Mylan Wins Court Block on Aurobindo’s Dye for Cancer Test

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By Dana A. Elfin

Drugmaker Mylan won a court ruling that will soon force Aurobindo Pharma Ltd. to pull a competing diagnostic imaging agent from the market ( Mylan Institutional LLC v. Aurobindo Pharma Ltd. , 2017 BL 36726, E.D. Tex., No. 2:16-CV-00491-RWS-RSP, 2/7/17 ).

Judge Robert W. Schroeder III of the U.S. District Court for the Eastern District of Texas said Feb. 7 Aurobindo’s sales of isosulfan blue, a diagnostic imaging agent to locate cancer, infringed patents covering Mylan’s own isosulfan blue product. Schroeder blocked Aurobindo from continuing to sell its competing product.

It’s a big win for Mylan because it leaves Mylan as the lone player in the isosulfan blue market. The total market for isosulfan blue is around $50 million to $57 million in annual sales, and its isosulfan blue is a $35 million product for Mylan, according to Bloomberg Intelligence analyst Elizabeth Krutoholow.

Before the ruling, 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, she said.

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 Date to 2010

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 U.S. Patent Nos. 7,662,992 and 8,969,616.

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 has been pricing its product at $700 per vial versus Mylan’s $750 per vial, Krutoholow told Bloomberg BNA Feb. 9.

Court Says Aurobindo Infringed

The judge ruled Aurobindo’s version of isosulfan blue infringed the two patents.

Granting the injunction in Mylan’s favor, the judge agreed there was irreparable harm.

Evidence in the case contained “hallmark examples of irreparable harm,” Schroeder wrote. These included “lost sales, lost research and development opportunities, price erosion, and the fact that Apicore must now directly compete with an infringer.”

Schroeder enjoined Aurobindo from manufacturing, selling or offering for sale, using, or importing the accused isosulfan blue product within the U.S., once Mylan and Apicore submit an adequate injunction bond.

He referred the case to Magistrate Judge Roy S. Payne of the U.S. District Court for the Eastern District of Texas for further proceedings.

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

Wilson Sonsini Goodrich & Rosati PC in San Francisco, Palo Alto, Calif., and Austin, Texas, and Gillam & Smith, LLP, Marshall, Texas, represented Rockford, Ill.-based Mylan Institutional LLC, a subsidiary of Mylan NV.

Sharma & DeYoung LLP, New York, and Gillam & Smith, LLP, Marshall, Texas, represented Somerset, N.J.-based Apicore US LLC.

Schiff Hardin LLP in Chicago and San Francisco and Potter Minton, PC in Tyler, Texas, 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 ruling is at

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