Patents & Commercial Assessment Workshop

ANESTHESIOLOGY INNOVATION & ENTREPRENEURSHIP PROGRAM Patents & Commercial Assessment Workshop JUNE 6, 2015 SCHAUMBURG, IL Jointly provided by and

Patents & Commercial Assessment Workshop Activities in entrepreneurship and innovation are critical to the future of medicine, the health and safety of patients, and the continued advancement of anesthesiology. To facilitate physician education in these areas, the Foundation for Anesthesia Education and Research has created the Anesthesiology Innovation and Entrepreneurship Program, which underscores key elements of successful translational medical research and the scientific discoveries that advance patient care. This program houses novel activities that exemplify FAER s mission to advance medicine through research and education in anesthesiology. As part of the Anesthesiology Innovation and Entrepreneurship Program, FAER is hosting the Patents and Commercial Assessment Workshop. The workshop will expand knowledge of invention and innovation in anesthesia, activities that ultimately improve patient health. LEARNING OBJECTIVES At the conclusion of this activity, participants should be able to: Explain patents and why they are critical to product protection Compare different types of patents and patent processes Identify the patent application process Summarize how companies evaluate technology Identify effective ways to work with offices of technology licensing in an academic environment Recognize the importance of commercial assessment to the due diligence process TARGET AUDIENCE This activity is intended for anesthesiologists. Researchers and other health care professionals with an interest in anesthesiology may also participate. ACCME ACCREDITATION AND DESIGNATION STATEMENTS This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American Society of Anesthesiologists and the Foundation for Anesthesia Education and Research. The American Society of Anesthesiologists is accredited by the ACCME to provide continuing medical education for physicians. The American Society of Anesthesiologists designates this live activity for 6.5 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity. INSTRUCTIONS ON HOW TO RECEIVE CREDIT In order to receive CME credit, participants must sign into the ASA Education Center, review the CME information and complete the evaluation. Further instructions will be emailed to each participant immediately prior to and after the activity. DISCLAIMER The information provided at this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient s medical condition. CONTACT INFORMATION Ginger Smith, Program Coordinator, Foundation for Anesthesia Education and Research, GingerSmith@faer.org, 630-912-2254

Workshop Agenda The workshop will kick off with a series of sessions designed to educate attendees on all-things patents. After lunch, participants will take a deep dive into commercial assessment and technology licensing. Each attendee will have the opportunity to participate in four breakout sessions, two in the morning and two in the afternoon. Opportunities for Q-and-A will be provided at the conclusion of each session and during the specified roundtable sessions. TIME SESSION FACULTY LOCATION 7 a.m. Registration and Continental Breakfast Foyer/Atrium 7:45 a.m. Welcome and Opening Remarks Donn Dennis, MD, FAHA 8 a.m. Improving Patient Care through Innovation: Why We are Here Today 8:30 a.m. Patents, Patent Types and Their Role in Protecting Products 9 a.m. The Importance of Protecting Your Intellectual Property Ted Stanley, MD Pam Palmer, MD, PhD Linda E.B. Hansen, JD 9:30 a.m. Patents Roundtable and Q-and-A Linda E.B. Hansen, JD; Kirk Hogan, MD, JD; Pam Palmer, MD; Ted Stanley, MD (moderator) 10 a.m. Networking Break with Refreshments 10:30 a.m. Morning Breakout Sessions (two sessions, 45 minutes each) Noon - 1:30 p.m. Lunch and Keynote Presentation Fail Early, Fail Often but Don t Fail Always 1:30 p.m. How Do Companies Evaluate Technology? 2 p.m. Understanding the Technology Commercialization Process 2:30 p.m. Commercial Assessment Roundtable and Q-and-A 3 p.m. Networking Break with Refreshments 3:30 p.m. Afternoon Breakout Sessions (two sessions, 45 minutes each) See table below for session options See table below for session locations Steve Shafer, MD Multipurpose Room 3 Raul Trillo, MD, MBA Michael Villalobos, PhD William H. Burns; Donn Dennis, MD, FAHA; Raul Trillo, MD, MBA; Michael Villalobos, PhD See table below for session options See table below for session locations 5 p.m. Closing Reception Foyer, Outdoor Patio MORNING BREAKOUT SESSIONS SESSION FACULTY LOCATION Writing Effective Patents Pam Palmer, MD Multipurpose Room 1 Steps to Protecting Your Intellectual Property Linda E.B. Hansen, JD Multipurpose Room 2 Understanding Patent Law Kirk Hogan, MD, JD Conference Room A/B AFTERNOON BREAKOUT SESSIONS SESSION FACULTY LOCATION Legal Methods to Optimize Commercial Exclusivity Navigating the Corporate Business Development Process Working with Technology Licensing Office Teams in Academic Settings William (Bill) Burns Multipurpose Room 1 Raul Trillo, MD, MBA Multipurpose Room 2 Michael Villalobos, PhD 2 Conference Room A/B

Participating Faculty KEYNOTE PRESENTER STEVE SHAFER, MD Adjunct Professor, Stanford University PLANNING COMMITTEE MARK BICKET, MD Massachusetts General Hospital FEATURED PRESENTERS WILLIAM (BILL) BURNS Chief Executive Officer, NeuroproteXeon LINDA E.B. HANSEN, JD Partner, Intellectual Property Litigation, Foley & Lardner LLP KIRK HOGAN, MD, JD Professor, Anesthesiology, University of Wisconsin School of Medicine PAMELA (PAM) PALMER, MD, PHD Chief Medical Officer, Co-Founder, AcelRx Pharmaceuticals THEODORE (TED) STANLEY, MD Managing Director, Upstart Ventures RAUL TRILLO, MD, MBA Vice President of International Marketing Latin America, Baxter International Inc. MICHAEL (MIKE) VILLALOBOS, PHD Manager of Biotechnology Licensing, Vanderbilt Center for Technology Transfer and Commercialization DONN DENNIS, MD, FAHA University of Florida and Xhale, Inc. EVAN KHARASCH, MD, PHD Washington University in St. Louis TED STANLEY, MD University of Utah and Upstart Ventures DENHAM WARD, MD, PHD Foundation for Anesthesia Education and Research FAER STAFF SARA LUEDERS Marketing and Communications Manager GINGER SMITH Program Coordinator DAVID WOLFSON, CFRE Chief Development Officer NOTE: Please see page 9 of this syllabus for the complete list of planning committee, faculty and staff disclosures. 3

8-8:30 A.M., AUDITORIUM Improving Patient Care through Innovation: Why We Are Here Today TED STANLEY, MD MANAGING DIRECTOR, UPSTART VENTURES This session will define innovation and entrepreneurship, what they are and what they are not. It will provide examples of innovation and entrepreneurship within and outside of anesthesiology, and explain how the correct culture and other requirements are extremely important for innovation and entrepreneurship to be able to occur. In addition, this session will discuss why entrepreneurial activities are important to the future of anesthesiology and the future of our ability to provide improved patient care. Define innovation and entrepreneurship Discuss examples of past innovations and entrepreneurs in anesthesiology Identify the conditions that are necessary for innovation and entrepreneurship to occur Recognize why innovation and entrepreneurship are necessary for improved outcomes in anesthesiology and patient care 8:30-9 A.M., AUDITORIUM Patents, Patent Types and Their Role in Protecting Products PAMELA (PAM) PALMER, MD CHIEF MEDICAL OFFICER, CO-FOUNDER, ACELRX PHARMACEUTICALS This presentation will cover the different types of utility patents, key aspects of a patent, strategies behind provisional applications, public disclosure rules, patent examination process and updates to patent law, including Hatch-Waxman and the America Invents Act. Define the different types of utility patents Identify when filing a provisional application may be of benefit Discuss disclosure rules, recent changes and how they apply Explain the patent examination process 4

9-9:30 A.M., AUDITORIUM The Importance of Protecting Your Intellectual Property LINDA E.B. HANSEN, JD PARTNER, INTELLECTUAL PROPERTY LITIGATION, FOLEY & LARDNER LLP This session will cover the topics of ownership of inventions, patentability and licensing and why it is important to protect your intellectual property. 9:30-10 A.M., AUDITORIUM Patents Roundtable and Q-and-A Session MODERATOR: DONN DENNIS, MD, FAHA PANELISTS: LINDA E.B. HANSEN, JD; KIRK HOGAN, MD, JD; PAM PALMER, MD, PHD In an open Q-and-A session with the audience, led by the moderator, the panel will provide their perspectives on the key factors required to effectively write and file patents, and protect intellectual property. MORNING BREAKOUT SESSION, MULTIPURPOSE ROOM 1 Writing Effective Patents PAMELA (PAM) PALMER, MD CHIEF MEDICAL OFFICER, CO-FOUNDER, ACELRX PHARMACEUTICALS In this session, we will discuss patent strategies for start-up companies, including what to include in a provisional application and when to file one, how to create patentable data in early preclincial and pharmacokinetic studies, and how to work with the USPTO to get your patent approved. MORNING BREAKOUT SESSION, MULTIPURPOSE ROOM 2 Steps to Protecting Your Intellectual Property LINDA E.B. HANSEN, JD PARTNER, INTELLECTUAL PROPERTY LITIGATION, FOLEY & LARDNER LLP Intellectual property is the title given to various legal means of protecting ideas the creations of the mind. The growing importance of protecting intellectual property can be seen by the adoption of the Leahy-Smith America Invents Act on September 16, 2011, which brought the U.S. patent system into alignment with most of the rest of the world. Anyone with an idea worth patent protection should be careful to learn how to obtain the best protection for the greatest reward. Explain the different types of intellectual property protection available in the United States Define who owns an invention Identify how to protect an invention Describe what is patentable and what is not 5

MORNING BREAKOUT SESSION, CONFERENCE ROOM A/B Understanding Patent Law KIRK HOGAN, MD, JD PROFESSOR OF ANESTHESIOLOGY, UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE The America Invents Act that become effective March 16, 2013 comprises sweeping changes from earlier patent prosecution practice (i.e. steps necessary to get a patent). Patent applications filed before March 16, 2013 are subject to earlier statues and case law for up to 20 years, whereas those filed after March 16, 2013 are subject to provisions of the new law and corresponding court opinions. Accordingly, for the next 20 years, inventors must take parallel but distinct laws arising from the date of their application into account in seeking to maximize the value of their inventions. The workshop aims to address the new law s changes of greatest impact to the interests of the inventor and early-stage business, and identify best practices compatible with both. Distinguish between older first to invent system and the newer first to file or first to disclose system Identify best practices in the conduct and documentation of preclinical and clinical research and development in support of strong patent protection Identify the new law s changes that favor small inventors and businesses, and those that favor larger corporate entities LUNCHEON KEYNOTE PRESENTATION, MULTIPURPOSE ROOM 3 Fail Early, Fail Often but Don t Fail Always STEVE SHAFER, MD ADJUNCT PROFESSOR, STANFORD UNIVERSITY Dr. Shafer will share his personal stories of entrepreneurial misadventures. 1:30-2 P.M., AUDITORIUM How Do Companies Evaluate Technology? RAUL TRILLO, MD, MBA VICE PRESIDENT, INTERNATIONAL MARKETING, LATIN AMERICA, BAXTER You have an idea for a new product or technology. You ve invested some time, effort and resources to develop your concept further. You believe this could have great commercial value to the right company or commercial partner. How do you know if you re ready to showcase your idea? How do you think about who might be the right partner? What will the target company be looking for once you are ready? Identify the fundamentals and gain insights into what companies are looking for in a new product or technology Describe how companies perform commercial assessments Recognize what questions you should be asking yourself, and demonstrate how to better position your product or technology once you are ready to move forward Explain some of the ways companies view new technology opportunities and provide you with insights into the evaluation process 6

2-2:30 P.M., AUDITORIUM Understanding the Technology Commercialization Process MICHAEL (MIKE) VILLALOBOS, PHD MANAGER OF BIOTECHNOLOGY LICENSING, VANDERBILT CENTER FOR TECHNOLOGY TRANSFER AND COMMERCIALIZATION At times, the complexity and factors impacting the commercial potential of a technology can seem cryptic and daunting. This session will demystify the technology commercialization process and provide a step-wise approach to evaluating the commercial potential of a technology. List the key factors analyzed when evaluating a technology Discuss strategies for assessing the market and customers for a technology Demonstrate familiarity with the valuation and negotiation process 2:30-3 P.M., AUDITORIUM Commercial Assessment Roundtable and Q-and-A Session MODERATOR: TED STANLEY, MD PANELISTS: WILLIAM (BILL) BURNS; RAUL TRILLO, MD, MBA; MICHAEL (MIKE) VILLALOBOS, PHD In an open Q-and-A session with the audience, led by the moderator, the panel will provide their perspectives on the commercial assessment and technology valuation process. AFTERNOON BREAKOUT SESSION, MULTIPURPOSE ROOM 1 Legal Methods to Optimize Commercial Exclusivity WILLIAM (BILL) BURNS CHIEF EXECUTIVE OFFICER, NEUROPROTEXEON This session will focus on the three most prevalent methods of legally establishing commercial barriers to entry: 1) Patenting in the United States and International Markets; 2) Grants of regulatory exclusivity in the United States and international markets; 3) Contracting. Explain where intellectual property (principally patents) provide real product protection Recognize the extent certain drug and device approvals provide regulatory exclusivity and the role of orphan product status in extending the duration of exclusivity Discuss the role of hospital contracts in effectively extending exclusivity 7

AFTERNOON BREAKOUT SESSION, MULTIPURPOSE ROOM 2 Navigating the Corporate Business Development Process RAUL TRILLO, MD, MBA VICE PRESIDENT, INTERNATIONAL MARKETING, LATIN AMERICA, BAXTER A company representative expresses interest in your new product or technology. You ve already had a preliminary presentation, and you re told the company wants to conduct additional due diligence. Shortly, you will be receiving a request for more information. What should you expect? What information should you provide? Whose information needs are you trying to satisfy? List the key stakeholders and decision makers involved in the corporate business development process Describe the expectations and information needs of the key stakeholders in order to navigate the process more smoothly Discuss potential pitfalls one might face as your product or technology is evaluated AFTERNOON BREAKOUT SESSION, CONFERENCE ROOM A/B Working with Technology Licensing Office Teams in Academic Settings MICHAEL (MIKE) VILLALOBOS, PHD MANAGER OF BIOTECHNOLOGY LICENSING, VANDERBILT CENTER FOR TECHNOLOGY TRANSFER AND COMMERCIALIZATION Most academic/research institutions have a technology licensing office, but working with them can seem foreign to an inventor. This session will guide the audience through the value and expertise a technology licensing office and provide in the technology commercialization process. Additionally, attendees will gain an understanding of how to use the technology licensing office to maintain their relationship with a potential licensee during the license negotiation process. Explain how to work with your technology licensing office and gain value from the partnership Describe how to use the technology licensing office expertise in marketing a technology and leverage the TLO during negotiations Discuss the goals of the technology licensing office 8

Honoring A True Innovator, Dr. David Paulus David Paulus, M.D., had a passion for patient care, a strong commitment to his specialty, and he understood the importance of innovation in advancing medicine. Dr. Paulus, an anesthesiologist and professor of anesthesiology at the University of Florida, passed away unexpectedly in 2012 at the age of 67. He was also a professor of in the College of Engineering s department of mechanical engineering. Cook Medical is honoring Dr. Paulus legacy through the David Paulus Anesthesia Fund. In the spirit of the late Dr. Paulus, whose memory is being honored by the Anesthesiology Innovation and Entrepreneurship Program, this workshop will advance medicine and improve healthcare by providing anesthesiologists and trainees with the tools and knowledge needed to transform their discoveries and innovations into patient care. Commercial Support COMMERCIAL SUPPORT ACKNOWLEDGMENT This CME activity is supported by educational grants from AcelRx, Cook Medical, Masimo and Piramal. PLANNER, FACULTY AND STAFF DISCLOSURES Individual Role Commercial Interest Nature of Relationship William H. Burns Faculty NeuroproteXeon Self, Salary, Ownership, Equity Paxx Pharma Piramal Self, Ownership Self, Consulting Donn Dennis Faculty, Planning Committee Xhale, Inc. Self, Salary, Ownership, Equity Position, Stock Options University of Florida HyGreen, Inc. NanoMedex Self, Royalties Self, Ownership, Equity Position, Stock Options Self, Ownership, Equity Position Pamela Palmer Faculty AcelRx Self, Salary, Ownership, Equity Position, Stock Options Raul Trillo Faculty Baxter Healthcare Self, Equity Position, Stock Options Steve Shafer Faculty Signature Therapeutics Self, spouse/partner, Equity Position Johnson and Johnson The Medicines Company Hospira Self, Consulting Fees Self, Consulting Fees Evan Kharasch Planning Committee The Medicines Company Self, Honoraria Spouse/partner, Consulting Fees The following planning committee members, faculty and staff have reported that they have no financial relationships with commercial interests to disclose: Linda E.B. Hansen, Kirk Hogan, Theodore Stanley, Michael Villalobos, Mark Bicket, Denham Ward, Ginger Smith, Sara Lueders, David Wolfson, Linda Matherson. DISCLOSURE POLICY The American Society of Anesthesiologists remains strongly committed to providing the best available evidence-based clinical information to participants of this educational activity and requires an open disclosure of any potential conflict of interest identified by our faculty members. It is not the intent of the American Society of Anesthesiologists to eliminate all situations of potential conflict of interest, but rather to enable those who are working with the American Society of Anesthesiologists to recognize situations that may be subject to question by others. All disclosed conflicts of interest are reviewed by the educational activity course director/chair to ensure that such situations are properly evaluated and, if necessary, resolved. The American Society of Anesthesiologists educational standards pertaining to conflict of interest are intended to maintain the professional autonomy of the clinical experts inherent in promoting a balanced presentation of science. Through our review process, all American Society of Anesthesiologists CME activities are ensured of independent, objective, scientifically balanced presentations of information. Disclosure of any or no relationships will be made for all educational activities. 9

Learn More About FAER OUR MISSION To advance medicine through research and education in anesthesiology. ABOUT FAER The Foundation for Anesthesia Education and Research (FAER) is a 501(c)3 non-profit, and a related organization of the American Society of Anesthesiologists (ASA). Its mission is to advance medicine through anesthesiology research and education. FAER is committed to ensuring physician anesthesiologists lead medicine into the future through scientific discovery and the creation of new knowledge. SUPPORT THE FUTURE OF ANESTHESIOLOGY Advances in anesthesiology are made possible by individuals who believe in education and research. Supporting talented anesthesiologists through the formative stages of their careers will expand research in anesthesiology, and will benefit our specialty, our medical centers and, most importantly, our patients. You can support research and education in anesthesiology by making a gift to FAER. ONLINE Donations made online have an immediate effect on FAER s ability to provide ongoing support for our programs and grants. You can make an online donation to FAER using your credit card. Visit FAER.org/donate to make your contribution today. SUSTAINING GIFT Your monthly, quarterly or semi-annual recurring gift of any amount is an excellent way to provide sustained support for anesthesia education and research. You can set up a recurring gift to FAER by visiting FAER.org/donate. BY MAIL You can support the future of anesthesiology by mailing a check to FAER. Send it to us at: Foundation for Anesthesia Education and Research 1061 American Lane Schaumburg, IL 60173 BY PHONE You can call FAER s office at 630-912-2554 to make a credit card donation. Our business hours are Monday through Friday, 8 a.m. to 5 p.m. CT. When you call, you may inform us whether your gift is a tribute in honor or in memory of a mentor, colleague, friend or family member. OTHER WAYS TO GIVE There are a number of ways to support FAER philanthropically. If you are interested in making a planned gift or would like to personalize your contribution to FAER, contact us at 630-912-2554. 10

1061 American Lane Schaumburg, IL 60173 630-912-2554 FAER@faer.org www.faer.org