BRIEF—Teva dismisses litigation after Mylan wins US court ruling on Copaxone

Netherlands-headquartered generics major Mylan has announced that Teva Pharmaceutical Industries has dismissed its pending district court litigation against Mylan regarding its glatiramer acetate injection 40mg/mL, the first generic version of Copaxone 40 mg/mL, the Israeli generics giant blockbuster multiple sclerosis drug.

The litigation involved two non-Orange Book listed patents, US Patent Nos 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products.

After the dismissals, Teva's only remaining patent challenges in the USA 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 US District Court for Delaware, the US Patent Trial and Appeal Board and the UK's High Court of Justice. Teva is appealing these decisions.

Copaxone is the most prescribed MS treatment for relapsing forms of MS in the USA with brand sales for the 20mg/mL dose of around $667 million and for the 40mg/mL dose of about $3.64 billion for the 12 months ending October31, 2017, according to IQVIA. Approximately 400,000 individuals in the USA have MS and relapsing MS accounts for 85% of initial MS diagnoses.