For medical device manufacturers and designers, the journey to market success hinges on two crucial milestones: securing regulatory approval and obtaining patent protection. While these processes might seem distinct, with regulation focusing on safety and efficacy, and patents on commercial rights, they can influence each other’s course.
Regulatory and Patenting Landscape for Medical Devices in Great Britain
In Great Britain, medical devices must bear a valid UKCA or CE mark and be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) to enter the market. The MHRA classifies medical devices into four categories, each representing an increased level of regulatory scrutiny: Class I, IIa, IIb, and III. Class I includes low-risk devices like bandages, while Class III encompasses high-risk devices such as pacemakers.
Patents are vital for protecting innovations, regardless of the device’s regulatory class. While the complexity and innovation level of a device do not necessarily correspond to its regulatory classification, the patent strategy can be influenced by this classification. For instance, obtaining regulatory approval for Class I and IIa devices is generally less challenging, making patents a stronger barrier against competitors entering the market. Conversely, Class III devices face rigorous regulatory hurdles, and patents offer protection for the significant investment in time and resources needed for approval.
Clinical Evaluations and Conflicts
The regulatory approval process involves a clinical evaluation to ensure the safety and performance of new medical devices. Using clinical data from an existing “equivalent” device can streamline this process. An equivalent device shares similar design and operational principles with the new device, making it possible to leverage existing data to reduce the regulatory burden. However, this approach can conflict with the patenting process. The regulatory strategy of highlighting similarities with existing devices to ease approval can clash with the patenting need to emphasize differences and innovations.
It should be noted that a claim during the regulatory process that an existing device is an equivalent of a new device does not necessarily mean that the two devices are the same, or even that they share the same patentable features. Therefore, a declaration of equivalence during the regulatory process is not necessarily a declaration that the new device is not patentable in the context of a patent application.
Additionally, recent High Court decisions 1 2 suggest that it can be harder to convince courts that particular features of a new medical device are inventive if those features are present in an existing medical device that has obtained regulatory approval. The thinking here is that, because these existing medical devices have been regulated, engineers are more likely to be motivated to include features from these devices when designing new medical devices. These court decisions further demonstrate that the regulation and patent processes can influence each other.
Strategic Considerations for Medical Device Companies
Medical device companies must understand that regulatory approval and patenting are not isolated processes. Public statements made during regulatory approval can impact the pursuit of patent protection, and vice versa. Therefore, strong communication between regulatory and intellectual property (IP) departments is crucial. Regulatory teams should avoid unnecessarily overstating similarities with equivalent devices, particularly regarding features under patent consideration. Similarly, IP teams should be mindful of regulatory statements about equivalent devices and should not unnecessarily overstate technical differences.
In conclusion, navigating the dual pathways of regulatory approval and patent protection requires a strategic, coordinated approach. By aligning efforts and maintaining open communication, medical device companies can successfully manage both processes and achieve market success.
1Advanced Bionics v. MED-EL [2022] EWHC 1345 (Pat)
2Insulet v. Roche Diabetes Care [2021] EWHC 1933 (Pat)
Blog Authors
This blog was co-authored by Andrew Mears and Joe Egelstaff.
Andrew is a Partner and Patent Attorney at Mewburn Ellis. He deals with drafting and prosecuting patent applications at the EPO and UKIPO, as well as global patent portfolio management, Freedom-to-Operate (FTO) work and advising on global patent filing strategies. Andrew works in the engineering and electronics fields, with a focus on medical device technologies. He has spent time working as a patent attorney in Singapore, where he specialised in providing advice on obtaining patent protection throughout South-East Asia, China and the Indian sub-continent. Andrew has also worked in Canada, developing an expertise in obtaining patent protection in North America.
Email: andrew.mears@mewburn.com
