Shire Comments on USPTO Petitions Related to Lialda and Gattex

Shire acknowledges the two petitions filed with the US Patent and Trademark Office (USPTO) on 2 April by Hayman Capital Management regarding Lialda (mesalamine) and Gattex (teduglutide [rDNA origin]). 

The patents listed in the FDA Orange Book for Lialda and Gattex protect the innovation and value Shire brings to patients who benefit from these important medicines. Shire will continue to defend vigorously its patents and pursue all legal options available to protect its products.

Lialda remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Lialda is protected by the following FDA Orange Book listed patent: US Patent No. 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the “’720 patent”), which expires in 2020. This patent has already withstood a challenge on its validity in the Federal District Court for the Southern District of Florida. There have not been any approvals of generic versions of Lialda.

Gattex is approved in the US to treat adults with short bowel syndrome (SBS) who are dependent on parenteral support. Gattex was awarded Orphan Drug Designation by the FDA in 2012 and has orphan drug exclusivity until December 2019. Gattex is also protected by FDA Orange Book patents which expire in 2015, 2022 and 2025. The recently filed petition only challenges a subset of claims of the Gattex patent expiring in 2022. The remaining claims of that patent, and the claims of the other patents, were not challenged in the petition.