Noven Pharmaceuticals Sues For Infringement of ADHD Patch Patent

By Joseph Mandour on October 14, 2011

stethoscope-200x150 Orange County – Noven Pharmaceuticals, Inc. has filed an action for patent infringement against Watson Pharmaceuticals, Inc. in a federal district court in New Jersey. The subject of the patent infringement action is the Noven owned Daytrana patent, a patch treatment of Attention Deficit Hyperactive Disorder (ADHD). Noven filed the action when it discovered that competitor Watson Pharmaceuticals filed an Abbreviated New Drug Application with the FDA, seeking to market a generic version of the Daytrana ADHD patch before the expiration of the Noven patent in 2018.

Noven responded quickly, filing the action against Watson within 45 days of receiving notice of Watson’s intent to manufacture the generic Daytrana patch. Therefore, under the Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act, the FDA cannot approve Watson’s generic patch for a period of 30 months. Watson will receive permission to distribute the patch before the expiration of the 30 month waiting period only if it can show that the patent was improperly registered or that the Watson patch does not infringe the Daytrana patent.

The patented Daytrana patch is designed for adolescent ADHD patients between six and twelve years of age. The patch, typically worn between nine and twelve hours a day, is meant to provide an alternative or supplemental form of ADHD treatment to patients who are not responding to oral treatment. ADHD affects about three to five percent of the world’s children, with 30 to 50 percent of those children experiencing symptoms into adulthood.

As Daytrana is a transdermal treatment and is not ingested orally, its ingredients are not subject to “first pass metabolism.” For example, l-threo-methylphenidate is absorbed at a concentration of 50 to 60 percent through the Daytrana patch, compared to 14 to 27 percent absorption through oral medications. Because of the patch’s effectiveness, as the expiration of the patent term approaches, more makers of generic pharmaceuticals are likely to seek approval to develop generic versions of the patented Daytrana patch.

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Posted in: Patent Infringement