Plaintiffs Avion Pharmaceuticals, LLC and Albion Laboratories, Inc. filed suit against defendants Lupin Limited and Lupin Pharmaceuticals, Inc. on Thursday in the District of Delaware. The complaint alleges that the defendants engaged in patent infringement when they filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) seeking to produce and market a generic version of the drug Balcoltra.
Balcoltra, the complaint says, is a drug developed, manufactured, and sold by plaintiff Avion. Avion holds an FDA-approved application for the drug, described in the complaint as a “birth control pill used by women to prevent pregnancy.”
In 2010, the patent-in-suit, was issued to Albion and exclusively licensed to Avion, according to the complaint. The complaint asserts that the defendants were aware of the drug’s publication in the FDA Orange Book.
The defendants filed their ANDA seeking approval to produce and market a generic version of the plaintiff’s drug prior to the expiration of the patent-in-suit. Though the FDA has not yet approved the defendant’s ANDA, the plaintiffs believe that the defendants will “engage in the commercial manufacture, use, import, offer for sale, and sale of Defendant’s Proposed ANDA Product promptly upon receiving FDA approval to do so.”
They further claim that the defendant’s ANDA represents that their product will have the same active ingredient as their drug, the same route of administration, the same dosage form, the same use, and other similarities.
Following their filing of the ANDA, the defendants also filed a certification in which they alleged that the claims of the patent-in-suit are invalid/unenforceable or will not be infringed upon by the defendant’s product. The plaintiffs maintain that the production of the defendant’s generic BALCOLTRA would infringe upon the patent-in-suit.
The complaint cites one count of patent infringement. The plaintiffs are seeking declaratory judgment on this count, a finding that the patent-in-suit is valid and enforceable, an injunction preventing the defendants from further infringement, an award of damages if the defendants do go forward with their generic product, litigation fees, and any other relief deemed proper by the court.
The plaintiffs are represented by Stamoulis & Weinblatt LLC and Perkins Coie LLP.
