Friday, April 20, 2018 @ 12:00 am
European General Court confirms that a new medicinal product containing the same active substance as a company’s existing medicinal product may be entitled to its own period of orphan exclusivity.
On 22 March 2018, the European General Court handed down its judgment in Case T-80/16 Shire Pharmaceuticals Ireland v. EMA, in which Covington represented Shire Pharmaceuticals Ireland (“Shire”). This is an important ruling that could have significant implications for companies developing orphan medicinal products.
Find more details in below PDF summarizing the case (Source: Covington & Burling LLP, international law firm) and in the court's judgment paper.