Indianapolis, Ind. -- Patent lawyers for Eli Lilly & Co. of Indianapolis, Ind. ("Lilly"), Eli Lilly Export S.A., of Vernier/Geneva, Switzerland (a wholly owned subsidiary of Eli Lilly & Co.) and Acrux DDS Pty Ltd. of West Melbourne, Victoria, Australia ("Acrux") filed a patent infringement suit alleging that Perrigo Company of Allegan, Mich. ("Perrigo Company") and Perrigo Israel Pharmaceuticals Ltd. of Bnei Brak, Israel ("Perrigo Israel," a wholly owned subsidiary of Perrigo Company), infringed Patent Nos. 8,435,9448,419,307; and 8,177,449, filed with the U.S. Patent Office.
Lilly is engaged in the business of research, development, manufacture and sale of pharmaceutical products. Acrux is engaged in the development and commercialization of pharmaceutical products for sale. Both sell their products worldwide.
Perrigo Company and Perrigo Israel (collectively, "Perrigo") are pharmaceutical companies that develop, manufacture, market and distribute generic pharmaceutical products for sale throughout the United States. These products include pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients. Perrigo's consumer-healthcare segment includes over 2,100 store-brand products which are marketed to major national chains such as Wal-Mart, CVS, Walgreens, Sam's Club and Costco. They also sell to major drug wholesalers.
Lilly is the holder of approved New Drug Application No. 022504 for the manufacture and sale of a transdermal testosterone solution made at a concentration of 30 mg/1.5L, which is marketed by Lilly under the trade name "Axiron." Axiron is a pharmaceutical drug which raises the amount of testosterone in a patient's body. Recent sales of Axiron are estimated to be $229 million annually, according to Symphony Health Solutions. Axiron is subject to Patent Nos. 8,435,944, 8,419,307, 8,177,449 (the "'944 patent," the "'307 patent," and the "'449" patent, respectively). All three patents have been licensed to Lilly.
Perrigo announced on May 29, 2013 that it had filed an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration ("FDA") for approval of a generic version of Axiron. Prior to filing the ANDA, No. 204255, Perrigo sent a letter to Lilly to inform Lilly that "in Perrigo's opinion and to the best of its knowledge, the '449 patent is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, sale, or importation of the drug product described in Perrigo's ANDA." Perrigo sent similar letters regarding the '307 and '944 patents.
After receiving the letter, Lilly filed suit alleging infringement of the three patents. It states in its complaint that the '944 patent claims, inter alia, methods of increasing the testosterone blood level of an adult male by applying a transdermal drug-delivery composition that contains testosterone. The '307 patent includes in its claims a method of increasing the level of testosterone in the blood by applying a liquid pharmaceutical that contains testosterone. The claims for the '449 patent include a method of transdermal administration of a physiologically active agent. All three patents are used in connection with Axiron.
Lilly's complaint lists the following claims:
· Count I for Patent Infringement (Direct Infringement of U.S. Patent No. 8,435,944)
· Count II for Patent Infringement (Inducement to Infringe U.S. Patent No. 8,435,944)
· Count III for Patent Infringement (Contributory Infringement of U.S. Patent No. 8,435,944)
· Count IV for Patent Infringement (Direct Infringement of U.S. Patent No. 8,419,307)
· Count V for Patent Infringement (Inducement to Infringe U.S. Patent No. 8,419,307)
· Count VI for Patent Infringement (Contributory Infringement of U.S. Patent No. 8,419,307)
· Count VII for Patent Infringement (Direct Infringement of U.S. Patent No. 8,177,449)
· Count VIII for Patent Infringement (Inducement to Infringe U.S. Patent No. 8,177,449)
· Count IX for Patent Infringement (Contributory Infringement of U.S. Patent No. 8,177,449)
· Count X for Declaratory Judgment (Infringement of U.S. Patent No. 8,435,944)
· Count XI for Declaratory Judgment (Infringement of U.S. Patent No. 8,419,307)
· Count XII for Declaratory Judgment (Infringement of U.S. Patent No. 8,177,449)
Lilly's lawsuit asks for an injunction to stop Perrigo from producing the generic version of Axiron until the expiration of Lilly's three patents-in-suit. In addition, Lilly asks that the court declare the three patents to be valid and enforceable; that Perrigo infringed upon all three by, inter alia, submitting ANDA No. 204255 to obtain approval to commercially manufacture, use, offer for sale, sell or import its generic version of the drug into the United States; that Perrigo's threatened acts constitute infringement of the three patents; that FDA approval of Perrigo's generic drug be effective no sooner than the expiration date of the patent that expires last; that this is an exceptional case; and for costs and attorneys' fees.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.