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Articles

Hatch-Waxman safe harbor expansion continues

February 12, 2014

Articles

Hatch-Waxman safe harbor expansion continues

February 12, 2014

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In a January 28 decision, the District Court of Maryland dismissed a patent infringement suit for failure to state a claim because the accused conduct was immune under the Hatch-Waxman safe harbor.  Even though the accused product had received FDA approval and had been commercialized, the safe harbor still applied.  Moreover, the court recognized that the safe harbor defense could be raised at the “to dismiss” stage.  Thus, patent owners and potential infringers should recognize the enlarged scope of safe harbor and that challenges to a complaint may be raised at the onset of a litigation.

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