At the end of last week, the US Court of Appeals for the Federal Circuit upheld a ruling that invalidated four Copaxone (glatiramer acetate)’s patents (8,232,250; 8,399,413; 8,969,302; and 9,155,776).
Just a few days prior, Novartis published data showing that its product, Gilenya (fingolimod), reduced annualised relapse rate (ARR) more effectively than Copaxone 20mg.
A number of companies, acting as defendants and invested in marketing generic alternatives to Copaxone 40mg, including Novartis, Mylan, and Pfizer, were involved in the case. The US court ruled that the original finding, that Teva’s patents were invalid on the grounds of obviousness, should stand.
One of the companies that fought this protection was Mylan, which released a statement reading: “[The] decisions are important milestones as we continue to focus our efforts on meeting the needs of multiple sclerosis patients in the US with Mylan's more affordable treatment option.”
Copaxone is an immunomodulatory used to treat multiple sclerosis and is Teva’s biggest selling product, bringing in sales of $3.8bn (€3.28bn) globally in 2017.
Sales are steadily falling due to generic competition, with Q2 sales falling from $859m in 2017 to $464m in 2018.
The four patents, that were found invalid, would have run through to 2030.
Teva did not respond immediately for a request for comment on the decision.
Branded competition also emerges
It is not only generic competition that Teva has to be wary of, Novartis announced data from its own branded rival to Copaxone that, when lined up against the 20mg dosage, boasted superior data –the first therapy to show superiority.
Gilenya 0.5mg, a once-daily oral tablet, proved to reduce AAR by 40.7% relative to Copaxone 20mg. In terms of safety, Novartis stated that more patients discontinued Copaxone due to adverse events and treatment effects compared with Gilenya.
This particular blow for Teva may be mitigated by the fact that Copaxone 40mg dosage is the more commonly prescribed treatment option.
A spokesperson for Novartis confirmed that the company is not planning on running a comparison trial between Gilenya and Copaxone 40mg.