Intellectual property policy

INTELLECTUAL PROPERTY, INNOVATION, AND

TECHNOLOGY TRANSFER MANAGEMENT 

NUMBE: 1436-04

TITLE: INTELLECTUAL PROPERTY, INNOVATION, AND TECHNOLOGY TRANSFER MANAGEMENT

ORIGINATING DEPT: KING ABDULLAH INTERNATIONAL MEDICAL RESERCH CENTER (417780)

ORIGINAL DATE: OCTOBER 2015

1. PURPOSE

To provide a process governing the safeguarding, disclosing, management of Intellectual Property (IP) and any invention made by faculty record researchers, faculty, students and employees of the Ministry of National Guard - Health Affairs (MNG-HA) and all its affiliated facilities. This APP also covers applying and processing of patents and the process of commercialization of the invention and

distribution of revenue.

2. APPLICABILITY

To all relevant staff, students, visiting staff and trainees of Ministry of National Guard - Health

Affairs (MNG-HA) and all its affiliated facilities.

3. RELATED REFERENCES:

3.1. APP 1429-19 Conflict of Interest

3.2. Committee Formation Order (CFO)

3.3. Patent Law of Saudi Arabia

3.4. Trademark law Ministry of Commerce and Industry Royal Decree NO MilS dated 12/81l420H

4. DEFINITIONS

4.1. Business Partner refers to an entity which has an agreement with the MNG-HA.

4.2. Innovation Technology Transfer Management Office (ITTMO) refers to the department under King Abdullah International Medical Research Center (KAIMRC) which primarily deals with Intellectual Property. ITTMO oversees the disclosure, safeguard, commercialization and management of (IP), as well as the ownership of any invention made by MNG-HA and its affiliated facilities.

4.3. Intellectual Property (IP) refers to creations of the mind, such as inventions literary, artistic works, designs and symbols, names and images used in commerce.

4.4. Invention refers to new and useful art, process, machine, software, manufacture or composition of matter developed by personnel ofMNG-HA and its affiliated facilities.

4.5. Inventor(s) refers to an individual or group which work for MNG-HA and/or its affiliated facilities who makes or develops an invention using, in any way, resources and facilities owned, operated or administered by the Program or its funds.

4.6. Net Revenue(s) refers to the sum of royalty, licensing and any other income received as a result of the development or commercialization of an invention after deduction.

4.7. Office Action refers to a letter from the Patent Office where the examiner from aformentioned office requests the innovator to provide a feedback.

4.8. Patent refers to the exclusive rights granted for an invention.

4.9. Patent Offices refer to the government bodies which may grant or reject a patent application based on the fulfillment of patentability requirements.

4.10. Primary Innovator refers to the individual whose contribution to an innovation is considered as representative by co-innovator(s) and is also considered as the legal focal point of communication with ITTMO.

4.11. Program refers to MNG-HA and all its affiliated facilities.

4.12. Prototyping refers to the first design, model or release of a product built to test a concept or process from which other forms are copied or developed.

4.13. Research Data refers to any written and/or non-written material which is produced by MNGHA personnel during the course of conducting research, including, data, records, computer software, program database and other computer related materials, product or documentation in any storage media.

4.14. Royalties refers to the amount paid to the inventor by the Program for the sale of a patented /copyright asset or intellectual property.

4.15. Sponsor refers to an external organization that is in research or joint research agreement or clinical trial agreement with the Program which initiate and fund the agreed research activities.

4.16. Trademark(s) refers to a word, symbol, and/or design legally registeried or estabished to represent a product or company.

4.17. Trademark Applicant refers to an individual or group working for MNG-HA and/or its affiliated facilities who makes or develops a trademark.

5. POLICY

5.1. The ownership of inventions, research data, and trademarks must be as follows:

5.1.1. In order to protect the public good and to fulfill obligations to research sponsors, the Program must retain ownership of all inventions except when

5.1.1.1. The invention results from activities carried out in collaboration with inventor(s) from other institutions in which case ownership must be negotiated by the Program on a case by case basis.

5.1.1.2. The invention results from activities carried out under a sponsored research contract, the terms of which assigned the ownership of inventions to the sponsor(s).

5.1.1.3. The invention results from private activities of the inventor(s) carried out in whole by the inventor(s)' on their own time with no involvement of the Program facilities or resources and the inventor can demonstrate that the Program did not provide or administer funds, space, personnel, or facilities for work leading to the discovery.

5.1.1.4. The rights have been returned to the inventor(s) by the Program, due to incomplete filing process for any reason.

5.1.2. The Program and inventor must jointly own all research data except when the research data results from activities carried out under a sponsored research contract, where the contract terms clearly assign the ownership of research data to either sponsor(s) or to the Program.

5.1.3. The Program must own all trademark(s) related to its products or services.

5.2. On behalf of the Program, ITTMO must negotiate with intellectual property owner(s) to acquire their ownership rights based on a formal agreement. The criteria to acquire such rights depend on the intellectual property economic or research impact.

5.3. The inventor(s) must not place the invention in the public domain through a lecture/publication or by any other means until a decision has been made regarding the patentability or commercialization of the invention.

5.4. If ITTMO decides to apply for a patent for the invention, the inventor(s) must assign all rights of the invention to the Program including, but not limited to, signing all the required documentations in order for the assignment to be effective.

5.5. ITTMO reserves the right to decide whether or not to file a patent based on the foreseen invention commercialization impact.

5.6. All communications related to the (IP) are managed and administrated by ITTMO internally and externally.

5.7. ITTMO must handle the external communications on behalf of the Program personnel that are related to the invention along with the external legal advisor, governmental entities and business partners.

5.8. ITTMO must communicate only with the primary innovator who officially represents the other co-innovator(s) to sign legal documentations, to provide information/data, to oversee negotiation, to receive royalty shares and distribution to other co-innovator(s) and to represent other innovator(s) in contacting external legal advisors.

5.9. Primary innovator is responsible to perform any tasks required during the filing process, such as but not limited to response to office actions, provide further clarifications to patent attorneys if required during commercialization process of the innovation.

5.9.1. Innovators abandoning future required communications related to their inventions must reimburse KAIMRC for all filing and legal fees incurred during the filing process.

5.10. Conflict of interest must be observed in accordance with APP 1429-19.

5.11. Ideas and Concepts Originality:

5.11.1. Innovators must ensure they are the original, first and sole owner of the idea/concept of the invention.

5.11.2. Innovators must state clearly ifthey are co-innovators for the intended innovation.

5.11.3. Innovators must state whether the innovation has been developed using other organizational funds.

5.12. Commercialization of an Invention and Distribution of Net Revenue

5.12.1. The commercialization of any product must only commence once the patent or copyright has been issued or preliminary registrations have been attained.

5.12.2. With respect to any invention subject to this policy, KAIMRC must be reimbursed for any/all expenses incurred associated with evaluation and patent research of the technology, obtaining of patent or other intellectual property protection, licensing or other technology transfer activity (such as but not limited to prototyping) including legal expenses.

5.12.3. In the event of any infringement action or other legal action involving technology disclosed under this policy, KAIMRC must also be reimbursed for any/all expenses borne by the Program associated with such action.

5.12.4. After such expenses are reimbursed, royalties and other proceeds from licenses or other technology transfer activities related to an invention patent or other intellectual property protection based thereon, must be distributed as follows:

5.12.4.1. Thirty percent (30%) to the inventor or inventors.

5.12.4.2. The remaining seventy percent (70%) must be distributed as follows:

5.12.4.2.1. Thirty percent (30%) to the unit(s)/section(s) in which the invention was made.

5.12.4.2.2. Seventy percent (70%) to the KAIMRC general research fund.

5.12.5. Royalties to inventors whose innovations were developed utilizing their own time, funds and premises must be distributed as follows:

5.12.5.1. Seventy percent (70%) to the inventor(s). Further development for the same invention, fifty percent (50%) of the inventor's share will be utilized as funds for the development phase.

5.12.5.2. The remaining thirty percent (30%) must go to the KAIMRC general research fund.

5.12.6. RITTC must decide and approve cases in 5.12.5.

5.12.7. The royalty payments processes are managed by the ITTMO on behalf of the Program in compliance with the Program policy.

5.12.7.1. No royalties must be paid directly to any inventor by any licensee.

5.12.7.2. Inventors must continue to receive royalties regardless of their future association with the Program.

5.13. Prototyping:

5.13.1. ITTMO must manage the innovation prototyping process as follows:

5.13.1.1. Decide the prototyping approach, whether to outsource to external company, build in house or assign it to non-profit entity.

5.13.1.2. Decide whether to fabricate the prototype for innovation or not. Materials as well as the prototyping method must be determined by ITTMO.

5.13.1.3. Choose the company which will develop the prototype.

5.13.1.4. Has the right to terminate the prototyping process at any stage of prototyping cycle without need to inform or get approval from innovator.

5.13.1.5. Coordanites communications between interested parties in the prototyping process such as but not limited to prototyping company, attorney, innovator or assign the primary innovator to contact directly with protoyping company.

5.13.2. Cost associated with prototyping must be taken or charged from research fund allocated for the development of the mentioned prototype.

5.13.3. Prototyping ownership:

5.13.3.1. The Program owns the intellectual property generated throughout the process of prototyping, design and develpoment. In addition, any tangible product as a result of prototype is owned by the Program.

5.14. Confidentiality

5.14.1. All Program personnel involved in the process of invention disclosure review, ownership determination, commercialization, patentability evaluation and commercial exploitation must maintain the confidentiality of the invention before and after it receives adequate intellectual property protection.

5.14.2. IP's documentations and communications must be maintained with high confidentiality restrictions.

5.14.3. ITTMO must secure softcopy as well as hardcopy for all documents related to inventions, contracts, agreements, emails and invoices for a period of time no less than twenty (20) years.

5.14.4. Where appropriate, ITTMO must require non-disclosure agreements to ensure confidentiality .

5.15. Any violation of any partner involved in intellectual properties must be escalated to RITTC.

6. PROCEDURES

6.1. Procedures for Patent:

6.1.1. Innovator will submit patent request to ITTMO.

6.1.2. ITTMO will review the patent application.

6.1.3. Innovators and ITTMO's representative will sign the following required documentations in order to initiate the patent application processing and reviewing.

6.1.3.1. Innovation Agreement (Appendix B)

6.1.3.2. Non-Disclosure Agreement (Appendix C)

6.1.3.3. Declaration Assignment/Oath Document (Appendix D)

6.1.4. ITTMO will assess the innovation through the invention disclosure form based on the following aspects:

6.1.4.1. Patentability

6.1.4.2. Economic benefits

6.1.4.3. Public benefits

6.1.5. Upon filing the patent, ITTMO facilitates the commercialization of the invention.

6.1.6. ITTMO will identify potential marketing partners for the invention and negotiate the best interests for the Program and inventors.

6.1.7. ITTMO will facilitate the development of licensing agreement between KAIMRC, the inventor and the interested commercial entities.

6.1.8. The revenue will be managed and distributed by KAIMRC.

6.1.9. Royalties are received and distributed by the ITTMOIRITTC on behalf of KAIMRC in January and July of each year.

6.2. Procedures for Trademarks

6.2.1. Applicant will submit a Trademark Registration Request to ITTMO.

6.3. ITTMO will review the trademark application.

6.3.1. Applicant and ITTMO will sign the following required legal documents in order to initiate the trademark registration reviewing and processing

6.3.1.1. Trademark Agreement (Appendix E)

6.3.1.2. Trademark Registration Form (Appendix F)

6.3.2. ITTMO will assess the trademark through the trademark registration form and identify potential protection outcome.

6.3.3. ITTMO will identify potential marketing opportunities.

6.3.4. The revenue will be managed and distributed by KAIMRC.

6.3.5. Royalties are received and distributed by the ITTMOIRITTC on behalf ofKAIMRC in January and July of each year.

6.4. Commercialization of Trademark and Distribution of Net Revenue

6.4.1. The commercialization of any product or service carrying a trademark must only commence once the trademark has been in the designated government registration office.

6.4.2. With respect to any trademark subject to this policy, KAIMRC must be reimbursed for any/all expenses incurred or associated with the registration process of the trademark including all legal and government expenses.

6.4.3. In the event of any infringement action or other legal action involving the use of the registered trademark under this policy, KAIMRC must also be reimbursed for any/all expenses borne by the Program associated with such action.

6.4.4. After such expenses are reimbursed, royalties and any other proceeds from trademark licensing or other sales or use activities related to the trademark or other intellectual property protection based thereon, must be distributed as follows:

6.4.4.1. Twenty percent (20%) to the trademark applicant.

6.4.4.2. The remaining eighty percent (80%) to KAIMRC general research fund.

6.4.5. The royalty payments processes are managed by the ITTMO on behalf of the Program in compliance with the Program policy.

6.4.5.1. No royalties must be paid directly to any trademark applicant by any licensee.

6.4.5.2. Trademark applicants must continue to receive royalties regardless of their future association with the Program.

7. RESPONSIBILITY

7.1. KAIMRC- ITTMO, RITTC and other relevant departments will be responsible for ensuring the implementation of the provisions of this APP.

7.2. Internal Audit and Organizational Development will randomly monitor implementation of the provisions within this APP.

8. APPROVALS

PREPARED BY:

________________ ________________

DR. AHMED AL ASKAR DATE

Executive Director

King Abdullah International Medical Research Center, MNG-HA

REVIEWED BY:

________________ ________________

SAAD AL OT AIBI DATE

Executive Director

Internal Audit and Organizational Development, MNG-HA

APPROVED BY:

________________ ________________

H.E. DR. BANDAR AL KNA WY DATE

Chief Executive Officer

Ministry of National Guard - Health Affairs