AI & IP Series
This is the second in a series of three articles directed at all innovators using artificial intelligence to solve problems in healthcare. Our aim is to address some of the misconceptions we hear frequently around the protection of AI-based HealthTech inventions and to provide some practical guidance on the steps that should be taken to secure protection that supports your commercial aims and the wider adoption of your technology.
For those interested in pursuing protection for AI-driven HealthTech innovations, please contact medtech@gje to arrange a free IP consultation.
Part 2 – IP strategies for AI innovators in Healthcare
This second article in the series examines some of the key considerations in determining whether patent protection is the right option to protect a particular AI-driven HealthTech innovation and looks at the wider IP considerations when developing an IP strategy in this field.
What is an IP strategy?
When we talk about an IP strategy, we are talking about developing a coherent approach to protecting your innovations, making full use of the IP rights available to you, in a way that supports the aims of the business, as well as managing the risk presented by third party IP rights. This involves identifying which of your innovations to protect, what form of IP rights are most appropriate for protecting those innovations, and how to exploit those IP rights in a way that supports the business. The next step is to prioritise which of those innovations to protect first, and you should then develop a roadmap for how to develop your IP in the future.
A good IP strategy will be continually evolving and will require regular discussions between you and your IP adviser. This article will focus on how you go about identifying which IP rights will best protect your innovations.
The first option, and the one that people most often think of first when looking to protect their innovations, is patent protection.
A patent grants its proprietor a monopoly over the patented invention. This means that whereas enforcing copyright, for example, requires you to demonstrate that an infringer has actively copied your work, a patent can be enforced against any competitor that is using the patented invention. Patents can therefore be a highly valuable form of IP. As part of developing an IP strategy, you should therefore identify which of your innovations are core to your business and investigate whether those innovations are suitable for patent protection.
By protecting the innovations at the core of your business, patents can provide a competitive advantage by blocking new entrants. Patents can also, depending on your business model, generate a new revenue stream through licensing, facilitate negotiations with prospective commercial partners, and lend weight to your marketing strategy and positioning by demonstrating technical expertise.
As explained in the first article in this series, AI inventions must clear a series of hurdles in order to be eligible for patent protection. While it is often possible to overcome these hurdles, as evidenced by a looking at the patent portfolio of any large technology company, it is important to also consider the question of whether patent protection is the right approach in the context of your specific technology and how it will be implemented.
An important consideration is that, in order for a patent application to be granted, you are required to disclose details of how the claimed invention works. This is particularly relevant for AI innovations where, depending on the specific technology and implementation, it may be possible to implement the technology without making details of the algorithm known to the public. For example, where the trained model is hosted on a secure server and your software product sends input data to the model to provide a prediction, such as a health condition diagnosis, it may be possible not to disclose specific details of the model itself. Filing a patent application in this situation would therefore result in a greater degree of disclosure than otherwise might be necessary and so it is important to consider whether you are likely to obtain protection of sufficient commercial value to make this trade-off worthwhile.
This can be managed to some extent due to the fact that you will receive the patent office’s opinion on the patentability of the innovation before it is published and it is possible to withdraw the application to prevent publication if there is little hope for meaningful protection. However, at this stage, there could have been fairly significant costs invested to prepare the patent application. As such, this is an especially important consideration for early stage companies who need to be mindful of the budget available for seeking patent protection.
Another concern is the extent to which you will be able to determine whether a competitor has implemented your claimed model or training method. A recommended approach is therefore to combine patent protection with trade secret protection.
Trade secrets are often overlooked when people are looking to protect their innovations, but they can prove invaluable when the innovation being protected is difficult to reverse engineer, which can often be the case where the innovations relate to the details of the model or training method itself, rather than a new application.
Although less robust than patent protection, trade secret protection protects you from competitors implementing innovations disclosed to them in breach of confidence. You are not protected from a competitor who arrives at your innovation independently or who reverse engineers your innovation, however, but this is where trade secret protection complements patent protection.
It is also important to bear in mind that trade secret protection is only available if your innovation is kept confidential. If you regularly publish details of your work, for example in scientific journals, or if a particular innovation is available to the public then trade secret protection will not be available. It is a good idea to maintain an internal registry of confidential information and implement company-wide policies, understood by employees, for maintaining the information as confidential. Incorporating the protection of trade secrets into contracts with employees and contractors/consultants is also key to maintaining control of your trade secrets.
As discussed above, an important trade-off you should be considering when looking into patent protection is whether the cost of disclosing the details of your innovation is worth the risk of your patent application being refused. For those innovations that are at a greater risk of either reverse engineering or independent discovery, the cost of disclosure is lower and patent protection may therefore be worth the investment. In contrast, it is those innovations that would be difficult for a competitor to arrive at on their own that are most suited to trade secret protection.
Another consideration is whether you would be able to achieve sufficiently broad protection for your innovation that would allow you to enforce the patent. For example, if patent protection were only possible for specific details of a back end algorithm it might be difficult for you to identify whether or not a competitor was implementing that algorithm, in which case you would have difficulty enforcing your patent. On the other hand, if the innovation is protectable at a scope that is more readily identifiable in a competitor technology, this would make the patent much more valuable. This balance can be explored to some extent through carrying out your own pre-filing searching of the prior art ahead of filing.
The question of whether to protect an innovation through the use of patents is therefore dependent on the answer to the question of whether an innovation is suitable for protection through the use of trade secrets, and vice versa. As such, the two questions cannot be considered in isolation, with the best solution often being a hybrid approach in which you seek patent protection for the important features of an innovation but rely on the law of trade secrets to protect some of the specific features and knowhow around the technical implementation.
However, patents and trade secrets are not the end of the story.
The value of trade mark protection is perhaps overlooked even more by early stage companies than trade secret protection, but brand identity is of enormous value and trade marks should therefore form a vital part of your IP portfolio.
The classic example of this in the technology sector is Google. Google’s initial success came about through having developed a search algorithm that was streets ahead of the competition. Although many competitors have now developed their own algorithms, by keeping their search algorithm a trade secret Google were able to establish their brand as the leading search engine and using trade marks to protect their brand identity has prevented any of their competitors from gaining a major foothold.
The value of brand identity is arguably even more pronounced in healthcare, where trust is of paramount importance to patients. By developing a positive brand identity and then protecting that brand through the use of trade marks, the trust of your customers can become a valuable moat.
Developing your IP strategy
It is important to consider all of the IP rights available to you when developing your IP strategy, and the rights discussed above are just three examples. Copyright, database rights and design rights are also all valuable tools which you will want to make full use of and should be carefully considered when developing your IP strategy.
Early stage companies, in particular, should not overlook this aspect of their business plan. Prospective investors are well aware of the value that IP rights add to a business, and will therefore want to see that you have carefully considered how best to make use of these rights.
It should also be emphasised that developing an IP strategy is more than a box-ticking exercise for prospective investors, but does in fact add real value to a business. Although its analysis of course needs to be viewed in light of the underlying motivations to promote the patent system, the European Patent Office (EPO) has recently published results of statistical analysis of European companies, which shows a strong positive correlation among the companies analysed between implementing an IP strategy by registering different types of intellectual property rights and both improved performance and higher growth rates.
Given an IP strategy must evolve with the business, the above considerations are equally important for early stage companies laying the initial foundations of an IP strategy to support their growth as they are for most established companies when reviewing their strategy to ensure it is still fit for purpose. Please find my contact details on my profile here or contact us at firstname.lastname@example.org.