German drug maker files patent lawsuit against Mylan

By Jessica Karmasek | Sep 4, 2015

WHEELING – A German pharmaceutical company has filed a patent infringement lawsuit against Morgantown-based Mylan Pharmaceuticals. Plaintiff Boehringer Ingelheim Pharmaceuticals Inc. contends that defendant Mylan submitted Abbreviated New Drug Applications, or ANDAs, to the Food and Drug Administration seeking the approval to make and sell generic versions of Boehringer’s Tradjenta and Jentadueto tablets. An ANDA is an application for a U.S.


WHEELING – A German pharmaceutical company has filed a patent infringement lawsuit against Morgantown-based Mylan Pharmaceuticals.

Plaintiff Boehringer Ingelheim Pharmaceuticals Inc. contends that defendant Mylan submitted Abbreviated New Drug Applications, or ANDAs, to the Food and Drug Administration seeking the approval to make and sell generic versions of Boehringer’s Tradjenta and Jentadueto tablets.

An ANDA is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

According to BIPI’s Aug. 25 complaint, filed in the U.S. District Court for the Northern District of West Virginia, Mylan sought ANDAs for the two drugs -- which are used in treating type 2 diabetes -- prior to the expiration of BIPI’s U.S. Patent Nos. 8,673,927; 8,846,695; and 8,853,156.

The ‘927 patent was issued by the U.S. Patent and Trademark Office March 18, 2014. The ‘695 patent was issued Sept. 30, 2014. The ‘156 patent was issued Oct. 7, 2014.

BIPI also is the holder of New Drug Applications, or NDAs, for both Tradjenta and Jentadueto.

According to BIPI’s complaint, both drugs are listed in the FDA’s so-called “Orange Book” as having chemical exclusivity until May 2, 2016.

The publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food Drug and Cosmetic Act.

BIPI asked the court to enter a judgment that Mylan infringed at least one claim of its three patents by submitting its ANDAs.

The drug maker also requested attorneys’ fees, costs, expenses and monetary relief if Mylan uses and sells their proposed generic versions.

Wheeling law firm Schrader Byrd & Companion PLLC is representing BIPI.

Judge John Preston Bailey has been assigned the case.

U.S. District Court for the Northern District of West Virginia case number 1:15-cv-145

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Organizations in this Story

Mylan Inc. Mylan Inc. Mylan N.V Schrader, Byrd & Companion, PLLC

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