This policy is designed to further Conscience’s goals to accelerate innovation through open science and improve the accessibility of therapeutics. For a more detailed explanation of our approach to openness and access, please refer to our Guiding Principles. To learn more about how our default open position may be modified, please see the examples below. Additionally, our FAQ pages answer many of the questions we often receive about open science, intellectual property, and commercialization.
1 – The outputs of Conscience-funded projects must be openly shared
Conscience’s primary goal is to increase availability and affordability of medicines. We believe that open science is the most powerful tool to achieve this goal.
Conscience’s default position is that anything practically necessary to access or use the outputs of the projects we fund must be openly shared as early as is practical but in any case by the end of the funding term. Open sharing means that the output is publicly accessible with no legal barriers (e.g., patents) or restrictions to use by anyone, other than protections necessary to preserve patient privacy and consent or regulatory exclusivity.
This open sharing requirement applies to any therapeutic or technology developed through a Conscience funded project, underlying data (e.g., efficacy, safety, manufacturability), as well as methods practically required for others to access or use it.
2 – Modifications to openness may be considered to ensure access
We can only achieve our goals if the projects we support make new therapies available to patients or make existing medicines more affordable. We recognize that there is no single path to developing medicines across modalities nor a single policy that can encompass all situations.
In light of this, we may consider modifications to our default position on full openness to permit limited intellectual property rights (e.g., patents and trade secrets) in the outputs of projects we support, if we consider such rights reasonably necessary to ensure medicines make it to patients. Any such modifications will be made on a case by case basis and will maintain maximal openness across project outputs. Grantees will be responsible for justifying departures from full openness.
3 – Grantees commit to transparency about access and use conditions
Recognizing that some projects may be allowed to depart from full openness — for example to maintain intellectual property rights necessary to ensure availability and affordability — it is crucial that we are transparent about when such departures are permitted and how those decisions are justified.
We ask every grantee we support to develop an Output Management and Sharing Plan that will be made publicly accessible no later than the end of the project. This Plan will list all output types generated through the project, provide details about where and how the grantee will share them, and the conditions under which they can be reused. Where a departure from our default position is permitted, the justification for doing so will be included. The original plan must be finalized before grant contracts are signed. Any changes made to the plan over the course of the project must be approved by Conscience.
Exclusivity Under Our Default Open Approach
The examples below illustrate how we envision our Open Science Policy would apply in the context of patient privacy and regulatory exclusivities, as well as how the default position may be modified if properly justified by the applicant. This list of examples is not exhaustive nor are the specific examples binding on Conscience. Rather, they provide a basis for potential applicants to think through their approach to open science in the context of a Conscience-funded project.
If you would like to discuss how our Open Science Policy would apply to a particular project or under specific circumstances, please contact us.
Protecting Privacy and Consent
If a Conscience funded project generates or relies on sensitive information, such as data about patient identities that patients did not consent to share openly, projects need not justify their choice not to share such information. Indeed, respecting patient privacy and consent is expected of all Conscience funded projects.
Projects should describe how data will be handled and protected. Where an appropriate, trusted, controlled access repository exists (i.e., a controlled access biobank), applicants should describe how they will share through that platform.
Regulatory Exclusivities
In order to obtain the funding necessary to conduct clinical trials, we recognize that it may be necessary to preserve some exclusionary rights. Under this policy, a project taking steps to preserve regulatory exclusivities (e.g., data and market exclusivities), whether through contract or licensing arrangements, need not justify this choice as long as they freely share all data, including clinical data. Doing so preserves commercially important exclusivity while eschewing the broad exclusive rights granted by patents, putting some limits on the ability of others to create competing products while broadly preserving openness. You can read more about regulatory exclusivities on our FAQ page.
Example – This regulatory exclusivities without patents strategy is currently being used by the Conscience funded project conducted by M4KPharma. You can learn more about their approach here.
Potential Modifications to Conscience’s Default Open Approach
It may be the case that an open strategy that accords with our open science approach will fail to improve access to medicines because technical, scientific, or commercial realities make the successful development of the therapeutic in question practically impossible. For example, a project may be developing a therapeutic where regulatory exclusivities do not apply, regulatory exclusivities by themselves may be insufficient to drive the investment required for full development, or a patent may cover a molecule that is useful for multiple indications only one of which is the subject of Conscience funding.
In such cases, Conscience may permit grantees to obtain or maintain limited intellectual property rights, such as patents and trade secrets. It will be the grantee’s responsibility to demonstrate to Coscience’s satisfaction that such further exclusionary rights are practically necessary to ensure access. Such justifications must be made at the time of application and must be convincing, clear, and enforceable.
Defensive Patenting
Some companies may wish to maintain or obtain patent rights in order to prevent others from taking actions intended to block the development of a particular technology. In these cases, the company does not enforce its patents against third parties that use the technologies in a good faith effort to test the product or develop them further, but will enforce those patents against third parties that attempt to take market measures (e.g., locking out suppliers, applying for blocking IP) the main point of which is to erect barriers to development. In such cases, Conscience may allow patents to be obtained or maintained as long as contractual measures are in place to ensure that the patent is only used for defensive purposes and the applicant demonstrates the organizational capacity to enforce the patent.
Field of Use Carve-Outs for Specific Indications
In certain therapeutic areas, particularly rare or underserved indications where commercial incentives are insufficient to support development and access, limited field of use carve-outs may be appropriate. For example, a company may have developed a small molecule therapeutic for a large lead commercial indication (e.g., cancer or diabetes), however there is evidence that the therapeutic may provide potential therapeutic benefit for another indication, like a rare disease. In these cases, Conscience may fund work to evaluate the potential therapeutic benefit in the unexplored indication while permitting the company to obtain and maintain patent rights covering the molecule for their existing commercial indication. Such new or maintained intellectual property rights will be permitted provided that the applicant grants a royalty-free, worldwide, non-exclusive license limited to the rare disease field of use, permitting any party to develop, manufacture, use, and conduct further research and clinical development of the molecule for that indication and disclaims any right to pursue those exercising the license for inducement of patent infringement. This requirement does not prevent the company from pursuing development in the rare disease indication but ensures that others are not excluded from doing so.
Field of Use Carve-Ins for Specific Indications
It may be the case that a therapeutic under development will only serve a patient population if IP rights over the use of the therapeutic in that particular indication are allowed. In such a case Conscience may allow maintained patent rights for use in that indication (i.e., through a method of use patent). However, this approach will only be considered if we can assure that other relevant outputs (e.g., clinical data, newly developed methods) will be openly shared, commercial and research uses of the therapeutic outside of the particular indication are without restriction, and we do not consider the IP rights to be a serious long term bar to generic manufacturing.
