Protecting Your Inventions, From Idea to Marketplace: The initial step in getting your medical device to promote would be to understand the master of the legal rights for your invention.
We’ve an abundance of suggestions for new medical devices. Many interventional vascular specialists have suggestions for new devices or procedures, or methods to improve existing ones. There’s an abundance of capital permanently ideas, either. The weak link within the innovation cycle may be the randomness underlying the procedure through which the minds, management, prototyping, ip, along with other foundational components interact with one another in the initial phase. If you’re like many inventors, you don’t have a skilled coach to handle the procedure. You’ve got a daytime job, perhaps a family, and also the path forward is uncertain.
You’re vaguely conscious that unless of course you receive a large amount of unfamiliar issues right, the possibilities low that you could produce a package which will attract the folks and capital essential to proceed. So, it comes down as no real surprise that although a lot of physicians in the area have clinically valuable inspirations inside the scope of the expertise, merely a couple of possess a realistic method to connect the dots. It makes sense a regrettable restraint around the pace of medical evolution. We lose suggestions for the incorrect reason, and promising therapies never achieve the individual. We have to fix that.
Initially printed in Endovascular Today on March 21, 2014.
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INVENTION AND INTELLECTUAL PROPERTY
MARCH 2014 ENDOVASCULAR TODAY 89
e have no shortage of ideas for new medi-
cal devices. Many interventional vascular
specialists have ideas for new devices or
procedures, or ways to improve existing
ones. There is no shortage of capital for good ideas,
either. The weak link in the innovation cycle is the
randomness underlying the process by which the ideas,
management, prototyping, intellectual property, and
other foundational components connect with each
other at the early stage.
If you are like many inventors, you do not have an expe-
rienced coach to manage the process. You have a daytime
job, maybe a family, and the path forward is uncertain.
You are vaguely aware that unless you get a lot of unfa-
miliar issues right, the odds are low that you can create a
package that will attract the people and capital necessary
to proceed. So, it comes as no surprise that although many
physicians out in the field have clinically valuable inspira-
tions within the scope of their expertise, only a few have a
realistic way to connect the dots. The result is an unfortu-
nate restraint on the pace of medical evolution. We lose
ideas for the wrong reason, and promising therapies never
reach the patient. We need to fix that.
One of the most daunting of the early stage challenges
is intellectual property (IP). Most people know that
unless you get the IP right, the effort is either wounded
or doomed to failure. But, at its core, there are only three
fundamental issues that provide the structural frame-
work for the byzantine statutory and jurisprudential
rules that follow. If you want to succeed, it is valuable for
you to understand that basic framework and consider
involving experts to manage or help manage the com-
plex details of the process.
This article is part one of a series that will present the
three big issues in IP: Do you own it? Can you protect it?
Do you have the freedom to practice it? In this article,
we set the context and explore common issues involving
that first question: Do you own it?
KNOW YOUR AGREEMENTS
The law always provides a starting point, and then
exceptions and qualifications. Regarding ownership, the
starting point is that your invention belongs to you,
unless you gave it away. Often, employees, faculty, con-
sultants, or others give future inventions away in the
form of an invention assignment clause in an employ-
ment, consulting, or other contract.
I have worked with inventors who genuinely did not real-
ize that the company or university would own their inven-
tion. They just sat down on the first day, maybe years ago,
and signed a stack of papers so they could get the keys to
their lab and start working. Like a mortgage, no one really
reads the details. But you need to know this one, so pull out
any agreements you have signed (or are planning to sign)
with your employer or other party and see whether any of
them contain an invention assignment clause or any other
provision affecting ownership or use of your inventions.
What if you can’t find your copy of the agreement(s)? Ask
for it. Human resources and legal departments are generally
quite skilled at retaining documents that might be helpful
to them. Once you have these, you might find that some
are quite clear and others are indecipherable. There is no
single standard. Some agreements also try to incorporate
external documents, such as a university’s policy manual
on IP, which might be 300 pages long and may have been
amended many times from the version that was in existence
when you signed your agreement. Unless your agreement is
quite clear, you may need legal counsel to understand it.
Let’s assume your contract contains an invention
assignment provision. The next issue involves the scope
Inventions, From Idea
The first step in bringing your medical device to market is to understand who
owns the rights to your invention.
BY GERARD VON HOFFMANN, JD
INVENTION AND INTELLECTUAL PROPERTY
90 ENDOVASCULAR TODAY MARCH 2014
of the provision and whether it is likely that your next
invention will belong to your employer. Here is a series
of successively narrower hypothetical descriptions of
subject matter that your agreement could purport to
require you to assign to your employer: (1) all inven-
tions you make, period; (2) all inventions you make
using employer resources on employer time; (3) all
inventions relating to the employer’s current and fore-
seeable business; (4) all endovascular inventions; (5)
all endovascular inventions above the iliac bifurcation;
(6) all neurovascular inventions; and (7) all inventions
relating to drug delivery coatings for nitinol embolic
coils for inhibiting hemorrhagic stroke. Some of these
provisions could be unenforceable, as they are exces-
sively broad; some could seem unfair but be enforce-
able because you signed the agreement.
You may be able to negotiate the scope of the obliga-
tion, within reasonable limits. Repeat inventors or key
opinion leaders sometimes have sufficient bargaining
power and can negotiate very narrowly tailored assignment
obligations, enabling them to consult with other people or
organizations on related, but not identical, technology.
Another agreement consideration is whether you should
carve out any inventions you made before signing the
agreement. Suppose you had an idea that you want to
pursue but have not yet been able to make the effort. If
you then sign an invention assignment agreement with
an institution and later pick the preexisting project back
up, the institution may understandably believe that you
invented that device during your employment, and as a
result, it should own the invention. You can seek to write a
carve-out into your agreement that identifies the previous
invention in sufficient particularity, but without revealing
the details. That elevates certainty, eliminates surprise, and
protects your ownership. You can also seek a carve-out in
advance for subject matter in which you might want to
invent in the future, if you want certainty that you will own
it if you do.
Sometimes, the scope of the assignment obligation
is unclear, it is too late to renegotiate it, and there is a
legitimate issue as to whether your invention falls within
the obligation. One course is to approach the institution
and seek a written release or acknowledgement that the
institution makes no ownership claim to that particular
invention. You may have some reluctance to take this
approach, and in some instances, it may be better to
do this through counsel. But if the issue of ownership
is cloudy, you will likely find it difficult to raise capital
or later sell the technology. If you do decide to seek
a release, earlier is better. Do not wait until you have
proved value or until you are walking into a financing
DISCLOSURE OF INVENTIONS
TO THIRD PARTIES
Let’s assume you start out owning the clear title to the
invention. Another set of ownership-related concerns
can arise if you disclose the invention to third parties. The
paradigm is common: you think you have a way to stop
endoleaks in abdominal aortic aneurysm grafts, or perival-
vular leaks in a transcatheter aortic valve replacement pro-
cedure, or something of similar clinical interest. A couple
of obvious business partners are already out there, so you
want to license the technology to one of them, rather than
try to start your own company. The natural tension is that
you do not want to disclose too much because of the con-
cern that the other party might take the idea and run, yet
the other party genuinely needs to understand sufficient
detail to evaluate the desirability and value of a deal.
If you disclose it without a confidentiality agreement,
sometimes called a nondisclosure agreement, you prob-
ably gave it away. At the same time, you irrevocably
lost patent rights, unless you have already filed a patent
application. The scope of that loss varies in different
countries, which is beyond the reach of the present
article. The bottom line is: do not disclose the invention
details without a confidentiality agreement in place.
Often, the other party will offer to let you use their
standard confidentiality agreement. This is nice of them,
but make sure you review it as carefully as you review
your employment agreement. These agreements can eas-
ily include provisions that you would not want to have,
leave ambiguity in areas of importance to you, or omit
provisions that you would like to have. Quite often, the
prudent course would be to consult with counsel on
issues raised by the agreement.
Even with a confidentiality agreement in place, you
take a variety of business risks if you have not filed a pat-
ent application before disclosure to a potential partner.
The safest course is to file the patent application first.
The considerations involved in that process are also
beyond the reach of the present article, but in most
cases, until you have considerable experience, you should
consult counsel with specific experience in the endovas-
cular field, rather than trying to do that on your own.
Another type of disclosure that can affect ownership
is a disclosure to a colleague. Assume that you have an
insight for an invention. A friend or coworker enters the
room, and in the excitement or in seeking validation, you
describe the idea. An impromptu brainstorming session
follows, and the idea begins to take a more defined form.
Inadvertently, you may have perfectly positioned your col-
league to become a coinventor on at least some aspect of
the technology. That happens frequently at the start of a
new project or company. Often, the coinventors proceed
INVENTION AND INTELLECTUAL PROPERTY
MARCH 2014 ENDOVASCULAR TODAY 91
to decide what business relationship (eg, prefinancing per-
cent equity) seems fair, have some agreements drafted, and
move forward in concert, but this does not always have
a happy ending. Your best friend might have the exact
obligation to assign to his or her employer that you negoti-
ated out of your employment agreement. Now you are
right back in some form of a partnership with someone’s
employer because of your coinventor’s obligation to assign
his or her interest in the invention. This issue is complex,
and the solution, if there is one, will always require involve-
ment of counsel. The best course is to avoid it at the front
end by preventing the creation of coinventors until you
are comfortable that you understand where that is likely to
WORKING WITH YOUR EMPLOYER
This article leads with the premise that complete own-
ership of your inventions is the goal. This is often but not
always the case. For example, if you were hired to invent
stent wall patterns, you should probably expect that
assigning them to the employer was a part of the deal.
New companies and deals are not an option.
Also, a growing number of institutions are imple-
menting acceptable, and possibly even generous, terms
that allow the inventor to share in the equity of a new
company that might arise from technology assigned to
the institution. Some institutions will be in a far better
position than you will be to advance the technology in
the direction of the marketplace in terms of both human
and financial resources, and while that is happening, you
get to stay focused on your daytime job.
Assume that your invention falls in a gray zone, such
that you might be able to obtain a release from your
employer if you push for it. Consider carefully the two
paths of (1) going it on your own or (2) taking what-
ever package your employer may offer before spending
energy seeking to perfect your title.
Remember that the end game for all of the stakehold-
ers in a new medical device effort is to improve patient
care. New products will never reach the patient unless
you can fund them and get all of the other foundational
steps right. If you succeed, you get to enjoy watching the
clinical implementation of your vision, and all of the par-
ticipants in the process may receive an economic return
As you start thinking about how to proceed with
your invention, consider whether you really have the
time and expertise to develop the technology. Also con-
sider whether you are prepared to surrender the equity
and control necessary to attract the right teams or to
run it through the institutional process. The path you
choose could affect the manner and extent to which
you seek to perfect the title to your inventions. n
The content of this article is provided for informational
purposes only, is not legal advice, and is not intended to be
a substitute for professional legal counsel.
Gerard von Hoffmann, JD, is a partner in the Silicon
Valley and Orange County offices of Knobbe Martens, LLP,
an IP law firm with extensive experience in patent strat-
egy and litigation in the medical device industry. Mr. von
Hoffman may be reached at firstname.lastname@example.org. See also www.
knobbe.com and www.knobbemedical.com for resources
and information for the medical device entrepreneur.
• The three big questions of IP: Do you own it? Can you
protect it? Do you have freedom to practice it?
• Know the scope of your agreement(s) with your
• It is safest to file a patent application and to sign a
nondisclosure agreement before presenting your
invention to a potential business partner.
• Disclosing an invention to a colleague may complicate
questions of ownership. Seek clarity.
• Some employers may be able to offer terms and equity
in the development of new inventions.
• Consult professional counsel with experience in the
endovascular field when applying for a patent.
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