Mesalamine – USA

On Sep. 12, 2017, Northern District of West Virginia issued an opinion ruling that Mylan’s proposed generic version of Apriso® does not infringe the asserted patent(s).

Salix / Valeant Pharmaceuticals hold an approved New Drug Application ("NDA") for Apriso® (Mesalamine) extended-release capsules.  It was approved by the United States Food and Drug Administration ("FDA") on Oct 31, 2008. There are total 07 patents listed in orange book (OB) of which 6 are expiring on Apr 20, 2018 & one US 8,865,688 is expiring on May 1, 2030.

Mylan Pharmaceuticals filed Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Apriso®.  Salix sued Mylan in Jun 2015 in Northern District of West Virginia & court held bench trial in March 2017. Court decided that plaintiffs have not carried their burden to prove that Mylan’s ANDA product will infringe claim 1 of the ‘688 Patent either directly or indirectly.

Lupin is the first ANDA filer for this product & has settled the case.  Other filers are Novel & Teva. Novel’s case was dismissed in Jul 2017 & Teva’s case is under discovery.

In a parallel PTAB proceeding, on Dec. 08, 2015, Generico LLC filed Inter Partes Review over the US’688 patent & Mylan joined this IPR. On May 19, 2017, the Patent Trial and Appeal Board of the USPTO issued its Final Written Decision in an IPR proceeding & held that two claims in dispute (1 and 16) of the US’688 patent were obvious in view of the prior arts. This decision is under appeal at CAFC.