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Enhancing your career through commercializationBrandon M Welch, MS, PhDAssistant ProfessorCenter for Biomedical InformaticsMedical University of South Carolina1

I have no conflicts to disclose

BS UtahDept of HealthMS TulaneStarted ItRunsVP at InformedDNAPhD UtahStarted Doxy.me

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#1 & #2~20 startups annually

~10 startups annually#3-#10

~$30 billion~$20 billion*~NIH budgetStartup business funding$50k-$250k$250k-$10M+Phase 1: $150k-$250k for 6 mosPhase 2: $1M-$1.5M for 2 yrsSuccess rates as high as 40%

Inventor(s)LabDepartmentMUSCCopyright40-60%15%10%15-35%Patent25-40%30%10%15-30%License Revenue15% RFD fee$1M sales @ 25% license fee$250,000$37,500$212,500$85,000$31,875$21,250$74,375

Grants

License IPSalesLicense revenueGrantsInvestmentSubcontractsR&D funding

Start a business

FundingJob creatorBetter researcherMore effectiveThink differentlyGreater opportunities

Ownership of IP

Types of Technologies Invented at MUSC

Research Tools

27Different Forms of Protection

Research ToolsKnow How

28Different Forms of Protection

Research Tools

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Share everything about your inventionGain exclusivity to use the inventionOthersMake UseSellPatent30Should I patent?ProsProvide exclusivity to invention Lasts 20 yearsInvestors more likely to invest

ConsOthers can design around it$10,000-$20,000 to file2-5 years to get patentOnly useful if you defend it (>$100,000)

Not Everything is PatentablePatentableNew compositions of matterMachineManufacturing processBusiness Process

Including:Method of use*Method of detectionImprovements ReformulationsNovel delivery platforms

Not PatentablePhysical phenomenaMechanism of actionNaturally occurring substance

Phsy phenomena gravityMOA identifying targets or putative compounds no longer patentable; MOA not required for patentabilityMyriad has expanded to genes and Prometheus for circulating analyte levels32Commercial Potential without Patent

Invented in 1974 by Erno Rubik

Patent application filed in Hungary in 1975

No patent protection outside of Hungary

Rubiks Cube is worlds highest selling puzzle toy at more than 400 million cubes sold worldwide

Today, Rubiks Cube sells for $10

Thats $4 BILLION in sales!One fifth of the worlds population has tried solving the rubiks cube33Research ToolsKnock-out mice sell for $500-$5000Extremely limited marketEnforcement issueHurdle to replicate is high

PatentsNew Drugs: High Risk VentureFrom bench to patient 12-15 yearsCost $350-800M Past preclinical testing1:1000 Failure in efficacy trials %60

Patent can provide freedom from competition 35If you are going to patentIs 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 rightsIs it enforceable?I.e. Would people pay for it?ManuscriptsPublic presentationsThesis/DissertationPublished Grant Abstracts (and perhaps funded grants)Posters displayed in public places (e.g., halls of MUSC)

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IP Questions?

GrantsManuscriptsYour ideasLeadership

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Gaining collaboratorsAlign your goals/ambitions with others. Create win-win relationshipsMake someone else look goodBecome indispensable

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Brandon M Welch, MS, PhDwelchbm@musc.edu @WelchBM

www.linkedin.com/in/welchbm/

How I got here.My storyBe a better entrepreneurDoxy.meBe a better researcher

AdvantagesAdditional sources of revenueSBIR/STTRInvestmentRevenueKnow the customer become a better researcherEconomic development jobsBench to bedside more efficient

FundingDiscussion of IP

Conflicts of interest != badIPMUSC Navigation Who Does What?SCTR budget consults for grants, stats consult, research infrastructure for basic and clinical research; IRB consults57Applies 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

Things to Know about the IP Policy58BedsideBenchIndustry

59Patent PowerRight to prevent others from

MakingUsingSelling

invention in country of patentIt does NOT give you the right to make/use/sell it yourself.Freedom-to-Operate60Barrier to Entry

Patents Spur Innovation by Rewarding RiskPatents provide exclusivity to practice inventionsLast 20 yearsMust fully describe the invention so that others know how to make & use itCan be designed around

Why have a patent system? Encourage innovation62Why Not Patent Everything?Provisional Patent Filing $

PCT/U.S. Utility Stage Filing$$$

National Stage Filings$$$$$

Issuance of patent claims $$ - $$$$12 months18 months2.5 - 4.5 yearsMoney & TimeTypical Patent Process63Provisional do not want to filed until within 1 year window of having supporting data to be market ready; once converted, costs grow significantly

Provisional: couple thousandPCT/Utility: additional 5-10k to file (no prosecution responses)

about $25k to get issued claims in the USFew 100 thousand to get international claims

40-60% C25-40% P15% C30% P10% C10% P15-35% C15-30% PLicense RevenueInventor(s)LaboratoryDepartmentMUSC- Legal/Admin expenses***See MUSC IP Policy for Details65

Patentability EvaluationSTART

Patentability EvaluationIs it novel?STARTHas it ever been publicly disclosed or sold anywhere in the world?

Patentability EvaluationSTARTCould your colleague have come to the same conclusion given the same body of information?Is it novel?Is it non-obvious?

Patentability EvaluationIs it enabled?STARTCan you describe it in sufficient detail that your colleague could

generate the same data in the lab, and/or build it per your specifications?Is it novel?Is it non-obvious?Diagnostics: data showing a marker corresponds to having a disease or not; trying to get prognostic capabilities, must have data demonstrating ability to predict outcomes69

Patentability EvaluationIs it novel?Is it non-obvious?Is it enabled?STARTDid you publish it? Foreign IP rights are lost upon disclosure

ManuscriptsPublic presentationsThesis/DissertationPublished Grant Abstracts (and perhaps funded grants)Posters displayed in public places (e.g., halls of MUSC)

Patentability EvaluationIs it novel?Is it non-obvious?Is it enabled?STARTMore than 1 year ago?US IP rights are lost 1 year after disclosure

ManuscriptsPublic presentationsThesis/DissertationPublished Grant Abstracts(and perhaps funded grants)Posters displayed in public places (e.g., halls of MUSC)

Did you publish it?

Other ConsiderationsIs it enforceable?STARTNow that weve 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 novel?Is it non-obvious?Is it enabled?More than 1 year ago?Did you publish it? Off-Label PrescriptionsBevacizumab (Avastin) is an angiogenesis inhibitorFDA approved for cancer treatmentPrescribed off-label by ophthalmologists for proliferative eye diseasesDrug X is approved for treating cancerYou find it also treats eye diseasesTo patent or not to patent?

20% of all drugs prescribed off-label~30% of psychiatric drugs & oncology related drugs

slowsthe growth of new blood vessels

Shrimp market US: $6MAsia $15.4BChina $6.7BJapan $103M73Recent Case LawsMyriad: banned patenting of gene sequences

Prometheus: banned diagnosis based on observed levels of a markerPatent 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-productsDecision: Natural phenomena and not patentablemethods to diagnose propensity to cancer by looking for mutatedDNAsequences, and methods to identify drugs using isolated DNA sequences74The ConundrumVery strict requirements for patentable substance

Without a barrier to entry, most companies wont undertake advancing a new therapy

This may prevent good therapies from being developed

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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

76When to Report?Before public disclosure!Including: Publication of the paperPoster in hallwayStudent presentationDepartmental seminarDiscussion with colleague from other institutionMaterial Transfer Agreement (MTA)Grants

Conference77ConclusionFRD provides IP and commercialization services on behalf of MUSCCall FRD with any questions 876-1900 or visit us in Suite 101 of the Bioengineering BuildingWebsitehttp://frd.musc.edu78