Roxane Face Patent Infringement Suit over Uloric Generic

Teijin and Takeda together launched a complaint on Feb 12, 2014 against Roxane, a generic drug manufacturer accusing the latter of infringing a patent owned by Teijin. The lawsuit concerned the filing of an abbreviated new drug application with U.S. Food and Drug Administration (FDA) for febuxostat tablets, 40 and 80 mg. This product is a generic version of Uloric®, which is indicated for the chronic management of hyperuricemia in patients with gout. The lawsuit was filed in the United States District Court for the District of Delaware.

According to the plaintiffs, the 40 and 80 mg tablets of generic febuxostat planned for release by Roxane infringe the patent US6225474, licensed by Teijin to its subsidiary Takeda for use in Uloric. The patent covers the method used to produce the drug's active ingredient “febuxostat”.

The patent entitled ‘Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and method of producing the same’ was issued on May 01, 2001 and expires[i] by Jun 19, 2018. The patent is currently assigned[ii] to Teijin (source: MaxVal’s Assignment Database).

Takeda is the current holder[iii] the new drug application no. 21856 approved by FDA for oral tablets containing 40 or 80 mg of the active ingredient febuxostat (source: Patent Marker). As per the complaint, Roxane plans to sell a generic version in the US prior to expiration of the patent.

Plaintiffs received written notifications from Roxane denying infringement of the patent and asserting invalidity, according to the complaint.

Plaintiffs requested Court to order that the effective date of approval of Roxane’s ANDA be a date that is not earlier than the expiration of patent term.

See 1:14-cv-00189 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.