- The U.S. Court of Appeals for the Federal Circuit last week found Teva's Copaxone 40 mg/mL dosing patents to be "invalid as obvious," supporting previous rulings made by the U.S. District Court for the District of Delaware and the Patent Trial and Appeal Board.
- Mylan's 20 mg/mL and 40 mg/mL glatiramer acetate injections, generic versions of Teva's Copaxone, were approved by the Food and Drug Administration in October 2017.
- Copaxone, one of the most prescribed treatment for relapsing forms of multiple sclerosis in the U.S., had brand sales of $527 million for the 20 mg/mL dose and $2.86 billion for the 40 mg/mL dose in the year ending August 31, 2018, according to data from IQVIA cited by Mylan.
Teva has been losing share in the U.S. multiple sclerosis market as competition stiffens and generics to Copaxone, such Momenta Pharmaceuticals and Novartis' Glatopa, gain approval.
Generic versions of Copaxone 20 mg have been on the market for several years, but dosing patents helped to protect Teva's 40 mg version until Mylan launched its copy last fall. The appeals court decision helps to cement Mylan's market entry.
According to the Israeli pharma, Copaxone's second quarter sales from the U.S. nearly halved compared to the same period a year ago, dropping from $843 million to $448 million.
Those declines looks set to continue in the quarters to come, particularly if Mylan's copy gains greater traction.
Copaxone turnover should "continue to drag this year and next year, as we see more generic competition on the product," Teva CEO Kåre Schultz said during the company's earnings call in August.
Mylan, meanwhile, has had its own struggles in 2018.
The drugmaker downsized the workforce at its Morgantown, West Virginia, plant in April. Several months later, Mylan initiated a strategic review, with a "wide range" of options on the table for the company's board of directors.
The appeals court's decision, therefore, is a piece of good news.
"These were the last remaining patent infringement cases Mylan was defending in the U.S. relating to Glatiramer Acetate Injection 40mg/mL," the company wrote in an Oct. 12 statement.
Shares in either company were little moved on the news, perhaps reflecting expectations the district court ruling would be upheld. Investors in Mylan might also be looking ahead to barriers the company's generic still needs to overcome to win greater market share.
"Our experience with Copaxone is representative of the perverse incentives embedded in the current system," Mylan CEO Heather Bresch claimed during the company's most recent earnings call.
"Even after substantially lowering the price of our product, the supply chain chooses a higher priced alternative. This provides evidence that the business of healthcare feeds on higher prices, frequently putting system interest ahead of patients," she said.