Shire Laboratories had sued Teva Pharmaceuticals for alleged infringement of two of Shire’s US Patent Nos. 6,322,819 and 6,605,300 covering attention deficit hyperactivity disorder drug - Adderall XR. Both 819’ and 300’ patents are due to expire on October 21, 2018 and April 21, 2019 with pediatric exclusivity.
The lawsuit had been filed in the U.S District Court for the Eastern District of Pennsylvania as a result of an abbreviated new drug application (ANDA) filed by Teva with Food and Drug Administration for the marketing approval of generic versions of Adderall XR.
Earlier on 24th February 2003, Shire Laboratories sued Barr for infringement of U.S. Patent No. 6,322,819 in the U.S. District Court for the Southern District of New York in response of an abbreviated new drug application (ANDA) submitted by Barr with Food and Drug Administration (FDA) seeking approval to market generic Adderall XR in the United States. The ‘819 patent was only orange book listed patent at the time of Barr ANDA submission in November 2002. Later, Shire submitted one more U.S. Patent No. 6,605,300 with FDA to be listed with orange book and in response of that Barr subsequently amended its ANDA to include a certification to the ‘300 patent and provided Shire with notice of that amendment. On September 02, 2003 Shire filed second lawsuit against Barr for infringement of ‘300 patent in the U.S District Court for the Southern District of New York in response of amended ANDA submission.
In December 2003 Shires also sued Impax for infringement of ‘819 and ‘300 patents in the U.S. District Court for the Southern District of New York in response of an ANDA filed by Impax in November 2003 with FDA seeking approval to market generic Adderall XR of 30mg strength prior to the expiration dates of the ‘819 and ‘300 patents in the United States. In January 2005, Shires filed second lawsuit against Impax for infringement of ‘819 and ‘300 patents in response of an ANDA submission seeking approval to market generic Adderall XR of 5mg, 10mg, 15mg, 20mg and 25mg strengths.
In December 2004, Shire even after receiving notification that Colony Pharmaceuticals has submitted an ANDA with FDA seeking approval to market generic Adderall XR of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg strengths prior to the expiration dates of the ‘819 and ‘300 patents, decided not to sue it.
In December 2004, Shire even after receiving notification that Colony Pharmaceuticals has submitted an ANDA with FDA seeking approval to market generic Adderall XR of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg strengths prior to the expiration dates of the ‘819 and ‘300 patents, decided not to sue it.
On October 20, 2005 Shires announced that it has filed yet another lawsuit against Barr and Impax for infringement of U.S. Patent No. 6,913,768 in the U.S District Court of the Southern District of New York in response of an ANDAs filed by Barr and Impax. The ‘768 patent was issued to Shire on July 05, 2005. This case, however, does not effect the ongoing litigations in the Southern District of New York between Shire and Barr involving ‘819 and ‘300 patents which later consolidated in December 2003 and scheduled to go to trial in January 2006. In January 2006, Shire and Impax settled all pending patent litigation concerning Adderall XR under an agreement that Impax will be permitted to market generic Adderall XR in the United States no later than January 01, 2010 and will pay Shire a royalty from those sales. In certain conditions, such as launch of another generic version of Adderall XR, Impax may be permitted to enter the market as Shire’s authorized generic. No payments to Impax are involved in the settlement agreement.
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