As academics in transplantation, we like to believe that our research could someday impact patient care, perhaps through development of new drugs, diagnostic assays, medical devices, or improved patient management. However, what would it really take to see our best ideas broadly adopted into clinical practice? In a word, commercialization. Apart from the immense costs and liabilities of developing new medical technologies, which are rarely met by public institutions, companies are almost always needed to supply products to market. Uncomfortable as the thought may be, the successful implementation of our research is ultimately dependent upon financial and infrastructural support from industry. As scientists and physicians, we may have little enthusiasm for business affairs; however, it benefits us to consider the needs of industry or, at least, know how to avoid killing the commercial prospects of our own work. There is an extensive academic and business literature dedicated to the economic,1 ethical, and legal2 aspects of commercializing medical research; however, there is surprisingly little practical guidance for researchers in the very early stages of projects with commercial potential. This article, which draws upon personal experience and published materials, is not an expert legal opinion or business advice, but instead aims to give an academic's perspective of commercialization through a variety of online resources.
Biomedical scientists value ideas according to criteria, such as unexpectedness and explanatory power,3 whereas business is motivated by their profitable exploitation. This seems like an obvious statement, but the academic mind-set grips us firmly. In an initial meeting to evaluate my work on regulatory macrophages, lawyers representing a prospective investor quickly dismissed years of careful mechanistic studies as unpatentable, but ascribed significant value to a few essentially technical details [A]. Faced with this verdict, it was hard not to feel defeated; however, this was not a scientific review and one must bear in mind the qualities of a research project suiting it for commercialization. As the investor explained, companies are generally seeking products, not only scientific concepts, for which a market exists or could be created. Investing in product development is a risk for a company, so the readiness of the product for market, the size of the market, and absence of competition are key issues for investors. It follows that acquiring intellectual property (IP) rights to a body of work and protecting these by patent are vital to investment strategy. These commercial considerations may not come naturally to academics. In our dealings with industry, being conscious of our cultural differences is valuable.
Links
[A] http://www.uex.eu/attorneys/dr-andre-guder.html
[B] http://isis-innovation.com/university-members/commercialising-technology/ip-patents-licenses/
[C] http://www.baypat.de/en/
[D] https://patents.google.com/
[E] http://www.uspto.gov/
[F] https://www.epo.org/index.html
[G] http://www.wipo.int/portal/en/index.html
[H] http://www.dpma.de/english/
[I] https://www.gov.uk/government/organisations/intellectual-property-office
[J] http://www.ipaustralia.gov.au/
[K] https://www.jpo.go.jp/
[L] https://www.gesetze-im-internet.de/arbnerfg/BJNR007560957.html
Ultimately, the commercial potential of a research project is not evaluated by scientists, but by experts in business. Many universities now have “technology transfer” offices that provide this service [B]. There are also technology transfer companies offering advice on a commercial basis. The decision to contact a technology transfer office should not be taken too lightly, as preparing for consultations can be time-consuming and expensive. Technology transfer advisors are business people and, although they may have a background in scientific research, are unlikely to be experts in transplantation; therefore, it is vital that we communicate our research in understandable terms and emphasize the marketable aspects.4 Despite their expertise, technology transfer offices are often criticized in the academic literature for overvaluing research, thereby losing potential deals, and hoarding meritless IP.5 Thus, if we wish to see our work taken forward, it may be necessary to press our agenda, which may conflict with the goal of technology transfer offices to maximize revenue. Where a potential market exists, it is essential to protect inventions or discoveries by patent. Obtaining and defending a patent is a complicated and expensive process that can only be justified by a reasonable likelihood of it being licensed or sold. University technology transfer offices are sometimes criticized for generating a surfeit of unlicensed patents, which are a drain on their resources.6 In many institutions, this is leading to a more selective approach to protecting inventions, hence obliging researchers to better explain the value of their inventions to a business audience.
A patent grants the holder the right to prevent others from commercial exploitation of an invention for up to 20 years. Investors rely on this period of protection to recoup the cost of developing products to market. To obtain patent protection, the applicant must demonstrate that the invention has utility, is novel, and inventive [C]. An invention is judged to be novel if it was not known to the “prior art.” The body of prior art is not limited to academic articles, but all publicly available information, including conference proceedings, casual communications, data repositories,7 and patents. There are many interfaces for searching patent information, including Google Patents [D], the United States Patent & Trademark Office [E], the European Patent Office [F], the World Intellectual Property Organization [G] and various national patent offices [H-K]. An ‘inventive step’ is taken if the invention does not follow from the prior art in a way that would be ‘obvious’ to an ordinarily skilled person. Assessing whether a piece of research meets these legal criteria is a task for a patent attorney; however, it may be valuable for researchers to have a broad concept of what is patentable or not. It is critical for researchers to understand that the patentability of our work could be destroyed by publishing or otherwise disclosing it before filing a patent application; moreover, that releasing any information that would enable a skilled person to derive the same invention can destroy or weaken a patent. This injunction against publishing or establishing open scientific collaborations makes academic life very difficult without exceptional departmental or institutional support.
Knowing your rights and responsibilities as an inventor is important. In many countries, researchers are legally [L] or contractually obliged to inform their employer of any inventions, as the employer is typically the owner. The entitlement of inventors to proceeds of any commercial exploitation of their work differs between countries and institutions, so researchers should investigate rules affecting their own situation. It is important to accurately identify the people who made an invention: namely, those who made the relevant inventive steps. Inventorship is not attributed to all those involved in a piece of research and is not equivalent to coauthorship on a paper. Notably, patents can be revoked if inventorship is incorrectly assigned. Formally defining the boundaries of any research collaborations through confidentiality agreements is vital. From personal experience, misunderstandings about commercialization strategies can strain even the most productive of scientific relationships.
Taking an idea from the research lab to a marketable product can be a long, slow and massively expensive process. In the product development phase, a manufacturer must consider issues such as optimal production procedures, marketing and pricing, safety and efficacy, regulatory affairs, and product authorization. Development work often implies a higher level of quality management than normally applies in research laboratories. The cost of product development is an up-front risk; therefore, projects where the inventors have undertaken a substantial part of the development work at their own expense can be very attractive for investors. As an academic, it is important to think carefully about the extent of your personal involvement in product development. The volume and duration of development work is easily underestimated. Development studies are not as easily published as basic research. Moreover, academics undertaking development work are likely to earn less than someone doing equivalent work in industry. How much academic effort to invest in developing a product is a matter of personal commitment to seeing your ideas brought into clinic. Be aware, although researchers may be sentimental about their projects, markets are not.
In conclusion, industrial support is essential for most basic research to be translated into clinical applications. Commercialization brings a level of investment that could not otherwise be realized; however, that investment has a cost in terms of academic freedom and commitment of effort. Whereas the economic barriers to developing new general immunosuppressive agents for use in transplantation are now very high, there is a great appetite in the pharmaceutical industry for new biologics, and Advanced Therapeutic Medicinal Products, especially gene and cell-based8 therapies. To capitalize on these opportunities, scientists should familiarize themselves with issues surrounding commercialization. In addition to the specialist literature, there are many excellent sources of online information concerning commercialization strategies, IP law and making deals with companies.
REFERENCES
1. Fletcher AC, Bourne PE. Ten simple rules to commercialize scientific research.
PLoS Comput Biol. 2012; 8: e1002712.
2. Jolly M, Fletcher AC, Bourne PE. Ten simple rules to protect your intellectual property.
PLoS Comput Biol. 2012; 8: e1002766.
3. Hutchinson JA. Peer review in transplantation.
Transplantation. 2015; 99: 1746–1748.
4. Zappe H. Innovation: bridging the market gap.
Nature. 2013; 501: 483–485.
5. Wadman M. The winding road from ideas to income.
Nature. 2008; 453: 830–831.
6. Ledford H. Universities struggle to make patents pay.
Nature. 2013; 501: 471–472.
7. Hutchinson JA. Data sharing.
Transplantation. 2015; 99: 649–650.
8. Hutchinson JA. Somatic cell-based therapy.
Transplantation. 2015; 99: 1103–1105.
