Bausch targets India-based firm over IBS drug generic
Pharma giant claims infringement of two patents | Hyderabad-based rival’s letter offering details of proposed generic allegedly lacked certain required details.
Salix Pharmaceuticals and its parent company Bausch Health have launched a lawsuit against MSN Laboratories and its US unit MSN Pharmaceuticals over a proposed generic version of constipation drug Trulance (plecanatide).
Orange book listing
In a complaint filed at a New Jersey federal court on Friday (June 16), Salix and Bausch Health Ireland alleged infringement of two patents for Trulance—a prescription medicine used to treat adults with irritable bowel syndrome and chronic idiopathic constipation.
The patents-in-suits, numbers 11,142,549 and 11,319,346, both cover “oral formulations of a purified peptide” and were issued by the US Patent and Trademark Office ( USPTO) in October 2021 and May 2022 respectively.
Both are listed in the Orange Book along with a New Drug Application (NDA) for Trulance held by Salix, which was approved by the US Food and Drug Administration (FDA) in 2017.
‘Substantial’ harm
Salix and Bausch claim that they received a letter from MSN last month (May) giving notice of an abbreviated new drug application (ANDA) for a generic version of Trulance, for which MSN was seeking FDA approval.
The letter stated that MSN’s ANDA “contains the required bioavailability and/or bioequivalence data from studies on the plecanatide oral tablet drug product” for MSN’s generic plecanatide oral tablets, according to the complaint.
However, the firms alleged that the letter provided “no explanation of any non-infringement defence related to claims 1 to 7 of the ’346 patent”, and insisted that the purified peptide in the ANDA would infringe claims under both patents.
Citing “substantial and irreparable harm” that would be caused by the sale of MSN’s plecanatide tablets, Salix and Bausch are asking for an order blocking the generic until the expiration of the patents, and a judgment that the ANDA constitutes infringement.
