Are supplementary protection certificates for medical devices on the horizon?
18 June 2014
A recent decision of the UKIPO Hearing Office (see here) has added to the growing body of case law concerning which products are, and which are not, entitled to a Supplementary Protection Certificate (SPC). Those familiar with the pharmaceutical sector will be aware that SPCs provide an extension to the lifetime of patent monopolies for “active ingredients” of “medicinal products” to compensate for the delays in bringing products to market due to the need to obtain regulatory approval. However, medical devices are also subject to marketing authorisation and various attempts have been made to extend the scope of SPCs to cover such products.
In this decision the applicant, Cerus Corporation, sought to obtain SPC protection for platelet and plasma preparations obtained by exposing blood components to photoactivated compounds. The applicant had obtained a valid marketing authorisation for the decontamination procedure and argued that the marketing approval obtained under the relevant medical devices legislation (Directive 93/42/EEC and Directive 93/43/EEC) was equivalent to marketing authorisation obtained under the rules for medicinal products (Directive 2001/82/EC and Directive 2001/83/EC).
Interestingly, the UKIPO hearing officer stated that the fact that an SPC was sought on the basis of medical device authorisation not medicinal product authorisation was not in itself sufficient to deny the applicant an SPC. However, the hearing officer did not accept the equivalence of the medical device authorisation with the medicinal product authorisation in this case. Closer inspection of the marketing authorisations obtained by the applicant revealed that the “ancillary medicinal products” for which marketing authorisation had been obtained were, in fact, the compounds used to treat the blood component preparations NOT the treated preparations themselves i.e. the decontaminated platelet and plasma preparations. Accordingly, an SPC could not be awarded for the decontaminated platelet or plasma compositions as these were not the subject of the marketing authentication.
This result emphasises the importance for marketing authorisations, where possible, to focus on the end product delivered to patients. It also shows that medical device and medicinal product authorisations are not necessarily interchangeable. It does, however, give some glimmer of hope to companies selling medical devices as it seems that, in this case, had marketing authorisation been granted for the blood preparations, an SPC may have been allowed.
Obtaining marketing approval for medical devices is likely to become more difficult over the next few years as new legislation is brought into effect. This will likely create further delays in products reaching market and provoke renewed interest in the question of whether or not SPCs ought to be granted for medical devices, not just for medicinal products.
Life Sciences & Chemistry
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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 2014