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Regulators can challenge deals that delay generic competition, says US Supreme Court

BMJ 2013; 346 doi: (Published 19 June 2013) Cite this as: BMJ 2013;346:f3964
  1. Michael McCarthy
  1. 1Seattle

The US Supreme Court ruled on 17 June that government regulators could sue drug companies for antitrust violation when they entered into “pay to delay” deals that often kept low cost generic drugs off the market.

Under US law a company can seek approval for a generic version of a brand name drug without conducting its own clinical trials if it can show the Food and Drug Administration that the drug has the same active ingredients and is biologically equivalent and it assures the FDA that the generic product does not violate the brand name drug’s patents.

The manufacturers of the brand name drugs often seek to delay or block such approvals by filing a suit claiming patent infringement. But many such suits end with what are known as “reverse payment” settlements in which the patent holder pays the generic drug maker for promising that it will not introduce its …

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