Policy on Inventions, Patents, Copyrights, Tangible Property, and Technology Transfer

It is the policy of the Center that all rights to inventions and discoveries (whether patentable or not), to copyrightable materials (except for scholarly works), and to tangible property (all Inventions) resulting from research or other work that is:

• conducted by employees of the Center within the scope of their employment; or
• specifically ordered from, or commissioned to, any person by the Center; or
• conducted by any person making significant use of the Center's resources

shall be the property of the Center unless and until expressly released in writing by the President of the Center. Furthermore, all Inventions that are conceived or reduced to practice within one year following termination of employment or association with the Center, and that are in any way connected to such employment or association, or that relate to scientific information made available as a result of such employment or association shall be the property of the Center unless released and until expressly released in writing by the President of the Center. All releases are reported to the Board of Managers of the Center.

Staff's Responsibility of Disclosure

As members of the staff, employees are bound by the Employee Agreement and are required to promptly disclose and to assign in writing all Inventions that are conceived or reduced to practice as a result of research or other work related to an employee's employment with the Center. All such intellectual property that employees conceive or reduce to practice, alone or jointly with others, within one year following the term of employment, and that are in any way connected with such employment or that relate to scientific information made available to employees as a result of such employment, must also be disclosed. Such disclosures during or after the employee's term of employment shall be submitted to the OIA.

A. Evaluation

Inventors need to disclose Inventions to the OIA in an Invention Disclosure Form, attaching all supportive scientific, technological, and other information related to it. The OIA will review all disclosures in order to attempt to determine the potential commercial value in the Invention. When, in the judgment of the OIA, there appears to be sound basis for pursuing commercialization of an Invention, the OIA will proceed to protect it at no expense to the inventor(s).

B. Protection

Patenting

When the OIA decides to file patent applications it retains patent attorneys to prepare, file, and prosecute them in conformance with applicable patent law and procedures. The inventors will be expected to cooperate fully with the OIA in defining the rights to such Inventions (e.g., joint ownership with another institution) and in the preparation and prosecution of any patent application that may result. Upon filing each patent application the employee will formally assign all rights and title to the Center. The OIA coordinates the interaction of inventors with patent counsel.

The criteria for determining inventorship are not the same as those for determining authorship of research publications. The inventors on a patent application will be determined according to patent law, because naming the wrong inventors can jeopardize validity of a patent. The individual contributions of each inventor must be the subject of specific claims in the patent application.

Copyright Protection

Copyright protection is in place the moment the work is created and fixed in a tangible form that is perceptible either directly or with the aid of a machine or device. There is no obligation to register a work unless the owner intends to bring a lawsuit for infringement. In some cases, it will be appropriate to register a copyright to reduce the likelihood of infringement and increase the Center's recovery of damages and expenses from infringements.

Although no longer required by law, notice of a copyright should for practical reasons be given to the public when a work is published. The copyright notice must include either the word "copyright," the abbreviation "Copr," or the symbol "©," accompanied by the name of the copyright owner and the year of first publication (designated as 2007 in the following examples).

Example:

© 2007 Memorial Sloan-Kettering Cancer Center

As for computer programs, all physical forms of the program, such as a printout, disc, tape, or magnetic card, should contain the following notice: "© 2007 Memorial Sloan-Kettering Cancer Center. All rights reserved. The computer program contained herein is the property of Memorial Sloan-Kettering Cancer Center and cannot be reproduced, copied, or used without written consent of Memorial Sloan-Kettering Cancer Center." In addition, the computer program itself should be set up to print out the above copyright notice at the beginning of the program. If the program is contained in a chip that becomes part of a solid-state device, the above notice should appear on the device. The notice should also appear on any containers or packaging for copyrightable material.

Tangible Property

Tangible property for purposes of this policy is defined as tangible (or corporeal) items resulting from research and/or other work. Such items could include biological materials (e.g., cell lines, clones, tissues), chemical compounds, formulations, extracts, databases, circuit diagrams, engineering drawings, integrated circuit chips, and prototype devices and equipment. Tangible property may have commercial value and, as such, is subject to the Center's Policy on Inventions, Patents, Copyrights, Tangible Property, and Technology Transfer.

Tangible property may be patentable or copyrightable, but patent protection is not always sought. Often, tangible property is so unique and difficult to replicate that it is protected simply by controlling its distribution. Biological materials may be deposited in the ATCC to make them available for non-commercial research with the proviso that if someone wishes to use them for commercial purposes he/she must take a license from the Center. Alternatively, tangible property may be transferred via Material Transfer Agreements with clear limitations for its use, and for sharing if economic benefit is realized from it.

C. Commercialization of the Center's Intellectual Property

Marketing

Through diverse proactive and reactive marketing pathways the OIA will seek licensees to develop Inventions, sell products and services, and pay royalties. As part of this process, the OIA may post available Inventions on the Center's Web site, make direct contact with potential licensees, send mailings and e-mailings, entrust Inventions to recognized intellectual property management organizations, receive visitors interested in licensing technologies, etc.

Licensing

In licensing, sale, or other disposition of rights, the OIA shall seek the best and fairest deal it can obtain through good faith negotiations for the common good, and on behalf of the Center and the inventors. The OIA will supervise and manage all license agreements throughout their duration.

Income Sharing

All income derived from Inventions in which the Center has proprietary rights and that is received after September 18, 2002, (the date on which the latest revised policy took effect), shall be distributed in accordance with the following guidelines:

1. Royalties

The cumulative gross proceeds derived from Intellectual Property shall be assigned to the corporation within the Center that originated it unless determined otherwise by the President of the Center. Due consideration shall be accorded to components other than the originating component if value added to the invention by other components was material from the licensing and commercialization of the invention. The cumulative gross proceeds from Intellectual Property resulting from research or other work conducted by or at the Center shall then be shared with the inventor(s) according to the rate table below:

*Cumulative Gross Proceeds shall mean the sum total of all license fees, milestone payments, and royalties paid at any time for a particular invention or discovery (including those paid before September 18, 2002), whether paid in cash or other form, such as shares of stock or other securities. Cumulative gross proceeds shall not include payments for research support, value of materials supplied, reimbursed patent expenses, or other specific reimbursements of expenses or costs. Distribution of the remaining income will be directed toward programs of high priority within the designated corporation with special consideration given to the program(s) of the inventor(s). All such income so distributed shall be subject to an indirect cost charge as estimated by the institution.

For any Intellectual Property disclosed to the Center prior to September 18, 2002, (and for which the Center receives income after September 18, 2002) the distribution to the inventors will be calculated according to the policy most favorable to the inventors, namely either the policy effective at the time of the disclosure or this policy, effective as of September 18, 2002. This policy will not affect payments made before September 18, 2002.

2. Income Derived from Stock or Equity

Institutional income derived from licensing agreements of Intellectual Property may include stock or other equity in a company. Such stock or equity will be held by the Senior Vice President, Finance, and will be managed and sold according to procedures that ensure that decisions to sell are made at arm's length from those Center members or staff who were involved in originating the licensed Intellectual Property. The proceeds from such sale of stock or equity will be treated as institutional income derived from Intellectual Property and will be distributed accordingly.

3. Other Income

Other income received as a result of, or corollary to, for example, technology transfer (including payments to support collaborative work in the development of Inventions, research support, patent expenses, and license management fees) will be considered institutional revenue, and shall be used in accordance with institutional and corporate policies.

4. Limits on Distribution

Under no circumstances may any royalty or other form of compensation (including financial awards, bonuses, annuities, etc.) exceed the total amount that may be paid under applicable federal and other laws and regulations (including those applicable to organizations exempt from taxes under Section 501(c)(3) of the Internal Revenue Code). In the event that there are multiple inventors, the Inventors' Share of Cumulative Gross Proceeds will be distributed among the inventors according to a written allocation agreement executed by the inventors. If there is no written allocation agreement, all inventors will receive equal portions of the Inventors' Share. In case of disputes or unusual circumstances, the distribution will be determined by the President of the Center.

5. Time of Payment

Each inventor's distributive share in the cumulative gross proceeds shall be calculated and paid to the extent practical (as determined by the Center), within three months of the receipt of funds by the Center.

6. Abandoned Royalty

If after diligent efforts the Center has been unable to deliver an inventor his or her share of royalties for three consecutive years, such money will henceforth become the property of the Center and will be treated in the same manner as the Center treats its own share of royalties. When the inventor resurfaces and claims his or her share of royalties, the Center will resume distributing his or her share.

A. Sponsored and Collaborative Research, Foundation Grants, and Federal Grants

In cases of sponsored or collaborative research and clinical trials, special arrangements regarding Inventions may be necessary, and the OIA negotiates these contracts. The Division of Research Resources Management manages all awards for projects sponsored by external agencies including, but not limited to, foundations, corporations, and the federal government.

Grants from foundations often have obligations to them when Inventions are made (e.g., sharing of income from Inventions). Therefore, the source of funds used to make an invention must be disclosed in the Invention Disclosure Form.

Inventions and discoveries arising from research funded by US government agencies will be controlled by the terms of the applicable grant or contract and statutes, specifically the Bayh-Dole Act of 1980. All licenses granted for such inventions and discoveries will also be subject to these terms. Grants from the NIH, and generally those from other government agencies, require the Center to disclose all patentable inventions to the funding agency. The Center may then elect to retain ownership of patents issued for such inventions, subject to rights retained by the government: (i) a nonexclusive license to use the invention for its own purposes and (ii) the right to "march in" and license patents that are not being actively used. The government also requires that preference be given to small businesses, and that patented products be manufactured substantially in the United States.

To the fullest extent possible, the Center's policies on Inventions, Patents, Copyrights, Tangible Property, and Technology Transfer will apply to all funded and collaborative research, whether or not there is an agreement pertaining to such research.

B. Delay of Publication

The Center, and other entities providing funds or materials for an employee's research, may request that the employee delay a publication or presentation of any research that discloses an invention or discovery until a US patent application has been filed. In no instance will the delay be unreasonable, as determined by the OIA. To avoid or minimize delay, it is important to promptly disclose Inventions to the OIA, and to provide drafts of any proposed publications or presentations as soon as possible.

This policy does not limit the right of individuals to publish or to make other types of public disclosures (abstracts, texts, posters, scientific presentations). However, it urges employees to consider how the timing of publication or presentation affects the ability to obtain a patent. Employees should be aware that public disclosure prior to the filing of a US patent application is a bar to the granting of foreign patents, and will also likely bar the granting of a US patent if the disclosure occurred a year earlier than the US filing date.

C. Journal Publication

MSKCC, as a nonprofit cancer center dedicated to advancing and disseminating knowledge about cancer, supports the Public Access Policy adopted in 2005 and revised in 2008 by the NIH that is intended to allow free Internet-based searching and downloading of all published work that the NIH has supported. (This policy can be found at www.grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html.)

The policy requires authors to deposit an electronic version of all manuscripts describing NIH-supported studies in PubMed Central after acceptance for publication in peer-reviewed journals. PubMed Central (www.pubmedcentral.nih.gov) is the open and fully searchable repository of full texts of biomedical research reports maintained by the National Library of Medicine at the NIH.

Although authors are free to choose the journals to which they submit their manuscripts for consideration, MSKCC favors publication in open-access journals, which license copyright from the author under the conditions of a Creative Commons license. Offering work under a Creative Commons license does not mean giving up copyright; it means offering some rights to any taker, and only under certain conditions. Creative Commons (www.creativecommons.org/about/licenses) offers six licenses from which to choose. Under a typical license an author allows others to copy, distribute, display, and perform the copyrighted work -- and derivative works based upon it -- but only if they give proper credit.

The author(s), the Center, and/or the sponsor(s) are sometimes requested to relinquish rights to copyrighted articles submitted to scholarly and professional journals. If the author(s), the Center, or the sponsor(s) are to retain title or other rights to copyright of the material in these cases, advance arrangements approved by the Division of Research Resources Management should be made with the publisher.

D. Commissioned Works of Nonemployees

Copyrightable works are owned by the author in the first instance. Thus, if you commission such works of nonemployees you must make sure that the results are not owned by the author but by the Center. Staff members of the Center must, therefore, generally require that contractors or other people to whom such work is commissioned sign a standard Nonemployee Agreement provided by the Human Resources Department that protects the Center's ownership rights to copyrightable material.

E. Material Transfer Agreements

Rapid changes have occurred in the science and business of medical research during the last 20 years. One such major change was a great increase in the kinds and number of samples of genetic materials that are exchanged by scientists. Because of the unusual characteristics of tangible property, which are particularly evident in the case of cell lines, clones, tissues, chemicals, and other reagents, it is often necessary to exchange the tangible property material itself to acquaint interested parties with what has been developed. The Center has revised its policies and procedures relating to tangible property in response to these changes.

To maintain orderly procedures with regard to the control and distribution of tangible property, employees have the obligation to use the procedures described in these guidelines to send or to receive tangible property.

Identification of Tangible Property

Each item of tangible property requires an unambiguous identification sufficient to distinguish it from other similar items developed at the Center or elsewhere. In certain instances, ownership marks may be necessary to meet the Center's contractual obligations and administrative requirements. Because of variation in the types of tangible property, the use of such ownership marks could include the name of the institution, the name of the developer of the tangible property, a copyright notice, a trademark, or other identifying marks. Selection of the ownership mark will depend upon the nature of the tangible property.

Disclosure of Tangible Property Transfers

All people who are involved in exchange of tangible property are responsible for promptly disclosing the nature and details of such activities to the OIA and their department chairman or laboratory head, and for complying fully with procedures for material transfers described herein.

All agreements relating to tangible property transfers, whether for sending or receiving tangible property, must be signed by the OIA prior to exchange of the tangible property.

Procedures for Sending Tangible Property to Other Organizations

Material Transfer Agreements are required for all tangible property sent from the Center to other organizations. The OIA is responsible for maintaining a central file of all Material Transfer Agreements and complying with legal and contractual matters regarding distribution and receipt of tangible property, and will assist employees in any matter relating to tangible property. Procedures to be used for distribution of tangible property differ, depending on whether the materials to be transferred are Undisclosed or Disclosed.

Undisclosed materials include materials like unpublished cell lines, cDNAs, and mutant animals, new proteins, tissue specimens, and other materials that cannot be reproduced from published materials. The Center has a protectable interest in undisclosed materials, and they are proprietary in nature.

Undisclosed materials should not be distributed without a signed Material Transfer Agreement. The OIA will prepare a Material Transfer Agreement and send it to the requesting party for signature. Human tissue samples are a special kind of undisclosed material. Therefore, a special approval procedure is used. Transfer of human tissue samples must always be in compliance with HIPAA and its guidelines. Employees will be advised of progress. When the OIA receives a fully signed Material Transfer Agreement, employees will receive a copy and may then send the tangible property to the requesting party.

Disclosed (or published) materials are those that have been described in literature and can be created without use of the requested materials (such as gene sequences); are available from another source (such as the ATCC); are protected by a patent application, patent, or copyright; or will not destroy a proprietary interest of the Center (e.g., sending an antibody will not diminish the proprietary value of the cell line that produces it). Disclosed materials can be distributed to not-for-profit organizations with the Uniform Biological Material Transfer Agreement (UBMTA). A UBMTA is preferable, but not required, when distributing published materials that cannot be created by the requestor (e.g., mice or cell lines). Necessary forms can be obtained from the OIA. Employees must send signed duplicate original forms with a description of the research to be performed directly to the OIA, where the other necessary signatures will be obtained. Disclosed materials may not< be sent to commercial, for-profit organizations using the MSKCC Material Transfer Forms. A more detailed Material Transfer Agreement must be used and may be obtained from the OIA.

Procedures for Receiving Tangible Property from Other Organizations

Usually organizations supplying tangible property to Center scientists (providers) will also insist on a Material Transfer Agreement. All Material Transfer Agreements for receipt of tangible property must be sent to the OIA for review. Acceptable Material Transfer Agreements must be signed by the OIA and will be promptly returned to the provider so that the requested material will be released to the employee. Employees will be informed of progress and given a copy of the signed agreement.

Material Transfer Agreements from provider organizations may contain conditions that the Center cannot accept. Two of the most common unacceptable terms are demands for ownership of any invention an employee makes using their tangible property and restriction of the employee's right to publish the research results. These demands conflict with Center policies and with federal law where government funding supports the research. These demands may also interfere with the employee's research by preventing him or her from obtaining materials and funding from other sources.

The OIA can usually resolve disagreements over terms through negotiations with the provider. In the case of ownership of Inventions, reasonable license rights may be offered, consistent with other commitments, legal requirements, and Center policy. Regarding the right to publish, a reasonable delay in publication may be granted, so that the provider can review proposed publications for confidential information and patentable discoveries.

Special Agreements

In some instances, a research agreement or other special agreement will have terms that provide for transfer of certain classes of tangible property. In such cases, transfers of covered materials will not require separate tangible property transfer agreements. Agreements have been made with certain organizations to use special Material Transfer Agreement forms to accommodate special needs. Examples include the Howard Hughes Medical Institute, the Ludwig Institute, and the National Institutes of Health.

F. Litigation

The Center will not bring, prosecute, or defend any litigation in court involving Inventions, or any patent or patent applications relating thereto, without the prior approval of the Board of Managers.

G. Release of Ownership Rights

The Center may determine that neither commercial possibilities nor the potential contribution to the public good warrants either managing or pursuing a particular Invention. In this event the employee, as the inventor, may petition the Division of Research Resources Management for a license to such Invention, or the reassignment of the rights. If such license or reassignment of the rights is approved, the employee will assume all future expenses related to the Invention, pay a portion of any future revenues resulting therefrom to the Center, and will allow the Center to retain a license for its own purposes.

H. Confidentiality

In the course of evaluating the commercial potential of Intellectual Property owned by the Center, it is often necessary to provide prospective licensees with specific information about the property to determine if there is commercial interest. In order to protect the Center's ownership and other rights, disclosure of unpublished Inventions, discoveries, or other pertinent information to third parties should be made only after the third party has signed a confidentiality agreement negotiated by the OIA.