March 21, 2018 / 5:09 PM / a year ago

U.S. judge dismisses FTC antitrust lawsuit against Shire unit

March 21 (Reuters) - A federal judge has dismissed a lawsuit by the U.S. Federal Trade Commission accusing a unit of Shire Plc of violating antitrust laws by abusing government processes to fend off generic competition to its antibiotic Vancocin HCl.

U.S. District Judge Richard Andrews in Wilmington, Delaware on Tuesday ruled the FTC had not met a prerequisite for bringing a lawsuit seeking an injunction in the first place by showing that Shire ViroPharma Inc was about to violate a law.

It was unclear if the FTC would seek to revise its lawsuit, which Andrews said he would allow. The FTC and Dublin-based Shire did not immediately respond to requests for comment on Wednesday.

In its lawsuit, the regulator alleged that ViroPharma, which Shire acquired in 2014, had from 2006 to 2012 filed repeated and unsupported filings with the U.S. Food and Drug Administration to slow approval of generic competitors to Vancocin.

The FTC said ViroPharma, which acquired the drug’s rights from Eli Lilly in 2004, began filing petitions with the FDA in 2006 when the agency set a streamlined procedure for proving that generic rivals were the same chemically as Vancocin.

ViroPharma flooded the agency with 46 petitions and other filings, slowing the FDA down as the regulator was preparing to approve a cheaper, generic version of the drug, the FTC said in the lawsuit.

The FDA ultimately approved a generic version in 2012. The FTC filed a lawsuit in February 2017 that sought a permanent injunction against Shire ViroPharma.

But Shire argued the alleged conduct occurred in the past and that the FTC had not claimed the company was about to violate the law again, which it needed to in order to invoke its limited authority to seek an injunction under the FTC Act.

Andrews called that argument “novel” but agreed that the FTC’s ability to seek a permanent injunction was dependent on showing that the drugmaker was violating or about to violate a law that the FTC enforces.

“I do not think these allegations, without more, plausibly suggest ViroPharma is ‘about to violate’ any law enforced by the FTC, particularly when the alleged misconduct ceased almost five years before filing of the complaint,” Andrews wrote.

The case is Federal Trade Commission v. Shire ViroPharma Inc, U.S. District Court, District of Delaware, No. 17-cv-00131 (Reporting by Nate Raymond in Boston; editing by Diane Craft)

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