MORGANTOWN — The tangled world of generic pharmaceuticals took another twist last week, as Mylan Pharmaceuticals filed suit in federal court against Israel-based Teva, alleging Teva illegally schemed to stifle competition for its multiple sclerosis drug Copaxone.
Morgantown-based Mylan Pharmaceuticals — not its parent Viatris — filed the suit in U.S. District Court for the District of New Jersey against Teva and several of its subsidiaries.
Back in 2015, Teva, the world’s largest generics manufacturer, made a failed bid to take over Mylan while Mylan was failing in a bid to take over another rival, Perrigo.
And Teva and Mylan are co-defendants in one of several lawsuits playing out in Pennsylvania federal court alleging they and other generics firms regularly collude to divvy up market share and control prices. (Last week Teva reached a $925,000 settlement with the state of Mississippi in this case.)
Also, as we reported last week, Mylan and Viatris won a significant victory in a federal class-action antitrust suit in Kansas alleging Mylan used its monopoly power to stifle competition and drive up the price of its EpiPen epinephrine auto-injector. Part of that suit — alleging that Pfizer and Teva entered into a “reverse payment” settlement that unlawfully delayed generic competition from entering the market and competing against the EpiPen — is set to go to trial.
In the new suit, Mylan alleges Teva “was in an unusual position with respect to its branded drug Copaxone. Specifically, Copaxone put Teva in the position of delaying and foreclosing, rather than championing, generic competition.” It cites a federal district court judge’s comment that “Teva has pursued every available avenue to prevent other glatiramer acetate [the generic for Copaxone] products from coming to market.”
Mylan says Teva’s scheme has lasted more than a decade and is largely aimed at Mylan, “the primary threat to Teva’s Copaxone franchise.”
Mylan says Teva used a variety of stalling tactics, such as abusing the regulatory and court processes, including suits against the FDA in 2014 and 2020, and preventing market uptake of Mylan’s bioequivalent product after it finally launched.
“Teva’s playbook worked perfectly,” Mylan says. “It delayed Mylan from launching its competitive product, substantially impeded Mylan from making sales of its product to patients despite offering a significantly lower-cost alternative to Copaxone, and enabled Teva to enjoy substantial ill-gotten gains at the expense of patients, insurers, and the government.”
Mylan reports that a recent study showed that the 2019 annual out-of-pocket for Copaxone for a Medicare patient was $6,672. A Teva employee’s price was $1,673.33, compared to $12 for Mylan’s generic.
In 2104, Mylan says, Teva undertook another strategy to maintain its monopoly: As its 20 mg/ml formulation began facing generic competition, it introduced a 40 mg/ml version, which still had market exclusivity, and pushed patients onto that by raising the price on the 20 mg dosage. “Experts estimate that the strategy cost the U.S. health care system between $4.3 and $6.5 billion in excess spending.”
Mylan also lists three other tactics Teva employed: It contracted with specialty pharmacies and pharmacy benefit mangers to limit generic substitution; it lobbied doctors to write band-name-only prescriptions; and it used patient programs to incentivize patients to remain on the brand-name version.
Copaxone was a critical part of Teva’s lineup, Mylan says, making up about 19% of its 2017 revenue, peaking at $3.3 billion in the U.S. in 2016.
Mylan is seeking various forms of relief. It wants an injunction against Teva representing that generic glatiramer acetate is less effective than Copaxone, and for Teva to take cortective action and issue retractions. It also wants an injunction against any other activity designed to hamper competition. And it wants various monetary damages.
With the suit just filed, Teva has not yet had time to file a response. The Dominion Post contacted Teva Friday afternoon for comment and was awaiting reply.
TWEET David Beard @dbeardtdp EMAIL dbeard@dominionpost.com
