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Questions and Answers
What does the term 'biotechnology' consist of?
What does the term 'biotechnology' consist of?
Biotechnology only focuses on living organisms.
Biotechnology only focuses on living organisms.
False
What is a primary purpose of biotechnology?
What is a primary purpose of biotechnology?
To develop products and/or services beneficial to human welfare.
The term biotechnology is derived from the Greek words for life, technology, and ______.
The term biotechnology is derived from the Greek words for life, technology, and ______.
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Match the following areas of biotechnology with their descriptions:
Match the following areas of biotechnology with their descriptions:
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Biotechnology is solely a part of the health sector.
Biotechnology is solely a part of the health sector.
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Which organization's meeting is referenced in relation to biotechnology statistics?
Which organization's meeting is referenced in relation to biotechnology statistics?
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What is the average cost of generating a single new drug?
What is the average cost of generating a single new drug?
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It takes approximately 15 years for a new drug to go from discovery to the marketplace.
It takes approximately 15 years for a new drug to go from discovery to the marketplace.
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What are the main phases involved in clinical trials for drug testing?
What are the main phases involved in clinical trials for drug testing?
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Novel foods must undergo a safety assessment before being placed on the EU market according to the ________ Regulation.
Novel foods must undergo a safety assessment before being placed on the EU market according to the ________ Regulation.
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Match the following regulatory entities with their area of regulation:
Match the following regulatory entities with their area of regulation:
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What is the first step in the drug development process?
What is the first step in the drug development process?
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Products considered 'substantially equivalent' can follow a simplified application procedure.
Products considered 'substantially equivalent' can follow a simplified application procedure.
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What two main agencies regulate drug approval in the US and Europe?
What two main agencies regulate drug approval in the US and Europe?
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What does Intellectual Property primarily refer to?
What does Intellectual Property primarily refer to?
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Industrial property rights and intellectual property rights are considered separate concepts worldwide.
Industrial property rights and intellectual property rights are considered separate concepts worldwide.
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What legal title confers the right to prevent others from commercially exploiting an invention?
What legal title confers the right to prevent others from commercially exploiting an invention?
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Intellectual Property seeks to protect _____ goods, which are products of human intellectual activity.
Intellectual Property seeks to protect _____ goods, which are products of human intellectual activity.
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Match the following types of Intellectual Property with their examples:
Match the following types of Intellectual Property with their examples:
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Which of the following is a requirement for an invention to be patentable?
Which of the following is a requirement for an invention to be patentable?
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A patent guarantees the invention will remain a secret for a specified period of time.
A patent guarantees the invention will remain a secret for a specified period of time.
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What is the primary purpose of intellectual property rights?
What is the primary purpose of intellectual property rights?
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____ refers to the exclusive rights granted for a certain period in exchange for invention disclosure to the public.
____ refers to the exclusive rights granted for a certain period in exchange for invention disclosure to the public.
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Which of the following best describes the role of the World Intellectual Property Organization (WIPO)?
Which of the following best describes the role of the World Intellectual Property Organization (WIPO)?
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What year was the first biotech IPO?
What year was the first biotech IPO?
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What was the first genetically engineered drug released?
What was the first genetically engineered drug released?
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Roche acquired Genentech for US$ 46.8 billion.
Roche acquired Genentech for US$ 46.8 billion.
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What are the primary focuses of agricultural biotech?
What are the primary focuses of agricultural biotech?
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Which color of biotechnology is associated with industrial processes?
Which color of biotechnology is associated with industrial processes?
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Roche acquired Genentech in _____ year.
Roche acquired Genentech in _____ year.
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Match the type of biotechnology with its primary focus:
Match the type of biotechnology with its primary focus:
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Companies involved in blue biotechnology often have low research and development costs.
Companies involved in blue biotechnology often have low research and development costs.
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What is a common funding source for biotech start-ups?
What is a common funding source for biotech start-ups?
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What major challenge do most biotech firms face compared to big pharma?
What major challenge do most biotech firms face compared to big pharma?
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Corporate spin-offs have a higher success rate than _____ spin-offs.
Corporate spin-offs have a higher success rate than _____ spin-offs.
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All biotech product candidates are considered significant for the company's success.
All biotech product candidates are considered significant for the company's success.
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What is the immediate consequence of product failures for biotech firms?
What is the immediate consequence of product failures for biotech firms?
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Which area does white biotechnology NOT focus on?
Which area does white biotechnology NOT focus on?
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Match the funding type with its description:
Match the funding type with its description:
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The product development process is essentially the same for both _____ and biotech firms.
The product development process is essentially the same for both _____ and biotech firms.
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Which of the following is NOT patentable?
Which of the following is NOT patentable?
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Aesthetic creations can be patented under the European Patent Convention.
Aesthetic creations can be patented under the European Patent Convention.
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What kind of practical invention may arise from a new scientific discovery?
What kind of practical invention may arise from a new scientific discovery?
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A discovery that a material is heat-resistant is not patentable, but a _____ incorporating the material may be patentable.
A discovery that a material is heat-resistant is not patentable, but a _____ incorporating the material may be patentable.
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Match the following patent categories with their descriptions:
Match the following patent categories with their descriptions:
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Which of the following statements is true?
Which of the following statements is true?
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An invention derived from a mathematical method can be patented.
An invention derived from a mathematical method can be patented.
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What must a discovery lead to in order for a patent to be granted?
What must a discovery lead to in order for a patent to be granted?
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Which of the following is NOT patentable under the European Patent Convention?
Which of the following is NOT patentable under the European Patent Convention?
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An invention must have a technical character to be patentable.
An invention must have a technical character to be patentable.
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What are the four criteria for patentability?
What are the four criteria for patentability?
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Products, substances, or compositions used in any method can be __________.
Products, substances, or compositions used in any method can be __________.
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Match the following patentable subject matters with their examples:
Match the following patentable subject matters with their examples:
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Which of the following databases can be used to search for patents in the USA?
Which of the following databases can be used to search for patents in the USA?
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It is possible to patent a treatment method for animals under the European Patent Convention.
It is possible to patent a treatment method for animals under the European Patent Convention.
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Name one type of invention that can be patented.
Name one type of invention that can be patented.
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Study Notes
Innovation and Creation of Businesses in Bioengineering
- Débora Ferreira & Salomé Duarte
- Department of Biological Engineering, University of Minho, Braga
- [email protected] ; [email protected]
Program
- The program outlines weekly topics and activities for a course on innovation and business creation in bioengineering.
- It details theoretical classes and practical class challenges.
- The schedule covers topics from introduction to the class, to intellectual property, market analysis, business models, and financial analysis.
- Practical exercises and discussions are part of the course.
BioBusinesses Regulation
- The slides emphasize the range of topics related to biobusinesses regulation, from DNA-manipulation, to genetic engineering, and plants and bacterial cultivation
- The word cloud includes concepts like: disorders, monoclonal, DNA, organisms, resistance, cells, manipulation, treatments, problems, diseases and genetico
Biotechnology
- Biotechnology is a science-driven industry sector
- It uses living organisms and their derivatives to produce products and processes.
- It is a multidisciplinary field
- It marshals concepts and methodologies across disciplines to develop beneficial products and/or services to human welfare
Biotechnology Industry
- One of the most research-intensive industries worldwide
- Requires extensive skills and technical knowledge
- Strong linkages with universities, and other companies in biotechnology
- Capital-intensive, with significant resources needed throughout an organization's life cycle
- Medium to very long product development times
- Necessitates ethical clearance, especially for animal or human testing
- Subject to strict regulations
- Intellectual property protection is crucial for success in biotechnology.
Biotechnology Timeline
- Summarizes significant breakthroughs, discoveries, inventors, and historical milestones in the field of biotechnology.
- Chronological milestones are presented on a timeline that includes major milestones from antiquity to the present era.
Biotech Startups & Emerging Companies
- A list of startups and emerging companies in biotechnology
- Includes companies in sectors like artificial intelligence, big data, gene editing, precision medicine, gene sequencing, biomanufacturing, synthetic biology, bioprinting, microfluidics, and tissue engineering
Top 10 BioTech Trends in 2025
- Lists the trending areas in biotechnology, based on predicted importance in 2025.
- Shows the percentage for each area
- The leading trends seem to be Artificial Intelligence, Big Data, Gene editing, Precision Medicine, etc
Biotechnology Types
- Categorizes different types of biotechnology activities/applications
- Classifies by the colors red, yellow, blue, green, dark, white, gold, and orange
Four Colors of Biotechnology
- Categorizes biotechnology into different areas via color-coding
- Red is for health and diagnostics
- White relates to industrial processes, like chemicals and products, or agriculture/environmental uses.
- Blue for aquaculture and marine biotech
- Green relating to agricultural biotechnology
Red Biotechnology
- Specializes in medicine and human health
- Including vaccines, medications, antibodies, genetic engineering for disease treatment
- Categorized as a heavily regulated sector.
- It includes high up-front development costs,
- FDA/EMA approval prior to market entry long time to market.
- High post-approval profit margins.
Market Red Biotechnology
- Dominated by Biopharmaceutical production
- Genetic engineering is expected to grow significantly
- APAC region predicted significant growth
- The market is concentrated with few key players
- The growth drivers are the rising need for biologic drugs, and personalized medicine
Humulin
- Human Insulin used to treat diabetes.
- Developed from recombinant DNA rather than solely from pig or cow pancreatic sources.
- Important historical step in biotechnology
Human Insulin Production
- A summary of how human insulin is produced using recombinant DNA technology.
- The process involves inserting human insulin-producing genes into bacteria.
- The bacteria then produce and secrete human insulin.
Genentech
- A biotech firm that partnered with Eli Lilly for the production of their product.
- Became the first biological company to do an IPO
- Developed and produced the first genetically-engineered drug.
- Its first drug release was human insulin
- Acquired by Roche in 2009
Green Biotechnology
- Focuses on agricultural processes.
- Seeks environmentally sound solutions.
- Involves plant genetic engineering (transgenic plants)
- Aims to mitigate climate change.
Global Agricultural Biotechnology Market
- Market growth will accelerate by 10% CAGR
- North America segment predicted the highest revenue contribution.
- Market is concentrated by a few large players
White Biotechnology
- Focuses on industrial processes.
- Uses enzymes and microorganisms to create products or processes.
- Produces a broad range of items, from chemicals to materials and fuels.
- Aims to reduce environmental impact and is an alternative to fossil fuels.
White Biotechnology Market
- Market size in 2023 and a predicted market size for 2030.
- Regional and application-wise breakdowns
- Key products such as foods and feeds, biomaterials, pharmaceuticals, biofuels, textiles, and biochemicals are highlighted
- Revenue contribution in 2023 for each segment
Blue Biotechnology
- The exploration and valorization of marine organisms
- Uses resources like algae, bacteria, fungi and invertebrates as raw materials.
- Involved in food production, energy, medicine, cosmetics, aquaculture, bioremediation and the chemical industry
- Characterized by high research & development costs
Blue Biotechnology Market
- Market will accelerate at 7% CAGR
- Health care predicted as a major driver of growth
- The growth is predicted to come largely from the Americas.
- Market is highly fragmented.
Colors of Biotechnology
- Categorizes biotechnology by its spectrum of application and practice
- Provides a breakdown of the 4 colors in biotechnology (red, blue, white and green).
- Demonstrates the variety of industries and applications involved in the field.
Patent for Invention vs Utility Model
- A comparison of patent types
- Shows how they differ based on novelty, inventive steps, and industrial aplicability
- Identifies the aspects of each patent that would give advantages or disadvantages depending on the goal.
Patents and the Idea of Property Protection
- Definitions associated with intellectual property (IP): concepts and types that are the foundation for ideas.
- Legal definitions associated with the concept, protection and exclusivity of ideas.
- Information on different forms of IP, such as copyright, trademarks, and patents
Intangible Assets
- A breakdown of tangible goods and intangible goods
- Categorizes intellectual property as a type of intangible asset.
- Covers the topic of legal protection of original creations in the form of copyrights, trademarks, patents, industrial secrets, and geographical indications.
Patents: These are not patentable
- A list of various aspects that aren’t patentable, such as scientific theories, mathematical methods, presentations, aesthetic creations, or projects related to gambling.
Regulation-Drugs
- FDA (Food and Drug Administration) / EMA guidelines and functions
- Testing guidelines and processes for pharmaceuticals and other drugs
- Overview of the three testing phases for drug candidates
New Drug Approvals
- A list of FDA and EMA drug approvals.
- A figure that shows the estimated sales in US Dollars of new drugs
Regulation-Food
- Rules for novel foods and ingredients in the EU
- Overview of how the safety of novel-foods is assessed to permit market entry.
Other Heavily Regulated Sectors
- A breakdown of other heavily regulated sectors
- Examples such as automobiles, cosmetics, medical devices, chemicals and construction.
University-Industry Interactions
- Role of universities in economic development, particularly in technology
- Mechanisms of knowledge generation, exploitation (transfer/sharing) within a social, political and financial/economic context.
- Access to scientific breakthroughs and how this contributes to development and activities
- Issues like risk sharing, access to resources and equipment are also noted
Technology Transfer
- Role and workings of technology transfer entities
- The functions of universities’ research organizations, licensing, and the creation of new companies to leverage research findings and IP
- The relationship between R&D, Technology transfer, and the market.
TecMinho
- Organization and ecosystem, including the University of Minho’s Innovation and entrepreneurship ecosystem.
National Framework
- The framework of initiatives underlining the Portuguese GAPI Network, and underlying organizations supporting industrial property.
- The partnership with 22 national entities for GAPI's work.
- The role of universities, technology centers, science and technology parks, and business associations.
European Framework
- The structure of the PATLIB network in Europe.
- The number of countries participating and the list of countries in the EU, as well as countries that partner with the EU system
Technology Transfer Offices
- These entities/organizations promote the transfer of knowledge, inventions, creations, discoveries, innovations, and processes from research environments to commercial environments.
- Their role includes identifying technologies, marketing and technology-based assets , collaborating between universities and industry, facilitating IP and supporting negotiation, and managing licensing agreements
Anatomy of a Patent
- Detailed explanation of the parts and importance of the different sections and aspects of a patent.
- A detailed breakdown of the information included in each page and section, from title to diagrams and claims. This includes background, summary, detailed description, and drawings.
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Description
Test your knowledge of biotechnology with this quiz covering its definitions, applications, and regulatory aspects. From the fundamental concepts to drug development processes, this quiz explores various areas within the field of biotechnology.
