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

Case IPR2014-01259 Patent 7,879,828

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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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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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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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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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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

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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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:

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.

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,

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

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.

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.

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

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

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,

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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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

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.

Case IPR2014-01259 Patent 7,879,828

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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.

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.

Case IPR2014-01259 Patent 7,879,828

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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.

Case IPR2014-01259 Patent 7,879,828

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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

Case IPR2014-01259 Patent 7,879,828

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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,

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.

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

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.

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.

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 anaini@raklaw.com Jay Chung jchung@raklaw.com 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