Sources point out that in the US, PTEs – the equivalent of European SPCs – are awarded by the USPTO to all medical products that have had their release delayed by regulatory approval. SPCs, however, cannot be awarded to the same inventions in the EU.
While not all medical devices necessarily need SPC protection, those designated as class-three devices because they sustain or support life should qualify because they face steep regulatory climbs and require clinical trials to support their applications, according to some in-house lawyers.
“With class-three medical devices, you are in a position that is akin to a pharmacological agent where you have to do the same standard tests for safety and efficacy,” says the senior IP transaction counsel for an US medical device company.
“You have to do extended studies, and it is the case that you can have a limited time left on your patent.”
But he points out that only revolutionary products without a predecessor have to undergo the arduous pre-market approval (PMA) process.
The senior IP transaction counsel says: “If you are trying to clear a device with the FDA, you usually aren’t going to get many delays. But if you have a class-three medical device requiring PMA it is going to cut into the life of your patent.”
He explains that devices with a prior model on the market can piggy-back on that predecessor’s PMA and only undergo the pre-market notification (PMN) process, which will likely not require stringent medical trials.
Only the truly revolutionary devices without a predicate must go through the PMA process before going to market. These revolutionary devices can face a seven-to 10-year wait to get approval from the FDA.
“In the medical device space, there are real and arduous clinical studies that are performed,” says the chief IP counsel for a US medical device company.
“There is a difference with European policy in regards to patent term extensions and certainly there are arguments to be made to have extensions in Europe. If it exists in the US, there are reasons it should be talked about in Europe.”
But some industry sources, who do not produce class- three medical devices, believe the lack of SPC protection is not a real issue.
The director of IP for a Finnish medical device company says: “We don’t have any real problem with the regulatory approval. Depending on the jurisdiction it can take six months to two years for our devices. I don’t see the lack of SPC protection to be a real problem.”
His sentiment is echoed on the other side of the Atlantic by the senior IP counsel for a US device company who says SPC patent extension is not needed for his company’s medical devices.
“Most medical devices we design are evolutionary and not revolutionary in nature, and thus we can almost always point to various predicate devices that allow us to obtain regulatory approval rather quickly.”
“I expect patent extensions to be more of an issue with med tech start-ups that are developing truly revolutionary technologies in new fields without predicate devices.”
The term ‘medical products’ in the US casts a wide net around everything from cancer drugs, to gene therapies, to heart stents.
Medical devices are divided between three classifications based on their level of potential harm to the patient. A simple bandage falls into class one and requires very little regulatory approval. Class two represents moderate risks such as pregnancy tests and MRI imaging systems.
According to the FDA, class-three medical devices are any that usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. The FDA cites examples including pacemakers, heart valves and breast implants.
SPC blockersAs it stands, there is a long way to go before any sort of SPC extension to medical devices is enshrined into EU law.
SPCs were introduced to the EU in 1992 to compensate medical companies for the time it takes to conduct pharmaceutical research that might subtract from the length of a patent.
According to Article 2 of the SPC Regulation, a product is only eligible for an SPC extension if it falls within the definition of the EU Medicinal Products Directive. Medical devices in Europe fall within the confines of the less restrictive Medical Device Regulation, and therefore do not qualify for SPC protection.
The theory behind the law is that as medical devices do not require as many years of clinical trials as a new drug, they should not be granted an SPC.
Hybrids of medical devices and active pharmacological ingredients also do not receive SPC protection. In 2018 a case was referred to the CJEU by the German Federal Patent Court when Boston Scientific tried to get an SPC for a heart stent that incorporated the drug Taxol (paclitaxel).
In this case, the CJEU denied Boston Scientific an SPC because it did not consider that having an active ingredient as an integral part of the device fell within the limits of the Medicinal Products Directive.
For the moment the difference in patent extension between both sides of the Atlantic grants more protection to devices in the US than Europe.
But as most medical devices are only evolutionary in nature, this discrepancy only affects the most revolutionary of products requiring several years’ of original clinical studies.
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