Tips for New Inventors: The Bench to Bedside Research Process

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Tips for New Inventors The Bench to Bedside
Research Process

• Kathleen CM Campbell, PhD
• Professor Director of Audiology Research
• SIU School of Medicine

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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.

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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!

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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
  process.

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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)

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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

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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

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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

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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.

10
Public Disclosure

• Meet with your technology transfer office or
  patent attorney before public disclosure of your
  idea.
• 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.

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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
  Obvious

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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
  grants.
• E-mails
• Dissertations/Theses on File at Library
• Books
• Lectures
• Papers
• Public Sale or Use

13
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
  patentability.
• Work with your technology transfer office before
  any disclosure. Once you have filed your patents
  they will probably let you proceed with
  disclosure.
• 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.

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Always Fully Disclose

• To tech transfer office
• To patent office

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Patents Take Time

• Before applying for patent do your homework.
  Dont expect your tech transfer office to do it
  alone.
• 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.

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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.

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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

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Patent Life Time-Line
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Idea to Bedside Timeline
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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
  possible.
• 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
  patents.
• 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.

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Assignment

• 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
  start.
• 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.

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Licensure

• 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.

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Licensure Usually Comes Through the Inventors
Connections

• 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.

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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.

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Confidential Disclosures

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

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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
  researcher.
• Freidman, J. and Silberman, J. (2003) University
  Technology Transfer Do Incentives, Management
  and Location Matter? Journal of Technology
  Transfer 21(1)

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FDA

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

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Things you should know when seeking licensure

• FDA process
• Clinical trials process
• INDs
• NDAs
• Marketing
• Competing drugs/devices
• Background of the company

29
Know Prospective Clinical Applications of Your
Work

• 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
  effective?

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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.

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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
  research
• Stop by and to visit

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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

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Further Reading on Universities and Patents

• Mind to Market A Global Analysis of
  University Biotechnology Transfer and
  Commercialization 2006.