Indianapolis, Indiana — Alcon Research, Ltd. of Fort Worth, Texas, and Alcon Pharmaceuticals Ltd. of Fribourg, Switzerland (collectively, “Alcon”) have filed a patent infringement lawsuit in the Southern District of Indiana alleging that Wockhardt Limited of Mumbai, Maharashta, India; Wockhardt Bio AG of Zug, Switzerland; Wockhardt Bio Ltd. of Zug, Switzerland; and Wockhardt USA, LLC of Parsippany, New Jersey (collectively, “Wockhardt”) infringed Patent Nos. 6,995,186 (the “‘186 patent”) and 7,402,609 (the “‘609 patent”), both for Olopatadine Formulations For Topical Administration, which have been issued by the U.S. Patent Office.
According to the complaint, the Wockhardt entities are engaged in the generic-pharmaceutical business. Alcon asserts that one or more of the entities manufacture, import, market, offer to sell and/or sell generic drugs throughout the United States.
Wockhardt filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version of Pataday™ ophthalmic solution, a drug product containing olopatadine hydrochloride. The two patents-in-suit, which Alcon claims to own, are asserted to cover Pataday™. Alcon contends that Wockhardt’s submission of this ANDA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale and/or importation of Wockhardt’s ANDA product before the expiration of the patents-in-suit is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
Plaintiff Alcon states that it believes that the Wockhardt entities are part of a vertically integrated and unified organization and that they will act in concert to introduce the generic version of Pataday™ to the United States market prior to the expiration of Alcon’s patents.
In the complaint, intellectual property attorneys for Alcon list the following claims:
· Count I: Infringement of the ‘186 Patent
· Count II: Infringement of the ‘609 Patent
· Count III: Declaratory Judgment of Infringement of the ‘186 Patent
· Count IV: Declaratory Judgment of Infringement of the ‘609 Patent
Alcon asks for a judgment that the ‘186 and ‘609 patents are valid and enforceable and have been infringed; a judgment providing that the effective date of any FDA approval of commercial manufacture, use or sale of Wockhardt’s ANDA product be not earlier than the latest of the expiration date of the patents-in-suit, inclusive of any extension(s) and additional periods of exclusivity; preliminary and permanent injunctions protecting products covered by the ‘186 patent prior to its expiration; preliminary and permanent injunctions protecting products covered by the ‘609 patent prior to its expiration; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Wockhardt’s ANDA product, or any other drug product covered by the ‘186 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a judgment declaring that the commercial manufacture, use, sale, offer for sale or importation of Wockhardt’s ANDA product, or any other drug product covered by the ‘609 patent, will infringe, induce the infringement of, and contribute to the infringement by others of, that patent; a declaration that this is an exceptional case and an award of attorneys’ fees; and costs and expenses.
Practice Tip: The FDA’s ANDA process for generic drugs has been abbreviated such that, in general, the generic drug seeking approval does not require pre-clinical (animal and in vitro) testing. Instead, the process focuses on establishing that the product is bioequivalent to the “innovator” drug that has already undergone the full approval process. The statute that created the abbreviated process, however, had also created some interesting issues with respect to the period of exclusivity. For an interesting look at some of these issues, see here.
This complaint was filed by Donald E. Knebel, Todd G. Vare and Deborah Pollack-Milgate of Barnes & Thornburg LLP. The case was assigned to District Judge Sarah Evans Barker, Southern District of Indiana, and assigned Case No. 1:13-cv-01452-SEB-TAB.