A Detailed Review on Intellectual Property Rights
Rushikesh Bachhav1, Rutuja Deore1*, Mayur Bhamare3, Khemchand Surana2,
Chandrashekar Patil3, Sunil Mahajan3
1Department of Pharmaceutical Quality Assurance, SSS’s Divine College of Pharmacy,
Nampur Road, Satana, Nashik, Maharashtra, India – 423301.
2Department of Pharmaceutical Chemistry, SSS’s Divine College of Pharmacy,
Nampur Road, Satana, Nashik, Maharashtra, India – 423301.
3Department of Pharmaceutics, SSS’s Divine College of Pharmacy,
Nampur Road, Satana, Nashik, Maharashtra, India – 423301.
*Corresponding Author E-mail: rutujadeore36@gmail.com
ABSTRACT:
The term "intellectual property" includes the development of innovationsworks of literature and art, as well as trade names, emblems, and images. Intellectual property rights, or IPRs, are ideas, innovations, and creative expressions that the public is willing to recognize as property. IPR give the property's inventors or creators certain exclusive rights, enabling them to make money off of their creativity or good reputation. symbols, and images used in trade, are included in the term intellectual property (IPR). Intellectual property rights, or IPRs, are ideas, innovations, and creative expressions that the public is willing to recognize as property. IPR give the property's inventors or creators certain exclusive rights, enabling them to make money off of their creativity or good reputation. Intellectual property rights can be compared to traditional property rights. They enable those who have created something or invested in something to profit from their own labor or ownership of a patent, trademark, or copyrighted work. A multitude of laws, such as those pertaining to patents, copyright, trademarks, and other intellectual property, safeguard it. Article 27 of the Universal Declaration of Human Rights provides for the protection of material and moral interests arising from research, literature or the writing of good results. Any mental works, including innovations, literary and creative compositions, designs, names, symbols, and images used in trade, are included in the term intellectual property (IPR). Patents are granted to inventions that meet the criteria of usefulness, nonobviousness and worldwide originality. Intellectual property (IPR) is important for research, planning, marketing, processing and protection of production or ideas. Every business needs to have its own intellectual property rights, management, strategies and other content based on its own expertise.
KEYWORDS: Copyright, Trade secrets, Indian Patent Office, Patents, Intellectual property rights.
INTRODUCTION:
Intellectual Property" (IP) refers to the exclusive rights related to intellectual property. Intellectual property law protects assets such as inventions, writings and drawings, designs, phrases, symbols and images. This protectionis provided by various intellectual property rights, including patents, trademarks, designs and certificates, which also allow the owner to make money or become famous for their work.
Intellectual Property (IP) is intellectual property that includes intangible creations of human intelligence. Intellectual property comes in a variety of forms, and some nations recognize it more than others. Trade secrets, patents, trademarks, and copyrights are the most well-known categories. Although the phrase "intellectual property" was first used in the 19th century, most legal systems throughout the world did not accept it as customary until the late 20th century.
Promoting the development of a diverse range of intellectual commodities is the primary goal of intellectual property law. The law allows people and organizations to do this by granting them property rights, usually for a limited period of time, over the knowledge and innovative goods they create. This gives people an economic incentive to create information and intellectual products since it makes it possible for them to profit from them.
Depending on the level of protection offered to innovators, it is anticipated that these financial incentives will encourage innovation and advance national technology.
Objectives:
· To heal their IPR and propose innovative ideas, people need to be motivated.
· It adds to the advancement of technology.
· Preserve each person's freedom to free speech.
· In the end, it serves the public interest.
· People need to receive incentives through IPR.
The Origins of IPRs:
The concept of intellectual property emerged as early as 500 BC. The Greek province of Sybaris was where it all began, allowing its citizens to apply for patents for “any new luxury development.” Since then, progress has been made and the complexity of business and law has increased. But the primary purpose of the law has not changed. These laws are designed to support inventors and allow innovators to make money from their original ideas.IPR is not a novel concept.
IPR is thought to have originated in North Italy in the Renaissance. A rule governing patent protection that gave the owner an exclusive right was passed in Venice in 1474. The printing press, which Johannes Gutenberg invented in 1440 A.D., had movable and replaceable wooden or metal letters. This is the original source of copyright. Some countries were forced to pass legislation protecting intellectual property rights in the latter half of the 1800s. The two international agreements that serve as the foundation of the intellectual property rights (IPR) system are the Berne Convention for the Protection of Literary and Artistic Works (1886) and the Paris Convention for the Protection of Industrial Property (1883).
Intellectual Property Rights' Importance:2,3
Every business entity places a high priority on intellectual property. A corporate organization should be committed to finding and putting into practice IP solutions since doing so will enable it to grow to new heights of success. The idea that IP assets can only be handled or dealt with by attorneys is untrue because managing and strategically utilizing a company's IP assets is critical to its ability to establish itself as a market leader. It is now essential for sustained competitiveness to have the knowledge and abilities needed to manage intellectual property assets. To manage and commercialize these assets and make money, management professionals are the most qualified candidates.
Nowadays, a key differentiator that sets businesses apart from their rivals is knowledge. The twenty-first century is known as the century of knowledge. According to Henry Ford, a man's knowledge base provides the only true security he has in the modern world. But it is crucial that this reservoir be safeguarded by different intellectual property rights protections. Intellectual property (IP) assets are crucial corporate resources that must be properly used and maintained in order to gain and maintain a competitive edgeIntellectual property owners have the right to exclusive use of their brand, innovative, new, and unique products, as well as creative designs.
The exclusivity offers a suitable incentive for making investments to raise their level of competitiveness. Through its trademark, a corporation cultivates significant goodwill with customers. The trademark serves as an assurance of quality and is the source of some very valuable goods and services. Clients or customers view a trademark or brand as a direct representation of the owner. For businesses in the media, film, and creative industries, copyrights are an incredibly valuable asset since they help these businesses stay in business.-sharp rivalry. It’s common knowledge that having intellectual property gives you a competitive edge when forming commercial alliances.
The sale of protected goods or services, franchising, and licensing are some of the ways that the asset class of intellectual property helps businesses make money. Protected intellectual property assets greatly raise the worth of a corporation in the event of a merger or purchase. It is also clear that intellectual property is important in export markets. Exporting assets protected by intellectual property or pursuing franchise partnerships with overseas businesses are two options. It is important to remember that the top three companies in the world, Apple, Microsoft, and Blackberry, are valued at billions of dollars, and they have amassed substantial intellectual property that has allowed them to create a strong revenue stream. A robust intellectual property portfolio can yield the greatest benefits and be leveraged to generate additional cash through licensing.
Due to rapid development, globalization, technological advancement, increase in the market, growth of international trade and finally increase in knowledge, business organizations have now realized the importance of intellectual assets and their role in development.
There is a certain class of assets that are vital for the basis of the business and no longer only add exclusivity to the organization; understanding their significance and need is required for the firm to thrive and expand at the intended rate. To wrap up, it would be appropriate to quote renowned the growth of every company organization is directly proportionate to Intellectual Property, as noted by American businessman Mark Getty.
"The 21st century equivalent of oil is property. Take a look at the wealthiest individuals a century ago; they were all involved in the extraction or transportation of natural resources. The wealthiest men of today have all made their fortunes on intellectual property.
Types of Intellectual Property:4,5
· Trade secret
· Patent
· Copyright
· Trademark
· Industrial design
· Geographical indication
Patent:6
It is defined as "a government agency or license that grants rights or rights to its members for a specified period of time, especially the right to prohibit others from making, using, or commercializing a product."When a person or organization creates a new method or invention, they go to the patent office, provide information about the process or product, and receive protection for their "goods" in exchange for value.This makes sense because these people put in years and a lot of money to build something, and they deserve payment for their work. Patents are a vital component of an innovative and expanding culture because they serve as a catalyst for the creation of new goods and methods. Patent protection is granted for a finite amount of timeten or twenty years.
An invention can only be made, used, or sold by the patent holder for a restricted amount of time. In return, the patent holder must publish an enabling disclosure of the invention. Most nations classify patent rights as To enforce their rights under private law, patent holders must file a lawsuit against those who infringe upon their patent. Patents are a necessary tool for gaining a competitive advantage in some businesses, but not in othersNational laws and international agreements state that the procedures for patent issue, The scope of liability and specific rights of patent owners vary from country to country. However, in general, a patent application must contain one or more claims that define the type of protection sought. A patent contains multiple applications, each representing a different type of copyrighted product. The World Trade Organization (WTO) TRIPS Agreement states that all works are patentable as long as the production of the work is new, constitutes an inventive step, and has commercial utility. Everyone should be comfortable in WTO members. However, even among WTO members, countries have different definitions of patentable content. TRIPS (TradeRelated Aspects of Intellectual Property Rights) provide protection for a minimum of twenty years.
Different types of Patents:7
Utility Patent:
Utility patents are those that cover the functional portion of the invention—that is, the part that is covered by the patent. New and useful machines, processes, compounds, or any improvements to already-existing machines, processes, or compounds may be covered under utility patents. Depending on the invention, these patents might be further categorized into mechanical, software, chemical, electronic, or any other discipline.
Design Patent:
Patents pertaining to an object's look, form, or arrangement are known as design patents. It is crucial that the thing incorporates this new design completely.
Plant Patent:
As the name suggests, patents for plants are used to safeguard novel and distinctive plant varieties. As the name suggests, patents for plants are used to safeguard novel and distinctive plant varieties. [1] This is the privilege granted to farmers for the advancement, preservation, and accessibility of plant genetic resources (PGR), hence eliminating the need for farmers to constantly visit breeders. The Indian parliament passed the Conservation of Plant Assortment and Agriculturists Right Act 2001 (PPV & FR act) to assist to empower the advancement of a competent system for plant assortment conservation.
Advantages of Patenting:
· Patents provide the right to prevent others from copying, reproducing, selling or distributing an invention without the owner's permission.
· For a certain amount of time, protection is offered to keep competitors at bay.
· The inventor is able to provide licenses to third parties for the use or sale of his creation.
Patent protection strategies:
It is commonly acknowledged that the pharmaceutical industry is facing significant financial difficulties. Many popular medications are moving toward generic versions when their patents expire. There isn't enough new medication in the pipeline to close the gap and create a foundation for expansion in the future. Furthermore, a large number of the new medications are biologics, which have a significantly smaller target patient base and cost a lot more than regular pharmaceuticals. It is now necessary for pharmaceutical scientists to gain a deeper comprehension of the principles of patents. Analyses of significant legal and scientific difficulties that surfaced in recent Prozac and Prilosec patent infringement cases serve to highlight this necessity. In response to this situation, the pharmaceutical industry has taken steps to quicken the medication development process while also using various tactics to prolong the patent monopoly's lifespan, which will offer financial incentives and be used to further drug discovery and development.
Tradmark:8
A brand is any word, phrase, number, sentence, symbol, pattern, mark, scent, form, color, sound, volume, texture, or any combination of these elements that makes it easier for consumers to find a particular product or service the idea of a distinctive trademark is to enable customers to identify the maker of goods or, in the case of services, the service provider, with the mark. It aids in assuring clients that the products are of a specific caliber and kind. Additionally, it enhances the manufacturer's or service provider's reputation or goodwill. For example, a customer can quickly grasp that a new product bearing the mark below is owned by Apple Inc. This is the ability a symbol has to foster goodwill toward the owner of a trademark.
The Tata group of firms uses the family name TATA for branding. For instance, Nike Inc. is the proprietor of the renowned "NIKE" trademark for apparel, footwear, and athletic goods. Conversely, for hydraulic lifting jacks and other heavy gear, Nike Corporation has registered the trademark "NIKE." Nonethele Symbols like Mc Donald's golden arches also grew increasingly important.
Nowadays, trademarks registered in the name of a business owner can also be registered in the name of another person for a different product group within the same group., if a business or an individual so desires, they may preserve their brand throughout all classifications. A trademark application must be received by the national Trademark Office where the mark wants protection. The applicant also has to carefully choose under that particular trademark the goods or services he intends to employ. Crucially also is the trademark's registration in relevant commercial classes.
Copyright:
Copyright is the legal protection of "original" creative works or related rights of authors, writers, artists and publishers. Like patent law, the law is a reflection of democratic rights.
Copyright grants the only authority to market, distribute, and duplicate any creative work produced by the author, including plays, novels, music, artwork, and architecture. Copyright protects books, novels, stories, novels, poems, plays, newspapers, magazines, advertisements, films, computer programs, databases, music, songs, choreography, movies, paintings, drawings, photographs, sculptures, buildings, maps, and technical drawings. The range of work is quite wide.
When it comes to computer software, copyright does indeed begin at the moment the code is written. Nevertheless, if it develops a brand-new, unique procedure, it might be patentable. Similarly, the expression of speech or the image or the logo (as the case may be) cannot be protected by copyright; instead, it must be protected by commercial rights.
Tradesecret:9
One crucial area of IPR law is trade secrets. As the term implies, it alludes to a company's trade secrets that provide it a competitive edge over others. If the trade secret is revealed, the company could sustain significant financial losses as well as irreversible harm to its brand. Trade secrets can be any combination of proprietary data, formulas, compositions, processes, designs, methods, compilations, or private information that should only be used by the company.
Trade secrets can be protected without requiring registration. Trade secrets cannot be treated the same way as patents because once a patent application is filed, all claims and applications become public knowledge. A great example is the Coca-Cola formula. As we all know, Coca-Cola milk was not patented because doing so would have caused the milk to leak out. According to Coca-Cola executives, they were very selective about the recipe, the two employees who knew the recipe only knew half of it and no one knew the whole recipe.
Industrial Designs:10
In legal terminology, the ornamental or aesthetically pleasant elements of a product are known as its industrial design. An industrial design could feature two-dimensional lines, patterns, or colours or three-dimensional components like the form of an object.
Theoretically, the owner of a registered trademark or design patent can prevent third parties from producing, importing or selling products bearing or containing evidence of copying or protection if this action is taken for commercial purposes.
Industrial designs are used on a broad range of manufactured goods and handcrafted things, such as textiles, lighting equipment, jewelry, packages, containers, furnishings, and technological devices. Additionally, logos, graphical user interfaces (GUI), and graphic symbols may be related to industrial designs.
Geographical Indexes:11
A geographical indicator (GI) is a designation used to describe items with origin-specific qualities or reputation distinctive to that origin. A product cannot be GI unless it has a sign designating it as being from a particular place.
Geographical indication rights allow the trademark owner to prevent the use of the trademark by third parties whose products do not meet the required standards. For example, a producer of Darjeeling tea cannot use the word "Darjeeling" to refer to tea grown outside its tea district or established under the Geographical Indications Code of Practice in the country where Darjeeling is a protected area. India also acted in 1999 when Parliament passed the Geographical Indications of Goods (Registration and Protection) Act.
The Act's main goal is to safeguard our nation's priceless geographical indicators. Only authorized users and geographical indications registered under the Act are eligible for protection under the Act. According to the Act, any group of people, producer, organization, or legal authority that represents the interests of the makers of commodities may register a geographical indication. One could contend that this regulation allows traditional knowledge holders to register and preserve their expertise in commodities made and sold with geographical indications (Chauhan, 2012).
Indian patent law: how affected the pharmaceutical sector? What might china learn from india? Juan she:12
China and India, two countries with growing drug trafficking, need to find a balance between respecting intellectual property rights and meeting the medical needs of their people.
They should support local economic growth and encourage innovation. As WTO members, China and India have updated their intellectual property rights to meet the minimum protection requirements of the TRIPS Agreement.
These changes include the implementation of a compulsory licensing system and the recognition of patents for pharmaceutical products. China should pay close attention to India's legal and judicial practices in order to support the growth of its domestic pharmaceutical industry.
These strategies include using TRIPS flexibilities to ensure access to medicines, using compulsory licenses to increase voluntary licensing negotiation opportunities, and changes in the process of evaluating prescription drug applications to protect the green extension of medicine patents.
India signed the General Agreement on Trade and Industry (GATT) very early. However, it is clear that GATT benefits developing countries more than developing countries. Some developing countries, especially Brazil and India, requested that the United Nations World Intellectual Property Organization (WIPO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) be the venue for resolving issues related to the protection of cultural heritage during the Uruguay Round negotiations. Conference on Trade and Development (UNCTAD). India argued that countries at different stages of development have the right to decide whether to grant patents for certain products, and during the negotiations it decided to join the newly established World Intellectual Property Organization (WTO). After the TRIPS agreement came into force on January 1, 1995, India had to give up some of its long-held intellectual property rights to comply with its WTO membership. As a developing country, India has a five, year transition period3 and an additional five years to update its patent laws regarding patent protection. The following is an analysis of the impact of the TRIPS Agreement on the Indian pharmaceutical patent system based on the amendments made to the Indian Patent Law in 1999, 2002 and 2005.
Amendment in 1999: Increased Exclusive Marketing Rights in Transition Period:13,14
Article 70.8 of the TRIPS Agreement requires countries that have not obtained patent protection for pharmaceutical and agrochemical products when the WTO Agreement enters into force to apply for patents for the product created from that date. This means that the patentability provisions of the TRIPS Agreement will be applied as they were in the member countries from the application date, thus ensuring the blocking of patent protection during the patent period. Preserve the uniqueness and importance of these practices. Sometimes called the "letter box" process, developing countries have used this process during the transition periods. Also, according to Article 70.9 of the TRIPS Agreement, although direct patent protection is not mandatory, pharmaceutical products and agrochemicals will have exclusive commercial rights during the transition period. However, this requires that these products have applied for patents after complying with the WTO agreement and have received marketing authorization from other members. The Patents (Amendment) Act, 1999 was passed on 26 March 1999 and the TRIPS Agreement came into force on 1 January 1995. Article 4 of the Act provides for exclusive control over private commercial printing.
Amendmentin 2002: Wide-Ranging Changes to meet the trips standards:
The Patents (Amendment) Act, 2002 was passed on June 25, 2002 and came into force on the date specified by the Government in a notification issued in Parliament. Different dates are given for different sections of the Bill. Many provisions of the Patents Act, 1970 have been amended to meet the TRIPS standards. These regulations have had a major impact on patent medicine in India; they define inventions, explain the purpose of patent protection, specify the conditions for patenting, explain the application process and grant compulsory licenses. The TRIPS Agreement clearly states that any invention (product or process) in any field can be patented provided it is a new step, novel and capable of doing business. This includes the concept of "invention" in patent law.
The Amendment of 2002 thus defines an invention as a novel process or product with an inventive step that can be applied in industry.
It also defines an inventive step as a feature that prevents an individual versed in the art from seeing the invention immediately.
Amendmentin 2005: Comprehensive Improvement Before the Expiration of Transition Period:15
The "Patents (Amendment) Act, 2005", promulgated on 4 April 2005, will come into force on 1 January 2005, the date on which the transition period will end in India will be determined by the centre on the last day of certain Special rules of the state. The 2005 Amendment is needed if India wants to fulfill the TRIPS agreement. The most significant change from the amendment is Section 5 of the Patents Act, 1970, which provides that no patent shall be granted for a claim for any product, food, drug or medicinal preparation or potentially any product, food, drug or medicinal preparation applicable to or affecting products prepared or manufactured by chemical substances or processes. The amendments also repeal Part IVA "All Business Acts", amended in 1999.This means that, once the transition period ends, patents for all inventions in all technical fields will be issued for all whether they are processes or products, in compliance with the TRIPS requirement. Important changes were also made to the provisions pertaining to forced licenses by the Amendment. First, the Amendment made it necessary to have a license in order to export patented medicinal items under specific special conditions.
The Effect of Indian Patent Law on the local Pharmaceutical sector rejection of product patent:16
Under Shri Justice N. Rajagopala, the 1959 Patent Law Amendment Commission report on the reform of the patent law Ayyangar noted that between 80% and 90% of India's patents at the time belonged to foreigners, and 90% of the patented goods were not produced within the country. The Indian domestic pharmaceutical sector may stagnate as a result of foreign businesses preventing the manufacture of their copyrighted medications in India. Therefore, the Commission believes that multinational companies, especially in the pharmaceutical, medicine and food industries, do business through the patent process. High prices are also a result of monopoly. Therefore, unlike the Indian Patents and Designs Act, 1911, which granted patents to product and process inventions in the pharmaceutical industry, the committee agreed that only the method or process in a particular field should be patentable. The Patents Act, 1970 followed these recommendations and laid the foundation for the current growth of the Indian pharmaceutical industry. As per the Patents Act of 1970, claims pertaining to substances that are made or produced by chemical processes, or that are intended for use as medicine or drugs, are not eligible for patent grants. Because product patents can hinder related research by preventing others from obtaining the same products via different means, the Patents Act of 1970 exclusively provides method patents in the pharmaceutical and chemical industries. Drug patent holders have the ability to control the manufacture of their patented products, which leads to the unjustifiable increase in the cost of necessary medications. As a result, the drug product patents were rejected, ensuring that generic medicine manufacturers in India could employ reverse engineering to create medications with an identical or comparable composition without facing infringement charges. India withheld product patents from the pharmaceutical industry until the TRIPS Agreement’s transition period ended. 1 January 2005. The pharmaceutical industry's more than 30-year history of rejecting product patents has made room for the growth of the generic medication market in India.
Mailbox Application Mechanism:17
India was able to accommodate its own development demands in addition to meeting TRIPS requirements during the transition period because to the mailbox application process. India has from 1995 to 2005 as its transitional time to comply with the pharmaceutical-related TRIPS commitments.
Applications for drug applications for the pharmaceutical sector can be sent and received through the mailbox, but under the 1999 amendment these applications will not be processed until January 1, 2005. Before 2005, regional pharmaceutical companies were allowed to withdraw top drug manufacturers to produce low-cost products for the local market and export to Russia, China, Brazil and Africa. Indian pharmaceutical companies trained their own technical staff and gained a great deal of experience in the process of making generic pharmaceuticals. Indian domestic pharmaceutical companies formed alliances with one another during the transition period in order to carry out research and development and produce drugs for international pharmaceutical companies. The pharmaceutical business in India expanded quickly, leading some regional enterprises to conduct research and development on medical products and file applications for drug patents in the US and EU.
Compulsory Licensing System:18
Originally included in the Patents Act 1970, the Patents (Amendment) Acts 2002 and 2005 improved the process by explicitly integrating patenting. The success of voluntary license negotiations between indigenous Indian pharmaceutical companies and foreign multinationals is increased by the mandatory licensing regime. According to the Indian Patent Law, three years after the date the patent was sealed, any interested party could ask the Controller.
Prior to requesting a forced license, the applicant must try to secure a voluntary license from the patent holder. The applicant may apply for a compulsory license if, after six months of the initial request, this endeavor fails to materialize.
Interpretive Reading of Patentable Subject Matter:19
The flexibility in interpreting patentable subject matter gives Indian generic medicine companies chances to increase their portfolio of pharmaceutical patents. The TRIPS Agreement provides leeway for interpretation on what constitutes a patentable invention; the term "invention" is not defined there. According to the Indian Patent (Amendment) Act, 2005, any new form of an approved drug which does not provide improved efficacy is not eligible for patent protection. With this amendment, it will be easier to fight for a patented drug in India. Novartis v. Union of India CFO rejected the patent application for Gleevec. This rejection was later upheld by the IPAB and the Supreme Court, which noted that the patent violated Section 3(d) of the Patent (Amendment) Act, 2005. According to Section 3(d), information about medical advances can only be patented if it increases therapeutic efficacy. The Supreme Court of Appeals explained that the molecule Novartis was trying to patent was different from the famous drug imatinib. Novartis, however, did not offer evidence showing how therapeutively effective the unrefined form of imatinib and the final Gleevec version varied. Rejecting patents was considered as a quick approach to stop the greening of drugs and to support local drug stores.
What Could China Learn from India?
To Prepare the Domestic Pharmaceutical Industry by Fully Utilizing the TRIPS Exceptions. Lawyers with an awareness of international regulations. Steps to develop generic drugs and encourage drug innovation.11
Historical Development of the Patent System of India and Its Effects on Indian Pharmaceutical Industry Innovation Uday R. Racherla Politicians, scholars, and business leaders all agree on the vital part innovation plays in long-term economic development, competitive advantage, and value creation. The information economy formed the basis for globalization, so chances for innovation in the production of value-added goods, services, and processes have grown worldwide to meet the growing needs, wants, opportunities, and challenges of the planet.
As a result, a large number of people, businesses, communities, and countries are currently engaged in innovative projects. Therefore, policy makers have realized that the innovation environment determines whether innovation thrives or fails on a national and worldwide scale. Nonetheless, the nation's innovation ecosystem is dependent on three main elements: the business, policy, and technology environments.
Summary of Indian Pharmaceutical Industry Business Performance:
One unique worldwide participant in the pharmaceutical sector is India. First of all, India has a large pool of very talented engineers and scientists that might guide the industry in new directions and support its long-term goals, demands, and vision realization. With a US $33 billion valuation in 2017, the Indian pharmaceutical industry is now the top worldwide provider of affordably cost generic drugs.
As a result, medicines manufactured in India are exported to over 200 countries worldwide; the India Brand Equity Foundation (IBEF) reported that in 2016 17, around 40.6% of India’s pharmaceutical exports (worth US$ 16.8 billion) were sold to the Americas, followed by Europe (19.7%), Africa (19.1%) and Asia (18.8%). Indian pharmaceutical companies meet more than half of the world’s demand for various vaccines; they account for 40% of US drug demand and 25% of UK drug sales. India also supplies around 80% of the anti-HIV drugs needed globally to treat acquired immunodeficiency virus (AIDS). In 2017, the United States Food and Drug Administration (USFDA) approved 304 New Drug Applications (ANDAs) for Indian pharmaceutical companies.
In the field of biotechnology, India is also becoming more and more important. Biopharmaceuticals, bioservices, bioagriculture, bioindustry, and bioinformatics are all part of India's biotechnology sector. With an annual growth rate of approximately 30%, this sub-sector of Indian pharmaceutical companies is expected to have expanded to US$ 100 billion by 2025. Actually, the bio-pharma sector—which comprises diagnostics, vaccines, and treatments contributes US$ 1.89 billion, or a sizable portion of the industry's whole profits.
Investments, Mergers, and Acquisitions:20
There are significant investment potential in the Indian pharmaceutical sector due to the country's expanding middle class, rising demand for improved healthcare access, advancing medical facilities, and more health insurance penetration. As expected, the Indian government has amended its foreign direct investment (FDI) policy in the pharmaceutical industry, allowing immediate 100% FDI in medical device manufacturing, subject to certain conditions and restrictions. Data provided by the Department of Investment and Development (DIPP) shows that the Indian pharmaceutical industry received foreign direct investment (FDI) of US$ 15.59 billion in 17 years from 2000 to 2017. Investment in Indian pharmaceutical industry. US$ 396 million. In 2017, 46 mergers and acquisitions worth US$ 1.47 billion took place in India in the pharmaceutical industry.
Objectives and Priority of the Indian Patent System:
The Indian pharmaceutical industry understands the importance of innovation for revenue generation, competitive advantage and long-term success. Innovation in the pharmaceutical industry often means high risk, high performance. Innovation failures can jeopardize a company's survival, even while successful innovations can yield large returns on investment (ROI). Consequently, in order to generate large profits, provide shareholders with a steady return on investment, and achieve sustainable growth, Indian pharmaceutical businesses rely on innovative breakthroughs. However, the Indian government's policymakers rely on the patent system to guarantee that pharmaceutical advancements provide accessible healthcare and reasonably priced medications to all residents. Thus, innovative pharmaceutical businesses that can meet the requirements, desires, and difficulties related to healthcare for millions of Indians are going to be successful in addition to generating strong sales, profitability, market share, and growth. Put another way, countries like India try to strike a compromise between their economic objectives—which support the interests of pharmaceutical companies and their social objectives, which guarantee that all citizens have access to affordable treatment.
CONCLUSION:
Intellectual property should be managed with business and economics in mind. Different types of intellectual property require different methods, management, planning and strategies, as well as the involvement of experts from sectors such as science, engineering, medicine, law, legal, finance, business and economics. Each department should develop specific intellectual property rights, management standards, strategies, etc. based on its own expertise. The pharmaceutical industry is currently revising its intellectual property strategy. Finally, we would like to emphasize that intellectual property (IPR), the most important of which are copyrights, trademarks, patents and trade secrets, are financial assets.
As emerging nations, China and India must strike a balance between upholding the rights to intellectual property and meeting the healthcare requirements of their citizens. They must also support the growth of indigenous industries and foster innovation. protection, such as the acceptance of patents for pharmaceutical products and the implementation of a system of mandatory licensing. In order to stop the greening of pharmaceutical patents, it is important to support the growth of the local pharmaceutical industry and update the standards for reviewing pharmaceutical applications.
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Received on 04.01.2025 Revised on 18.01.2025 Accepted on 01.02.2025 Published on 03.03.2025 Available online from March 07, 2025 Asian J. Res. Pharm. Sci. 2025; 15(1):35-43. DOI: 10.52711/2231-5659.2025.00006 ©Asian Pharma Press All Right Reserved
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