Mylan vs Astrazeneca: IPR2015-01340

Mylan filed an IPR against US RE44,186 which is a reissue of US 6,395,767. US ‘767 originally issued to Bristol-Myers Squibb Company. US ‘186 claims Saxagliptin and listed in Orange Book.


Before filing an IPR mylan was sued by Astrazeneca for the patent infringement of U.S. Patent Nos. 7,951,400, RE44,186 and 8,628,799. The cause of action was triggered when Mylan filed two Abbreviated New Drug Applications (“ANDA”) Nos. 205980 and 205981 with the U.S. Food and Drug Administration (“FDA”) for approval to market Saxaglitptin HCl tablets-generic versions of AstraZeneca’s ONGLYZA ® drug product-and Saxaglitptin HCl and Metformin HCl extended-release tablets-generic versions of AstraZeneca’s KOMBIGLYZE™ XR drug product-prior to expiration of the ‘400 Patent, the ‘186 Patent, and the ‘799 Patent.

Mylan filed a motion (Civil Action No. 14-696-GMS) to dismiss the above suit for lack of personal jurisdiction pursuant to Federal Rule of Civil Procedure 12(b)(2). Further, on Nov 05, 2014 the court denied Mylan’s motion to dismiss for lack of personal jurisdiction.


Saxagliptin is a dipeptidyl peptidase-4 inhibitor. Saxagliptin is developed by Bristol-Myers Squibb (BMS-477118), in 2007 AstraZeneca joined with Bristol-Myers Squibb to co-develop the final compound and collaborate on the marketing of the drug. Saxagliptin was approved by FDA on Jul 31, 2009, which is marketed under the brand name ONGLYZA. Further, Astrazeneca also received FDA approval to Metformin HCl; Saxagliptin HCl which is marketed under the brand name KOMBIGLYZE XR. Currently there are two patents (US ‘400 and US ‘186) listed in OB for Saxagliptin.


Mylan brought this challenge against US RE44,186 (reissue of  US ‘767) on the grounds of obviousness over the disclosures of Bio-organic & Medicinal Chemistry Letters, Vol. 6, No. 10, pp. 1163-1166, 1996, WO 1998/19998, Biochemistry 1991, 30, 2674-2684 and Angew. Chem. Int. Ed. Engl. 1997. 36,,No. 17.

US ‘186 claims Saxagliptin as a product, and it is set to expire on July 31, 2023.

It can be understand that Mylan is just applying a generic company strategy by challenging the patents by both para iv certifications and Inter Partes Review.


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