February 4, 2015
Frank Grassler, J.D.
VP for Technology Development


The Office for Technology Development
(“OTD”) promotes the research enterprise at
UT Southwestern Medical Center by
commercializing research results in order to
bring medicine to many.
We manage UT Southwestern’s
◦
◦
◦
◦
◦
Inventions
Patents
Licenses
Startup company initiatives
BioCenter, UTSW’s commercial biomedical center




For the benefit of society, to initiate and sustain
cooperation between UT Southwestern and the
biomedical industry so as to advance new
technologies and therapies;
To provide our faculty with strategic & legal
guidance to effectively manage intellectual
property developed on campus;
To generate revenue for UT Southwestern and
our inventors, to support the research enterprise;
and
To facilitate the growth of the North Texas
biomedical industry.


Intellectual property (“IP”) is a general term
for intangible property rights that are the
result of intellectual effort. Patents,
copyrights, trademarks and trade secrets are
the main categories of IP rights.
At UT Southwestern, IP most frequently refers
to patentable inventions.

Underlying a patent is an
agreed exchange between
the US government and the
inventor(s).
◦ The US gives the inventor the
exclusive right to benefit from
their invention for a period of
years.
◦ The inventor discloses to the
public the knowledge of what
the invention is, how to make it,
and how to use it.


The US Constitution empowers Congress to
secure exclusionary rights to inventors for
their inventions for a limited period of time.
Although the inventor receives an
exclusionary right, they don’t automatically
have the right to commercialize their own
invention because someone else may already
have an earlier, broader exclusionary right.
Limited Territory-A US patent has no
power outside of the US. Likewise, no
foreign nation’s patent has any power
outside of that nation, nor any power
in the US.
 Property Rights-A patent can be
bought, sold, assigned, given as a gift,
willed to heirs, and used as collateral
for a loan.

Licenses-A patent owner can
negotiate with others to permit them
to commercialize the patent, in effect
allowing them to trespass onto the
property.
 Enforceability-A US court can grant
monetary damages for infringement or
a permanent injunction against further
infringement.





Since it’s property, a patent is always owned by
someone.
Under the Constitution, the first owner is
always the inventor.
Typically, inventors are subject to employment
agreements, where they automatically assign
their ownership to an institution/corporation.
In our own case, all UT Southwestern faculty
have already assigned their invention
ownership to the UT Board of Regents as part
of their employment agreement.

Although the patent property is owned by the
UT Board of Regents, any royalty revenue
generated by the patent is shared:
◦ 50% to the inventor
◦ 25% to the inventor’s lab
◦ 25% to UT Southwestern

The UT Southwestern revenue sharing policy
is not necessarily followed at other UT System
institutions.



Frequently, corporation vs corporation,
institution vs institution, or institution vs
corporation races are underway to discover or
invent something first.
The old rule in the US was that the first party
to invent, if proven by sufficient evidence,
was awarded the patent.
The rule in the rest of the world, and now in
the US as well, is that the first to file a patent
application will be awarded the patent.



The old rule in the US was that the patent
had a term of 17 years from the date the
application issued as a patent.
The current rule in the US is that the
patent’s term is 20 years from the day the
application is filed.
Term is important because legal action to
enforce a patent can’t commence until the
application issues as a patent, nor can a
patent be enforced after it expires.


A patent application describes how to make
and use the invention and sets forth precisely
what the inventor regards, or claims as being,
the invention.
A patent application frequently ends up being
the first in a series of related applications e.g.
◦
◦
◦
◦
◦
Provisional application
Non-provisional application
Continuation application
Continuation in part application
Divisional application



Examination can take many years.
Examiners look for eligibility, novelty,
obviousness, sufficient description and
enablement, specificity of the claim language
and patentable utility of the claimed
invention.
Novelty
◦ Novelty in the legal sense means that the claimed
invention was not identically described in a
publication released to the public before the date
the application was filed.

Obviousness
◦ Obviousness in the legal sense means that the
claimed invention was not obvious, to a person of
ordinary skill in the invention’s field, if that
person were to have read all of the relevant
publications released to the public prior to the
date of filing the application.
◦ Obviousness therefore CANNOT be determined
by looking solely at the invention; obviousness
can only be determined by looking at the claimed
invention at the same time as looking at all of the
relevant prior publications-i.e. “prior art”.




Prior art is any relevant publication, in any form,
or any demonstrative act, that was available to
the public before the application filing date, i.e.
the Priority Date.
No publication or public demonstration can be
considered that occurred after the Priority Date.
The inventor’s own publication or demonstration
can be used against them if it took place before
the Priority Date.
Therefore, we always advise filing before
publishing.



If your publication or poster completely
describes the invention, you have lost
novelty.
If your publication or poster only describes
part of the invention, it can be used against
you as part of an obviousness rejection.
There is a grace period in the US of one year
to file a US patent application from the date
of publication, but there is no grace period
outside the US and foreign patent rights will
be completely lost.



This is the date that the first application is
filed with a patent office.
Here, this is typically a Provisional application
filed in the US Patent Office.
Subsequent patent applications in a chain of
applications can claim the benefit of the
priority date of the first provisional
application.

The invention must be described fully in the
application
◦ The description has to enable someone of ordinary skill
in the field i.e. “the art” to make and use the invention
without undue experimentation.
◦ The scope of the claim has to be supported by the scope
of the description.
 A claim to a series of tetracyclic compounds and anthracene
compounds is not supported by description of one category
but not the other.
 A claim to a pharmacogenetic association between a
genotype and multiple clinical characteristics is not
supported by a description of only a single clinical
characteristic.


There are only four categories of patent-eligible
subject matter:
◦
◦
◦
◦
Compositions of matter
Articles of manufacture
Machines
Processes
◦
◦
◦
◦
Laws of nature
Natural or physical phenomena
Mental processes
Abstract ideas
Our research often results in scientific discovery
that falls into four categories of unpatentable
subject matter:









Small molecules (MW <500)
Peptides
Proteins
DNA and RNA sequences, whether coding or
non-coding, e.g. siRNA
Vectors
Cell Lines
Bio-processing reactors, machinery or processes
Software
Robotics


One cannot patent a natural law or
correlation, fundamental truth, abstract idea
or disembodied concept without applying it,
using applied science or engineering that
goes significantly beyond an instruction on
how to make use of that law or concept.
In Mayo v. Prometheus, the inventor
discovered that administration of
azathioprine for immune-mediated GI
disorder resulted in 6-thioguanine metabolite
levels that correlated with myelosuppression.


The correlation led to the conclusion that
levels of 6-thioguanine should stay in a range
of 230 to 400 pmol per 8 x 108 RBC’s to be
efficacious yet avoid myelosuppression.
The claimed invention was a method of
optimizing therapy by administering drug,
determining levels of metabolite and
adjusting subsequent dosing as needed.



The Supreme Court found that this amounted to
an attempt to monopolize a basic natural
biological relationship.
It is not enough to inform a relevant audience
(doctors) about certain laws of nature (observed
levels of a metobolite result in toxicity) and
telling them to adjust dosing accordingly.
Today, this might be a patentable invention if
coupled with specific novel kit, apparatus or
software that requires complex programming for
a specific application to a narrow field or resolves
a data field.


Association for Molecular Pathology v. Myriad
Genetics
Another recent Supreme Court case, holding
that a gene, i.e. the unit of information
conferring a heritable trait, is not patentablebut note carefully that the cDNA analog to the
natural DNA sequence, being a man-made
composition of matter and non-naturally
occurring, is patentable.

Questions left unanswered by the Myriad case
◦ Claims to methods of using a gene sequence
◦ Claims to mutations of naturally-occurring
sequences
◦ Claims to useful compounds extracted from natural
sources

Composition of Matter
Target
Natural ligand
Synthetic ligand
Analogs, homologs and congeners
Enantiomers, salts, esters, prodrugs, hydrates,
solvates, ultrapurified concentrations
◦ Alternative crystalline forms
◦ Fixed dose combinations
◦ Pharmaceutical formulations
◦
◦
◦
◦
◦
 Improvements in timing of release, GIT crossing, BBB
crossing, location in depots.

Composition of matter-products of:

Method of synthesis

Method of Use

Article of manufacture
◦
◦
◦
◦
◦
◦
Organic chemistry
Nucleic acid chemistry
Peptide chemistry
Bioengineering
Fermentation
Extraction & purification from natural sources
◦ Improvements over bench synthesis
◦ New medical utilities/therapy
◦ Diagnostic devices
◦ Therapeutic devices
◦ Research tools, platforms, software


In the pharmaceutical industry, by far the
most important patents are those that cover
the chemical formula of the therapeutic
product itself, i.e. new chemical entity (NCE)
patents
NCE patents frequently cover small changes
to a molecule’s structure that confer some
therapeutic difference. Such a small
difference may leave the new drug within the
coverage of an older patent, thus
necessitating a license, or a cross-license.

Other patent types valued by the industry:
◦
◦
◦
◦
◦
◦
◦
Pharmaceutical formulations
Method of treatment
Pharmacogenomic
Mechanism of action
Improved method of synthesis
Key intermediates in the synthesis
Research tools




Targets
Naturally occurring ligands
Screening technologies
Libraries

Reach-through claims
◦ A patent on a target or a pathway does not cover all
ligands of the target or molecules that target a part
of the pathway.

Reach-through royalties
◦ A patent on a target or a mechanism of action does
not generally entitle the inventor to royalties on the
sale of a drug discovered using that target.





OTD receives many disclosures describing early
stage inventions. In Translational Medicine, the
inventions are not so much research as
development.
What is the product and can we protect it?
Would the availability of patent rights positively
impact the attractiveness of the invention?
Even if available, does it make financial sense to
pursue patent rights?
What other third party rights may be required to
practice the invention? Are they available? At
what cost?



An inventor recognizes that a unique observation
or development has taken place that may be
valued by the marketplace.
The invention is disclosed to the OTD by filing an
Intellectual Property Questionnaire (“IPQ”) online
or by filling out the form provided for. See
http://www.utsouthwestern.edu/aboutus/administrative-offices/technologydevelopment/transfer/intellectual-propertypolicies.html .
Or call us and schedule an appointment-our
place or yours (we like to see what you’re
working on).



It is important to file any IPQ as far in
advance as possible before any intended
public disclosure to enable a thorough
evaluation of the invention and to permit
adequate time to file a patent application.
The information submitted in the IPQ should
be as accurate as possible. Any helpful
information should be attached to the IPQ.
The filing of an IPQ is NOT the same as filing
a patent application.
Frank Grassler, J.D.
Ray Wheatley, MS, CLP®
Kathy Schutt, CLP®
Vice President for Technology
Development
214-648-1902
Frank.Grassler@utsouthwestern.edu
Director for Technology
Commercialization
214-648-1888
Ray.Wheatley@utsouthwestern.edu
Director for Cooperative and Sponsored
Research
214-648-1881
Kathy.Schutt@utsouthwestern.edu