Passport to survival in the fiercely emerging competitive world is the ability to capitalise on innovations at speeds faster than others in the market, gain proprietary rights on intellectual assets and strategically utilise them to establish and sustain competitiveness. The framework of Intellectual Property Rights (IPR) offers a wide range of options such as Patents, Trademarks, Copyright, Design Registrations, Trade Secrets, Anti-competitive Practices in Contractual Licences, Protection of New Plant Varieties and Data Protection. What needs to be appreciated is that each of these instruments of IPR protects a specific aspect of the innovation and a judicious combination of these tools provides a reasonable protective canopy for the innovations. This article dwells with the basic aspects of these instruments of IPR. The TRIPS agreement requires the member states to comply with the minimum standards set for each of these IPR Instruments under the agreement.

The IPR Tools ….. a brief survey

This section highlights key features of each of the tools in the .IPR TOOL KIT.

Patent

It protects inventions that are novel, non-obvious with respect to the prior art and useful. The invention must be disclosed in a specified format in a patent specification. A granted patent has a specific "term" of 20 years as required by the TRIPS. A patent must be periodically renewed up to the end of the term to retain the rights from it. If the renewal process is not done by the inventor/assignee as required by the Patent Act of the country, the patent becomes public property for free use there by anyone. However the patent term cannot be renewed beyond its term of 20 years. In several countries, under certain special circumstances, a patent term can be extended up to 5 years beyond the term. A granted and valid patent gives the patentee the right to stop others from commercially practicing his invention without his permission. If any one wishes to use a patented invention (other than the patentee) for commercial purposes, then he must seek a licence from the patentee or have the patent assigned to him generally at a reasonable cost. The patentee licences or assigns his patent to someone or to any organisation for a consideration in the form of down-payment, royalty or a combination of them. A granted patent is valid in the territory in which it is granted. There is nothing called an "international patent". Therefore the patentee is expected to file his patent in all countries of his business interest have a follow-up through his attorney to have them granted in such countries to enable him to enforce his rights in those countries.

It should be appreciated that a patent document remains as a secret document with the patent office only for 18 months after it is filed with the patent office. Thereafter the filed patent specification is officially published in a gazette. Anyone interested to read the patent specification might procure it from the patent office of that country by paying the prescribed fee. It may be noted that the publication is only for the purposes of information to the public and not for free/unauthorised commercial usage of the invention.

Patent laws in most countries have special sections (as allowed by TRIPS) that entitles the government of that country to exercise control on misuse or over use of the rights by the patentee by issuing compulsory licences to third parties for its commercial exploitation or using the patented invention by itself for public good in that country for specified periods under special situations such as a national emergency, epidemics etc. The terms of compulsory licensing are defined in the respective National Patent Acts and those interested in these aspects must go into the details of the Patent Laws / Competition Laws/Anti-trust Laws in those countries. Articles 27-34 of TRIPS outline the minimum standards for the patent laws in the member counties.

Trademark & Service Mark

These are Registrable Marks (includes device, brand, heading, label, ticket, name, signature, word, letter, numerical, shape of goods, packaging or combination of colours or any combination thereof) that are capable of distinguishing the goods or services in connection with which they are used in course of trade which are certified by the proprietor of the mark in respect to the origin, material, mode of manufacture of goods or performance of services. A trademark may be registered or it may not be registered. There is another concept of a "well known trade mark" in relation to any goods or services, meaning a mark that has become so to the substantial segment of the public which uses such goods or receives such services that the use of such mark in relation to other goods or services would be likely to be taken as indicating a connection in the course of trade or rendering of services and a person using the mark in relation to the first mentioned goods or services. Unlike a patent or a design registration, a registered trademark can be perpetually renewed. It is always advisable to register a trademark in the countries of commercial interests to the proprietor of the mark as it gives statutory protection and makes enforcement easier. A trademark may be licensed, assigned like any other intellectual property.

Articles 15-21 of TRIPS outline the minimum standards for the trademark laws in the member counties

Design Registration

A registered design includes features of shape, configuration, pattern, ornament or composition of lines or colours, applied to any article either in two or three dimensional or in both forms by any industrial process which in the finished article appeal to and are judged solely by the eye. The industrial process or means can be manual, mechanical or chemical, separate or combined.

The protection does not include
- the mode or principle of construction
- anything which is in substance a mere mechanical device
- Trademark or property mark.

This registration has a specific term (initially 10 years and renewable for another term of 10 years). If it is not renewed in a country as required by statute the registered design becomes public property in that country and after that the design can be freely used by anyone without fear of infringement in that country. Articles 25-26 of TRIPS outline the minimum standards for the design registration laws in the member counties

Copyright

Protects creative works that are musical, literary, artistic, lectures, plays, art reproductions, models, photographs, computer software, etc. The rights under this also have specified duration of protection. The term of a work, [other than a photographic work or a work of applied art] is calculated on a basis other than the life of a natural person,
- a term not less than 50 years from the end of the calendar year of the authorized publication or failing such authorized publication within 50 years from the making of the work [50 years from the calendar year of making].

For example, the term of protection available to performers is at least 50 years computed from the end of the calendar year when the performance took place. It may be noted that a copyright is obtained as soon as the work is completed. It is not necessary to register a copyright to derive the rights from it. Articles 9-14 of TRIPS outline the minimum standards for the copyright laws in the member counties

Layout Designs For Integrated Circuits

Substantive provisions of the Washington Treaty for protection of Layout Designs for integrated circuits must be respected. The scope of protection not only includes the protected chip but also the articles incorporating it. The term of protection is 10 years. An innocent infringer must be free from liability, but once he has received the notice of infringement, he is liable to pay a reasonable royalty. Articles 35-38 of TRIPS outline the minimum standards for the layout design (topographies of integrated circuits) laws in the member counties

Trade Secrets & Undisclosed Information

This provides protection to persons/institutions on information, which is lawfully under their control from being disclosed to, acquired by or used by others without their consent in a manner contrary to commercial practices so long as the information is secret and has commercial value because it is secret. It is expected that the person/institution has taken reasonable steps to keep the information secret. This also applies to test data whose origination requires considerable effort (e.g. for marketing approval/ FDA clearances, etc.) submitted to the government or governmental agencies for statutory clearances. This underlines the significance of institutions having a well established and operative " information classification policy " and confidentiality clauses in service contracts with employees/associates. Article-39 of TRIPS outline the minimum standards for the protection of undisclosed information in the member counties

Geographical Indications

This tool affords protection to goods that can be identified as originating or manufactured in the territory of a country, or a region or locality in that territory where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin. In the case where such goods are manufactured goods, one of the activities of production or of processing or preparation of goods concerned takes place in such territory or locality as the case may be. The term is initially for a period of 10 years and can be renewed from time to time. Articles 22-24 of TRIPS outline the minimum standards for the geographical indications laws in the member counties

Protection of New Plant Varieties

Countries that exclude patent protection to inventions related to plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes, are required to provide protection to plant varieties by an effective "sui generis" or any combination of "sui generis" and patents. The international conventions followed on this feature are UPOV '78 and UPOV'91 and the "Convention of Biodiversity" (CBD). There could be a variation in the adoption of these features in the National Laws of different countries. An aspect of this requirement is outlined in Article 27 of TRIPS.

Anti-competitive Practices in Contractual Licences

It is accepted that some licensing practices related to IPR, which restrain competition may have an adverse impact on trade and impede transfer of technology. Examples of such restrictive practices may include exclusive grant back conditions, conditions preventing challenges to validity and coercive package licensing, etc. Countries are at liberty to introduce legislations that discourage such restrictive practices in contractual licences but remain consistent within the provisions of TRIPS. This generally links to the national anti-trust / anti-competition laws and "compulsory licensing" that regulate "monopolistic practices". These are country specific and are guided by international principles. Article 40 of TRIPS outlines the minimum standards for the anti competitive practices in contractual licences laws in the member counties

An Illustrative Application of IPR tools

Let us assume a product in the market that cures common cold. A patent may protect the active molecule for this indication. Further several patents may also protect the formulations of drug delivery systems. The processes for making the active molecules and the drug delivery systems may also be protected by patents. The distinctive shape of the tablets, capsules, etc may be protected by design registrations. Similarly a trademark may protect the distinctive name of the medicine e.g. "lungcure". The literature included in the packed medicine is a subject matter protected by copyright. Several aspects of the manufacture of the delivery system may remain as undisclosed information with the company and may be protected by trade secrets. The data submitted to the government authorities for the clearance of the product for market is protected in several countries under "protection of test data". Any overuse or misuse of the rights of the IPR holders may be corrected with the help of the government by invoking clauses under compulsory licensing, anti competitive practices in contractual licences, etc.

It is therefore advisable that the pharmaceutical sector gears up to face the competitive world by equipping itself with appropriate IPR capabilities.

-- The author is Advisor, "VISION-IPR"