By Dennis Crouch
Braintree Labs v Novel Labs (Fed. Cir. 2014)
I see this case as highlighting the most critical and problematic problem with our patent system – that patent claim scope is intentionally ambiguous and malleable. Consistent with the subject matter of the invention, this case may potentially serve as a trigger for cleaning-out the patent system.
Braintree’s U.S. Patent No. 6,946,149 (asserted claim 15) covers a “composition for inducing purgation of the colon of a patient” and is used to help prepare patients for colonoscopies. A major problem with colon cleansing is the risk of having a dramatic electrolyte shift in the body as a whole – leading to potential emergency health problems. Of course, colonoscopies have become very big business and this patent is potentially quite valuable.
Here, Braintree’s patent includes the clearly functional claim limitation of “wherein the composition does not produce any clinically significant electrolyte shifts.” The appeal is about the meaning of that the terms purgation, patient, and “clinically significant electrolyte shifts.” The panel here included Judges Dyk, Prost, and Moore. Each Judge had their own version of how the term should be construed and how that relates to infringement.
What is “a patient”: The preamble of asserted claim 15 indicates that that the invention covers a composition for inducting purgation of the colon of a patient. All parties agreed that the preamble term “a patient” should be seen as limiting since it is implicitly referenced by the later reference to electrolyte shifts. Here, both the district court and Judge Moore saw the “a patient” term as indicating “one or more patients” whereas Judges Dyk and Prost saw the term as meaning “a patient population.” This ends up being important since the plaintiffs provided evidence of a patient who had received the accused product and fit within the electrolyte shift limitation. However, the “general class of patients” interpretation would require evidence that the result is generally expected in all patients.
Judge Prost: Indeed, [the "one or more patients"] interpretation would allow a composition to meet the claims even if 99 patients out of 100 experienced clinically significant electrolyte shifts, as long as one patient did not. . . . [The] application of the claim terms “a patient” leads to the absurd result of infringement even if a composition causes clinically significant electrolyte shifts in a large percentage of patients
Judge Moore: The majority believes this to be an “absurd result” because it would allow “a composition to meet the claims even if 99 patients out of 100 experienced clinically significant electrolyte shifts, as long as one patient did not.” I understand the majority’s concern. But this is a question of damages, not infringement. . . . Infringement, whether on a large or small scale, is still infringement.
Judge Dyk: (Agreeing with Judge Prost) The sole evidence in the summary judgment record concerning the percentage of individuals experiencing such electrolyte shifts is data from two clinical studies … and those data are sufficient to show that the claim limitation was not met [since] a majority of patients experienced clinically significant electrolyte shifts.
In this case, the district court had awarded summary judgment of infringement to the patentee. On remand, the district court will need to revisit whether the patentee has proof that the patient population as a whole would react to the treatment as claimed. We’ll likely see this case again on revise-and-resubmit after the district court has redone its work. Of course, there is a chance that the Supreme Court may take this case – potentially seeing it as a subject matter sequel to Sakraida (“that cow shit case”).
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This is a bit of an off-the-wall thought, but I might question whether an infringement finding is appropriate even under Judge Moore’s interpretation. Here, we basically have a setup where one claim limitation (no-electrolyte-shift) occurs in some patients and not in others – the cause of the difference is unknown but is likely a somewhat random operation of the laws of nature. What we know is that a particular treatment protocol will usually result in an electrolyte shift, but sometimes does not have such a result. Of course, for infringement to occur, the accused infringer must practice each and every step of the invention as claimed – here that includes the “no-electrolyte-shift” limitation. Now, although patent law does not require that the accused have intented to infringe the patent, the acts that eventually resulted in infringement must have been intentional.
My question on infringement, is whether performance of that no-electrolyte-shift element is properly attributable to a deliberate act by the accused or instead should it be seen simply as an occurrence of a natural phenomena – an Act of God as the old Lords might have said. See Tennent v. Earl of Glasgow (1864).