Genetic modifications: technologies, patents and FTO
Each research program is unique; therefore, each genetically modified research model must be precisely tailored to address specific aspects of the project and business constraints.
The generation of such adapted mouse, rat or cell lines is only possible when the right technologies can be applied. That’s why genOway maintains an exhaustive technology portfolio – to serve such models to its clients.
While some technologies are free to use, others are not
While some technologies are free to use, others are patented and therefore not free to use, unless a license has been acquired.
genOway holds all relevant licenses of patented technologies required to generate mouse, rat and cell line models, and guarantees you freedom to operate (FTO) along with the provision of the model.
Need more information?
Reach out to our licensing experts, or read answers to frequently asked questions:
What is a patent?
A patent is a legal title that enables inventors to temporarily protect their investment by forbidding anyone to use their invention. It is granted to the holder by regional or national patent offices after rigorous analysis. In fact, approximately half of patent demands are declined worldwide. The protection lasts up to 20 years in the countries where the demands have been filed. In return for the protection of the patented invention, the holder has to disclose the invention to the public so that everyone may be inspired by it, thereby spurring innovation.
What is a patent license?
By the license, the patent holder grants licensees the right to use their invention. The right can be either very specific or very broad, depending on the needs of the licensee.
Such suitable rights can vary, depending on the type of use. Regarding genetically modified (GM) models, your needs will mostly depend on what you intend to do with your model. Here are the main fields of use for GM rodent animals:
- Basic research – Analysis of genes and their functions or products
- Biopharmaceutical research – Activities aimed at developing drugs, including but not limited to target validation and drug screening, e.g., mice expressing a druggable protein
- Biologics engineering – Discovery and engineering of biologics molecules, e.g., humanized mouse models for human antibody development
Do I need to acquire licenses from patent holders to use the models provided by genOway?
genOway guarantees its clients the FTO when it provides its models. That means the client has no need to acquire extra licenses to safely use the models under the terms of the contract. As an example, genOway has acquired an exclusive license under Merck’s foundational CRISPR/Cas9 patents portfolio that enables genOway to provide its clients with the necessary rights to use CRISPR/Cas9-based GM models.
What if my GM model was not developed by genOway?
In that case, you need to quickly and carefully analyze all potential intellectual property rights covering the technologies used to develop your model in order to identify all licenses needed to securely keep and use your model.
Directly acquiring a license is unquestionably cheaper, faster and far more efficient for your organization versus investing a great deal of time and effort only to be denied one and find yourself unable to move forward.
Most big biopharmaceuticals are fully aware of the importance of such technologies as CRISPR. Consequently, when your organization negotiates with them, FTO will naturally be requested by these partners, so having previously acquired the right licenses is a major asset.
What if I don’t have all of the necessary licenses to keep and use my GM models?
If you do not possess the required rights to legally use your model, you are infringing on the intellectual property rights of inventors who can then legally sue your organization.
What are the consequences of an infringement?
If you and your service provider infringe on the intellectual property rights, you and your service provider may then:
- be obliged to stop all use of the invention and pay for past uses
- have to destroy all GM models made with the use of the patent
- have to pay damages to the patent owner (or exclusive licensee)
- have to pay all related costs of the lawsuit (at least US$10 million, if in the US)