Following on from part 3 of the guide, which focused on stages 3 and 4 of the Medical Device Lifecycle and regulatory considerations for specialised medical devices, part 4 will unpack patent term extensions for medical devices in the US, Europe, and Australia, and other IP strategy considerations. To read the rest of our Medical Device Regulations and IP Strategy series, see here.
Patent term extensions restore a portion of the patent term that was effectively lost while the product was undergoing regulatory approval and was not able to be marketed after issuance of the patent. Patent term extensions are available for certain medical devices, although this tends to be underutilised relative to applications for patent term extensions for new drugs or biologics.
Patent Term Extensions in the US
In the US, only Class III medical devices are eligible for a patent term extension, since they must undergo extensive regulatory review under the Premarket Approval pathway, given that these relate to devices that sustain life or are critical to human health. If there are a family of patents covering a single medical device, only one patent (which must have undergone regulatory review) is eligible for receiving the patent term extension. Furthermore, the patent term extension must be based on the first approval of the product subjected to regulatory review.
An application for patent term extension must be filed within 60 days of the date of when the product received regulatory approval, regardless of whether this is for a medical device or a pharmaceutical product. There is an exception if the patent is due to expire beforehand; an interim extension can be requested 6 months prior to the patent expiry date up until 15 days prior to the expiry date.
The length of patent term extension cannot exceed five years and cannot extend the term of the patent beyond 14 years from regulatory approval. Typically, patent term extensions are granted for an average period of 3 years for medical devices.
Importantly, to maximise the length of the patent term extension, it would be advantageous to try and achieve early issuance of patents, which may be candidates for receipt of a patent term extension. This is due to the fact that the calculation for determining patent term extension relies on the post-issuance regulatory review period. Hence, early grant can assist an Applicant to maximise their duration of patent term extension. It also helps to ensure that the Applicant acts diligently throughout the regulatory review period, as lack of such may result in the extension term being reduced by any amount of time that the Applicant fails to exercise due diligence during this time.
Patent term extensions act to strengthen the barrier to entry for competitors, as it enables innovators to extend their market exclusivity, which is useful in highly competitive markets. This can lead to stronger IP portfolios, as investors may be particularly attracted to products that carry such patent term extensions. In turn, this can result in greater investor confidence and therefore higher valuations and better financial returns for the medical device company.
Patent Term Extensions in Europe
In Europe, pharmaceutical formulations that have experienced regulatory delays in bringing the product to market are often eligible for patent term extensions of up to 5 years after the patent expiry date, via supplementary protection certificates (SPCs).
On the surface, it would appear that the SPC Regulation excludes medical devices, because it requires that an SPC must be for an “active ingredient or combination of active ingredients of a medicinal product.” A medicinal product is defined as “any substance or combination of substances” for treatment in humans or animals for a therapeutic purpose. However, there are a number of drug-device combinations, which may include active ingredients.
Overall, there has been very little guidance in case law for medical device SPC applications. Most likely the reason for this is because the active substances incorporated in medical devices have normally already undergone authorisation as pharmaceuticals. Crucially, it has been established by the Court of Justice of the EU (CJEU) that authorisation obtained for an older product is not relevant and will not affect the authorisation of a later product, if the earlier authorised product is not within the scope of the patent on which the SPC is based.
European Directives 2001/83/EC or 2001/82/EC are relevant to drug-device combination products, in which the device and the drug work together as an integrated product, the device being assisted in its function by the drug. These Directives provide guidance in understanding what is covered by the definition of drug-device combination products. Specifically, examples are provided such as, pre-filled syringes, wound dressings containing an antimicrobial agent where the dressing delivers the agent to the wound, aerosols containing a medicinal product, and transdermal drug delivery patches, amongst others. These products are treated as medicinal products and are therefore eligible for SPC protection.
For medical devices that fall outside of the above European Directives, but are approved under a Directive not specifically recited in the SPC Regulation, there is some guidance provided by the National Courts. Examples of other drug-device combinations covered by other Directives may include devices where the function of the device is achieved primarily by physical means, for example by mechanical action, physical barriers, or providing a replacement of or support to organs or body functions, such as wound dressings coated with an antimicrobial agent and root canal fillers with ancillary medicinal substances.
In Germany and in the Netherlands, the National Courts have held that drug-device combination products where the medical devices incorporates the drug as an integral part of how the device functions are eligible for SPC protection, regardless of which Directive is specifically applicable, as long as the requisite safety and efficacy testing has been performed. These decisions at the National level are presently valid, at least until a ruling is made by the Court of Justice of the EU (CJEU), the highest Court in Europe. Guidance on medical device SPCs by the UK Intellectual Property Office is less clear.
Patent Term Extensions in Australia
In Australia, patent term extensions are not available for medical devices, but are available for pharmaceutical patents that claim new active pharmaceutical ingredients (APIs).
Other IP Strategy Considerations
According to data from the first quarter of 2026, the most influential countries in the international medical device trade include the US, Germany, China, Mexico, Costa Rica, Japan and South Korea, which lead the way for medical device manufacturing.
Depending on the type of medical device product, medical device companies, particularly for implantable devices, may choose to file in many countries. Conversely, companies may choose to file in a select few countries for ancillary components that are not themselves medical devices but are intended to be used with one or more medical devices.
For innovators targeting Europe, a key decision will be whether to pursue traditional European patent validation in individual countries or opt for a Unitary Patent (UP). The UP provides a single right covering multiple EU states, offering simplified administration and enforcement via the Unified Patent Court (UPC). medical device companies in particular have embraced the UP, drawn by its cost-effectiveness and broad territorial scope. There is a growing body of UPC case law, including high-profile device litigation, highlighting the increasing strategic value of this system. However, the UPC’s centralised enforcement also means that an adverse decision could have cross-border impact—making strategic portfolio segmentation and risk assessment essential.
Filing design applications in important global jurisdictions is also a strategy worth considering for many medical device companies, as these types of applications provide an additional level of protection at a minimal additional cost.
Design filings could encompass the overall design of the device itself, the electronic components, the graphical user interfaces and even the packaging.
For medical device companies with access to greater funding, defensive patent strategies may also be useful to further strengthen their IP portfolio, if they seek to file patent applications that offer alternative technical solutions to the same technical problem, and thus are peripheral to the company’s core invention. Such a strategy may be useful in highly competitive medical device fields and would even be useful to start-up companies who may be looking to be acquired by another company.
Conclusion
Whilst it is important to file patent applications early, particularly before disclosures to third parties, having some testing in place and ideas of possible alternatives often helps to develop better and more robust initial patent filings that remain relevant for longer, even if the design of the product changes.
By understanding global commercialisation and regulatory processes for medical devices, attorneys can better serve their clients by offering appropriate IP strategies according to where the product is in its dynamic life cycle. New opportunities for IP protection may also arise throughout each stage of the life cycle, which makes it important for IP attorneys to check in with clients periodically. Being active in protecting a company’s medical device innovation helps them to maintain a competitive advantage in the market, by keeping their product relevant in a constantly evolving technological landscape.
This instalment brings our series on medical device regulations and IP strategy to a close. If you have further questions about the topics discussed in this series or related issues, please feel free to contact MBIP. Our attorneys are experts in this area and would be happy to discuss.
