•  Intellectual property rights to sustain innovation and creation

With the development of new technologies, new ways of testing chemicals have emerged and will increasingly develop given the trend to move away from animal testing. These new methods generally include IPR. To date, many Test Guidelines for in vitro methods already include proprietary elements.

• Implementing good licensing practices

It is desirable that the field of test method development benefit from continuous technical innovation. It is important that new methods containing protected innovation are easily accessible to users for generating chemical safety data for purposes of human health and environmental protection. In September 2017, the OECD held a workshop to present and discuss issues associated with the availability, distribution means and transparent access to protected elements in OECD Test Guidelines (TGs). This workshop report summarises the presentations and discussions held, and recommendations for further work in this area for the OECD Test Guidelines Programme.

In 2019, the OECD published Guiding Principles on Good Practices for the Availability/Distribution of Protected Elements in OECD Test Guidelines. These Guiding Principles promote the implementation of Fair, Reasonable And Non-Discriminatory (FRAND) licensing terms and conditions. The owner of protected elements contained in a candidate Test Guideline should sign the FRAND declaration included in Annex to the Guiding Principles when submitting a project proposal at OECD. National Coordinators can be contacted for further details on the process.

Intellectual property rights (IPR) aim to stimulate innovation by enabling inventors to appropriate the returns on their investments. IP also plays an important role in the creation, dissemination and use of new knowledge for further innovation, as contained in the inventions disclosed in patent documents such as Trademark and Patent.

There are different ways in which rights may be transferred.

• Material Transger Agreement (MTA):

An MTA is an agreement between the cell bank (provider) owning the biological materials concerned and the recipient of such materials. It is used to document the transfer of protected materials and may include a number of terms and conditions. For several in vitro test methods in OECD Test Guidelines, a MTA is required with respect to the cell line or other proprietary components of the test method. 

However, they should not include terms or conditions that would prevent or limit availability of cell lines or other components of these Test Guidelines for testing.

Furthermore, MTAs should refer to the Test Guidelines concerned to avoid any doubts whether users of the OECD Test Guidelines can obtain the MTA-covered components. Consult the Example test guideline material transfer agreement (MTA) template.

Disclaimer: Any MTA is an agreement between the cell bank (provider) owning the biological materials concerned and the recipient of such materials. Therefore, the OECD shall have no responsibility.

• License:

In a license agreement, the licensor, typically the rights holder with respect to a protected invention, will grant to the licensee the right to use the protected invention according to the conditions outlined in the agreement and for a specified period in return for various considerations. Moreover, the license agreement and the scope of the licence may be worldwide or may be limited to certain jurisdictions (country or region).

•  OECD policy for confidential elements in candidate Test Guidelines under development and after adoption:

Test developers are encouraged to use other protection means than confidentiality claim for protected elements in test methods candidate for Test Guideline development. The OECD will temporarily host information on confidential elements on a protected community webpage accessible to National Coordinators only, until the completion of the TG development. When a Test Guideline is adopted, this information becomes publicly available as supporting material to the Test Guideline. Test developers should seek other means of protecting their IP than confidentiality. The OECD Secretariat or the National Coordinators should held no significant liability in case of leaching of confidential information from protected community webpage.

•  Criteria for pioneers to submit new Test Guidelines proposals:

Proposals for projects aiming at the development of new Test Guidelines should provide information on IPR aspects, as transparently as possible. 

OECD Test Guidelines should not contain elements that are confidential to the extent that this impedes adequate scientific validation and independent review of thhod. 

Test method developers have to contact their National Coordinator to develop a project proposal for a new Test Guideline. Project proposals for new Test Guidelines need the active support of regulatory authorities in at least one member country, and have to meet regulatory need in member countries.

•  Criteria for developers to integrate similar methods in Test Guidelines:

OECD’s interest in standardising similar test methods is primarily to 1) assess methods with potentially better performance or practicability, and 2) avoid monopolies from single supplier in case of protected elements. 

New proposals are made by member countries based on their regulatory needs and are included in the work plan once they have been approved. 

The following criteria are considered for uptake of mechanistically and functionally similar methods in an OECD Test Guidelines:

• No intellectual property restriction/freely available
• Broader geographical availability
• Broader/complementary domain of applicability
• Reduced cost or reduced time to perform the test and analyse data
• Reduction in animal/animal product use 
• Inherent metabolic capacity or proven possibility of combination with a metabolic system
• Improved mechanistic insight
• Additional toxicity endpoint(s) (to those covered in the VRM)
• Reduction in hazardous reagents
• Improved performance (reproducibility and/or predictive capacity)

Other aspects influence decisions on project proposals, such as: resources available and priorities in the Programme, dictated by the needs of OECD member countries, to develop new approaches and address emerging issues.