Waiver In IPR Proceedings: Arguments in Patent Owner's Preliminary Statement are Waived Unless Reiterated During Trial Phase

December 8, 2016

 

The CAFC recently held that arguments in a Patent Owner’s Preliminary Statement must be reiterated during an IPR’s trial phase to preserve them for appeal.  In re NuVasive, Inc, Case No. 2015-1670 (Fed. Cir. Dec. 7, 2016).

 

When Medtronic petitioned for inter partes review of NuVasive’s spinal fusion patent, NuVasive filed a Preliminary Statement attacking the petition for neglecting to prove that its primary reference (a product brochure) was sufficiently available to the public to qualify as a “printed publication.”  The Board disagreed and instituted an investigation based upon the brochure combined with other prior art. 

 

Having lost the challenge to the brochure in the pre-trial phase, NuVasive chose not to revisit the issue at trial in their subsequent Patent Owner Response.  When asked about this decision at the hearing, NuVasive confirmed that they were “leaving that issue aside [and] focusing entirely on the obviousness” issues.   Slip at 6.   

 

On this record, the CAFC held that NuVasive had waived their arguments as to whether the brochure qualified as prior art.  The Court noted that the PTAB explicitly warns Patent Owners of this issue in a caveat printed in the Board's standard scheduling order (shown below):

 

“The patent owner is cautioned that any arguments for patentability not raised and fully briefed will be deemed waived.” 

 

The Court therefore turned to the obviousness of the claims in view of the brochure combined with other art.   On this issue, the CAFC was critical of the PTAB’s lack of analysis behind its obviousness conclusion.   The Court said that the PTAB had merely summarized the parties’ arguments and had not offered a sufficient motivation to combine the brochure with the other prior art. 

 

The PTAB reasoned that it had analyzed the motivation issue when it “effectively adopted Medtronic’s arguments” on that topic.  But the CAFC was not satisfied: “Because we cannot 'reasonably discern' the PTAB’s reasoning as to motivation to combine, judicial review cannot meaningfully be achieved.”  Slip at 13.  The CAFC sent the case back to the PTAB for the requisite analysis.

 

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