*** Below is the Questions that need to be answered****** Attached is the resource document for use with the question***
- Provide some pros and cons on pursuing formal protection for IP in the academic research setting.
- How do you think IP from academic settings reach patients?
Importance of intellectual property generated by biomedical research at universities and academic hospitals Importance of intellectual property generated by biomedical research 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, Cambridge, 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 biomarkers 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 broadly referred 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 rights (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 researcher. Importance for patients—Adequate patent protection of inventions generated through biomedical 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 *Corresponding author: Joris Heus, Innovation Exchange Amsterdam, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands Tel: +31 (0)20 5667911,
[email protected]. 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:10.18053/jctres.03.201702.005. A uthor M anuscript A uthor M anuscript A uthor M anuscript A uthor M anuscript otherwise would not be accessible. As a consequence, patented inventions are more likely to become 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 business 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 Heus et al. Page 2 J Clin Transl Res. Author manuscript; available in PMC 2018 April 03. A uthor M anuscript A uthor M anuscript A uthor M anuscript A uthor M anuscript 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 rules 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 researchers; (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 Heus et al. Page 3 J Clin Transl Res. Author manuscript; available in PMC 2018 April 03. A uthor M anuscript A uthor M anuscript A uthor M anuscript A uthor M anuscript respect 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 business-related aspects of science. Therefore, KTO personnel who are trained in these aspects