Tuesday, July 22, 2014

Gilead Challenges Lupin over Anti-HIV Generics

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.

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 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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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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