The Entry Point
The Technology Transfer Office within the Partners HealthCare System is called Research and Licensing and is a division of the Research, Ventures and Licensing Office. This office is the entry point for any discovery, invention or idea that may have commercial utility and that is made by you while you are an employee of the Partners HealthCare System or of any of its member hospitals. Research and Licensing is the office that implements the Partners Intellectual Property Policy (discussed in Module 1) and determines whether a hospital has an ownership or other interest in inventions or discoveries made by hospital staff or other employees. Research and Licensing is staffed by professionals having backgrounds in science and medicine, law and business. In addition to managing intellectual property and relationships with industry, Research and Licensing professionals serve as a resource with respect to questions relating to intellectual property and business.
The Process-Part 1: Invention evaluation and patent filing
The process is typically initiated by an investigator through the filing of an Invention Disclosure Form with the Research and Licensing Office. If an investigator has questions regarding the form or his or her invention, he or she may contact a Research and Licensing staff directly or may work through on-site resources including the Invention Liaison Program at MGH. New inventions disclosed to Research and Licensing are assigned a case number, logged into the Research and Licensing database and assigned a Research and Licensing business manager who is responsible for the management of all subsequent activity with respect to the invention evaluation. Research and Licensing encourages early disclosure of new inventions (i.e. prior to any public disclosure through presentation or publication), however, in order for a business manager at Research and Licensing to thoroughly evaluate any new invention, it is critical that a complete disclosure be made providing the information requested in the Invention Disclosure Form. Once a completed and signed form is received, the professional staff will evaluate the invention, discovery or idea to determine the commercial potential of the invention and formulate a strategy for protection of the intellectual property. This analysis will include types of products, markets served, and competing technologies. Other considerations will include the stage of development of a technology (e.g. concept, proof of principle, in vitro data, in vivo data) and plans, if any, for continued research. If it is determined that patent protection is possible and advisable, then the business manager will engage outside patent counsel to draft, file and prosecute the patent application. Outside patent counsel will work closely with inventors to ensure that any patent application filed is technically sound and of appropriate breadth so as to cover the invention and any permutations. All out-of-pocket costs associated with protection of intellectual property are paid by the hospital. The Research and Licensing evaluation process will typically take about 2 to 4 weeks followed by another 4 to 6 weeks for drafting and filing of a patent application.
The Process –Part 2: Patent issuance and commercialization
Once a patent application is on file, the business manager begins his or her work in earnest, looking for commercial partners to develop the invention into a product. This activity may take several years and involves identifying potential company partners through database and other searches and sending out technical summaries of the invention to a target list of companies with follow-up to determine interest. The optimal route for commercialization of an invention may not always be immediately apparent, and the business manager may have to modify his or her approach based on feedback from commercial entities. A business manger typically considers all options, including start-up company formation in order to determine the best approach to technology development. Once an interested party is identified, the business manager enters into negotiations to conclude an agreement transferring commercial rights to the invention to the company in return for financial compensation to the hospital. Compensation received by the hospital is shared with the inventors according to the royalty-sharing formula outlined in the Intellectual Property Policy – making the inventors and the hospital/Research and Licensing true partners in technology implementation.
In a parallel process, outside counsel works with the United States Patent and Trademark Office (USPTO) to determine what aspects of the technology are novel, useful and non-obvious (i.e. patentable: these are the criteria for patentability). This is a lengthy process due in part to a back log of several years at the USPTO. Currently the back log is about 2-4 years. Added to a typical examination period of 1 to 4 years, the total time for getting a patent application to issuance approaches 3 to 8 years and costs approximately $30,000 to $50,000 per country. Based on the commercial potential of the invention, Research and Licensing staff may recommend protection of international patent rights in selected countries with important market shares.
The Invention Disclosure Form (IDF):
Once you have decided that it is time to inform your technology transfer office of a discovery in your lab you should document that discovery in a tangible form, the Invention Disclosure Form (IDF). The IDF is an important document that serves many purposes. First we will walk you through how to provide the appropriate information and in the right detail to submit the IDF to your technology transfer office. Then we will go into some of the reasons for the information requested in the IDF and the ramifications of that information.
One of the most critical parts of the IDF is the description of your discovery (Question 3 of the IDF). You are prompted with three questions in this section 3 and are asked to attach any manuscripts, poster presentations, or slides from research talks. One of the goals of the IDF is to outline your discovery so that someone who is not skilled in that specific technology or field of research can pick it up, review it, and understand the essentials of the discovery and the problem that it seeks to address.
The first question in section 3 asks you to describe what it is you believe you have created that is you consider your “invention”. The second question asks you to distinguish the novel feature of your invention relative to what is known in the field. The third question asks for what you envision the products, processes or application of your invention would be.
Please provide more detailed description as you see fit by attaching additional documents as necessary where you can give a more detailed description of the stage of development and your future research plans. Please make sure to accurately describe what experiments were done, for example, in vitro or in animal models or in a clinical setting. This is important in assessing technology risk and investment requirements.
It is also important for the reviewer to understand the future research plans in particular, if you plan to continue to work on the discovery. This could have a couple of ramifications. First if your disclosure isn’t quite ready for patenting it means that when more work is done it might rise to the level of being ready for patent protection. Or if it is ready for patenting the reviewer may file a patent but decide to hold off on trying to find a partner until more work has been completed.
It is important to summarize what problem your discovery addresses and how your discovery uniquely addresses the problem. Provide more, rather than less, detailed information. It is appropriate to provide links to websites or citations to review papers that discuss the particular problem your discovery addresses.
You should provide a description of the current solutions to the problem, how they fall short of solving it, and how your solution overcomes or improves on the current solutions. Please provide any information that you have regarding the history of existing approaches and companies who are applying them. For example, you may know that Novartis has a research program in this area or that Medtronic made a similar device but it was not adopted by clinicians. From there you should then explain what is unique and better about your approach to the problem. For example your discovery is easier to manufacture or cheaper or more user friendly. The goal is to help the reviewer begin to understand the commercial applicability of your discovery.
Finally when you have collected all of the above information, take a top level view of the information provided and ask yourself if it is clear what the product or products would be. In the end having clearly identifiable products is the most critical information for the reviewer to have to make an assessment of your discovery. It is important for inventors to provide signature on the completed IDF form.