Indiana Patent Litigation: Lilly Sues Generic Drugmaker for Third Time Regarding ALIMTA

Indianapolis, Indiana – Patent attorneys for Plaintiff Eli Lilly and Company filed a lawsuit in the Southern District of Indiana alleging infringement.  Defendant is Fresenius Kabi USA, LLC of Lake Zurich, Illinois.

Lilly, an Indianapolis-based company, is a developer and seller of pharmaceutical drugs.  One of its drugs, ALIMTA®, is marketed as a chemotherapy agent used for the treatment of various types of cancer.

Fresenius, formerly known as APP Pharmaceuticals, LLC, manufactures and sells generic drugs.  Earlier this year, Fresenius amended its Abbreviated New Drug Application (“ANDA”), which was previously filed to seek U.S. Food and Drug Administration (“FDA”) approval to manufacture three different concentrations of ALIMTA.  Through its recent amendment, Fresenius now asks for approval to manufacture and sell a fourth generic version of ALIMTA.  Lilly filed this litigation in response.

This complaint follows two prior lawsuits filed against Fresenius in the same jurisdiction, the first in 2010 and another in 2015, regarding the same ANDA.  Earlier litigation pertained to Fresenius’ ANDA seeking approval for three concentrations of the drug: 100 mg Base/Vial, 500 mg Base/Vial and 1000 mg Base/Vial products.  At issue in the current lawsuit, which relates to the recent amendment to the ANDA, is Fresenius’ request for FDA approval for a 750 mg Base/Vial product.

As in its prior complaints, patent lawyers for Lilly assert infringement of U.S. Patent No. 7,772,209.  Plaintiff seeks judgment in its favor, including injunctive relief and attorneys’ fees.

The case was assigned to District Judge Tanya Walton Pratt and Magistrate Judge Tim A. Baker in the Southern District and assigned Case No. 1:16-cv-02960-TWP-TAB.


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