IP portfolio management is often overlooked, but is extremely important if the goal is to protect products or services in the most cost-efficient way possible. However, the process of mapping an IP portfolio to a company’s products or services can be complex, and there can be significant differences in the ease with which this can be done in biotech vs medtech.
In our first post, we discussed how biotech investors are increasingly moving towards medtech companies – attracted by products that can be brought to market quicker. However, when it comes to intellectual property, different approaches have to be taken; it is not ‘one size fits all’.
How do you map the IP rights to the product?
Biotech can generally only be protected by patents until a drug is approved, and the legal requirements dictate that a patent is usually directly protecting a single product or the use or manufacture of a single product. Hence, mapping patents to products is 1:1 and relatively straightforward.
In medtech, however, an IP portfolio often involves multiple different forms of IP, including unregistered rights such as design rights and copyright, as well as patents, registered designs, and trade marks, which need to be applied for at different stages of development. Furthermore, patents are often directed to particular aspects of a device, meaning one product could need multiple patents. medtech devices therefore require careful analysis to unpick when and how IP rights should be applied for.
When should freedom to operate be considered?
A subtlety of IP is that patents and other IP such as trade marks only provide the owner with the right to exclude others from using the innovation, and not the right to use the innovation itself – which is known as freedom to operate (FTO). Put simply, this means that if third parties have other rights that are still in force in the relevant jurisdiction, and cover what a company intend to do, then the organisation will have to seek a licence or challenge their rights in the intellectual property office or courts.
It is of course commercially important to be aware of a competitor’s activities, but the timing of when a detailed freedom to operate assessment should be conducted may differ between biotech and medtech projects. These differences are partly due to the different levels of investment needed, and partly due to regulatory differences and the relative ease or difficulty of making changes to design around third-party IP.
In biotech, a good understanding of FTO should be sought early to avoid potentially sinking large amounts of money into an innovation that will never be able to reach the market. Indeed, a positive to an FTO assessment is that if a conflict is found, it could identify a company that may be an attractive option for exit by acquisition.
In medtech, early FTO is less critical given the smaller sums of money often involved in production, and there is usually more flexibility to make changes to a product during development. Furthermore, due to the multiple forms of IP involved, it can actually be very difficult and costly to perform anything approaching a comprehensive FTO assessment in medtech.
Biotech vs medtech intellectual property
These are just some of the considerations to bear in mind when developing an IP strategy, and the takeaway should be that the worst approach a company can take is to assume that what will work for one product will also work for another. In order to figure out the nuances, expert advice should be sought from day one to ensure that the innovation – medtech or biotech – and the investment that has been made in it – is adequately protected.
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