Mylan Again Defeats Allergan’s Efforts to Deny Patients Access to More Affordable Medicine

Global pharmaceutical company Mylan N.V. announced that the US Court of Appeals for the Federal Circuit affirmed the decision of the US Patent Trial and Appeal Board (PTAB), which found that tribal sovereign immunity cannot apply to prevent inter partes review (IPR) proceedings. Today’s decision allows Mylan’s IPR challenges to Allergan’s Restasis patents to proceed.  Mylan CEO Heather Bresch commented, “This win is a victory in our ongoing efforts to stop patent abuses by brand companies and to help drive access to more affordable medicine. Today’s ruling reaffirms that Allergan’s attempt to leverage the Saint Regis Mohawk Tribe for patent protection represents another inappropriate tactic to delay the availability of generic medicines for patients who need them. Mylan will continue to do its part to fight these types of abuses and to restore the careful balance between innovation and access that is so important to ensuring a sustainable US healthcare system.”

In a move admittedly designed to protect the Restasis patents from cancellation by the PTAB, Allergan assigned the rights of six patents to the Saint Regis Mohawk Tribe. The Tribe then moved to dismiss the proceedings, arguing that its tribal sovereign immunity prevented the PTAB from reviewing the patents. In February 2018, Mylan announced that the PTAB denied the Tribe’s motion to terminate the Restasis patent challenge and confirmed that Tribal sovereign immunity did not apply to IPR proceedings. Mylan also previously announced that the Eastern District of Texas held Allergan’s patents invalid after a trial on the merits. The case is currently on appeal before the US Court of Appeals for the Federal Circuit. – Medical Buyer Bureau