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Patent 7,879,828
Case IPR2014-01259
Patent 7,879,828
Case IPR2014-01259
Patent 7,879,828
TABLE OF CONTENTS
I.
II.
III.
IV.
A.
B.
Argument ......................................................................................................... 7
A.
B.
C.
D.
Conclusion ..................................................................................................... 22
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TABLE OF AUTHORITIES
CASES
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Case IPR2014-01259
I.
Patent 7,879,828
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. IPR201400115). 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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II.
Patent 7,879,828
Related Proceedings
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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
References herein to Apotex Exhibits refer to exhibits from the Apotex trial.
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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.
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. IPR201401259, 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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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
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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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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
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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,
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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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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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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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.
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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In any event, given that offering not to file petitions in exchange for valuable
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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.
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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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,
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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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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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
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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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. MercedesBenz 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
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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
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CERTIFICATE OF SERVICE
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