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27 March 2018Americas

Shire welcomes Adderall generic ruling

A US judge handed a win to Shire late last week, finding that a generic version of its attention deficit hyperactivity disorder drug Adderall XR (amphetamine/dextroamphetamine mixed salts) would infringe Shire’s patents.

Adderall contains a combination of amphetamine sulphate, amphetamine aspartate monohydrate, dextroamphetamine sulphate, and dextroamphetamine saccharate.

On Thursday, March 22, District Judge William Young held that a proposed Abbreviated New Drug Application (ANDA) submitted by Florida-based pharma company Abhai infringes the claims of US patents RE42,096 (a reissue of patent 6,322,819) and RE41,148 (a reissue of patent 6,605,300).

Both of the patents are called “Oral pulsed dose drug delivery system”.

Abhai is now prohibited from marketing its ANDA product until the expiration of the two patents.

Shire brought the lawsuit in November 2015, after learning of the ANDA. In March 2016, the case was referred for mediation, but it returned to the docket in January this year, when the parties failed to come to an agreement.

In a statement, Shire said it was pleased with the ruling and that it will “continue to vigorously defend its patents to protect the innovation and value Shire products bring to patients”.

Young also sanctioned Abhai for its litigation misconduct, finding that Abhai had “recklessly squandered five days”.

In April 2017, Abhai revealed that an essential factual matter—its stability dissolution testing data—was incorrect. Abhai produced its corrected data, admitting that it had failed to supplement this data in place of the incorrect data it had originally provided during discovery

Abhai had retested the specific shelf lives and dosage strengths back in November 2016.

The court directed that a certified copy of the court’s opinion be sent to the Food and Drug Administration in light of Abhai’s “pervasive corporate unwillingness to play by the rules”, adding that sanctions are “amply warranted”.

Based on the reported misconduct, Shire produced a $2.75 million claim for attorneys’ fees.

“Unfortunately Shire, which otherwise presented a clear, cogent, and compelling case, asks for far too much,” noted Young.

The court added that Shire may submit a revised claim for attorneys’ fees and costs limited to recovering for time wasted dealing with Abhai’s inaccurate data, discovering the litigation misconduct, and dealing with revised data.

Abhai’s ANDA product was found to infringe claim 1 of the ‘096 patent and claims 1, 11 (as it depends from other claims), and 13 of the ‘148 patent.

“Abhai never developed a viable evidentiary attack on the validity of either of Shire’s patents and the court necessarily finds in Shire’s favour on Abhai’s counterclaims,” concluded Young.

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More on this story

Asia-Pacific
3 April 2018   Japan-based Takeda has revealed that it is considering plans to acquire biopharmaceutical company Shire.

More on this story

Asia-Pacific
3 April 2018   Japan-based Takeda has revealed that it is considering plans to acquire biopharmaceutical company Shire.