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Case IPR2014-01259 Patent 7,879,828
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
INITIATIVE FOR RESPONSIBILITY IN DRUG PRICING LLC Petitioner
v.
WYETH LLC Patent Owner
Case IPR2014-01259 Patent 7,879,828
PATENT OWNER WYETH LLCS PRELIMINARY RESPONSE
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Case IPR2014-01259 Patent 7,879,828
i
TABLE OF CONTENTS
I. Introduction and Summary of Argument
........................................................ 1
II. Factual Background and Related Proceedings
................................................ 2
A. Related Proceedings
..............................................................................
2
B. IRDP and Its Duplicative Petition
......................................................... 4
III. Argument
.........................................................................................................
7
A. Legal Framework
..................................................................................
8
B. IRDPs Petition Should Be Dismissed Because It Is Wholly
Duplicative Under 35 U.S.C. 325(d)
................................................ 11
C. IRDPs Motive Rationale Is Insufficient To Sustain Its
Petition ........ 14
D. IRDPs Petition Is Unsupported Because Its Expert Is Not
Qualified To Offer Opinions In This Matter
....................................... 17
IV. Conclusion
.....................................................................................................
22
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Case IPR2014-01259 Patent 7,879,828
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TABLE OF AUTHORITIES
CASES
Cholakyan v. Mercedes-Benz USA, LLC, 281 F.R.D. 534 (C.D. Cal.
2012)
........................................................................
22 Envtl. Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693
(Fed. Cir. 1983)
......................................................................
19, 21 Hunt v. McNeil Consumer Healthcare, 297 F.R.D. 268 (E.D. La.
2014)
.........................................................................
22 Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., No.
IPR2013-00324, Paper 19 (P.T.A.B. Nov. 21, 2013)
.......................... 8, 9, 10 KSR Intl Co. v. Teleflex Inc.,
550 U.S. 398 (2007)
............................................................................................
21 Medtronic, Inc. v. Nuvasive, Inc., No. IPR2014-00487, Paper 8
(P.T.A.B. Sept. 11, 2014) .................................... 10
Medtronic, Inc. v. Robert Bosch Healthcare Sys., Inc., No.
IPR2014-00436, Paper 17 (P.T.A.B. June 19, 2014)
.................................. 10 Unified Patents, Inc. v.
PersonalWeb Techs., LLC, No. IPR2014-00702, Paper 12 (P.T.A.B. July
24, 2014) ............................. 11, 16 Unified Patents,
Inc. v. PersonalWeb Techs., LLC, No. IPR2014-00702, Paper 13
(P.T.A.B. July 24, 2014) ......................... 9, 10, 12 ZTE
Corp. and ZTE (USA) Inc. v. ContentGuard Holdings, Inc., No.
IPR2013-00454, Paper 12 (P.T.A.B. Sept. 25, 2013)
.................................. 10
OTHER AUTHORITIES
35 U.S.C. 316(b)
.....................................................................................................
9
35 U.S.C. 325(d)
............................................................................................passim
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Case IPR2014-01259 Patent 7,879,828
iii
37 C.F.R. 42.1(b)
..............................................................................................
9, 13
37 C.F.R. 42.108(c)
...............................................................................................
17
37 C.F.R. 42.122(a)
.................................................................................................
9
37 C.F.R. 42.122(b)
..............................................................................................
16
157 Cong. Rec. S5319-03 (daily ed. Sept. 6, 2011)
................................................ 13
H.R. Rep. No. 112-98 (2011), reprinted in 2011 U.S.C.C.A.N. 67
........................ 13
Office Patent Trial Practice Guide, 77 Fed. Reg. 48756-01 (Aug.
14, 2012) .........................................................
9, 15
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Case IPR2014-01259 Patent 7,879,828
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I. Introduction and Summary of Argument
Petitioner, the Initiative for Responsibility in Drug Pricing
LLC (IRDP), is
an organization formed five months ago for the sole purpose of
using the inter
partes review system to attack or threaten to attack
pharmaceutical patents. This
Petition, the first ever filed by IRDP, seeks to invalidate U.S.
Patent No. 7,879,828
(the 828 patent) relating to formulations of tigecycline, a
novel tetracycline
derivative, owned by Wyeth LLC (Wyeth). But rather than develop
its own
Petition supported by testimony from experts in the relevant
field, IRDP simply
copiedin most cases verbatimthe arguments being litigated in
another ongoing
inter partes review (IPR) proceeding (Apotex Inc. v. Wyeth LLC,
No. IPR2014-
00115). And its expert, himself a principal of IRDP but not a
pharmaceutical
scientist, merely appropriated the previously published
testimony of Apotexs
expert, again often in word-for-word synchronicity. The result:
IRDPs Petition is
entirely duplicative of the issues being litigated in the Apotex
trial, is unsupported
by qualified expert testimony, and amounts to an abuse of the
IPR procedures.
Wyeth respectfully submits that the Patent Trial and Appeal
Board (Board)
should exercise its discretion under 35 U.S.C. 325(d) and
dismiss IRDPs
Petition.
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Case IPR2014-01259 Patent 7,879,828
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II. Factual Background and Related Proceedings
The 828 patent relates to TYGACIL, a breakthrough antibiotic
product
developed by Wyeth to fight bacterial infections that have
become resistant to
older antibiotic therapies. Tigecycline, the active
pharmaceutical ingredient of
TYGACIL, proved to be unstable due to degradation in ordinary
hospital
environments, thus severely limiting its usefulness. In
searching for a solution to
tigecyclines degradation problem, Wyeth researchers discovered a
surprising fact:
combining tigecycline with lactose in specific molar ratios and
pH levels yielded
stable compositions that could be used to deliver the
breakthrough antibiotic.
Wyeth patented the invention, disclosing and claiming the
composition of
tigecycline and lactose at the specified molar ratios at
specified pH ranges as well
as processes for manufacturing the composition. Ex. 1001, col.
1:7-21; 14:35-67;
15:1-12; 16:1-10.
A. Related Proceedings
An ongoing IPR proceeding involving the 828 patent is separately
before
the Board and already at an advanced stage. Generic drug
manufacturer Apotex
Inc. (Apotex) filed its Petition on November 1, 2013,
challenging the validity of
the 828 patent on several different obviousness grounds. Apotex
Inc. v. Wyeth
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Case IPR2014-01259 Patent 7,879,828
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LLC, No. IPR2014-00115, Paper 10 (April 21, 2014) (Apotex
Petition).1 One
ground presently is being litigated between Wyeth and Apotex:
obviousness over a
combination of (1) Chinese Patent Publication No. CN 1390550A
(CN 550)
(Apotex Exhibit 1046); (2) V. Naggar et al., Effect of
Solubilizers on the Stability
of Tetracycline, Pharmazie 29(2) 126-129 (1974) (Naggar) (Apotex
Exhibit
1007); and (3) E. Pawelczyk et al., Kinetics of Drug
Decomposition, Pol. J.
Pharmacol. Pharma. 34:409-421 (1982) (Pawelczyk) (Apotex Exhibit
1006).
Wyeth filed its Patent Owner Response on July 22, 2014,
carefully detailing its
contention that this ground does not render the claims obvious,
Apotex, No.
IPR2014-00115, Paper 36, and Apotex filed its Reply on November
5, 2014, id.,
Paper 61. The case is scheduled for oral argument on January 23,
2015. Id., Paper
11 at 6.
In addition to the Apotex IPR proceeding, three cases are
pending in federal
district court in which generic drug companies that seek to
market a copy of
TYGACIL are challenging the validity of the 828 patent: Pfizer
Inc. et al. v.
Fresenius Kabi USA LLC, Case No. 1:13-cv-01893-SLR (D. Del.);
Pfizer Inc. et
al. v. CFT Pharmaceuticals LLC, Case No. 1:14-cv-00781-SLR (D.
Del.); and
1 References herein to Apotex Exhibits refer to exhibits from
the Apotex trial.
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Case IPR2014-01259 Patent 7,879,828
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Pfizer Inc. et al. v. Aurobindo Pharma Ltd. et al., Case No.
1:14-cv-00872-SLR
(D. Del.). All three of these cases are in the discovery
stage.
B. IRDP and Its Duplicative Petition
This is the first Petition filed by IRDP, a newly-formed entity
that does not
itself have the ability to manufacture or sell pharmaceutical
products. IRDPs
business model appears to be based on generating revenue by
threatening to file
petitions for inter partes review unless pharmaceutical
manufacturers deed them
tremendous value, e.g., in the form of supply agreements. Wyeth
declined IRDPs
pre-filing demands, and IRDP in turn filed the instant Petition.
Gaming the IPR
system further, IRDPs Petition essentially required only a
photocopier to prepare;
in lieu of new arguments, IRDP reargued the same issues being
litigated in the
Apotex trial and, in place of a declaration from an actual
expert in the field, IRDP
regurgitated, under its owners signature, the opinions
propounded by Apotexs
expert.
IRDP filed the instant Petition on August 8, 2014, over nine
months after
Apotex filed its Petition, and after Wyeth submitted its Reply.
No. IPR2014-
01259, Notice of Filing Date Accorded Petition, Paper 4 at 1
(P.T.A.B. Aug. 22,
2014). IRDPs Petition does not even attempt to obscure that its
Petition
duplicates the arguments that are being litigated in the pending
trial with Apotex:
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Case IPR2014-01259 Patent 7,879,828
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obviousness over (1) CN 550,2 (2) Naggar, and (3) Pawelczyk.
Id., Petition for
Inter Partes Review of U.S. Patent No. 7,879,828, Paper 1 at 4
(IRDP Petition).
Nor does Apotex advance different arguments in support of this
identical
obviousness contention; rather, IRDP acknowledges that it agrees
with Apotex,
and confesses that it adopts the grounds of invalidity advanced
by Apotex
therefore creating substantial overlap between IRDPs arguments
in this petition
and Apotexs arguments in IPR2014-00115. Id. at 1-2. In addition
to advancing
the same arguments using the same prior art, the language in the
substantive
portion of IRDPs Petition is almost entirely duplicative of
Apotexs. Compare
Apotex Petition with IRDP Petition. IRDP in fact admits that it
repeat[s] the
language of Apotexs petition when appropriate. Id. at 1.
In support of its Petition, IRDP submits a single Declaration
from a witness
who is himself the founder of IRDP, Dr. Albert J. Berger. Dr.
Berger holds
Ph.D.s in physiology and chemical engineering, with a specialty
in synaptic
transmission and respiratory neurobiology. Exhibit 1002, 6-7
(Berger
Declaration). He does not claim any experience working with
tigecycline or any
2 The translation of CN 550 on which IRDP relies (IRDP Exhibit
1004) is
substantively identical to the translation submitted by Apotex
(Apotex Exhibit
1046) on which the Apotex trial is currently being
litigated.
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Case IPR2014-01259 Patent 7,879,828
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compound in the tetracycline family of antibiotics, and his
curriculum vitae
reflects none. See Exhibit 1002 at 67-93 (Berger CV). He does
not claim any
expertise in formulations of pharmaceutical compounds or efforts
to address the
issues of epimer instability and degradation to which the 828
patent is directed.
None of the publications on his CVpeer-reviewed or notappear
from their
titles to address tigecycline, tetracyclines, antibiotic
molecules, stability against
degradation, or any type of chemistry formulation process. Id.
Rather, his
publications and research focus primarily on the inapposite
subject of hypoglossal
motoneurons, which are nerves that activate the tongue. Id.
As with its Petition, the language and arguments in Dr. Bergers
Declaration
are likewise lifted wholesale from those of Apotexs expert, Dr.
Mark L. Nelson.
Compare Apotex Exhibit 1002 (Nelson Declaration) with Berger
Declaration.
Dr. Berger admits that he reviewed and relied on the Nelson
Declaration, the
Apotex Petition, and the Boards decision to institute IPR
proceedings in the
Apotex trial, that his Declaration is consistent with the
analysis in all three
documents, and that he even repeats language when appropriate.
Berger
Declaration, 3-4.
IRDP neither refutes nor attempts to justify the ineluctable
conclusion that
the Boards institution of trial would produce entirely
duplicative and wasteful
litigation. Rather, IRDP proudly announces that, if the Board
institutes a trial here,
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Case IPR2014-01259 Patent 7,879,828
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it will be on the same grounds of invalidity advanced by Apotex.
IRDP Petition
at 1. While requiring Wyeth to expend considerable time and
resources for its
attorneys, employees, and experts to defend its patent may
further IRDPs scheme
to force pharmaceutical companies to pay a ransom in exchange
for an agreement
not to file an IPR petition, the law does not and should not
countenance this effort.
Incentivizing IRDPs admittedly wasteful and duplicative
litigation by instituting a
trial would be unprecedented, unnecessary, and unwise.
III. Argument
Congress vested the Board with broad discretion to reject
petitions that
duplicate the arguments and positions already before the Board
in another IPR. 35
U.S.C. 325(d). IRDPs Petition presents a prototype of such a
duplicative filing.
As IRDP itself admits, the Petition mirrors the pending trial
with Apotex,
challenging the same claims on the basis of the same arguments
about the same
prior art. IRDP Petition at 1-2. IRDPs only argument for
instituting a duplicative
IPR here is that, because it is not a generic drug manufacturer,
its allegedly pure
motives for challenging the 828 patent somehow better serve the
public interest.
Such a contention, even were it true (and IRDPs pre-filing offer
not to file the
Petition suggests that it is not), has no basis of support in
law or policy. Finally,
IRDPs expert is not qualified to offer opinions in the field
occupied by the
compositions and processes claimed in the 828 patent, and thus
the Board should
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Case IPR2014-01259 Patent 7,879,828
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not credit his Declaration. Granting IRDPs copycat Petition and
instituting a
proceeding would unnecessarily burden the Board and harass the
patent owner, and
therefore IRDPs Petition should be terminated pursuant to the
Boards discretion
under 35 U.S.C. 325(d).
A. Legal Framework
Congress made the institution of IPR proceedings discretionary
and
explicitly suggested that petitions urging duplicative
proceedings should be denied.
35 U.S.C. 325(d); Intelligent Bio-Sys., Inc. v. Illumina
Cambridge Ltd., No.
IPR2013-00324, Paper 19 at 5 (P.T.A.B. Nov. 21, 2013) (Boards
discretion is
guided by 325(d)). This provision, which addresses Multiple
Proceedings,
provides in pertinent part:
[D]uring the pendency of any post-grant review under
this chapter, if another proceeding or matter involving the
patent is before the Office, the Director may determine
the manner in which the post-grant review or other
proceeding or matter may proceed, including providing
for the stay, transfer, consolidation, or termination of any
such matter or proceeding. In determining whether to
institute or order a proceeding . . . the Director may take
into account whether, and reject the petition or request
because, the same or substantially the same prior art or
arguments previously were presented to the Office.
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Case IPR2014-01259 Patent 7,879,828
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35 U.S.C. 325(d).3 See also 37 C.F.R. 42.122(a); Office Patent
Trial Practice
Guide, 77 Fed. Reg. 48756-01, 48756-57 (Aug. 14, 2012) (Trial
Guide).
The statute is clear that the key factor in determining whether
to reject the
later-filed duplicate petition is whether the same or
substantially the same prior
art or arguments previously were presented to the Office. 35
U.S.C. 325(d); see
also Trial Guide at 48765 (same). This instruction to deny
duplicative petitions is
essential to avoid the inefficient and wasteful use of the
Boards limited resources
and time. See 35 U.S.C. 316(b) (regulations should take into
account, inter alia,
the effect of any such regulation on the . . . efficient
administration of the Office,
and the ability of the Office to timely complete proceedings
instituted under this
chapter); 37 C.F.R. 42.1(b) (This part shall be construed to
secure the just,
speedy, and inexpensive resolution of every proceeding.).
The Board repeatedly and consistently has exercised its
discretion to deny
petitions that rely on the same prior art to challenge the same
claims, on the basis
that it would be a waste of time, effort, and resources to
re-litigate the same
issues. Unified Patents, Inc. v. PersonalWeb Techs., LLC, No.
IPR2014-00702,
3 Although 325(d) appears in the chapter covering post-grant
proceedings, the
Board has recognized that by its terms it is applicable also to
[IPR] proceedings.
Intelligent Bio-Sys., No IPR2013-00324, Paper 19 at 5 n.2.
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Case IPR2014-01259 Patent 7,879,828
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Paper 13 at 7 (P.T.A.B. July 24, 2014) (denying third-party
petition challenging
same claims using same prior art and arguments as an ongoing
IPR); see also ZTE
Corp. and ZTE (USA) Inc. v. ContentGuard Holdings, Inc., No.
IPR2013-00454,
Paper 12 at 7 (P.T.A.B. Sept. 25, 2013) (rejection of
duplicative petition was just
and appropriate in order to secure just, speedy, and inexpensive
resolution of
IPR proceeding); Medtronic, Inc. v. Nuvasive, Inc., No.
IPR2014-00487, Paper 8 at
6 (P.T.A.B. Sept. 11, 2014) (rejecting petition covering claims
denied in a previous
petition and involving same claims and same prior art and
arguments as ongoing
IPR because petitioner does not provide any specific reasoning
to support new
petition); Medtronic, Inc. v. Robert Bosch Healthcare Sys.,
Inc., No. IPR2014-
00436, Paper 17 at 12 (P.T.A.B. June 19, 2014) (denying petition
partly because
[n]othing in the Petition accounts for th[e] substantial overlap
between it and
prior IPR proceeding); Intelligent Bio-Sys., No. IPR2013-00324,
Paper 19 at 7
(rejecting petition because a previous IPR presented the same,
or substantially the
same, prior art and arguments).
In so ruling, the Board has recognized that the efficient
resolution of IPR
proceedings justifies rejecting duplicative petitions even when
it prevents a
different petitioner from having an opportunity to submit
arguments or evidence
with respect to the challenged patent claims. Unified, No.
IPR2014-00702, Paper
13 at 7. Indeed, given IRDPs acknowledged decision to copyin
large measure
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Case IPR2014-01259 Patent 7,879,828
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verbatimthe arguments and Declaration advanced by Apotex, IRDP
cannot
credibly seek to avoid dismissal on the basis that it is a
different party. Neither
logic nor the Boards case law permits that result.
B. IRDPs Petition Should Be Dismissed Because It Is Wholly
Duplicative Under 35 U.S.C. 325(d)
IRDPs Petition is undeniably (and admittedly) duplicative. IRDP
attacks
the same claims in the same patent as Apotex. It parrots the
same arguments
regarding claim construction and invalidity, and it asserts the
same prior art. Its
expert Declaration reads as a blatant facsimile of the expert
Declaration supporting
Apotexs Petition, though without the same expert qualifications.
And in an
admirable combination of candor and chutzpah, IRDP freely admits
to its
plagiarism. IRDP Petition at 1 (IRDP repeat[s] the language of
Apotexs
petition). Such a petition presents the textbook example of
duplication under 35
U.S.C. 325(d), which permits the Board to reject the petition if
the same or
substantially the same prior art or arguments previously were
presented to the
Office. If IRDPs Petition is not duplicative and worthy of
dismissal under this
standard, then the statutory language essentially has no meaning
or force.
The Boards decision in Unified is instructive here. In Unified,
the petitioner
was an organization founded by intellectual property
professionals to fight poor
quality patents being asserted against strategic technologies
and industries. No.
IPR2014-00702, Paper 12 at 5 (P.T.A.B. July 24, 2014). The same
patent, prior
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Case IPR2014-01259 Patent 7,879,828
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art, and invalidity arguments were at issue in two ongoing IPR
proceedings
pursued by third parties, the first of which was before the
Federal Circuit and the
second of which was before the Board. Id., Paper 13 at 6-7. The
Board found that
the Federal Circuits decision in the first proceeding could moot
several (but not
all) of the challenged claims, but that regardless of the
outcome of [the first
proceeding] before the Federal Circuit, each of the challenged
claims is under
review in [the second proceeding] and, if that trial were to
proceed to a final
written decision, a determination will be made about the patents
validity. Id. at
8. Thus, despite the fact that the petitioner would be prevented
from submit[ting]
arguments or evidence with respect to the challenged claims, id.
at 7, the Board
exercised its discretion under 35 U.S.C. 325(d) to deny the
duplicative petition.
IRDPs Petition occupies an exceedingly similar posture. IRDP is,
like the
petitioner in Unified, an organization founded purportedly
(notwithstanding its
efforts to extract a pre-filing settlement) for the purpose of
invalidating patents
that it claims are unjustifiably delaying generic competition.
IRDP Petition at 1.
There is no dispute that its Petition repeats verbatim the
arguments and prior art at
issue in the Apotex proceeding and that, if the Apotex trial
were to proceed to a
final written decision, a determination will be made about the
828 patents
validity. Unified, No. IPR2014-00702, Paper 13 at 8.
Consequently, as in Unified,
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Case IPR2014-01259 Patent 7,879,828
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the Board should secure the just, speedy, and inexpensive
resolution of this
matter by denying IRDPs Petition. 37 C.F.R. 42.1(b).
Rejecting IRDPs Petition comports with Congresss purpose in
preventing
wasteful and harassing duplicative proceedings. Congress
intended that IPR
proceedings be an inexpensive substitute for district court
litigation. 157 Cong.
Rec. S5319-03 (daily ed. Sept. 6, 2011) (statement of Sen. Kyl).
To that end, in
creating the IPR procedure, Congress left broad discretion with
the Board in order
to address potential abuses that might divert resources from
research and
development of inventions. H.R. Rep. No. 112-98, at 48 (2011),
reprinted in
2011 U.S.C.C.A.N. 67, 78 (IPR proceedings are not to be used as
tools for
harassment or a means to prevent market entry through repeated
litigation and
administrative attacks on the validity of the patent).
There is no denying that duplicative petitions such as IRDPs
undermine
Congresss goal by pointlessly increasing the costs required to
adjudicate a patent
dispute capable of being resolved in a prior proceeding. A
copycat filers costs for
pursuing an IPR proceeding are miniscule in comparison with
those expended by
the original petitioner, because the copycat is not forced to
construct novel
arguments, conduct legal research, develop evidence, hire
qualified experts, or
perform any of the usual tasks related to building an invalidity
case against a
patent. Rather, the copycat petitioner piggybacks on the work of
the original filer.
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Case IPR2014-01259 Patent 7,879,828
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And when a second petitioner copies the vast majority of its
petition and
supporting documents directly from the original petitioners
public filings (as
IRDP copied from Apotex), the copycat petitioner avoids even the
modest cost of
crafting its own original language. In contrast, as subsequent
identical petitions are
filed, the burden and costs on the Board to adjudicate the
repeat petitions and on
patent owners to defend their patents only increase. That is
exactly IRDPs goal
here. The Board should not tolerate such underhanded tactics, or
future copycat
filers will hear the message loud and clear. Because IRDP
advances the exact
same arguments and prior art being litigated in the Apotex
proceeding, the Board
should reject its Petition as duplicative.
C. IRDPs Motive Rationale Is Insufficient To Sustain Its
Petition
IRDP provides only one reason why the Board should accept its
duplicative
Petition: that IRDP is not affiliated with any pharmaceutical
company, and is
therefore not susceptible to the considerations that often
result in settlements
between brand-name and generic pharmaceutical companies that, in
IRDPs view,
do not serve the public interest. IRDP Petition at 1. There is
no basis in law for
such a motive-based distinction, nor is there any reason to
believe that IRDPs
motives serve the public interest better than any other
petitioners motives.
First, nothing in the statute or regulations creating the IPR
procedure
suggests that a petitioners motives should be a factor for the
Board to consider
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Case IPR2014-01259 Patent 7,879,828
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when determining whether to reject a duplicative petition. To
the contrary, the
statute states only that the Board should evaluate whether a
petition advances the
same or substantially the same prior art or arguments as a prior
petition.
35 U.S.C. 325(d). As discussed in more detail above, the prime
directive of the
IPR process is efficiency and timeliness, not the underlying
motives of the parties.
It would unnecessarily complicate the IPR process if the Board
were to examine
each petitioners motives to decide whether they are worthy
enough to warrant
instituting duplicative IPR proceedings.4 Practically speaking,
reading a motive
exception into 325(d) would permit copycat filers to harass
patent owners
through duplicative petitions by issuing self-serving
declarations that they are
motivated by enhancing the public good rather than their bottom
lines.
Second, while IRDP argues that settlements do not serve the
public interest,
the Offices published guidelines state unequivocally that
[t]here are strong public
policy reasons to favor settlement between the parties to a
proceeding. Trial
Guide at 48768. Settlement, like terminating duplicative
proceedings, eliminates
unnecessary litigation and conserves limited judicial resources.
Moreover, if IRDP
4 In any event, given that offering not to file petitions in
exchange for valuable
supply agreements appears to be IRDPs modus operandi,
Petitioners professed
altruistic motive of reducing drug prices would not withstand
scrutiny.
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Case IPR2014-01259 Patent 7,879,828
16
was truly concerned about Apotex settling its IPR proceeding,
then IRDP could
have submitted its Petition before Apotex. Or it could have
filed its Petition within
the time frame for requesting joinder. 37 C.F.R. 42.122(b).5 Or
it could have
assembled a non-duplicative Petition. That IRDP chose none of
the above does not
provide reason to grant it a duplicative proceeding.
Third, IRDPs implicit assumption that its purported motive is
alone
sufficient to serve the public interest is mistaken. In Unified,
the Board rejected
the petitioners concurrent motion for joinder because further
discovery would be
necessary to determine what companies, if any, fund and control
the advocacy
organization. No. IPR2014-00702, Paper 12 at 5. Similarly,
further discovery
would be necessary to ascertain who funds and controls IRDP and
to ensure it has
no connection with persons or entities that do not share its
avowed interests.
Thankfully, such an inquiry into the Petitioners motives is not
necessary, because
the only question before the Board is whether the IRDPs Petition
is duplicative,
which it undeniably and admittedly is.
5 Under 37 C.F.R. 42.122(b), a petitioner must file within one
month of the
institution of IPR in a prior proceeding in order to request
joinder. Apotex filed its
Petition in November 2013, placing IRDPs Petition well outside
this time limit.
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Case IPR2014-01259 Patent 7,879,828
17
Finally, although Petitioner has raised the specter of a
settlement between
Wyeth and Apotex to urge institution, presumably to suggest that
such a settlement
would render its Petition non-duplicative. But Wyeth and Apotex
have not settled
the pending trial, so the potential that IRDPs Petition may one
day become non-
duplicative is purely speculative. Quite simply, the relevant
question is whether
the instant Petition is duplicativea question that permits only
an affirmative
answer. The fact that a settlement could occur in the future
cannot prospectively
transform an undeniably duplicative petition into a
non-duplicative petition that
may be granted.
D. IRDPs Petition Is Unsupported Because Its Expert Is Not
Qualified To Offer Opinions In This Matter
IRDPs Petition cannot demonstrate a reasonable likelihood that
the 828
patent is invalid, 37 C.F.R. 42.108(c), because Dr. Albert J.
Berger, whose
Declaration serves as the basis for IRDPs Petition, IRDP
Petition at 1-2, plainly is
not qualified to offer opinions on the relevant scientific
matters related to the 828
patent. Apparently recognizing that Dr. Berger lacks any
experience relevant to
the scientific disciplines at issue, the one area where IRDP
chooses to depart
substantively from the arguments advanced by Apotex is in its
definition of the
person of ordinary skill in the art. This decision, of course,
was not coincidental.
IRDP drastically altered the definition of the person of
ordinary skill in the art so
that even Dr. Bergerwithout a shred of relevant experiencemight
qualify.
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Case IPR2014-01259 Patent 7,879,828
18
Compare Apotex Petition at 12 (person of ordinary skill is a
chemist who has
three years of additional experience in pharmaceutical
formulation or a Ph.D.
degree in Pharmaceutical Sciences who is familiar with
pharmaceutical
formulation) with IRDP Petition at 13 (person of ordinary skill
is a chemist who
is familiar through experience or education with basic chemical
principles
relevant to pharmaceutical formulation). IRDPs effort to broaden
the person of
ordinary skill definition agreed to by all other parties in
cases involving the 828
patenta definition that necessarily includes at least some
experience in
pharmaceutical researchis a transparent attempt to put before
the Board
statements from an unqualified expert and, as such, should be
rejected.
Dr. Bergers lack of experience in the relevant field becomes
even clearer
when assessed in the context of the very specialized, technical
matters on which he
(by copying Apotexs expert) renders an opinion. Dr. Bergers
Declaration
addresses highly technical matters such as the chemical
structure of tigecycline and
processes and mechanisms related its degradation by
epimerization, and on that
basis includes opinions about whether prior artfrom the
perspective of a person
having ordinary skill in the artrenders the claims of the 828
patent invalid. See,
e.g., Berger Declaration, 19, 32, 51, 67, 81, 95, 106, 115. But,
as discussed
above, Dr. Berger asserts no experience with the stability of
drug molecules,
formulating drug products, epimerization, tigecycline,
tetracyclines, or any other
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Case IPR2014-01259 Patent 7,879,828
19
subject that relates to the issues of validity raised in the 828
patent. See Berger
CV. His specialty in synaptic transmission, Berger Declaration,
7, and
hypoglossal motoneurons, Berger CV, hardly could be less
relevant to the validity
of the 828 patent. See Envtl. Designs, Ltd. v. Union Oil Co. of
Cal., 713 F.2d 693,
697 (Fed. Cir. 1983) (person of ordinary skill is not one who
is, inter alia, skilled
in remote arts).6
Moreover, Dr. Bergers explanation about why he is qualified to
opine on
tigecycline instability and related degradation processes is
unconvincing, at best.
He points to his Ph.D. in Chemical Engineering and brief stints
as a research
engineer at Shell Development Company and as an assistant
professor of chemical
engineering at Rensselaer Polytechnic Institute. Berger
Declaration, 6. But
while Dr. Berger states that his education and work gained [him]
experience in
chemical engineering, he makes no statement that this experience
involved
tetracyclines, antibiotics, pharmaceuticals, or issues of drug
product instability. Id.
(In fact, his research engineer position involved Computer
Applications,
6 By way of comparison, the three technical experts who have
submitted
declarations in the Apotex trialDr. Mark Nelson (Apotexs
expert), Dr. Robert
Williams, and Dr. Lester Mitscherall have decades of experience
in the
pharmaceutical field.
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Case IPR2014-01259 Patent 7,879,828
20
Modeling and Analysis and he was only an assistant professor for
two years.
Berger CV at 67.) Furthermore, this wholly inapplicable
experience on which Dr.
Berger relies, which appears to have had nothing whatsoever to
do with
pharmaceuticals, ended forty-two years ago. Berger CV at 67. It
is simply not
credible that a three-year position as a chemical engineer at an
oil company
working on computer applications, and a two-year assistant
professorship during
the Nixon administration, somehow qualify a witness to opine on
the obviousness
of a patent directed to formulating a pharmaceutical product to
make it more stable
against epimerization.
Dr. Berger also attempts to shoehorn tetracycline expertise into
his
specialization by stating that he has gained experience with
numerous scientific
methods over the course of [his] career, including many of those
relevant to the
chemistry of the tetracycline class of antibiotics, explaining
that his past work has
exposed him to the analytical methods used in some of the prior
art, and that he
has previously studied and become familiar with large organic
molecule
stabilization. Berger Declaration, 7. Once again, any experience
in the
pharmaceutical area, or the stability of pharmaceutical
products, is glaringly
absent. Experience in scientific and analytical methods he deems
relevant
does not provide expertise to opine on whether certain
pharmaceutical antibiotic
compositions and processes are preempted by prior art.
Analytical methods can be
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Case IPR2014-01259 Patent 7,879,828
21
used to measure stability, but familiarity with an analytical
method is very different
with familiarity with the field of drug formulation and
techniques for improving
drug stability. Nor does stud[ying] and bec[oming] familiar with
certain topics
enable him to testify about the expectations and beliefs of a
person of ordinary
skill in the art in the field relevant to the validity of the
828 patent. See Envtl.
Designs, 713 F.2d at 697. In essence, Dr. Berger is a chemical
engineer with
expertise on nerves in the tongue (and no experience relating to
the formulation or
stability of pharmaceutical products) who reviewed materials (in
particular, a
declaration that he copied from an expert in the field) to
familiarize himself with a
field about which he knew essentially nothing and now attempts
to initiate a trial
on behalf of the company he owns.7
A petition that relies solely on a declaration from such an
expert cannot
possibly meet the governing standard of demonstrating a
reasonable likelihood
of prevailing at trial. See KSR Intl Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007)
([S]ome rational underpinning [must] support the legal
conclusion of
obviousness. (citation omitted)). Dr. Bergers obvious lack of
relevant expertise
7 Dr. Bergers position as founder and president of IRDP calls
his credibility into
question, but because his obvious bias is a proper subject for
cross-examination,
Wyeth does not raise it in this Preliminary Response.
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Case IPR2014-01259 Patent 7,879,828
22
explains his decision to copy the opinions in Dr. Nelsons
Declaration (many of
which have been disavowed by Dr. Nelson himself). That Dr.
Berger copied his
Declaration provides further reason, were it required, not to
credit this evidence.
See, e.g., Hunt v. McNeil Consumer Healthcare, 297 F.R.D. 268,
274-75 (E.D. La.
2014) (excluding expert testimony on causation from trial
because expert merely
parroted the opinions and conclusions of other experts);
Cholakyan v. Mercedes-
Benz USA, LLC, 281 F.R.D. 534, 545-46 (C.D. Cal. 2012)
(excluding as unreliable
expert declaration from class certification determination
because it was
reproduced . . . wholesale from another experts). The Board
should give no
credit to Dr. Bergers Declaration because he lacks expertise in
the relevant field.
Were Dr. Bergers Declaration accepted to establish the
requisite
reasonable likelihood of proving invalidity, and trial initiated
on that basis, then
trial could be instituted on the basis of a declaration from any
witness who
photocopies the declaration of an actual expert in the relevant
field and affixes his
signature. The Board should not initiate a costly trial on the
basis of a Declaration
from IRDPs patently unqualified owner and thereby reward and
incentivize the
mischief in which IRDP has engaged.
IV. Conclusion
For the foregoing reasons, the Board should deny IRDPs Petition
and
decline to institute IPR of the 828 patent.
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Case IPR2014-01259 Patent 7,879,828
23
Dated: November 21, 2014 Respectfully submitted,
/David I. Berl/ Stanley E. Fisher Lead Attorney for Wyeth LLC
Reg. No. 55,820 David I. Berl Backup Attorney for Wyeth LLC Reg.
No. 72,751 Williams & Connolly LLP 725 Twelfth Street, N.W.
Washington, DC 20005 Phone: 202-434-5491
-
Case IPR2014-01259 Patent 7,879,828
CERTIFICATE OF SERVICE
The undersigned hereby certifies that the above-captioned Patent
Owner
Wyeth LLCs Preliminary Response was served on November 21, 2014,
by filing
this document through the Patent Review Processing System as
well as delivering
a copy via electronic mail upon the following attorneys of
record for the Petitioner:
Amir Naini [email protected] Jay Chung [email protected] Russ
August & Kabat 12421 Wilshire Blvd., 12th Fl. Los Angeles, CA
90025
Dated: November 21, 2014 Respectfully submitted,
/David I. Berl/ David I. Berl Backup Attorney for Wyeth LLC Reg.
No. 72,751 Williams & Connolly LLP 725 Twelfth Street, N.W.
Washington, DC 20005 Phone: 202-434-5491