Mylan’s Preliminary Injunction Against Aurobindo Affirmed

Mylan Institutional LLC v. Aurobindo Pharma Ltd., (Fed. Cir. May 19, 2017) (Before Lourie, Moore, and Reyna, J.) (Opinion for the court, Lourie, J.)

The Eastern District of Texas granted a preliminary injunction against Aurobindo in favor of Mylan. On appeal, Aurobindo challenged three district court findings: 1) it was likely that Aurobindo infringed; 2) Aurobindo failed to raise a substantial question of validity; and 3) there was irreparable harm to Mylan.  The Federal Circuit found that, while the district court made some errors, it correctly analyzed one of the three Mylan patents, and the preliminary injunction was affirmed.

At issue were three patents concerning isosulfan blue (“ISB”), a dye used to map lymph nodes.  The Court lumped the two “process patents” together, analyzing them separately from the “purity patent.”

The Court found that the district court erred in its analysis of the process patents and the likelihood of success on the merits.  It misapplied the “way” portion of the function-way-result (FWR) test, because it failed to address the prong entirely, or it did not adequately consider Aurobindo’s arguments (that the accused and patented processes had different oxidation strengths, plus the use of an acid in the accused process, which the patents explicitly omitted).  The Court also suggested an “insubstantial differences” analysis, because that “non-mechanical cases may not be well-suited to consideration under the FWR test . . . .”

As to the purity patent, the Court found no error in the district court’s finding of a lack of a substantial question as to validity, which was the only finding challenged.  The district court adequately explained that there was a lack of anticipation because of weak evidence. There was a lack of obviousness because the claims would “not necessarily have been prima facie obvious over the prior art mixture of (less pure) ISB . . . .” Further, the use of “HPLC” was sufficiently definite because HPLC is a common way of designating purity.  Further, the evidence of secondary considerations, including failure of others, weighed in favor of validity.

Finally, the Court stated that the district court did not err in its irreparable harm analysis.  It was not clear error for the court to find that: 1) Mylan would continue to suffer lost sales, etc.; 2) there was a causal nexus because the infringing product would not be on the market “if it had not obtained FDA approval for a product that will likely be found” infringing; and 3) without infringing the patents, the defendant would not be able to make its product.

The district court’s analysis as to the purity patent was upheld in its entirety, and the preliminary injunction was affirmed.

The Court affirmed a preliminary injunction against an accused product, although asserted process patents were not likely infringed, because the product did likely infringe a product patent, the patent was likely valid, and the patentee would suffer irreparable harm from ongoing infringement.

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