Purdue Pharma L.P.v.Depomed, Inc.

Patent Trial and Appeal Board

Aug 6, 2014

09282233 (P.T.A.B. Aug. 6, 2014)

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