Bivalirudin - USA

On Apr 06, 2017, The Federal Circuit ruled that Mylan Inc.’s planned generic version of the blood-thinner Angiomax does not infringe two patents owned by The Medicines Co., partly reversing a lower court’s decision.

The Medicines Company (“Medicines”) is the owner of U.S. Patent Nos. 7,582,727 (“the ’727 patent”) and 7,598,343 (“the ’343 patent”). In response to an Abbreviated New Drug Application (“ANDA”) submitted by Mylan, Inc. (“Mylan”), Medicines filed suit in the United States District Court for the Northern District of Illinois alleging that Mylan’s ANDA infringed claims 1–3, 7–10, and 17 of the ’727 patent, and claims 1–3 and 7–11 of the ’343 patent. Mylan counterclaimed seeking a declaration that the asserted claims were invalid. The district court held on summary judgment that the asserted claims of the ’343 patent were not infringed because Mylan did not satisfy the “efficient mixing” limitation of those claims. After conducting a bench trial, the court held that the asserted claims of the ’727 patent were infringed because those claims did not include an “efficient mixing” limitation.

The injectable product is made by dissolving bivalirudin into a solution, adjusting the pH with a solvent, and then by removing the solvent. The infringement issue revolved around how the bivalirudin was mixed. First, the Court of Appeals concluded that the Illinois District Court should have construed the claims of both patents to be the same – requiring “efficient mixing” to achieve the end product.

We hold that both the ’727 and ’343 patents include a “batches” limitation that requires batch consistency, which, according to the patents in suit, is achieved through efficient mixing. Efficient mixing is therefore required by the asserted claims of both patents. We further construe efficient mixing as defined by Example 5 of the patents’ specification. We therefore reverse the district court’s judgment of infringement with respect to the ’727 patent, and affirm its summary judgment of non-infringement with respect to the ’343 patent. We do not address the validity of the patents in suit.