Case Closed: Oct 17, 2013
Court: Delaware District Court
Judge: Leonard P. Stark
Case Summary:
Par resolved suits brought in by
Horizon accusing the generic manufacturer of infringing its patents relating to
treating arthritis.
Judge granted the stipulation filed by the parties and dismissed the cases without
prejudice, ending the litigations over Horizon’s abbreviated new drug
application for a generic version of Duexis® infringing the ‘127, ‘202 and ‘033
patents covering the medication.
It appears that the Parties
entered into settlement with licensing agreements, and Horizon has granted Par
the non-exclusive right to market a generic ibuprofen and famotidine product in
the US under Par's Abbreviated New Drug Application (ANDA), beginning January
1, 2023, or earlier under certain circumstances. Other details of the
settlement were not disclosed.
Horizon filed complaints to
protect three of its patents after Par submitted an ANDA no. 203658 to the U.S.
Food and Drug Administration (FDA) for tablets containing 800 mg of ibuprofen
and 26.6 mg of famotidine as active ingredients (a generic version of Duexis)
by which it alleged that Par had committed an act of infringement. The court
document said, unless a judge stops the alleged infringement, “Horizon will be
irreparably harmed”. Horizon sought the court to declare a permanent enjoinment
of Par from marketing and selling its generic version of Lotrel, as well as a court
order that any approval of Par’s ANDA would not be effective until after
expiration of the ‘127, ‘202 and ‘033 patents.
The patents in suits were: US8309127,
US8318202 and US8067033 all entitled Stable
compositions of famotidine and ibuprofen were issued on Nov 13, 2012, Nov 27,
2012 and Nov 29, 2011, respectively. The patents expire[*]
by Nov 26, 2028 and are assigned to Horizon Pharma as per face page. As per the
complaints, the ‘127 patent covers the Duexis® product and the '033 and '202
patent discloses a composition containing famotidine and ibuprofen.
Horizon’s Duexis is a combination
drug used to treat signs and symptoms of rheumatoid arthritis and
osteoarthritis and to decrease the risk of developing upper gastrointestinal
ulcers. Horizon currently holds[†]
the new drug application no. 022519 for tablets, which contains 26.6 mg of famotidine
and 800 mg of ibuprofen as active ingredients, which it sells under the brand
name Duexis® (source: MaxVal’s Patent Marker) and
approved by FDA on Apr 23, 2011.
See cases 1:13-cv-00102
and 1:12-cv-00393 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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