Trials@uspto.gov Paper 8 571-272-7822 Date: February 13, 2015

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 No. 7,879,828 B2

____________

Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and JO-ANNE M. KOKOSKI, Administrative Patent Judges. CRUMBLEY, Administrative Patent Judge.

DECISION Denying Institution of Inter Partes Review

37 C.F.R. 42.108

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I. INTRODUCTION The Initiative for Responsibility in Drug Pricing (IDRP) filed a

Petition seeking inter partes review of claims 123 of U.S. Patent No.

7,879,828 B2 (Ex. 1001, the 828 patent). Paper 1, Pet. The owner of

the 828 patent, Wyeth LLC, filed a Patent Owner Preliminary Response.

Paper 7, Prelim. Resp. Pursuant to 35 U.S.C. 314(a), we may not

institute an inter partes review unless the Director1 determines that the

information presented in the petition . . . and any response . . . shows that

there is a reasonable likelihood that the petitioner would prevail with respect

to at least 1 of the claims challenged in the petition. For the reasons that

follow, the Board does not institute an inter partes review.

A. Related Matter: Case IPR2014-00115

Over a year ago, Apotex Inc. filed a petition requesting an inter partes

review of claims 123 of the 828 patent. IPR2014-00115, Paper 1 (115

Petition). On April 21, 2014, the Board instituted review of claims 123

based on the 115 Petition. IPR2014-00115, Paper 10 (115 Decision).

Oral hearing was held in IPR2014-00115 on January 23, 2015, and, barring

termination, a final written decision as to the patentability of claims 123

will issue on or before April 21, 2015.

1 The Board institutes the trial on behalf of the Director. 37 C.F.R. 42.4(a).

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B. The 828 Patent

The 828 patent, titled Tigecycline Compositions and Methods of

Preparation, is directed to compositions comprising tigecycline, a suitable

carbohydrate, and an acid or buffer. Ex. 1001, 1:812. Tigecycline, a

chemical analog of minocycline, is a tetracycline antibiotic used to treat

drug-resistant bacteria. Id. at 1:2225. Due to poor oral bioavailability,

tigecycline typically is formulated as an intravenous solution that is prepared

from a lyophilized tigecycline powder immediately prior to administration.

Id. at 1:4550. In solution, tigecycline undergoes oxidation at slightly basic

pH, causing the tigecycline to degrade relatively rapidly. Id. at 2:2426, 33

40. When the pH of the solution is lowered, however, oxidative degradation

decreases, and degradation by epimerization predominates. Id. at 2:4349.

The tigecycline epimer lacks antibacterial effect, and is, thus, an undesirable

degradation product. Id. at 3:1922. According to the 828 patent, the

claimed compositions reduce tigecycline degradation, because the acidic pH

of the solution comprising tigecycline and a suitable carbohydrate minimizes

oxidative degradation, while the carbohydrate stabilizes the tigecycline

against epimerization in the acidic solution. Id. at 4:4959.

The specification of the 828 patent discloses various embodiments,

such as compositions comprising tigecycline, lactose, and hydrochloric acid,

at pH values between 3.0 and 7.0. Id. at 7:6310:35, 11:1512:53. The

specification further discloses embodiments where the molar ratio of

tigecycline to lactose varies between 1:0.24 and 1:4.87. Id. at 13:4014:33.

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C. Prior Art Relied Upon

IRDP relies upon the following prior art references: Chinese Patent Publication No. 1390550A, published January 15, 2003 (CN 550). (Ex. 1003 and Ex. 1004 (English translation)).

E. Pawelczyk et al., Kinetics of Drug Decomposition. Part 74. Kinetics of Degradation of Minocycline in Aqueous Solution, POL. J. PHARMACOL. PHARMA. 34:409-421 (1982) (Pawelczyk). (Ex. 1006).

V. Naggar et al., Effect of Solubilizers on the Stability of Tetracycline, PHARMAZIE 29(2) 126-129 (1974) (Naggar). (Ex. 1007).

IRDP asserts that all three references are prior art to the 828 patent

under 35 U.S.C. 102(b). Pet. 27.

D. The Asserted Ground

IRDP asserts the following ground of unpatentability (Id.):

Claims Basis References

123 103 CN 550, Pawelczyk, and Naggar

Notably, this ground of unpatentability is identical to the ground upon

which we instituted inter partes review in IPR2014-00115. 115 Decision, 9.

II. ANALYSIS Congress did not mandate that an inter partes review must be

instituted under certain conditions. Rather, by stating that the Directorand

by extension, the Boardmay not institute review unless certain conditions

are met, Congress made institution discretionary. Intelligent Bio-Systems,

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Inc. v. Illumina Cambridge Ltd., Case IPR2013-00324, slip op. 4

(PTAB Nov. 21, 2013) (Paper 19). Our discretion is guided by 35 U.S.C.

325(d), which reads as follows (emphasis added):

MULTIPLE PROCEEDINGS -- Notwithstanding sections 135(a), 251, and 252, and chapter 30, during 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 under this chapter, chapter 30, or chapter 31, 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.2 Several factors counsel against institution in the present case. As we

noted above, in the 115 Decision, we instituted inter partes review of claims

123 of the 828 patent on the same ground presented in the instant Petition.

The Petition, therefore, presents the same art previously presented to the

Office in IPR2014-00115.

IRDP notes that its Petition adopts the grounds of invalidity

advanced by Apotex and repeat[s] the language of Apotexs petition when

appropriate. Pet. 1. IRDP, therefore, concedes that there is substantial

2 Although this provision appears in Chapter 32 of the Patent Act, which is directed to post-grant reviews, by its terms it is applicable also to proceedings under Chapter 31, which covers inter partes review proceedings.

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overlap between IRDPs arguments in this petition and Apotexs arguments

in IPR2014-00115. Id. at 2.

Furthermore, IRDP submits with its Petition the Declaration of

Dr. Albert J. Berger. Ex. 1002. As Wyeth notes, Dr. Bergers testimony is

substantially similar to that of the testimony of Dr. Mark L. Nelson,

submitted as Exhibit 1002 in IPR2014-00115. Prelim. Resp. 6. Dr. Berger

admits that his testimony repeats Dr. Nelsons testimony where

appropriate. Ex. 1003 34. Based on our review and the

characterization of the references in IRDPs petitions, the teachings of the

references relied on in the instant Petition are substantially similar, if not the

same, as those relied upon in the 115 Decision.

The instant Petition, therefore, presents the same or substantially the

same prior art [and] arguments [that] previously were presented to the

Office in the 115 Petition. Under 35 U.S.C. 325(d), this is a basis to

exercise our discretion to deny IRDPs Petition.

We also note that IRDP has not provided any justification for filing

the instant Petition, other than the possibility that Apotex and the Patent

Owner will settle and move to terminate IPR2014-00115 so that no written

decision issues for the 828 Patent in a timely fashion. Pet. 1. Given the

stage of the IPR2014-00115 proceeding, however, this possibility is remote.

As we noted above, oral argument has been held in IPR2014-00115,

increasing the odds that the Board will proceed to a final written decision

even if the parties were to settle.

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Nor was IRDPs Petition necessary to preserve its rights in the face of

an impending statutory bar. IRDP argues that it is not a pharmaceutical

company like Apotex and should be permitted to mount its own challenge to

the 828 Patent. Id. at 2. The fact that IRDP is not a pharmaceutical

company, however, counsels against institution in this case because it

drastically reduces the possibility that IRDP will be sued for infringement of

the 828 patent. As such, it is unlikely that a statutory bar under 35 U.S.C.

315(b) will arise to prevent IRDP from re-filing its Petition, even if the

Board were to terminate IPR2014-00115 prior to a final written decision.

Wyeth argues that institution of an inter partes review in this case

would be entirely duplicative and wasteful. Prelim. Resp. 6. On these

facts, and given the stage of the proceedings in IPR2014-00115, we agree.

In light of the foregoing, and exercising our discretion under 35 U.S.C.

314(a) and 325(d), and 37 C.F.R. 42.108(b), we decline to institute an

inter partes review in the instant proceeding.

III. ORDER Accordingly, it is

ORDERED that the petition is denied as to all challenged claims of

the 828 patent.

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For Petitioner:

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

For Patent Owner:

Stanley E. Fisher sfisher@wc.com David Berl dberl@wc.com

Galina Fomenkova gfomenkova@wc.com