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Patents and Licensing FAQ's
Via direct license from Emmanuelle Charpentier (to her co-ownership rights in the CVC patents), ERS Genomics has the right to provide licenses to this fundamental portfolio of foundational CRISPR/Cas9 patents. A license from ERS provides access to the full CVC portfolio and no other license from any of the other co-owners (University of California or University of Vienna) is required. ERS is the only company whose sole focus is on out-licensing to maximize commercial access to the CVC global patent portfolio.
CVC stands for University of California, University of Vienna, and Emmanuelle Charpentier and is the acronym used to describe the owners of what are commonly referred to as the UC Berkeley CRISPR patents.
In Europe the CVC inventors have been awarded three broad patents on the CRISPR/Cas9 technology that include claims to the following:
- A composition comprising a chimeric Cas9 protein and a DNA targeting RNA which includes a DNA-targeting segment and a protein-binding segment comprising tracrRNA and CRISPR RNA (crRNA)
- A method of modifying a target DNA in a single-cell eukaryotic organism, an animal cell, or a plant cell comprising contacting the target DNA with a CRISPR/Cas9 complex
- A method of modifying a target DNA comprising contacting the target DNA with a CRISPR/Cas9 complex where the crRNA and tracrRNA are covalently linked by intervening nucleotides (single guide RNA)
In the USA the CVC portfolio currently contains 35 issued or allowed and 35 pending patents which claim the following:
- Compositions and methods of using Cas9 with a guide RNA to form a CRISPR/Cas9 complex that binds a specified DNA sequence
- Various formats for delivering these complexes in cells of all types
- Use of the CRISPR/Cas9 complex to cleave DNA (resulting in knock-outs, insertions or mutations)
- Use of mutated Cas9 to ‘nick’ DNA (in place of cleavage) or to bring an effector domain to a specified DNA sequence to regulate gene expression in a cell
- Compositions of guide RNAs in a variety of formats including various lengths, chemical modifications, and base compositions
Outside of the US and EPO the CVC patent portfolio includes 33 issued and allowed patents with an additional 43 pending applications covering methods and compositions similar to the EPO patents.
ERS founder (and Nobel Prize winner!) Emmanuelle Charpentier is a co-owner of the CVC patents and formed ERS to provide licenses to companies and groups looking to commercialize products and services from the technology. ERS can provide licenses in all areas except use of CRISPR to directly treat a human. The gene/cell therapy rights to CRISPR were given to CRISPR Therapeutics so that they could focus on curing human diseases. ERS meanwhile, is able to provide full focus on other important areas without the distraction of developing its own therapeutics, products, or services. ERS does not compete with any of its licensees and is able to treat all parties fairly.
If you are performing commercial activities in any of the following areas, a license from ERS would be required:
- Internal R&D use¹
- Discovery and validation of novel targets
- Discovery and screening of novel drug candidates
- Cell line and animal model generation, including iPSC and stem cells
- Commercialization of research tools, kits, or reagents
- Commercialization of cell lines and animal models for laboratory research
- CRO, CMO, and CDMO services including GMP production of healthcare products
- Clinical diagnostics
- Companion animal healthcare
- Industrial production of materials such as enzymes, biofuels and chemicals
- Synthetic biology
¹ Importantly, most users who purchase reagents from 3rd party licensee providers may only conduct discovery research, preclinical research, and clinical research activities that fall within safe harbor statutes of 35 U.S.C. §271(e)(1) without obtaining additional licenses.
No other license from any of the other co-owners of the CVC patents would be required, however there is a large and growing list of CRISPR/Cas9 intellectual property throughout the world and the need for other licenses depends on where you are located in the world and what types of applications you are pursuing. Each user must analyze their own situation with regard to these factors. However, any use of the CRISPR/Cas9 complex will require a license to the fundamental intellectual property available from ERS.
The over 30 CVC issued patents are excluded from this interference, so only the Broad patents are at risk of being fully revoked.
If CVC wins… the Broad patents are likely fully revoked, only the CVC patents will be valid.
If Broad wins… the status quo will be preserved in the U.S. with BOTH groups having valid claims that cover use of CRISPR/Cas9 in eukaryotes.
No, those patents are separate from the CVC family of patents and practice of any of the claims under those patents also requires a license to the underlying CVC patents.
CVC’s issued patents are to the composition and use of the core type 2 CRISPR/Cas9 complex to modify DNA in ANY ENVIRONMENT without limitation to uses in eukaryotic cells. CVC further has issued patents on single guide RNA (sgRNA) which greatly enhances the efficiency of CRISPR gene editing in many applications.
In the United States, Broad’s issued patents (currently subject to a patent office initiated interference) are for certain methods of genome editing and uses only in eukaryotic cells.
In December, 2012, Broad requested “accelerated examination” of its application. This meant the USPTO considered the application more quickly. CVC did not request accelerated examination when it applied for a patent in May, 2012.
CRISPR research is a large field that involves contributions from many talented scientists around the world. The USPTO had issued more than 570 patents as of September 2020, with claims to CRISPR and/or Cas9 to approximately 900 inventors from more than 200 applicant organizations. The European Patent Office (EPO) had issued more than 190 such patents to more than 460 inventors from about 110 applicant institutions. In addition, there have been more than 9,200 applications filed (and published but not yet granted) around the world.
The Current CVC patent list can be viewed here.
Over the next several years, there will be many more patents issued in the CRISPR field, to many inventors from many institutions, in recognition of each individual’s contribution to advancing CRISPR technology.
ERS was founded in 2014.
No, ERS is privately owned.
Although our team has significant expertise in genome editing, ERS is focused on licensing of the patents to enable others to use the technology and so we do not offer ancillary services.