IIPTA Launch a Career. Be Awesome www.iipta.com Role of Intellectual Property Rights in Biotechnology Industry
INTRODUCTION TO THE WORKSHOP Intellectual Property Rights is a tool to protect innovation and exploit it to earn money. But now days, to shorten the time and money spent in research and development, various companies have also started using it to bypass competitors patent and enter new markets. This workshop is designed for students and budding scientists to understand the basic concepts of IPR and its various applications in research and development. This workshop is based on case study method. Various groups activities will encourage participants to apply the concepts of IPR in the real challenges of product / process development at commercial scale. By the end of the workshop, participants will be able to successfully understand the patent strategy and management. Participants will develop a non infringing adjuvant ready to manufacture and market in the US and European Market. www.iipta.com 1
WORKSHOP SYLLABUS Part 1 1.1 1.2 1.3 1.4 Introduction to intellectual Property Law? What is intellectual Property? Patents Plant Breeder sight Trade Secrets (undisclosed information) Trade mark Industrial Design Copy right IP and the Lifecycle of new product To illustrate, we will use lifecycle of a hypothetical new research program on new genetically engineered vaccine / vector Research Planning Phase Research Phase Research Break Through Development Phase Marketing Phase Why have intellectual Property Rights? National Economics Encourage and reward innovation and development Benefit from international trade opportunities Attract foreign investments and tech transfer Case studies: 1. IP for traditional products: Coconut cream soap 2. Patenting improved drug: Gleevac by Novartis India What is the international framework for IP? WTO agreement on trade related aspects of Intellectual Property Rights TRIPS The Paris Convention Patent cooperation treaty Budapest Treaty for deposit of micro organisms International convention or the protection of new varieties of plants (UPOV) FAO international treaty on plant genetics resources Convention on biological diversity (CBD) Group Exercise: Comparison of different types of IP. www.iipta.com 2
Part 2 2.1 2.2 2.3 2.4 2.5 2.6 Biotech and IP Case Studies: From Laboratory to the clinic: Eli Lilly Overview of patenting principles: To illustrate we will use hypothetical new research program on drug / new genetically engineered vaccine / vector and answer following questions? Does it fit the definition of an invention? Is the invention permitted or excluded as subject matter for a patent? Is the invention new or novel? Does it have an inventive step or is it not obvious? Is it industrially applicable or useful? Are the claims sufficiently supported by the disclosure? International Standards on Patenting Patent Corporation Treaty Time is of essence: the priority date What subject matter is patentable? Case Studies Harvard Onco Mouse [US Patent number 4736866] What is inventive step? Case Study Hepatitis and Antigen Biogen Inc. Group Activity Use of turmeric in wound healing [US Patent # 5401504] Vicco Laboratories, Goa, India Basmati Rice Patent [US Patent # 5663484] www.iipta.com 3
Part 3 Reading patents and patent process 3.1 3.2 3.3 3.4 3.5 Structure of patent document The cover page The specifications The claims Background Summary Classification Drawings Gene sequence listing Activity Reading Patent How are patent documents used? Researchers Scientific perspective Patent Office Administrative perspective Lawyers Legal perspective What is the process of getting patent? In India At International Level Case Study Examination of a patent application for sun block cream Group Activity Analysis of scope of a patent 1. How should we analyze the scope of patent right? 2. What is the technological problem is it proposing a solution for? 3. What parts of the patent document should analyzed and why? Group Activity Determination of the cost of filing a patent www.iipta.com 4
Part 4 Searching patent database (Demonstration) 4.1 4.2 4.3 4.4 4.5 How can patent help you? State of the art search or technology survey Technological Search Patentability Search Technology landscape Freedom to operate How is patent information classified? How does IPC work? (International Patent Classification) How do I develop search Strategy? Nature of Invention Aim of your search Time and Money You have available Source of Information Techniques to search database Keyword Boolean search Query Search IPC Search Assign Search Group Activity Practical Exercise on patent searching www.iipta.com 5
Part 5 5.1 5.2 5.3 Finding Patentable inventions Group Exercise on patent validity Neem Oil Patent [European Patent EPO 436257] Apply the legal principles relating to validity Access whether and invention is patentable or non patentable having regard to issues of Novelty Inventive step Industrial application Usefulness Read an examination report and consider how to oppose the grant of patent Group Exercise developing a new Adjuvant How to bypass existing patents to develop new adjuvant Developing Different bypass strategies for US and Europe Developing new adjuvant formulation ready to manufacture, sell and market using patent data. Group Exercise developing a new drug using Clarithromycin as API How to bypass existing patents (Abbott Laboratories) to develop new drugs Developing Different bypass strategies for US and Europe Developing new non infringing Clarithromycin formulation ready to manufacture, sell and market using patent data. www.iipta.com 6
Prerequisite for Workshop Passion to learn about how to gain rights on your research. Knowledge of general techniques in pharmaceuticals / biotechnology Having interest in research and development Passion to find new career opportunities and jobs in IPR in Pharmaceuticals and biotech companies. Who could attend? College students pursuing graduation in life sciences/ pharmaceuticals/ biotechnology. Students looking forward to jobs in biotechnology sector. Researchers & Budding Scientists Science students interested in taking career in management. Requirements for Workshop Minimum 100 students for conducting the workshop. A Hall with sitting capacity of 100 students. An LCD Projector. An effective collar microphone with a Sound System. Program Benefits & Highlights By the end of the workshop, every participant will able to apply knowledge of patents in their research projects. Techniques learnt will help student develop their own new patentable or commercially important products ready to use in market. This workshop broadens the Intellectual Property perspective of students for higher growth. Learn & Interact with Industry Experts. Receive an unparalleled education on the art of embedding Intellectual Property in your research and easily replicate you success for potentially unlimited growth. Covers all the basic and advance aspects of Intellectual Property in Research and Development. Printed material developed by well established Industry experts. On the spot implementation of IP strategies on research carried from the audience. PowerPoint Presentation, Live Demos, Interactive Question & Answer sessions and comprehensive reading material. Key Benefits of IIPTA IIPTA is recognized by World Intellectual Property Organization under its Outreach Program. India s First workshop providers on Intellectual Property for students and scientists. Helped numerous research organizations and well established companies realize their intellectual asset worth and make profit out of it. www.iipta.com 7
IIPTA is also a Intellectual Property service provider and not just an educational facility. IIPTA publishes India s First and still the only Intellectual property and Business magazine IP and Business Course Material Activity sheets and Feedback forms will be provided to participants. Workshop Duration 1 Day (8 hours/day) Charges for Workshop Rs.1000/ per student Certification Certificate will be awarded to all the participants from Indian Institute of Patent and Trademark Attorney and Mabbit Intellectual Asset Management. www.iipta.com 8
IIPTA Launch a Career. Be Awesome For more information, visit www.iipta.com or call +91-9212344782.