Tuesday, March 25, 2014

Hikma Pharmaceutical, AbbVie Resolve Suit over Zemplar® Patent

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

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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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