Case Filed: Mar 04, 2014
Court: New Jersey District Court
Case Summary:
Janssen, a company which produces
and markets mental health prescription pharmaceutical products claimed
violation of their patent covering the drug Prezista used in the treatment of
human immunodeficiency virus (HIV-1) infection. The lawsuit attempts to block
the release of generic Prezista tablets in the US. The patent at issue is: US8518987
entitled ‘Pseudopolymorphic forms of a HIV protease inhibitor’, duly issued by United
States Patent & Trademark Office on Aug 27, 2013. The patent is set to
expire[i]
by May 16, 2022 and is currently assigned[ii]
to Janssen (source: MaxVal’s Assignment
Database).
The complaint alleges that Lupin
infringed claims of the ‘987 patent by filing Abbreviated New Drug Application
(ANDA) seeking approval to sell generic versions of Janssen’s highly successful
Prezista® (darunavir) 75 mg, 150 mg, 300 mg, 400 mg, 600 mg, and 800 mg
products prior to the expiration of the '987 patent, the complaint said. It added
further that if approved and marketed, the generic would infringe the ‘987
patent.
Janssen is the current holder[iii]
of approved New Drug Application (NDA) No. 21-976 for Prezista® (source: Patent Marker). On or about
November 4, 2013, plaintiff received a letter from Lupinstating the submission
of ANDA No. 202-073 seeking approval for Lupin's generic tablets, asserting that
the claims of the '987 patent are invalid and/or will not be infringed by the
commercial manufacture of the generic tablets.
Plaintiff requested Court to
order that the effective date of approval of Lupin’s ANDA be a date that is not
earlier than the expiration of the ‘987’s patent term.
See 2:14-cv-01370
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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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