James M. Burns Comments on the "Antitrust Issues to Watch" in the Pharmaceutical Industry for 2014

January 13, 2014
James Burns, a Member in Dickinson Wright’s Washington D.C. office and co-leader of the firm’s Antitrust practice, recently provided his insights to BNA’s Pharmaceutical Law & Industry Report regarding the antitrust issues expected to be “hot” in 2014 in the drug and biotech industry.

Mr. Burns noted that the Federal Trade Commission’s response to “pay-for-delay” agreements in drug patent litigation will likely continue to be the most significant pharma-related antitrust issue in 2014. He commented that the lower courts’ implementation of the Supreme Court’s 2013 Actavis decision, which found that patent litigation settlements could, in some cases, violate the antitrust laws, left “ample room for interpretation [of the issue] by the lower courts.” In addition, Mr. Burns said that he would not be surprised to see legislative action on the “pay for delay” issue in 2014, particularly if the lower courts do not all interpret Actavis in the same manner.

Other antitrust issues likely to be “hot topics” in 2014, according to Mr. Burns, include alleged efforts by branded drug manufacturers to stifle generic drug competition through “product-hopping” activities, deals in which a branded company agrees not to sell an authorized generic, and as well as the denial of access to branded samples to generic manufacturers.

A link to the article including Mr. Burns’s comments that appeared in the Pharmaceutical Law & Industry Report can be found here.

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