The U.S. District Court for the District of New Jersey has issued a summary judgment ruling that GlaxoSmithKline’s U.S. Patent Nos. 5,578,628 (the ‘628 patent) and 4,753,789 (the ‘789 patent) for Zofran ODT(R) (ondansetron) Orally Disintegrating Tablets are valid, enforceable and infringed by Kali Laboratories, Inc., a wholly-owned subsidiary of Par Pharmaceutical Companies, Inc. There are “method of use” patents covering the way that the active ingredient in Zofran works. These are often difficult to protect.
Zofran ODT(R) is used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual U.S. sales of Zofran ODT(R) are approximately $225 million.
Kali filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) in September 2002 seeking marketing clearance for its generic version of Zofran ODT(R). In October 2002, Kali’s ANDA was accepted for filing by the FDA. GlaxoSmithKline did not file suit against Kali on U.S. Patent Nos. 5,955,488 and 6,063,802, which expire in May 2016. The ‘628 method of use patent expires August 16, 2005 and the ‘789 method of use patent expires December 24, 2006, following expiration of pediatric exclusivity.
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