Intellectual Property Rights by Shiv Kalia.pptx

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.

1. INTELLECTUAL PROPERTY RIGHTS Guided by- Ms. Alka Sonker Mam (Ph.D Research Scholar) Presented by- Shiv Kumar M.Pharma 1 st year (1 st sem ) Pharmaceutical Analysis Department Of Pharmaceutical Sciences. Babasaheb Bhimrao Ambedkar University ( A Central University ) Lucknow,U.P .

2. Content INTRODUCTION TO INTELLECTUAL PROPERTY RIGHTS TYPES OF INTELLECTUAL PROPERTY RIGHTS FACTORS AFFECTING INTELLECTUAL PROPERTY INFRINGEMENT OF INTELLECTUAL PROPERTY PENALITIES OF IP INFRINGEMENT IN INDIA ROLE OF IPR IN PHARMACEUTICAL INDUSTRY

3. 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. Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. Intellectual property rights (IPR) refers to the legal rights given to the inventor or creator to protect his invention or creation for a certain period of time. These legal rights confer an exclusive right to the inventor/creator or his assignee to fully utilize his invention/creation for a given period of time.

4. TYPES OF INTELLECTUAL PROPERTY RIGHTS

5. PATENT is an exclusive right granted by the government to the innovators to create, use, sell, industrial production, and import. It prevent others from doing the likewise without seeking prior consent, within the boundaries of the nation. Patent is granted for a new product or a process which involves industrial applications. All inventions are not patentable. The innovations coming under section 3 and 4 of the Indian Parliament Act, 1970 are exempted from giving patent.

6. COPYRIGHTS A legal right granted to the owner of a literary, artistic or scientific work to make use of it, is widely known as copyright. The protection authorize others also to make use of it for reproduction and public demonstration by obtaining prior permission from the authors. Only the expression of ideas are protected by this law and these ideas are free to use to all as their own interest. The works such as literary, dramatic, musical work, computer programs, software, drawings, paintings, cinematographic films and recordings are cover under copyright .

7. TRADEMARKS These are distinctive and unique in nature helping to identify the source of specific products from their competitors in the field. It makes easy for people to identify the exact one for which they are searching from a range of similar enterprises. Trademarks may consist of alphabets, numerals, words/combination of words, symbols, drawings, three dimensional signs and voice recordings. Even colours and fragrances are being used as distinguishable trademarks in the industry .

8. INDUSTRIAL DESIGNS The aesthetic aspects like pattern, colour or lines of two dimensional or three- dimensional features of an article are protected under the category of Industrial Designs. There are no technical factors regarding Industrial Designs. The design should be novel and not utilised anywhere even outside the country. The known shapes or pattern experimented on new context which involves any mental activity for conceptualization maybe considered for granting Industrial Designs. Such articles must have Independent existence from the designs applied to it. The maximum period of protection will be of fifteen years in total. At the initial stage, the period will be for ten years and it tends to be extended for five years duration by paying. The power of issuing registration is vested with the Controller of Patents and Designs situated at the Intellectual Property Office, Kolkata.

9. PROTECTION OF NEW PLANT VARIETIES AND FARMER’S RIGHTS (PPVFR) The rights under the Protection of new Plant Varieties and Farmer’s Rights (PPVFR) cover a wide chain of rights conferred exclusively for specific groups, such as Breeders’ rights, Researchers’ rights and Farmers’ rights. Breeder will have rights to cultivate, sell, and market the product. Importing and exporting goods are also permissible. A researcher can use any of the registered varieties, for research purpose or conducting experiments. A researcher has to get consent from the breeder of the initial source of a variety, on experiment, for conducting further development. In addition, farmers’ interest in being a part of the development of a plant variety is entitled with the registration and protection. The farmers’ general works and eligibility to get honours and awards for conservation of plant genetic resources and wild family of economic plants are also protected by law. The office of the Registrar of Protection of Plant Varieties and Farmer’s Rights authority in New Delhi is the authorized registration centre for the protection of all rights for plant varieties and farmers guaranteed by law. The registration process involves complex procedures and it varying depends on the type of legal right required.

10. PROTECTION OF UNDISCLOSED INFORMATION/TRADE SECRETS The trade secrets of an enterprise provide a competitive edge in business. A trade secret may refer to a chemical product, a combination of some elements or single chemical formulae related to the industry. Taking some measures like restricting access to the information and maintaining non-disclosure agreements among the employees in the industry are part of protecting trade secrets. There is no specific legislation in India for protecting undisclosed information. For example, the Coco-Cola has a trade secret. The formulae for the taste and the combination of Coco-Cola, is kept as secret in the vault of a bank in Georgia. GEOGRAPHICAL INDICATIONS The Geographical Indication is a sign of merchandise possesses some specific qualities and known in the name of a particular geographical area as its origin and a similar product may not be available elsewhere satisfying all these characteristics. It is assigned along with the name of the place from which it is originated. This can be used for a wide variety of products. Among them agricultural products like Darjeeling tea, Alphonso mango, Mysore sandel , Pokkali rice, and Nagpur orange are widely recognised in India and foreign countries. Kancheepuram Silk and Aranmula kannadi are exceptional and familiar to public as the names of genuine and trustable products guaranteeing certain qualities. The office of the Registrar of Geographical Indications, Chennai receives all requests on GI in the country.

11. LAYOUT DESIGN OF INTEGRATED CIRCUITS The designing of layout of an integrated circuit is the process involving a two or three dimensional layout or the topography of an IC. It is also termed as mask work. This structure consists of elements include transistors, other circuitry elements and lead wires connecting to them. In order to get protection for semiconductor IC layout designs, an act came into force in India in the year 2000. In the event, the layout of a circuit found not original, commercially exploited anywhere in India, inherently not distinctive or not in a distinguishable form from registered layout design will not be considered for registration under this act. The period of legal coverage will be of ten years. The Semiconductor Integrated Circuit Layout Design Registry at New Delhi is the issuing authority of rights regarding design of Integrated Circuits.

12. FACTORS AFFECTING INTELLECTUAL PROPERTY T he strength of patent claims and other IP; How much of a competitive advantage the IP brings its owner; The size and profitability of the markets for products that are protected by the IP (and whether those products can be brought to market); How the IP will be used (e.g., to improve products, as a barrier to competitive entry, or defensively as a cross licensing tool); and How rich and determined are other parties that may wish to challenge the IP.

13. FACTORS AFFECTING INTELLECTUAL PROPERTY Term of market exclusivity Market exclusivity provided by regulatory approval Extensions for pediatric investigation Extensions for orphan drugs Patentability standards Utility/industrial applicability Novelty (and grace periods) Priority rules Trademarks Protection of brand names Protection of "trade dress" Copyright - Marketing/training materials Database protection - Proprietary collections/linking of physical, genomic, epidemiological data

14. INFRINGEMENT Infringement is breach or the contravention of the prescribed procedure of the law. When a person acts ultravires , it becomes a breach of law which ultimately results in violation or infringement of law. Infringement is described as "a crime less serious than a felony.“ Infringement of Intellectual Property The use of intellectual property by a stranger without the prior consent of the owner is infringement of intellectual property. The infringement of Intellectual Properties includes Patent Infringement, Trademark Infringement, Copyright Infringement, etc. Patent Infringement A person can use a patented product by seeking permission from the owner. This permission may typically be granted in the form of a license. In case of India, the patent infringement proceedings can be initiated only after the grant of patent. Persons involved in making, using, selling, distributing, importing or offering any of the above may be held liable for infringement.

15. TRADE MARK INFRINGEMENT It is a violation of exclusive rights attaching to a trademark without the authorization of the trademark owner or licensees (provided that such sanction was within the scope of the license). Infringement may occur when one party, the "infringer", uses a trademark which is identical or confusingly similar to a trademark owned by other party, in relation to products or services which are identical or similar to the products or services which the registration covers. COPYRIGHT INFRINGEMENT Copyright infringement or copy right violation is the unauthorized use of material that is covered by copyright law, in a manner that violates one of the copy right owner's exclusive rights, such as the right to reproduce or perform the copyrighted work, or to make derivative works. For electronic and audio visual media, unauthorized reproduction and distribution is occasionally referred to as piracy The true test to determine infringement is when a trader, spectator or viewer after having read or seen both the works should get an unmistakable impression that the subsequent work appears to be a copy of the first.

16. PENALITIES OF IP INFRINGEMENT IN INDIA Intellectual property Infringement is basically using someone else’s Intellectual property without the consent of the owner of that Intellectual Property. When a person acts Ultravires, he is breaching the law. Infringement is “ a crime less serious than a felony ”. I P laws in India are governed and protected under the Patents Act, 1970; Trademarks Act, 1999; Copyrights Act, 1957; Designs Act, 2001 etc.  Civil and Criminal remedies  mentioned under these acts are of utmost importance for the IP rights enforcement. In this context, the principal function of the judiciary is to provide legal remedies against infringement of personal and property rights of persons. Infringement of intellectual property rights is considered as tortious invasion of property. The courts in India have the power to grant reliefs in cases pertaining to the violation and/or infringement of intellectual property rights. The judiciary not only does the adjudication of the intellectual property matters but it also interprets several IP statutes for better understanding. The various IP laws in India mention the provisions of civil and criminal remedies for IP rights enforcement. These civil and criminal remedies are distinct and independent. Also, they can be availed simultaneously.

17. CIVIL REMEDIES Upon IP infringement civil remedies can be enforced by filing a suit for infringement and/or passing off (in case of unregistered trademarks) in the competent court. Following reliefs of civil nature can be granted: 1. Injunction 2. Anton Pillar orders or Ex-parte orders 3. Orders for deliver up/surrender or seize and destroy 4. An award of costs and damages 5. Tracing orders An injunction is the prohibition of an action by a party to a lawsuit. If the plaintiff establishes that the prima facie case is in his favour , an injunction is granted. Anton Pillar orders permit the plaintiff’s counsel to enter the infringer’s premises and seize evidence of infringement. This order is passed when there is a serious danger of removal/destruction of the infringing articles. Such an order is granted on an ex-parte application. Infringing goods are delivered to the plaintiff or destroyed if the orders of delivery-up and destruction are passed. Under tracing remedies, an infringer can be ordered to provide details like from where he got his supplies of infringing goods. Failure to provide such information is taken as contempt of court. An award of cost and damages are two mutually exclusive remedies. Damages are granted to compensate the losses incurred by the plaintiff on account of the defendant’s infringing act, whereas actual amounts of profits are handed over to the plaintiff as the second measure.

18. CRIMINAL REMEDIES Criminal remedies in India are provided only for  Trademarks  and copyrights . Section 63 of the Copyright Act, 1957 deals with ‘Offences of Infringement of copyright or other rights conferred by the act’. It mentions about imprisonment for a term not less than 6 months which may extend up to 3 years and fine not less than 50,000 rupees which may extend up to 2 lakh rupees, as punishment if found guilty in a copyright infringement case. This term and fine can be increased according to the provisions of Section 63A of the Copyright Act, 1957. Chapter XII of the Trademarks Act, 1999 deals with offences, penalties and procedures pertaining to trademark infringement. Here on account of trademark infringement, the punishment can go as high as imprisonment up to 3 years with or without fine. The fine ranges from 50,000 to 2 lakh rupees. This term and fine can be increased as per the provisions of the Section 105 of the Trademarks Act, 1999. Indian Patent Act, 1970 also considers falsification of entries in register, claiming patent rights in an unauthorized way etc. to be punishable criminal offences. Such penalties are mentioned under Chapter XX of the Indian Patents Act, 1970.

19. REMEDIES AVAILABLE FOR INFRINGEMENT When there is a violation or an infringement of an intellectual property, it becomes the sole right of the Intellectual property holder to obtain a remedy for the infringement of something that he has acquired with a lot of hard work and tremendous efforts . Patent Infringement Remedies A Suit for Infringement of Patent has to be filed before the District Court or the High Court (depending on the pecuniary jurisdiction) within whose territorial jurisdiction the cause of action has arisen.However if the counter claim for revocation has been filed against the same, only the High Court has the jurisdiction to entertain the matter. The reliefs that a court may grant in a patent infringement suit, would include an injunction and, at the option of the plaintiff either damages or an account of profits. The court may also order that the goods which are found to be infringing and materials and implement, the predominant use of which is in the creation of infringing goods shall be seized, forfeited or destroyed, as the court deems fit under the circumstances of the case without payment of any compensation

20. TRADEMARK INFRINGEMENT REMEDIES An owner of a Trademark may commence legal proceedings against a party which infringes its registration O A Suit for Infringement has to be filed before the District Court or the High Court (depending on the pecuniary jurisdiction) within whose territorial jurisdiction the cause of action has arisen. The Criminal Remedies available are that a suit for the above offences can be filed before the magistrate within whose territorial jurisdiction the offence is committed or Police can register an FIR and prosecute directly; (statutory requirement to obtain the Registrar's approval). COPYRIGHT INFRINGEMENT REMEDIES A Suit for Infringement of copyright has to be filed in a District Court or a High Court (depending on the pecuniary jurisdiction) within whose territorial jurisdiction the cause of action has arisen. There are also Administrative Remedies available to the copyright, trademark and patent which include ban of import or export of goods including protection of patents, trademarks and copyrights confiscation of infringing material by Excise Authorities and delivery to the owner

21. ROLE OF IP IN PHARMACEUTICAL INDUSTRY Intellectual Property is essential for the continued innovation of new medicines, and holds utmost importance in the pharmaceutical industry, explained in the points mentioned below. PROTECTION OF MEDICAL INVENTION Once a person or a company has designed or developed a new drug or medical treatment, they must protect it either by filing a  Patent Application  or by keeping it as Trade Secret. However, in the case of trade secrets, a drug can be reverse-engineered, leading to the invention getting stolen, whereas a patent offers much more watertight protection. DRIVES ECONOMIC GROWTH AND COMPETITIVENESS Intellectual Property leads to the significant economic growth of a pharmaceutical company by awarding the sole intellectual property rights to the inventor of a medication or treatment. All the marketing rights of the invention lie solely with the inventor with further options of even selling or licensing it. PROTECTION OF CONSUMERS AND FAMILIES In the pharmaceutical industry, Intellectual Property’s main interest lies in public safety as it helps the consumers in making the right choice while selecting a medical product. Intellectual property rights help in ensuring a standard by assuring quality, which further establishes a reliable and effective public health infrastructure.

22. PROTECTION AGAINST POTENTIAL INFRINGERS Intellectual property rights allow pharmaceutical companies to take strict actions against counterfeit drugs. Without such rights, countries across the globe would have a difficult time in ensuring the safety of their medical inventions. GENERATE SOLUTIONS TO GLOBAL CHALLENGES Promoting innovation is very important but at the same time you need funding to do it. IPR gives you the right encouragement to do it. There is a need for developing new drugs and vaccines as there are new diseases being discovered daily or there is resistance development by the pathogen.

23. ENCOURAGE INNOVATION AND REWARD ENTREPRENEURS It is very important that the right push is given for inventors to keep them motivated. It is also important that they are recognized for their work. IPR gives them this encouragement. It enables a free flow of information by enabling a safe environment. When you know it is safe to share your invention then there is going to be a safe channel for exchange. BOTTOM LINE The pharmaceutical industry should make sincere efforts to manage their IP Rights rather than just acquiring them from the national or regional IP Offices. It is a matter of fact that yes; Patent and Trademark Rights are not of much worth unless they are adequately exploited. Enterprises in the pharmaceutical industry should extract full value from their IP assets and medical inventions by taking adequate steps to develop an IP strategy for dealing with possible infringers. Therefore, enforcement of IP Rights is crucial to ensure that their intellectual property is respected in the marketplace.