the International Trade Organization (ITO), but left the problem of designing it to their colleagues in government ministries with responsibility for trade. By the late 1940s, representatives of the American government had met several times with representatives of other major nations to design a postwar international trading system that would parallel the international monetary system. These meetings had two objectives: 1) To draft a charter for the ITO and 2) to negotiate the substance of an ITO agreement, specifically, rules governing international trade and reductions in tariffs. Although a charter was drafted, the ITO never came into being. By 1948, support for yet another international organization had waned in the U.S. Congress. Without American participation, the institution would have been greatly weakened and, in the event, the effort to create an organization to manage problems relating to international trade was

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abandoned. However, although the U.S. Congress would not support another international institution, in 1945 it had given the U.S. president the authority to negotiate a treaty governing international trade by extending the 1934 Reciprocal Trade Agreements Act. This led to the establishment of the General Agreement on Tariffs and Trade (GATT) in 1947—a treaty whereby 23 member countries agreed to a set of rules to govern trade with one another and maintained reduced import tariffs for other members.4 The GATT treaty did not provide for a formal institution, but a small GATT Secretariat, with a limited institutional apparatus, was eventually headquartered in Geneva to administer various problems and complaints that might arise among members. Over the next 40 years, GATT grew in membership and in its success at reducing barriers to trade. GATT members regularly met in what came to be known as negotiating rounds. These rounds were primarily focused on negotiating further reductions in the maximum tariffs that countries could impose on imports from other GATT members. The success of these rounds is evident. Tariffs on manufactured products fell from a trade-weighted average of roughly 35 percent before the creation of GATT in 1947 to about 6.4 percent at the start of the Uruguay Round in 1986.5 Over the same time period, the volume of trade among GATT members surged: In 2000 the volume of trade among WTO members stood at 25 times its 1950 volume. This growth in the volume of trade is impressive and appears to have accelerated in recent decades. Comparing the growth of world GDP, expressed as an index number, to the growth of the volume of trade among GATT/ WTO members, also expressed as an index number, while trade grew more slowly than world GDP in the early years of the GATT/WTO, in recent years it has outpaced GDP growth. Despite this success, by the 1980s several problems had surfaced with the GATT apparatus. Firstly, the dispute resolution mechanism of GATT was not functioning as effectively as had been hoped. Countries with longstanding disagreements were unable to reach any sort of resolution on a number of issues, ranging from government subsidies for exports to regulations regarding foreign direct investment. Secondly, a number of commodities, most importantly, agricultural products and textiles, were widely exempt from GATT disciplines. Thirdly, it was widely believed that certain forms of administered trade protection—antidumping duties, voluntary export restraints, and countervailing duties— were restricting trade and distorting trade patterns in many important sectors. Fourthly,

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trade in services was expanding rapidly and GATT had no rules regarding trade in services. Fifthly, countries that produced intellectual property —movies, computer programs, patented pharmaceuticals—were becoming increasingly frustrated by the lack of intellectual property protection in many developing nations. Lastly, the rules regarding trade-related investment measures —for example, domestic purchase requirements for plants built from foreign direct investment—were hotly disputed. To address these problems, a new round of trade negotiations—the Uruguay Round—was launched in 1986. The goals of the Uruguay Round were far more ambitious than in previous rounds. It sought to introduce major reforms into how the world trading system would function. The treaty negotiated during the Uruguay Round, the GATT treaty of 1994, established the WTO—the international institution to govern trade that was first visualized by the attendees of the Bretton Woods Conference 50 years earlier. The new GATT treaty provided for an entirely new and different dispute resolution mechanism to eliminate the gridlock of the old system. Furthermore, the Uruguay Round expanded GATT’s authority to new areas—agreements regarding trade in textiles, agriculture, services, and intellectual property were major achievements. Finally, new sets of rules regarding administered protection came into effect with the creation of the WTO in 1995.

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14. CONCLUSION From the study of the above project it can be concluded that, The Intellectual Property Rights & Patents plays an important role in protecting the rights of an inventor or a company. The rights conferred give creators an exclusive right over the use of their creations for a specified period of time. In pharmaceutical context these are required to protect inventions such as new drug entity (NDE). The protection of data exclusivity is also becoming a focus for more attention. It also be concluded that in the process of preparing a new chemical entity (NCE) for regulatory approval, a pharmaceutical company conducts a massive array of laboratory, animal, and human trials. The data so obtained are the property of the company developing them but the patent rights that protect the NCE do not protect the data. In the normal course of events, the licensing process requires that much of these data be turned over to the regulatory body that provides the final approval to market the drug. The introduction of product patents will contribute to more R&D being done in India. Although strong intellectual property rights are important to MNCs in deciding where to locate R&D facilities, given the centralized nature of R&D and fact that costs are not the paramount concern there does not seem to be any compelling reason for them to locate in India even after product patents are available. Further, a number of MNCs are already increasing their use of local subsidiaries to do development work. Although stronger intellectual property rights may make the Indian environment more appealing to MNCs as a location for R&D, it is unlikely that product patents will make a dramatic difference to their choices.

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15. REFERENCES •

Arora, Ashish (1996) “Contracting for Tacit Knowledge: The Provision of Technical Services in Technology Licensing Contracts,” Journal of Development Economics.

•

Barral, P. Etienne (1990) "Research, Medicines, Competition, Communication: Fifteen Years of Pharmaceutical Research Results Throughout the World (19751989)," Fondation Rhone-Poulenc Sante.

•

Boston Consulting Group (1996) “Sustaining Innovation in U.S. Pharmaceuticals: Intellectual Property Protection and the Role of Patents.” Mimeo.

•

CDRI (1996a) "Patents: Indian," Drugs and Pharmaceuticals: Industry Highlights. NISSAT. Vol. 19, nos. 3 and 6, pp. 35-9 and 43-8.

•

CDRI (1996b) "News & Views: Indian," Drugs and Pharmaceuticals: Industry Highlights. NISSAT. Vol. 19, no. 6, pp. 7-8.

•

Chemexcil (1995) "Trend of Exports: 1991-92, 1993-94, and 1994-95." Basic Chemicals, Pharmaceuticals and Cosmetics Export Promotion Council, Bombay. Government of India.

•

Chin, Judith and Gene Grossman (1990) "Intellectual Property Rights and NorthSouth Trade," in Ronald W. Jones and Anne O. Krueger (eds.)

•

The Political Economy of International Trade: Essays in Honor of Robert E. Baldwin. (Cambridge, MA: Basil Blackwell) pp. 90-107.

•

CIPLA, Ltd. (1996) Annual Report 1995-96. Bombay.

•

Clippings: "Pharmaceuticals". Major Indian Newspapers, various years. On file at the Institute for Studies in Industrial Development. New Delhi.

•

Controller General of Patents, Designs and Trade Marks (1996) "Patents: Twentysecond Annual Report, 1993-94," (Nashik, India: Government of India Press).

•

Danzon, Patricia (1997) Pharmaceutical Price Regulation. (Washington D.C.: The AEI Press).

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•

Danzon, Patricia M. and Jeong D. Kim (1995) "International Price Comparisons for Pharmaceuticals," Mimeo, the Leonard Davis Institute of Health Economics, University of Pennsylvania.

•

Deardorff, Alan (1992) "Welfare Effects of Global Patent Protection," Economica, Vol. 59, pp. 35-51.

•

Diwan, I. and Dani Rodrik (1991) "Patents, Appropriate Technology, and NorthSouth Trade," Journal of International Economics. Vol. 63, pp. 79-90.

•

Drugs and Pharmaceutical Industry Highlights (1996) "News and Views: Indian," Vol. 19, no. 6.

•

Economist (1997) "Glaxo: Coping with Unwelcome News," April, 26th. pp. 87-8.

•

Fikkert, Brian (1994) “An Open or Closed Technology Policy? The Effects of Technology Licenses,

•

Foreign Direct Investment , and Domestic and International Spillovers on R&D in Indian Firms,” IRIS Working Paper No. 131. University of Maryland.

•

Gambardella, Alfonso (1995) Science and Innovation: The U.S. Phamaceutical Industry during the 1980s. (Cambridge: Cambridge University Press).

•

Ghemawat, Pankaj and Kazbi Kothavala (1996) "Repositioning Ranbaxy," Harvard Business School Case Study no. N9-796-181.

•

Ghosh, P. K. (1996) "Indian Experience in Commercializing Institutionally Developed Biotechnologies," Journal of Scientific and Industrial Research. Vol. 55, pp. 860-872.

•

Government of India (1996a) "Drugs (Prices Control) Order-1995," Department of

Chemicals

and Petrochemicals.

Reprinted by the

Organisation of

Pharmaceutical Producers of India, Bombay. •

Government of India (1996b) "Research and Development in Industry - An Overview," Department of Scientific and Industrial Research. Ministry of Science and Technology. New Delhi.

•

Government of India (1994a, 1995) Industry Collaborations: Chemical. Department of Science and Technology. Department of Scientific and Industrial Research. Delhi.

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•

Government of India (1994b) "Modifications in Drug Policy, 1986," Department of

Chemicals

and Petrochemicals.

Reprinted by the

Organisation of

Pharmaceutical Producers of India, Bombay. •

Hamied, Y. K. (1993) "Patents and the Pharmaceutical Industry: A Review," Presentation at the International Conference on Patent Regime Proposed in the Uruguay Round, New Delhi. Cipla, Ltd.

•

Helpman, Elhanan (1993) "Innovation, Imitation, and Intellectual Property Rights," Econometrica. Vol. 61, no. 4. pp. 1247-80.

•

Indian Pharmaceutical Guide 1996. 34th ed. (New Delhi: Pamposh Publications).

•

Indian Drug Manufacturers Association (1997) "Thirty-fifth Annual Publication, 1997," Bombay.

•

Indian Drug Manufacturers Association (1996) Submission before the International Conference organized by the Forum of Parlimentarians on Intellectual Property and the National Working Group on Patent Laws. New Delhi, November.

•

International

Monetary

Fund

(1997)

International

Financial

Statistics.

Washington, D.C. •

Iyer, V.R. Krishna, O. C. Reddy, D.A. Desai and Rajinder Sachar (1996) Peoples' Commission on GATT: On the Constitutional Implications of the Final Act Embodying the Results of the Uruguay

•

Round of Multilateral Trade Negotiations. Centre for Study of Global Trade System and Development. New Delhi.

•

Jaffe, Adam, Manuel Trajtenberg and Rebecca Henderson (1993) “Geographic Localization of Knowledge Spillovers as Evidenced by Patent Citations,” Quarterly Journal of Economics. Vol. 108, pp. 577-598.

•

Keayla, B. K. (1996) "New Patent Regime: Implications for Domestic Industry, Research and Development and Consumers," National Working Group on Patent Laws (Center for Study on GATT Laws). New Delhi.

•

Lanjouw and Schankerman (1997) "Stylized Facts of Patent Litigation: Value, Scope and Ownership," Mimeo, Yale University.

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