News Release Detail

July 20, 2018

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

U.S. Court of Appeals for the Federal Circuit rejects Allergan's attempt to use tribal sovereign immunity to avoid Restasis® patent challenge
Mylan's IPR challenges to Restasis® patents can proceed
Federal District Court previously held patents invalid

HERTFORDSHIRE, England and PITTSBURGH, July 20, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent Trial and Appeal Board (PTAB), which found that tribal sovereign immunity cannot apply to prevent inter partesreview (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 U.S. 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 U.S. Court of Appeals for the Federal Circuit.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at We routinely post information that may be important to investors on our website at

Mylan (PRNewsfoto/Mylan N.V.)

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Christine Waller (Media), 724.514.1968; Melissa Trombetta (Investors), 724.514.1813

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