This article, published in Getting the Deal Through, reviews the legislation that creates the pharmaceutical regulation framework in Italy, particularly with regard to mergers and acquisitions, anticompetitive conduct, product development and licensing agreements, and marketing agreements.
On Wednesday, August 31, the Federal Trade Commission issued a report on "Authorized Generic Drugs: Short-Term Effects and Long-Term Impacts." In the report, the Commission indicated that it would take a hard-line approach to pay-for-delay deals in which brand-name drug makers agree to defer introduction of their own generic formulations in exchange for competitors delaying entry into the market. The report signals that the FTC pay-for-delay pharmaceutical patent settlements continue to be a "hot button" at the FTC, including deals that contain commitments by branded players to withhold generic versions of their own products.
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