LICENSING AND TECHNOLOGY DEVELOPMENT-
BACK
Don’t Get Tangled up in Encumbrances
and Get a Handle on the Strings Attached
Scientists at JHU bring in a tremendous
amount of biological materials from the outside to work with
in the pursuit of scientific research. Some materials are from
other Universities but the majority is from commercial sources.
Just look at the mountain of boxes from companies that end up
in the hallway destined for the trash or recycling. Don’t
be misled. These materials, whether purchased or not, usually
come with strings attached. The good news is that you can and
you can keep from getting tangled if you get a handle on the
encumbrances!
JHU also brings in research materials
from companies under corporate sponsored research relationships.
In addition, materials can be brought into JHU from companies
at the request of the faculty members without such sponsored
support. In both scenarios, the incoming materials are usually
accompanied by incoming Material Transfer Agreements (MTAs)
that stipulate the “rules of handling and transfer to others.”
The sponsored research materials many times have pre-agreed
MTAs that expedite the transfer.
Because companies are always looking for
technology to incorporate into new products, they are particularly
interested in any intellectual property that may fall out of
research they sponsor. Sometimes they wish to have rights to
improvements, data, derivatives, etc in return for merely providing
JHU with a compound, antibody, cell line, construct, etc. They
usually want and get something in return for their sponsorship
investment and this is where encumbrances can originate.
It is the obligations and restrictions
that JHU has agreed to or exchanges for receiving sponsored
research funding or for receiving materials to be used in research
which determine the extent and nature of what we can do with
the research findings and the research tools that may be discovered
and produced along the way.
If we agree that the company that provided
funds or materials has rights to the findings, then those findings,
whether tangible or not, are encumbered. This means that JHU
has as least some restrictions on their freedom to operate.
We may have restrictions of dissemination to third parties.
We may have restrictions on licensing. We may even have restrictions
on dissemination to other JHU scientists, whether collaborators
or not.
There may even be encumbrances on materials
that we purchase from companies. Every company sells product
pursuant to their “ terms and conditions of sale.”
This can be found in the fine print of the package inserts,
on the catalog and web sites. Just take a look at the Invitrogen’s
Limited Use Label Licenses list for an impressive list of technology
patents with their use and transfer restrictions see: http://www.invitrogen.com/content.cfm?pageid=101
It’s a great source of who owns what research reagent technology.
An encumbrance can also arise from purchased
reagents because some reagents contain materials that become
included or co-mingled in novel biological materials made at
JHU. For example a commercially available plasmid can contain
the CMV promoter, owned by the University of Iowa, luciferase,
owned by the University of California. A JHU investigator purchases
the plasmid and inserts a novel gene into it. The investigator
speaks at meetings, publishes papers and as a result the scientific
community wants to use it and other companies compete to license
it.
If the research was funded by NIH, JHU
is obligated to disseminate to the scientific community as the
Guidelines for Recipients of PHS Grant Funds require dissemination
of novel materials so as to further expedite scientific knowledge
and discovery. The Bayh-Dole Act of 1980, allows research institutions
to retain title of PHS funded intellectual property as long
as there is effort to offer discoveries, including any tangible
components, to the commercial sector to stimulate product development
and more timely advances destined for public use and benefit.
Because of common provisions in incoming
MTAs and certain reagent Terms and Conditions of Sale, Investigators
must pay close attention to any dissemination restrictions,
approved fields of use, permission to use in sponsored research,
and most importantly, the retention by the provider of materials
of any resulting intellectual property rights before they begin
to work with the materials.
Researchers obtain materials from companies,
friends, colleagues, and collaborator wannabes at other Universities,
usually with some restrictions. Be assured there is usually
a catch! Some things we can agree to and some things we cannot.
For instance, JHU would never enter into
an agreement that would restrict JHU’s academic freedom
or right to publish. At LTD we try to help investigators navigate
through the language that binds in an effort to de-tangle the
strings that may potentially become attached to the results
and outcomes of the great work performed here at JHU.
Catherine E. Vorwald, M.S.
Associate Business Development
Licensing and Technology Development
cvorwal1@jhmi.edu
Tel: 410 516-4964
