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25 September 2015Americas

Shire’s ADHD patents are valid, rules Federal Circuit

A US appeals court has upheld a lower court ruling that patents owned by Shire covering an ADHD treatment drug are valid, but reversed a separate judgment that said pharmaceutical company Johnson Matthey induced infringement.

The four patents at the centre of the dispute cover derivatives of the drug Vyvyan (lisdexamfetamine) and are specifically targeted at limiting its activity inside the human body when it is administered in high doses.

Yesterday, September 24, the US Court of Appeals for the Federal Circuit upheld a 2013 ruling by the US District Court for the District of New Jersey which said that the patents are not obvious.

The patents had been challenged by Amneal Pharmaceuticals, Roxane Laboratories, Allergan and Mylan.

All four parties filed Abbreviated New Drug Applications (ANDAs) to market a generic version of the drug in 2012.

In a separate claim, Shire sued Johnson Matthey on the grounds that it induced other parties to infringe the four patents. Johnson Matthey had not filed an ANDA, but did supply the four companies with the active ingredient of the drug LDX dimesylate.

The district court, which consolidated the cases, judged the patents to be valid and said that Johnson Matthey had induced infringement.

But in yesterday’s ruling, the federal circuit said that although the court was correct to say that Shire’s patents are valid, Johnson Matthey could not be held liable for induced infringement.

Judge Richard Linn, who wrote the 3-0 opinion, said that the evidence of prior art submitted by the applicants “fails to raise a genuine issue of material fact” concerning whether the patents are obvious.

Linn added that because the US Food and Drug Administration (FDA) had not yet approved the ANDAs, Johnson Matthey could not be liable for induced infringement.

He said: “Because in the circumstances of this case Johnson Matthey cannot be liable for induced infringement prior to the grant of FDA approval of the application filed by the ANDA defendants, we reverse the district court’s judgment.”

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