n the latest flap over EpiPen, Sanofi filed a lawsuit on Monday alleging that Mylan violated antitrust law by taking several steps to thwart its rival from gaining any traction in the marketplace.
Sanofi used to sell Auvi-Q, a different type of auto-injector that provides voice instructions and resembles a deck of cards. Both EpiPen and Auvi-Q provide life-saving doses of epinephrine to individuals suffering from severe allergic reactions. However, Sanofi voluntarily withdrew its device in October 2015 over problems with dosing and the device is now sold by another company called Kaleo.
In its lawsuit, which was filed in federal court in New Jersey, Sanofi alleged Mylan “ran up the price” of EpiPen well before the Auvi-Q launch in January 2013. In November 2012, the list price was $219 for a package of injectors, and that rose to $461 in October 2015, according to Medi-Span and Wells Fargo data cited in the lawsuit.
Then, however, Sanofi claimed Mylan offered higher rebates to insurers, pharmacy benefit managers, and state Medicaid programs that would be “practically impossible to refuse,” and that these rebates were contingent upon states excluding Auvi-Q from coverage. Auvi-Q market share dropped nearly 50 percent from December 2013 to January 2014 after rebates took effect, the lawsuit charged
Such an “exclusive” requirement is fair game in the cutthroat world of pharmaceutical pricing — but not when the company demanding exclusivity has a monopoly, Sanofi argued. “Pharmaceutical companies with monopolies for a given drug product do not — and under US antitrust law, cannot — condition large rebates to block new rival drugs from key access to the market,” the complaint states.
By undertaking these maneuvers, Mylan artificially raised Sanofi’s costs to market Auvi-Q, as well as the cost for patients to buy the device, the lawsuit alleged, because the moves ensured that Auvi-Q would carry a higher co-pay than EpiPen at pharmacy counters.
The lawsuit also charged Mylan “took the extreme step” of requiring schools to certify in writing they would not purchase rival devices as a condition of participating in an EpiPen discount program. STAT was first to report last year that the school discount program may have violated antitrust law. Such tactics are known as exclusive dealing and can be illegal when a company has a high market share, according to Herbert Hovenkamp, a University of Iowa law professor and antitrust expert.
Given that EpiPen dominated the market, “I think the complaint is plausible at this stage,” Hovenkamp said, adding that the exclusive dealing accusation appears to be the strongest of the claims cited in the lawsuit. The allegations concerning rebates, he explained, may be harder to prove.
Sanofi goes on to claim that Mylan misclassified EpiPen to federal and state governments and, as a result, paid less in required Medicaid rebates. This allowed Mylan to “subsidize its deep conditional rebates to commercial third-party payers and states,” crowding Auvi-Q out of the marketplace. Mylan reached a tentative, $465 million settlement with the US Department of Justice over the misclassification. One analysis says this may cost taxpayers, though.
The lawsuit comes on the heels of revelations about another legal technique Mylan used to try and stop competing products from being covered by insurance. Mylan sued West Virginia after the state decided to promote the Auvi-Q, instead of the EpiPen, among its Medicaid patients.