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TABLE OF CONTENTS
INTRODUCTION ........................................................................................................................................ 2 THE GLOBAL INSTITUTIONS RESPONSIBLE FOR ADMINISTERING THE PATENT SYSTEM ........ 4 NATIONAL PATENT OFFICES............................................................................................................. 4 THE WORLD INTELLECTUAL PROPERTY ORGANIZATION (WIPO) .......................................... 4 THE WORLD TRADE ORGANIZATION (WTO) ................................................................................. 4 PARIS CONVENTION FOR THE PROTECTION OF INDUSTRIAL PROPERTY ............................ 5 PATENT COOPERATION TREATY (PCT) .......................................................................................... 5 PATENT TYPES .......................................................................................................................................... 6 THE PATENT APPLICATION ................................................................................................................... 7 PATENTS IN INDIA: LAWS , PROCEDURES, REGISTERING AND CHALLENGING PATENTS ... 9 THE PATENT TERMS GENERAL TERMS ....................................................................................... 9 LEGISLATION ...................................................................................................................................... 12 SALIENT FEATURES OF THE PATENTS ACT 1970 .................................................................... 12 ADMINISTRATION .............................................................................................................................. 13 MEMBERSHIP OF INTERNATIONAL TREATIES ........................................................................... 14 TYPES OF PATENTS ............................................................................................................................ 14 WHO CAN APPLY ................................................................................................................................ 14 PATENTABLE INVENTIONS .............................................................................................................. 14 WHAT IS NOT PATENTABLE ............................................................................................................ 15 DOCUMENTS REQUIRED FOR FILING AN APPLICATION .......................................................... 16 APPROPRIATE OFFICE FOR FILING AN APPLICATION .............................................................. 16 PROCEDURE FOR PATENT APPLICATION..................................................................................... 17 CLAIMS ................................................................................................................................................. 20 EXAMINATION & PUBLICATION .................................................................................................... 20 OPPOSITION ......................................................................................................................................... 21 GRANT OR SEALING OF PATENT .................................................................................................... 22 REGISTER OF PATENTS ..................................................................................................................... 22 RIGHTS OF PATENTEE ....................................................................................................................... 22 RENEWAL FEE ..................................................................................................................................... 22

WORKING ............................................................................................................................................. 23 COMPULSORY LICENSE AND LICENSE OF RIGHT...................................................................... 23 ASSIGNMENT ....................................................................................................................................... 23 LICENSE ................................................................................................................................................ 24 DURATION ............................................................................................................................................ 24 RESTORATION ..................................................................................................................................... 24 INFRINGEMENT................................................................................................................................... 24 APPEAL ................................................................................................................................................. 24 COMPARISON OF INDIA'S PATENT ACT AND TRIPS .................................................................. 25 CONDITIONS ON PATENT APPLICANTS ............................................................................................. 26 PATENTS IN BIOTECHNOLOGY........................................................................................................... 29 SPECIAL PROBLEMS OF PHARMACEUTICAL PATENTS ................................................................ 32 INADEQUATE PATENT PROTECTION DISCOURAGES THE DEVELOPMENT OF A MARKET FOR PHARMACEUTICALS ADDRESSED TO THE DISEASE BURDEN OF DEVELOPING COUNTRIES .............................................................................................................................................. 35

INTRODUCTION
A patent may be described as a monopoly granted by a government to an inventor, such that only the inventor may exploit the invention/innovation for a fixed period of time (up to 20 years). In return, the inventor makes available a detailed technical description of the invention/ innovation so that, when the monopoly period has expired, it may be exploited by others without the inventors permission.

A patent, therefore, encourages innovation by promoting research and development. It can also be regarded as a physical asset, which can be sold or licensed to third parties for cash. Patents also represent a unique source of technical information regarding the patented product. The philosophy underlining patent law is fairly similar throughout the world. Thus, although there is no worldwide patenting office, patent practice in different world regions is often quite similar. This is fortuitous, as there is a growing tendency towards world harmonization of patent law, fuelled by multinational trade agreements.

In order to be considered patentable, an invention/innovation must satisfy several criteria, the most important four of which are: novelty; non-obviousness; sufficiency of disclosure; utility.

To be novel, the invention/innovation should not be what is described as prior art, i.e. it should not be something already known or described previously. Prior disclosure of the invention/innovation, e.g. by publishing its details in a scientific (or other) journal, or a verbal description given, e.g. at a scientific meeting, puts this innovation in the public arena. This can effectively make it prior art. While this can hinder a subsequent patent application, it may not be entirely fatal. To preclude a successful subsequent patent application, prior publication usually must be enabling, i.e. the detail given must be sufficient to allow an average person,

familiar with the discipline relating to the patent (i.e. a person with ordinary skill and knowledge in the art), to repeat the experiment or process described. A bare prior disclosure, which describes the innovation but not to an enabling level, will not normally prevent its subsequent patenting. Patenting law in relation to this point is more flexible in the USA. Here, even in the case of an existing enabling publication, patenting is usually possible as long as the patent is filed in under 1 year after the date of that publication. The USA, unlike many other world regions, also adopts the first to invent principle. Put simply (although patent disputes are rarely simple), if two inventors file similar patents, the patent will be granted to the one who proves that he/she was the first to invent the product, even if he/she was not the first to file for a patent. Proving you were the first to invent can be complex and usually hinges around the availability of full and detailed laboratory notebooks or other records as to how and when the invention was made.

Non-obviousness (inventiveness) means that the invention/innovation process must not be something that would be immediately obvious to somebody skilled in the art. Non-obviousness, although it sounds straightforward, is often a difficult concept to apply in practice. Obviousness could be described as a simple and logical progression of prior art, thus non-obviousness requires an additional ingredient of inspiration or often chanced good luck. Sufficiency of disclosure is a more straightforward requirement. Sufficient technical detail must be provided in the patent application such that somebody of ordinary technical skill in the area could reproduce/repeat the innovation.

Utility or industrial applicability is the last major prerequisite to patenting. This simply means that the innovation must have some applied use.

THE GLOBAL INSTITUTIONS RESPONSIBLE FOR ADMINISTERING THE PATENT SYSTEM

NATIONAL PATENT OFFICES Every country with a patent system has a national patent office where claims of inventors may be made a matter of public record. As mentioned above, in many countries there is an examination before an inventor is given any substantive rights. In other countries patent claims are registered but detailed examination is delayed until a dispute over infringement arises. However, even in these countries a search of the prior art is often conducted as a part of the registration process, and the search results are published so that members of the public can assess the claims made by the registrant. THE WORLD INTELLECTUAL PROPERTY ORGANIZATION (WIPO) Headquartered in Geneva, WIPO is the specialized United Nations Agency that serves as the secretariat for administration of most of the global intellectual property treaties. It is the principal forum for negotiation of new patent treaties and the leading provider of technical assistance to developing countries in the field of intellectual property rights. WIPO was created in 1967 as the successor organization to the International Bureau for the Protection of Intellectual Property, which had been in existence since the 19th Century. WIPO Currently has 179 member states. THE WORLD TRADE ORGANIZATION (WTO) The World Trade Organization was established in 1994 in Marrakech following the successful conclusion of the Uruguay Round of Trade Negotiations. The predecessor to the WTO was the General Agreement on Tariffs and Trade (GATT). A key reform of the Uruguay Round was the Agreement on Trade Related Aspects of Intellectual Property Rights, known as TRIPS, codified as an annex to the treaty establishing the WTO. It is important to recognize that the TRIPS Agreement was intended to create a more equitable system of international trade. Wealthy countries agreed to reduce barriers to imports of price competitive imports from abroad while developing countries agreed to open their markets to the high value added exports of the developed nations. These high value added exports

disproportionately consist of technology in which much of the value is intangible and must be protected by strong intellectual property regimes to be effectively exploited. Pharmaceutical products constitute one of the most important categories of high technology products. Among the major requirements of the TRIPS agreement are the following: WTO Member States must provide a level of rights equal to those provided in the major global intellectual property treaties administered by WIPO, including the Paris Convention on Industrial Property. WTO member states may not discriminate among technologies in providing patent protection, meaning that exceptions to patent protection in many countries for pharmaceutical products must be eliminated. WTO member states must provide patent protection for at least 20 years from the date of filing a patent application WTO Member States must provide effective judicial enforcement of intellectual property rights. PARIS CONVENTION FOR THE PROTECTION OF INDUSTRIAL PROPERTY The Paris Convention for the Protection of Industrial Property, signed in Paris, France, on March 20, 1883, was one of the first intellectual property treaties. As a result of this treaty, intellectual property, including patents, of any contracting state are accessible to the nationals of other states party to the Convention PATENT COOPERATION TREATY (PCT) The Patent Cooperation Treaty (PCT) is an international patent law treaty, concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its Contracting States. A patent application filed under the PCT is called an international application or PCT application.

PATENT TYPES
Patent types can be subdivided into Product, Process and Use patents. In the first case, a specific substance is patented (e.g. a revolutionary new car engine, a new cytokine with applicability in cancer treatment, a novel microorganism capable of degrading oil, etc.). In the case of process patents, a specific novel process, rather than an end product, is patented (e.g. a new combination of chromatographic methods capable of purifying a therapeutic protein with very high yield). Use patents are appropriate when a novel application for a specific substance is discovered, particularly if the substance itself is not patentable. An example might be the inclusion of a specific chemical that boosts yields of end product in a microbial industrial fermentation process. To be successfully filed, all of these patent types must satisfy the four major criteria already discussed.

THE PATENT APPLICATION

The patent application process can be both lengthy and costly. Generally, it takes 25 years from the initial filing date to get a patent approved, and the anticipated cost would be in the region of $10 000 per country. Any patent is a national right, granted by the government of the country in question. In the USA, the government patenting organization is known as the Patent and Trademark Office (PTO). While there are national patenting agencies within Europe, most European countries are members of the European Patent Organization (EuPO, based in Munich, Germany). These member countries have adapted national patent law such that, in most instances, any patent application approved by the EuPO can be enforced automatically in the constituent countries. Many of the most significant patenting regions (e.g. Japan, the USA and Europe) are also signatories of the International Patent Cooperation Treaty (PCT). This allows for an initial review of the patent application to be undertaken by a single patent office. The office then provides a summary assessment of this application, which provides an indication of the likely response that would be obtained from individual PCT countries. For many, this initial assessment plays a major role in deciding whether to proceed with the patent application in individual countries. The patent application document may be considered under a number of headings.

Headings of the most important sections found in a generalized patent application Patent title Abstract Background to patent application Outline of problems the innovation will solve Detailed technical description of innovation The specific patent claims

After the title comes the abstract, which identifies the innovation and the innovation area. Relevant prior art is then overviewed in detail in the background section. This is drawn mainly from published research articles and pre-existing patents. An adequate preparation of this section

relies on prior completion of a comprehensive literature and patent search. Next, a short paragraph that details the problem the innovation will solve is presented. This should emphasize why the innovation should be considered novel and non-obvious. This in turn is followed by a detailed technical description of the innovation, such that an ordinary person skilled in the art could reproduce it. If, for example, microbial cultures or animal cells form part of the innovation, these must be deposited in an approved depository (e.g. the American Type Culture Collection, ATCC). The last section of the patent outlines exactly what claims are being made for the innovation. While the inventor often prepares the first draft of the patent application, a patent specialist is normally employed to prepare a final draft and guide the application through the patenting process. After its submission to a patent office, the patent application is briefly reviewed and, if all the required information is provided, a formal filing date is issued. A detailed examination of the patent will then be undertaken by patent office experts, whose assessment will be based upon the four main criteria previously outlined. A report is subsequently issued accepting or rejecting the patent claim. The applicant is given the opportunity to reply, or modify the patent and resubmit it for further evaluation. In some cases, two or three such cycles may be undertaken before the patent is granted (or perhaps finally rejected). The normal duration of a patent is 20 years. In most world jurisdictions, patent protection on pharmaceutical substances is extended, often by up to 5 years. This is to offset the time lost between the patenting date and final approval of the drug for general medical use.

PATENTS IN INDIA: LAWS , PROCEDURES, REGISTERING AND CHALLENGING PATENTS

The concept of intellectual property (IP) and the origin of intellectual property were introduced. Perhaps the most important of intellectual properties is the patents. Patents are most important for two reasons:
1. 2.

Patents are a way to make more money for those who obtain a patent Patent policies can be tailored by a country based on its needs to foster and promote industrial development

3. 4.

Patents enable research and development Most importantly, patents provide the most fool proof form of intellectual property rights.

THE PATENT TERMS GENERAL TERMS Several terms define the various aspects of patents. As far as possible these terms are explained in the most logical manner for the reader to understand this in perspective. Patent policy details a country's policy for the patent system. The polices are made by the legislature and based on this policy the patent statute is drafted. For example, the patent policy of India in the 1950 was to ensure that there was local production of drugs. Hence the patent legislation catered to such a need by so drafting the legislation. Patent legislation is what is called the Patent Act. The patent outlines the gist of the patent system in the country. For example, the Indian Patent Act details what can be patented and that patent applications need to be made in order to get a patent. Now, those interested in obtaining a patent need to understand what the application should contain, where the application has to be submitted etc. All these procedural rules are covered in India by the Patent Rules. Thus the patent rules supplement and compliment the patent legislation. Sometimes the patent office issues rules that are within their powers. These are called as patent notifications. In the US,

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such rules are laid down in the form of patent guidelines. In Europe these same rules are laid down in the form of guidelines or Directives. A patent itself is nothing but a document issued by the government. This document tells the holder of the document that a particular product is protected by a patent. This means that the product is patent protected. This means that the product is protected from duplication and copying. The manner of protection is by patents. The person in whose name the document is issued is the patent owner. Most often, the patent owner will also be the inventor. Sometimes companies or other entities can also be a patent owner by entering into an agreement with the patent owner. Such agreements are called as license agreements. These agreements will essentially give the companies and other entities (the licensee) the right to sell, produce, re-sell etc the invention. In return the inventor will get monetary returns termed as royalties. Once a person becomes a patent owner, he gets exclusive rights to sell, manufacture and market the product for a specified period of time. For example, in the US this is 20 years, in India it is 14 years now. This period is called patent term. This means that during the patent term no person other than the patent owner can ever sell the product. Thus the patent owner is vested with exclusive monopoly rights over that product. This right is the "the right to exclude others from making, using, offering for sale, or selling" the invention or "importing" the invention. What is granted is not merely the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Thus there will be no other competing products during the patent term. Hence the patent owner can meet the demand of the market by supplying the entire market. Lack of competition also allows the patent owner to set a higher price for the product since consumers can only access the patented product. This monopoly right is given so that research and development leading to inventions are encouraged. This means that the government encourages people to invent more and tells that that their incentive for inventing more is the monopoly rights which enables the inventor to make more money during the patent term. In return the government ensures that the patent owner describes the invention, the making of the inventions and the working of the invention in the application. It then ensures that after the patent term expires, any person interested can gather

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the information and manufacture similar or the same product. Thus the government on the one hand promotes research and development and on the other hand ensures that the public continues to get the benefit from inventions. The public make an implied agreement to ensure that they get the benefit of research and development for indefinite period by paying a little extra during the patented term. Patents affect trade internationally because of the above. That is, a lot of times patent owners sell products at higher prices. Therefore copying patented products (called as patent infringement) enable those who copy to sell the same products at the cheaper price. This affects the right of the patent owner. Most often, developed countries are the source of research and development. In these countries, they protect the rights of the inventors by adequate mechanisms. On the other hand, developing nations could survive only with a little copying in specified industrial sectors like pharmaceuticals etc. Hence developed nations wanted what is called as patent harmonization. The term patent harmonization essentially means that patents laws and patent protection becomes very similar across the world in all countries. This will ensure that the rights of patent holders of any country are protected internationally. Such harmonization is attempted through patent conventions or patent treaties, (TRIPS is one such convention. Other patent conventions are Paris Conventions, Patent Cooperation Treaty etc). These treaties and conventions are enforced by international organizations. The most important international organization for patent law is WIPO and WTO. WIPO stands for World Intellectual Property Organization and WTO for World Trade Organization. The WTO governs the trade related aspects of intellectual property rights. WI PO is the main organization for the governance of all the treaties other than TRIPS. Patents are sought from the patent office by making a patent application. In the US there is only one patent office located centrally at Washington DC. The patent office is spread through several buildings in the US. There is one central patent office in Calcutta and regional offices in India.

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LEGISLATION The Patent system in India is governed by the Patents Act, 1970 (No 39 of 1970) & The Patents Rules 1972, effective from April 20,1972. Subsequently The Patents Act, 1970 is amended effective from January 1, 1995 & The Patents Rules, 1972 is amended effective from June 2, 1999. SALIENT FEATURES OF THE PATENTS ACT 1970 Elaborate and clear-cut definition of patentable and non patentable inventions. Provisions for filing provisional applications The filling for application by inventor, assignee or even by the legal heirs. Provision for patent of addition.

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Opposition to the patent before the grant of the patent Term of patent 14 years a) Except in case of methods or processes of manufacture of a substance b) Intended or capable or being used as food, medicine or drug. c) In such cases the term of patent is five years from the date of sealing or seven years from the date of the patent whichever is shortever. d) Subject to the payment of renewal fees. Revocation of the patent allowed on certain grounds as mentioned in section 64 of the act. Compulsory licenses on the grounds of non-satisfactory of reasonable requirement of public or the invention being unavailable to the public at a reasonable price. Certain categories of patents are endorsed with the words Licenses of Rights on the ground of reasonable requirement of public of non-availbility of the invention at a reasonable price under section 86, and also deemed endorsement of certain mehtos of their menufacture and the methos of manufacture of chemical substances under section 87. Power of central Government in respect of compulsory licensing and power to use/acquire patents for its own use under section 100 and 102 respectively. Judicial review of powers of the controller and the use by Government. Provisions to stop infringement of patents and provisions of appeals. As regards the cinematography the right to make copies, exhibition in public, make records and right to broadcast. ADMINISTRATION The Patent Office, under the Ministry of Commerce & Industry, Department of Industrial Policy & Promotion, has been established to administer the various provisions of the Patents Law

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relating to the grant of Patents & The Designs Law, relating to the registration of Industrial Designs. MEMBERSHIP OF INTERNATIONAL TREATIES India is member of the following treaties governing patents:

Convention establishing World Intellectual Property Organization (WIPO) Trips Agreement under the World Trade Organization. Paris Convention for the protection of Industrial Property with effect from Dec. 7, 1998. Patent Cooperation Treaty (PCT) with effective from Dec. 7, 1998.

TYPES OF PATENTS

Ordinary Patent Patents of addition Convention

WHO CAN APPLY Application may be made, either alone or jointly with another, by the inventor, assignee, legal representative of deceased inventor or assignee. The inventor is entitled to be mentioned in the patent if he applies to do so. Application may be made jointly by two or more corporations as assignees. PATENTABLE INVENTIONS An invention means any new and useful art, process, method or manner of manufacture; machine, apparatus or other article; or substance produced by manufacture, and includes any new and useful improvement of any of them, and an alleged invention.

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WHAT IS NOT PATENTABLE (1) An invention that is frivolous or that claims anything obviously contrary to well-established natural laws; (2) An invention the primary or intended use of which would be contrary to law or morality or injurious to public health; (3) The mere discovery of a scientific principle or the formulation of an abstract theory; (4) The mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant; (5) A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; (6) The mere arrangement or rearrangement or duplication of known devices, each functioning independently of one another in a known way; (7) A method or process of testing applicable during the process of manufacture for rendering the machine, apparatus or other equipment more efficient, or for the improvement or restoration of the existing machine, apparatus or other equipment, or for the improvement or control of manufacture; (8) A method of agriculture or horticulture; (9) Inventions relating to atomic energy. In the case of inventions relating to substances prepared or produced by chemical processes (including alloys, optical glass, semiconductors and inter-metallic compounds) & substances intended for use or capable of being used as food. No patent will be granted in respect of claims for the substances themselves, but claims for the methods or processes of manufacture will be patented.

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DOCUMENTS REQUIRED FOR FILING AN APPLICATION Application form in triplicate. Provisional or complete specification in triplicate. If the provisional specification is filed it must be followed by complete specification within 12 months (15 months with extension). Drawing in triplicate (if necessary). Abstract of the invention (in triplicate). Information and undertaking listing the number, filing date and current status of each foreign patent application in duplicate. Priority document (if priority date is claimed). Declaration of inventorship where provisional specification is followed by complete specification or in case of convention application. Power of attorney (if filed through Patent Agent). Fee in cash/by local cheque/by demand draft. APPROPRIATE OFFICE FOR FILING AN APPLICATION Application is required to be filed according to the territorial limits where the applicant or the first mentioned applicant in case of joint applicants for a patent normally resides or has domicile or has a place of business or the place from where the invention actually originated .If the applicant for the patent or party in a proceeding having no business, place or domicile in India., the appropriate office will be according to the address of service in India given by the applicant or party in a proceeding.

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PROCEDURE FOR PATENT APPLICATION The 1970 Act in section 6 reflects the first to file system by placing emphasis on date of application and not on the date of invention. Applications for a patent can be made by the true and the first inventor, or their assignees or legal representatives. The first importer of an invention or a person to whom the invention is first communicated from outside India will not be considered a first inventor. Every patent application has two important aspects that will decide the fate of the application. These are Specification and Claims. The specification clause originates from Section 4 of the Patents Act, 1949 of United Kingdom. The Patents Act provides that every application shall contain a specification the specification can either be a provisional or a complete specification.

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Provisional specification A provisional specification is a document drawn in a prescribed format. It contains a description of the essential features of the invention. It does not include claims and description of manner of performing the invention. It is notable that in a first to file system like India the date of application for the patent becomes important. If two inventors file patent application for the same invention, then the one whose application has the earlier date has the advantage of being awarded the patent. Therefore it is very important to file the application as soon as possible. The provisional specification facilitates this. The date of filing the provisional specification becomes the date of the application. This date is called the priority date and this date is accorded to the claims in the complete specification which can be filed later based on the provisional specification. A provisional specification should be drawn in Form 2 of the Rules. This application will contain a description of the nature of the invention. The title to the provisional specification should give a fair detail of area of science the application will deal with. The object of the invention and a statement of the actual invention need to set forth in the provisional specification. The most important aspect is that when a complete specification is files, the provisional specification should with reasonable certainty relate to the same invention. However, it is advised that the provisional specification be couched in broad terms. This is preventing a competing inventor to seek a broader patent based on the provisional specification. Complete Specification: After filing a provisional specification, the applicant should submit a complete specification within 12 months of the date of filing of the provisional application without which the application will be deemed to be abandoned unless a request to file the same within 15 months is filed with the controller. If the applicant is unable to file the complete specification within the prescribed time, then the applicant can request for post dating of the application for a six Month period. The advantage is that the applicant gets another 6 months to file a complete specification. The

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disadvantage is that the applicant will lose the priority dates. Thus a later filed application may get priority because of this. Every complete specification shall, a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed, b) disclose the best method of performing the invention which is known to the applicant, and c) end with claim or claims defining the scope of the invention. CLAIMS All complete specifications end with claims. Section 10 (5) notes that the claims shall relate to a single invention. The requirement of a claim seems is "fairly based on the matter disclosed in the specification." The object of claims is to:
1. 2.

State with precision the detail of the invention Define the exact scope of the invention. This will enable a narrow invention to be patentable later Example, a claim for a folding chair should clearly so specify the features of a chair and limit the claim to chairs that fold. This will enable inventor No 2 to patent a revolving chair or may be a non-folding chair.

3. To clearly set the limits of the claim. This is interrelated to the above concept. In the above example, if chairs already exist, and if inventor No 1 is the first inventor if just the folding quality of the chair, then the claims should set the limitation properly. This will keep all Chairs other than the folding chairs within the public domain. That is, this inventor does not have exclusive rights over that chair. At the same time, it will encourage other inventors to find newer forms of chair say a cushion chair, revolving chair, floating chair and so on. EXAMINATION & PUBLICATION All the applications for patent accompanied by complete specification are examined substantively. A first examination report stating the objection(s) is communicated to the

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applicant or his agents. Application or complete specification may be amended in order to meet the objection(s). Normally all the objections must be met within 15 months from the date of first examination report. Extension of time for three months is available, but application for extension therefore must be made before the expiry of normal period of 15 months. If all the objections are not complied with within the normal period or within the extended period the application will be deemed to have been abandoned. When the application is found to be suitable for acceptance it is published in the gazette of India (Part III, Section2). It is deemed laid open to the public on the date of publication in the gazette of India.

OPPOSITION Notice of opposition must be filed within four months of notification in the Gazette. Extension of one month is available, but must be applied for before expiry of initial four month period. In India, there are several grounds for opposing a patent. Some of the most important grounds are:
a.

That the applicant has wrongfully obtained the patent from the person opposing the application

b. c. d.

The invention is already known to a person skilled in the art (obviousness) The invention has been in public use in India The claims do not relate to an invention within the ambit of the Act

e. The best mode is not disclosed in the complete specification. Best mode is a very important requirement in across the world. The term best mode means that in the patent application the inventor should disclose not only the invention but the best method of making the invention. This is because after the expiry of the term of the patent (that is after the inventor loses his exclusivity and monopoly rights), the public should be able to work the patent. Therefore the inventor ought to have disclosed the best method of making. This requirement is called the enablement requirement in the US. That is unless the patent application reveals the best mode of making; the application is not enabled for

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the public. Therefore the application will fail. There are several ways to determining the best mode of making in India as well as in the US. GRANT OR SEALING OF PATENT If the application is not opposed or the opposition is decided in favour of the applicant or is not refused the patent is granted or sealed on payment of sealing fee within 6 months from the date of advertisement. However, it is extendable by three months. REGISTER OF PATENTS The Register of Patents will be kept in the Patent Office and its branch offices. Register of Patents can be inspected or extract from it can be obtained on payment of prescribed fee. Register of Patents contains full details of the Patent which include Patent number, the names and addresses of the patentee; notification of assignment etc.; renewals, particulars in respect of proprietorship of patent etc. RIGHTS OF PATENTEE A patent grant gives the patentee the exclusive right to make or use the patented article or use the patented process. He can prevent all others from making or using the patented process. A patentee has also the right to assign the patent, grant licenses under, or otherwise deal with it for any consideration. These rights created by statute are circumscribed by various conditions and limitations.

RENEWAL FEE Renewal fees are payable every year. The first renewal fee is payable for third year of the patents life, and must be paid before the patents second anniversary. If the patent has not been issued within that period, renewal fees may be accumulated and paid immediately after the patent is sealed, or within three months of its recordal in the Register of the Patents.

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Date of payment of Renewal fees is measured from the date of the patent. Six months grace is available with Extension fee. No renewal fees are payable on patents of addition, unless the original patent is revoked and the patent of addition is converted into an independent patent; renewal fees then become payable for the remainder of the term of the main patent. No renewal fees are payable during the pendency of the application for a patent; renewal fees that become overdue during pendency are payable upon sealing within three months of recordal in the Patent Register. WORKING Annual reports as to the extent of working, by every patentee and licensee, are a statutory requirement and must be submitted by March, 31 each year for the previous year ending December, 31.

COMPULSORY LICENSE AND LICENSE OF RIGHT On failure to work a patent within three years from the date of its sealing, an interested party may file petition for grant of a compulsory license. Every patent for an invention relating to a method or process for manufacture of substances intended for use, or capable of being used, as food, medicines, or drugs, or relating to substances prepared or produced by chemical process (including alloys, optical glass, semi-conductors and inter-metallic compounds) shall be deemed to be endorsed "Licenses of Right" from the date of expiry of three years from the date of sealing the patent. ASSIGNMENT Applications must be filed on the prescribed form with the Controller for the registration of assignments and any other documents creating an interest in a patent in order for them to be valid. In order to be valid, an assignment must be recorded within six months from the date of the document. A six-months extension may be obtained.

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LICENSE Applications must be filed on the prescribed form with the Controller for the registration of licenses and any other documents creating an interest in a patent in order for them to be valid. A license must be recorded within six months from the date of the document. DURATION A patent lasts for 14 years from the date of filing the complete specification (if an application is filed with provisional specification on January 1, 1989, and a complete specification is filed on January 1, 1990, the duration is counted from January 1, 1990). However, for food, drug and insecticide patents, the life is seven years from the date of complete specification, or five years from date of sealing, whichever is shorter. RESTORATION Application for restoration of a patent that lapses due to nonpayment of renewal fees must be made within one year of lapse. If an overdue annuity is not paid within the extension period, the one-year period for seeking restoration commences from the date of recordal. INFRINGEMENT Infringement can consist of taking away essential features of the patented invention; utilizing claimed features; copying patented substances; mechanical equivalence; taking part of the invention. while the patent is in force. Use by the government or for government purposes is not infringement. Such use must be paid for on terms to be agreed upon before or after use. Accidental or temporary use, use for research, use on foreign vessels, do not constitute infringement. APPEAL Appeal lies in the High Court. Appeal must be lodged within three months from the decision of the Controller.

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COMPARISON OF INDIA'S PATENT ACT AND TRIPS INDIAN PATENT ACT OF 1970 Only process not product patents in food, medicines, chemicals Term of patents 14 years; 5-7 in chemicals, drugs Compulsory licensing and license of right Several areas excluded from patents (method of agriculture, any process for medicinal surgical or other treatment of humans, or similar treatment of animals and plants to render them free of disease or increase economic value of products) Government allowed to use patented invention to prevent scarcity TRIPS Process and product patents in almost all fields of technology Term of patents 20 years Limited compulsory licensing, no license of right Almost all fields of technology patentable. Only area conclusively excluded from patentability is plant varieties; debate regarding some areas in agriculture and biotechnology Very limited scope for governments to use patented inventions

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CONDITIONS ON PATENT APPLICANTS

The Article 29 of the TRIPS which mandates WTO members to impose a disclosure requirement on patent applicants such that a person skilled in the art will be enabled to carry out the invention has been universally accepted. Also applicants may require disclosing the best mode known to him to work the invention as on the date of filing or priority. Article 29.2 allows members to require patent applicants disclose their corresponding foreign patent applications

It is contented that developing countries take advantage of these provisions to get full disclosure and the best- known method to work the inventions. But everybody knows that patent applicants rarely disclose all the know- how, but disclose only what is strictly required. Pre-grant opposition following early publication of applications is one way of ensuring that others get the opportunity to question various aspects of the application. TRIPS Agreement is silent on this matter and hence countries are free to adopt pre-grant or post-grant opposition method. Developed countries are moving toward post-grant system, Since this allows grant of patents without much delay, at the same time provide for fair opportunity to invalidate wrongly granted patents. EPO allows opposition only on grounds of patent eligibility, lack of novelty or inventive step or inadequate disclosure and the opposition should be filed within nine months' time. In the US, post-grant reexamination procedures are more limited as these are ex parte and confined to novelty issues arising out of documented prior art. But this system allows for a cheaper alternative to patent infringement suits.

Eventually, world will have to move towards patent law harmonization where there will be uniformity even in procedural details.

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PATENTS WORK DIFFERENTLY IN DIFFERENT INDUSTRIES

Almost all inventions are patented prior to being made available to the market, regardless of the technology involved. The means by which patent rights are exercised, however, varies from technology to technology. For example, in the field of consumer electronics patents are widely shared among competitors through cross licenses. Patents on chemical compounds on the other hand are normally not licensed to others and exclusivity is closely guarded. Whatever patent strategy is employed by the inventor, the aim is always the same to maximize the profit accruing to the inventor and those who have supplied him or her with the capital necessary to develop and commercialize the invention. For a patent to have any commercial value there must be a market for the invention embodied in the patent, which will support the cost of development of the invention and return a profit. Markets are morally neutral. They operate on the principal of scarcity. Scarce products cost more than widely available products. Thus, expensive, high-end electronic gadgets, such as plasma television screens are much more expensive to consumers than much bulkier cathode ray television screens. The higher expense is a reflection of the market power given to manufacturers of the plasma screens by virtue of the patents in the technologies embodied in them, while the lower cost of the cathode ray television screens is partly a function of the fact that patents have long ago expired on the technologies embodied in them. The market exclusivity and higher prices made possible by the patent rights function as a reward for the risk undertaken by those who financed the research and development leading to the new technologies. Thus, prices of plasma television screens exceed the purchasing power of poor consumers and they must be satisfied with older cathode ray screens or no television at all. This example illustrates a very important point: A very high percentage of the worlds population exists without purchasing any products embodying patents simply because they are too poor to afford innovative technology. It is a fact that the worlds poor live without making use of the vast majority of inventions available in developed countries. While this has significant implications for the economic gap between wealthy and poor countries, in most cases the lack of access to the most innovative technologies is not a necessity. However, to the extent the poor cannot afford access to

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necessary inventions, governments normally bear the cost of providing their citizens with such inventions. Thus, in most of the world, governments bear the cost of purchasing inventions that relate directly to sanitation, public health, national defense, public order and security, public transportation and education. For these inventions, the market is primarily a market of governments, not individuals.

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PATENTS IN BIOTECHNOLOGY
Many products of nature (e.g. specific antibiotics, microorganisms, proteins, etc.) have been successfully patented. It might be argued that simply to find any substance naturally occurring on the earth is categorized as a discovery, and would be unpatentable because it lacks true novelty or any inventive step. However, if you enrich, purify or modify a product of nature such that you make available the substance for the first time in an industrially useful format, that product/process is generally patentable. In other words, patenting is possible if the hand of man has played an obvious part in developing the product. In the USA, purity alone often facilitates patenting of a product of nature. The PTO recognizes purity as a change in form of the natural material. For example, although vitamin B12 was a known product of nature for many years, it was only available in the form of a crude liver extract, which was of no use therapeutically; development of a suitable production (fermentation) and purification protocol allowed production of pure, crystalline vitamin B12 which could be used clinically. On this basis, a product patent was granted in the USA. Using the same logic, the US PTO has, for example, granted patents for pure cultures of specific microorganisms, as well as medically important proteins [e.g. factor VIII, purified from blood and erythropoietin, purified from urine].

Some products of nature which are generally patentable under US patent law. Additional patenting criteria (e.g. utility) must also be met. For many products, the patent will include details of the process used to purify the product. However, process patents can be filed, as can use patents. Refer to text for further details A pure microbial culture Isolated viruses Specific purified proteins (e.g. erythropoietin) Purified nucleic acid sequences (including isolated genes, plasmids, etc.) Other purified biomolecules (e.g. antibiotics, vitamins, etc.)

Rapid technological advances in the biological sciences raises complex patenting issues, and

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patenting law as applied to modern biotechnology is still evolving. In the late 1980s, the PTO confirmed that they would consider issuing patents for non-human multicellular organisms, including animals. The first transgenic animal was patented in 1988 by Harvard University. The Harvard mouse carried a gene which made it more susceptible to cancer and, hence, more sensitive in detecting possible carcinogens. Another area of biotechnology patent law relates to the patenting of genes and DNA sequences. Thus far, patents have been issued for some human genes, largely on the basis of the use of their cloned products (e.g. erythropoietin and tissue plasminogen activator). The human genome project continues to make available vast quantities of DNA sequence informationof both genes and non-coding regions. Moreover, the function of the bulk of the putative genes sequences at the moment remain unknown. Most of the groups working on this project are funded by public bodies. Some sequencing groups, however, are funded by private companies. These wish to see a payback on their investment. Gaining a patent for a nucleotide sequence that is of medical or diagnostic use would provide very significant payback potential. Patenting DNA sequences came under heavy legal and public scrutiny in 1992, when the US National Institutes of Health (NIH) filed a patent application on partial human cDNA sequences of unknown function. This patent was rejected, and the consensus has emerged that patent protection should only be considered for nucleotide sequences that can be used for specific purposes, e.g. for a sequence which can serve as a diagnostic marker or codes for a protein product of medical value. This appears to be a reasonable approach, as it balances issues of public interest with encouraging innovation in the area. The issue of patenting genetic material or transgenic plants or animals remains a contentious one. The debate is not confined to technical and legal argumentethical and political issues, including public opinion, also impinge on the decision-making process. The increasing technical complexity and sophistication of the biological principles and processes upon which biotechnological innovations are based also render resolution of legal patenting issues more difficult. A major step in clarifying EU-wide law with regard to patenting in biotechnology stems from the introduction of the 1998 European patent directive. This directive (EU law) confirms that biological materials (e.g. specific cells, proteins, genes, nucleotide sequences, antibiotics, etc.)

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which previously existed in nature, are potentially patentable. However, in order to actually be patentable, they must (a) be isolated/purified from their natural environment and/or be produced via a technical process (e.g. recombinant DNA technology in the case of recombinant proteins), and (b) they must conform to the general patentability principles regarding novelty, non-obviousness, utility and sufficiency of disclosure. The utility condition, therefore, in effect prevents patenting of gene/genome sequences of unknown function. The directive also prohibits the possibility of patenting inventions if their exploitation would be contrary to public order or morality. Thus, it is not possible to patent: the human body; the cloning of humans; the use of human embryos for commercial purposes; modifying germ line identity in humans; modifying the genetic complement of an animal if the modifications cause suffering without resultant substantial medical benefits to the animal or to humans.

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SPECIAL PROBLEMS OF PHARMACEUTICAL PATENTS

The pharmaceutical industry is one of three technology-based industries in which the patent virtually equals the product. The others are the chemical industry (including agricultural chemicals) and the biotechnology industry, whose innovations span the spectrum from engineered plant varieties to human pharmaceutical therapies. These three industries are much different than other patenting industries such as computers and electronics. While responsible for many patent filings the computer and electronics industries are characterized by extensive use of other techniques for managing inventions, including the use of trade secrecy and the pooling of patents with those of competitors to accommodate government and industry technical standards. Most importantly, unlike industries which produce products requiring expensive and complex manufacturing infrastructures, the patented products of pharmaceutical companies can be easily and cheaply replicated by copiers with little capital investment. Since capital investment in the pharmaceutical industry disproportionately is directed to laboratory research and clinical trials rather than the manufacture of the final product, patent exclusivity is the only effective way to protect and receive a return on that investment. The pharmaceutical industry has an important characteristic that sets it apart from other industries that rely on patent protection. In many technology-based industries it is possible to keep inventions a secret until the moment they are marketed. This enables inventors to delay patent filings until the last possible moment and, therefore, to maximize the effect of the 20 year patent term which runs from filing of the patent application. The culture of medical research, however, emphasizes very early disclosure of inventions, usually long before a resulting product can be placed on the market. This is because scientists working in the field of human pathology have an obligation to share their findings as soon as possible with their peers so that those peers will be able to benefit from the new knowledge in their own research. And, unlike industries such as computers and software, the pharmaceutical industry is heavily regulated by government agencies to assure the safety and efficacy of products which will be sold to consumers. In the United States the Food and Drug Administration performs this function. Much of the investment in new drugs is in the clinical trials which are necessary to satisfy safety and

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efficacy regulators. The tolerance for a buyer beware philosophy in the pharmaceutical industry is extremely low compared to other industries. The lengthy time period between patent filing and placing a product on the market means that pharmaceutical manufacturers receive far shorter periods of patent exclusivity than is the case for other patent dependent industries. This problem has been addressed in legislation in the United States and elsewhere which permits a patent applicant to apply for extensions of patent term to compensate for the inability to market inventions due to safety and efficacy regulation. However, the time periods permitted for such extensions do not equal the time lost in ability to market. In the United States patents can be extended only for half the time period consumed by the regulatory approval process, and for a maximum effective patent term of fourteen years. Further, the legislation restricts the exclusive right of use which normally accompanies the patent grant by permitting generic competitors to use the product for testing and developing the generic alternative while the patent is still in effect. This permits a generic product to be marketed virtually the moment the patent expires. While the contribution of the patent-based pharmaceutical business to job creation and the economy is impressive, the inventions of pharmaceutical researchers have a dimension difficult to quantify in economic terms their impact in extending life and alleviating human suffering. In 2001 the pharmaceutical industry pipeline contained 402 new cancer medicines, 123 new treatments for heart disease and stroke, 83 new AIDS treatments and 176 new medicines for neurological diseases. These statistics are particularly sobering in light of the current debate over whether patents covering HIV drugs should be respected. None of the new drugs in the pipeline, much less the 74 medicines that already have caused deaths from AIDS to plummet in the United States, would have come into existence without the patent incentive and the prospect of a return on investment provided by that incentive. This is not to dismiss the fact that many patients in the world cannot pay for these drugs and do not have access to them. However, this is not the result of the patent system. It is the result of lack of a source of funding for the purchase of drugs for those currently too poor to buy them themselves. While in the United States Medicaid provides a safety net for those without health insurance or other means to pay for drugs, in many parts of the world there is no similar source of

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public financing. However, the Bush Administration has recognized this, and Congress currently is in the process of appropriating U.S. tax money for the 2004 fiscal year to subsidize purchases of HIV medicines by public health authorities in poor countries.

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INADEQUATE PATENT PROTECTION DISCOURAGES THE DEVELOPMENT OF A MARKET FOR PHARMACEUTICALS ADDRESSED TO THE DISEASE BURDEN OF DEVELOPING COUNTRIES
The global market for pharmaceutical products was estimated to have a value in 2002 of $406 billion. The United States, the European Union and Japan currently account for 80% of this market, while the rest of the world combined, including Africa, Asia, Latin America and the Middle East, represent only 20% of the market. Patents play an integral role in pharmaceutical research and development occurring in these developed countries. And, the presence of strong patent protection combined with the concurrent ability to assure a profitable return on investment means that commercial pharmaceutical research and development is being overwhelmingly directed at producing drugs which will meet patient needs in these developed countries, especially the needs of patients in the United States of America. This is confirmed by economic research that has compared the relationship between gross profit margins of pharmaceutical companies with research and development outlays. The power of these economic forces to focus pharmaceutical research and development on the disease burden of richer countries with strong patent systems is seen in the fact that of the 308 essential drugs listed by WHO in 2002 as essential to developing country public health systems, only five percent were patented in any jurisdiction. And, by WHO estimates at least a third of all patients globally lacked access even to these mainly off-patent medications. Much of the research and development that occurs in developing countries is financed by the public sector rather than private pharmaceutical companies, which in these countries overwhelmingly manufacture generic versions of drugs developed elsewhere. An example of a country with significant public sector investments in life sciences research is Brazil. The State of Sao Paulo directs 1% of its annual tax collections to the support of public sector research and development through a foundation established by the state. Sao Paulo state generates 70% of the GDP in the 10th largest economy in the world. Yet, this investment has not resulted in commercial pharmaceutical products. This should not be surprising in that

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until very recently Brazil provided no patent protection for the health related inventions flowing from these public investments. And, few government and university laboratories in Brazil have a mechanism in place for patenting and licensing to the commercial sector the work of their scientists. Most patents on pharmaceuticals granted in Brazil today are issued to foreign nationals and protect work done abroad, not research results of Brazilian scientists. Brazils experience is similar to many countries in the developing world, such as India and Argentina. This means that countries with ecosystems rich in the genetic starting material of possible new drugs and traditions of folk medicine providing clues to the potential of this starting material lack policies most likely to encourage commercialization of these resources. Yet, this is the kind of pharmaceutical innovation most likely to address local and regional disease burdens.