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
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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.