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Tips for New Inventors: The Bench to Bedside Research Process


Tips for New Inventors: The Bench to Bedside Research Process Kathleen CM Campbell, PhD Professor & Director of Audiology Research SIU School of Medicine – PowerPoint PPT presentation

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Title: Tips for New Inventors: The Bench to Bedside Research Process

Tips for New Inventors The Bench to Bedside
Research Process
  • Kathleen CM Campbell, PhD
  • Professor Director of Audiology Research
  • SIU School of Medicine

D-methionine (D-met) Current Translational
Research Status
  • Provides excellent protection from CDDP and
    carboplatin induced ototoxicity. Phase II results
    from India demonstrating significant cisplatin
    otoprotection in preparation for publication.
  • No anti-tumor interference in our tumor models
    and dosing protocols. FDA reviewed tumor models
    for IND.
  • Provides partial but significant protection
    against amikacin and gentamicin induced hearing
    loss. NIH funded further studies in our lab which
    are in progress.
  • Excellent protection from noise-induced hearing
    loss for pre/peri- and even post exposure
    administration in animal studies to date.
    Clinical trials are planned.
  • Phase II clinical trials for protection from
    radiation induced oral mucositis from India are
    in preparation for publication.
  • FDA approved IND January 2005.
  • All patents owned by Southern Illinois University
    School of Medicine.

Technology Transfer and Why it is Important
  • Technology Transfer is the key to bringing new
    ideas to market for the public benefit.
  • Companies gravitate to ideas and products that
    are properly protected by intellectual property.
  • Patients cannot enjoy a new drug or device if it
    is not approved by the FDA which typically
    requires the deep pockets of Industry.
  • You or your employer may not be in the business
    of manufacturing, but Industry is!

Realities of Translational Research
  • Without patents and licensure your good therapies
    will probably never get FDA approval
  • Without FDA approval it is unlikely that your
    discoveries will ultimately improve patient care.
  • Many good potential therapies are never developed
    because they were not appropriately protected and
    shepherded through the technology transfer

Services of the Office of Technology Transfer
  • Technology Evaluation for patentable merit and
    market readiness
  • Patent Prosecution services
  • Marketing and Promotion services
  • Trademark Prosecution where appropriate
  • License Negotiations
  • Patent and License Enforcement services
  • Material Transfer Agreements/Material Service
    Agreements (MTAs/MSAs)

Get to Know Your Tech Transfer Office Before You
Need Them
  • Start learning early
  • Consider asking your technology transfer office
    to do seminars for your faculty and students.
  • Credibility
  • Proof of concept money

University Patents
  • Usually must address best interest of the public
    and the university.
  • The university will want to make money.
  • However the university will also want to serve
    its academic missions and missions to its public
    (eg medical school patients)
  • Universities interest in technology transfer is
    greatly increasing high profile, unlike grants
    the income is discretionary for the school

Requirements of Patentability
  • The invention must be useful or have utility
    (doesnt necessarily have to be better than
    everything else)
  • The invention must be novel
  • The invention must be non-obvious to someone
    normally skilled in the arts in view of prior art

Novel Product vs Method Patents
  • Most patents are utility or method patents.
  • You can patent a novel compound, but you are more
    likely to patent a process.
  • (i.e. you dont patent the plastic but rather the
    device you make with the plastic-can be same
    concept for drug patents.)
  • In short, work with your technology transfer
    office and patent attorneys to determine what is
    patentable. Dont try to decide yourself without
    contacting them.
  • However some things that can be patented may not
    be worth patenting.

Public Disclosure
  • Meet with your technology transfer office or
    patent attorney before public disclosure of your
  • If invention has been described in printed
    publication or patent anywhere in the world or is
    in public use or on sale in the US for more than
    one year prior to patent filing it is not novel
    for US patentability.
  • Can be other grey areas of disclosure (eg web)
  • For most foreign countries, there is no grace
    period at all.

Patent Protection Killers
  • Early Publication of any type that gives away use
    or benefit
  • May be journal publications
  • May be abstract for a presentation
  • Prior Art by 3rd Parties before you receive a
    Priority Date
  • Any that may read on Novelty
  • Any combination that would deem your idea to be

Prior Art Points for Discussion
  • Not all of these constitute prior art in every
    case. However these are all things to consider
    and to discuss with your technology transfer
    office and patent attorney.-Hopefully before you
    are involved in them.
  • Clinical Trials
  • Posters
  • Abstracts
  • Web Postings including abstracts and funded
  • E-mails
  • Dissertations/Theses on File at Library
  • Books
  • Lectures
  • Papers
  • Public Sale or Use

Trust Everyone But Cut the Cards
  • Sometimes the usual scientific approach of
    sharing all information fully with colleagues
    and/or immediate publication, grant applications
    etc is immediately is at odds with protecting
  • Work with your technology transfer office before
    any disclosure. Once you have filed your patents
    they will probably let you proceed with
  • The patent applicant is required to fully
    disclose all prior art they are aware of to the
    patent office.
  • Some patent applicants dont fully disclose and
    it can be expensive to fight it.

Always Fully Disclose
  • To tech transfer office
  • To patent office

Patents Take Time
  • Before applying for patent do your homework.
    Dont expect your tech transfer office to do it
  • You will probably have to respond to patent
    office many times
  • Sometimes you will need to review and respond to
    obscure data
  • Dont be above dealing with patent issues.
    Patients need new therapies.

Filing Your Patent
  • Inventors can prepare and prosecute their own
    patent but it is generally advisable to use a
    patent attorney or patent agent.
  • Patent attorneys are attorneys with a technical
    background and are licensed to practice before
    the Patent and Trademark Office (PTO).
  • Patent Agents are not attorneys but have a
    technical background and are registered to
    practice before the PTO.
  • The process can be complicated.

Time Frame for Patent Submission and Licensure
  • File your patent before public disclosure
  • Your patent life dates from 20 years from the
    date of patent filing
  • The more years left on your patent the more
    likely it is to be licensed and developed
  • Safety and Efficacy are needed for FDA approval,
    but not elucidation of all mechanisms

Patent Life Time-Line
Idea to Bedside Timeline
If You are Considering Patents
  • Keep good lab records and notebooks, to establish
    inventorship. Obtain co-signatures if possible.
  • Make inventorship disclosure as comprehensive as
  • Work closely with the patent attorney and review
    every document fully and carefuly. You may not be
    able to correct it later.
  • Do not publicly (or sometimes privately) disclose
    before you file.
  • Give your attorney as much lead time as possible.
  • The patent process is time consuming and you may
    not have much lead time for responses.
  • Inaccurate listing of inventors can invalidate
  • However each inventor may have full rights to
    entire use of patent so work with your technology
    transfer office and patent attorney regarding
    collaborations outside your institution.

  • Assignment is a transfer by the inventor of all
    or part of the rights, title and interest in the
    patent to his or her employer.
  • Always work with your employer regarding
    assignment of patents and ownership from the
  • You may or may not have the option of retaining
    the ownership of your patents depending on the
    rules in your work setting.
  • Even if you have the option to retain ownership,
    it may be to your advantage to assign the patent
    to your employer or university for patent
    prosecution expertise, costs, licensure and the
    ability to use employer resources to further
    develop the patents.

  • The newer your patent submission is, the more
    marketable it may be.
  • In the US you have 20 years of patent life from
    time of patent submission.
  • Work with tech transfer office to seek licensure
    as soon as possible.
  • If your patent only has a few years left,
    companies will not have time for FDA approval and
    market protection.

Licensure Usually Comes Through the Inventors
  • What to expect
  • The company may check out your reputation with
    your colleagues. They cant afford to invest
    millions if data may have been withheld.
  • You will probably be asked to go and lecture for
    the company, sometimes with short notice
  • You will be expected to know the market for your
    anticipated product.
  • Many companies have a cutoff for external

Licensure Making Connections
  • Be willing to consult with companies and/or FDA
  • Dont be shy about having them make connections
    for you.
  • Be very cautious about serving on boards or in
    any official capacity with a company. It may
    inhibit your chances for licensing elsewhere. It
    may be prohibited by your university or employer.
  • Always fully disclose to your employer.

Confidential Disclosures
  • Before you talk to any companies about your
    invention, work with your technology transfer
    office regarding confidential disclosure

Licensure A Process
  • a faculty researchers continued involvement in
    a licensure deal contributes to the success of
    that deal and the additional involvement
    translates into higher compensation for the
  • Freidman, J. and Silberman, J. (2003) University
    Technology Transfer Do Incentives, Management
    and Location Matter? Journal of Technology
    Transfer 21(1)

  • Safety and Efficacy
  • Use Gold Standard Methods not innovative
    methods to determine safety and efficacy
  • Mechanisms secondary
  • excellent resource
  • Learn about GLP, GMP, GCP terms

Things you should know when seeking licensure
  • FDA process
  • Clinical trials process
  • INDs
  • NDAs
  • Marketing
  • Competing drugs/devices
  • Background of the company

Know Prospective Clinical Applications of Your
  • How will it be used?
  • Ease of use?
  • Safety?
  • FDA approved for other uses? Prescription or OTC?
  • Competition?
  • Safe for all patients?
  • How many patients could be helped? Cost

Why Do You Need Licensure?
  • It may commonly cost 800 million to 1 billion
    dollars to take a drug or device through clinical
    trials and the FDA approval process
  • The process is complicated. Our Investigational
    New Drug Application (IND) was 1,600 pages. There
    are very specific requirements for data
    submission and review. Few universities have the
    resources for this process.
  • Universities are generally not designed for
    marketing and sales.

Suggested Activities to Ensure Success with the
Office of Technology Transfer
  • Get Educated!!
  • Talk to other faculty members that have patents
    or licensed technologies
  • Invite the OTT to visit your lab and review your
  • Stop by and to visit

Quick Reference Materials
  • Prior Art Silent Time Bombs That Can Blow Away
    Your Licensing Deals by Malilay,GP, Mueting, AM,
    and Viksnins, AS
  • An Inventors Guide to Patents and Patenting by
    von Bargen Mueller, L. and Sorenson, JT.
  • Both published by Association of University
    Technology Managers (AUTM) Educational Series

Further Reading on Universities and Patents
  • Mind to Market A Global Analysis of
    University Biotechnology Transfer and
    Commercialization 2006.
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