Tuesday, January 29, 2013

Abbvie Sues Indian Generic Drugmaker Sun Pharmaceutical for Infringing Zemplar® Patent

Plaintiff: Abbvie, Wisconsin Alumni Research Foundation (WARF)

Defendant: Sun Pharmaceuticals

Case Number: 1:13-cv-00138

Date Filed: January 24, 2013

Court: Delaware District Court

Patent-in-Suit: US5597815

The patent US5597815 involved in this suit is currently assigned[*] to The National Institute of Health (source: Maxval’s Assignment Database). The patent entitled Prevention of hyperphosphatemia in kidney disorder patients was issued on January 28, 1997 and expires[†] on July 13, 2015. The ‘815 patent is assigned to WARF (per complaint and the face page). 

The Parties:
Abbvie is a research-based biopharmaceutical company which is engaged in the discovery, development, manufacture and sale of a broad line of proprietary pharmaceutical products. Its products are used to treat rheumatoid arthritis, psoriasis, Crohn's disease, HIV, cystic fibrosis complications, low testosterone, thyroid disease, Parkinson's disease, and complications associated with chronic kidney disease, among other indications.

WARF is a university intellectual property organization that patents the discoveries of the University of Wisconsin-Madison scientific community. The company also distributes the income from commercial licenses to the University of Wisconsin-Madison Graduate School, the inventors, and their departments. 

Sun Pharma is a specialty pharma company manufacturing and marketing pharmaceutical formulations as branded generics, as well as generics in India, US and several other markets across the world.

As in complaint:
Defendant with the Abbreviated New Drug Application (ANDA) No. 20-4564 seeks approval of  FDA to market a generic version of AbbVie’s Zemplar® paricalcitol capsules in 1 mcg, 2 mcg, and 4 mcg formulations, which is covered by the patent-in-suit. 

Plaintiff is the current holder[‡] of the New Drug Application (NDA) no. 021606 for Zemplar, (source: Patent Marker) (see Fig. 1) with active ingredient as paricalcitol that is approved by FDA on May 26, 2005. Zemplar is used to treat secondary hyperparathyroidism (overactivity of the parathyroid gland) in people with chronic kidney failure. It works by blocking the formation and release of parathyroid hormone.

Other Cases Filed:
Abbvie has filed cases against the following companies:
Case Number
Date Filed
Watson Pharmaceuticals
Banner Pharmacaps
Amneal Pharmaceuticals
Table information sourced from Maxval’s Litigation Database

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[*] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[†] 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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