There are several ways to break such exclusivity - if the new drug is better or safer or if there is a shortage and patients cannot get treatment, are few ways. Cerezyme shortage is not entirely over plus Shire has reached its capacity limit, so seems to me as a valid claim. I most certainly agree on the 2nd claim being a stronger one. Just hope PLX people read this :-)
EU orphan exclusivity statue is different from US orphan exclusivity. EU has maintenance clause where granted orphan exclusivity not only compared to treatment availability/benefit at the time of orphan exclusivity grant, but also to treatment availability/benefit to current situation. Currently, both old treatment availability of Cerezyme and new treatment option of Elelyso have changed from the time of grant.
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