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Baxter Healthcare Corp., Apatech, Inc., and Apatech Limited v. Millenium Biologix, LLC, Order Excluding Evidence IPR2013-00582, 590
Thursday, October 16, 2014

Takeaway: Any experimental data to support a petitioner’s argument regarding what a prior art reference discloses should be submitted with the petition.

In its Order, the Board excluded certain evidence filed by Petitioner with its Reply in response to objections made by Patent Owner. Patent Owner emailed the Board twice – six business days and seven business days after Petitioner’s Reply was filed – copying Petitioner to seek guidance regarding how to proceed in light of its objections to the evidence submitted with Petitioner’s Reply. The Board held a conference call with the parties to discuss the objections and potential excluding of evidence.

In particular, Petitioner had asserted in its Petition that a prior art reference inherently disclosed a material having a particular structure that was recited in the challenged patents. The Petition did not include any test data in support of the inherency argument, and Patent Owner argued in response that a person of ordinary skill in the art could not conclude anything about the prior art material’s structure without actually making the material as described in the prior art. Petitioner made the material as taught by the prior art showing that it has the structure as recited in the challenged claims, and submitted this evidence with its Reply.

Patent Owner argued that the evidence was “belatedly-presented new evidence” that went beyond the proper scope of a petitioner’s reply. Patent Owner argued that Petitioner should have presented any experimental data related to its inherency argument when the Petition was filed and that it was unfairly prejudicial to Patent Owner to, at such a late stage, possibly conduct tests and prepare a rebuttal declaration while preparing a motion to exclude. Petitioner argued that the evidence was proper as it was submitted in response to Patent Owner’s argument that a person of ordinary skill in the art would need to conduct experiments to show the prior art material would have the claimed structure.

The Board agreed with Patent Owner. In particular, the Board noted the Trial Practice Guide’s explanation that new issues or belatedly presented evidence in a reply would include “new evidence necessary to make out a prima facie case for the patentability or unpatentability of an original or proposed substitute claim, and new evidence that could have been presented in a prior filing.” The Board stated that Petitioner could have presented the evidence in support of its inherency argument with the Petition, and that Petitioner did not request authorization to file any supplemental information more than one month after institution of trial. Further, the Board acknowledged that while the evidence was submitted in response to Patent Owner’s argument, “it was Petitioner who decided to rely on the declaration of its expert without experimental evidence in support of its inherent anticipation argument.” Accordingly, the Board held that it would not consider the objected-to evidence in Petitioner’s Reply when rendering its final written decisions.

Baxter Healthcare Corp., Apatech, Inc., and Apatech Limited v. Millenium Biologix, LLC, IPR2013-00582; IPR2013-00590
Paper 32: Order on Conduct of the Proceeding
Dated: October 13, 2014
Patents: RE41,251; 6,585,992
Before: Michelle R. Osinski, Scott E. Kamholz, and Brian P. Murphy
Written by: Murphy

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