M. D. Anderson Cancer Center
Date: February - April, 2008
Duration: 0 / 28:20
So I'll take more question as we go along. At this point, it is my
honor to present Elizabeth Heilman, Miss Heilman how we call her.
Please no booing comes, from Texas A&M where you tea here and then
made her Ph.D here at M. D. Anderson so it's kinda high grade between.
Ultimately.
Ultimately. So she went from the dark world to the bright world
and now worked in our Tech Transfer Office for many years and then
worked with some faculty member and when he heard that she was
somewhere out in that orbit, we grabbed her right away because we enjoy
highly working with her while she has in the Tech Transfer Office who
valued her contribution and today she is part of our office. So
if you combine, have question, she is one of the ones that gonna sit
down and she, of course, brings all the expertise that I didn't have
about technology transfer. So with that set, she's gonna tell a
little bit more what to do with your invention. Please applause
for Liz Heilman.
Ohh. Thanks anyway, so sweet. Let's see if I can...It's
okay I got it. It's...I got it. Okay. Well thanks Oli
for that really nice introduction and so Oli invited me to come today
and talk to you guys about new invention disclosures here at the M. D.
Anderson and as he mentioned, at one point, in my career I was a part
of the office of technology commercialization and I worked there as a
technology analyst and a large part of what I did and I actually still
work with Tom Lee. He's gonna follow me next and talk about
license as in start ups. And a big part of what I did back then
was deal with invention disclosures from the faculty and as I look at
in the audience today and actually over the past few weeks as well I
see many familiar faces from when I was at OTC and so some of what I'm
gonna present today may be familiar to some of you but for those of you
that are not familiar with this process and except you need to take in
order to disclose invention and why it's important, hopefully, I can
give you a broad overview of that. Before I dive right into the
topic though, I thought it would be a good idea to give everyone sort
of an overview of our office and so I'm a member of the office of
technology discovery here at M. D. Anderson and that's actually a
separate office from the Office of Technology Commercialization or
OTC. So OTC is gonna be the office that you will deal with as far
as actually having a patent filing in any business transactions related
to licensing and or start-up of your really just invention. But
Office of the Technology discovery were actually part of the Office of
Translational Research here at M. D. Anderson surrounding the academic
side of things and the umbrella of translational research is overseen
by Dr. Bob Bast, who is the Vice-president for Translation Research
here at M. D. Anderson. So we all and report directly to Dr. Bast
and of course our office is comprised of myself, Dr. Stan Tucker and
Dr.Oli Wenker. And so we actually interact with the faculty
members sort of upstream of what you might consider of the traditional
tech transfer and activities. Our mission is pretty clear.
We were here to support use the faculty and staff inventors of M. D.
Anderson, increase translational research and ultimately to help
facilitate commercialization within M. D. Anderson. So although
we are separate entity from OTC, I have to say that we work very
closely with that office on various projects and so we were in constant
contact with them and we try to help streamline new inventions that our
new discoveries from faculty and staff and work with OTC to determine
what might perhaps the best route to go and what to do. And so
from our mission, we accomplish this in several ways and, first and for
most, is technology development planning and so again we're in the
early stages with the faculty. Faculty will frequently contact us
and say I have this really interesting observation or hey I have this
really neat discovery. Do you think...what should I do with
this? How do I move forward? Is there something that I can
really commercialize and so and like all will just sort of touching
almost sit down; we'll meet with them or go through. What is
their data, what they found so far and what they plan to do and what
they wanna do with their work and we try to guide them towards
developing their technology and to perhaps marketable product that OTC
then can take and actually license or build the start-up around.
In addition to that, we also work a lot with outside pharmaceutical
companies. And Stan Tucker and myself, actually spend a
significant amount of time working on strategic alliances on the broad
institutional level for all of M. D. Anderson and this is
really meant to bring in I guess more funding for
preclinical and clinical research here at M. D. Anderson and also
provides hopefully our faculty faster access to the newest and best
drugs that the pharmacies have to offer. But in addition to that,
if you as a faculty member wanting to collaborate with industry in any
level, you certainly can contact us and we can put you in touch with
many of our former partners that we have current agreements with.
And the third bullet point here, we can also provide access to funding
and this is referred to internally as the Technology Review Committee
or TRC Funding and I know Keith just talked about the Texas Ignition
Fund and that model is very similar to what TRC's model is and that
these are not research funds. These are meant specifically to
drive your invention towards commercialization. So our office,
myself, Stanley, and Oli will help you form a project team and we'll
help you for the proposals together with very specific
commercialization milestones and budgets attached to those milestones
and help you go to the TRC and ask for funding. And OTC is very
involved with that and that's really where we interphase with the OTC a
lot and OTC is a member of the Technology Review Committee and so this
is a great example of how our two offices work together to help move
inventions towards commercialization with any institution. And
the last bullet point here which is obviously the topic of my
discussion with you today is we help facilitate invention disclosure to
OTC and this is really important and again many of you maybe seasoned
inventors and have done this many times. A lot of the time
though, there are many faculty members or either new to the institution
or junior faculty and aren't the process by which to go or maybe you've
been here for a long time and you just aren't really sure if you should
disclose and this is really where we step in and can help the faculty
inventor to move forward. I know some of these bullet points on
why disclosing your inventions is so important. I know this has
been touched on both a little today and also in previous weeks but I
just can't emphasize it enough. First and for most, any of the
policy people or the legal people with any institution are going to
preach to you that disclosure of your inventions is an obligation of
your employment here at M. D. Anderson and so and if nothing else, you
have to do it based on your employment contract with the
institution. And Keith also mentioned this earlier and I know I
will state it here again, it's a Federal requirement if your invention
is made with Federal grant money, for example, NCI, NIH, DOD, all of
these things require the institution to report this and actually if I'm
not mistaken, sure we can't send OTC as still the individual that does
this and it's very important that we keep up with these and you can
imagine in an institution the size of M. D. Anderson, how hard it can
be to actually track this and so we rely on the use of the inventor to
really report this. Perhaps the third bullet point, may be the
most important, on this slide and that is the public benefit from your
invention and lab discoveries can only really be realized if it's
brought to the market place and so many people and you know again they
asked why disclose and for no other reason, you can't really help in
our situation here at M. D. Anderson being the patients that come here
everyday and nothing can really help the patients unless it's actually
transferred to the market place. And then of course financial
benefit is always possible, should the inventions be successfully
commercialized and your license or start-up or whatever the
commercialization activity maybe related to that. So these are
all really important reasons to keep in mind for why you should always
be thinking about these when you're creating things in a laboratory
setting. So if you believe that you do have an invention, there
are three main criteria that are defined by the U.S. Patent and
Trademark Office that determine whether or not your invention can be
protected by a patent for example. And these criteria may give
you at least a preliminary idea as to whether you have an invention
that can be protected and perhaps commercialize. And I always
like to list this out just because I know that people always ask, what
are their requirements for patentability? So of course your
invention must be useful and I think that the scientist of course can
identify a used quarter. You probably wouldn't be working towards
this. So usefulness is typically easy to show and more difficult
in some cases is novelty and non-obviousness. And so of course
novelty cannot be previously identified in any patent literatures,
scientific literature, any other prior art of any kind out there and
non-obviousness relates to...it cannot be obvious based on the prior
art that's known to a person having ordinary skill in the field and can
just go and read it, the prior art will like oh! Let me put A
plus B together, that's obvious. And Tommy maybe able to give you
a little bit better idea on this because OTC is dealing with this all
the time now especially with more strange requirements coming down from
the USPTO; but non-obviousness is really becoming, I think, more and
more difficult to overcome if it's identified. So some types of
inventions and I always like to list this out as well just to give you
an idea that coming from cancer center, composition of matter maybe
something that we can immediately think of, oh, a new drug that treat
cancer. That's a great example of composition in matter but also
just as important in certain cases is identifying a new method of use
for example a drug. Perhaps, you're looking at an immunological
drug but you've identified that no one really else has looked up before
that it's also active in breast cancer or ovarian cancer or leukemia or
whatever it maybe; such a known composition of matter but you've
identified a new method of use for that so that's also something to
think about. And of course new devices, new research tools.
This relates to, for example, cell lines, knockout mice and different
methods of manufacture. So once you've identified that yes I have
an invention, now what will I need to do. And of course you can
always go directly to the Office of Technology Commercialization or
OTC. But if you're not really sure, again, coming back to well
how do I move forward? What do I do? You can always contact
one of us and Stan, Oli or myself through the Office of Technology
discovery and if you contact us, we're gonna sit down and we're gonna
meet with you and we're gonna go over everything with you and we're
gonna help you plan. When you need to do certain things, is it
too early now to consider for commercialization to OTC funding or is
this a great time to move right forward and you're already planning
your next steps and have you disclosed it? We always,
always. We can't stop preaching this and that how do you disclose
the invention and if not, we are gonna urge to submit what we call an
invention disclosure report or IDR. And the IDR, I know Keith
kinda related to this about, some of them are simple and some of them
are more detailed. I think the more detailed one is coming.
This is my experience coming from a Tech Transfer Office at one point
in my life but the more detailed it is, the more valuable it is, I
think, to the tech transfer people and so that I, again the more time
you spend on this and the more valuable it will be and possibly the
quicker things we can look forward. Our IDR here at the M. D.
Anderson encompasses many different points and bullet points and some
of the important ones here, the creators of the invention or the
inventors, public disclosures, in conferences and details of the
invention. I'm gonna go through each one of these in the
following slides and a bit more detailed. So, of course the
creators of the invention. Now these are the persons or people
involved in the conception or creation of the inventions and the IDR is
gonna ask you to list up the people's names and describe their creative
activity and not only do that but then they're gonna also asked you to
define the percent contribution and this is really important that to
determine and because I think and again, correct me if I'm wrong, Tom
but this is what is to use later. Based on this percent
contribution this is what is to use later. Should any revenue be
realized from your invention and the pay back that goes to the
inventor. This is gonna be broken down by this percent
contribution. And I always like to also put this slide in here
about inventorship and this is a matter of patent law. That's the
bottom line here and it is not the same as authorship and frequently
this is sometimes difficult for especially scientist to really grasp
onto. Just because the publication that you're working on has
eight or ten authors on it does not mean that you have eight or ten
inventors on the invention that the publication encompasses and that
something to really think about and again it comes back to who was
involved with the conception of the invention. I understand that
laboratory technicians, for example, are very important in moving your
work forward. You probably couldn't get a lot of this done and
publications published unless you had that extra work in your hands in
the lab. But those types of people that are just simply carrying
out experiments under your direction for example would probably likely
not be an inventor and so thus those kinds of people probably shouldn't
be named on the invention disclosure report or on any patent following
that would occur. An inventorship is just for your knowledge is
determined at two times and we're talking about patent filings.
First, determine at the time of the filing itself when the first claims
are drafted and then again a patent issuance. And this is
important to think about just because you have one set of inventors at
the time of filing does not necessarily mean that it will be the same
set at issuance because the claims can evolve overtime, over the
examination and prosecution of the patents and the claims that are
actually issued at the end will dictate who the final inventors
are. Public disclosures. The IDR is going to also ask you
about public disclosures and a lot of times, people just skip over this
section and I think it's really important to emphasize and because of
course any public disclosure can impact your patent ability. This
is what I'm talking about prior disclosures. If you've got
anything that you've already published, you've already presented this
at ACR last year or you're about to present for example at ACR this
year and I'll just take this opportunity to plug that if you do have
something in ACR that you feel covers and invention that you have not
disclosed; you probably need to act on that pretty quickly 'cause ACR
is going to release those abstracts publicly online, I believe on March
15th. So this is something to think about. And public
disclosure means anything really in the public domain. I've
listed out an array of things here including your manuscripts, your
posters, your abstracts and you're talking about ASCO/AACR top of
things. Seven hours that you might give outside of the
institution and including job interviews and this is important too for
example post stocks. If you're out interviewing for a job
interview, of course you're presenting on your work that you'd
accomplished so far and it's important to know that again if you have
not this clear or you're about to prepare for example to get a job
interview, similar for job interview you probably need to go and
disclose the OTC anything that you feel is a true invention in that
presentation. Of course, anything on the web, online
publications, postings, and even verbal conversations. I also
didn't put in writing here but let me emphasize, it's also a great idea
and Keith eluded this a moment ago to let OTC know as far in advance as
you possibly can. When you have plan to public disclosure so if
you're saying okay I'm working on this with you know on a paper and
we're gonna submit to cell on you know April 5th, let OTC know.
They need to know where things are going. They need to know when
you're gonna send it and you maybe thinking well I don't know what's
gonna go back and forth with eventual revisions and that doesn't
matter. Let OTC know as soon as you're going to be planning your
submission. And in conferences, this isn't really spelled out as
the word in conferences on the IDR you don't believe. But this is
gonna be where they ask questions about others that may lay claim to
your invention and this is gonna really be important when you're
talking about different sources of funding especially when you're
dealing with the sponsor research agreement for example. If you
have an SRA or sponsor research agreement with an outside company,
chances are that there is some IP closes in that contract and you need
to let OTC know and there's a specific section on the ITR that says do
you have any contractual relationship or outside funding? Yes,
then you need to spell it out. And then OTC goes and checks that
to see what kind of claim to this invention based on the funding that
came in for it that that company might have. Same as true for
material transfer agreements, many of you will receive a compound from
outside the institution and those material transfer agreements are very
important or you may send something, a specimen or something outside of
the institution. And let me also give the opportunity to say, don't
ever send anything without doing an under material transfer agreement
right? And so this also includes any clinical trial release. Any
of these contractual things, software agreements and also it's
important to know that if one of the inventors is employed elsewhere
outside of M. D. Anderson. And this is not a true hurdle to
commercialization or anything like that; we just need to know who
you're working with, if you're working with Dr. X at Stanford, that's
great. We just need to know that it's from Stanford and that will
cue OTC to get in touch with Stanford and start working out okay how
are we gonna do this? Who's gonna take the lead on
commercialization and how we're gonna break this out later and so it's
really important to note this to OTC. And then once you've
gotten all of that other information out of the way, of course the most
vital information may very well be that's your details of your
invention. What is the product? That saying is simple but a
lot of the time when people are disclosing, they're giving very
elaborate scientific reasons for why they went this route and that's
all very important that you really need to spell out for OTC what the
product is. What can they market here? They really can't
market in observation. What are you gonna...what are you really
driving towards based on your observation? These are the things
that you really have to spell out. How is that product
competitively, what are the competitive advantages of that
product? In other words, how is it faster, how is it cheaper or
how is it better than what's already known in the market? Again,
it seemed like really hardcore business type of approach but, you as
the inventor, are probably gonna know your market better than
anyone. And so it's really important to help OTC and tell them
exactly what you know, where the niches in the market that's missing
and how you're gonna feel it. And of course any data that you've
obtained today, any proof of concept or proof of principle that you've
achieved but what are your future plans? Okay, you have gotten
this far, you've have your invention, you've disclosed. What are
you gonna do now? And on a time people think that just okay, that's
it. No. That's usually not right. What do you plan to
do and follow up with this and keep it driving towards
commercialization? And you also plan your any potential licensees
and those questions on the ITR's and a lot of the time, licensing or
business transactions happen simply because the inventor has been
contacted directly by one of the companies. This again, I'll use
the AACR example. You're presenting at AACR and Mark comes up
after and says hey that was a fantastic presentation, what are you
doing? And this is when this is gonna cue you? Oh my
goodness, I probably should have disclosed to my tech transfer office
but if not, that's fine. Just come back and do it and you need to
let OTC know. If you have already disclosed or you're planning to
disclose, let them know if one of the companies has approached
you. This is really the key because, then immediately, OTC can
follow up and that's a really easy route to see what type of interest
there really maybe on the other end. Once all gotten the whole
idea are completed and all inventors have signed and returned the IDR,
then what do you do? Well it's submitted again like I said to the
Office of Technology Commercialization and OTC has meetings what they
call assessment meetings every other week where they are reviewing the
latest disclosures to the office. And our office is also involved
with that meeting and OTC sets and determines exactly what they need
and next steps for protection might be and what might be the best route
for commercialization. And it is important to note OTC, of
course, will handle all the negotiation of any business transactions
related to licensing or start-up or anything like that. But
again, our office can help you move from your very early discoveries
into the OTC side and how they will move it out from there. And I
wanted to put the royalty sharing policy. I know Keith also said
this but I think it's important in the list up here. Because many
times people will come to us and say what's the break out and we always
say will, you know, you didn't check the policy and they are like, we
don't know where the policy is so I just wanted to put it up here and
UT system has the break out; it's 50 percent to the inventors and 50
percent to the institution and M. D. Anderson breaks out that 50
percent as I've listed here, 15 percent to the creator or creators,
lab--to support the research and 10 percent also goes to the department
chair. More times than not, I'll say that the department chair
will usually funnel that right back into the inventors labs because it
was the inventor that brought the revenue in. Technically, it's
at the discretion of the chair but typically that's you know more times
than not, that's how it happens and of course 25 percent to the
institution itself. So with that, I'm gonna end. That was a
quick talk but hopefully it was at least a general overview of why you
should disclose and the important process and again, I'll just say it
one more time, the more time you spend on your invention disclosure
report, the more valuable it's gonna be. That went to you but to
your tech transfer officials that are trying to move that out into the
market place. So with that I'm gonna turn it over to Tom Lee
unless there are any immediate questions.
Once you have filed IDR, are you free to discuss it in seminar or summit and others?
No. Just because you disclose your invention to the Tech Transfer
Office that doesn't mean you're automatically covered and there kinda
any kind of confidentiality. You still need to be aware of the
fact that you need to be put in confidentiality agreements and place if
you're going outside the institution. If you're talking about
meetings is what I'm talking about. Now if you're gonna go to
AACR like I said you need to let them know, that's a public
thing. You can't obviously have a CDA and place for that but if
you're gonna go out and wanna talk to companies or go and talk with
other individuals elsewhere, you need to be concerned about that okay,
confidentialities out to place and Tom can probably comment more on
that but if you have a patent filing and you know that's underway, you
may not need to worry about public disclosure per se meeting like AACR,
that's what I'm referring to. Companies, always a CDA.
I have two questions. First, invention has to be useful, novel,
and non-obvious. There are a lot of patterns on genes, just genes
have been sequenced and we know what they are and know people how to
put patterns on them and nobody can use them in any kind of
translational applications?
And that will, okay so I'll just bring one comment on that. Not a
patent attorney. First and for most but in my experience, those
were much older patents that were put in place. Those were faults
sometime ago. That's no longer a common practice within the
Patent and Trademark Office and I think that they realize sometime ago
and what was happening there and they didn't, I don't know if you can
comment more on that Tom what the trend is but I know that my personal
experience is that that is no longer a common practice there.
Okay my other question is, how well developed the idea should be?
I usually have done already a lot of experiments for the observation
you have or could you just report it or disclose it before its fully
developed?
You mean at what stage should you disclose? My general answer to
that is as soon you've identified you had a real invention I will
disclose it. OTC may not wanna file a patent on it today but they
may tell you okay this looks really good, get us some in vivo
data. Show us some more proof of concept and then we know that we
can act and we really have something here. So in general, I don't
ever wanna suggest that you delay disclosing 'cause that is not really
what we're after here. We want you to disclose as soon as you've
identified that you have a real invention or something that you feel as
a noble invention. Yes!
I have a question. Is the post stocks considered an inventor and
how does it benefit from that and the second question is if there is an
invention that you do not acknowledge, are you able to write the letter
saying you do not wanna deal anything with this invention?
I will answer the first question. Maybe Tom.
Repeat the question.
Let me repeat the question. You're asking first of all, post
stocks that maybe inventors or personal, or their even inventors, I
think that's your question and my answer to that is if you contributed
to the conception and the invention, then you are an inventor. If
you are, it doesn't matter what your ranking is. Inventorship is
a matter of law, like I was saying, and it's just as simple at
that. Now how will you benefit? Well that again comes down
to percent contribution that's defined and for what I understand as the
post stocks, you're probably working directly with your mentor and your
faculty adviser and here she may also be an inventor on there. I
would imagine you likely are and again that's really, all of that's
decided among the inventors. And again if you created anything
towards the conception of that invention and you are an inventor.
Now, how they deal with it, if you're saying M. D. Anderson chooses not
to pursue commercialization or file a patent, I don't know what the
standard practices now about that. But typically, I don't think
M. D. Anderson, I mean, is going to just give it up. I mean, if
you really feel you have a reason for why it needs to be commercialized
and you feel they haven't moved on it, get in touch with them, talk to
them further. Find out why. Maybe they're lacking a piece
of information that just hasn't been communicated or maybe you feel you
communicated it and I missed it. All of these things are
important and you have to... constant communication that's what Keith
was talking about and I just emphasized it again and go from there.
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