Case Summary:
Irish-headquartered
biopharmaceutical company, Shire along with Supernus Pharmaceuticals filed a
patent infringement lawsuit against Indian pharmaceutical company, Ranbaxy for
infringing on two patents that support Intuniv, a prescription medicine used to
treat attention deficit hyperactivity disorder (ADHD). The lawsuit was filed in
Delaware District Court on Jun 25, 2014. The lawsuit was filed to block a generic
version of Intuniv filed with FDA by Ranbaxy. The complaint also named OHM
Laboratories, a wholly owned subsidiary of Ranbaxy, as the other defendant.
Patents-in-Suit:
The patents
involved in this suit were: US6287599 and US6811794 both entitled ‘Sustained release
pharmaceutical dosage forms with minimized pH dependent dissolution profiles’,
legally issued on Sep 11, 2001 and Nov 02, 2004, respectively. The patents are scheduled to expire[i]
by Dec 20, 2020 and are currently assigned[ii]
to U.S. Bank National Association (source: MaxVal’s Assignment
Database). According to the complaint, Supernus is the owner of the patents
and Shire is exclusive licensee of the patents. The ‘599 and ‘794 patents relates
to pharmaceutical compositions of the drug, Intuniv.
As in complaint:
Shire alleged
that Ranbaxy filed its ANDA with the FDA seeking approval to engage in the
manufacture, of generic Intuniv with active ingredient as guanfacine hydrochloride,
extended-release tablets, 1, 2, 3 and 4 mg before the expiration of the ’599
and ’794 patents.
The complaint
stated that Ranbaxy sent Shire a letter notifying ANDA product, which Shire
believes that Ranbaxy was aware of the patents-in-suit and acted without
reasonable basis for believing that they would not be liable for infringement.
Shire requested court to render this case “exceptional”.
NDA Holder:
Shire is the current
holder[iii]
of new drug application (NDA) no. 022037, which was approved by the FDA in Sep 2009
for the manufacture and sale of guanfacine hydrochloride extended release
tablets, eq. 1, 2, 3 and 4 mg base,
which Shire markets under the name of Intuniv (source: Patent Marker.)
About Intuniv:
It is a
prescription medicine used to treat attention deficit hyperactivity disorder
(ADHD) in children who are at least 6 years old. The drug can be taken once
daily at approximately the same time each day. It can be used in combination
with an ADHD stimulant medication. According to Shire, Intuniv sales in 2013
were up by 16% ($335m) compared to 2012 ($288m).
See 1:14-cv-00827
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[i]
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.
[ii]
MaxVal offers Patent Assignment Alert service where subscribers receive email
alerts when assignments relating to target applications, patents or entities of
interest are recorded.
[iii]
Patent Marker provides an online environment where patentees can virtually mark
products and search products for patent-related information.
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