In its Order, the Board denied Petitioner’s request for authorization to file a motion for additional discovery in relation to three out of four items that had been identified by Petitioner. At the same time, the Board conditionally granted Petitioner’s request for authorization to file a motion for additional discovery with respect to the fourth item, in the event that the parties were not able to resolve among themselves the issues relating to that item.
Petitioner had requested authorization to file a motion for additional discovery with regard to four categories of items: (1) cross-examination of Mr. William Fiske on his Declaration submitted during prosecution of a related patent application; (2) underlying “raw source data” on certain Patent Owner exhibits; (3) cross-examination of a witness for Patent Owner on clinical testing relevant to certain clinical study reports submitted by Patent Owner to the U.S. Food and Drug Administration as part of a New Drug Application; and (4) an underlying “clinical study report” relating to one of Patent Owner’s exhibits.
The Board denied Petitioner’s request with respect to item (1) in part because Petitioner will have a chance to depose Dr. Burgess regarding her reliance on Mr. Fiske’s Declaration and in view of the Board’s reluctance to “compel Patent Owner to produce a witness who is not under Patent Owner’s control, especially where such action may require a court subpoena.” The Board denied Petitioner’s request in regard to item (2) because it was based on mere speculation of the type associated with the first Garmin factor. The Board denied Petitioner’s request relating to item (3) because this request would involve the Boarding having to compel Patent Owner to produce a witness with first-hand knowledge of FDA clinical study reports and because Petitioner will have a chance to depose Dr. Burgess about these reports in a deposition.
As for item (4), in a related district court litigation, Petitioner had obtained from Patent Owner an “underlying clinical report document, currently under seal in the litigation, providing information inconsistent with Figure 1 in the Adams article (Ex. 2014), reproduced and discussed in Dr. Burgess’ Declaration.” Petitioner requested that Patent Owner provide Petitioner with the document under a Protective Order in the instant proceeding because, due to a Protective Order in the litigation, Petitioner cannot discuss or produce the document as evidence in this case. In response, counsel for Patent Owner said that it was different from counsel in the litigation and previously did not know about the document, but would inquire with the client (Patent Owner) to see if the document could be served to Petitioner in this proceeding. The Board gave the parties five business days to resolve this issue, and if the issue could not be resolved, then the Board said that it would authorize Petitioner to file a motion for additional discovery relating to the clinical study report associated with item (4).
Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc., IPR2014-00360
Paper 39: Order on Request for Authorization to File a Motion for Additional Discovery
Dated: December 3, 2014
Patent: 8,329,216 B2
Before: Toni R. Scheiner, Francisco C. Prats, and Jacqueline Wright Bonilla
Written by: Bonilla