Eligibility of medical devices for SPCs
15 June 2016
Supplementary Protection Certificates (SPCs) provide valuable patent term extensions that compensate both the pharmaceutical and agricultural industries for the delays suffered in bringing their products to market as a result of complex regulatory processes.
Despite sometimes requiring similar levels of regulation to pharmaceutical products, medical devices are still not entitled to SPC protection. Whilst this is less of a problem for non-invasive and low risk devices (such as type 1 medical devices), which have minimal regulatory requirements, more complex and more invasive devices often require substantial clinical trials and assessments before marketing approval is granted. Accordingly, medical device manufacturers looking to sell products in Europe are at a disadvantage.
A recent case in Germany (14W(pat)45/12) shows that the interpretation of the SPC Regulation is not likely to change any time soon and that a consistent approach is being adopted across Europe. This decision follows a similar finding against the same product by the UK Intellectual Property Office (BL O/328/14).
The Leibniz-Institut für neue Materialien, herein referred to as “Leibniz“, obtained a patent (EP 0 636 111) for surface-modified ceramic nanoparticles which are used in the treatment of cancers, such as brain tumours. The particles collect around cancerous tissue and, when heated via magnetic induction, cause damage to any nearby cancerous tissue.
The German patent office refused to grant an SPC on the grounds that the product was a “medical device” (governed by the Medical Devices Directive MDD 93/42/EEC) not a “medicinal product“. The decision was appealed and reviewed by the German Federal Patent Court which held that because the device worked by physical means and not chemical interaction, the product could not be considered a medicinal product. Andrea Fleuchaus, a German patent attorney and partner at Fleuchaus & Gallo, comments:
“This decision places a heavy burden on companies innovating in certain technical areas. Clearly, technology is developing faster than our legislation, which means that valuable therapies will stay – at least for the meantime – excluded from SPC protection. While the industry has to lobby their interests, patent attorneys also need to develop new and creative ways to help our clients protect their innovations as efficiently and for as long as possible.”
This seemingly arbitrary delineation may have the effect of disincentivising companies from pursuing promising therapeutics that wholly or partial rely on physical effects to treat various conditions.
The court acknowledged that the medical devices sector was disadvantaged as they, like pharmaceutical companies, were required to endure time-consuming and expensive clinical trials procedures before products could be marketed. However, they outlined that the power to extend SPC protection lies with the legislators, not the court.
Accordingly, until new legislation is enacted, it seems that SPC protection for medical devices will not be granted, making it difficult for medical device manufacturers to recoup their substantial R&D investment.
Life Sciences & Chemistry group
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This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP, June 2016