Monday, June 30, 2014

Shire Sues India’s Ranbaxy to Delay Generic Intuniv

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.

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 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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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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