Enhancing your career through commercialization Brandon M Welch, MS, PhD Assistant Professor Center for Biomedical Informatics Medical University of South Carolina.
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Enhancing your career through commercialization Brandon M Welch, MS, PhD Assistant Professor Center for Biomedical Informatics Medical University of South Carolina “I have no conflicts to disclose” #1 & #2 ~20 startups annually #3-#10 ~10 startups annually Startup business funding Grants $50k-$250k $250k-$10M+ Seed/angel investment Venture investment ~$20 billion ~$30 billion *~NIH budget Revenue • Phase 1: $150k-$250k for 6 mos • Phase 2: $1M-$1.5M for 2 yrs • Success rates as high as 40% License Revenue $250,000 15% RFD fee $37,500 $1M sales @ 25% license fee $212,500 Inventor(s) Lab Department MUSC Copyright 40-60% 15% 10% 15-35% Patent 25-40% 30% 10% 15-30% $85,000 $31,875 $21,250 $74,375 Grants Grants License IP License revenue Subcontracts R&D funding Investment Sales Start a business Better researcher Funding Think differently More effective Greater opportunities Job creator Ownership of IP Types of Technologies Invented at MUSC Therapeutics Diagnostics Technologies Medical Devices Imaging & Algorithms Copyright Materials Research Tools Different Forms of Protection Therapeutics Diagnostics Patents Medical Devices Imaging & Algorithms Copyright Copyright Materials Know How Research Tools Different Forms of Protection Therapeutics Diagnostics Patents Medical Devices Imaging & Algorithms Copyright Materials Research Tools Patent Share everything about your invention Gain exclusivity to use the invention Others • Make • Use • Sell Should I patent? Pros • Provide exclusivity to invention • Lasts 20 years • Investors more likely to invest Cons • Others can design around it • $10,000-$20,000 to file • 2-5 years to get patent • Only useful if you defend it (>$100,000) Not Everything is Patentable Patentable • New compositions of matter • Machine • Manufacturing process • Business Process Including: – Method of use* – Method of detection – Improvements – Reformulations – Novel delivery platforms Not Patentable • Physical phenomena • Mechanism of action • Naturally occurring substance Commercial Potential without Patent Invented in 1974 by Erno Rubik Patent application filed in Hungary in 1975 No patent protection outside of Hungary Rubik’s Cube is world’s highest selling puzzle toy at more than 400 million cubes sold worldwide Today, Rubik’s Cube sells for $10 That’s $4 BILLION in sales! Research Tools • Knock-out mice sell for $500-$5000 • Extremely limited market • Enforcement issue • Hurdle to replicate is high New Drugs: High Risk Venture • • • • From bench to patient Cost Past preclinical testing Failure in efficacy trials 12-15 years $350-800M 1:1000 %60 Patents Patent can provide freedom from competition If you are going to patent… • • • • Is it novel? Is it non-obvious? Can it be enabled? Did you publish or publically disclose? – If so, lost foreign patent rights – > 1yr lose US patent rights • Is it enforceable? – I.e. Would people pay for it? IP Questions? Passion Your ability to sell Your smarts Luck Your political skills Brandon M Welch, MS, PhD [email protected] @WelchBM www.linkedin.com/in/welchbm/ How I got here. My story • Be a better entrepreneur – Doxy.me • Be a better researcher Funding Advantages • Additional sources of revenue – SBIR/STTR – Investment – Revenue • Know the customer become a better researcher • Economic development jobs • Bench to bedside more efficient Discussion of IP • Conflicts of interest != bad MUSC Navigation – Who Does What? • Research Opportunity Core • Regulatory & Navigation Consults • Pilot Project Funding • Scientific Retreats • Invention Disclosures • Patent Filing • Copyright Registration • IP Licensing • Confidentiality Agreements SCTR Institute FRD IP • Corporate Sponsored Research Agreements • MTAs ORSP CIE • Business Plan Assistance • Startup Company Formation • Education & Outreach Things to Know about the IP Policy • Applies to employees (faculty and staff) and students (including trainees) • FRD acts as the agent for MUSC in commercialization of inventions. • Unless there is a prior agreement, all Inventors are equal in terms of ownership. • Revenue from licensing IP is shared with Inventors • http://academicdepartments.musc.edu/frd/inventors/policy Bench Industry Bedside Patent Power Right to prevent others from Making Using Selling invention in country of patent It does NOT give you the right to make/use/sell it yourself. Freedom-to-Operate Barrier to Entry Patents Spur Innovation by Rewarding Risk • Patents provide exclusivity to practice inventions • Last 20 years • Must fully describe the invention so that others know how to make & use it • Can be designed around Why Not Patent Everything? Typical Patent Process • Provisional Patent Filing $ • PCT/U.S. Utility Stage Filing $$$ • National Stage Filings $$$$$ • Issuance of patent claims $$ - $$$$ Money & 12 months 18 months 2.5 - 4.5 years Time License Revenue - Legal/Admin expenses 40-60% C 25-40% P Inventor(s) 15% C 30% P Laboratory 10% C 10% P Department 15-35% C 15-30% P MUSC ***See MUSC IP Policy for Details Patentability Evaluation Patentability Evaluation Has it ever been publicly disclosed or sold anywhere in the world? Is it novel? Patentability Evaluation Could your colleague have come to the same conclusion given the same body of information? Is it non-obvious? Is it novel? Patentability Evaluation Can you describe it in sufficient detail that your colleague could 1) generate the same data in the lab, and/or 2) build it per your specifications? Is it enabled? Is it non-obvious? Is it novel? Patentability Evaluation Foreign IP rights are lost upon disclosure • • • • • Manuscripts Public presentations Thesis/Dissertation Published Grant Abstracts (and perhaps funded grants) Posters displayed in public places (e.g., halls of MUSC) Did you publish it? Is it enabled? Is it non-obvious? Is it novel? Patentability Evaluation US IP rights are lost 1 year after disclosure • Manuscripts • Public presentations • Thesis/Dissertation • Published Grant Abstracts (and perhaps funded grants) • Posters displayed in public places (e.g., halls of MUSC) More than 1 year ago? Did you publish it? Is it enabled? Is it non-obvious? Is it novel? Other Considerations Now that we’ve told people how to make/do it, can we figure out: 1) Are people infringing? 2) What would it take to stop infringement? 3) Are people willing to pay for the right to use the technology? Is it enforceable? More than 1 year ago? Did you publish it? Is it enabled? Is it non-obvious? Is it novel? Off-Label Prescriptions • Drug X is approved for treating cancer • You find it also treats eye diseases To patent or not to patent? • Bevacizumab (Avastin) is an angiogenesis inhibitor • FDA approved for cancer treatment • Prescribed off-label by ophthalmologists for proliferative eye diseases • 20% of all drugs prescribed off-label • ~30% of psychiatric drugs & oncology related drugs Recent Case Laws • Myriad: banned patenting of gene sequences • Prometheus: banned diagnosis based on observed levels of a marker – Patent subject matter: • Method of (1) administering the drug to a subject, (2) determining metabolite levels, and (3) being warned that an adjustment in dosage may be required. – Argument: • Metabolites detected are natural by-products – Decision: • Natural phenomena and not patentable The Conundrum • Very strict requirements for patentable substance • Without a barrier to entry, most companies won’t undertake advancing a new therapy • This may prevent good therapies from being developed How to Get Started? • Write up your idea and supporting data in a Record of Invention (ROI) http://academicdepartments.musc.edu /frd/inventors/inventors.forms When to Report? Before public disclosure! Including: – – – – – – – Publication of the paper Poster in hallway Student presentation Departmental seminar Discussion with colleague from other institution Material Transfer Agreement (MTA) Grants Conclusion • FRD provides IP and commercialization services on behalf of MUSC • Call FRD with any questions 876-1900 or visit us in Suite 101 of the Bioengineering Building • Website – http://frd.musc.edu