by Dennis Crouch
MedCo v. Mylan (Fed. Cir. 2017)
In this Hatch-Waxman dispute, the Federal Circuit has sided with the accused infringer Mylan and reversed a lower court’s judgment that Mylan’s proposed Bivalirudin formulation would infringe The Medicines Company (MedCo) U.S. Patent No. 7,582,727 (covering ANGIOMAX). This decision appears to clear the way for Mylan’s generic launch. (An authorized generic is already being marketed by Sandoz).
Claim construction: Rather than focusing solely on individual dosages, the MedCo patents include a limitation for consistant “batches” of the active ingredient based upon various impurity level targets and a target pH that is “adjusted by a base.” Although not expressly claimed, the patent describes an “efficient mixing” process used to ensure the consistency. Mylan’s proposal would use a different process to ensure batch consistency and pH level – Thus, the issue is whether the claims – as properly interpreted – require efficient mixing.
We hold that [the] patents include a “batches” limitation that requires batch consistency, which, according to the patents in suit, is achieved through efficient mixing. . . . We further construe efficient mixing as defined by Example 5 of the patents’ specification.
To reach this conclusion, the court applied a canon of construing-for-validity: Here, the claim language require a particular impurity level but the court found that they could not simply apply to individual-batches since that is already taught by the prior art. “Such a construction would render the claims of the ’727 patent invalid in light of Medicines’ numerous pre-critical-date sales of ANGIOMAX® batches having Asp9 levels below 0.6 percent.” Rather, the requirement that “the batches have a maximum impurity level” limitation must be construed to require cross-batch consistency — which requires that all of the batches be produced with the “same compounding process.” Looking to the specification, the court found that the patentee had stated its “development of a compounding process for formulating bivalirudin that consistently generates formulations having low levels of impurities is desirable” and later discussed “the compounding process . . . of the invention” . . . “and as prepared by the new process of the present invention.” When then further delving into the specification, it became clear that the compounding process discussed is the efficient mixing process. The specification spells out that process in “example 5” and contrasts it with the non-efficient process of “example 4.” (Example 5 was the only embodiment of efficient mixing described). The court writes:
Although the specification provides that Example 5 is “non-limiting,” no other part of the patents’ written description sufficiently teaches the affirmative steps that constitute efficient mixing. In this circumstance, we think it entirely appropriate to limit the term “efficiently mixing” to the sole portion of the specification that adequately discloses “efficient mixing” to the public.
Once the efficient mixing limitation was read into the claims, it was accepted by the parties that the Mylan proposal would not infringe.
To spell out the results here. The appellate court reversed the district court’s decision based upon its revised claim construction. The claims require “batches” of the active ingredient that “have a maximum impurity level.” The court construed that term to require a consistent process for making all the batches, and then looked to the specification to note that the patentee intended to use an “efficient mixing” process as that consistent process since that was the type of process described in the specification; And then finally zeroed-in on the the “efficient mixing” process and required that it follow the particulars of “example 5” of the patent since that was the only detailed example given of efficient mixing. With that narrowed claim construction, non infringement was easy.
Although the court does not state as much here, this appears to me a case that de novo review was critical in the appellate court’s analysis.