UK Shire Pharmaceuticals group said this week that its US subsidiary Shire Laboratories has filed a lawsuit in the US District Court against Barr Laboratories for the infringement of the US patent No. 6,322,819 ( '819 Patent')
The lawsuit results from an ANDA (Abbreviated New Drug Application) filed byBarr for a generic version of ADDERALL XR, pursuant to which Barr providednotice that it would seek to market its generic product before the expirationof the `819 Patent in 2018. ADDERALL XR is Shire's leading extended releaseAttention Deficit Hyperactivity Disorder medicine.
Barr is unable launch a generic version of ADDERALL XR before it receives finalapproval of its ANDA from the FDA. The lawsuit triggers a stay of FDA approvalof up to 30 months from Barr's notice to allow the court to resolve the case.Even if Barr receives a final approval from the FDA, it cannot lawfully sellits generic version without successfully resolving the legal challenge to theShire patent, claims Shire in a statement.
Rolf Stahel, Shire chief executive remained firm this week when he commented:"With this lawsuit we are vigorously enforcing our intellectual property. Wewill fight this challenge to our issued, valid and enforceable patent whichexpires in 2018.
Hatch Waxman also provides exclusivity for ADDERALL XR andwill not allow any generic launch until at least October 2004. "