<h5 id="131-concept-of-entrepreneurship">13.1 Concept of Entrepreneurship</h5> <ul> <li>The term “entrepreneur” comes from the French word “entreprendre” meaning “to undertake”. It refers to an individual who starts and manages a business, undertaking risks and seeking profits.</li> <li>Entrepreneurship involves three prominent roles: innovator, organizer, and risk bearer. Entrepreneurs bring new products to the market, organize factors of production, and shoulder uncertainties associated with the venture.</li> <li>Howard Stevenson (1983) defined entrepreneurship as the process by which individuals pursue opportunities without regard to the resources they currently control.</li> <li>Debbie Roxarzade, founder and CEO of Rachels Kitchen, described entrepreneurship as a persistent progression towards an innovative solution to a key problem and a constant hunger for making things better.</li> <li>Bruce Bachenheimer, Clinical Professor of Management, described entrepreneurship as a mindset that involves imagining new ways to solve problems, recognizing opportunities, and methodically analyzing them to capture their value.</li> <li>James Bedal, CEO of Bare Metal Standard, stated that a successful entrepreneur must have a passion for learning from customers, employees, and even competitors.</li> </ul> <p>======</p> <h5 id="1311-importance-of-entrepreneurship">13.1.1 Importance of entrepreneurship</h5> <ul> <li>Entrepreneurship plays a crucial role in economic growth and development.</li> <li>Entrepreneurs are responsible for capital creation, bringing together resources of people, and introducing new products in the market.</li> <li>They are significant employment creators, leading to increased standard of living and purchasing power of people.</li> <li>Entrepreneurship promotes overall development of the community, leading to stability and higher quality of life.</li> <li>It is a key driver for social change and community development, especially in the form of self-employment and start-ups.</li> </ul> <p>======</p> <h5 id="1312-qualities-of-a-successful-entrepreneur">13.1.2 Qualities of a successful entrepreneur</h5> <ul> <li>Successful entrepreneurs take initiative and endure struggles to launch new ventures, as seen with Dr. Krishna Ella and Bharat Biotech International Ltd.</li> <li>They possess relevant knowledge and skills related to their industry, economy, consumer choices, technology, and future growth prospects.</li> <li>Entrepreneurs are risk-takers, ready to withstand short-term risks for long-term success, as demonstrated by Dr. Ella’s development of COVAXIN® in eight months.</li> <li>Adaptability is a key quality, as entrepreneurs must monitor and adapt to changing business environments.</li> <li>Self-confidence drives entrepreneurs to make decisions with conviction, enabling them to take risks and succeed.</li> <li>Entrepreneurs are wealth creators, providing valuable employment opportunities and contributing to the economy, as exemplified by Bharat Biotech’s 4 billion doses of human vaccines.</li> </ul> <p>======</p> <h5 id="1313-difference-between-entrepreneur-and-intrapreneur">13.1.3 Difference between Entrepreneur and Intrapreneur</h5> <ul> <li>Entrepreneur and intrapreneur share similar values of innovation and creativity.</li> <li>An entrepreneur is a person who starts a business venture to earn profit by identifying opportunities for products and services and coordinating with factors of production.</li> <li>An intrapreneur, however, is an employee within an organization who promotes innovation among other employees.</li> <li>Intrapreneurs are hired to bring about success in a business venture.</li> <li>While entrepreneurs take personal risks in starting their own business, intrapreneurs operate within an established organization.</li> </ul> <p>======</p> <h5 id="1314-planning-and-resourcing-an-enterprise">13.1.4 Planning and Resourcing an Enterprise</h5> <ul> <li>The feasibility report is a crucial step in starting a new business venture to evaluate the business idea and confirm its validity.</li> <li>The preparation of the feasibility report involves a preliminary analysis of the product, service, activities, target market, and competition.</li> <li>A projected income statement is prepared considering direct and indirect costs and anticipated income growth curve.</li> <li>A market survey is conducted to define geographic influence, analyze environmental factors, competitors, market share, and expansion opportunities.</li> <li>The business organization and operation structure are planned in detail to determine technical feasibility, start-up costs, fixed investment, and operation costs.</li> <li>An opening day balance sheet is prepared to reflect the assets and liabilities of the proposed venture accurately.</li> <li>The data is reviewed and analyzed to evaluate the risks and contingencies before making a decision to proceed with the business idea.</li> </ul> <p>======</p> <h5 id="132-sources-of-funds">13.2 SOurces of Funds</h5> <ul> <li>A startup is a private limited company or registered partnership/LLP, with less than INR 100 crores turnover, up to 10 years old, working towards innovation and employment generation.</li> <li>Seven sources of financing for startups are: <ol> <li>Personal investment: Entrepreneur’s own money, showcasing commitment.</li> <li>Venture capital: Investors in high-growth potential tech firms, taking equity for high returns.</li> <li>Angel investors: Wealthy individuals investing money, ideas, and experience in promising startups.</li> <li>Business incubators: Investors supporting high-tech sectors, providing support in development stages.</li> <li>Government grant and subsidy: Financing from government agencies to promote business.</li> <li>Bank loans: Most common funding source, requiring a good idea, appealing business plan, and personal guarantee.</li> </ol> </li> </ul> <p>======</p> <h5 id="133-entrepreneurship-in-biotechnology">13.3 Entrepreneurship in Biotechnology</h5> <ul> <li>Biotechnology entrepreneurship involves creating value through innovative biotechnological applications.</li> <li>It requires a deep understanding of both the scientific and business aspects of biotechnology.</li> <li>The biotechnology industry has unique challenges, such as lengthy and expensive research and development processes, high regulatory hurdles, and substantial initial investment requirements.</li> <li>Successful biotechnology entrepreneurs often have a strong scientific background, a clear vision for their technology’s application, and the ability to attract funding and build a strong team.</li> <li>They must also be skilled in navigating the complex regulatory landscape and protecting intellectual property.</li> <li>Equation: Not applicable in this text.</li> </ul> <p>======</p> <h5 id="1331-significance-of-biotechnology-entrepreneur">13.3.1 Significance of Biotechnology Entrepreneur</h5> <ul> <li>Biotechnology entrepreneurship involves building and sustaining an enterprise based on biotechnological innovation, combining science and business.</li> <li>Biotechnology is defined as the use of living organisms or parts of living organisms through biological processing to develop new products or provide new methods of production (Hine & Kapeleris, 2006).</li> <li>Bio-entrepreneurship is the process of creating value from life science innovation, moving a life science discovery or invention from the research phase through development to a commercial market (Meyers, 2008).</li> <li>Biotech entrepreneurs are innovators with a vision, motivated by solving real-life problems, altruism, and financial rewards, starting companies to impact lives positively.</li> <li>Biotech entrepreneurs are the backbone of the biotech industry, commercializing life-saving medical products, advanced fuels, and efficient crops through biotechnology enterprises.</li> </ul> <p>======</p> <h5 id="1332-assimilation-of-two-distinctly-different-disciplines">13.3.2 Assimilation of two distinctly different disciplines</h5> <ul> <li>Competitiveness is crucial for success, and taking calculated risks with perseverance is essential.</li> <li>Teamwork is necessary, and having experienced teams is vital.</li> <li>The gestation period varies, usually being high for most types of enterprises.</li> <li>Capital requirements are significant, typically high depending on the enterprise type.</li> <li>The relevance of academic qualifications is moderate to negligible, while the regulatory framework is moderately complex, often high.</li> <li>Business uncertainty is present, carrying inherent scientific uncertainty, unlike other types.</li> </ul> <p>======</p> <h5 id="1333-process-of-starting-a-biotech-enterprise">13.3.3 Process of starting a Biotech enterprise</h5> <ul> <li>Conducting a thorough need assessment of the market demand for the biotech product is crucial. The entrepreneur must ensure there is a real market need and the technology is protected by intellectual property rights.</li> <li>Identification of like-minded founders and key personnel with expertise in diverse disciplines is necessary. This group is indispensable to the success of the entrepreneurial idea.</li> <li>A legal expert is a key partner to help the entrepreneur move through corporate and business issues during all stages of establishing and growing the company.</li> <li>It is advisable for biotech startups to incorporate as a Private Limited Company under the Companies Act 2013 due to the high capital investment and gestation period required.</li> <li>Designing a well-designed business and marketing strategy is essential to raise money. The strategy must clearly describe the market problem, product solution, revenue generation, fund utilization, and expected return on investment.</li> <li>After raising seed capital, the focus should be on technology development. Consistent innovation in the key product is vital to keep market sentiments positive and establish and grow the biotech enterprise.</li> </ul> <p>======</p> <h5 id="134-concept-of-ipr">13.4 Concept of IPR</h5> <ul> <li>The concept of Intellectual Property Rights (IPR) is crucial in modern biotechnology.</li> <li>TRIPS Agreement of WTO gave IPR legal authority on international level.</li> <li>IPR includes copyrights for artists, musicians, computer programmers, performers, traders, manufacturers, designers and inventors.</li> <li>It also includes rights of plant breeders, farmers, biological diversity and computer technologists.</li> <li>IPR extends to protection of undisclosed information on technology and management for businessmen.</li> </ul> <p>======</p> <h5 id="1341-the-aspects-of-ipr-involved-in-biotechnology">13.4.1 The aspects of IPR involved in Biotechnology</h5> <ul> <li> <p>The Patents Act of 1970, amended several times to comply with international agreements like TRIPS, allows for process patents in areas such as drugs, medicines, food, and chemicals. Post-2005 amendment, product patents are also allowed in biotechnology, chemicals, and pharmaceuticals.</p> </li> <li> <p>Plant Breeder’s Rights (PBRs) provide exclusive commercial rights for 20-25 years for new plant varieties, provided they are novel, distinct, uniform, and stable. This protection prohibits unauthorized growing or selling of the variety without permission, with exceptions for research and farmer’s seed saving.</p> </li> <li> <p>A trademark is a graphically representable mark that distinguishes goods or services. Two essential requirements for trademark registration are the mark’s graphical representation and its ability to distinguish goods and services from others.</p> </li> <li> <p>Copyright is a right granted to creators of literary, dramatic, musical, and artistic works, as well as producers of cinematograph films and sound recordings. It includes reproduction, communication to the public, adaptation, and translation rights, with specific exceptions for research, private study, criticism, review, reporting current events, judicial proceedings, and performances by amateur clubs or societies.</p> </li> <li> <p>Trade Secrets are protected in India through common law principles, as there is no specific legislation for trade secret protection. They can be protected through contractual means, such as restrictive covenants and non-disclosure agreements, and by actions against misappropriation under common law.</p> </li> </ul> <p>======</p> <h5 id="135-biopiracy">13.5 Biopiracy</h5> <ul> <li>Biopiracy is the commercial exploitation of naturally occurring biochemicals or genetic materials.</li> <li>Traditional knowledge relevant to global survival includes farming, medicinal plants, and varieties of food crops.</li> <li>Examples of biopiracy include the patenting of Neem tree of India by the European Patent Office in 1995, and the patenting of the use of Turmeric in wound healing by the US Patent Office in 1995.</li> <li>The patent for Neem was revoked in 2000 and the patent for Turmeric was revoked in 1997 due to existence of prior art.</li> <li>RiceTec Inc was granted a patent by the US patent office to call the aromatic rice grown outside India ‘Basmati’ in late 1997, but all the patent rights were rejected.</li> <li>Traditional Knowledge Digital Library (TKDL) has been set up in India to prevent the misappropriation of country’s traditional medicinal knowledge at International Patent Offices.</li> </ul> <p>======</p>