Takeaway: A motion to submit supplemental information must demonstrate why the supplemental information reasonably could not have been obtained earlier and that consideration of the supplemental information would be in the interests of justice, which includes showing the relevance of the information sought to be submitted.

In its Decision, the Board granted in part and denied in part Patent Owner’s motion to submit supplemental information.

The Board began with a reminder that, under 37 C.F.R. § 42.123(b), “a motion to submit supplemental information must show why the supplemental information reasonably could not have been obtained earlier, and that consideration of the supplemental information would be in the interests of justice.”

The Board then considered the merits of Patent Owner’s motion to submit five documents as supplemental information. Patent Owner argued that statements in the documents are contrary to Petitioner’s argument that the use of Vyvanse® (LDX) to treat binge-eating disorder (BED) would have been obvious and that other, non-pharmacological treatments were available and sufficient to treat the needs of patients with BED. It further argued that the documents are “particularly relevant to the objective indicia of non-obviousness, including, but not limited, to long-felt but unmet need.”

The first document was a press release issued by the United States Food & Drug Administration announcing the approval of LDX for the treatment of binge eating disorders. According to Patent Owner, the press release stated that “LDX was reviewed under the FDA’s priority review program ‘which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy.’” Petitioner argued that Patent Owner did not “explain why FDA approval is relevant to obviousness,” that the document is cumulative to information in specific exhibits already submitted by Patent Owner, and that the document is inadmissible hearsay. The Board agreed that the document may be relevant to objective indicia of non-obviousness and noted that “the information could not have been earlier submitted because the press release was issued by the FDA after the filing of the Patent Owner Response.” Accordingly, the Board concluded that the “the interests of justice are served by permitting entry of this document as supplemental information.”

The second document was a press release issued by Petitioner “announcing that Vyvanse® is the first, and only, treatment approved by the FDA for the treatment of moderate to severe BED.” Patent Owner argued that the statement contradicts Petitioner’s argument that the method of the challenged claims would have been obvious. Petitioner, in response, argued that the Motion should not be granted as to this document on the grounds that it is cumulative to previously-submitted information. The Board agreed with Petitioner that the document is cumulative to information in other exhibits already submitted by Patent Owner and concluded that Patent Owner did not “explain how the statement in this second document adds significantly to that evidence, such that the submission of this document at this state of the proceeding is in the interest of justice.”

With respect to the remaining three additional documents—an article published by Telegraph Media stating that the drug was approved by the FDA, an article noting that Petitioner has retained a tennis star to serve as a spokesperson for promotion of the drug, and a transcript of a conference call in which Petitioner’s executives discussed the FDA approval—the Board concluded that Patent Owner did not demonstrate that it would be in the interest of justice to submit the documents into the record at this stage of the proceeding. For the article concerning the spokesperson, the Board agreed with Petitioner that Patent Owner had not explained sufficiently how the document supports the non-obviousness of the claims. The other documents were determined to be cumulative.

Finally, the Board addressed Petitioner’s argument that Patent Owner should not have attached the documents it was seeking to have entered into the record as attachments to its Motion and that the exhibits should be expunged, or in the alternative, the Motion and attached exhibits should be expunged. The Board noted that Patent Owner filed the exhibits with its Motion without prior authorization but declined to expunge the Motion in its entirety. Instead, the Board ordered Patent Owner to refile the Motion without the attached exhibits and to file the first document as a separate exhibit, after which the original Motion with attached exhibits would be expunged.

Shire Development LLC v. Lucerne Biosciences, LLC, IPR2014-00739
Paper 23: Decision on Patent Owner’s Motion to Submit Supplemental Information
Dated: March 12, 2015
Patent: 8,318,813 B2
Before: Linda M. Gaudette, Lora Green, and Kristina M. Kalan
Written by: Green