Baxter Healthcare Corp. v. Millenium Biologix, LLC

The U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB or Board) has explained that an inter partes review (IPR) petitioner should fully support its positions in its initial petition and is not entitled to raise new experimental evidence in a reply to a patent owner’s response to the petition.  Baxter Healthcare Corp. v. Millenium Biologix, LLC, Case Nos. IPR2013-00582, 00590 (PTAB, Oct. 13, 2014) (Murphy, APJ).

In its petition, Baxter asserted that the challenged claims were inherently anticipated.  In response to the petition, the patent owner countered that Baxter had not submitted any experimental evidence to support its inherent anticipation argument.  In reply, Baxter filed multiple additional exhibits, including a declaration by an author of one of the prior art references cited by Baxter in connection with its inherent anticipation argument.  This declaration provided new experimental evidence that purportedly supported Baxter’s inherent anticipation argument.  The patent owner objected, arguing that the experimental evidence was new evidence, belatedly presented.  The patent owner added that, if the petitioner had wished to support its inherent anticipation argument with experimental evidence, it had the opportunity—and the obligation—to do so in its initial petition.

The PTAB explained that the Office Patent Trial Practice Guide provides that a reply brief raising new issues or belatedly presenting evidence will not be considered and may be returned.  In this case, the PTAB found that the new evidence exceeded the permissible scope of a reply.  Although the submission of the new experimental evidence may have been stimulated by arguments made in the patent owner’s response to the petition, the PTAB noted that there was no reason why the petitioner could not have presented the experimental evidence when it initially filed its petition, and that to permit petitioner to do so at such a late stage in the proceedings would impose unfair prejudice on the patent owner and would not serve the interests of justice.  Accordingly, the PTAB refused to consider the newly submitted experimental evidence.

Practice Note: Before filing a petition to institute an IPR, petitioners should consider whether any arguments will require support in the form of experimental evidence or declarations.  If a petitioner anticipates that the patent owner may undermine its arguments based on a lack of experimental evidence, the petitioner is well advised to present such evidence with its petition.  If, more than one month after the trial is instituted, the petitioner concludes that experimental evidence may be necessary (and it was unable to acquire the necessary evidence before filing), the petitioner may request authorization to file supplemental information in support of the petition.  This request must explain why the new information could not have been obtained earlier.