Investigators: Frequently Asked Questions

You should protect your invention by contacting the RVL 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.

Licensing Associates 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 Associate 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.

Research and Licensing professionals 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.

All agreements for personal consulting are subject to institutional review and approval for compliance with institutional policies. RVL 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. RVL, through its outside counsel (Rackemann, Sawyer & Brewster or “RSB”), reviews these agreements solely for their compliance with institutional policies, not for the personal, business matters of the consultant.

To start the process, the interested consultant should send an email, with the proposed agreement, to the Consulting Agreement Review Coordinator for RVL. The email address is phsrvl@partners.org. This will initiate the review process. The coordiantor will ask the consultant to complete a conflicts questionnaire, will ask for all written documents from the third party, and will forward all such information to RSB. RSB will then provide the consultant information regarding the status of the review and approval.

Investigators/employees who are considering personal consulting activities should consult the PHS “Policy on Consulting and Other Outside Activities,” PHS “IP Policy,” the PHS “Code of Conduct & Conflicts of Interest Policy,” and the Harvard University “Faculty Policies on Integrity in Science.” Investigators/employees should consider retaining their own attorney to review any consulting agreement regarding their personal, business matters.

a) 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 Research Management [link to website] for assistance.

b) Receive it for free (or a nominal transfer fee) under a Material Transfer Agreement (MTA). The Transactional Affairs Group within RVL negotiates most MTAs concerning research materials provided to you by another researcher or company. Please complete the PI MTA-in Questionnaire [link], and email it to the Transactional Associate responsible for your department [link to departmental assignments]. Please also email the Transactional Associate any related documents, such as the MTA (if you received one) and copies of your correspondence with the provider institution or company.

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.

To request an MTA to send material to an outside party, please complete the PI MTA-out Questionnaire [link] and email it to the Transactional Associate responsible for your department [link to departmental assignments]. For transfers to U.S. academic institutions, you may complete the Mini-Questionnaire [link]; if the answer to all questions are “no,” you may send materials without an MTA. You still must provide your Transactional Associate, in advance, with a copy of the Mini-Questionnaire, as RVL tracks these transfers.

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 further guidance, you may refer to the IRB website at http://healthcare.partners.org/phsirb/guidance.htm

Transfer of Human Tissue to a for-profit entity will always require an MTA and an actual collaboration. 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).

Typically, a CDA can be finalized in a matter of several days. 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. Usually, negotiations in a CDA will center on the definition of confidential information and the period of time in which it is to be held in confidence; the exceptions to confidentiality; and the law to be applied in the event of a dispute.

As a rule, there is far greater variability with respect to MTAs when it comes to a timeline for completion. Often, if there are no complicating circumstances, a Simple Letter Agreement or a UBMTA Implementing Letter is finalized within a week. More extensive MTAs with other academic institutions are likelier to be concluded within a few weeks. MTAs with companies, however, frequently entail more protracted negotiations. During such negotiations, draft documents are exchanged and revised, and the parties may confer to discuss particular areas of disagreement. Such negotiations characteristically focus on protecting the hospital’s interests in the research results and in any intellectual property coming out of the research, and on assuring that the investigator will be able to publish his or her study timely and without undue restriction.

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 is completely filled out, specifically remember to include a phone number and email address when listing contact information for the other side. Avoid using interoffice mail and the fax machine as much as possible. Email and FedEx are far superior. Please provide us with all of the information you have; more is better.

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 RVL in order to avoid taking on legal risk by the institution and investigator.

A patent is a property right granted by the Government of the United States of America which allows the owner(s) of that right “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time in exchange for public disclosure of the invention. 

There are three different types of patents: utility, design, and plant species.  In all but very rare cases, RVL  prepares and files patent applications for the purpose of obtaining a utility patent.  For this reason, only utility patents and applications therefor will be discussed hereinafter.  (If you have a question regarding design and/or plant species patents, please contact RVL.)

An invention that is the subject of a utility patent application will receive patent protection if the U.S. Patent & Trademark Office (“USPTO”) determines the invention to be a novel and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.  Further, the USPTO must determine that the invention is “not obvious” in view of all information publicly known at the time the invention is conceived.

An invention will not meet the “novel” standard of the Patent Office if the Office determines that the invention was previously invented by someone other than the applicant(s) applying for a patent, was previously described in a publicly available, written document by someone other than the applicant(s) applying for a patent, or was described in a written document  authored by the applicants(s)  that became publicly available more than one year prior to the filing of a patent application by the applicant(s). (This one-year grace period for public disclosure does not apply for patent applications in most countries outside the U.S.)

Also generally speaking, an invention will be deemed to be “obvious”, and therefore unpatentable, by the Patent Office if the Office determines that although the invention has not been fully described in any prior, single written, publicly available, document, the invention is suggested (and therefore obvious to one of skill in the art to which the invention pertains)  by the aggregate content of all prior, publicly available, written documents.  In other words, an "obvious" finding may be thought of as the Patent Office's way of saying, "You are not describing anything that those in your field would not have readily recognized when apprised of all available prior publicly available, written documents." 

A utility patent expires on the twentieth anniversary of the date on which the original patent application was filed.  (However, this period will be extended by the USPTO in instances in which the USPTO takes an excessive amount of time to review a patent application.)  The patent owner cannot exclude others from practicing the invention after the date that the patent expires.

On average and depending on the nature of the invention, it takes as long as four (4) to ten (10) years from the filing of a patent application to obtain a patent.

No, patents only grant the right to “exclude” others.  As one illustrative example, a patent owner may receive patent protection for a method of using a particular compound to treat a particular disorder.  However, the owner would not be able to practice this treatment method absent a license from the owner of a patent covering the compound, if applicable, or without FDA approval to do so.

RVL requests that the completed Invention Disclosure Form fully describe the invention and all of its aspects.  Information disclosed in the Invention Disclosure to RVL is confidential.  This confidential information is critical to any decision to pursue patent protection for the invention as the information defines the scope of the invention that would be sought in the patent application.

No.  Therefore, submitting an Invention Disclosure to RVL will not protect the invention from possible invalidation due to public disclosure of the invention. 

In the U.S., a patent application must be applied for within one year of the date on which the invention is first publicly disclosed.  (However, because the laws of virtually every other country in the world  require that a patent application be filed prior to any public disclosure of the invention, we ask that completed Invention Disclosures be provided to our office as far in advance of any public disclosure as possible.)

There is no bright line rule regarding what constitutes a “public disclosure”.  Generally, any written document that is made available to at least one member of the public is a public disclosure.  (For example, in a famous patent case, a Ph.D. thesis that was available to the public only in single copy in one library was judicially determined to be a public disclosure even though there was no evidence that any member of the public had actually accessed the thesis.)  However, because it is difficult to know for certain whether any particular action will be deemed to be a public disclosure, we err on the side of caution and therefore recommend that you submit an Invention Disclosure to us prior to taking any one of the following actions:

(1)  File a grant application which describes the invention;

(2)  Submit a manuscript which describes the invention to a journal for publication consideration;

(3)  Submit an abstract which describes the invention for the purpose of presenting the invention in a talk or poster;

(4)  Discuss the invention with a prospective license of the invention; and

(5)  Make any other disclosure of the invention to anyone outside of your lab, your institution or RVL.

No.  However, if you have taken any one or more of these steps, please contact RVL right away so that we may determine what rights (U.S. and/or foreign), if any, have been lost.  If some but not all rights have been lost, RVL may still elect to pursue patent protection for the invention.  Because a patent application may need to be filed in a timely manner in these instances to preserve whatever patent rights remain, your expeditious disclosure of the invention to RVL is greatly appreciated.

The threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the conception of the invention, he is not an inventor.  Because more than one person can conceive of an invention, a patent application may name (and often does name) more than one inventor.

Patent law strictly requires that everyone who is an inventor, and that no one who is not an inventor, be named in the patent application.  An error made here may be grounds for invalidating any patent that ultimately issues from the application.  In the process of filing a patent application, patent attorneys assess the contribution of different contributors to determine inventorship.

Not necessarily.  Please note that the standard for who is an inventor (see above) is stricter than that for a manuscript author.  For example, please note in particular that a lab technician who is asked to carry out experiments under the guidance of a primary investigator may not necessarily be an inventor under the standard described above (even though such a person often is named as an author on a journal manuscript).  It can be difficult to determine who should and who should not be named as an inventor on the Invention Disclosure Form.  Therefore, if you have any doubts, you are encouraged to list all persons on the Invention Disclosure Form who have made an intellectual contribution to the invention.  If you have any questions regarding inventorship, please contact RVL.

Yes.  RVL and any law firm that we engage has a duty to keep the content of a patent application confidential until the USPTO makes the application publicly available. 

In general, the USPTO makes a patent application available for public inspection 18 months after the earliest filing date noted for the application’.