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A combination of patents, SPCs and regulatory exclusivities should be considered carefully in order to maximise the exclusivity available for cell therapies, as Glyn Truscott of Elkington + Fife explains.
The use of living cells as therapeutic agents is a revolutionary step forward, often said to be the next major development in human medicine. Cell therapies present unique therapeutic opportunities and differ significantly from conventional small molecule therapies, and also more complex biologics, in many respects: in development, production, mechanism of action, regulation, and in some cases even the ability to be copied.
While the science develops and the regulatory framework adapts to these developments, the European patent and supplementary protection certificate (SPC) framework does not change each time a new technology is established. Therefore, careful thought must be given to the strategies employed to protect cell therapies effectively, using a combination of patents, SPCs and regulatory exclusivities, to ensure that the very significant investment made in the development of these therapies is adequately compensated.
In 2009 the European Medicines Agency (EMA) approved its first cell therapy: TiGenix’s Chondrocelect, comprising autologous cartilage cells expanded ex vivo, to treat knee cartilage defects. Since then, several further cell therapies have been approved: Genzyme’s MACI and Dendreon’s Provenge, in 2013; Chiesi’s Holoclar in 2015; and GSK’s Strimvelis and MolMed’s Zalmoxis in 2016. The first stem cell therapy, Holoclar, was approved in February 2015, comprising corneal epithelial cells containing stem cells for the repair of corneal injury. The first allogeneic (donor) cell therapy, Zalmoxis, comprising genetically modified donor T cells, was approved earlier this year as an adjunct to haematopoietic stem cell (HSC) transplantation of patients with high-risk haematological malignancies.
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regulatory, patent, patenting, biosimilar, medicinal, European, patentability, SPCs