Case Summary:
Canada-based pharmaceutical
company Duchesnay filed a suit against Dublin headquartered generic maker, Actavis
on July 11, 2014, in the New Jersey District seeking to prevent Actavis from
commercializing its ANDA product prior to the expiration of Duchesnay’s patent US6340695
entitled ‘Rapid onset formulation’. This action formally initiates the patent
challenge process under the Hatch-Waxman Act, which grants a 30-month stay to
drug companies that file suit against generic manufactures challenging their
patents.
The patent was issued by USPTO to
inventor Eric Gervais on Jan 22, 2002 and expires[i]
by Jun 21, 2021. Duchesnay is the current assignee[ii]
of the ‘695 patent (source: MaxVal’s Assignment
Database).
Actavis filed an Abbreviated New
Drug Application (ANDA) no. 205811 with the FDA seeking approval to market
doxylamines and pyridoxine hydrochloride delayed-release tablets, 10 mg/10 mg.
The complaint futher added that Actavis’s generic product labeled the same indications
and dosage as the drug, Diclegis.
Duchesnay is the current holder[iii]
of Diclegis (source: Patent
Marker) with NDA no. 021876, approved by FDA on Apr 08, 2013. The active
ingredients of the drug include: doxylamine succinate and pyridoxine
hydrochloride.
Duchesnay alleged that Actavis'
ANDA product is a generic version of Duchesnay‘s Diclegis, which is indicated
for the treatment of nausea and vomiting of pregnancy in women who do not respond
to conservative management.
See 2:14-cv-04384 for
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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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