Representatives from Penningtons Manches recently attended a talk at Oxford University staged by the Progress Education Trust about Genomics England’s new project titled “The 100,000 Genomes Project”. As the clue in the name suggests, Genomics England (GE) intends to sequence roughly 100,000 genomes of patients suffering from cancers and rare genetic disorders. Each cancer patient will provide samples of affected and unaffected cells, and for rare genetic disorders the patient and two family members will provide samples, so that a genomic comparison can be done. At the end of the project, the hope is that GE will hold a large database of annotated genetic sequence information and the NHS will benefit from a genomic sequencing service that uses that information. We think the potential for generating new patents, database rights and know how, and the commercial opportunity for genetics/genomics service providers, is huge. We look forward to seeing the project progress.
The distribution of rights required to commercialise possible new therapeutic products presents some interesting challenges for the parties involved. In particular, the output of the project must remain attractive to commercial entities who want to exploit new intellectual property. The knowledge gained from the project is likely to be useful for diagnostic, prognostic and patient stratification purposes, but GE must succeed in producing a valuable, licensable and practical dataset. Like the controversial address database owned and licensed by Royal Mail, debate will continue about who should own and have access to the GE dataset, the value of the dataset as a commercial asset, and the restrictions that should apply to licensees.
It is likely that important patentable inventions and database rights will arise in the project.
One of the interesting questions in this project is “what does over £100 million of public money buy you?”. Since GE is buying sequencing services from an established company, Illumina, new patentable sequencing technology is probably not the end goal for them. To the extent that Illumina manages to make its technology better, then one might argue that GE should have the benefit of that technology (since Illumina may not have had the opportunity to create it without GE). This may have been achieved to some extent, but it does not look like GE is specifically interested in advances in sequencing technology. This fits with the general priority of GE in securing a genomics service for the NHS. In other words, GE is not a commercialiser and the project is about obtaining genomic information not the technology used to obtain it.
So, while sequencing patents are not a driver for GE, there may be many therapeutic inventions that arise from the clinical investigations, sequencing activity and data generated during the project. Remembering the issues raised by the recent Myriad Genetics cases, and looking at the Biotechnology Directive (implemented into UK law by a new insertion into the Patents Act 1977 as a result of the Patents Regulations 2000), discovered biological matter is not patentable if it is merely naturally occurring (like gene sequences). However, isolated forms of RNA and DNA, the process of isolation and related inventions are. These are the things that businesses will seek to commercialise.
Of more significance for GE are database rights in the data it creates and collects. Where significant investment is made into the obtaining, verification and presentation of data, database rights automatically arise. In addition, copyright may arise in the sequence data, the annotations and the other data entries themselves as well as in the format of the database as a whole work. Identifying and securing these rights will be the key to the GE data licensing model.
The GE literature explains that it is a key aim of the project to attract private capital investment. This would be based on the potential commercialisation of the GE dataset using a business model of “Exclusive Time Limited Access”, “Pay for Access”, “Royalty model” or “JV model”. Essentially, GE would allow commercial companies to use the dataset for a fee (and this is how the public sector and private investors would make money out of the project). The hope is that the commercial sector will invest in, research, develop and manufacture new treatments based on knowledge generated during the project and arising out of paid commercial use of that knowledge. GE and the NHS will not themselves develop the treatments.
GE Clinical Interpretation Partnerships (GECIPs) offer the academic, public and third sector opportunities to collaborate to advance the dataset in a particular field (GE calls these collaborations “domains”). In return for a domain’s contribution to the data set, a domain’s users will receive royalty-free, priority access to the dataset relevant to their field for six months (after which access will be widened). This is intended to encourage research and publication by the GECIP domains. The GECIP guidance published by GE suggests that GE will own any new intellectual property rights generated from the data by the domains. GE would then licence those IPRs to commercial entities on “favourable terms”. But what about new IPRs generated by the commercial entities that access data after the GECIP domain exclusivity period ends? These commercial entities will be paying for access to the dataset, so should they also pay a licence fee to GE for things they invent? This may be a sticking point for some commercial entities.
A genomics service ready for adoption by the NHS
GE wants to make sure that the NHS is one of the main beneficiaries of the project. A publicly funded healthcare project could not be seen as a success if it failed to deliver benefits to patients via the NHS. But what does the intended genomics service look like? Presumably, it means a genome sequencing service that would allow a patient’s genome to be sequenced and then compared to the project dataset to identify diagnostic or prognostic harmful mutations. So, someone will need to carry out the sequencing services for the NHS, and a business like Illumina would obviously be best placed to do that. The winning biorepository contractor (discussed above) will also be in a good position to win more work after the project. Such large future workstreams would need to be procured carefully in compliance with procurement rules. There are also a few big questions to explore:
- How would NHS access to the dataset be funded? Agreeing a data licence for all the NHS organisations that would want access to the data would be at the very least an administrative burden. Perhaps a single, centrally-funded NHS licence would be a better alternative.
- Will diagnostic and prognostic analysis require access to patient identifiable data? Much of the discussion around the project centres on patient data protection issues. The proposed NHS genomics service appears to present a significant area of risk. As such, the lessons from the pilot project will need to guide data protection practices after the project.