Antitrust Suit Alleges Pharma Company Rubbished Its Own Product In Order To Stave Off Competition From Generics

from the commercial-motives-played-no-part dept

Techdirt has written a number of stories about how Big Pharma is never content with the patent bargain -- that, in return for a time-limited, government-enforced intellectual monopoly, products will afterwards enter the public domain. Instead, companies have come up with various schemes to extend the life of that monopoly -- and thus to cheat the public of the low-cost generic versions of the drug in question that should have appeared. The Daily Beast points to an antitrust lawsuit brought by 35 states and the District of Columbia against the makers of Suboxone, a prescription drug used to treat opioid addiction, over the alleged use of one such scheme, known as "product hopping". That's where: a company makes modest changes to a product to extend its patent protections so that other companies cannot enter the market and offer less-expensive generic alternatives. In this particular example: Reckitt Benckiser Pharmaceuticals, Inc. -- now known as Indivior PLC -- and MonoSol Rx are accused of conspiring to switch Suboxone from a tablet version to a film, which dissolves in the mouth, in order to prevent or delay generic alternatives and maintain artificially inflated profits.



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Over time, the states allege that Reckitt converted the market away from the tablet to the film through marketing, price adjustments and other methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the tablet from the U.S. market. The "other methods" are particularly interesting. In September 2012, Reckitt announced that it was going to "voluntarily discontinue the supply of Suboxone tablets", because it was worried they might be dangerous for children: The company received an analysis of data from U.S. Poison Control Centers on September 15, 2012 that found consistently and significantly higher rates of accidental unsupervised pediatric exposure with Suboxone Tablets ... than seen with Suboxone Film ... The rates for Suboxone Tablets were 7.8-8.5 times greater depending on the study period. Curiously, though, Reckitt didn't mention that the study had been commissioned by itself, as the Guardian noted in an article at the time. Quite why Reckitt would want to pay for and then publicize a study that showed one of its own products was dangerous became clearer just a few hours later, when it submitted a "citizen petition" to the Food and Drug Administration: urging the US regulator to ban any future competitor pills to its suboxone tablets that were insufficiently "child resistant". In other words, Reckitt effectively wanted the FDA to ban any generic versions of its own tablets, now out of patent, while leaving its patented film formulation on the market to enjoy a new monopoly. As the Guardian reported: A company spokesman has insisted commercial motives played no part in Reckitt's decision to withdraw suboxone tablets from the market. However, Martin Deboo, an analyst at Investec Securites said: "We view these moves as consistent with Reckitt's strategy of protecting the suboxone franchise by hastening migration to [strip] and raising barriers to entry to generics." The new antitrust lawsuit will doubtless explore these moves in detail, and the harm they might have caused, both financial and in terms of patient suffering. The plaintiffs allege: that federal and state healthcare programs, including Medicaid, as well as consumers and other purchasers have paid artificially high monopoly prices since late 2009, when generic alternatives of Suboxone might otherwise have become available. During that time, annual sales of Suboxone topped $1 billion and, since then, rates of opioid abuse in Connecticut and across the country have increased significantly. That's a useful reminder that pharma patents are not just about monopolies and money, but also about people and pain.

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Filed Under: disparagement, fda, monopolies, patents, pharmaceuticals, suboxone

Companies: indivior, monosol, reckitt benckiser