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11 April 2017Americas

Shire files motion to dismiss FTC allegations

Shire Viropharma has filed a motion to dismiss a complaint by the Federal Trade Commission (FTC), following competition allegations made against the pharmaceutical company.

The motion, which was filed yesterday, April 10 at the US District Court for the District of Delaware, asked the court to dismiss the case entirely and without prejudice.

Shire filed the motion based on two grounds. The first is that the FTC “failed to plead facts necessary for it to invoke its limited authority” and the second is that the conduct alleged by the FTC is constitutionally-protected petitioning activity.

In February this year, the FTC accused Shire of violating competition rules and sought an injunction against the company to “prevent unfair methods of competition”.

According to the FTC, Shire had allegedly abused the Food and Drug Administration’s (FDA) citizen petition process to maintain a monopoly on  Vancocin (vancomycin), a treatment for gastrointestinal infection.

Shire was also accused of inundating the FDA with regulatory and court filings to delay the FDA’s approval of Vancocin generics.

The FTC claimed that Shire had filed more than 45 regulatory and court files.

In the complaint, the FTC said: “That number is, by far, the most filings that any firm has ever made to the FDA concerning a single drug product.”

In 2012, the FDA disposed of ViroPharma’s filings, stating that they were “unsupported” and “without merit”.

But by that point, ViroPharma had successfully delayed generic competition, according to the FTC.

The FTC said that without the serial petitioning abuses, generic entry would probably have occurred by July 2010, or even earlier.

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8 February 2017   The US Federal Trade Commission has filed a complaint against Shire ViroPharma, accusing the pharmaceutical company of violating antitrust laws.
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12 April 2018   The US Federal Trade Commission is to appeal against a court’s decision to dismiss its competition complaint against Shire ViroPharma, a subsidiary of pharmaceutical company Shire.

More on this story

Americas
8 February 2017   The US Federal Trade Commission has filed a complaint against Shire ViroPharma, accusing the pharmaceutical company of violating antitrust laws.
Americas
12 April 2018   The US Federal Trade Commission is to appeal against a court’s decision to dismiss its competition complaint against Shire ViroPharma, a subsidiary of pharmaceutical company Shire.

More on this story

Americas
8 February 2017   The US Federal Trade Commission has filed a complaint against Shire ViroPharma, accusing the pharmaceutical company of violating antitrust laws.
Americas
12 April 2018   The US Federal Trade Commission is to appeal against a court’s decision to dismiss its competition complaint against Shire ViroPharma, a subsidiary of pharmaceutical company Shire.