Type 2 Diabetes Case Summary

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• Takeda Chemical Industries, Ltd. & Takeda Pharmaceuticals North America, Inc. (collectively “Takeda”) manufacture the Type 2 diabetes drug pioglitazone, sold in the US under the trade name ACTOS® & the subject of Takeda’s ’777 patent.
• ACTOS® is a member of a group of drugs known as thiazolidinediones (“TZD”)
• Alphapharm filed ANDAs pursuant to the Hatch-Waxman Act seeking FDA approval to manufacture and sell generic versions of pioglitazone.
• Alphapharm filed pursuant that the relevant claims of Takeda’s ’777 patent were invalid.
• Takeda sued Alphapharm, alleging that Alphapharm had infringed claims 1, 2, and 5 of the ’777 patent.

Background & Facts
Diabetes is a disease, characterized by the body's inability to regulate blood sugar. It is caused by …show more content…
Takeda Chemical Industries, Ltd., and Takeda Pharmaceuticals North America, Inc. (collectively “Takeda”) first invented certain TZDs in the 1970s. Takeda's research revealed that TZDs acted as insulin sensitizers, i.e., compounds that ameliorate insulin resistance. Although the function of TZDs was not completely understood, TZDs appeared to lower blood glucose levels by binding to a molecule in the nucleus of the cell known as PPARgamma, which activates insulin receptors and stimulates the production of glucose transporters. Takeda, 417 F.Supp.2d at 348-49. The transporters then travel to the cellular surface and enable glucose to enter the cell from the bloodstream.
Takeda developed the drug ACTOS®, which is used to control blood sugar in patients who suffer from Type 2 diabetes. ACTOS® has enjoyed substantial commercial success since its launch in 1999. By 2003, it held 47% of the TZD market, and gross sales for that year exceeded $1.7 billion. Id. at 386. The active ingredient in ACTOS® is the TZD compound pioglitazone, a compound claimed in the patent in

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