“The research that most doctors are doing today is dead”. This is the clear opinion of Antoni Rosell when talks about his experience with the clinical research. Rosell is a researcher of the Pneumology research group of IDIBELL and chief of section of Pneumology at the Bellvitge Biomedical Research Institute, and two years ago discovered a new world. “Then I did a complete turnabout in the direction of my research. I knew nothing about patents or transfer, but I had many ideas. I contacted the office of research transfer of IDIBELL and some months later I created a spin-off”.
Antoni Rosell is one of the IDIBELL researchers decided to exploit commercially the results of their research. In 2011, he created Adbroncus, a spin off to exploit a tracheal prosthesis invented by him, which now is under patent application.
The researcher acknowledges that this initiative could not have been brought forward alone. Leading the Transfer Technology Office (TTO) at IDIBELL, Montse Ballarín supports researchers who want to transfer, from the definition of a strategy that suits the characteristics of each case.
As a centre for health research, the IDIBELL is aimed at applying the results of research in improving the health of people, through the development of new therapies, new medical devices or technologies that may be offered as business services. Technology transfer is therefore a strategic area of the institution. Two years ago, IDIBELL opted to strengthen this area. The joining of Ballarín, on March 2010, allowed setting up a strategy that has already begun to bear fruit. And, as emphasizes the TTO manager, “in the year 2011 we have arrange as many patents as we had done before.” IDIBELL's transfer office has received funding from the Innovation Net for Medical Technologies and Health of the Instituto de Salud Carlos III, with the help of European FEDER funds.
Matter of time
Once we have the structure, it's time to make aware the researchers about the importance of transferring the knowledge they generate. “Many times we are not aware that we are working with public money, and this will create liability for using responsibly the resources, putting forward the applicability of the research, what is sometimes hard to convey to the researchers”, explains Ballarín. Josep Maria Aran answers that this is a matter of time. Aran is a researcher at the Human Molecular Genetics Group and has experience in the transfer of research results. His diagnosis is clear: “there are researchers who simply have no interest in transferring, because it is not always easy. You must have completed the proof of concept, with consistent data, and there is a lot of pressure, conferences, funding agencies, which often make it difficult to patent a particular discovery. You have to assume that if you bet to patent, there will be things that you will not do”.
Ballarín disagree. “Protecting doesn’t means to stop publishing” says the IDIBELL transfer chief. The trick to doing this is through a good strategy. Montse Ballarin notes that the day after a patent application is deposited could be published, so that “you can prepare the scientific article and the patent application simultaneously and, when the application is deposited, the article can be sent to publish, both things are compatible”. The head of the TTO asks researchers to be left advising for people working in technology transfer and who know what is the best strategy to transfer their knowledge. And every application is treated individually.
When a researcher wants to patent an idea or product, the transfer office evaluates its feasibility. This evaluation is performed with a specialised patent agent. “We must consider whether [what the researcher wants to patent] has a market application, if it is feasible from an economic standpoint”, explains Monte Ballarín. If we decide to proceed, a priority request EU-wide patent is made in a Spanish patent office. When the application is accepted, the inventor has one year during which the researcher can improve the product, validate the results or the test the concept, which give more value to the patent. After twelve months an international patent could be requested through the procedure fixed by the Patent Cooperation Treaty (PCT). Thirty months after the priority request, it’s necessary to decide in which countries the invention should be protected. “This is very expensive, and neither the inventor nor IDIBELL they can take it directly”, says the TTO chief. She continues: “Our strategy as a public research centre is to assume the costs until the PCT and reach agreements with licensees before going to the next phase”.
To assume the cost of the early stages of the patent, IDIBELL has grants. “As a public institution, we have advantages, because there are exclusive grants to public institutions”, explains Ballarín. “In TTO we have a special grant, named PETRA [Transfer Strategic Plan, of the Spanish Ministry of Science and Innovation], and there are private entities that offer other grants. So far, we have obtained much of these grants, and this is because our products are patented are very good, with a high quality”, notes Montse Ballarín. These contributions allow IDIBELL to bear the cost of all performing patents. “Anyway, it is important that the researchers are aware that they must order at least part of the cost of the patent when applying for a project”, remarks the responsible of the TTO.
Having protected the invention, it begins the task of marketing. “This means to know which company is interested in the product, get in touch with business, see what is the best choice of license, and know the market very well” says Ballarín. One way to facilitate this process is through the creation of a spin-off.
“Creating a spin-off is a very interesting challenge”, reflects Antoni Rosell. Josep Maria Aran explains that “it is very laborious: you must write a lot, have a lot of meetings... But if you want that your discoveries can have an application, it is, along with the licenses, the only way”. The last year, Aran, along with Josep Maria Grinyó, created a spin-off to exploit a new anti-inflammatory and immunomodulatory for transplantation and autoimmune diseases. The creation of a spin off implies a business function. “Sometimes it's the same investigator who assumes the role of entrepreneur and sometimes it includes someone who is in charge of its management”, explains the head of TTO.
Montse Ballarín suggests that the companies increasingly want products with more value. “The pharmaceutical company is specializing in the later stages of the process, so rather they prefer to buy more expensive but less risky”, says Ballarín. The function of the spin-off is to increase the product value, validating it experimentally or testing it in the clinic. But, this function couldn’t be done directly by the research institution? Montse Ballarín answers no: “often it’s necessary to work with GLP [good laboratory practice] and quality standards that the institution does not have. In addition, the development of a product to transfer it to market is beyond the purely scientific work, the spin-off can focus on looking for investors, making a business plan, establish partnerships. All these things could not be done directly by the research institution”.
But the patent is not the only solution to get to market. “When a researcher publishes a patent everyone knows how it was done, and sometimes wants to keep the secret”, explains the transfer manager. In these cases the researcher can keep the secret, and thus can be exploited commercially.
Another way is to transfer technology through agreements with other institutions. In this case, a researcher or research group sign a contract with a company to validate a molecule, to evaluate the application to market of a product or to conduct a clinical trial. Ballarín explains “in this contract it must be clear who will be the ownership of the results, who will exploit it, which will be the return to the institution, to the researcher... And everyone should receive a part according to its participation on the project.”
Another case according is the material transfer agreement (MTA), which occurs when a biological material is transferred from a centre to another with research purpose. This document should states who will be the property if there are new results. “At first no one think on that, but someday this may be exploited and so it is important that from the beginning it is clear who owns the property and which are the rules”, says the responsible for the TTO.
Once the research results are transferred to the market, the TTO tracks the process and, if all goes well, the researcher and the institution finally obtain an economic return. For sharing this revenue, “each institution has its policy and now we are establishing our own policy. Normally it is distributed one-third for the inventor, one third of the research group and the remaining third to the institution”, says Montse Ballarín.
Antoni Rosell is convinced that research for the fun of it is outdated. “The transferability is a new challenge to raise funds to finance future research”. The researchers Antoni Rosell and Josep Maria Aran are examples of IDIBELL researchers who have dared to go for transferring the results of their research. Both agree that this step cannot be done alone. “It is vital to be accompanied; you need someone who knows the business world”, says Rosell. Meanwhile, Aran, who has experience in having taken out a patent in 2003 alone, is clear that “the institution should support you, because this is a big job”.
The best year of the research transfer in IDIBELL
Currently IDIBELL has innovative results that are attractive to businesses. The manager of the IDIBELL transfer office notes that “the centre's researchers have developed products that can be marketed in the form of services.” Among these services, Montse Ballarín mention the screening of new molecules for selecting precandidate compounds as ex vivo models of apoptosis in the study of leukaemia, in vitro studies of cancerous processes or in vivo models of metastasis. Ballarín also highlights the personalized response to treatments, as the development of orthotopic models for different solid tumours, the cell culture of models for haematological malignancies and the metabolic response to treatment.
Besides these experimental models, Ballarín mention products that are on track to be licensed by companies such as medical devices, biomarkers, antiinflammatory agents or new drugs.
The head of the TTO indicates that 2011 was the best year of transfer in IDIBELL and illustrate it with the seventeen research contracts made, the seven patent applications and seven more in the process, the creation of a spin-off (Zyrnat, launched by Josep Maria Grinyó, head of the research group in Nephrology and Transplantation), the three patent license agreements signed, the implementation of a technology transfer agreement and two more in process, and the 17 invention disclosure procedures. Apart from that, IDIBELL has done 176 clinical trials during this year.