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.
Patents-in-Suit:
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
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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.