James M. Woods, Ph.D. Director, Office of Research and Sponsored Programs

1. MWU’s Research Patenting Process James M. Woods, Ph.D. Director, Office of Research and Sponsored Programs

2. Overview of Today’s Talk • Brief Introduction to Patenting • Brief Overview: How much patenting has MWU done? • I think I discovered something worth patenting… How do I proceed at MWU? • MWU’s Invention Disclosure Form • MWU’s IP Assignment Agreement • MWU’s Ad Hoc Patent Committee meeting • Who’s on it? • What does it do? • Criteria used? • Review of White Paper info

3. Every Patent Starts with an Idea • The faculty member has a “eureka” moment • Every patent starts with an invention, and every invention starts with an idea • Ideas alone are not patentable • As you work to fully develop your idea, it will cross the boundary between idea and invention

4. A Protectable Invention • A protectable invention requires that you can describe it with sufficient detail so that someone of skill in the relevant technical field can understand how to make and use the invention • Once you are at that point you may want to start the patent process

5. What is Patentable? For an invention to be patentable, law requires it must: • Be of a patentable subject matter – in general, research findings in the lab meet this criteria • Be novel (i.e. at least some aspect must be new) • Be non-obvious • Be useful

6. Start with a Patent Search • A good first step should be for the inventor to perform a patent search • The whole point of a patent application is to articulate how the invention is unique • How else can that be accomplished without a comprehensive understanding of what exists as Prior Art?

7. Can I Patent My Invention? • In the majority of cases, your patent search will suggest that a patent could be obtained • However, the key question is not whether a patent could be obtained, but rather “Can a useful and profitable patent be obtained?” • You want a patent that is more than just framed and hung on your wall – it has to have value because the patent process can be very expensive

8. It’s a Delicate Balance • If you layer on a good number of specifics onto your invention, you will cross the point where the USPTO will determine that your invention is new and non-obvious • However, including specifics in the claims that don’t add to the value or the marketability is not usually a wise move because many layers of specifics can make your claims narrow and of less value • Conversely, claims that are too broad can likewise reduce value because they can be exposed to prior art

9. Shifting Gears to focus on MWU’s Process • Important highlights in MWU’s patenting history • What is MWU’s 4 step process today

10. Background on MWU • Dr. Alejandro Mayer filed for MWU’s first patent in 1999, and MWU received its first patent in 2002 followed by its 2nd in 2003 • Dr. Anil Gulati licensed MWU’s 1st patent in 2008 and another subsequently

11. MWU Patent Activity • The provisional and non-provisional numbers above reflect only those on which MWU submitted alone • They do not include several inter-institutional patents with which we are involved

12. I think I have a patentable idea that will result in a profitable invention • What do I do now?? • Step 1: Familiarize yourself with MWU’s Patent Policy

13. Where is MWU’s Patent Policy? • Faculty Handbook • Anyone wanting to start the process should familiarize themselves with it

14. FAQ: What amount does the MWU faculty member receive? • MWU’s Faculty Handbook essentially states that the faculty member shall be paid 35% of the net income resulting to MWU, after deduction of all expenses incurred by MWU in the development and/or disposition of the invention and patent rights • The remaining 65% of the net income shall revert to the institution (MWU) with 25% restricted to further support research at MWU and 75% directed to the support of institutional goals as determined by the President.

15. Step 2: MWU Invention Disclosure form • This form will take you some time to fill out, but it is VERY IMPORTANT that it is done so in a complete manner

16. Invention Disclosure Form

17. Invention Disclosure Form

18. Invention Disclosure Form Answering “Yes” to any of these will not necessarily be viewed negatively by MWU. Often times it is a positive for MWU to split the initial patent costs with another institution, but this requires MWU to have an Inter-Institutional Agreement (IIA) in place. MWU needs to know if any prior assignments were made.

19. Invention Disclosure Form Use as much detail as you can in answering these questions. Don’t hesitate to add pages. This info will likely be reviewed with an attorney before being submitted to the USPTO to document the dates and the detail with which you understood your invention.

20. Invention Disclosure Form

21. Invention Disclosure Form What is the Bayh-Dole Act? The Bayh-Dole Act was a landmark piece of legislation adopted in 1980 that allowed universities to own patentable IP that they created that were funded with federal dollars. Prior to this legislation, universities had to surrender this IP to the government, but the government ultimately realized that it didn’t have the resources to move those inventions forward.

22. Invention Disclosure Form • Please understand that this process takes considerable time • Large research universities that have an IP Office with staff and attorneys on site might be able to allow their faculty to publish potentially patentable inventions in a matter of a few weeks • This process at MWU takes some time – please do not plan to publish quickly!

23. Invention Disclosure Form Personal observation: Those faculty who have an entrepreneurial spirit, with appropriate contacts are most successful in moving their inventions forward to be patented and licensed. Making the appropriate contacts can be very difficult.

24. After the Invention Disclosure • Once the ORSP has received a complete form, you and your Chair/PD should notify your Dean by providing him/her the form • If your Dean is supportive and believes there is true feasibility with the potential to develop and exploit the invention to a substantial market, then he/she will notify the ORSP Director

25. Step 3: Assignment to MWU • As soon as the ORSP has a complete Invention Disclosure Form we will ask you to assign the invention to MWU • What does it mean to Assign a patent to MWU, and why would I do that? • A patent has many of the attributes of personal property, so the owner can assign the legal rights of the patent to another. This is done with a formal legal document.

26. Step 3: Assignment to MWU • Similar to most universities, MWU’s faculty handbook requires assignment of inventions that result from MWU research: • “MWU research means any research supported by funds administered by MWU or for which facilities operated or controlled by MWU are used” • “At the request of MWU, any faculty member who develops an invention owned by MWU… shall be required to execute the papers required for making application for patents in the United States and abroad and for assignment of such patent applications or patents, and/or all right, title and interest in and to the inventions, to MWU, together with such instruments confirming the complete ownership by MWU of such inventions as MWU may desire. The expenses of the patent proceedings undertaken pursuant to this paragraph shall be paid by MWU.”

27. Step 3: Assignment to MWU • The recent Stanford/Roche lawsuit decided by the U.S. Supreme Court underscores the importance of patent assignments

28. Step 4: The Ad Hoc Patent Committee Meeting • Before a meeting, we may enlist the help of an outside attorney (JD/PhD) who knows the legal side and can ask questions to help us determine whether the invention is at a point where it is ready to move forward in the process • The MWU ORSP has confidentiality agreements in place with appropriate attorneys • MWU’s CFO typically covers up to $5,000 for this initial review and/or a patent search (when needed)

29. What’s Involved with an MWU Ad Hoc Patent Committee? • Once attorney concerns are addressed, an Ad Hoc Patent Committee meeting is usually called • The role of the committee is to make a recommendation regarding how to proceed • Final determinations are made by MWU’s President/CEO

30. What’s Involved with an MWU Ad Hoc Patent Committee? • Typically scheduled for 2 hours – Starts off with you presenting your idea to the committee from all aspects: • Scientific concept/background • Current stage of development • Why should MWU pursue this/potential value? • What is the potential market size? • What is known about existing/competing patents? • What role did collaborators play/sharing of revenue?

31. What’s Involved with an MWU Ad Hoc Patent Committee? • You need to sell your idea to us! • It’s a little like ABC’s Shark Tank - but we typically don’t have anyone as brutally honest as Mr. Wonderful

32. Who is on MWU’s Ad Hoc Patent Committee? • The Director of ORSP serves as the chair • MWU’s Sr. Vice President/CFO is an ex officio who has financial authority over all decisions • Your Department Chair/Program Director • Your Dean • A faculty member with senior investigative experience (I typically choose your CAO)

33. Who is on MWU’s Ad Hoc Patent Committee? • Others with expertise selected by the chair • Interestingly, many universities with a IP Office do not allow those in the chain of command to serve on their Ad Hoc Patent Committees • This is mainly because those in the chain of command will want to show support to their direct reports, and they will struggle to tell the inventor that they don’t support them because they don’t believe their invention will make money • MWU has recently begun recruiting outsiders to serve on its committees to provide an outsider’s opinion

34. Please recognize: • Due to the very full schedules of those who serve on MWU’s Ad Hoc Patent Committees and the outsider(s) recruited, it typically takes about 1 - 2 months before the actual meeting can take place

35. How Does the Committee Make Decisions? • The committee is asked to utilize the White Paper to Guide Decision Making by MWU’s Ad Hoc Advisory Committee on Patents • This document outlines a “technology commercialization assessment process” taking into account the major factors involved in determining the potential commercial value of an invention

36. How Does the Committee Make Decisions? • It is intended to provide a framework for consistently evaluating, analyzing, and making solid decisions on how to proceed with commercial development of an invention at MWU

37. Key Elements of the White Paper • Many research-intensive institutions have previously been interested in filing patents at the very early stages of an invention’s development • When they were mainly a conceptual idea with little evidence to back it up • Inventions with only in vitro data • In today’s economy, these research-intensive institutions are now becoming very selective because of the associated costs of the process

38. Key Elements of the White Paper • MWU is a teaching institution where research is very important, but since research is not our primary goal, we may take a more conservative approach than research-intensive institutions • MWU intends to patent a select number of well conceived inventions that are significantly developed • It helps considerably if the PI has a well crafted development plan at the time of disclosure

39. Key Elements of the White Paper • A development plan with potential identified partners to meet future goals and potential licensors will be viewed more favorable than plans which lack these elements (but realize you can’t disclose anything to them!) • MWU’s ORSP has taken steps towards partnering with a major institution to see if they would be willing to “pitch” our patents to their industry contacts • But we anticipate this relationship will take some time to develop

40. Key Elements of the White Paper • MWU’s approach to patenting might be likened to that of industry, which is often unwilling to take the risks associated with licensing a technology which lacks proof-of-principle studies (in vivo work) or the development of an assembled prototype with a demonstrated use • It is a tremendous advantage to have: • Proof-of-principle studies completed • Milestones in place of anticipated future achievements • Identified a potential licensor for your invention

41. Factors Considered by the Committee • Is it novel? • Has anything been disclosed on the topic, which potentially gives up rights? • Does the data support the claims and its proposed uses? • Would MWU own the technology alone? • If collaborators are involved, is everyone’s role clear and agreed upon? • Do the other institutions wish to share in the costs of filing for a patent? • Have grants or MTAs given away rights to the invention?

42. Factors Considered by the Committee • Have commercial products been identified? • How far along is the invention? • How much additional testing is needed? • Is a plan in place for additional testing? • In a teaching-focused institution, this can be a major challenge: The 20 year patent clock starts ticking the moment a provisional patent is filed • Have proof-of-principle studies been completed?

43. Factors Considered by the Committee • If it is a drug for pharmaceutical development: • Have 3 genotoxicity studies been completed as required by the FDA? • Are there reasonable pharmacokinetics? • Bioavailability • Absorption • Protein binding • Distribution • Metabolism • Half-life • Clearance • Stability data

44. Factors Considered by the Committee • If it is a drug for pharmaceutical development: • Are there solubility challenges? • Is the size of the molecule anticipated to cause issues? • Have dosing and formulation been determined? • Is scale-up of the compound anticipated to face challenges? • Have side effects been noted in vivo? • Has the candidate drug been confirmed to not lead to cardiac arrhythmias? • Has the drug been compared to the market’s “gold standard”?

45. Factors Considered by the Committee • What is known about the potential market? • What are the current revenues of the market (if applicable)? • Who are the competitors? • Who would use/purchase the potential invention? • What are the current needs of the market? • What hurdles would a company that licenses this invention need to overcome to sell the invention? • Do competing inventions already exist?

46. Factors Considered by the Committee • What is known from “prior art” searches? • Does the inventor have a product development plan with the appropriate connections to advance the value and licensability of the invention? • Are partners identified who can help achieve steps where the inventor does not have expertise? • Has a potential licensor of the invention been identified?

47. Potential Outcomes of the Meeting • The committee may recommend that MWU support the invention and move forward with either a provisional or non-provisional patent • The committee may recommend not to support the invention, and to return the rights to the faculty member; a few reasons for this include: • Likelihood of obtaining commercially meaningful claims is deemed low • Anticipated income does not validate the anticipated expenses • For example: A market size that is not sufficiently significant

48. Potential Outcomes of the Meeting • The committee may determine that the invention is too “preliminary” • This usually suggests that the committee thinks the concept is promising, but falls into one of two categories: • There is no identifiable commercial product to date • The invention lacks sufficient supporting data to convince the committee that it is worth patenting at this stage of development • In this case, the committee will tell the PI how they believe s/he can advance the invention

49. Patenting Vs. Publishing • As an academic institution, publishing of scientific findings is very important to MWU’s faculty because of its implications on promotion • Yet publishing findings can reduce the value of inventions • Criteria for promotion as outlined in MWU’s faculty handbook, as well as handbooks of specific colleges, do not generally recognize the value of filing a patent on an applicant’s CV – you as faculty should work to change that!

50. Patenting Vs. Publishing • MWU recognizes that the need to publish is in conflict with the need to make decisions on patenting an early-stage invention • In these cases, the faculty member may need to weigh the value of these against each other for the particular stage of their career, and consult with administration to make the decision: • To publish results and forego the potential of a patent • Hold off on publishing to fully develop proof-of-principle studies or a useful prototype