Too much too soon? Filing IP and patent applications

Chris Froud and Alexander Ford, senior associates and patent attorneys at European intellectual property firm, Withers & Rogers, explain why there is such a thing as filing IP and patent applications too early.

Companies are often advised to file patent applications at an early stage to prevent competitors from copying their inventions and beating them to market. However, those developing solutions specifically for medical applications, such as surgical robots, could lose years of market exclusivity by taking this approach. Instead, they should learn lessons from drug developers and adapt their intellectual property (IP) strategy accordingly.

It’s rare to find an area of medicine that doesn’t use technology for something. As advancements are made, more innovations are being introduced to the field, such as a growing use of surgical robots.

In robotically assisted surgery, rather than applying surgical tools directly to a patient by hand in the traditional manner, a surgeon directs a surgical robot to carry out the procedure. The surgeon uses a remote manipulator or computer control to guide surgical tools held by the robot’s end effector, which carries out the procedure. By improving stability and precision, these robots reduce the chance of human error during challenging surgeries and are less invasive than traditional open surgery.

The first procedure assisted by a surgical robot was carried out in 1985. However, it wasn’t until 2000, when Intuitive Surgical launched the Da Vinci Surgical System, that this technology became more mainstream. For years, Intuitive were the market leaders in this field, but recently new players have entered the space, such as CMR Surgical, the creator of the Versius minimal access suturing tool. Although the company is a relative newcomer in this field, it is making a big impact in the UK.

The more common robot-assisted surgery becomes, the more innovation activity is likely to take place. R&D activity in this field is growing rapidly, which means innovators would normally seek patent protection at an early stage to secure their slice of the market. Usually, this approach would be recommended by IP professionals, however it might not be the best choice for medtech innovators.

In pharmaceuticals, achieving market and regulatory approval for new drugs can take up to 20 years, so it’s possible for a patent to have expired before the product is ready to go to market. As such, drug developers would typically keep their innovations secret for as long as possible. With this approach, they can maximise the period of exclusivity during which they can commercialise their innovations once the drugs are approved and market ready. Medtech innovators should consider doing likewise.

Surgical robots must also complete an approval process before they are introduced to the mainstream market, which can take several years. As patents provide 20 years of exclusivity, this could mean the patent is only useful for a portion of its lifetime if it is granted while the product is still going through the approval process. In some cases, it could even be about to expire by the time that the product reaches peak sales, opening the door for competitors. Pharmaceutical innovators have the option of supplementary protection certificates (SPCs), which extend the life of the patent beyond 20 years, but this is currently not the case for medtech companies.

Rather than filing for a patent as soon as the idea is formed, medtech innovators should consider keeping the invention a trade secret while the approval process is ongoing. While there are risks attached, this approach should ensure that information regarding the product is protected throughout the approval process and could help to optimise the commercial rewards that might result when the product is brought to market. If the approval process for a new product takes three years, and a patent is filed on completion, the innovator will have a total of 23 years of exclusivity to make the most of.

It is also important to consider that patents contain a wealth of technical detail that is made public once they are allowed to publish. If an innovator files for a patent on their surgical robot, and then market and regulatory approval is denied after the patent has published, all this technical detail will be out in the public domain for competitors to take advantage of. Once the innovation has been refined and is ready for the approval process again, the original patent may no longer cover the refined product. Although the patent can be revised, it may not be as broad as if it was filed after approval, leaving the innovator in a weaker position commercially.

Choosing not to file for patent protection at an early stage does come with the risk of someone else developing the same innovation and filing first. For medtech innovators, IP strategies need careful consideration - balancing the complexities of a crowded marketplace with making the most of any commercial benefits.