JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD. et al

On July 28, 2021, Jazz Pharmaceuticals Ireland Limited (“Jazz Pharmaceuticals” or “Plaintiff”), represented by Charles M. Lizza of Saul E. Arnstein & Lehr LLP, filed an intellectual property lawsuit against Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. (together, “Lupin” or “Defendants”), seeking declaratory and injunctive relief along with damages for allegedly infringing Patents owned by the Plaintiff. This case was filed in U.S. District Court in the District of New Jersey with Judge Jessica S. Allen and Judge Stanley R. Chesler presiding.

In the complaint the Plaintiff alleged that “This is an action for patent infringement under the patent laws of the United States, 35 U.S.C. §100, et seq., arising from Lupin’s submission of Abbreviated New Drug Application (“ANDA”) No. 215911 (“Lupin’s ANDA”) to the United States Food and Drug Administration (“FDA”) seeking approval to manufacture, use, import, distribute, offer to sell, and/or sell a generic version of Jazz Pharmaceuticals’s Xywav® drug products prior to the expiration of United States Patent Nos. 8,591,922 (“the ’922 patent”), 8,772,306 (“the ’306 patent”), 8,901,173 (“the ’173 patent”), 9,050,302 (“the ’302 patent”), 9,132,107 (“the ’107 patent”), 9,486,426 (“the ’426 patent”), 10,195,168 (“the ’168 patent”), 10,213,400 (“the ’400 patent”), 10,675,258 (“the ’258 patent”), and 10,864,181 (“the ’181 patent”) (collectively, “the patents-in-suit”), all owned by Jazz Pharmaceuticals.”

The Plaintiff also alleged that “Jazz Pharmaceuticals holds an approved New Drug Application (“NDA”) under Section 505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for calcium, magnesium, potassium, and sodium oxybates oral solution (NDA No. 212690), which it sells under the trade name Xywav®. The claims of the patents-in-suit cover, inter alia, methods of use and administration of calcium, magnesium, potassium, and sodium oxybates, or pharmaceutical compositions containing calcium, magnesium, potassium, and sodium oxybates.”

Further, the Plaintiff alleged that “Pursuant to Section 505 of the FFDCA, Lupin submitted Lupin’s ANDA seeking approval to engage in the commercial manufacture, use, sale, or offer for sale in, or importation into, the United States of 0.5 g/mL calcium, magnesium, potassium, and sodium oxybates oral solution (“Lupin’s Proposed Product”) before the patents-in-suit expire.”

It has also been alleged that “On information and belief, Lupin Ltd. intends to benefit directly if Lupin’s ANDA is approved by participating in the manufacture, importation, distribution, and/or sale of the generic drug products that are the subject of Lupin’s ANDA.”

There are ten claims for relief laid down by the Plaintiff, one for the alleged infringement of each of the patents-in-suit.

In its prayer the Plaintiff has requested the Court to pass an order that Defendant has infringed the patents-in-suit and that FDA approval of ANDA No. 215911 be a date which is not earlier than the later of the expiration of the patents-in-suit, or any later expiration of exclusivity to which Jazz Pharmaceuticals is or becomes entitled. The Plaintiff also requested the Court to pass an order for an injunctive relief pursuant to 35 U.S.C. § 271(e)(4)(B) along with damages, costs, attorney fees and such other relief as the court may deem fit.

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