Tips for New Inventors: The Bench to Bedside Research Process

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

2. 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.

3. 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!

4. 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.

5. 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)

6. 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

7. 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

8. Requirements of Patentability • The invention must be useful or have utility (doesn’t 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

9. 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 don’t 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. Don’t 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.

11. 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”

12. 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 don’t fully disclose and it can be expensive to fight it.

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

15. Patents Take Time • Before applying for patent do your homework. Don’t 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 • Don’t be “above” dealing with patent issues. Patients need new therapies.

16. 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.

17. 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

18. Patent Life Time-Line

19. Idea to Bedside Timeline

20. 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.

21. 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.

22. 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.

23. Licensure Usually Comes Through the Inventor’s Connections • What to expect: • The company may check out your reputation with your colleagues. They can’t 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.

24. Licensure: Making Connections • Be willing to consult with companies and/or FDA • Don’t 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.

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

26. Licensure: A Process • “…a faculty researcher’s 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)

27. 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

28. 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?

30. 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.

31. 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

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

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