With the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Congress required pharmaceutical companies to file certain patent settlement agreements with the FTC.
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Last week, Bureau of Competition staff published a report on filings received in fiscal year (FY) 2016 under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), the thirteenth such report since the MMA took effect in 2004.
For more than 15 years, one of the FTC’s top priorities has been to put an end to anticompetitive reverse-payment settlements between brand-name drug makers and their potential generic rivals. In our view, these settlements are anticompetitive agreements not to compete in which the brand pays the generic to refrain from marketing a lower cost, generic product for a period of time.
There is a basic but important difference between antitrust cases brought by the government and those brought by private parties: All plaintiffs, including government enforcers like the FTC, must prove an antitrust violation, which requires showing harm to competition. But private plaintiffs must make an additional showing: to establish antitrust ‘standing,’ private plaintiffs must prove that the antitrust violation caused harm to them.
Since 2004, brand-name and generic drug manufacturers have filed certain agreements with the FTC and DOJ as required by the Medicare Prescription Drug, Improvement and Modernization Act (also known as MMA filings).
In a recently published article, we discuss our finding that generic drug companies successfully use low-pricing strategies to discourage entry by new competitors in certain circumstances.