FTC to appeal Shire ViroPharma ‘abuse’ decision
The US Federal Trade Commission (FTC) is to appeal against a court’s decision to dismiss its competition complaint against Shire ViroPharma, a subsidiary of pharmaceutical company Shire.
Yesterday, April 11, the FTC filed its notice of appeal at the US District Court for the District of Delaware, noting that it would stand by its original complaint and appeal against the decision to dismiss its claim to the US Court of Appeals for the Third Circuit.
In February last year, the FTC accused ViroPharma of abusing government processes to delay generic competition of its Vancocin HCl Capsules (vancomycin hydrochloride), an antibiotic used to treat severe bacterial infections.
According to the FTC, ViroPharma’s actions resulted in consumers and other purchasers having to pay hundreds of millions of dollars in excess for their medication.
“After ViroPharma acquired the rights to Vancocin capsules in 2004, it raised the price of the drug significantly and continued to do so through 2011,” said the agency.
It went on to claim that ViroPharma had inundated the Food and Drug Administration (FDA) and courts with “a campaign of serial, repetitive, and unsupported filings” to delay approval of generics and exclude competition, alleging that Shire had filed more than 45 regulatory and court files.
The FDA disposed of ViroPharma’s filings in 2012, after finding that they were “unsupported” and “without merit”.
Without the serial petitioning abuses, generic entry would have probably occurred by July 2010, or even earlier, claimed the FTC.
In response, Shire argued that it played no role in ViroPharma’s challenged petitioning, which took place between 2006 and 2012. Shire acquired ViroPharma in January 2014.
Two months after the FTC filed its claim, ViroPharma filed a motion to dismiss, claiming that the FTC had “failed to plead facts necessary for it to invoke its limited authority” and that the conduct alleged by the FTC is constitutionally-protected petitioning activity.
US District Judge Richard Andrews agreed to dismiss the dispute in mid-March, while giving the FTC leave to amend its complaint.
He said that the FTC had failed to plead facts that allowed the court to infer that ViroPharma “is about to violate” the law.
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