Novartis takes on Roxane Laboratories over drug application

Novartis takes on Roxane Laboratories over drug application
December 3, 2013
Life Sciences Intellectual Property Review

Bill Baton, a partner in the Intellectual Property & Technology and Commercial Litigation practices, is quoted in this article about a lawsuit alleging that Roxane Laboratories will infringe a patent owned by Novartis Pharmaceuticals for an oral tablet to treat schizophrenia.

Roxane has filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration for approval of a tablet containing iloperidone, the same active ingredient in the patented Novartis product. Bill explains that this ANDA case appears to have been brought under the Hatch-Waxman Act and its provisions relating to generic company challenges to brand company patents.

“Under the act, the generic company filer of an Abbreviated New Drug Application (ANDA) submits its ANDA to the FDA seeking approval for a generic version of the brand drug prior to the expiration of the “Orange Book” patent(s) associated with that drug,” Baton said in the story.

To read the entire article, click here.