Partnership

ToolGen own and patent the original technology for applying CRISPR-Cas9 to eukaryotic cells, and ToolGen also own patents for technologies that refine or apply the action of CRISPR-Cas9. In this regard, ToolGen has more than 200 patent applications and 84 registered patents in major countries around the world.

Companies that develop and commercialize therapeutics/drugs, plants/seeds, animals, research tools, cell lines/model animals, etc. using CRISPR-Cas9, as well as CROs/CMOs, need to license our patents.

The need for other CRISPR-Cas9 licenses depends on where you are located in the world and what types of applications you are pursuing. Since there is a large and growing list of CRISPR-Cas9 intellectual property throughout the world, it’s essential that each user analyze their own situation with regard to these factors. However, it is important to note that if you plan to use of the CRISPR-Cas9 system in eukaryotic cells, you will require a license from ToolGen.

Interference in the United States is an examination system that was in effect prior to the amendments to the U.S. Patent Act (i.e., prior to March 2013), under which the first-to-file system grants patent rights to the first inventor when multiple applications exist for the same invention. In contrast, under the first-to-file system, if there are multiple applications for the same invention, the patent is granted to the first person to file a patent application, without considering the priority of the applications at the time of filing. First-to-file in the U.S. is a uniquely U.S.-specific standard for granting patents that existed in the U.S. at the time of ToolGen’s CRISPR original patents application in 2012.

An inter partes review begins at the U.S. Patent Trial and Appeal Board (“PTAB”). An interference proceeding before the PTAB is a two-phase process. The first phase, called the motion phase, determines whether the multiple inventions that are the subject of the inter partes review are identical and who the electorate is. If the PTAB determines that the inventions are not identical, the PTAB determines that there is no interference in fact and closes the interference proceeding. On the other hand, if the first phase determines that the inventions are identical and that there is a senior party and a junior party, the second phase proceeds to determine the priority of the multiple applicants. In the second phase, the Junior party, which was determined to be the junior applicant in the first phase, first files a motion claiming to be the priority applicant. The senior party, who was found to be the first-to-file, then responds and asserts a first-to-file claim. The PTAB considers the parties’ arguments and evidence to determine who the first-to-file is.

ToolGen is currently embroiled in a patent interference with CVC Group and Broad Institute in the US, as it seeks to establish itself as the original inventor of the CRISPR-Cas9 patent. As an early applicant, ToolGen enjoys a favorable position in the interference process, where it is recognized as a senior party opposing CVC and Broad, respectively. Consequently, it is challenging to ascertain who will eventually own the US CRISPR-Cas9 patent until the interference is resolved and the patent ownership determined.

No. Despite the ongoing interference of the CRISPR-Cas9 patent, many of our licensees continue to do business as usual in the U.S. We have been granted Senior Party status in the interference, which gives us an advantage in the interference proceedings.

Patent rights arise and lapse independently in each country. Our original patent for the application of CRISPR-Cas9 to eukaryotic cells has the earliest filing date, and our patents in other countries have a higher status than our patents in the U.S. because the U.S. uses a first-to-file system, which grants rights to the first patent to file.

Yes, you must obtain a patent license if your development is for commercialization and not research purposes. To ensure that CRISPR-Cas9 researchers are not overwhelmed, ToolGen has a tiered licensing policy.

Because ToolGen’s technology is available to apply in various technical fields, and each field has a different market value. Therefore the exact cost is negotiated with ToolGen’s licensing team.

In most cases, licensing a ToolGen technology involves two factors; a licensing fee and royalties. The license fee is due after the agreement is executed, and royalties are due when a product is commercialized and sold.

We generally grant a general license to our partners to enable as many customers as possible to apply CRISPR-Cas9 technology to their business. If you require an exclusive license, please contact our business development office at BD@toolgen.com.

The scope of our technical support services under our license agreements with our partners varies depending on the field of application and the terms of the agreement, but we support our partners who are unfamiliar with CRISPR-Cas9 technology as much as possible to avoid technical difficulties. In addition to providing technical support, we also aim to promote mutual growth through joint research with our partners.

ToolGen’s patents are registered and pending in major countries around the world.