ICNB4 PI e Regulamentação PDF

1 Program Week Theoretical Class Practical Class SEPTEMBER W1. [10/09] Introduction to the class W2. [...

1 Program Week Theoretical Class Practical Class SEPTEMBER W1. [10/09] Introduction to the class W2. [17/09] Ideas presentation Creativity Challenge W3. [24/09] Innovation and entrepreneurship Projects distribution OCTOBER Starting a new venture. Intellectual Property and Regulation W4. [01/10] Preparation for M1 CEB-LABBELS Intelectual Property office M1. Project Idea [01/10] Market & Marketing: segmentation, beachhead market, end user profile, total addressable Discussion M1 W5. [08/10] market Preparation M2 Exercise: SWOT. Porter analysis W6. [15/10] Market: full life cycle use, product specialization, customers Preparation M2 W7. [22/10] Market: value proposition core, competition, acquiring a paying customer, follow on markets Preparation M2 W8. [29/10] Business models and Funding Preparation M2 M2. Intellectual Property & Market [29/10] NOVEMBER W9. [05/11] Tutorial – Discussion and feedback on M2 (online) Financial analysis: map sales process to acquire customer, assumptions viability analysis, W10. [12/11] Preparation M3 minimum viable business product / FINICIA W11. [19/11] Financial analysis (cont.) Preparation M3 W12. [26/11] UMinho success enterpreneurship cases Preparation M3 M3. Business Model & The Voice of the Customer [26/11] DECEMBER W13. [03/12] Tutorial – Discussion and feedback on M3 (online) W14. [10/12] Exam (1 hour) Preparation M4 W15. [17/12] How to make a pitch Preparation M4 JANUARY M4. Financial Analysis [06/01] 2 W16. [17/01] Projects Presentation – pitch (5 min) (in-person) BioBusinesses Regulation 3 4 Term “biotechnology” derives from three Greek words: bios (βίος)- life; technos (τεχνηος) – technology and logos (λόγος) - thinking Biotechnology is defined as the application of science and technology to living organisms as well as parts, products and models thereof, to alter living or non- living materials for the production of knowledge, goods and services. Second OECD Ad Hoc Meeting on Biotechnology Statistics, OECD, May 2001. Organisation for Economic Cooperation and Development (OECD) It is broadly defined as a multidisciplinary field marshalling concepts and methodologies from various basic and applied disciplines, to develop products and/or services beneficial to human welfare. 5 6 7 8 9 10 https://www.sciencedirect.com/science/article/abs/pii/S0160791X15000354 11 Paweł Kafarski 2012. Rainbow code of biotechnology. CHEMIK 66, 8, 811-816 Barcelos et al. 2018. The colors of biotechnology: general overview and developments of white, green and blue areas. FEMS Microbiology Letters, 365, fny239 12 Specialized in medicine and human health: -vaccines, medicaments, antibodies, as well as genetic engineering for disease treatment CATEGORY RED: MEDICINAL BIOTECH DESCRIPTION DRUGS AND OTHER AGENTS TO TREAT, CURE OR PREVENT DISEASE AND PRODUCTS THAT ASSIST IN THE DIAGNOSIS OF DISEASES OR MEASUREMENT OF CRITICAL FACTORS IN HEALTH AND DISEASE CHARACTERISTICS HIGH UP-FRONT DEVELOPMENT COSTS, FDA APPROVAL REQUIRED PRIOR TO SALE, LONG TIME TO MARKET, HIGH POST-APPROVAL PROFIT MARGINS. 13 14 Humulin is human insulin used for Insulin is a hormone made by the pancreas that allows your body to use sugar treating diabetes. (glucose) from carbohydrates in the food that you eat for energy or to store glucose for future use. Prior to its development, diabetics used insulin isolated from pig and cow pancreas. 15 Swanson Cohen Boyer 1973, first recombinant DNA organism via recombinant DNA technology (rDNA) First recombinant DNA product approved by the U.S. Food and Drug Administration (FDA) 16 1976: Founded Venture capitalist Robert Swanson Biochemist, Herbert Boyer Swanson Cohen Boyer Biochemist, Stanley Cohen Genentech partnered with insulin manufacturer Eli Lilly and Company. The product (Humulin) was licensed to and manufactured by Lilly, and was the first-ever approved genetically engineered human therapeutic. 1980: First biotech IPO (Initial Public Offering) 1982: released the first genetically engineered drug—human insulin In 2009 Genentech was acquired by the Swiss pharmaceutical company Roche Roche payed US$ 46.8 billions for Genentech 17 Specialized in agricultural processes: - environmentally friendly solutions, alternative to traditional industrial agriculture - Plant genetic engineering (transgenic plants) - Fight climate change, greenhouse reduction (crop adaptation) CATEGORY GREEN: AGRICULTURAL BIOTECH DESCRIPTION PRODUCTS AND APPLICATIONS RELATED TO LIVESTOCK AND CROP PRODUCTION TOWARDS AGRICULTURAL ENDS CHARACTERISTICS DEVELOPMENT COSTS ARE OFTEN SIMILAR TO DRUGS, PROFITS ARE OFTEN LOWER 18 19 Specialized in industrial processes: - use of enzymes and microorganisms to produce products - wide range of products (chemicals, materials, food and beverages, biofuels and biodrugs) from bio-based raw materials - reduce environmental impact by using biomass as an alternative to fossil resources CATEGORY WHITE: INDUSTRIAL BIOTECH DESCRIPTION MODIFICATION OR IMPROVEMENT OF INDUSTRIAL PROCESSES OR PERFORMING TASKS PREVIOUSLY SERVED BY INDUSTRIAL PROCESSES SUCH AS PAPER PROCESSING, BIOREMEDIATION AND SYNTHESIS OF ORGANIC COMPOUNDS, TANNING, BIOREFINERY, BIOCATALYSIS, ETC CHARACTERISTICS REDUCED REGULATORY BURDEN DECREASES DEVELOPMENT COSTS 20 21 Dedicated to the exploration and valorisation of the diversity of marine organisms: - Algae, bacteria, fungi, and invertebrates are among the marine resources used as raw materials CATEGORY BLUE: MARINE BIOTECH DESCRIPTION PROCESSES THAT TRANSFORM MARINE RESOURCES INTO SERVICES AND GOODS IN A MULTITUDE OF FIELDS, INCLUDING FOOD PRODUCTION, ENERGY, MEDICINE, COSMETICS, AQUACULTURE, BIOREMEDIATION, AND THE CHEMICAL INDUSTRY CHARACTERISTICS COMPANIES ARE OFTEN TOO CAPITAL-INTENSIVE – DUE TO THE HIGH COSTS OF RESEARCH & DEVELOPMENT 22 23 Colours of biotechnology – applied to YOUR project Group Four colours of Biotecnology 1 2 3 4 5 6 7 8 9 10 11 12 13 14 24 Colours of biotechnology – applied to YOUR project Group Four colours of Biotecnology 1 2 3 4 5 6 7 8 9 10 11 12 13 14 25 26  ELEMENTS OF SUSTAINABILITY SUCCESS Market strategy /Financing strategy Financial estimates Management Management team Executive summary Bio Business plan Businesses Business model Financing Technology Market opportunity Intellectual property 27 WAYS TO BORN Independent companies Formed by a scientist or group of scientists who seek to commercialize a technology 3F’s: Friends, Family, Fools Often the initial funding is provided by “friends and family” Angel Investors Seed investors The bulk of early capital comes from Seed, Venture Capital or Angel Investors Venture Capital 28  WAYS TO BORN Spin-offs An established company or a university create a new company to develop a potentially lucrative technology The established company can maintain its focus on core technologies The nascent company can obtain sources of funding unavailable to the existing company Corporate spin-offs are more likely to succeed than university spin-offs (15% against 45% of failure rate)… 29 BIOTECH BUSINESS Key difference is that big pharma has ongoing product revenues to cushion the inevitable product failure and often does not have to reveal when those failures occur Unfortunately, most biotech firms do not have that luxury Every product candidate is crucial to their success, and any speed bump usually must be reported 30 BIOTECH BUSINESS For investors in any biotechnology or pharmaceutical company Angel Investors the driver of both opportunity and risk is product development Seed investors All the exciting science in the World won’t generate long-term Venture Capital value unless it is used to create products that bring a significant revenue stream into the company 31 BIOTECH BUSINESS Most biotech investors are not able to judge the basic science of a company But a good understanding of the product development process can give guidelines for judging the relative risk of individual product candidates The product development process – and risk – is essentially identical for small biotech companies and for large pharmaceutical firms 32 33 INNOVATION@DSM IS NOT JUST ABOUT GREAT IDEAS, STATE-OF-THE- ART TECHNOLOGY AND HIGH-TECH LABORATORIES. IT’S ABOUT FINDING THE BEST SUSTAINABLE AND COMMERCIALLY VIABLE SOLUTIONS TO MARKET NEEDS DSM HAS A SUCCESSFUL TRADITION OF ‘REINVENTING’ ITSELF IN RESPONSE TO CHANGING MARKET DEMAND. IN OUR LONG HISTORY, WE HAVE MOVED FROM COAL TO FERTILIZERS... TO PETROCHEMICALS AND PLASTICS... TO LIFE SCIENCES AND MATERIALS SCIENCES https://www.dsm.com/corporate/about/businesses.html 34 35 36 37 38 BIOTECH BUSINESS The discovery and development of a new pharmaceutics are long and arduous tasks It takes ~15 years for a new drug to move from the discovery phase, into animal testing, through clinical trials, past the US FDA, and into the marketplace The average cost of generating a single new drug is US$500 million 39 Pharmacoeconomics Drug development Investigational New Drug (IND) Application New Drug Application (NDA) 40  Pharmacoeconomics Drug development 41  Pharmacoeconomics Drug development 42 REGULATION - DRUGS FDA (Food and Drug Administration) /EMA (European Medicines Agency) Identification of potential drug compounds - Laboratory and Animal Models Testing safety of Potential drugs – animals and cell cultures – pre-clinical trials Clinical trials – humans Phase I – Safety Phase II – Safety and Efficacy Phase III – Expanded trials 43 44 REGULATION - FOOD Yellow Biotechnology Novel Food Regulation (EU 2015/2283) - lays down detailed rules for the authorization of novel foods and novel food ingredients Novel foods must undergo a safety assessment before they can be placed on the EU market Applications must be submitted in accordance with 97/618/EC concerning the scientific aspects and the presentation of information required to support an application Products can be considered "substantially equivalent" by a national competent food authority as regards their composition , nutritional value, metabolism, intended use and the level of undesirable substances, may follow a simplified procedure 45 Other heavily regulated sectors Cosmetics Medical devices Chemicals (e.g. pesticides, polymers, paints) Automobile Textile Construction …. 46 47  INTELLECTUAL PROPERTY Intellectual Property refers to the creations of the mind and intellect: inventions, artistic and literary works, symbols, names, images and drawings used commercially World Intellectual Property Organization (WIPO) Includes the concept of legal protection of original creations The law prevents others from copying or unfairly benefiting from the work or reputation from others In many countries, such as those whose legislation is of Anglo-Saxon origin or source, industrial property and intellectual property merge into a single concept: that of Intellectual Property 48 The objects that arise from the intellectual activity of the human being are called intangible goods or immaterial goods, so that both industrial property rights and intellectual property rights aim to protect intangible goods, property of companies or people who create or display them its ownership. 49  INTELLECTUAL PROPERTY It protects technical creations, It protects the expression of aesthetic creations (designs) or the ideas designations of goods and services Industrial Property Copyright Sui Generis Law Trademarks Computer programs, Cultivars, Logos Scientific works (books and Integrated circuit topography, Patents, chapters), Folklore, Industrial secrets, Literary and artistic works, Traditional knowledge Industrial design, Other literary and artistic forms Geographical indications 50 51 PATENT FOR INVENTION VS UTILITY MODEL 52 PATENT FOR INVENTION VS UTILITY MODEL 53 54 PATENT Legal title that confers the right to prevent others from commercially exploiting the invention without the authorization of the owner Legal and economic instrument Set of exclusive rights granted for a certain period of time and geographical limit in exchange for the complete disclosure of the invention to the public Encourages inventiveness (reward) Stimulates the development of alternatives and improvement of existing patents Contribute to the dissemination of new techniques to the public, allowing an increase in global knowledge 55 PATENTABLE Technical Process, Product nature Novelty The invention is not described in the state of the art Inventive The invention is not an evident result of the state activity of the art Industrial The invention can be produced or used in some application industrial activity 56 Novelty and inventive activity Technical Features 1 1 blade 2 blades 2 handle handle New? Obvious? 3 Box for the blade Box for the blade 57 Novelty and inventive activity New? Obvious? New? Obvious? 58  The European Patent Convention Article 52: Patentable inventions PATENTS: THESE ARE NOT PATENTABLE Scientific theories, Discoveries, Mathematical methods; Presentations; Aesthetic creations; Projects, principles and methods of exercising intellectual activities in the field of gambling or in the field of economic activities; as well as computer programs without any attributes; 59  The European Patent Convention Article 52: Patentable inventions PATENTS: THESE ARE NOT PATENTABLE Ex: Abstract and purely intellectual ideas are excluded from patentability. A discovery may be new and may be very significant scientifically and industrially, but you cannot prevent others from taking advantage of that discovery per se. That said, discoveries, theories and methods often lead to practical inventions, and those inventions are patentable. Some examples include: -The discovery that a particular known material is heat-resistant is not patentable, but a fireproof safe incorporating the material would potentially be an invention -A material which has always existed (undiscovered) in nature is not patentable, but a process to isolate or extract this material may be an invention. The isolated / purified material itself is also potentially patentable -A theory as to how and why a known process works in the way it does is not patentable. However, a better understanding of the mechanism behind the process may lead to improvements being made. Those improvements would be patentable subject-matter 60  The European Patent Convention PATENTABLE VERSUS NOT PATENTABLE Article 52: Patentable inventions Discovery: lightning and its Discovery: mold contamination inhibits explanation bacterial growth Invention: apparatus to simulate Invention: isolated fungus, medium for its lightning growth, isolated antibiotic 61 PATENTS: THESE ARE NOT PATENTABLE Treatment/Diagnostic methods Surgical or therapeutic treatment methods for the human or animal body, and diagnostic methods applied to the human or animal body Products, substances, or compositions used in any method can be patented A"treatment by surgery" consists of a "physical intervention that requires specialized medical skills and involves health risks, even when performed with the necessary medical care and expertise 62  The invention must: Have a technical character Be new Involve an inventive step Have industrial application Patentability criteria 63 65 66 67 Drawings 68 69 70 71 72 -https://justica.gov.pt/Registos/Propriedade-Industrial/Patente/Como-apresentar-um-pedido-de-patente -https://justica.gov.pt/Registos/Propriedade-Industrial/Patente/Como-apresentar-um-pedido-de-patente PATENTS - DATABASES European Patent office: https://worldwide.espacenet.com/ USA: https://www.uspto.gov/patents/search/patent-public-search World Intelectual Property Organization: https://patentscope.wipo.int/search/en/search.jsf Google Patents: https://patents.google.com/ 75 WHAT INFORMATIONS CAN WE RETRIEVE FROM PATENTS DATABASES? State of the art Products and markets Technological base of a company Collaborations / Cooperation network Emergent and mature technological areas Watch the competition Avoid court lawsuits 76 UNIVERSITY-INDUSTRY INTERACTIONS Universities have been a major source of entrepreneurial and technology-based economic development Knowledge generation Access to scientific breakthroughs Knowledge/technology exploitation Increasing the predictive and applied power of (i.e. by transfering or sharing) science; includes modelling, training Social Delegating selected development activities; includes risk sharing, cost saving Political Lack of resources; e.g., getting access to Financial/economical laboratories and equipment 77 TECHNOLOGY TRANSFER – A LINK BETWEEN RESEARCH AND INDUSTRY R&D Technology Transfer Market Research Marketable Results IP Development of IP Contract research University Research Licensing MARKET Organization Creation of new company 78  CIIES – Centro de Inovação, Investigação e Ensino Superior 79  NATIONAL FRAMEWORK PATLIB centres", standing for PATent LIBrary 1 4 3 2 80 AVEPARK  NATIONAL FRAMEWORK This Network created in mid 2001 by INPI - National Institute of Industrial Property, within the scope of a public initiative called ‘Partnership for the Valorisation of the Industrial Property System’, established the GAPI - Industrial Property Support and Promotion Offices This project was founded as a partnership with 22 national entities, including Universities (10), technological centers (7), science and technology parks (3) and business associations (2) Given its logic of action, the European Patent Organization (EPO) officially recognized, in 2003, these units as PATLIB centers in Portugal 81  EUROPEAN FRAMEWORK The PATLIB network in Europe PATLIB centres", standing for PATent LIBrary 82  Technology Transfer Offices Gabinetes de Apoio e Promoção da Propriedade Industrial (GAPI) TTO (Technology Transfer Office) KTO (Knowledge Transfer Office) LTO (Licensing Technology Office) IPO (Intellectual Property Office) Technology Transfer Offices whose central objective is to promote and manage the “transfer of knowledge to a commercial environment of new inventions, creations, discoveries, innovations, processes and others that result from scientific research carried out at the institution where it operates ”(European Commission, 2007) - Identification of technologies; - marketing of technological assets; - management of University-industry relations; - support services for IP protection; - support in negotiation and concluding licensing agreements 83