Everything You Wanted to Know About Technology Transfer (and then some) Catherine Innes Scott Forrest UNC Office of Technology Development Office of Technology Development OTD’s Goal OTD’s goal is to find the development path giving the best chance of product(s) based on the technology getting to the market University-based technology is always interesting, but does no good unless it is successfully commercialized (products on the market!) Discovery of technology is just a first step, development is often more costly, more risky and more involved than discovery—thus choosing the proper development route is extremely important Office of Technology Development What? Authorized managers of UNC’s intellectual property (IP) “Cradle-to-grave” project management Process disclosures made by UNC faculty Decision -- file Intellectual Property? Goal: Bring UNC technology to market Decision -- Collaborate? License? Startup? • Negotiate the license • B-plan, Fundraising, management searching • Brokering interactions with potential partners (pharma, service-for-equity, investors) Office of Technology Development Making Patent Decisions • Inventions selected for investment have: – – – – Solid technical merit No unmanageable obligations to others Strong patent protection available Good prospects of a commercial market and business opportunity Office of Technology Development Reasons Not to Patent • Idea is not an invention – Doesn’t qualify as eligible subject matter – Publication created bar to patenting • Idea is not fully developed – Enablement issues – Patent issuance unlikely • Patent position is not commercially useful – Narrow coverage – Dominated by other patents Office of Technology Development Reasons Not to Patent • No viable commercial market – No promising application – Small market for products • No interested commercial investors – Return on investment not sufficient – Difficulties in making products • UNC does not fully own the work – Inventors haven’t assigned rights – Commercial co-owner doesn’t want license Office of Technology Development Strategic Technology Transfer • Commercialization Readiness Assessment – Within 60 days of receipt of an ROI, OTD Project Managers evaluate the following: • Stage of development of the technology • Strength of available patent protection or ability to consolidate of copyrights • Commercial opportunity • Encumbrances Office of Technology Development Technology Licensing Basics Licensing is the primary vehicle for commercializing University-based technology To understand licensing, we must understand: •What a license accomplishes •The role of a license’s different components •How the nature of our partner (startup, big public company) dictates some aspects of licensing Office of Technology Development What does a license accomplish? A patent: Allows holder to exclude others from making, using, selling, importing/exporting the invention. Protects a product/process. A Copyright: Allows holder to make/copy, distribute, display, perform, import/export the work. Protects the tangible expression of an idea. A license: Exempts our partner—the “licensee”—from the right to exclude under a patent or permits them to make/copy, etc. under a copyright (can be called “covenant not to sue”). Office of Technology Development How do we end up at a license? Marketing to companies Idea from UNC inventor Patent protection Negotiate major deal terms Company infringing Office of Technology Development License structure: Summary Preamble/Definitions: Framework Grant: What we’re allowing licensee to do Compensation: What we get for allowing them to do it Diligence: Mechanism for ensuring they work hard IP: Who controls the process Legal: What happens if things go awry Office of Technology Development Differences in licenses: Licensing to an established company Grant: Scope = Exclusive Field = Generally limited Territory = Varies Ability to sublicense? = Yes Compensation: Upfront = Cash (much discussion) Milestone payments = spread out Running royalty = Varies % of sublicensing = Fixed Diligence: Mix of early and later-stage diligence milestones Office of Technology Development Differences in licenses: Licensing to a startup company Grant: Scope = Exclusive Field = Varies Territory = Worldwide Ability to sublicense? = Yes Compensation: Upfront = Equity Milestone payments = Back-loaded Running royalty = Varies % of sublicensing = Tiered Diligence: Heavy! May include fundraising milestones as well as early product development Office of Technology Development Differences in licenses: Licensing non-exclusively Grant: Scope = Non-exclusive Field = Limited Territory = Varies Ability to sublicense? = No Compensation: Upfront = Cash (less than exclusive) Milestone payments = Varies (sometimes none) Running royalty = Varies (sometimes none) % of sublicensing = n/a Diligence: Light. Sometimes non-existent, since rights are not being “tied up.” Office of Technology Development Differences in licenses: Licensing tangible property (ie. mouse lines) Grant: Scope = Non-exclusive Field = Limited (frequently to internal R&D) Territory = Worldwide Ability to sublicense? = No Compensation: Upfront = Cash Milestone payments = n/a Running royalty = Varies (frequently none) % of sublicensing = n/a Diligence: None typically required. Office of Technology Development Start a Company… …or Partner with an Existing one? This is a choice that has to be made for commercially attractive technologies We will discuss: •Requirements/demands of each development route •Factors considered when deciding on a route Office of Technology Development Academia and startup companies •Many large life science companies struggle to develop new commercial products; fill the gap by purchasing/partnering products developed by smaller players •Passage of Bayh-Dole act in 1980 allowed academic institutions to patent their inventions; a source of innovation for small companies •Resultant environment supported new companies, rewarded the investors that financed them and encouraged academics to think about how to translate their research •About 2/3 of life science-based startups originate from academia Office of Technology Development Start a Company… …or Partner with an Existing one? Before we begin to consider what technology lends itself to each route, we must first understand what each route entails. Office of Technology Development Starting a Company vs. Partnering: Time Commitment Starting a company requires lots of extra time and effort from both Inventor(s) and OTD (part of our job). •Business must be incorporated and issue shares, find a suitable business model and craft a business plan, recruit management and/or board members, raise money. •Inventor will drive project development in a startup company •Investors will be betting on Jockey as well as horse Office of Technology Development Starting a Company vs. Partnering: Near-Term Financial Return Starting a company requires both OTD and inventor to sacrifice short-term license fees (usually OK with OTD) •All $ invested in a startup is spent on essential costs (IP, development) •No/low cash reserves Office of Technology Development Start a Company… …or Partner with an Existing one? Now that expectations are set, we can evaluate which development route is more appropriate Office of Technology Development A startup is a good choice when… …the technology base is broad Multiple product opportunities! -A must for investors -More shots on goal = better chance of getting a product onto the market Examples: -Novel drug vs. Novel drug + methods of finding more (new assays, etc) -Polymer chemistry with a wide range of applications Office of Technology Development A startup is a good choice when… …the technology is “disruptive” Cutting edge: Sometimes established companies are slower to accept—reduces chances that companies will put adequate resources into the technology and increases development time. Result = decreased chance of product reaching the market Contrarian: Acceptance also difficult. Often times, this type of technology is a new approach to an old problem that companies have given up on. Office of Technology Development A startup is a good choice when… …lots of “know-how” is involved “Know-how” is generally unpublished, unpatented technical information that conveys a significant advantage (research technique, manufacturing process) Know-how is more difficult to transfer to an established company and evolves rapidly If there is substantial value in the Know-how (cannot be easily engineered), a startup may make more sense Office of Technology Development A startup is a good choice when… Example: Vascular Pharmaceuticals Recent UNC startup (Endocrinology) with a focus on treatments for the vascular complications of diabetes • Broad technology base—have a lead therapy, two novel screens for finding more and a broad base of IP • Disruptive technology—initial focus is a “discarded” pharma target • Valuable Know-how—trade secret toxicity assays to differentiate Vascular’s approach from competition Office of Technology Development Partnering a good choice when… …one has an improvement on existing technology • Value of UNC technology is enhanced by existing technology • Capitalizes on company Know-how, established manufacturing, distribution, R&D infrastructure. Result = increased chance of product reaching the market • Often, UNC technology will be “dominated” by existing IP. Then, partnering isn’t the better choice, it’s the only choice. Office of Technology Development Partnering is a good choice when… …a company is well-positioned to develop the technology • Complimentary R&D efforts • Established expertise in area • Large amounts of early R&D required in an area that investors shy away from --development financed via product sales/cash on hand vs. via money raised from investors expecting a fixed return amount/timeline Office of Technology Development Partnering is a good choice when… Example: immuoproteasome inhibitors Novel class of drugs discovered by Lineberger research group • An improvement—more specific versions of existing drugs • Company was well-positioned—Development partner performed chemistry that enhanced the drugs, had established means for assaying them and Know-how related to approaches that have failed Office of Technology Development Summary: Goal = find commercialization route most likely to result in products on the market • • • • Startup: Broad IP Disruptive UNC Know-how Partner: Narrow/dominated IP Improvement Company well-positioned • Lots of time/effort • Low initial $ return Less effort Typically some $ upfront Office of Technology Development What do I get out of it? • Universities are required to share at least 15% of income with inventors • UNC policy mandates 40% of the income is shared with the inventor (among highest in the country) -- 40% to inventor’s department, 20% to OTD Office of Technology Development Licensing expectations: University as Licensor Need to understand motivations of the TTO: •Bayh-Dole requirements •University priorities •Time constraints •Realities of investment climate •Return on investment Office of Technology Development Licensing expectations: University as Licensor Bayh-Dole act requirements Bayh-Dole act (1980) allowed institutions to patent discoveries made with federal $--but caveats attached to licensing those patents: 1. 2. 3. 4. 5. 6. Preference for US companies; small business over large No assignment of rights (license instead) Grant non-exclusive rights to US Gov’t US manufacturing requirements (flexible) Distribution of $ to inventors (UNC 40%) Actively promote commercialization of inventions (diligence, non-exclusivity) Office of Technology Development Licensing expectations: University as Licensor University priorities Many schools seek to use technology licensing, in part, as a tool to: •Retain best faculty •Increase research sponsorship •Promote regional economic development •Generate publicity (smaller schools) •Benefit society Office of Technology Development Licensing expectations: University as Licensor Time constraints •Many TTOs are very busy (OTD has): -200+ cases per Project Manager -4 “interference” proceedings with USPTO -10 to 20 ongoing negotiations at a time •Result: -Most of us can size up a potential license deal quickly (have your s**t together) -Most of us would rather close on a reasonable deal that is less that what we were after then haggle forever Office of Technology Development Licensing expectations: University as Licensor Reality of Investment Community •Most larger TTOs will have reasonable idea of what terms will be acceptable / unacceptable to institutional investors •Deals too slanted to the TTO (inexperienced company negotiator) will have to be renegotiated later (time constraints!) or will prevent investment and company viability •Deals too slanted away from the TTO leaves us without “skin in the game,” which can worry investors (not always…) Office of Technology Development Managing conflicts of interest • 1. 2. 3. 4. Conflicts of interest refer to outside activities that may: Interfere with an employee’s duty to carry out primary UNC duties Involve inappropriate use of UNC resources Misuse the name of UNC Claim UNC responsibility for conduct/outcome of such activities *All of the above are not permitted* Office of Technology Development Conflicts of interest - Permitted activities If managed properly, UNC faculty may, with appropriate oversight: 1. 2. 3. Accept sponsored research $ from a company in which they have equity Serve as an officer in a company in which they have equity and which is based on UNC technology Consult for a company in which they have equity *Many institutions prohibit these activities (eg. Stanford)* Office of Technology Development