Techbio platforms: to patent or not to patent?
Techbio refers to the use of machine learning and other data-driven computational techniques to advance learning in the fields of life sciences and biotechnology. In recent years considerable development effort has been undertaken to produce platforms capable of making predictions for use in areas including drug discovery, target selection, patient subgroup identification and clinical trial design. In drug discovery, such data-driven predictions can be valuable in reducing the amount of wet lab experimental work needed to screen many candidates and identify the best options to investigate further, hence reducing research cost and time.
When a new techbio platform is invented, one question to be tackled early is whether to apply for a patent for the platform. One perspective is that it is not worth filing patent applications for techbio platforms, and that instead it is best to keep the platform secret and to file patent applications only for the products developed using the platform. However, in reality the decision may be more nuanced.
It is true that the value of a techbio platform patent should not be overstated. Techbio is increasingly a crowded field, and there are various patentability exclusions which prohibit patenting of subject matter which is purely a mathematical method or a computer program. This often means that to obtain a granted patent for a techbio platform the claims may need to define specific details of the workings of the computational platform. This may mean that the scope of protection granted is relatively narrow in some instances. Even if the patent is granted, it may be difficult to determine whether anyone is infringing the claimed method. For example, if a company is using a computational method internally for its own research purposes, then it will be difficult for outsiders to know what is being done. Therefore, some investors may not assign as much value to techbio platform patents as to patents protecting the products of such platforms.
Another point to be aware of is that patent applications are published 18 months after filing, and to be granted the patent must disclose the invention in sufficient detail that a skilled person in the field could work the invention. Therefore, unless the application is withdrawn before publication, applying for a platform patent will cause key details of your research platform to be made public. Many are not prepared to risk giving information away to competitors and so choose instead to keep the platform secret and protected as confidential information or a trade secret.
Reasons to file for techbio platform patents
Despite all of these points, we see several reasons why techbio platform patents can in some circumstances be worthwhile, and in practice we see many applicants who choose to file patent applications for techbio platforms.
The advice to keep the platform invention secret is easy to give, but much harder to follow in practice.
Although data security policies, employee and contractor agreements and other measures to prevent leakage of proprietary information are advisable regardless of whether a patent application is filed, in practice it is hard to ensure complete secrecy and eventually the platform method may be inadvertently disclosed.
In any case, it may be difficult to avoid actively publishing information about the workings of the platform. If the platform is developed based on academic research, the academics involved may be under pressure to publish their research in scientific journals.
Further, in the likely event that a patent application is filed to the biotech product produced using the techbio platform, details of the platform should be included to support the product patent application.
For example, details of any in silico data derived using the platform should be included in the product patent application to support arguments for a therapeutic effect of the claimed products. Here the patent application will also need to specify the methods used to derive that data, otherwise there is a significant risk that the data will be disregarded as not being based on an accepted model. Omitting all in silico data to avoid disclosing the platform is likely to jeopardize the chances of obtaining broad protection for the product. Without any computational data the scope of protection may have to be limited to fewer examples supported by available wet lab data, or the amount of wet lab data may have to be increased, escalating research costs and causing a delay to filing of the product patent application, risking relevant prior art publishing in the meantime. Therefore, in practice, to maximize chances of commercially valuable product protection, one may be forced to rely on computational data and so need to disclose the methods used in the platform.
If no platform patent application is filed, this means that details of the platform are disclosed without any hope of obtaining protection for the platform, but this is often overlooked when deciding to keep a platform secret rather than filing a platform patent application.
For all of the reasons given, we consider that the eventual disclosure of a platform is likely. Therefore, it may be advantageous to apply for a patent application for your platform, to give greater control on the use of your methods.
Investors may find it more reassuring if your commercial plan includes the filing of patent applications for the platforms, and you reduce the risk of third parties being able to replicate your platform once it has been disclosed.
The UK Patent Box
Another point to consider is the Patent Box. This is a system of tax breaks which can provide a commercial incentive to file patent applications. In the UK, a company that develops a patented invention can obtain a reduction in corporation tax from 25% to 10% on qualifying profits. Similar schemes are available in other countries. For a company that developed a techbio platform and expects to derive profits from licensing the platform or from a fee for service model, owning a patent may be of value even if it has relatively narrow claim scope. You should seek advice from your accountant on what may be possible.
Whether to file a patent application for a techbio platform invention can be a nuanced decision. We would recommend consulting with your patent attorney to help determine what is best for you.