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Biomarin Pharmaceutical Inc. v. Genzyme Therapeutic Products Limited Partnership: Granting Motion to Submit Supplemental Information IPR2013-00534, 537
Wednesday, January 14, 2015

Takeaway: The Board may waive the requirement of 37 C.F.R. § 42.123(b) that a party show that supplemental information which it seeks to submit reasonably could not have been obtained earlier.

In its Order, the Board granted Petitioner’s Motion to Submit Supplemental Information, which had sought to admit Exhibit 1182 into the record. According to Petitioner, Exhibit 1182 is relevant to the issue of the public availability of the Duke Press Release (Exhibit 1002) upon which Petitioner is basing its obviousness arguments.

After the Board had instituted inter partes review based on the obviousness grounds relying upon the Duke Press Release, Patent Owner filed a Motion to Exclude Evidence seeking to exclude the Duke Press Release as being inadmissible unauthenticated hearsay.  Petitioner, in reply, filed an Opposition to Patent Owner’s Motion to Exclude Evidence which referenced the aforementioned Exhibit 1182.  As characterized by Petitioner, Exhibit 1182 was “an affidavit of Ms. Beth Nichol explaining the process in which she obtained from a Duke University library a copy of [the Duke Press Release].”  Patent Owner argued in its Reply to the Opposition that it was “not the press release from Duke University because it lacks indicia that Duke University is the source of the document and contains typographical errors not found in the Duke Press Release provided in Exhibit C of Exhibit 1182.”

Petitioner then filed a Motion to Submit Supplemental Information, in which Petitioner requested authority to file Exhibit 1182 in order to address Patent Owner’s hearsay and authentication objections, and in which Petitioner relied upon certain evidence in support of its Motion. As characterized by the Board, Petitioner was “requesting to submit Exhibit 1182 as supplemental information, and not just as supplemental evidence with its Opposition to Patent Owner’s Motion to Exclude Evidence, which would permit Petitioner to rely on Exhibit 1182 to support its position that the Duke Press Release was publicly available.”

The Board determined that allowing the submission of Exhibit 1182 was in the interests of justice, and thus waived the 37 C.F.R. § 42.123(b) requirement that a party show that the supplemental information which it seeks to submit reasonably could not have been obtained earlier. Among the factors the Board cited in support of its decision on this point were that the supplemental information to be submitted did not change the authorized grounds of unpatentability; that the supplemental information to be submitted merely constituted additional evidence allegedly confirming the public accessibility of the Duke Press Release; that the supplemental information to be submitted was not withheld intentionally; that Petitioner appears to have made “continuous attempts” to obtain the information; and that the submission of the supplemental information at this time would not appear to limit the Board’s ability to complete the proceedings in a timely manner.

Biomarin Pharmaceutical Inc. v. Genzyme Therapeutic Products Limited Partnership, IPR2013-00534, IPR2013-00537 
Paper 80: Order on Conduct of Proceedings 
Dated: January 7, 2015
Patents 7,351,410 B2 and 7,655,226 B2 
Before: Lora M. Green, Jacqueline Wright Bonilla, and Sheridan K. Snedden
Written by: Snedden

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