Indianapolis, Indiana - An Indiana patent attorney sued in the Southern District of Indiana on behalf of Eli Lilly and Company of Indianapolis, Indiana; Daiichi Sankyo Co., Ltd. of Tokyo, Japan ("Daiichi Sankyo"); Daiichi Sankyo, Inc. of Parsippany, New Jersey ("DSI"); and Ube Industries, Ltd. of Yamaguchi, Japan alleging that Par Pharmaceutical Companies, Inc. ("Par Pharmaceutical Companies") and Par Pharmaceutical, Inc. ("Par"), both of Woodcliff Lake, New Jersey, (collectively "Par Pharmaceutical") infringed Medicinal Compositions Containing Aspirin, Patent No. 8,404,703 (the "'703 patent") and Method of Treatment and Coadministration of Aspirin and Prasugrel, Patent No. 8,569,325 (the "'325 patent"), which have been issued by the U.S. Patent Office.
This is a civil action for patent infringement. It arises out of the filing by Defendant Par of an Abbreviated New Drug Application ("ANDA") with the United States Food and Drug Administration ("FDA") seeking approval to manufacture and sell generic versions of two of Lilly's pharmaceutical products, Effient® 5mg and Effient® 10mg tablets, prior to the expiration of Daiichi Sankyo's and Ube's U.S. patents, which purportedly cover methods of using Effient® products. Lilly asserts that it holds an exclusive license to these products. DSI currently co-promotes Effient® products in the United States with Lilly.
Effient® products were approved by the FDA for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI, or angioplasty). The instructions accompanying Effient® products state that patients taking Effient® products should also take aspirin. The use of Effient® products in combination with aspirin for the reduction of thrombotic cardiovascular events in patients with ACS who are to be managed with PCI is covered by the claims of the '703 and '325 patents.
Par has submitted an Abbreviated New Drug Application (the "Par ANDA") to the FDA pursuant to 21 U.S.C. § 355(j), seeking approval to market a generic version of Lilly's product for oral administration (the "Par Products") in the United States.
Plaintiffs assert that Par will knowingly include with the Par Products instructions for use that substantially copy the instructions for Effient® products, including instructions for administering the Par Products with aspirin as claimed in the '703 and '325 patents. Moreover, Plaintiffs contend that Par knows that the instructions that will accompany the Par Products will induce and/or contribute to others using the Par Products in the manner set forth in the instructions. Plaintiffs also contend that Par specifically intends that health care providers, and/or patients will use the Par Products in accordance with the instructions provided by Par to directly infringe one or more claims of the '703 and '325 patents. Par therefore will actively induce and/or contribute to infringement of the '703 and '325 patents, state Plaintiffs.
In the complaint, the Indiana patent lawyer for Plaintiffs listed the following counts:
• Count I: Infringement of U.S. Patent No. 8,404,703
• Count II: Declaratory Judgment of Infringement of U.S. Patent No. 8,404,703
• Count III: Infringement of U.S. Patent No. 8,569,325
• Count IV: Declaratory Judgment of Infringement of U.S. Patent No. 8,569,325
Plaintiffs ask the court for judgment:
A. That Defendants, either individually or collectively, have infringed or will infringe, after the Par ANDA is approved, one or more claims of the '703 patent;
B. That Defendants, either individually or collectively, have infringed or will infringe, after the Par ANDA is approved, one or more claims of the '325 patent;
C. That, pursuant to 35 U.S.C. § 271(e)(4)(B), Par and Par Pharmaceutical Companies be permanently enjoined from making, using, selling or offering to sell either or both of the Par Products within the United States, or importing either or both of the Par Products into the United States prior to the expiration of the '703 and '325 patents;
D. That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of the Par ANDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the latest of the expiration dates of the '703 and '325 patents, including any extensions;
E. A judgment declaring that the '703 patent remains valid and enforceable;
F. A judgment declaring that the '325 patent remains valid and enforceable;
G. If either Par or Par Pharmaceutical Companies commercially makes, uses, sells or offers to sell either or both of the Par Products within the United States, or imports either or both of the Par Products into the United States, prior to the expiration of either of the '703 and '325 patents, including any extensions, that Plaintiffs will be awarded monetary damages for those infringing acts to the fullest extent allowed by law and be awarded prejudgment interest based on those monetary damages;
H. That this case be deemed exceptional under 35 U.S.C. § 285; and
I. That Plaintiffs be awarded reasonable attorney's fees, costs and expenses.
Practice Tip: Lilly is not an infrequent litigant. This may be in part due to the fact that the company is facing a significant patent cliff. Its patent for a former top product, the antipsychotic Zyprexa - which once generated $5 billion in annual revenues - expired in 2011. Its top-selling drug of 2013, the antidepressant Cymbalta, lost patent protection last year. The patent on blockbuster Evista, a drug for breast cancer and osteoporosis, will expire this March.