Case Filed: Jul 16, 2014
Court: New York Southern District
Court
Case Summary:
Foster City, California-based
Gilead along with Emory University lodged a suit against Lupin, claiming that
Lupin’s generic product would infringe its patents, after the generic-drug
maker filed an abbreviated new drug application (ANDA) with the U.S. Food and
Drug Administration (FDA) seeking permission to sell its own version of Atripla.
The drug is used as part of highly active antiretroviral therapy (HAART) for
the treatment of human immunodeficiency virus (HIV) type 1.
Patent-in-Suit:
The complaint accuses
Mumbai-based Lupin of infringing two patents:
- US6642245 entitled ‘Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane,’ issued on Nov 11, 2003 and expiring* by Nov 04, 2020
- US6703396 entitled ‘Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers,’ issued in Mar 09, 2004 and expiring* by Mar 09, 2021
The patents were originally assigned
to Emory University by USPTO. Emory and Gilead entered into an agreement under
which Gilead is the licensee with rights to sue for infringement, the complaint
said. The patents claim methods for treating HIV infections in humans with emtricitabine.
As in Complaint:
Gilead alleged that the commercial manufacture, use, sale and/or
importation of tablets containing 600 mg of efavirenz, 200 mg of emtricitabine
and 300 mg of tenofovir disoproxil fumarate for which Lupin seeks approval of
ANDA no. 91-168, if approved by FDA, will infringe one or more claims of the
‘245 and ‘396 patents.
According to the complaint, Lupin’s
notice letter asserted that the ‘245 and ‘396 patents were invalid and would
not be infringed by the proposed generic product, but Gilead claimed that the
letter failed to comply with the law and FDA regulations as full and detailed
explanation regarding non-infringement and invalidity of the patents were not
provided.
NDA Holder:
Gilead is the current holder+
of Atripla (source: Patent
Marker) with NDA no. 21-937, which was approved by FDA in 2006 for the
treatment of HIV. According to Gilead 2014 quarter results, the drug was sold
for $489,929 in US (ending Mar).
Prayer for Relief:
Gilead wants judgment declaring
FDA approval date of the drug should not be earlier than the patents’
expiration dates, an order barring Lupin from manufacturing the ANDA product as
well as unspecified damages and attorneys’ fees.
See 1:14-cv-05352
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*
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.
+
Patent Marker provides an online environment
where patentees can virtually mark products and search products for
patent-related information.
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