Mylan N.V. announced that Teva has dismissed its pending district court litigation regarding Mylan’s Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL. The litigation involved two non-Orange Book listed patents, U.S. Patent Nos. 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products.
Teva dropped litigation on the patents after the U.S. District Court for the District of Delaware issued a decision adopting Mylan’s interpretation of the patents’ claims. In addition, Teva has agreed to withdraw the Irish equivalent to these patents from the recently filed proceeding in Ireland.
After the dismissals, Teva’s only remaining patent challenges in the U.S. and Ireland against Mylan’s Glatiramer Acetate Injection 40mg/mL relate to the three-times-a-week dosing regimen, which Mylan has already successfully invalidated at the U.S. District Court for Delaware, the U.S. Patent Trial and Appeal Board and the United Kingdom’s High Court of Justice. Teva is appealing those decisions.
In early October, Mylan received FDA approval and launched its Glatiramer Acetate Injection 40 mg/mL for three-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone 40 mg/mL. According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete Abbreviated New Drug Application for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification.
Copaxone is the most prescribed MS treatment for relapsing forms of MS in the U.S. with brand sales for the 20 mg/mL dose of approximately $667 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending Oct. 31, 2017, according to IQVIA. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85 percent of initial MS diagnoses.
(Source: Mylan N.V.)