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Medicines Co. v. Mylan, Inc.

Broad Definition in Patent Insufficient to Establish Scope; Claim Limited to Description’s Express Teaching

Medicines Co. v. Mylan, Inc., (Fed. Cir. Apr. 6, 2017) (DYK, Wallach, Hughes) (N.D. Ill.: St. Eve) (3 of 5 stars)

Fed Cir reverses bench judgment of infringement as to one Medicines patent and affirms summary judgment of noninfringement as to another. The opinion mostly concerns claim construction. Medicines’ patents relate to techniques for minimizing impurities in batches of bivalirudin (a synthetic peptide used to prevent blood clotting). Representative claims from both patents addressed “pharmaceutical batches” of bivalirudin compounds, and the parties agreed that “pharmaceutical batches” meant a single batch, or multiple batches, made by the same “compounding process.” The claims went on to require that the batches not exceed a maximum impurity level. The issue was whether (and which) of Medicines’ claims required that the “batches” be made using an “efficient mixing” process—i.e., a process that mixed more efficiently than the prior art techniques that the patents described as “old” and “inefficient.”

The district court correctly held that one of Medicines’ patents required “efficient mixing,” but erred in holding that the other did not. The opinion discusses the specification and file history in detail and reasons that all Medicines’ claims required “the use of a process that achieves batch consistency.” Slip op. at 11. From that, it concludes that “batch consistency” required “efficiently mixing.”

In both Medicines’ patents, “efficiently mixing” meant mixing in the manner described by one of the examples in Medicines’ written description. The opinion rejects Medicines’ argument that the term simply meant mixing in such a manner as to minimize the relevant impurity. Though the patent described “efficiently mixing” in such terms, the opinion reasons that such was not definitional “because it does not accord with the linguistic formula used by the patentee to signal the designation of other defined terms[.]” Slip op. at 18. The opinion also cites concerns that Medicines’ definition was essentially functional. “Although functional limitations in patent claims are not per se objectionable even when the means-plus-function format is not invoked, they cannot be ‘so broad that they cause the claim to have a potential scope of protection beyond that which is justified by the specification disclosure.’” Id. at 18–19 (quoting Swinehart, 439 F.2d 210 (C.C.P.A. 1971)). One of ordinary skill would have been guided by the specification to define “efficiently mixing.” “As the only embodiment of efficient mixing, Example 5 is ‘highly indicative of the scope of the claims.’” Slip op. at 23 (quoting Johns Hopkins, 152 F.3d 1342 (Fed. Cir. 1998)).

Applying this construction, Mylan did not infringe as a matter of law because its mixing technique did not comport with the written description’s relevant description of “efficiently mixing.”

ASIDE: This case has been pending since 2014, largely because the patents involved are the same patents at issue in Medicines Co. v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. 2016) (en banc). Following the Hospira panel opinion finding Medicines’ patents invalid, the Fed Cir entered a per curiam order terminating this case in Mylan’s favor. When the en banc Fed Cir reached a different outcome, the panel here had to reopen the appeal and take up the issues.

KEYWORDS: CLAIM CONSTRUCTION; INFRINGEMENT (NO)