You should protect your invention by contacting the Innovation office and documenting your ideas in writing, using an invention disclosure form. In order to preserve worldwide patent rights for your idea, a patent application must be filed with the patient office prior to sharing your ideas in a public forum, publication, internet abstract, poster or any forum that includes external people.
Innovation’s Licensing Managers will assess appropriate commercialization strategies for your patented idea. They will identify the appropriate markets and locate companies who may be interested in further developing your ideas into marketable products. Once a "partner company" is identified, the licensing professional will negotiate an agreement transferring commercial rights to the company in return for appropriate compensation to the institution.
Licensing Managers evaluate your idea within the context of what is publicly known about the subject (prior art). This may require the use of patent counsel outside of the institution. It is important that you supply the Licensing Manager with a detailed written description of the invention, and any references and other information as needed. Also important in the filing decision is whether the idea can be turned into a marketable product. Not every invention disclosure/idea is appropriate for patent protection.
Buy it. If the material is commercially available – i.e., you can buy it – and the seller asks you to sign a contract, please contact Supply Chain (formerly Materials Management) here for assistance.
Receive it for free (or a nominal transfer fee) under a Material Transfer Agreement (MTA). The Transactional Affairs Group within Innovation negotiates most MTAs concerning research materials provided to you by another researcher or company. All MTA requests must be initiated through Insight 4.0. For assistance with the Insight 4.0 process, please reference the attached instructions, or contact the Insight 4.0 at InsightHelpDesk@partners.org.
Transfer of Human Tissue to a for-profit entity will always require an MTA and should be transferred as part of a scientific collaboration between the providing investigator and the company. Such transfer is permissible only if it is part of a genuine research collaboration in furtherance of the hospital’s medical and educational mission; the hospital investigator intends to maintain an active, ongoing involvement in the company’s work with the specimens in an area of science that is of interest to him or her; the results of the study will be made readily available to the hospital investigator; and it is reasonably likely that a publication may result and the investigator may freely publish. PHS entities do not accept compensation for these human tissue transfers (except for documented preparation costs and shipping fees).
In the majority of circumstances an investigator must have a finalized MTA, signed by an authorized Hospital signatory and the recipient institution, prior to transferring any materials to an outside party. A completed, fully executed MTA is the only way the Hospital can protect the rights and interests of MGH/BWH and yourself as well as be certain the institution is compliant with its own agreements. If research materials are sent before the MTA is signed by both sides, there may be no restrictions on how the recipient may use the materials – such as for commercial use, or to further distribute to other parties.
All MTA requests must be initiated through Insight 4.0. For assistance with the Insight 4.0 process, please reference the attached instructions, or contact the Insight 4.0 Help Desk at InsightHelpDesk@partners.org. All transfers of human specimens (including whole blood, plasma, cell lines, etc.) must first be approved by the IRB (or a waiver provided by the IRB), so be sure to obtain IRB approval prior to submitting an MTA request in Insight 4.0 for sending out or receiving human specimens, and include the IRB protocol number that has been approved in your Insight 4.0 submission.
If there are several different sources from which you can obtain a material, try to pick a non-profit or academic entity. For-profit corporations tend to require longer negotiations. Make sure the questionnaire in Insight 4.0 is completely filled out, specifically remember to include a phone number and email address when listing contact information for the other side. Be sure to attach any draft agreements received from the other side, as well as applicable information such as protocol numbers for IRB approval.
Under Partners policy, only an authorized official may negotiate and execute agreements on behalf of the hospitals. In addition, Material Transfer Agreements often contain a license to intellectual property rights to another entity and as such, need to be fully vetted by Innovation in order to avoid taking on legal risk by the institution and investigator.
The transfer out of any Human Tissue – i.e., clinical specimens, research specimens, and/or patient data – always requires IRB review, but an MTA is not always required. As a matter of course, the transfer out of Human Tissue to an academic institution or academic collaborator will not require an MTA: If you expect no compensation other than the costs of preparing and shipping the material; if the specimen or data were not collected in a protocol or study funded by a company; if the recipient does not plan to use the Human Tissue in industry-supported research; and if the Human Tissue has not been previously transferred to a for-profit company. In these circumstances, a letter agreement prepared by IRB is sufficient. If the answer to any of these questions is yes, an MTA may be necessary. For transfers that do not meet the criteria for use of the investigator template, please submit a request for a Material Transfer Agreement, using the InfoEd process, as described above.
Typically, a CDA can be finalized in a matter of several days to a few weeks. An MTA, depending on its complexity, may require a few weeks to a few months to be finalized. In the case of a CDA, the process is expedited when the other party agrees to accept the hospital’s draft agreement. Where a company insists on using its own form agreement, finalization of the agreement may be protracted if the document requires any considerable degree of negotiation for compliance with Hospital policies.
All agreements for personal consulting are subject to institutional review and approval for compliance with institutional policies. The Office for Interactions with Industry (OII) administers this process. These agreements are entered into by an investigator or PHS employee (the "Consultant"), to perform services for a third party. This does not, and must not, involve PHS resources, property, technology, information or other assets of PHS or the hospitals. OII reviews these agreements solely for their compliance with institutional policies, not for the personal, business interests of the Consultant.
To start the process, the interested consultant should send an email, with the proposed agreement, to PHSOII@partners.org or fax it to Tasha Murray's attention at 617-643-9223. This will initiate the review process. The consultant will be asked to complete a conflicts questionnaire, and after the questionnaire has been completed OII will proceed to review the agreement. The Consultant should contact OII through the above address with questions or queries about status of the approval process.