MYR Privacy & Information Security (All Staff)

MYR Privacy & Information Security (All Staff)

2015 Intellectual Property (IP) Policy Boston Childrens Hospital promotes the development of research and clinical discoveries and innovations in order to benefit the public, to encourage inventorship, and to build our research endowment. Guidance Documents available on TIDO website Online NetLearning training due by September 15, 2015 Outline Overview of Innovation Support at BCH Context for IP Policy Basis for Intellectual Property (IP) Policy Bayh-Dole Act Specifics of the IP Policy What you need to do Questions

Support for Innovation at Boston Childrens Hospital Technology & Innovation Development Office (TIDO) Building partnerships to increase the impact of BCH research on patient health Identify research with commercial potential Build commercialization strategy (marketing, IP protection) Fund proof-of-concept (Technology Development Fund) Structure commercial deals Confidentiality agreements License agreements Startup companies Industry sponsored research agreements Collaboration agreements Research support Material transfer agreements (MTAs) Innovation Acceleration Program

Identify, catalyze and support new opportunities for innovation Promote and facilitate grassroots innovation Translational Research Program Stimulate the development of non-clinical and human clinical trials Translational Neuroscience Center Innovative clinical programs; outstanding basic science; and efficient translation of novel ideas into practical tools for diagnosis, treatment and prevention of childhood diseases Selected Products Invented at Boston Childrens On the Market Name Pomalyst and Revlimid On the Market Company

Name Company Alprolix - Fc-Factor IX Thalidomide Namenda - Memantine Eloctate - Fc -Factor VIII Neumega IL-11 In Clinical Trials Dystrophin Diagnostic Name

INF2 (FSGS) DNA Sequencing Test Bax-111 - rVWF T3 Patient monitoring software Omegaven - Omega 3-based parenteral nutrition Surgical Sam Simulator IGF-1 AutisMate, TeachMate, Puddingstone Prohema - dmPGE2

Patient Communication Board NeoSTX Quickchange Mutagenesis Kit Beloranib - MetAP2 inhib Neuro-Spinal Scaffold Company Boston Childrens Startup Companies Healthcare IT Diagnostics

Medical Device Therapeutics/Platform TIDO Intellectual Property Commercial Partner Academic Medical Center

Clinical care Basic research Translational research Clinical research Publication Training Dissemination of knowledge Product development Scale up and testing Regulatory approval

Manufacturing Marketing Sales History of Ownership of IP Most research at Boston Childrens is federally funded Prior to 1980, federal funding agencies owned patents Makes sense, they paid for it Very little economic benefit from patented discoveries Only 4% of federally funded research was licensed The Bayh-Dole Act P.L. 96-517 (1980) 35 U.S.C. 200 Grants universities/AMCs the right to elect title to patents arising from federally funded research Rationale: to promote transfer of taxpayer funded research from lab bench to the marketplace for public benefit

Create jobs Create companies and industries New products for public benefit Provides incentives to institutions, inventors and companies to participate Boston Childrens New IP Policy Update to the existing policy Boston Childrens has had an IP policy for many years Addresses the increasingly complex environment Addresses issues such as collaborations with industry, startup companies, distribution of copyright and consulting This IP Policy is designed to support Boston Childrens mission of translating the excellence of the laboratory and clinical

research and clinical care at Boston Children's into lifesaving biomedical products, devices, software and procedures for the public benefit. Through active partnering with biotechnology, pharmaceutical, IT and medical device companies at all stages, Boston Children's works to translate the world-class, cutting-edge research, discoveries and innovations developed at Boston Childrens into new therapies, diagnostics, software and devices that can benefit the public. What is Intellectual Property? Set of laws covering ideas and discoveries, and other intangible property, including Inventions Patents Copyright Trademark

Materials Who owns my Intellectual Property? Boston Childrens ownership of IP is tied to the resources used to develop it. Boston Childrens owns IP when any of the following apply: The IP was developed in whole or in part using Boston Childrens facilities; or The IP was developed in whole or in part using materials, funds or other resources owned or administered by Boston Childrens; or The IP is related to the inventor/authors responsibilities at Boston Childrens Joint Appointments & Participation Agreement The IP Policy applies to all Boston Childrens faculty, including faculty with joint appointments at other institutions

Boston Childrens will respect faculty obligations to other institutions On the Participation Agreement, list other obligations and TIDO will work with those institutions to determine how to fairly share the rights to any IP generated by a faculty member The relevant section of the Participation Agreement is Paragraph 5, which includes the following language: I further agree to assign and do hereby assign to CHILDRENS all Intellectual Property developed by me as a Covered Person, subject to any existing obligations that I have identified on Exhibit A Copyright

Creative work fixed in a tangible medium, such as: Journal articles, scholarly work and books Photographs and drawings Software Academics Works: a subset of copyright related to your academic appointment and shared for public benefit Who owns a copyright? May I transfer a copyright? Copyrights are owned by Boston Childrens, but You may transfer any academic copyright, without Boston Childrens permission, for academic or charitable purposes You may receive royalties and honorarium for academic works You own private works of authorship (such as textbooks and novels) that are not made with Boston Childrens resources

Disclosure of Inventions Examples of inventions: Composition of matter Design Device Manufacture; or Method Inventions must be disclosed to TIDO Our office will work with you on patenting and licensing To protect inventions, disclose to TIDO before discussing publically or publication Startup Companies Startup companies are an important way to commercialize discoveries

Before starting any company or receiving equity from a company taking a license to Boston Childrens IP, you must contact your Chief or Program Director, TIDO and the General Counsel for approval TIDO negotiates the agreements with the startup companies Consulting Agreements Faculty may consult for up to 20% of your professional time, providing that your Chief, Program Director or VP approves Consulting agreements require review by the General Counsels Office, and the inclusion of Boston Childrens mandatory consulting terms Exclusions from these requirements:

Speaking engagements for de minimus or no compensation Expert witness testimony do not require prior approval or review Conflict of Interest The Conflict of Interest Committee reviews situations in which involvement with a company could be seen to influence the impartiality of your research, such as: Holding equity in a company that is commercializing your research Being on the Scientific Advisory Board of a company sponsoring a clinical trial In such situations, the conflicts committee sets up a management plan to provide oversight if there is a conflict Before accepting equity in a startup, you should meet with the

conflicts committee Foundation or Department/Program Investments in Technology If BCH and/or the Department or Program make an extraordinary investment (over $100,000) to further your research, they will be repaid through royalties, if any, and this will affect the inventors royalty share A meeting will be held with you, your Chief/Department Head, TIDO and the General Counsels Office to discuss the investment and how it will affect royalty distribution Transferring Materials: [email protected] TIDO will provide and negotiate Material Transfer Agreements (MTA) A new self-service MTA is available for materials that fit the following criteria:

Chemical and biological materials Transfer is to a non-profit Not human tissue Does not have third party obligations Transfer of materials to or from commercial entities: A full MTA required and TIDO will negotiate Human tissue or samples, or materials that raise safety concerns A full MTA required and TIDO will negotiate Revenue Sharing from Licensing of Intellectual Property Party Royalty Share Inventor(s) 30%

Research Endeavor (e.g., lab) 12.5% Department or Program 12.5% Boston Childrens 30% TIDO 15% Who helps when I invent something? The Technology and Innovation Development Office (TIDO) administers the IP Policy

and is here to support you in your vital research and innovation work. Contact your departments licensing manager, or [email protected] Jane Amara, PhD Connie Caron, MBA Ryan Dietz, JD Vascular Biology Associate Director Adolescent & Cardiology Cardiac Surgery Dentistry Endocrinology GI/Nutrition Nursing/Patient Care Plastic & Oral Surgery Psychiatry Young Adult Med Dermatology General Pediatrics Gynecology

Laboratory Med Molecular Med Nephrology Neurobiology Neurology Neurosurgery Pathology PCMM Abbie Meyer, PhD Raj Khunkhun, JD Alan Yen, PhD Hem/Onc Immunology Infectious Disease Rheumatology Stem Cell Program Anesthesiology Critical Care Med

Orthopedic Surgery Respiratory Dis Surgery Urology Developmental Med Emergency Med Genetics Genomics Informatics Newborn Med Ophthalmology Otolaryngology Pharmacy Radiology Questions? Irene Abrams Senior Director, Technology and Innovation Development Office

[email protected] 617-919-3026 Guidance Documents: www.childrensinnovations.org Reminder: Complete your IP Policy Training Module in NetLearning by Sept. 15

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