Initiative for Responsibility in Drug Pricing LLCv.Wyeth LLC

Patent Trial and Appeal Board

Feb 13, 2015

11374330 (P.T.A.B. Feb. 13, 2015)

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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Patent No. 7,879,828 B2

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I. INTRODUCTION
The Initiative for Responsibility in Drug Pricing (“IDRP”) filed a
Petition seeking inter partes review of claims 1–23 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 1–23 of the ’828 patent. IPR2014-00115, Paper 1 (“115
Petition”). On April 21, 2014, the Board instituted review of claims 1–23
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 1–23
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, 1:8–12. Tigecycline, a
chemical analog of minocycline, is a tetracycline antibiotic used to treat
drug-resistant bacteria. Id. at 1:22–25. 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 1:45–50. In solution, tigecycline undergoes oxidation at slightly basic
pH, causing the tigecycline to degrade relatively rapidly. Id. at 2:24–26, 33–
40. When the pH of the solution is lowered, however, oxidative degradation
decreases, and degradation by epimerization predominates. Id. at 2:43–49.
The tigecycline epimer lacks antibacterial effect, and is, thus, an undesirable
degradation product. Id. at 3:19–22. 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 4:49–59.
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 7:63–10:35, 11:15–12:53. The
specification further discloses embodiments where the molar ratio of
tigecycline to lactose varies between 1:0.24 and 1:4.87. Id. at 13:40–14:33.
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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
1–23 § 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 Director—and
by extension, the Board—may 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
1–23 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 Apotex’s 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 IRDP’s arguments in this petition and Apotex’s 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. Berger’s 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. Nelson’s testimony “where
appropriate.” Ex. 1003 ¶¶ 3–4. Based on our review and the
characterization of the references in IRDP’s 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 IRDP’s 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 IRDP’s 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