Paroxetine – USA

Paroxetine – USA

On June 09, 2017 a New Jersey federal judge delivered a victory to ANDA filers accused of infringing patents related to Sebela International Ltd.’s nonhormonal drug Brisdelle® (Paroxetine) for menopausal hot flashes, finding that they did not infringe one patent and invalidating the other two.
Prinston & Actavis were seeking to market a generic version of Brisdelle®, a non-hormonal (i.e., non-estrogen based) treatment for hot flashes associated with menopause. Plaintiff Sebela International Limited filed a Hatch-Waxman suit against both drug companies, alleging they had infringed patents related to Brisdelle®.
The U.S. District Court for the District of New Jersey held a five-day bench trial in Dec. 2016 and allowed additional days of closing arguments in Feb and Mar. 2017, after post-trial briefing was concluded.

The court issued a ruling concluding that one patent (US 7,598,271) claiming a particular solid form of the active ingredient was not infringed and that two other patents (US 8,658,663 & US 8,946,251) were invalid because their claims would have been obvious over what was previously known in the field.  Additionally, the court determined that had it not found the latter two patents obvious, it would have invalidated them on two other, independent grounds.
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