Mylan and Development Partner, Synthon, Win Significant EPO Ruling Related to Copaxone® 40mg/mL

Press release by Mylan

HERTFORDSHIRE, England and PITTSBURGH, Sept. 15, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced that the Technical Board of Appeal of the European Patent Office (EPO) has held that Yeda Research and Development Company, Ltd.'s European Patent no. 2 949 335 related to Teva's Copaxone® 40 mg/mL three times weekly product is invalid and revoked across Europe.

With the EPO's decision, Mylan has once again overcome Teva's attempts to restrict MS patients' access to safe and affordable alternatives. Over the course of the last eleven years, Mylan has successfully defeated Teva's four waves of U.S. patent litigation, eight Citizen Petitions, injunction proceedings in India, and more than 15 regulatory challenges, patent litigations or commercial actions across Europe. The EPO's positive ruling will allow Mylan to immediately return to the market and accelerate commercialization in other markets across Europe.

Mylan CEO Heather Bresch commented: "There are many ways in which we demonstrate our commitment to expand access to medicine, including by leveraging our legal expertise to overcome barriers on behalf of the patients we serve. The decision by the EPO marks a significant step forward for Mylan in several ongoing legal actions around Europe related to this important product, and further increases our confidence in our ability to continue to expand access to a lower-cost, high quality, therapeutically equivalent version of Copaxone to the multiple sclerosis community across even more markets in Europe and beyond."

Indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system, Mylan's lower-cost therapeutically equivalent version of Copaxone® will benefit thousands of MS patients across Europe who are living with this very difficult condition and in need of a more affordable treatment option. Mylan's product is currently marketed under a number of brand names in European markets including Brabio, Clift, Copemyl, Copemyltri and Glatiramyl.

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 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 Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.