The Medicines Co. v. Mylan Inc.

Case Name:  The Medicines Co. v. Mylan, Inc., No. 2015-1113, -1151, -1181 (Fed. Cir. Apr. 6, 2017) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Dyk, J.) (appeal from N.D. Ill., St. Eve, J.)

Drug Product and Patent(s)-in-Suit: Angiomax® (bivalirudin); U.S. Patents Nos. 7,582,727 (“the ’727 patent”) and 7,598,343 (“the ‘’343 patent”)

Nature of the Case and Issue(s) Presented:  Between 2001 and 2005, The Medicines Co. (“TMC”) and its contract manufacturer, Ben Venue Laboratories (“BVL”), produced and sold numerous batches of compounded bivalirudin having Asp9 levels of less than 1.5 percent. In 2005 and 2006, however, TMC produced two batches of Angiomax with Asp9 levels above the 1.5 percent limit specified by the FDA. After failing to solve the problem of inconsistent batches internally, TMC identified the compounding process used by BVL as the source of the problem, and developed an improved, “efficient mixing” process for mixing the pH-adjusting solution with the bivalirudin solution that minimized the formation of impurities. This improved “efficient mixing” process resulted in batches that consistently satisfied the FDA’s 1.5 percent limit on the level of Asp9-bivalirudin. This batch consistency of bivalirudin drug products compounded using “efficient mixing” is the invention disclosed and claimed by the patents in suit.

TMC is the owner of the patents-in-suit and alleged that Mylan’s ANDA infringed its patents. 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 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 Federal Circuit, affirming-in-part and reversing-in-part, held 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.

Why Mylan Prevailed: During the underlying litigation, the parties disputed the meaning of two claim terms: “pharmaceutical batches” and “efficiently mixing.” The district court construed the first term consistent with the definition set forth in the patents’ specification to refer to either: (i) “a single batch, wherein the single batch is representative of all commercial batches … made by a compounding process, and wherein the levels of, for example, Asp9 bivalirudin, total impurities, and largest unknown impurity, and the reconstitution time represent levels for all potential batches made by said process;” or (ii) “all batches prepared by a same compounding process.” Relying on Mylan’s proposed construction, the district court construed the second term to require “not using inefficient mixing conditions such as described in Example 4.”

Mylan argued on appeal that the district court erred by declining to interpret the claims of the ’727 patent to require “efficient mixing” as part of the batches limitation, and the Federal Circuit agreed. The batches limitation requires the use of a process that achieves batch consistency. This requirement follows from simply reading the batches limitation against the specification’s definition of the term “batches,” as slightly revised by the district court with the agreement of the parties to clarify that the “batches” must be made by a particular compounding process. The batches limitation therefore requires a process that achieves consistency between batches. On the other hand, adopting TMC’s interpretation of the batches limitation would necessitate forward-looking assessments of whether an accused infringer’s production of future or “potential” batches would be likely to generate Asp9 levels greater than “about 0.6%.” TMC’s interpretation also failed to consider the intrinsic record, which demonstrated that the invention was a compounding process that achieved batch consistency. Finally, TMC admitted to the district court that “when viewed in the context of the specification, it is readily apparent that the [definition of ‘pharmaceutical batches’] refers to the compounding processes described in the patents-in-suit.”

Next, the Federal Circuit found that the compounding process must use efficient mixing in view of the intrinsic record. TMC, however, argued that reading the batches limitation to require “efficient mixing” would render the asserted claims of the ’343 patent—which already recite an “efficiently mixing” step—superfluous, and that the batches limitation extended to compounding processes that did not use efficient mixing. The Federal Circuit disagreed. The recitation of other product-by-process limitations in the claims of the ’343 patent meant that the claims of the patents in suit would merely overlap, and “overlapping patent claims are not unusual.” Now even though TMC’s proposed construction for “efficient mixing” was taken directly out of the specification, the Federal Circuit rejected that definition because it does not accord with the linguistic formula used by the patentee to signal the designation of other defined terms. More importantly, the Federal Circuit reasoned that TMC’s construction was problematic because it amounted to a mere recitation of the results obtained from “efficient mixing” rather than a definition of what the efficient mixing process was. The other portions of the specification were also not helpful in construing that term. Apart from the detailed description, two embodiments disclosed by the specification, Examples 4 and 5, clearly stated what efficient mixing was and was not. The court thus relied on Example 5 in particular to ascertain the metes and bounds of “efficiently mixing.”

The net effect of the Federal Circuit’s claim construction was that to infringe either of the patents-in-suit, infringing batches needed to be compounded using a process that employed the efficient mixing conditions of Example 5. Example 5 required multiple mixers and added the pH-adjusting solution at a continuous rate using a peristaltic pump. This was not part of Mylan’s ANDA, and it therefore could not infringe the asserted claims of the patents-in-suit.