The US Supreme Court rules that the “pay for delay” settlements in the pharmaceutical sector are to be analyzed under the rule of reason (Actavis)

Facts In 1999, Solvay Pharmaceuticals filed a New Drug Application (NDA) for a topical testosterone hormone drug, called Androgel. In 2003, Solvay obtained patent protection for it. Subsequently, the generic companies Actavis (before Watson Pharmaceuticals) and Paddock Laboratories filed an Abbreviated New Drug Application (ANDA) and made a “Paragraph IV certification” [1], ensuring FDA that their products did not infringe Androgel’s patent protection. Although Solvay started a patent litigation against the two generic companies, in 2006 the parties agreed on a settlement, under the terms of which Actavis and Paddock would not place in the market their generic drugs until 31 August 2015 and would promote Androgel to

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  • European Commission - DG CNECT (Brussels)

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Athina Tsitsou, The US Supreme Court rules that the “pay for delay” settlements in the pharmaceutical sector are to be analyzed under the rule of reason (Actavis), 17 June 2013, e-Competitions Bulletin Competition in the Pharmaceutical sector, Art. N° 57706

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