MAYNE Pharma Group Limited has filed a patent infringement suit against Sun Pharmaceutical Industries Ltd and Inc., in the United States District Court, according to yesterday's ASX announcement.
The company alleges that Sun Pharma infringed on 20 Orange Book listed patents related to Imvexxy (estradiol vaginal inserts).
The lawsuit follows Sun Pharma's submission of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration, which includes a Paragraph IV certification challenging Mayne Pharma's patents.
The action under the Hatch-Waxman Act triggers a 30-month stay on any potential FDA approval for Sun Pharma's ANDA.
"This lawsuit reflects Mayne Pharma's commitment to protecting our intellectual property rights," said Mayne Pharma CEO, Shawn Patrick O'Brien.
"As one of the top two specialised women's healthcare companies in the United States, intellectual property is important to our business, and we are confident in our ability to vigorously defend the Imvexxy franchise for the benefit of our patients," added O'Brien.
Mayne Pharma had acquired an exclusive license agreement for Imvexxy in the United States from TherapeuticsMD Inc. in Dec 2022.
Earlier this month, Mayne Pharma settled a shareholder class action for $38 million (PD 12 Jul) for alleged misleading or deceptive conduct and breaches of continuous disclosure obligations related to alleged anti-competitive behaviour in the US. JG
The above article was sent to subscribers in Pharmacy Daily's issue from 26 Jul 24
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 26 Jul 24
