Mylan, Aurobindo End Litigation Over Imaging Agent

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By Dana A. Elfin

Mylan Institutional LLC and Aurobindo Pharma Ltd. settled patent infringement litigation over Aurobindo’s diagnostic imaging agent used to detect cancer ( Mylan Institutional LLC v. Aurobindo Pharma Ltd. , E.D. Tex., No. 2:16-CV-00491-RWS-RSP, stipulation and order of dismissal 8/1/17 ).

At the request of the parties, U.S. Magistrate Judge Roy S. Payne of the U.S. District Court for the Eastern District of Texas dismissed the case Aug. 1. In May, the U.S. Court of Appeals for the Federal Circuit upheld the district court’s preliminary injunction barring Aurobindo from continuing to sell its competing isosulfan blue product, a dye used to map lymph nodes, finding the product infringed patents licensed to Mylan and undercut Mylan’s sales of its own isosulfan blue product.

The settlement details are confidential, so it’s unclear whether the deal they struck will enable Aurobindo to reenter the market at some point before the patents expire. For now, Mylan remains the sole seller of isosulfan blue products.

Isosulfan Blue Market

Annual sales for isosulfan blue are between $50 million and $57 million, and isosulfan blue is a $35 million product for Mylan, according to Bloomberg Intelligence analyst Elizabeth Krutoholow.

Before the appeals court barred Aurobindo from selling its product, Mylan and Aurobindo were essentially the only major competitors in the U.S. isosulfan blue market, Krutoholow said.

Tyco Healthcare Group LP and Novation LLC had products on the market, but both have fallen off, Krutoholow told Bloomberg BNA.

Patent Challenge Dropped

Apicore US LLC licenses the isosulfan blue patents to Mylan. The patents at issue in the litigation include U.S. Patent Nos. 9,353,050 (the ‘050 patent), 7,662,992 and 8,969,616.

In addition to terminating litigation with Mylan in district court over the patents, Aurobindo subsidiary Auromedics Pharma LLC also agreed to end a challenge to the ‘050 patent it filed before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board in January. The ‘050 patent claims a process for preparing isosulfan blue.

Auromedics, based in East Windsor, N.J., filed a joint motion Aug. 1 with Apicore to terminate the inter partes review (IPR) proceeding ( Auromedics Pharma LLC v. Apicore US LLC, P.T.A.B., No. IPR2017-00762, joint motion to terminate 8/1/17 ).

Cancer Imaging Agent

Isosulfan blue injection is a blue dye used to stain lymph nodes and lymph vessels to test how well a patient’s lymphatic system works and check for serious medical problems, including cancer.

Isosulfan blue 1% is the only commercially available FDA-approved blue dye indicated for sentinel lymph node mapping, according to information on Mylan’s website.

Mylan partnered with Apicore US LLC, a manufacturer of active pharmaceutical ingredients, to commercialize a high purity isosulfan blue product. Apicore owns patents covering the manufacturing process it developed for the product and exclusively licenses the patents to Mylan.

Mylan Sales

Mylan has been selling its isosulfan blue product since 2010.

The Food and Drug Administration approved Aurobindo’s competing product in February 2016 and Aurobindo started marketing it the following month.

Mylan and Apicore subsequently sued Aurobindo in federal court in Texas for infringing the aforementioned three patents.

Aurobindo was offering its competing isosulfan blue product to Mylan’s customers at a price significantly below Mylan’s contract price with those customers, according to the complaint. Mylan sought an injunction to bar Aurobindo’s product, citing irreparable harm.

Aurobindo had been pricing its product at $700 per vial versus Mylan’s $750 per vial, Krutoholow said.

Bloomberg BNA contacted Mylan and Aurobindo but neither company would comment on the settlement.

Wilson Sonsini Goodrich & Rosati P.C., Austin, Texas, represented Rockford, Ill.-based Mylan Institutional, a subsidiary of Mylan NV, which is based in the United Kingdom with U.S. headquarters in Canonsburg, Pa.

Sharma & DeYoung LLP, New York, represented Somerset, N.J.-based Apicore US, a subsidiary of India-based Apicore Pharmaceuticals Pvt. Ltd.

Schiff Hardin LLP, Chicago, represented India-based Aurobindo.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

The stipulation of dismissal is at

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