If your patent protects a pharmaceutical, veterinary or agrochemical product, then considering a Supplementary Protection Certificate (SPC) is extremely important. In these industries, even a small number of additional days of exclusivity is very valuable, and for a blockbuster product may equate to several millions of dollars in sales. An SPC allows you to extend patent safeguards by up to five and a half years and thereby compensate for the long time needed to obtain regulatory approval of these products.
At Abel + Imray, we’re proud of our track record in securing SPCs. In fact, we’re one of the UK’s most frequent filers of SPC applications. Offering a wealth of collective experience, our dedicated bioscience and pharma team is perfectly placed to negotiate different European countries’ individual requirements and the constantly evolving law. And we can also suggest patent filing and prosecution strategies to make the best use of SPCs – maximising the protection for your most important products.
Regulatory approval also gives rise to other types of exclusivity, including data protection, data exclusivity and orphan market exclusivity, and further terms of paediatric exclusivity. Understanding these exclusivity regimes is of critical importance, given the enormous costs and time involved in generating data during regulatory approval. Our attorneys are well versed in helping clients understand the scope of protection these regimes afford.
For more information on SPC and regulatory protection, contact Paul Brady or your usual Abel + Imray attorney.