Bausch Health asserts push to 'vigorously' defend Xifaxan patent litigation
01 Aug 2022
Bausch Health will continue litigating over its Xifaxan drug, threatening to appeal all the way up to the US Court of Appeals for the Federal Circuit.
The Quebec-based company, through its gastroenterology business Salix Pharmaceuticals, said it will
file an appeal
if the final order is consistent with an oral order in a Delaware district court last week centered around a case against Norwich Pharmaceuticals.
The company has been here before, having previously entered into settlement agreements with Teva, Sun Pharmaceuticals and Novartis’ Sandoz unit concerning a generic rifaximin product.
In the case vs. Norwich, also known as Alvogen, Bausch and its Salix unit are attempting to retain the patent on Xifavan, known generically as rifaximin, for the treatment of irritable bowel syndrome with diarrhea (IBS-D) and reduction in risk of overt hepatic encephalopathy (HE) recurrence, a neurological disorder that is caused by chronic, severe liver disease.
According to the oral order, not yet finalized, the US District Court of Delaware is expected to find certain US patents protecting the drug’s 550mg tablets for reduction in risk of HE recurrence valid and infringed, Bausch said in a statement on July 28. Further, the court is expected to find the US patents protecting the composition and use of Xifaxan for treating IBS-D invalid.
“While the Court has not yet entered any final judgement, absent Norwich’s removal of the HE indication and data from their Abbreviated New Drug Application (ANDA), it is expected that the Court will enjoin Norwich’s pending ANDA until expiration of the XIFAXAN HE Patents in 2029,” Bausch said in a statement.
With that, Bausch intends to “vigorously oppose any attempt by Norwich to remove the HE safety data from its ANDA” in an effort to sidestep the patents. The company thrice mentions it will “vigorously” defend its IP and pursue any route possible to do so.
Norwich can’t launch a generic equivalent of Xifaxan until a revised ANDA approval from the FDA and an expected injunction modified by the court, Bausch said.
“We are disappointed with today’s development. We strongly disagree with any conclusion that our patents are not valid and intend to file an appeal to any such order,” Bausch CEO Thomas Appio said in a statement.
Under previous agreements with Teva, Sun and SandozSandoz, a generic version of the drug can’t be sold until 2028 or upon earlier approval and launch of such a product.
The IBS-D indication was approved in May 2015 after securing the HE nod in March 2010. It had also been approved for traveler’s diarrhea in 2004.
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