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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