Introduction to Law and Legal System PDF

Approved by Quality Council of India, Government of India Institute of Good Manufacturing Practices India General Introduction to Law and Legal System By : Ria Banerji Assistant Professor IGMPI For feed...

Approved by Quality Council of India, Government of India Institute of Good Manufacturing Practices India General Introduction to Law and Legal System By : Ria Banerji Assistant Professor IGMPI For feedback on this lecture please mail on –[email protected] Institute of Good Manufacturing Practices India www.igmpi.ac.in  Intellectual Property Rights Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The most well-known types are copyrights, patents, trademarks, and trade secrets. The modern concept of intellectual property developed in England in the 17th and 18th centuries. The term "intellectual property" began to be used in the 19th century, though it was not until the late 20th century that intellectual property became commonplace in the majority of the world's legal systems. The main purpose of intellectual property law is to encourage the creation of a wide variety of intellectual goods. To achieve this, the law gives people and businesses property rights to the information and intellectual goods they create, usually for a limited period of time. This gives economic incentive for their creation, because it allows people to benefit from the information and intellectual goods they create, and allows them to protect their ideas and prevent copying. These economic incentives are expected to stimulate innovation and contribute to the technological progress of countries, which depends on the extent of protection granted to innovators. The intangible nature of intellectual property presents difficulties when compared with traditional property like land or goods. Unlike traditional property, intellectual property is "indivisible", since an unlimited number of people can "consume" an intellectual good without it being depleted. Additionally, investments in intellectual goods suffer from problems of appropriation: a landowner can surround their land with a robust fence and hire armed guards to protect it, but a producer of information or literature can usually do very little to stop their first buyer from replicating it and selling it at a lower price. Balancing rights so that they are strong enough to encourage the creation of intellectual goods but not so strong that they prevent the goods' wide use is the primary focus of modern intellectual property law. Institute of Good Manufacturing Practices India www.igmpi.ac.in  Intellectual Property Rights  IPR is concerned with ownership and control of ideas-intellectual output  “It is an important issue in research, because it can get infringed”  IPR are exclusive rights given to a person over the creation of their minds.  They usually give the creator an exclusive rights over the use of his/her creation for a certain period of time Institute of Good Manufacturing Practices India www.igmpi.ac.in What is Intellectual Property? An intellectual property is any product of the human intellect that is unique, novel, and unobvious (and has some value in the marketplace) Institute of Good Manufacturing Practices India www.igmpi.ac.in Intellectual property rights: An overview and implications in pharmaceutical industry Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is a recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era. Institute of Good Manufacturing Practices India www.igmpi.ac.in  IPR Legislation IPR legislation The idea of IPR legislation is to protect all owners of Intellectual Property Covered by international and national law: International: Berne Convention for the Protection of Literary and Artistic Works (1886 onwards) European Union legislation UK: Copyright, Designs and Patents Act(1988) Institute of Good Manufacturing Practices India www.igmpi.ac.in  Paris Convention for the Protection of Industrial Property The Paris Convention for the Protection of Industrial Property, signed in Paris, France, on 20 March 1883, was one of the first intellectual property treaties. It established a Union for the protection of industrial property. The Convention is currently still in force. The substantive provisions of the Convention fall into three main categories: national treatment, priority right and common rules. National Treatment Under the provisions on national treatment, the Convention provides that, as regards the protection of industrial property, each contracting State must grant the same protection to nationals of the other contracting States as it grants to its own nationals. Nationals of non-contracting States are also entitled to national treatment under the Convention if they are domiciled or have a real and effective industrial or commercial establishment in a contracting State. Institute of Good Manufacturing Practices India www.igmpi.ac.in  Common Rules The Convention lays down a few common rules which all the contracting States must follow. The more important are the following: Patents 1. Patents granted in different contracting States for the same invention are independent of each other. 2. The granting of a patent in one contracting State does not oblige the other contracting States to grant a patent. 3. A patent cannot be refused, annulled or terminated in any contracting State on the ground that it has been refused or annulled or has terminated in any other contracting State. 4. The inventor has the right to be named as such in the patent. 5. The grant of a patent may not be refused, and a patent may not be invalidated, on the ground that the sale of the patented product, or of a product obtained by means of the patented process, is subject to restrictions or limitations resulting from the domestic law. 6. Each contracting State that takes legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exclusive rights conferred by a patent may do so only with certain limitations. Thus, a compulsory license based on failure to work the patented invention may only be granted pursuant to a request filed after three or four years of failure to work or insufficient working of the patented invention and it must be refused if the patentee gives legitimate reasons to justify his inaction. Institute of Good Manufacturing Practices India www.igmpi.ac.in The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) TRIPS is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to nationals of other WTO member nations. TRIPS requires member states to provide strong protection for intellectual property rights. For example:- Copyright terms must extend at least 50 years, unless based on the life of the author. (Art. 12 and 14) Copyright must be granted automatically, and not based upon any "formality", such as registrations, as specified in the Berne Convention. (Art. 9) Computer programs must be regarded as "literary works" under copyright law and receive the same terms of protection. National exceptions to copyright (such as "fair use" in the United States) are constrained by the Berne three-step test. Institute of Good Manufacturing Practices India www.igmpi.ac.in  Patents must be granted for "inventions" in all "fields of technology" provided they meet all other patentability requirements (although exceptions for certain public interests are allowed (Art. 27.2 and 27.3) and must be enforceable for at least 20 years (Art 33). Exceptions to exclusive rights must be limited, provided that a normal exploitation of the work (Art. 13) and normal exploitation of the patent (Art 30) is not in conflict. No unreasonable prejudice to the legitimate interests of the right holders of computer programs and patents is allowed. Legitimate interests of third parties have to be taken into account by patent rights (Art 30).  The TRIPS Agreement, which came into effect on 1 January 1995, is to date the most comprehensive multilateral agreement on intellectual property. The areas of intellectual property that it covers are: (i) Copyright and related rights (i.e. the rights of performers, producers of sound recordings and broadcasting organisations); (ii) trade marks including service marks; (iii) Geographical indications including appellations of origin; (iv) Industrial designs; (v) Patents including protection of new varieties of plants; (vi) the lay-out designs (topographies) of integrated circuits; (vii) the undisclosed information including trade secrets and test data. After India became a signatory to the TRIPS agreement, the Patents Act, 1970 has been amended in the year 1995, 1999, 2002 and 2005 to meet its obligations under the TRIPS Agreement. The law of trademarks is also now modernized under the Trademarks Act of 1999. Copyright Act, 1957 has been amended several times to keep pace with the changing times. The most notable amendment was introduced in 1984 including “computer programmes” within Institute of Good the definition Manufacturing Practices Indiaof "literary work”. Institute of Good Manufacturing Practices India www.igmpi.ac.in www.igmpi.ac.in  The Role of Patent Cooperation Treaty The patent cooperation treaty (PCT) is a multilateral treaty entered into force in 1978. Through PCT, an inventor of a member country contracting state of PCT can simultaneously obtain priority for his/her invention in all or any of the member countries, without having to file a separate application in the countries of interest, by designating them in the PCT application. All activities related to PCT are coordinated by the world intellectual property organization (WIPO) situated in Geneva. In order to protect invention in other countries, it is required to file an independent patent application in each country of interest; in some cases, within a stipulated time to obtain priority in these countries. This would entail a large investment, within a short time, to meet costs towards filing fees, translation, attorney charges, etc. In addition, it is assumed that due to the short time available for making the decision on whether to file a patent application in a country or not, may not be well founded. Inventors of contracting states of PCT on the other hand can simultaneously obtain priority for their inventions without having to file separate application in the countries of interest; thus, saving the initial investments towards filing fees, translation, etc. In addition, the system provides much longer time for filing patent application in the member countries. The time available under Paris convention for securing priority in other countries is 12 months from the date of initial filing. Under the PCT, the time available could be as much as minimum 20 and maximum 31 months. Further, an inventor is also benefited by the search report prepared under the PCT system to be sure that the claimed invention is novel. The inventor could also opt for preliminary examination before filing in other countries to be doubly sure about the patentability of the invention. Institute of Good Manufacturing Practices India www.igmpi.ac.in  Advantages of PCT Filing The advantages of PCT filing for the applicant, the patent offices and the general public are given below: (1) The applicant has up to 18 months more than in a procedure outside the PCT to reflect on the desirability of seeking protection in foreign countries, (2) to appoint local patent agents in each foreign country, (3) to prepare the necessary translations and to pay the national fees. The PCT filing assures the applicant that if his international application is in the form prescribed by the PCT, it cannot be rejected on formal grounds by any designated Office during the national phase of the processing of the application. On the basis of the international search report, the applicant can evaluate with reasonable probability the chances of his invention being patented. On the basis of the international preliminary examination report, that probability is even stronger; the applicant has the possibility to amend the international application to put it in order before processing by the designated Offices. Institute of Good Manufacturing Practices India www.igmpi.ac.in  The Berne Convention The Berne Union has an Assembly and an Executive Committee. Every country member of the Union which has adhered to at least the administrative and final provisions of the Stockholm Act is a member of the Assembly. The members of the Executive Committee are elected from among the members of the Union, except for Switzerland, which is a member ex officio. The Berne Convention, concluded in 1886, was revised at Paris in 1896 and at Berlin in 1908, completed at Berne in 1914, revised at Rome in 1928, at Brussels in 1948, at Stockholm in 1967 and at Paris in 1971, and was amended in 1979. The Convention rests on three basic principles and contains a series of provisions determining the minimum protection to be granted, as well as special provisions available to developing countries. The three basic principles are the following: 1. Works originating in one of the contracting States must be given the same protection in each of the other contracting States as the latter grants to the works of its own nationals. 2. Such protection must not be conditional upon compliance with any formality. 3. Such protection is independent of the existence of protection in the country of origin of the work. If, however, a contracting State provides for a longer term than the minimum prescribed by the Convention and the work ceases to be protected in the country of origin, protection may be denied once protection in the country of origin ceases. Institute of Good Manufacturing Practices India www.igmpi.ac.in  The Trademark Act of 1999 The law of trademarks is also now modernized under the Trademarks Act of 1999. A trademark is a special symbol for distinguishing the goods offered for sale or otherwise put on the market by one trader from those of another. In India the trademarks have been protected for over four decades as per the provisions of the Trade and Merchandise Mark (TMM) Act of 1958. India became a party to the WTO at its very inception. One of the agreements in that related to the Intellectual Property Rights (TRIPS). In December, 1998 India acceded to the Paris Convention. The Bill pointed towards the changes which were contemplated and were under consideration of the Government of India, but it lapsed in 1994. A comprehensive review was made of the existing laws in view of the developments in trading and commercial practices, and increasing globalization of trade and industry. The Trademarks Bill of 1999 was passed by Parliament that received the assent of the President on 30th December, 1999 as Trade Marks Act, 1999 thereby replacing the Trade and Merchandise Mark Act of 1958. The important salient features of the Act inter-alia include: It broadens the definition of infringement of a registered trademark to include action against the unauthorized use of a confusingly similar mark, not only in respect of the goods and services covered by registration, as was previously the case, but also in respect of goods and services which are so similar that a likelihood of deception or confusion exists. An action for infringement will also be available against the unauthorised use of a mark in relation to dissimilar goods, if such mark is similar to a registered mark that is well known in India and the interest of the owner is likely to be affected adversely. The remedy for infringement of a trademark is also strengthened under the new law by authorising the police with the power to seize infringing articles without a warrant. Institute of Good Manufacturing Practices India www.igmpi.ac.in FOOD TECHNOLOGY IN FOOD INDUSTRY Institute of Good Manufacturing Practices India www.igmpi.ac.in  The World Intellectual Property Organization The World Intellectual Property Organization (WIPO) is a specialized agency of the United Nations. It is dedicated to developing a balanced and accessible international intellectual property (IP) system, which rewards creativity, stimulates innovation and contributes to economic development while safeguarding the public interest. WIPO was established by the WIPO Convention in 1967 with a mandate from its Member States to promote the protection of IP throughout the world through co-operation among states and in collaboration with other international organizations. Its headquarters are in Geneva, Switzerland. The Paris Convention entered into force in 1884 with 14 member States, which set up an International Bureau to carry out administrative tasks, such as organizing meetings of the member States. In the year 1886, copyright also entered the international arena with the Berne Convention for the Protection of Literary and Artistic Works to help nationals of its member States obtain international protection of their right to control, and receive payment for, the use of their creative works such as novels, short stories, poems, plays; songs, operas, musicals, sonatas; and drawings, paintings, sculptures, architectural works. Like the Paris Convention, the Berne Convention set up an International Bureau to carry out administrative tasks. In 1893, these two small bureaux united to form an international organization called the United International Bureau (BIRPI) for the Protection of Intellectual Property. The BIRPI indeed was the predecessor of the World Intellectual Property Organization. Institute of Good Manufacturing Practices India www.igmpi.ac.in  WIPO and WTO  WIPO expanded its role and further demonstrated the importance of intellectual property rights in the management of globalized trade in 1996 by entering into a cooperation agreement with the World Trade Organization (WTO).  It provides for co-operation concerning the implementation of the TRIPS Agreement, such as notification of laws and regulations and legal-technical assistance and technical co-operation in favour of developing countries.  In July 1998, a joint initiative to help developing countries meet their TRIPS obligations till the year 2000 was launched.  Mention should be made that today WIPO, administers 24 treaties (three of those jointly with other international organizations) and carries out a rich and varied program of work, through its member States and secretariat, that seeks to: harmonize national intellectual property legislation and procedures, provide services for international applications for industrial property rights, exchange intellectual property information, provide legal and technical assistance to developing and other countries, facilitate the resolution of private intellectual property disputes, and marshal information technology as a tool for storing, accessing, and using valuable intellectual property information. Institute of Good Manufacturing Practices India www.igmpi.ac.in IPR and its Types Institute of Good Manufacturing Practices India www.igmpi.ac.in  The Patent Act of 1970 The Patents Act, 1970 remained in force for about 24 years without any change till December 1994. Being a landmark in the industrial development of India, the basic philosophy of the Act is that patents are granted to encourage inventions and to secure that these inventions are worked on a commercial scale without undue delay; and patents are granted not merely to enable patentee to enjoy a monopoly for the importation of the patented article into the country. Patents Rules: Under the provisions of Section 159 of the Patents Act, 1970 the Central Government is empowered to make rules for implementing the Act and regulating patent administration. Accordingly, the Patents Rules, 1972 were notified and brought into force w.e.f. 20.4.1972. These Rules were amended from time to time till 20th May 2003 when new Patents Rules, 2003 were brought into force by replacing the 1972 rules. These rules were further amended by the Patents (Amendment) Rules, 2005 and the Patents (Amendment) Rules, 2006. The last amendments are made effective from 5th May 2006. There are four Schedules to the Patents (Amendment) Rules 2005; the First Schedule prescribes the fees to be paid; the Second Schedule specifies the list of forms and the texts of various forms required in connection with various activities under the Patents Act. These forms are to be used wherever required and if needed, they can be modified with the consent of the Controller. The Third Schedule prescribes form of Patent to be issued on Grant of the Patent. The Fourth Schedule prescribes costs to be awarded in various proceedings before the Controller under the Act. SALIENT FEATURES Institute of Good Manufacturing Practices India www.igmpi.ac.in  PATENT A patent is a contract between the government and the inventor, in other words it is a legal protection granted by the government. The government gives the inventor the right to exclude others from making, using or selling the invention for a term of years. The exclusive right does not give the inventor the right to make, use or sell his invention. The inventor gives the public a full and complete disclosure of the invention with a teaching of how it works. The right created by a patent is a monopoly right The right to take action against any person exploiting the patented invention in the country without the agreement of the patent owner Patent are given only for inventions Once issued, patentee must enforce the rights. Thus Patentee has the right to exploit the patent to withdraw to protect and sue when infringed and to get remedies for infringement Institute of Good Manufacturing Practices India www.igmpi.ac.in There are three different types of patents for which an inventor may apply: Institute of Good Manufacturing Practices India www.igmpi.ac.in Why Patent?  Patents are most important of IP because of:  Patents are a way to make more money from those who obtain a patent  Patent policies can be tailored by a country based on its need to foster and promote industrial development  Patents enable Research and Development  Most importantly, patent provides the most fool proof form of IP rights Institute of Good Manufacturing Practices India www.igmpi.ac.in  Patentability:- Must meet the following three criteria:- Utility - The invention must perform some useful function for society, i.e. it must have useful purpose operativeness (invention must serve purpose) Novelty - It must be new, i.e. it must Not known or used by others Different from prior art Not patented or publicly disclosed previously Note: 1 year grace period in US and Canada most other jurisdictions have absolute novelty requirement Non-Obvious – It should not be obvious to a person ordinary skilled it the art, i.e. “sufficiently different from what has been used or described before that it may be said to be nonobvious to a person having ordinary skill in the area of technology related to the invention” Institute of Good Manufacturing Practices India www.igmpi.ac.in  PATENT SYSTEM Patent system Precisely includes:- Inventor- true and first inventor/assignee Invention- novelty, inventive step, industrial application Registration and renewal-patent offices Exclusive right-to make, use, vend, assign through license Protection-by statutes (the Patents act 1970) Remedies- through civil and criminal law proceedings Institute of Good Manufacturing Practices India www.igmpi.ac.in How do I get a patent? To get a patent on an INVENTION, You must have an invention that is patentable You must describe the invention and apply for a patent The patent office must examine the patent (and criticize it) and hopefully grant/issue the patent & payment of fees and argue/justify/clarification of the invention through the prosecution process Institute of Good Manufacturing Practices India www.igmpi.ac.in  Rationale of a patent Patent is recognition to the form of IP manifested in invention. Patents are granted for patentable inventions, which satisfy the requirements of novelty and utility under the stringent examination and opposition procedures prescribed in the Indian Patents Act, 1970, but there is not even a prima-facie presumption as to the validity of the patent granted. Most countries have established national regimes to provide protection to the IPR within its jurisdiction. Except in the case of copyrights, the protection granted to the inventor/creator in a country (such as India) or a region (such as European Union) is restricted to that territory where protection is sought and is not valid in other countries or regions. For example, a patent granted in India is valid only for India and not in the USA. The basic reason for patenting an invention is to make money through exclusivity, i.e., the inventor or his assignee would have a monopoly if, the inventor has made an important invention after taking into account the modifications that the customer, and if the patent agent has described and claimed the invention correctly in the patent specification drafted, then the resultant patent would give the patent owner an exclusive market. The patentee can exercise his exclusivity either by marketing the patented invention himself or by licensing it to a third party. Institute of Good Manufacturing Practices India www.igmpi.ac.in What can I patent The list of inventions which are/and not patentable  Inventions Machine, Apparatus or  Frivolous or obvious other Articles; patentable inventions.  Substances produced by  Inventions which could be Manufacturing contrary to law or morality or  Computer Software which injurious to human, animal or has Technical application plant life and health or to the to Industry or is used with environment. Hardware  Mere discovery of the scientific  Art, Process, Method or principle or the formulation of an Manner of manufacture; abstract theory or discovery of  Product Patent for Food / any living thing or non-living Chemical / Medicines or substances occurring in nature Drugs Institute of Good Manufacturing Practices India www.igmpi.ac.in  Any process for the medicinal or surgical, curative continued prophylactic, diagnostic, therapeutic or other treatment of human beings, animals to render them free of disease or to increase their economic value or that of their products. The biological processes for production or propagation of plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species (new plant varieties can be protected by the protection of plant varieties and farmers act 2001). A mathematical or business method or algorithms. A Computer Programme other than its technical application to industry or a combination with hardware. Aesthetic creation including cinematography and television production. Institute of Good Manufacturing Practices India www.igmpi.ac.in Continued  Method for performing mental act or playing game.  Presentation of information.  Topography of Integrated Circuits.  Invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known components.  Inventions relating to Atomic Energy. Institute of Good Manufacturing Practices India www.igmpi.ac.in  Rationale of a license A license is a contract by which the licensor authorizes the licensee to perform certain activities, which would otherwise have been unlawful. For example, in a patent license, the patentee (licensor) authorizes the licensee to exercise defined rights over the patent. The effect is to give to the licensee a right to do what he/she would otherwise be prohibited from doing, i.e., a license makes lawful what otherwise would be unlawful. The licensor may also license ‘know-how’ pertaining to the execution of the licensed patent right such as information, process, or device occurring or utilized in a business activity can also be included along with the patent right in a license agreement. Some examples of know-how are: technical information such as formulae, techniques, and operating procedures and commercial information such as customer lists and sales data, marketing, professional and management procedures. Indeed, any technical, trade, commercial, or other information, may be capable of being the subject of protection. Benefits to the licensor: (i) Opens new markets (ii) Creates new areas for revenue generation (iii) Helps overcome the challenge of establishing the technology in different markets especially in foreign countries – lower costs and risk and savings on distribution and marketing expenses Benefits to the licensee are: (i) Savings on R&D and elimination of risks associated with R&D (ii) Quick exploitation of market requirements before the market interest wanes (iii) Ensures that products are the latest Institute of Good Manufacturing Practices India www.igmpi.ac.in The Role of Patent Cooperation Treaty The patent cooperation treaty (PCT) is a multilateral treaty entered into force in 1978. Through PCT, an inventor of a member country contracting state of PCT can simultaneously obtain priority for his/her invention in all or any of the member countries, without having to file a separate application in the countries of interest, by designating them in the PCT application. All activities related to PCT are coordinated by the world intellectual property organization (WIPO) situated in Geneva. In order to protect invention in other countries, it is required to file an independent patent application in each country of interest; in some cases, within a stipulated time to obtain priority in these countries. This would entail a large investment, within a short time, to meet costs towards filing fees, translation, attorney charges, etc. In addition, it is assumed that due to the short time available for making the decision on whether to file a patent application in a country or not, may not be well founded. Inventors of contracting states of PCT on the other hand can simultaneously obtain priority for their inventions without having to file separate application in the countries of interest; thus, saving the initial investments towards filing fees, translation, etc. In addition, the system provides much longer time for filing patent application in the member countries. The time available under Paris convention for securing priority in other countries is 12 months from the date of initial filing. Under the PCT, the time available could be as much as minimum 20 and maximum 31 months. Further, an inventor is also benefited by the search report prepared under the PCT system to be sure that the claimed invention is novel. The inventor could also opt for preliminary examination before filing in other countries to be doubly sure about the patentability of the invention. Institute of Good Manufacturing Practices India www.igmpi.ac.in Patent Disputes and Forum (a) Patent Administrative Cases  Includes disputes on grant of a patent, patent invalidation and upholding, and compulsory licensing. (b) Patent Infringement Cases Includes, infringement of patents, disputes relating to ownership of patent, contractual disputes, regarding assignment, patent licensing, and revocation. Forums: Controller general of patents, IPAB, District court, High court under Article 226/227 and Supreme court under Article 32,133,136,or 142 Institute of Good Manufacturing Practices India www.igmpi.ac.in  Claims of a Patent As claims in a patent define boundaries of the invention claimed, a product or process patent will be infringing if it falls within the scope of a claim in the patent Therefore, understanding the meaning and scope of patent claims is important for determining infringement. Institute of Good Manufacturing Practices India www.igmpi.ac.in Patent Infringement Institute of Good Manufacturing Practices India www.igmpi.ac.in Types of Patent Infringement Patent infringement Direct Infringement Indirect Infringement Institute of Good Manufacturing Practices India www.igmpi.ac.in Patent Infringement Types Patent infringement is the unauthorized making, using, offering for sale, selling of any patented invention within a jurisdiction, or importing into the jurisdiction of any patented invention during the term of a patent. Three basic types of patent infringements: Direct patent infringement Anyone who makes, uses, or sells the patented invention Indirect patent infringement A person actively encourages another to make, use, or sell the invention, Contributory patent infringement Knowingly, selling or supplying an item for which the only use is in connection with a patented invention Institute of Good Manufacturing Practices India www.igmpi.ac.in Direct Infringement It directly states that the third party has willfully or intentionally stolen the technology from the inventor without his prior permission It occurs when someone directly makes, uses or sells the patented invention within the country Institute of Good Manufacturing Practices India www.igmpi.ac.in  Literal Infringement If all elements of a claim are literally present in an patented product or process Claim #1: A pharmaceutical composition, comprising: element A; element B; element C; and element D. Claim #2: A drug composition, comprising: element A ; element B; element C; and element D. Determination of literal infringement is done by comparing elements of a claim to those of a product or process one on one Institute of Good Manufacturing Practices India www.igmpi.ac.in Equivalence Infringement If the elements of a product or process differing from those of claim elements are present by equivalence Claim #1: A pharmaceutical composition, comprising: element A; element B; element C; and element D. Claim #2: An analgesic compound, comprising: element AE; element BF; element CG; and element DH. “Triple identity” or “function-way-result” test for determining equivalence – Doctrine of Equivalents (DOE) Institute of Good Manufacturing Practices India www.igmpi.ac.in Doctrine of Equivalents A person is liable for infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed invention. The difference between a feature in an accused device and the limitation literally recited in a patent claim may be found to be “insubstantial” if the feature in the accused device: Performs substantially the same function In substantially the same way To yield substantially the same result as the limitation literally recited in the patent claim Institute of Good Manufacturing Practices India www.igmpi.ac.in TYPES OF INDIRECT INFRINGEMENT Institute of Good Manufacturing Practices India www.igmpi.ac.in  Reliefs Available Accounts of profit- assessment of the un lawful gain by the infringer Injunction- prima facie, balance of convenience, irreparable loss Damages- compensatory relief for the loss. Damages: Monetary compensation that is awarded by a court in a civil action to an individual who has been injured through the wrongful conduct of another party. measure in financial terms the extent of harm a plaintiff has suffered by the defendant.  generally regarded as remedial rather than preventive or punitive  may even be more than monetary profits reaped by the defendants by the misuse of the plaintiff’s patent. Institute of Good Manufacturing Practices India www.igmpi.ac.in  THANK YOU Institute of Good Manufacturing Practices India www.igmpi.ac.in