Friday, August 8, 2014

Novartis Wins Ruling Against Watson over Exelon Generics

Case Filed: Nov 09, 2011

Case Closed: Aug 04, 2014

Court: Delaware District Court

Judge: Richard G. Andrews

Case Summary:
Novartis filed a patent infringement suit against Watson over the generic-drug maker's plans to manufacture a generic version of Exelon® Patch, a treatment of mild to moderate dementia of the Alzheimer’s type and Parkinson’s disease. The other defendant named in the suit was LTS Lohmann Therapie-Systeme AG. The judge signed off the final judgment favoring Novartis delaying FDA approval of the generic versions.

The patents involved in the suit were:

  •        US5602176 entitled ‘Phenyl carbamate,’ issued on Feb 11, 1997 and expired* on Feb 11, 2014
  •     US6316023 entitled ‘TTS containing an antioxidant,’ issued on Jan 01, 2002 and expiring* by Apr 14, 2019
  •     US6335031 entitled ‘TTS containing an antioxidant,’ issued on Nov 13, 2001 and expiring* by Jan 08, 2019
The ’023 and ‘031 patents claim pharmaceutical compositions of the drug and the ‘176 patent also claims methods of treating conditions such as Alzheimer’s disease.

The ’176 patent was initially assigned to Sandoz, which subsequently became Novartis AG after the merger. The ’023 and ’031 patents are currently assigned± to Novartis AG and LTS (source: MaxVal’s Assignment Database).

As in Complaint:
Novartis alleged that Watson committed an act of infringement by filing ANDA no. 202119 for obtaining approval to engage in the commercial manufacture, use, or sale of Watson’s ANDA Products before the expiration of the ’176, ’023, and ’031 patents. According to the complaint, Watson asserted that the ’176, ’023, and ’031 patents are invalid, unenforceable and/or will not be infringed.

NDA Holder:
Novartis currently holds· an approved new drug application (NDA) no. 22-083 for Exelon® Patch (rivastigmine transdermal system or extended release film) (4.6 mg and 9.5 mg/24 hr dosages), which contains the active ingredient rivastigmine (source: Patent Marker). Exelon® Patch was approved by FDA in Jul 2007 and is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type and Parkinson’s disease.

District Court Judgment:
The court entered final judgment favoring plaintiff and against Watson, finding that the rivastigmine transdermal products, subject to Watson's ANDA infringe claims 3, 7, 13, 16 and 18 of the '031 patent and claims 2 and 7 of the '023 patent. The judge also stated that those claims are valid and not obvious. The effective date of any final approval by FDA of Watson's ANDA should not be earlier than expiration date of the '031 and '023 patents.

See 1:11-cv-01112 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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* Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.

± MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
· Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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