Aptamer intellectual property and licensing
Aptamers function as chemical antibodies across a range of applications. From quality control reagents to point-of-care diagnostics and clinically relevant therapeutics, regardless of the end-use of the developed reagent, what rights and protection do you have over the final Optimer™?
We understand that each project is unique and that the requirements of each customer vary over time and so we are open to working flexibly to support you with the delivery of novel solutions driving discovery.
This article will discuss the intellectual property (IP) of aptamers, how Aptamer Group typically work with our partners and customers and how you can use any custom Optimer reagent developed by Aptamer Group.
Aptamer discovery process
Since the first description of aptamer selection in 1990, many companies have worked to develop and commercialize aptamer-based technologies. Aptamers have many potential uses across the life sciences and are being increasingly explored across research, diagnostics and therapeutics to refine and improve assays, hit novel targets, or offer an alternative therapeutic moiety.
Aptamers are identified by a process of in vitro selection from a random oligonucleotide library. A similar process was reported in the same year that Tuerk and Gold patented a modified aptamer discovery process of SELEX. Since then, many extensions and adaptations have been made to the aptamer isolation process, some of which have also been patented, such as:
- Chimeric- SELEX
- Parallel- SELEX
- Transcription free- SELEX
The early patents covering the SELEX processes have now expired.
At Aptamer Group we use our own automated variant of the in vitro selection approach. Starting from a diverse library of potential binders, we refine the population and enrich sequences that have the required binding characteristics (affinity, specificity, cross reactivity, buffer/reagent compatibility). We then screen the refined library to identify the best performing sequences. These are then processed to Optimers that deliver the best performance to meet your needs.
Patents around the aptamer selection approach are still common, but there has been a significant shift towards protecting the IP for specific aptamer sequences against defined targets. In the same way that an antibody or alternative affinity reagent can be patented, the sequence and use of a specific aptamer can be patented for use in specific applications.
Aptamer binders are predominantly composed of single stranded DNA or RNA (or variants thereof), which fold into complex secondary and tertiary structures. As solid phase synthesis of oligonucleotides is now readily available and scalable the security of supply is assured. Unlike antibodies, there is no need to store cell lines or recombinant plasmids for the future manufacture of aptamers. The aptamer sequence information can be stored digitally, allowing simple information storage and transfer.
As aptamers are nucleic acid-based, rather than protein-based (like antibodies), there is often freedom to operate in diagnostic and therapeutic applications where significant, well-established antibody-based IP already exists. This FTO will also depend on the target and the use of the aptamer, so Aptamer Group cannot guarantee that generation of aptamers against your target will not infringe any third-party IP rights.
IP for Aptamer Group’s Optimers
We understand the importance of IP to our customers and strongly encourage discussions surrounding IP at an early stage. Following a custom Optimer selection, we can work with you in many different ways to secure the intellectual property rights you need for each Optimer. A research use only (RUO) licence is granted with the delivery of the Optimers to allow the Optimer binders to be assessed in your lab. You are free to use the reagent under this licence on an ongoing basis if the Optimer-based application will not be further commercialized. If you wish to commercialize your Optimer-based product we work in a variety of ways to help mitigate the risk throughout the process.
It is possible to agree on the exclusivity of using the developed target-specific Optimer as a research reagent for an annual fee. Many of our customers exercise this option as part of their Optimer selection process. We agree on a fee for exclusivity with each customer based on the target and application of interest. In these cases the aptamer sequence remains the IP of Aptamer Group and is not shared with the customer.
The ownership of the IP can be jointly shared between Aptamer Group and the customer.
Full Commercial Rights
If required, we can transfer, assign or licence the IP to the customer to distribute or commercialize the Optimer for research, diagnostic and therapeutic purposes. This option is available for a ‘no strings attached’ control of the final selected Optimer sequence.
Other ways we work with partners
Other options that we regularly work with include licence fees and royalties and mark-up models.
At Aptamer Group our flexible approach to both technical development and commercial offering ensure that we deliver not just the specific, sensitive reagents that you need, but also fair commercial terms that enable your projects to be a success.