Importance of intellectual property generated by biomedical research at universities and academic hospitals
Importance of intellectual property generated by biomedical
esearch at universities and academic hospitals
Joris J. Heus1,*, Elmar S. de Pauw1, Mirjam Leloux2, Margherita Morpurgo3,4, Michael R
Hamblin5,6,7, and Michal Heger8
1Innovation Exchange Amsterdam (IXA) Office AMC, Academic Medical Center, University of
Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands 2Innovation Exchange
Amsterdam (IXA) Office UvA-HvA, University of Amsterdam, Science Park 904, Amsterdam, the
Netherlands 3Department of Pharmaceutical and Pharmacological Sciences, University of
Padova, Padova, Italy 4Technology Transfer Office, University of Padova, Padova, Italy 5Wellman
Center for Photomedicine, Massachusetts General Hospital, Boston, Massachusetts, United
States 6Department of Dermatology, Harvard Medical School, Boston, Massachusetts, United
States 7Harvard-MIT Division of Health Sciences and Technology, Cam
idge, Massachusetts,
United States 8Department of Experimental Surgery, Academic Medical Center, University of
Amsterdam, Amsterdam, the Netherlands
Abstract
Biomedical research has many different facets. Researchers and clinicians study disease biology
and biochemistry to discover novel therapeutic targets, unravel biochemical pathways and identify
iomarkers to improve diagnosis, or devise new approaches to clinically manage diseases more
effectively. In all instances, the overall goal of biomedical research is to ensure that results thereof
(such as a therapy, a device, or a method which may be
oadly refe
ed to as “inventions”) are
clinically implemented. Most of the researchers’ efforts are centered on the advance of technical
and scientific aspects of an invention. The development and implementation of an invention can be
arduous and very costly. Historically, it has proven to be crucial to protect intellectual property
ights (IPR) to an invention (i.e., a patent) to ensure that companies can obtain a fair return on their
investment that is needed to develop an academic invention into a product for the benefit of
patients. However, the importance of IPR is not generally acknowledged among researchers at
academic institutions active in biomedical research. Therefore this paper aims to (1) raise IP
awareness amongst clinical and translational researchers; (2) provide a concise overview of what
the patenting trajectory entails; and (3) highlight the importance of patenting for research and the
esearcher.
Importance for patients—Adequate patent protection of inventions generated through
iomedical research at academic institutions increases the probability that patients will benefit
from these inventions, and indirectly enables the financing of clinical studies, mainly by opening
up funding opportunities (e.g. specific grants aimed at start-ups, pre-seed and seed capital) that
*Co
esponding author: Joris Heus, Innovation Exchange Amsterdam, Academic Medical Center, University of Amsterdam,
Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands Tel: XXXXXXXXXX, XXXXXXXXXX.
HHS Public Access
Author manuscript
J Clin Transl Res. Author manuscript; available in PMC 2018 April 03.
Published in final edited form as:
J Clin Transl Res. 2017 ; 3(2): . doi: XXXXXXXXXX/jctres XXXXXXXXXX.
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otherwise would not be accessible. As a consequence, patented inventions are more likely to
ecome clinically tested and reach the market, providing patients with more treatment options.
Keywords
invention; technological innovation; medical and pharmaceutical research; patents; protection;
commercialization
1. Background
The majority of biomedical researchers at universities and academic medical centers work
on projects ultimately intended to benefit patients. Whether the project entails the
elucidation of mechanisms in different diseases or the development of novel medical devices
or therapeutics, it is the eventual clinical problem that initially motivates the researcher. An
easy yet illustrative example is the problem of cancer. Due to its status as a “dread disease,”
cancer is a top-priority medical problem that is well-funded and extensively researched at
multiple levels. Some investigators study cancer biology and biochemistry in the hope to
discover novel therapeutic targets, others investigate how to improve cancer diagnosis and
study epidemiology, while another group of researchers focuses on devising new clinical
approaches to pinpoint and eradicate tumors. In the grand scheme of research, the overall
goal of any of these projects is to ensure that the information, drug, or device is eventually
commercialized in order for it to achieve clinical implementation.
An important fact in this grand scheme is that the costs associated with clinical application
and testing of a drug or device typically amount up to many millions (if not billions) of
dollars. Pharmaceutical and medical device companies operate on business models that
account for these costs, whereas universities and affiliated hospitals have a different business
model. Universities and academic hospitals mainly use their primary source of income that
is received from tuition costs and patient care revenue to cover general business operations
and employee costs, leaving few remaining funds to invest in product development and
clinical trials.
Instead, universities and academic hospitals commonly make use of grants acquired from
secondary (industry) or tertiary sources (government) to fund research projects. Such
funding however, is generally insufficient to develop a clinical product.
A solution to this problem is to combine academic research with elements of the corporate
usiness model, illustrated in Figure 1 for pharmaceutical product development. This means
that intellectual property (IP) rights should be established on inventions that have been
conceptualized during the course of the research project. These patented inventions may be
further exploited in R&D trajectories by existing (pharma or biotech) companies or within a
university spin-off or start-up company, separate from the university, but often still
connected with the inventors. Such an R&D trajectory becomes attractive for funding from
pharma companies or for infusions of pre-seed capital (up to ~250K Euro, often provided by
a government-related fund or university holding company) and seed capital (~500K–1M
Euro, provided from angel investors or early stage venture capital firms). Often, such
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external funding is sufficient to cover the large expenses of pre-clinical development and
clinical trials.
To fully take advantage of this stream of research funding, most academic institutions and
affiliated hospitals have established a knowledge transfer office (KTO), in the US also
known as Innovations Departments. In addition, some national governments have set up
monetary support programs to enable researchers to obtain proof-of-concept data e.g., to
facilitate patented inventions and to stimulate the discoverers to investigate the possibility of
starting a spin-off company. These programs, which have gained momentum in the last
decade, have matured and as a result many academic institutions now boast a portfolio of
spin-off companies.
A significant bottleneck that still remains is that academic researchers often do not have the
awareness, business mindset, or in-depth knowledge of IP-related issues to efficiently
proceed with patenting their invention in addition to publishing their data. The problem here
is that a public disclosure of research findings may destroy the patentability of any invention
arising from data contained in the publication (i.e. the invention is not considered to be novel
anymore), and therefore reduces the possibility that such invention will ultimately benefit
the end-users of their research (i.e., the patients). Especially in the pharmaceutical business,
decisions on whether or not to develop a certain product heavily depend on the existence of a
strong IP position, as the chances of generating a good return on investment is low when
competitors cannot be blocked. No investor will finance a development project if the
underlying IP has been lost by a too early disclosure. As a result, potentially good inventions
are lost for patients, because of the lack of patent protection leading to weak commercial
prospects.
The above situation can be avoided. If scientists would be (made) more aware of the basic
ules dictating the process of IP protection, it would be easier for them to adopt simple
practices that allow free scientific exchange, while providing proper background for
potential business exploitation (see also section 3.2.1).
The goal of this paper is to: (1) increase IP awareness amongst clinical and translational
esearchers; (2) provide a concise overview of exactly what patent protection entails; and (3)
highlight important implications of IP for research and the researcher.
2. Benefits of IP protection for scientific research(ers)
The prime reason that should motivate researchers to be engaged in the development of IPR
is that it is very rewarding to see a technology, originating from their own lab, developed
into a final product that ultimately benefits patients.
Secondary to this, there is the potential for financial income, both for their research group
and for them personally, even though the chance of substantial revenues accruing from any
given patent application is typically low. Generally speaking, only a small minority of
patented inventions will generate a significant return, and even then the amounts concerned
are small in comparison to the institute’s total R&D budget. There are however good
opportunities for funding of invention-related research, as alluded to in section 1. With
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espect to personal remuneration, the majority of research institutes has IP guidelines that
allow individual inventors to receive a certain share of the revenues received by the
institution. This income is generally being obtained through licensing of patents to a
commercial entity or through the sale of shares held by the institute and/or the inventor in
the spin-off company in which the invention is further developed.
A third advantage for academics that are actively involved in developing IP, is that such
activities are becoming increasingly better appreciated by research institutions and are often
used as a criterion to rate academics when promotions or tenure positions are to be decided
upon.
Not only translational or clinical researchers may think of getting engaged in the
development of IP. The example of the invention of the polymerase chain reaction shows
that also fundamental researchers should keep an open eye to what possible exploitable
inventions may come forth from their projects.
2.1 Role of the knowledge transfer office
For researchers the KTO serves as an important intermediary for contact with industry and
patent lawyers. Most researchers are not trained in IP law, business development, and other
usiness-related aspects of science. Therefore, KTO personnel who are trained in these
aspects