Purdue Pharma L.P.v.Depomed, Inc.Download PDFPatent Trial and Appeal BoardAug 6, 201409282233 (P.T.A.B. Aug. 6, 2014) Copy Citation Trials@uspto.gov Paper 18 571-272-7822 Entered: August 6, 2014 UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ PURDUE PHARMA L.P., Petitioner, v. DEPOMED, INC., Patent Owner. ____________ Case IPR2014-00378 Patent 6,340,475 B2 Before ERICA A. FRANKLIN, GRACE KARAFFA OBERMANN, and TINA E. HULSE, Administrative Patent Judges. HULSE, Administrative Patent Judge. DECISION Order Denying Petitioner’s Request for Rehearing 37 C.F.R. § 42.71 IPR2014-00378 Patent 6,340,475 B2 2 INTRODUCTION I. Purdue Pharma L.P. (“Petitioner”) filed a Petition requesting an inter partes review of claims 1, 8-15, 61, and 62 of U.S. Patent No. 6,340,475 B2 (Ex. 1001, “the ’475 patent”). Paper 1 (“Pet.”). The Petition included eight different grounds of unpatentability based on anticipation or obviousness. The Board issued a Decision granting the Petition in part and instituting an inter partes review of claims 1, 8-10, 13-15, 61, and 62 of the ’475 patent based on obviousness over various combinations of prior art references. Paper 10 (“Decision”) at 24. Petitioner filed a request for rehearing of the Board’s decision not to institute trial based on the unpatentability of claims 1, 8, 9, 13, 14, and 61 as anticipated by Baveja. 1 Paper 12 (“Req.”) at 1. For the following reasons, Petitioner’s request is denied. ANALYSIS II. A party requesting rehearing has the burden of showing a decision should be modified by specifically identifying all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). Petitioner asserts that the Board misapprehended or overlooked: (1) the declaration and experimental results of Dr. Park (Exs. 1014 and 1015); and (2) Dr. Bodmeier’s opinion that the Baveja dosage forms would 1 Baveja et al., Zero-Order Release Hydrophilic Matrix Tablets of β- adrenergic Blockers, 39 INT’L J. OF PHARM. 39-45 (1987) (Ex. 1005). IPR2014-00378 Patent 6,340,475 B2 3 remain “substantially intact” (Ex. 1004). Req. 2-13. As explained below, however, we considered each of these submissions, but deemed them insufficient to establish a reasonable likelihood that Petitioner would prevail at trial. A. Declaration and Report of Dr. Park Petitioner argues that Dr. Park reproduced Baveja’s formulations accurately. Req. 3-9. Petitioner asserts that the Methocel K4M Premium that Dr. Park used was the same Methocel K4M Premium used in Baveja. Id. at 4. As support, Petitioner offers new evidence relating to Methocel K4 Premium, including evidence about a strategic alliance between Dow Chemical Company and Colorcon, as well as the meaning of certain letter designations and nomenclature. Id. at 4-5. Although it was not raised in the Petition, Petitioner asks us to take “judicial notice” of that evidence. Id. at 5-6. We decline that invitation, because, under these circumstances, a request for rehearing is not an opportunity to raise new argument or evidence that was not advanced in the Petition. Petitioner also argues that Dr. Park made reasonable assumptions regarding the compression pressure and tablet thickness based on his knowledge of pharmaceutical formulations. Id. at 6-9. As an initial matter, the Petitioner did not acknowledge in the Petition that Dr. Park had to make these assumptions, and, therefore, Petitioner makes this argument for the first time in its Request. Regardless, even if Dr. Park’s assumptions were reasonable, that does not change the Board’s determination that Dr. Park failed to confirm that the dosage form that he prepared was identical or substantially identical to the dosage form that Baveja prepared. Decision 11. As explained in the Decision, Dr. Park could have, for example, subjected IPR2014-00378 Patent 6,340,475 B2 4 the tablets that he prepared to the same dissolution study disclosed in Baveja to demonstrate that his tablets achieved the same results as those disclosed in Baveja. Id. Petitioner argues that the law does not require a positive control to establish inherent anticipation. Req. 9-10. The question, however, is whether Petitioner comes forward with sufficient evidence from which we can reasonably find that Dr. Park prepared a dosage form that was the same as Baveja’s dosage form. Based on the particular facts presented in this case, we are persuaded that the lack of basic control evidence—which is a fundamental tenet of the scientific method—precludes such a finding. It is Petitioner’s burden to establish inherent anticipation, and Dr. Park’s experiments are insufficient to support that inherency contention. Specifically, Dr. Park’s experiments do not demonstrate that Baveja necessarily teaches the “substantially intact” limitation of the claim. See In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (“To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference . . . .’”) (citation omitted). Accordingly, on this record, Petitioner failed to establish a reasonable likelihood that it would prevail in showing Baveja anticipates the claim. B. Declaration of Dr. Bodmeier Petitioner contends that the Board misapprehended the facts in determining that Dr. Bodmeier failed to provide objective support for his testimony that Baveja’s dosage forms would remain “substantially intact.” Req. 11-13. Petitioner asserts that Dr. Bodmeier’s testimony is supported by IPR2014-00378 Patent 6,340,475 B2 5 his expertise in the field, the state of the art references discussed in his declaration, and the graphs disclosed in Baveja. Id. at 11-12. In particular, Petitioner argues that Dr. Bodmeier is an expert in the field and that his objective knowledge of the properties and performance of Methocel K4M Premium should be given considerable weight. Id. at 11. As we explained in our Decision, however, 37 C.F.R. § 42.65(a) warns that “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” See Decision at 11-12 (and cited support). Furthermore, Petitioner cites various paragraphs from other portions of Dr. Bodmeier’s declaration, asserting that Dr. Bodmeier relied on that evidence regarding the state of the art in support of his opinion. Req. 11-12 (citing Ex. 1004 ¶¶ 42, 44, 61). Petitioner also argues that Dr. Bodmeier relied on the Baveja graphs, expanding on Dr. Bodmeier’s opinion with explanation that was not in Dr. Bodmeier’s declaration. Id. at 11-12; see also Ex. 1004 ¶ 81. Dr. Bodmeier, however, did not cite any of this support or explanation for his opinion that 75% Methocel K4 Premium “displays particularly robust gelling properties” and “will remain substantially intact until substantially all of the drug is released.” Ex. 1004 ¶ 81. It is not the Board’s role to play archeologist to uncover any additional support in the record that is not raised and discussed in the Petition and that may bolster Dr. Bodmeier’s opinion. In other words, we could not have overlooked or misapprehended arguments that were not raised in the Petition. Finally, Petitioner asserts that Dr. Bodmeier relied on Dr. Park’s tests as support for his opinion. Req. 12-13. Because we have already IPR2014-00378 Patent 6,340,475 B2 6 determined that Dr. Park’s tests are insufficient to demonstrate what Baveja’s dosage forms inherently teach, Dr. Bodmeier’s reliance on those experiments similarly is insufficient to demonstrate a reasonable likelihood that Petitioner would prevail in showing that Baveja anticipates the claims. Accordingly, we determine that Petitioner has not established that the Board misapprehended or overlooked any matter that would require modification of the decision to deny institution of Petitioner’s ground for anticipation over Baveja. CONCLUSION III. We conclude that Petitioner has not carried its burden of demonstrating that the Board’s Decision misapprehended or overlooked any matters. 37 C.F.R. § 42.71(d). ORDER IV. In consideration of the foregoing, it is hereby ORDERED that Petitioner’s request for rehearing is denied. IPR2014-00378 Patent 6,340,475 B2 7 PETITIONER: Gasper J. LaRosa gjlarosa@jonesday.com Kelsey I. Nix knix@jonesday.com Lynda Q. Nguyen lqnguyen@jonesday.com PATENT OWNER: Judy M. Mohr JMohr@MWE.com Geoffrey G. Hu GHu@kramerlevin.com Copy with citationCopy as parenthetical citation