Case Filed: Sep 13, 2013
Case Closed: Mar 20, 2014
Court: Delaware District Court
Judge: Gregory M. Sleet
Case Summary:
AbbVie a research-based
biopharmaceutical company and Wisconsin Alumni Research Foundation (WARF) a
foundation that patents and licenses the discoveries of the University of
Wisconsin-Madison scientific community together filed a complaint against London-based
Hikma Pharmaceuticals, manufacturer of branded and non-branded generic and
in-licensed pharmaceutical products. The suit claimed violation of AbbVie’s patent
covering a method of preventing hyperphosphatemia in a patient having a kidney
disorder. The other named defendants in the suit were West-Ward Pharmaceuticals
Corp. and Exela Pharma Sciences, LLC.
The case was filed in response to
Hikma’s filing of a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) for approval to manufacture and sell a generic copy of
AbbVie’s Zemplar® paricalcitol injectable drug products prior to the expiration
of the patent covering Zemplar.
The complaint alleged that Hikma,
West-Ward and Exela Pharma collaborated in the research, development,
preparation and filing of NDA No. 205917 for generic paricalcitol injectable
drug products in 2 mcg/ml and 5 mcg/ml formulations, which are covered by the
patent-in-suit. AbbVie and WARF received letters notifying that Hikma had filed
NDA No. 205917 and that none of the claims of the ’815 patent will be infringed
by Hikma’s commercial manufacture of its paricalcitol injectable formulations
that are the subject of the NDA, and/or that those claims are invalid or
unenforceable.”
Plaintiffs wanted the Court to
declare that the ’815 patent is valid and enforceable, and defendants would
infringe one or more claims of the patents and enjoining them from commercializing
the NDA product.
The patent at issue was: US5597815
entitled ‘Prevention of hyperphosphatemia in kidney disorder patients’, issued
on Jan 28, 1997 and expiring[i]
by Jul 13, 2015. The National Institutes
of Health is the current assignee[ii]
of the patent (source: MaxVal’s Assignment
Database). According to the complaint, AbbVie is the exclusive licensee of
the ʼ815 patent.
The parties moved for a joint
stipulation of dismissal in which they stated that no parties admit liability,
each party will bear its own costs, attorney fees, and expenses incurred and plaintiffs’
claims against defendants shall be dismissed without prejudice. Upon
consideration, the Court granted the motion, thereby ending the case.
See 1:13-cv-01557 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.
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