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Following all of the latest IP developments in life sciences.

 

Raising An Argument For The First Time On Appeal Is Fraught With Danger

There is always a danger in raising an argument for the first time on appeal. The Federal Circuit’s recent decision in Boston Scientific Neuromodulation v. Nevro (No. 2019-1584) provides yet another example of this particular peril. 

The case began with Nevro filing an IPR petition challenging the validity of a Boston Scientific patent that claimed an implantable medical device that stopped “listening for” one type of “telemetry” (i.e. a wireless signal to program the device) when the battery level dropped too low, but continued “listening for” a second type of “telemetry” from the medical device’s wireless charging unit. 

In a preliminary response, Boston Scientific proposed a construction of “telemetry” to mean the “transmission of data or information,” which Boston Scientific contended the prior art did not disclose the second type of telemetry—the signal from the external wireless battery charger.

In its institution decision, the PTAB held that Boston Scientific had not proven its construction of “telemetry,” and that the prior art indeed disclosed the second type of telemetry under a broader construction, as well as disclosing that the implanted medical device continued “listening for” that second type of “telemetry.”

In response, Boston Scientific submitted further evidence supporting its proposed construction of the term “telemetry,” including a declaration from an expert witness. In its final written decision, the Board changed its prior position in the institution decision and actually agreed with Boston Scientific’s construction of the term “telemetry,” but nonetheless found that the prior art still disclosed “listening for” the second type of “telemetry,” as claimed, even under Boston Scientific’s proffered construction.

Boston Scientific appealed. In the appeal, Boston Scientific argued for the first time that not only must “telemetry” be construed, but that “listening for … telemetry” must be construed as well. Boston Scientific further argued that even if the prior art disclosed transmitting the second type of telemetry, it did not disclose “listening for” the second type of telemetry.

The Federal Circuit held that Boston Scientific waived this argument by not raising it with the PTAB. The Federal Circuit stated that the “Board construed ‘telemetry’ in its Institution Decision, providing Boston Scientific ample opportunity to offer a construction for the ‘listening for’ term in its patent owner response,” and that the Board’s finding that the prior art discloses “listening for” the second type of telemetry meant that the Board’s construction in its final written decision “was therefore not [] unexpected … as Boston Scientific contends.”

The remainder of the case contends with whether there was “substantial evidence” to support the Board’s findings, but in each case, the Federal Circuit pointed out that Boston Scientific’s own expert testified on cross examination that the Board’s findings were indeed supported. The case thus provides a further lesson that there is rarely a point to challenging a factual issue on appeal, which is reviewed with deference to the underlying tribunal, when one’s own expert provides support for the holding being appealed.

Takeaways:

  • It remains important to make all arguments possible at the trial level. While a court of appeals sometimes is willing to consider issues not raised below, don’t count on it as a trial strategy.
  • In preparing an expert for their deposition, prepare the expert for the tough questions to prevent the expert from agreeing with the opposing party’s position outright.
  • And if you do need to appeal a decision based on whether there is substantial evidence, pick a holding to dispute where your expert’s own testimony does not support the holding.