Natco's partner Mylan went ahead and launched Copaxone 40 mg “at-risk” in US in October last year even as the patent litigation is still on. Any setbacks in the patent litigation could have led to significant damages among other remedies for both the companies.
Mylan on Friday said it has prevailed in the infringement litigation against Teva in US Appellate Court over the multiple sclerosis drug Copaxone 40mg/mL patent.
"The US Court of Appeals for the Federal Circuit has affirmed the District of Delaware's decision that Teva's Copaxone 40 mg/mL dosing patents are invalid as obvious," Mylan said in a statement.
The US court's decision is expected to bring cheer to Mylan's partner Natco Pharma.
The Federal Circuit also affirmed the final written decisions issued by the Patent Trial and Appeal Board in three inter partes reviews filed by Mylan related to the same patents.
Mylan was defending the last remaining patent infringement cases in the US relating to Glatiramer Acetate Injection 40mg/mL.
The invalidated patents are U.S. Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva.
"Today's decisions are important milestones as we continue to focus our efforts on meeting the needs of multiple sclerosis patients in the U.S. with Mylan's more affordable treatment option," Mylan said in a statement.
Natco impact
Natco has teamed up with US generic major Mylan for the two dosage versions of Copaxone generically known as glatiramer acetate injection. As per the agreement Natco will supply the drug, while Mylan markets it in the US.
Natco's partner Mylan went ahead and launched Copaxone 40 mg “at-risk” in US in October last year even as the patent litigation is still on. Any setbacks in the patent litigation could have led to significant damages among other remedies for both the companies.
Copaxone is the most prescribed MS treatment for relapsing forms of Multiple sclerosis in the United States with brand sales for the 20 mg/mL dose of approximately $527 million and for the 40 mg/mL dose of approximately $2.86 billion for the 12 months ending August, 2018, according to IQVIA.
Mylan-Natco has share of around 15-20 percent for generic Copaxone 40 mg, but they have been slashing prices to undercut Teva's domination for this drug.
Approximately 400,000 individuals in the US have MS and relapsing MS accounts for 85 percent of initial MS diagnoses.
