[email protected] paper 19 tel: 571-272-7822 entered: july 28,...
TRANSCRIPT
[email protected] Paper 19
Tel: 571-272-7822 Entered: July 28, 2015
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
PAR PHARMACEUTICAL, INC. and AMNEAL PHARMACEUTICALS,
LLC,
Petitioners,
v.
JAZZ PHARMACEUTICALS, INC.,
Patent Owner.
_____________
Case IPR2015-00551 (Patent 8,457,988 B1)
Case IPR2015-00554 (Patent 7,668,730 B2)1
______________
Before JACQUELINE WRIGHT BONILLA, SUSAN L.C. MITCHELL,
and BRIAN P. MURPHY, Administrative Patent Judges.
MURPHY, Administrative Patent Judge.
DECISION
Institution of InterPartes Review
37 C.F.R. § 42.108
1 This Decision addresses common issues raised in both cases. The patents
at issue in Case IPR2015-00551 and Case IPR2015-00554 are related, and
the arguments by Petitioners and Patent Owner are largely the same in each
case. Therefore, we issue one Decision to be entered in each case. The
parties are not authorized to use this caption without prior authorization of
the Board.
IPR2015-00551 (Patent 8,457,988 B1)
IPR2015-00554 (Patent 7,668,730 B2)
2
I. INTRODUCTION
Par Pharmaceutical, Inc. (“Par Inc.”), and Amneal Pharmaceuticals,
LLC (“Amneal”) (together, “Petitioner”) filed a Petition requesting an inter
partes review of claims 1–11 (all claims) of U.S. Patent No. 7,668,730 B2
(Ex. 1001, “the ’730 patent”). Paper 1 (“Petition” or “Pet.”). Jazz
Pharmaceuticals, Inc. (“Patent Owner”) filed a Preliminary Response to the
Petition. Paper 10 (“Prelim. Resp.”). Petitioner also filed a Petition
requesting an inter partes review of claims 1–15 (all claims) of U.S. Patent
No. 8,457,988 B1 (“the ’988 patent”). IPR2015-00551, Paper 1 (“the ’551
Petition” or “’551 Pet.”). Patent Owner filed a Preliminary Response to the
Petition. IPR2015-00551, Paper 9 (“’551 Prelim. Resp.”). Because the
challenged claims in these two cases are very similar, with the exception of
preambles, we consider the two cases together in this Decision. For clarity
and expediency, we treat IPR2015-00554 as representative of both cases.
We have statutory authority under 35 U.S.C. § 314(a), which provides that
an inter partes review may not be instituted “unless . . . there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.”
Petitioner challenges claims 1–11 of the ’730 patent as unpatentable
under 35 U.S.C. § 103(a). Pet. 11–12.2 Based on the information presented
in the Petition and Preliminary Response, we are persuaded there is a
reasonable likelihood Petitioner would prevail with respect to the claims
2 As noted above, for clarity and expediency, we treat IPR2015-00554 as
representative of both cases. All citations are to IPR2015-00554 unless
otherwise noted. Petitioner also challenges claims 1–15 of the ’988 patent as
unpatentable under 35 U.S.C. § 103(a). ’551 Pet. 2.
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3
challenged in the Petition and the ’551 Petition. Therefore, we institute inter
partes review of claims 1–11 of the ’730 patent and claims 1–15 of the ’988
patent.
A. Related Proceedings
The parties identify the following as related district court proceedings
regarding the ’730 patent: Jazz Pharmaceuticals, Inc. v. Roxane
Laboratories, Inc., 2:10-cv-6108 (D.N.J.); Jazz Pharmaceuticals, Inc. v.
Amneal Pharmaceuticals, LLC, 2:13-cv-391(consolidated) (D.N.J.); Jazz
Pharmaceuticals, Inc. v. Ranbaxy Laboratories Ltd., 2:14-cv-4467 (D.N.J.);
and Jazz Pharmaceuticals, Inc. v. Watson Laboratories, Inc., 2:14-cv-7757
(D.N.J). Pet. 58; Paper 8, 1. Patent Owner identifies two other district court
proceedings concerning patents related to the ’730 patent: Jazz
Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 2:14-cv-3235
(D.N.J.) and Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., 2:14-
cv-5139 (D.N.J.). Paper 8, 2.
The parties identify the following as petitions for inter partes review
of patents related to the ’730 patent: IPR2015-00545 (Patent 8,589,182);
IPR2015-00546 (Patent 7,765,106); IPR2015-00547 (Patent 7,765,107);
IPR2015-00548 (Patent 7,895,059); and IPR2015-00551 (Patent 8,457,988.
Pet. 58–59; Paper 8, 2. The parties also identify the following as petitions
for covered business method patent review regarding the ’730 patent and
related patents: CBM2014-00149 (Patent 7,895,059); CBM2014-00150
(Patent 8,457,988); CBM2014-00151 (the ’730 patent); CBM2014-00153
(Patent 8,589,182); CBM2014-00161 (Patent 7,765,106); and CBM2014-
00175 (Patent 7,765,107). Pet. 58; Paper 8, 2–3.
IPR2015-00551 (Patent 8,457,988 B1)
IPR2015-00554 (Patent 7,668,730 B2)
4
We note that the Board has denied institution in all six of the above-
mentioned CBM cases. In addition, a different petitioner has filed a Petition
for inter partes review of related U.S. Patent No. 7,895,059 in IPR2015-
01018.
Patent Owner identifies the following pending U.S. patent
applications claiming priority benefit from U.S. Patent Application No.
10/322,348—the application from which the ’730 patent issued: U.S. Patent
Application No. 14/196,603, filed March 4, 2014; U.S. Patent Application
No. 14/219,904, filed March 19, 2014; and U.S. Patent Application No.
14/219,941, filed March 19, 2014. Paper 8, 3.
B. Proposed Grounds of Unpatentability
Petitioner advances two grounds of unpatentability under 35 U.S.C.
§ 103(a) in relation to all challenged claims in the ’730 patent and the ’988
patent (IPR2015-00551): 3
3 Petitioner advances additional grounds of unpatentability for obviousness
of claims 2 and 10 of the ’988 patent, addressed separately below in Section
II. G.
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Reference[s] Statutory
Basis
Challenged
Claims
Advisory Committee Art (Exs. 1003–
1006), including FDA Advisory
Committee Transcript and Slides (Ex.
1003),4 Preclinical Safety Review (Ex.
1004),5 Briefing Booklet (Ex. 1005),
6 and
Xyrem Video and Transcript (Ex. 1006)7
§ 103(a) 1–11 of the
’730 patent
Talk About Sleep (Ex.1033)8 in view of
Honigfeld (Ex. 1034),9 Elsayed (Ex.
1035),10
and Lilly (Ex. 1010)11
§ 103(a) Same as above
4 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
Transcript and Slides (“Advisory Committee Transcript and Slides”) (July
13, 2001) (Ex. 1003). 5 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
Briefing Information, Division of Neuropharmacological Drug Products
Preliminary Clinical Safety Review of NDA 21-196 (“Preclinical Safety
Review”) (July 13, 2001) (Ex. 1004). 6 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
Briefing Information, Briefing Booklet (“Briefing Booklet”) (July 13, 2001)
(Ex. 1005). 7 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
Briefing Information, Xyrem Prescription and Distribution Process Video
and Transcript (“Xyrem Video and Transcript”) (July 13, 2001) (Ex. 1006). 8 Talk About Sleep, “An Interview with Orphan Medical about Xyrem®,”
available at http://www.talkaboutsleep.com/an-interview-with-orphan-
medical-about-xyrem/ (“Talk About Sleep”) (Feb. 12, 2001) (Ex. 1033). 9 Honigfeld et al., “Reducing Clozapine-Related Morbidity and Mortality: 5
Years of Experience with the Clozaril National Registry,” J. Clin. Psych. 59
(suppl. 3): 3–7 (1998) (“Honigfeld”) (Ex. 1034). 10
Elsayed et al., U.S. Patent No. 6,045,501, filed Aug. 28, 1998, issued
Apr. 4, 2000 (“Elsayed”) (Ex. 1035). 11
Lilly et al., U.S. Patent Appl. Pub. No. 2004/0176985, filed Mar. 18,
2004, published Sept. 9, 2004 (“Lilly”) (Ex. 1010).
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In addition, Petitioner supports its challenges in each case with a
Declaration by Robert J. Valuck, Ph.D., R.Ph. (“Valuck Decl.”) (Ex. 1007).
C. The ’730 Patent
The ’730 patent, titled “Sensitive Drug Distribution System and
Method,” issued February 23, 2010 from an application filed December 17,
2002. Ex. 1001.12
The ’730 patent is directed to a method for controlling
access to a sensitive prescription drug prone to potential abuse or diversion,
by utilizing a central pharmacy and database to track all prescriptions for the
sensitive drug. Id. at Abstract, 1:38–42. Information regarding all
physicians authorized to prescribe the drug and all patients receiving the
drug is maintained in the database. Id. Abuses are identified by monitoring
the database for prescription patterns by physicians and prescriptions
obtained by patients. Id. at Abstract, 1:42–44.
Figures 2A, 2B, and 2C comprise flow charts representing “an initial
prescription order entry process for a sensitive drug.” Id. at 4:7–8. In
overview, a physician submits prescriber, patient, and prescription
information for the sensitive drug to a pharmacy team, which enters the
information into a computer database. Id. at 4:7–25, Fig. 2A (steps 202–
210). The pharmacy team then engages in “intake reimbursement” (Fig.
2A), which includes verification of insurance coverage or the patient’s
willingness and ability to pay for the prescription drug. Id. at 4:26–28.
Steps 226–230, 234–238 of Figure 2A are reproduced below:
12
The ’730 patent issued from patent application US 10/322,348 (“the ’348
application”). Ex. 1001.
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Figure 2A, above, depicts steps for verifying insurance coverage or
ability to pay. Id. at 2:22–24, 4:45–61. The “pharmacy” workflow also
includes verification of the prescribing physician’s credentials. Id. at 5:9–
26, Fig. 2B (steps 274–280). Filling the prescription includes confirming the
patient has read educational materials regarding the sensitive drug,
confirming the patient’s receipt of the sensitive drug, and daily cycle
counting and inventory reconciliation. Id. at 5:27–67. Steps 240, 242, 246,
and 258–266 of Figure 2C, are reproduced below.
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IPR2015-00554 (Patent 7,668,730 B2)
8
. . .
Figure 2C, above, depicts a portion of a prescription fulfillment flow
diagram. Id. at Fig. 2C. The “CHiPS” system, referenced in steps 260 and
266, is an application database “used to maintain a record of a client home
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9
infusion program (CHIP) for Xyrem®.”13
Id. at 4:28–33. If a patient
requests an early prescription refill, for example, the pharmacist generates a
report evaluating “the patient’s compliance with therapy or possible product
diversion, misuse or over-use.” Id. at 6:33–38, Fig. 4B (step 436).
D. Illustrative Claim
The ’730 patent contains multiple independent claims (1, 2, and 7–11)
and several dependent claims (3–6), of which claim 1 is illustrative and
reproduced below:
The invention claimed is:
1. A computerized method of distributing a prescription
drug under exclusive control of an exclusive central pharmacy,
the method comprising:
receiving in a computer processor all prescription requests,
for any and all patients being prescribed the prescription drug,
only at the exclusive central pharmacy from any and all medical
doctors allowed to prescribe the prescription drug, the prescription
requests containing information identifying patients, the prescription
drug, and various credentials of the any and all medical doctors;
requiring entering of the information into an exclusive
computer database associated with the exclusive central
pharmacy for analysis of potential abuse situations, such
that all prescriptions for the prescription drug are processed
only by the exclusive central pharmacy using
only the exclusive computer database;
checking with the computer processor the credentials of
the any and all doctors to determine the eligibility of the
doctors to prescribe the prescription drug;
13
Xyrem® is the brand name for gamma hydroxy butyrate (“GBH”),
indicated for the treatment of cataplexy (excessive daytime sleepiness) in
narcoleptic patients. Ex. 1001, 3:14–19. Xyrem® is a sensitive prescription
drug prone to potential abuse or diversion. Id.
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confirming with a patient that educational material has
been read prior to shipping the prescription drug;
checking the exclusive computer database for potential
abuse of the prescription drug;
mailing the prescription drug to the patient only if no
potential abuse is found by the patient to whom the
prescription drug is prescribed and the doctor prescribing
the prescription drug;
confirming receipt by the patient of the prescription drug;
and
generating with the computer processor periodic reports
via the exclusive computer database to evaluate potential
diversion patterns.14
II. ANALYSIS
A. Real-Parties-in-Interest
Patent Owner asserts that the Petition incorrectly identifies Amneal
and Par Inc. as the only real parties-in-interest. Prelim. Resp. 9. Patent
Owner argues that to comply with statutory requirements under 35 U.S.C.
§ 312(a)(2), the Petition also should have identified all parent companies of
Par Inc., i.e., Par Pharmaceutical Companies, Inc. (“Par Co.”), Par
Pharmaceutical Holdings, Inc. (“Par Holdings”), Sky Growth Intermediate
14
The preamble of the independent claims in the ’988 patent recites a
“method of treatment of a narcoleptic patient . . . while controlling potential
misuse, abuse or diversion of said prescription drug, comprising.” IPR2015-
00551 Ex. 1001, 8:38–40. The method steps recited in the independent
claims of the ’988 patent are very similar to the method steps recited in the
independent claims of the ’730 patent, such that the analysis concerning
claim construction and the grounds is similar.
IPR2015-00551 (Patent 8,457,988 B1)
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Holdings I Corporation (“Sky I”), and Sky Growth Intermediate Holdings II
Corporation (“Sky II”), collectively “Par parents” or “parent” companies.
Id. at 9–23. Patent Owner contends that because the Petition fails to name
all real parties-in-interest, the Petition’s filing date should be vacated. Id. at
9, 21. Patent Owner requests, therefore, that we dismiss the Petition as
untimely under 35 U.S.C. § 315(b), which states that we may not institute an
inter partes review if the Petition is filed more than one year after the
Petitioner or any real party-in-interest is served with a complaint alleging
infringement of the patent. Id. at 9, 22–23.
1. Patent Owner’s Contentions
Patent Owner asserts, in particular, that “Par Inc.’s parent companies
exercise control over Par Inc.’s business, including control over this IPR
proceeding.” Id. at 9, 11–20. Patent Owner contends the evidence
establishes that Par Inc. and its parent companies do not maintain well-
defined corporate boundaries and act as a single unit, controlled by a single
master. Id. at 12–16. Patent Owner points to financial disclosure documents
indicating that Par Inc. and its parents refer to themselves and act
collectively as “we,” that the companies undertake acquisitions as a single
unit, and that the companies operate from a single website that does not
differentiate among them. Id. at 13–15 (citing Ex. 2016, 8–9, 12, 38–40; Ex.
2015, 5, 207, 209, 224; Ex. 2019); id. at 19–20 (citing Ex. 2015, 122, 127;
Ex. 2016, 33, 36). Patent Owner provides further evidence that Par
Holdings has “no independent operations or material assets other than [Par
Holdings’] ownership of equity interest in [its] subsidiaries,” and depends on
its subsidiaries “to distribute funds to use so that [Par Holdings] may pay
[its] obligations and expenses.” Id. at 15, 19 (citing Ex. 2015, 45; see also id.
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at 51 (“[O]ur ability to pay dividends . . . will be dependent upon cash
dividends and distributions or other transfer from our subsidiaries, including
from [Par Inc.]”)).
Patent Owner also cites evidence indicating that Par Inc. and its parent
companies share the same corporate officers, and that Par Holdings and Par
Inc. share the same principal place of business. Id. at 15, 16 (citing Ex.
2020; Ex. 2015, 13, 133, 143, 154, 55; Ex. 2021, 28; Paper 3, 2). Patent
Owner further contends that an in-house attorney participating in this case is
employed by Par Co., not Par Inc., as evidenced by a printed page from
LinkedIn, and that Par Inc.’s outside counsel in this IPR proceeding also acts
as outside counsel for Par Co. in unrelated district court litigation. Id. at 20
(citing Ex. 2025; Ex. 2026, 16; Ex. 2027, 19).
Patent Owner argues that because “Par Inc. and its parent companies
blur the lines of corporate separation, such that the entities operate as a
single unit,” “[e]ach has the ability to control (and does control) this IPR.”
Id. at 16.
2. Petitioner’s Response
In its response addressing the real-parties-in-interest (“RPI”) issue
(Paper 12, “Pet. RPI Resp.”), Petitioner relies on the Declaration of Mr.
Barry Gilman, Deputy General Counsel and Secretary for Par Inc. (Ex. 1040
¶ 1). Petitioner confirms that Par Inc. is a wholly-owned subsidiary of a
series of holding companies, i.e., the Par parents discussed above. Pet. RPI
Resp. 2 (citing Ex. 1040 ¶¶ 2). Petitioner states that Par Inc. makes, sells,
and distributes pharmaceuticals, and that Par Inc. prepared and filed the
abbreviated new drug application (“ANDA”) for a generic form of Xyrem
that led to the co-pending district court action filed by Patent Owner against
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Par Inc. Id. at 2–3 (citing Ex. 1040 ¶¶ 2–5). By contrast, the Par parents “do
not conduct any such operations.” Id. at 2 (citing Ex. 1040 ¶¶ 2–4).
Consistently, Patent Owner has not sued any of Par Inc.’s parent companies
for infringement of the challenged patent. Id. at 3–4 (citing Ex. 1040 ¶ 6);
Ex. 1026).
In response to Patent Owner’s contention that Par Inc. and its parent
companies “hold themselves out as a single unit” based on statements in
financial disclosure documents, Petitioner argues that “using these generic
descriptors in such documents is commonplace.” Id. at 5 (quoting Prelim.
Resp. 13). In addition, even assuming Par Inc. and its parents act as a single
unit, Petitioner argues that such parent/subsidiary relationships are
inadequate to show sufficient opportunity to control this IPR proceeding. Id.
at 6. Petitioner contends that Par Inc. was the only party responsible for
directing, controlling, and funding the preparation and filing of the Petition,
and none of the Par parents participated in any of those activities. Id. at 4
(citing Ex. 1040 ¶ 6), 7 (citing Ex. 1040 ¶ 7). According to Petitioner, the
“opportunity for control was simply not present.” Id. at 7.
3. Analysis
A patent owner challenging a petitioner’s RPI disclosure must provide
sufficient evidence to show the disclosure is inadequate. Intellectual
Ventures Mgmt., LLC v. Xilinx, Inc., Case IPR2012-00018, slip op. at 3
(PTAB Jan. 24, 2013) (Paper 12). When a patent owner provides sufficient
evidence prior to institution that reasonably brings into question the
accuracy of a petitioner’s identification of real parties-in-interest, the overall
burden remains with the petitioner to establish that it has complied with the
statutory requirement to identify all real parties-in-interest. Zerto, Inc. v.
IPR2015-00551 (Patent 8,457,988 B1)
IPR2015-00554 (Patent 7,668,730 B2)
14
EMC Corp., Case IPR2014-01254, slip op. at 6–7 (PTAB Feb 12, 2015)
(Paper 32).
The RPI requirement exists to ensure that a non-party is not “litigating
through a proxy.” See Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc.,
Case IPR2014-01288, slip op. at 12 (PTAB Feb. 20, 2015) (Paper 13). The
RPI analysis, moreover, is an inquiry into the “relationship between a party
and a proceeding;” not “the relationship between parties.” Id. at 11. Thus,
our focus “is on the degree of control the nonparty could exert over the inter
partes review, not the petitioner.” Id.
As stated in the Office Patent Trial Practice Guide, whether a party
who is not a named participant in a given proceeding is a “real party-in-
interest” to that proceeding “is a highly fact-dependent question.” 77 Fed.
Reg. 48,756, 48,759 (Aug. 14, 2012) (Trial Practice Guide). There is no
“bright line test.” Id. Considerations may include whether a non-party
“funds and directs and controls” an IPR petition or proceeding; the non-
party’s relationship with the petitioner; the non-party’s relationship to the
petition itself, including the nature and/or degree of involvement in the
filing; and the nature of the entity filing the petition. Id. at 48,760. A party
does not become a “real party-in-interest” merely through association with
another party in an endeavor unrelated to the AIA proceeding. Id.
A non-party’s participation with a petitioner may be overt or covert,
and the evidence may be direct or circumstantial, but the evidence as a
whole must show that the non-party possessed effective control over the
inter partes review (“IPR”) proceeding. Zoll Lifecor Corp. v. Philips Elec.
N. Am. Corp., Case IPR2013-00609, slip op. at 10 (PTAB Mar. 20, 2014)
(Paper 15).
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With regard to the funding, direction, and control of the Petition and
this IPR proceeding, we begin with Petitioner’s evidence that Par Inc.: (i) is
the only operating company among the asserted real parties-in-interest; (ii)
“solely prepared and filed” the ANDA that precipitated the co-pending
patent infringement action filed by Patent Owner against Par Inc.; (iii) was
“the sole Par entity responsible for directing, controlling, and funding” the
preparation and filing of the Petition in this IPR proceeding; and (iv) “was
the only Par entity that paid any filing or legal fees associated with . . . the
instant Petitions.” Pet. RPI Resp. 2–4, 7 (citing Ex. 1040 ¶¶ 2–7). Evidence
also indicates that none of the Par parents “participated in the decision to
file” the Petition or “exercise[d] any control over the filing or content” of the
Petition. Id. at 7 (citing Ex. 1040 ¶ 7). The evidence further indicates that
Patent Owner has not filed suit alleging infringement of the challenged
patent against any of the Par parents and that none of the Par parents has
intervened in the co-pending patent infringement action or sought a
declaratory judgment of invalidity of the challenged patent. Id. at 7–8
(citing Ex. 1040 ¶ 8). Patent Owner does not cite contradictory or
inconsistent evidence. Papers 17, 18, Patent Owner Reply to Pet. RPI Resp.
(“PO RPI Reply”) 1–5.
With regard to the relationship among Par Inc. and the Par parents, we
accept Patent Owner’s evidence that Par Inc. and its parents, in certain
capacities, act as a single unit. Such a parent-subsidiary relationship where
“it is difficult for both insiders and outsiders to determine precisely where
one ends and another begins,” however, is only one factor that weighs in
favor of finding a parent company to be a real party-in-interest. Atlanta Gas
Light Co. v. Bennett Regulator Guards, Inc., Case IPR2013-00453, slip op.
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16
at 11 (PTAB January 6, 2015) (Paper 88). Petitioner, moreover, provides
evidence establishing that all Par parent companies are non-operational
holding companies that do not engage in the manufacture, distribution, or
sale of drugs. Ex. 1040 ¶¶ 2–4, 8.
The evidence also indicates that the holding companies do not
generate any revenues themselves (outside of revenues generated by Par
Inc.), nor have legal departments of their own. Ex. 2033 (deposition
transcript of Mr. Gilman), 52:16–53:3, 39:2–8, 40:11–18; see also Prelim.
Resp. 15 (noting that Par Holdings describes itself publicly as having “no
independent operations or material assets other than our ownership of equity
interest in our subsidiaries”), 18 (stating that Par Holdings admits that it
“will depend on our subsidiaries to distribute funds” to pay dividends); PO
RPI Reply 4 (stating that “Mr. Gilman admitted the Par Parents do not have
independent legal departments”).
Thus, this case is distinguishable from other cases where the Board
has found that “Petitioner’s actions have blurred sufficiently the lines of
corporate separation with its parent, [] such that [the parent] could have
controlled the filing and participation of the IPRs.” Zoll Lifecor Corp. v.
Philips Elec. N. Am. Corp., Case IPR2013-00606, slip op. at 10 (PTAB Mar.
20, 2014) (Paper 13) (“Zoll”). For example, in Zoll, the absence of
Petitioner’s management team and presence of the parent company’s
management team at a relevant, court-ordered mediation “suggest[ed] an
involved and controlling parent corporation representing the unified interests
of itself and Petitioner.” Id. In other words, evidence in Zoll indicated that
the parent company exerted control over the inter partes review.
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Here, in contrast to Zoll, the evidence indicates that Par Inc. calls the
shots as it pertains to the inter partes review and related litigations. If
anything, Par Inc. (rather than any parent) represents its own interests in this
IPR proceeding, even though those interests may inure, ultimately, to the
benefit of one or more of its parent companies. The evidence here indicates
that no parent company has the ability (e.g., via a legal department or
operations) to exert control over the IPR. Cf. GEA Process Eng’g. Inc. v.
Steuben Foods, Inc., Case IPR2014-00041 (PTAB Feb. 11, 2015) (Paper
140) (finding a nonparty that paid petitioner’s legal fees for an IPR to be a
real party-in-interest).
In Atlanta Gas, a panel of the Board addressed whether a parent
“holding company that . . . conducts substantially all of its operations
through its subsidiaries” was a real party-in-interest. Atlanta Gas, Case
IPR2013-00453, slip op. at 2–3, 9 (Paper 88). In that case, however, a sister
subsidiary company provided support services, such as legal services, to
subsidiaries of the parent, such as the petitioner. Id. at 2–3. In addition, a
corporate officer of the petitioner (and parent and other subsidiaries)
engaged in negotiations regarding indemnification on behalf of the parent
company and its subsidiaries, and worked with counsel for the parent
company when preparing for a deposition in the IPR. Id. at 3–6, 9–10. It
also was unclear who paid the filing fees and legal expenses associated with
the proceeding. Id. at 10–11. The panel found “the demonstrated
participation of officers and employees of [the parent] and [sister subsidiary]
and the lack of clarity over who actually financed filing fees and attorney
costs” to be significant when determining that the parent should have been
named as a real party-in-interest. Id. at 12–13.
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In Zerto, evidence indicated a parent and wholly own subsidiary had
“not maintained well-defined corporate boundaries,” and it was again
“unclear who paid the filing fees and legal expenses” associated with the
IPR. Zerto, Inc. v. EMC Corp., Case IPR2014-01254, slip op. at 13 (PTAB
Feb 12, 2015) (Paper 32). Moreover, evidence in that case included an inter-
company agreement with an indemnification clause indicating that the parent
would pay expenses for any action brought against the petitioner, as well as
equivocal testimony by the CEO of both companies on the issue of which
company controlled or funded the proceeding. Id. at 11–13; see also
Galderma S.A. v. Allergan Industrie, SAS, Case IPR2014-01422, slip op. at
12, 8–13 (PTAB Mar. 5, 2015) (Paper 14) (stating that “historical evidence
for a pattern of control by” the parent over a subsidiary distributor acquired
by the parent indicated that the parent had effective control over the
subsidiary).
Here, by contrast, the evidence indicates that Petitioner Par Inc. is the
only Par company with a legal department and the only Par company paying
relevant legal fees and expenses, such as those associated with this
proceeding. Prelim. Resp. 15 (citing Ex. 2015, 45); PO RPI Reply, 4 (citing
Ex. 2033, 52:16–53:3); Ex. 1040 ¶¶ 4, 7. Again, the evidence indicates that
no parent company of Par Inc. has had the ability (e.g., via a legal
department or operations) to control this IPR proceeding. Moreover, there is
insufficient evidence that Par Inc. has acted as a proxy for any Par parent in
this proceeding. See TRW Automotive U.S., LLC, v. Magna Elect. Inc., Case
IPR2014-01346, slip op. at 8 (PTAB Feb. 20, 2015) (Paper 7) (citing RPX
Corp. v. Virnetx, Inc., Case IPR2014-00171, slip op. at 6–10 (PTAB June
23, 2014) (Paper 49)).
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As noted in TRW Automotive, evidence that a parent “ʻconduct[s]
substantially all of [its] operations through subsidiaries’ [] is not persuasive
or sufficient evidence by itself to establish ʻan involved and controlling
parent corporation representing the unified interests of itself and
Petitioner.’” TRW Automotive, Case IPR2014-01346, slip op. at 7–8 (Paper
7) (quoting Zoll, Case IPR2013-00609, slip op. at 12 (Paper 15)); see also
Galderma, Case IPR2014-01422, slip op. at 12 (Paper 14) (noting “the
Board has not found the existence of a parent-subsidiary relationship alone
sufficient to justify a parent’s status as a real party-in-interest”). Similarly,
the fact that in-house counsel and corporate officers in this case may hold
themselves out in some instances as employees of Par Co., rather than Par
Inc., does not persuade us to find RPI status for the Par parents in this IPR
proceeding in view of the totality of the evidence before us. Prelim. Resp.
20; PO RPI Reply, 4–5 (citing Ex. 2033, 48:17–51:13, 53:4–60:18; Ex.
2025; Ex. 2037).
Thus, we are persuaded that the evidence of record sufficiently
establishes that none of the Par parent companies have had the ability to
exert control over Par Inc. in relation to this IPR, notwithstanding the
“parent” status of those companies. Petitioner has established that it has
complied with the statutory requirement to identify all real parties-in-
interest.
B. Claim Construction
For inter partes review, claim terms in an unexpired patent are given
their broadest reasonable interpretation in light of the patent specification.
37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 2015 WL 4097949
at *6–8 (Fed. Cir., July 8, 2015). Claim terms are given their ordinary and
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customary meaning, as would be understood by one of ordinary skill in the
art in the context of the entire disclosure. In re Translogic Tech., Inc.,
504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a claim
term must be set forth in the specification with reasonable clarity,
deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
1994).
Claim 1 of the ’730 patent claims a method of “distributing a
prescription drug” under “exclusive control” of an “exclusive central
pharmacy.” Ex. 1001, 8:38–40, 10:17–19. The claimed method recites
receiving all prescription requests “only at the exclusive central pharmacy,”
entering the physician, patient, and prescription information into an
“exclusive computer database,” and utilizing a series of checks and controls
to prevent “potential abuse” and “evaluate potential diversion patterns.” Id.
at 8:41–9:3. The series of checks and controls are claimed as follows:
“entering . . . information . . . for analysis of potential abuse situations;”
“checking . . . credentials . . . to determine the eligibility of the doctors to
prescribe the prescription drug;” “checking . . . for potential abuse of the
prescription drug;” “mailing the prescription drug to the patient only if no
potential abuse is found by the patient . . . and the doctor;” and “generating .
. . periodic reports . . . to evaluate potential diversion patterns.” Id. The
claimed method steps correspond to portions of the intake, pharmacy, and
prescription fulfillment workflows described in the patent. The claim as a
whole recites a method for controlling access to a prescription drug to guard
against potential abuse and unauthorized diversion.
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1. “exclusive central pharmacy” and “exclusive computer
database”
Petitioner emphasizes that, during prosecution of the application
leading to the ’730 patent, applicants defined the term “exclusive” as “single
or sole.” Pet. 10 (citing Ex. 1002, 577). Petitioner, therefore, argues for
constructions of the cited claim terms to mean “single or sole pharmacy” and
“single or sole database,” respectively. Id. Patent Owner does not address
Petitioner’s constructions.
The claim language is consistent with Petitioner’s proposed claim
constructions. The claims consistently recite actions involving “only” an
exclusive central pharmacy and “only” an exclusive computer database in an
effort to control access to a prescription drug and guard against potential
abuse and unauthorized diversion. Ex. 1001, 8:42, 52–53. The ’730 patent
specification does not elaborate on the definition of the exclusive central
pharmacy and exclusive computer database, but the prosecution history cited
by Petitioner is consistent with the claim constructions proposed by
Petitioner. See Microsoft Corp. v. Proxyconn, Inc., Nos. 2014-1542, 2014-
1543, 2015 WL 3747257, *3 (Fed. Cir. July 9, 2015) (“The PTO should also
consult the patent’s prosecution history in proceedings in which the patent
has been brought back to the agency for a second review.”).
Therefore, we construe “exclusive central pharmacy” to mean “single
or sole pharmacy,” and we construe “exclusive computer database” to mean
“single or sole computer database.”
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2. “generating with the computer processor periodic reports via
the exclusive computer database [to evaluate potential
diversion patterns]”
Petitioner highlights the quoted claim phrase without the bracketed
language and proposes the following construction: “querying the computer
database to obtain information, such as, prescriptions by physician,
prescriptions by patient name, prescriptions by frequency, and prescriptions
by dose.” Pet. 10–11 (citing Ex. 1001, 2:13–15, 7:53–67, 8:22–29; Ex. 1007
¶ 37). The bracketed language is part of the claim phrase at issue, and when
considered in context, requires amending Petitioner’s proposed construction.
Patent Owner does not address Petitioner’s argument.
Petitioner cites portions of the specification explaining, for example,
that “several queries and reports are run against the database to provide
information which might reveal potential abuse of the sensitive drug, such as
early refills.” Id. at 10 (citing Ex. 1001, 2:13–15). Figure 7 of the ’730
patent reflects prescriber, patient, prescription, and insurance information
input into the database, and Figures 13A–13C reflect various types of reports
that may be generated, including reports regarding “pharmacy,” “inventory,”
“reimbursement,” “patient care,” and “drug information.” Ex. 1001, 7:41–
48, 8:22–29, Figs. 7, 13A-C. A user generates reports by running various
queries through the exclusive computer database to obtain information of the
type illustrated. Id.
The recited use of the reports is “to evaluate potential diversion
patterns,” such as when a patient requests the same prescription from
multiple doctors, a patient requests an early prescription refill, or a
prescriber writes multiple prescriptions for a patient. Id. at 1:24–29, 2:13–
15. Figure 4B illustrates a refill request process that permits a pharmacist to
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identify an early refill request, generate a “risk diversion report,” and
evaluate “possible product diversion, misuse or over-use” of a prescription
drug. Id. at 6:33–39, Fig. 4B (406, 432, 434, 436). The ability of a
pharmacist or other user to evaluate potential diversion patterns from the
generated reports, in order to prevent product diversion, misuse, or abuse,
necessarily informs the types of reports generated and must be reflected in
the claim construction.
Therefore, we construe the phrase “generating with the computer
processor periodic reports via the exclusive computer database to evaluate
potential diversion patterns” to mean “querying the exclusive computer
database via the computer processor to generate periodic reports containing
prescriber, patient, and/or prescription related information that permits
evaluation of potential diversion, misuse, or abuse of a prescription drug.”
3. “the exclusive central pharmacy authorizing the company's
prescription drug to be dispensed to the narcoleptic patient by
another pharmacy”
Dependent claims 3 and 11 of the ’988 patent recite the quoted claim
phrase. IPR2015-00551, Ex. 1001, 9:19–23, 10:34–38. Petitioner, citing to
an embodiment described in the specification, asserts the phrase should be
construed to mean “making the prescription drug that was dispensed by the
central pharmacy available for pick-up by the patient at another pharmacy.”
Pet. 10–11 (citing Ex. 1001, 2:8–9). Patent Owner does not address
Petitioner’s argument.
The claim language reflects a situation where a second pharmacy may
be authorized to dispense a sensitive prescription drug, if “[t]he second
pharmacy’s ability to protect against diversion before shipping the drug” is
confirmed. IPR2015-00551, Ex. 1001, 2:9–11. Although the description in
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the specification cited by Petitioner refers to “patient pick-up,” the plain and
ordinary meaning of the claim language “dispensed to the narcoleptic
patient” is not so limited. Merriam-Webster’s defines “dispense” as “to
prepare and distribute (medication).” Ex. 3001.15
Nothing in the claim
language requires patient pick-up of the drug from another pharmacy, as
opposed, for example, to mailing the drug to the patient.
Therefore, we construe the phrase “the exclusive central pharmacy
authorizing the company's prescription drug to be dispensed to the
narcoleptic patient by another pharmacy” to mean “the exclusive central
pharmacy may authorize another pharmacy to prepare and distribute the
prescription drug to a narcoleptic patient.”
C. 35 U.S.C. § 325(d)
Patent Owner requests that we exercise our discretion under 35 U.S.C.
§ 325(d) to deny the Petition because it relies upon prior art and arguments
that are the same or substantially the same as those considered in previous
CBM Petitions relating to the ’730 patent and other patents in the same
family. Prelim. Resp. 34–36 (citing CBM2014-00149, Paper 12; CBM2014-
00161, Paper 16). Patent Owner contends that the first ground in the current
Petition “offers identical art and arguments” as presented in the CBM
Petitions, and alleges that the second ground, while citing two new
references, “merely offer[s] . . . substantially the same arguments” as in the
first ground. Id. at 34.
Here, even assuming Petitioner asserts grounds that are identical to art
and arguments presented in the earlier CBM Petitions, decisions denying
15
http://www.merriam-webster.com/dictionary/dispense (last visited July
28, 2015).
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institution in those cases do not address the merits of any ground raised in
the Petitions. CBM2014-00149, Paper 12; CBM2014-00161, Paper 16.
Rather, as Patent Owner concedes, those decisions concluded that Petitioner
failed to establish that the ’730 patent qualified as a CBM patent under
Section 18 of the AIA, and declined to institute for lack of jurisdiction.
Prelim. Resp. 34; CBM2014-00161, Paper 16, 2, 21. Under the
circumstances before us, we decline to exercise our discretion under
35 U.S.C. § 325(d) to deny the Petition.
D. Public Accessibility of Exhibits 1003–1006
The priority date of the ’730 patent is December 17, 2002. Ex. 1001.
Petitioner asserts that Exhibits 1003–1006 (collectively referred to as the
“Advisory Committee Art” or “ACA”) were publicly accessible as prior art
in connection with an FDA Advisory Committee meeting regarding
Xyrem®, held on June 6, 2001. Pet. 12–17. Patent Owner counters that
Petitioner’s evidence is insufficient to establish a public accessibility date
for at least Exhibits 1004–1006 of the ACA, prior to the December 17, 2002
priority date. Prelim. Resp. 23–33.
The key inquiry is whether a reference was made “sufficiently
accessible to the public interested in the art” before the critical date. In re
Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). Indexing of a reference is
not “a necessary condition for a reference to be publicly accessible,” but it is
one among various factors that may bear on public accessibility. In re
Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009). “A given reference is
‘publicly accessible’ upon a satisfactory showing that such document has
been disseminated or otherwise made available to the extent that persons
interested and ordinarily skilled in the subject matter or art exercising
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reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc.,
445 F.3d 1374, 1378 (Fed. Cir. 2006). With these principles in mind, we
consider the parties’ arguments below.
1. Exhibit 1003 Advisory Committee Meeting Transcript and
Slides
Exhibit 1003 is a written transcript, including presentation slides, of
the Peripheral and Central Nervous System Drugs Advisory Committee
meeting held June 6, 2001, in Bethesda, MD (“the Advisory Committee
Meeting”). Pet. 14 (citing Ex. 1003). The Advisory Committee Meeting
was convened to discuss Xyrem®, with the “main focus of the deliberations
. . . on risk management issues.” Pet. 17 (citing Ex. 1007 ¶ 47; Ex. 1015);
Ex. 1003, 5:23–6:3. A Federal Register Notice, dated May 14, 2001,
provided public notice of the Advisory Committee Meeting. Ex. 1015. The
notice further identified a website for providing “[b]ackground material from
the sponsor and FDA” and stated that “the minutes, transcript, and slides
from the meeting” are “generally posted about 3 weeks after the meeting.”
Pet. 14 (citing Ex. 1015).
Petitioner also cites evidence from the Internet Archive: Wayback
Machine (located at https://archive.org/web/web.php) indicating that the
Advisory Committee Meeting transcript and presentation slides were
available no later than October 4, 2001. Id. at 16 (citing Ex. 1020, 8). The
cited Internet Archive page contains a Universal Resource Locator (“URL”)
date code of October 4, 2001. Id. Petitioner’s Internet Archive evidence is
supported by a June 15, 2012 Affidavit of Christopher Butler, the Office
Manager of the Internet Archive at that time. Id. at 18 (citing Ex. 1028).
Mr. Butler’s Affidavit explains the URL date codes used to determine the
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availability of archived internet records as of a particular date. Ex. 1028
¶¶ 3–5.16
Patent Owner does not contest Petitioner’s evidence that Exhibit 1003
was publicly available as of October 4, 2001, more than one year before the
December 17, 2002 priority date of the ’730 patent. Prelim. Resp. 30. The
date of the Advisory Committee Meeting, the Federal Register Notice, and
the Internet Archive evidence all support a public accessibility date for
Exhibit 1003 of no later than October 4, 2001. Therefore, we are persuaded
on the present record that the evidence provided by Petitioner indicates
sufficiently that Exhibit 1003 was publicly accessible to a person of ordinary
skill in the art, exercising reasonable diligence, no later than October 4,
2001.
2. Exhibits 1004–1006
Petitioner and Patent Owner consider Exhibits 1004–1006 together,
with respect to their public accessibility date. Exhibit 1004 is a Xyrem
Preclinical Safety Review, asserted by Petitioner to have small portions
redacted, thereby indicating an intent to make the document publicly
available. Pet. 15. The cover page of the Preclinical Safety Review
indicates FDA completed its review on May 3, 2001. Ex. 1004, 1 (“Review
Completed: 5/3/01”). Exhibit 1005 comprises a three-page cover letter
from the Xyrem® sponsor, dated May 3, 2001, and the enclosed Briefing
Booklet for the Advisory Committee Meeting. Pet. 15 (citing Ex. 1005).
The cover page of the Briefing Booklet says “AVAILABLE FOR PUBLIC
16
We note that the entry for the Advisory Committee Meeting on page 8 of
Exhibit 1020 appears to be very similar to the entry on page 20 of Exhibit
1028, except for the “7/2/2014” date appearing on the upper left-hand corner
of each page of Exhibit 1020.
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DISCLOSURE WITHOUT REDACTION.” Id. at 15–16 (citing Ex. 1005);
Ex. 1005, 4. Exhibit 1006 is a Xyrem Video and Transcript of the video
dated February 2, 2001.17
Id.; Ex. 1006, 1.
Petitioner argues that Internet Archive evidence shows Exhibits 1004–
1006 were publicly accessible on the FDA’s website no later than July 1,
2001. Id. at 16 (citing Ex. 1018, 5; Ex. 1019).18
Exhibit 1018 contains a
URL date code of June 17, 2001, and a hyper-text link to “Briefing
Information” on the page for the Advisory Committee meeting. Id. (citing
Ex. 1018). Exhibit 1019, dated July 1, 2001, contains Portable Document
Format (“pdf”) links to “Safety Review,” “Briefing Information,” and
“Video Script 2/2/01” documents relating to the Advisory Committee
Meeting, as well as a hyper-text file for the Xyrem Video. Id. (citing
Ex. 1019). Petitioner, in reliance on Mr. Valuck’s testimony, argues that one
of skill in the art would have been able to locate Exhibits 1004–1006 no later
than July 1, 2001 by exercising reasonable diligence and “following this
link[s].” Id. (citing Ex. 1007 ¶ 47; Ex. 1015).
Patent Owner contends that Petitioner’s Internet Archive evidence
“does not establish that the destination of those links” in Exhibits 1018 and
1019 led to Exhibits 1004–1006 on the dates indicated. Prelim. Resp. 25–
26. Patent Owner asserts that if one clicks on the links of the archived web
17
Petitioner has submitted Exhibit 1006 in fifteen parts, comprising fourteen
parts of the video and the transcript of the entire video. All citations to Ex.
1006 are citations to the transcript (“Exhibit 1006 Xyrem Video
Transcript”). 18
We note that the entry for the Advisory Committee Meeting on page 5 of
Exhibit 1018 appears to be very similar to the entry on page 11 of Exhibit
1028, except for the “7/2/2014” date appearing on the upper left-hand corner
of each page of Exhibit 1018.
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pages shown in Exhibits 1018 and 1019, as explained in Mr. Butler’s
Affidavit (Ex. 1028), the results show Exhibits 1004–1006 “were first
archived” in 2011, not 2001. Id. at 26–30 (citing Ex. 2029; Ex. 2030; Ex.
2031). Patent Owner argues, therefore, that Exhibits 1004–1006 were not
publicly accessible before December 17, 2002, and cannot be used as prior
art to challenge the patentability of the ’730 patent claims. Id. at 30.
Our review of the evidence on the present record, including the dates
on the documents themselves (Exs. 1004–1006), the Federal Register Notice
(Ex. 1015), the Internet Archive evidence (Exs. 1018–1020; Ex. 1028), and
Mr. Valuck’s Declaration testimony (Ex. 1007 ¶ 47), indicates that, based on
the present record, Petitioner has shown sufficiently that Exhibits 1004–
1006 were publicly accessible to one of ordinary skill more than one year
before the December 17, 2002 priority date of the ’730 patent. We further
note Patent Owner’s contention, that the earliest archive dates of Exhibits
1004–1006 are in 2011 not 2001, is not explained fully nor sufficiently
supported by the evidence of record before us at this time.19
For example,
Patent Owner has not explained the meaning of the “Note” that appears at
the bottom of Exhibits 2029–2031 – “This calendar view maps the number
of times [the FDA URL] was crawled by the Wayback Machine, not how
many times the site was actually updated.” Ex. 2029; Ex. 2030; Ex. 2031.
Therefore, we proceed to consider Petitioner’s unpatentability grounds.
19
See 37 C.F.R. § 42.107 (c) (“The preliminary response shall not present
new testimony evidence beyond that already of record, except as authorized
by the Board.”).
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E. Asserted Obviousness of claims 1–11 of the ’730 Patent over the
Advisory Committee Art (Exs. 1003–1006)
Petitioner contends that claims 1–11 (all claims) of the ’730 patent
would have been obvious over the ACA (Exhibits 1003–1006). Pet. 18–38.
Petitioner relies on the Declaration testimony of Dr. Valuck in support of its
argument that a person of ordinary skill in the art would have had reason to
combine the ACA documents because the documents were prepared for the
Advisory Committee Meeting and “relate to the same restricted distribution
program, which the meeting was convened to discuss.” Id. at 19 (citing
Ex. 1007 ¶ 51). Petitioner further relies on Dr. Valuck’s Declaration
testimony in support of its argument that all method steps recited in
independent claim 1, identified as Steps 1.1–1.8, are found in the ACA. Id.
at 21 (citing Ex. 1007 ¶¶ 52–84). Petitioner also cites to specific disclosures
in the ACA and to Dr. Valuck’s Declaration testimony in support of its
argument that the method steps recited in claims 2–11 are disclosed in the
ACA. Id. at 33–38 (citing Ex. 1003; Ex. 1004; Ex. 1005; Ex. 1006;
Ex. 1007 ¶¶ 81, 89, 90, 93–95, 97, 98).
Patent Owner challenges Dr. Valuck’s opinions as unsupported,
conclusory, and based on improperly incorporated claim charts. Prelim.
Resp. 36–39. Patent Owner also challenges Petitioner’s contentions with
respect to the disclosure of the Preamble and Steps 1.1, 1.4, and 1.8 of
claim 1 in the ACA. Prelim. Resp. 39–46.
We are persuaded by Petitioner’s analysis and supporting evidence
that there is a reasonable likelihood that it would prevail on this ground in
relation to the challenged claims.
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1. Dr. Valuck’s Declaration Testimony
Patent Owner argues that we should disregard Dr. Valuck’s
Declaration testimony because his opinions are unsupported and without
adequate factual bases. Id. at 37. Patent Owner also objects to the claim
charts in Dr. Valuck’s Declaration as “citing portions of the references
without any further elaboration” and as improperly incorporated by
reference into the Petition. Id. at 38. To the contrary, Dr. Valuck’s
Declaration consistently explains each step of the claim and the reasons for
his opinion that each claim limitation is found in the ACA, which he
supports with specific evidentiary citations.
For example, with regard to Step 1.1—“receiving in a computer
processor all prescription requests, for any and all patients being prescribed
the prescription drug, only at the exclusive central pharmacy from any and
all medical doctors allowed to prescribe the prescription drug, the
prescription requests containing information identifying patients, the
prescription drug, and various credentials of the any and all medical doctors”
(Ex. 1001, 8:40-47) —Dr. Valuck describes his opinion, in detail, where
each aspect of the claim limitation is found in the ACA. Ex. 1007 ¶¶ 56–61.
The claim chart for Step 1.1 appears in paragraph 61 of Dr. Valuck’s
Declaration, in further support of his opinion, and the claim chart is in
proper form. Id. at ¶ 61. The Petition, moreover, contains three pages of
analysis with citations to the ACA and Dr. Valuck’s Declaration in support
of Petitioner’s argument that step 1.1 is disclosed in the ACA. Pet. 25–27.
Therefore, we are not persuaded to disregard Dr. Valuck’s Declaration
testimony as urged by Patent Owner.
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2. Preamble: “A computerized method of distributing a
prescription drug . . .”
Patent Owner argues that Petitioner’s evidence and argument are
inadequate to support a finding that the preamble language is disclosed in
the ACA, because “[t]he words ‘computer database’ and ‘computerized’ are
entirely absent from the ACA materials.” Prelim. Resp. 39–40. Patent
Owner assumes, without discussion, that the preamble is limiting. Id. Even
if the relevant portion of the preamble is considered to be limiting, however,
on the present record we are persuaded by Petitioner’s argument and
evidence that the limitation is met.
Petitioner provides evidence that the ACA discloses a closed
distribution system for Xyrem through a single national pharmacy
responsible for receiving data from potentially “thousands of [prescription]
requests.” Pet. 22–23 (citing Ex. 1003, 177:24–178:11, 183:12–16, Slide
146 (Xyrem Closed Dist’n System); Ex. 1004, 108; Ex. 1006, 4, 10;
Ex. 1007 ¶¶ 53, 54). Although Petitioner does not cite text from the ACA
stating that the Xyrem database is “computerized,” Petitioner (i) relies on the
description of the Xyrem closed distribution system, (ii) cites an illustration
of a pharmacist at a computer terminal (Id. at 23 (citing Ex. 1003, slide
146)), and (iii) argues that a person of ordinary skill would have understood
and appreciated that such a closed distribution system, using a single
national pharmacy to centralize large amounts of patient, prescriber, and
prescription related data, would need to be computerized. Id. at 24 (citing
Ex. 1003, 16:4–7, 24:21–25, 259:4; Ex. 1005, 1; Ex. 1007 ¶ 54).
Therefore, on the present record, we are persuaded that Petitioner’s
evidence in support of the inference—that the Xyrem closed distribution
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system disclosed in the ACA would have been understood by a person of
ordinary skill to be computerized—is sufficient.
3. Step 1.1: “receiving in a computer processor prescription
requests . . . the prescription requests containing information
identifying patients, the prescription drug, and various
credentials of the any and all medical doctors”
Patent Owner raises the same argument made above with regard to the
preamble being limiting, namely, that the ACA does not disclose a
computerized system or an exclusive computer database for receiving
prescription requests. Prelim. Resp. 41–42.20
For the same reasons stated
above, in Section II.D.2. of this Decision, we are not persuaded by Patent
Owner’s argument on the present record.
Patent Owner further objects to the sufficiency of Petitioner’s
evidence regarding Step 1.1, asserting that Petitioner improperly relies on
another prior art reference (Ex. 1012) not identified in any ground of
unpatentability. Id. at 42. We do not find support in the present record for
Patent Owner’s assertion, which lacks a specific supporting citation to the
Petition itself. Id.; see also Pet. 25–27 (citing Exs. 1003–1007 but not
Ex. 1012). In any event, we do not consider citing an additional reference to
provide background regarding the state of the art (i.e., “it was well-known in
the art to make use of a computer to receive and organize prescriptions”) to
be improper. Ex. 1007 ¶ 54 (citing Ex. 1012).
Patent Owner further asserts that the ACA does not disclose
“prescription requests containing information identifying patients, the
prescription drug, and various credentials of the any and all medical
20
Step 1.1 requires that prescription requests be received in a “computer
processor,” and step 1.2 requires entering the prescription information into
“an exclusive computer database.” Ex. 1001, 8:41, 8:49–50.
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doctors.” Id. at 43. Patent Owner argues that Petitioner’s attempt to “fill the
gap” is unsupported. Id. The Petition, however, contains citations to the
ACA and Dr. Valuck’s Declaration to support Petitioner’s argument that a
person of ordinary skill in the art would have known that the “unique
prescribing forms” described in the ACA would have included the
information recited in Step 1.1 of the ’730 patent. Pet. 25–26 (citing, inter
alia, Ex. 1003, 180:6–181:22, 391–93 (Slides 151–53); Ex. 1004, 109;
Ex. 1005, 306, 310; Ex. 1006, Tr. 5 n.20, 6 n.21, n.24; Ex. 1007 ¶¶ 57–59).
Therefore, on the present record, we are persuaded that Petitioner’s
cited evidence sufficiently supports the conclusion that Step 1.1 is disclosed
in the ACA.
4. Step 1.4: “confirming with a patient that educational material
has been read prior to shipping the prescription drug”
Patent Owner argues that Petitioner’s ACA evidence indicates that the
Xyrem educational material (“Xyrem Patient Success Program”) will be sent
to patients with their first shipment of Xyrem, not “prior to shipping the
prescription drug” as recited in the claim. Prelim. Resp. 44. Petitioner
acknowledges this evidence. Pet. 30 (citing Ex. 1003, 182:3–8). Petitioner,
however, cites additional evidence indicating a change in plan was
considered to present patients with a “registry form” for signature prior to
receiving their first shipment of Xyrem to confirm that “that they have read
the materials [Xyrem educational materials], they have received them and
they have read them.” Id. (citing Ex. 1003, 374:7–20); see also Ex. 1003,
375:15–23 (“[A] registry card. That presumably could be something that
says ‘I have read the material. I assert that I know how to draw the
appropriate dose up. I know how to mix it. I know that I have to mix both
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doses first.’”); Id. (citing Ex. 1004, 115 (“The patient registry information
and benefit forms should be received by Nova Factor prior to the initial
dispensing of the drug.”)).
On balance, given the present record, we are persuaded Petitioner’s
evidence sufficiently supports the conclusion that Step 1.4 is disclosed in the
ACA.
5. Step 1.8: “generating with the computer processor periodic
reports . . . to evaluate potential diversion patterns”
Patent Owner argues that the ACA does not disclose generation of
“periodic reports” in accordance with Step 1.8, but rather the ACA discloses
providing federal agencies with access to collected data, “but upon request
and not periodically.” Prelim. Resp. 45 (citing Ex. 1004, 110; Ex. 1005,
306). Page 306 of the Briefing Booklet states that “database checks (AMA,
NPD and State Medical Boards available on-line) will periodically occur to
ensure that physician eligibility has not changed.” Ex. 1005, 310.
Therefore, we are not persuaded by Patent Owner’s argument regarding the
disclosure of Step 1.8 in the ACA.
6. Other steps recited in challenged claims.
Based on the record before us, Petitioner has demonstrated a
reasonable likelihood of prevailing in its assertion that independent claim 1
would have been obvious over the ACA. Pet. 19–33 (addressing steps 1.1–
1.8 in claim 1). We also are persuaded that independent claims 2 and 7–11
are similar enough to claim 1 such that Petitioner’s analysis regarding
claim 1 equally applies, and that the ACA discloses the aspects of those
claims that differ from claim 1. Pet. 33, 35–38. For example, Petitioner
points us to where the ACA discloses checking the exclusive computer
database “for potential abuse associated with the patient and the authorized
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prescriber,” as recited in claim 7. Pet. 35–36 (citing Ex. 1003, 184:24–
185:4; Ex. 1004, 110). In addition, we are persuaded that Petitioner
sufficiently points us to where the ACA describes the elements recited in
dependent claims 2–6. Pet. 33–35 (citing Ex. 1003, 177:24–178:11, 184:24–
185:7, slide 147; Ex. 1004, 108 [and 109]; Ex. 1005, 304[308], 306 [310];
Ex. 1006, 4 n.13–14, 6 n.24; Ex. 1007 ¶ 81).21
F. Asserted Obviousness of Claims 1-11 of the ’730 Patent over Talk
About Sleep (Ex. 1033), Honigfeld (Ex. 1034), and Elsayed (Ex.
1035,) and Further in View of Lilly (Ex. 1036)
Petitioner contends that claims 1–11 (all claims) of the ’730 patent
would have been obvious over TAS, Honigfeld, and Elsayed, and further in
view of Lilly. Pet. 38–57. Petitioner relies on Dr. Valuck’s Declaration
testimony in support of its argument that a person of ordinary skill in the art
would have had “ample” reason to combine the references, because the
references all relate to controlled distribution of prescription drugs
susceptible to “abuse.” Id. at 38; see id. at 39, 41–43 (citing Ex. 1007
¶¶ 102, 107–09, 116, 117). Petitioner further relies on Dr. Valuck’s
Declaration testimony in support of its argument that all method steps
recited in independent claim 1 are disclosed in the asserted combination of
references. Id. at 39–48 (citing Ex. 1007 ¶¶ 105–132). Petitioner also cites
to Dr. Valuck’s Declaration testimony in support of its argument that the
method steps recited in claims 2–11 are disclosed in the asserted
combination of references. Id. at 48–52 (citing Ex. 1033; Ex. 1034;
Ex. 1035; Ex. 1036; Ex. 1007 ¶¶ 100, 133–135, 137, 138, 140–144).
21
For the same reasons, we reach the same conclusion with respect to
Ground 1 of the ’551 Petition challenging claims 1, 3–9, and 11–15 of the
’988 patent.
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Patent Owner challenges Petitioner’s allegation that a person of
ordinary skill in the art would have been motivated to combine TAS,
Honigfeld, Elsayed, and Lilly as conclusory and unsupported. Prelim.
Resp. 46–49. Patent Owner also challenges Petitioner’s contentions that the
asserted combination of references discloses the limitations of claim 1 in the
’730 patent. Prelim. Resp. 46, 49–53. We address the parties’ arguments
below.
1. Talk About Sleep (“TAS”), Honigfeld, Elsayed, and Lilly
Petitioner relies on TAS as the primary reference for its obviousness
challenge. Pet. 39–39. TAS is a February 12, 2001 published interview of
representatives from Orphan Medical, the sponsor of Xyrem. Id. (citing Ex.
1033). TAS states that Xyrem will be available through a “central pharmacy
that will handle the delivery of medicine to the patients.” Id. at 39 (citing
Ex. 1033 ¶ 8). TAS further indicates that the central pharmacy will process
received prescription requests and “set up a delivery time directly to the
patient” for receipt of Xyrem. Id. at 39 (citing Ex. 1033 ¶ 9). TAS does not
disclose entering prescription information into “an exclusive computer
database associated with the exclusive central pharmacy for analysis of
potential abuse situations, such that all prescriptions for the prescription drug
are processed only by the exclusive central pharmacy using only the
exclusive computer database ” as recited in Step 1.2 of the ’730 patent.22
Id.
at 43; Ex. 1001, 8:49–54; Prelim. Resp. 49–51.
22
The preamble of claim 1 provides antecedent basis for “the exclusive
central pharmacy” recited in Step 1.2. Ex. 1001, 8:39–40. Independent
claims 7–11 all recite “an exclusive computer database under exclusive
control of the central pharmacy.” Id. at 9:56–57, 10:27–28, 10:61–62,
11:31–32, 12:20–21.
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Honigfeld discloses a national registry system for controlling
distribution of a prescription drug product called Clozaril. Ex. 1034. “The
heart of the CNR [Clozaril National Registry system] is an integrated,
computerized, confidential database that is maintained by the manufacturer.”
Id. at 2:2 ¶ 4. Honigfeld discloses a centralized registration system where all
patients, prescribers, and pharmacies must register in the database
maintained by the manufacturer. Id. Multiple pharmacies may dispense
Clozaril “through participating treatment systems,” each of which “consists
of a physician, a pharmacist, and a quality assurance chairperson.” Id. at
¶ 2. Prescriptions “may be filled only at participating pharmacy service
providers registered with the manufacturer” of the drug. Id. at 3:1 ¶ 1.
Elsayed discloses a method for delivering a potentially dangerous
drug to a patient while preventing the exposure of a fetus or other
contraindicated individuals to the drug. Ex. 1035, 1:10–21. Elsayed, like
Honigfeld, teaches a centralized registration system using “one or more
computer databases” or a “computer readable storage medium” for
registering prescribers, pharmacies, and patients to prescribe, dispense, and
receive a controlled prescription drug. Id. at Abstract, 4:50–60, 5:24–34.
Prescribers, pharmacies, and patients provide registration information “to the
manufacturer or distributor of the drug, or other authorized recipient of the
registration materials.” Id. at 4:30–34, 5:8–14, 37–51. Once registered, a
decentralized system of multiple “pharmacies may be eligible to dispense
the involved drug to patients.” Id. at 4:57–60.
Lilly discloses a method for tracking prescription medications where
computer data information, such as drug, doctor, pharmacist, and patient
data, is “stored for a plurality of patients utilizing a plurality of pharmacies,
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wherein the pharmacies may be affiliated or unaffiliated.” Ex. 1010,
Abstract, ¶¶ 37, 41, 68. Lilly discloses that “at least one of the plurality of
entities comprises a pharmacy with a pharmacist, such that when the . . .
purchaser requests that the pharmacist fill a new prescriptive medication
then the pharmacist utilizes the pharmaceutical computer data to compare
the new prescriptive medication with respect to the medication history” of
the patient. Id. at ¶ 39.
2. Analysis
An essential difference between TAS and Honigfeld, Elsayed, or Lilly
is the use by Honigfeld, Elsayed, and Lilly of (i) a centralized registration
database, and (ii) de-centralized systems that permit multiple registered
pharmacies to dispense the prescription drug directly to patients. Prelim.
Resp. 50 (citing Ex. 1034, 2; Ex. 1035, 4:50–60, 5:30–34; Ex. 1036,
Abstract). As Petitioner acknowledges regarding Honigfeld, once registered,
a prescribing physician sends a prescription request directly to a registered
pharmacy for processing and fulfillment. Pet. 40 (citing Ex. 1034, 5 [3]:1
¶ 1, Fig. 1; Ex. 1007 ¶ 106). The physician does not send the prescription
request to the centralized registration database for processing and checking
prior to dispensing the prescription drug to the patient.23
Therefore,
Honigfeld does not disclose “receiving all prescription requests . . . only at
the exclusive central pharmacy,” “entering” the prescriber, patient, and
23
Honigfeld discloses a quality assurance function where “a large, full-time
CNR staff is charged with reviewing data on a retrospective basis. Their
primary function is to identify discrepancies . . . associated with continued
prescriptions.” Ex. 1034, 5 [3]:1 ¶ 2 (emphasis added). The quoted
disclosure supports the finding that the described quality assurance function
is controlled by the manufacturer who maintains the database and is not
associated with a central [single] pharmacy.
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prescription information “into an exclusive computer database associated
with the exclusive central pharmacy for analysis of potential abuse
situations,” or “mailing the prescription drug to the patient only if no
potential abuse is found,” as recited in Steps 1.1, 1.2, and 1.6 of claim 1.
The evidence of record, therefore, does not support Petitioner’s statement
that “Honigfeld teaches using a single computer database to receive
prescriptions and distribute prescription drugs.” Pet. 40 (without citation).
Honigfeld’s centralized computer database is controlled by the drug
manufacturer, not a pharmacy. Ex. 1034, Abstract, 2:2 ¶ 4, 3:1 ¶ 1.
Honigfeld’s database, like Elsayed’s computer readable storage medium,
receives registration information identifying physicians, patients, and
pharmacies; it does not receive prescriptions, and it does not process or
dispense prescriptions. Ex. 1034 2:2 ¶ 4, 3:1; Ex. 1035, 4:50–60, 5:30–37.
Moreover, there is insufficient evidence of record to suggest that either
Honigfeld’s database, Elsayed’s computer readable storage medium, or
Lilly’s tracking system is “associated with” or “under exclusive control of”
any pharmacy, much less “the exclusive central [single] pharmacy” recited
in Step 1.2 of the ’730 patent.
TAS, for its part, generally describes a different system using a central
pharmacy to receive, process, and dispense prescriptions. TAS, however,
does not disclose details regarding what type of database and protocols
would be used to implement the system, what type of analysis would be
performed on the data, or what roles would be performed by the
manufacturer, physician, and pharmacy. Petitioner glosses over the
differences between TAS and Honigfeld, Elsayed, or Lilly and does not
address the specific language of the Steps 1.1 and 1.2, in context of the
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entire claim, to explain why it would have been obvious for one of ordinary
skill to combine the prior art references in the manner recited. As argued by
Patent Owner, Honigfeld, Elsayed, and Lilly all disclose the use of multiple
pharmacies in a decentralized system for prescribing and dispensing
prescription drugs, rather than the use of an “exclusive central [single]
pharmacy” to receive, process, and check for potential abuse situations prior
to dispensing a prescription . Prelim. Resp. 50–51 (citing Ex. 1034, 4 [2];
Ex. 1035, 4:50–60, 5:30–34; Ex. 1036, Abstract).
Petitioner asserts it would have been obvious for a person of ordinary
skill to modify TAS to incorporate the teachings of Honigfeld, Elsayed, and
Lilly, because they are all directed to the “same endeavor – controlled
distribution of prescription drugs that are susceptible to abuse.” Pet. 38–39
(citing Ex. 1007 ¶ 102). We agree with Patent owner that Petitioner’s
statement of motivation is conclusory.
Petitioner’s further citation to Dr. Valuck’s Declaration testimony
regarding Step 1.2 does not persuade us otherwise. Pet. 43 (citing Ex. 1007
¶¶ 116, 117). Dr. Valuck’s opinion testimony repeats Petitioner’s error in
asserting that Honigfeld and Elsayed teach the concept of centralizing the
receipt, processing, and dispensing of prescriptions. Ex. 1007 ¶ 117.
Dr. Valuck also does not provide adequate reasoning based on rational
underpinnings to persuade us, in the absence of hindsight, that one of
ordinary skill would have modified the TAS system to incorporate the
decentralized prescription systems of Honigfeld, Elsayed, or Lilly to achieve
“an exclusive computer database associated with the exclusive central
pharmacy for analysis of potential abuse situations, such that all
prescriptions for the prescription drug are processed only by the exclusive
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central pharmacy using only the exclusive computer database ,” as recited in
Step 1.2 of the ’730 patent. As recognized by the Patent Examiner in his
statement of “Reasons for Allowance” of the ’730 patent claims, which
included consideration of TAS and Lilly:
[T]the closest prior art of record does not teach or fairly suggest
that all prescriptions for GHB [Xyrem] are processed only by
the exclusive central pharmacy using only the exclusive
computer database. The exclusive computer database is
checked for potential GHB abuse and GHB is provided/mailed
only if no potential abuse is found by the patient to whom GHB
is prescribed and the doctor/authorized prescriber of the GHB.
Prelim. Resp. 50–51 (citing Ex. 1002, 789–90).
For the reasons given above, we are not persuaded Petitioner has
shown a reasonable likelihood of prevailing in its assertion of
unpatentability of the ’730 patent claims as obvious over TAS, Honigfeld,
Elsayed, and Lilly.24
G. Asserted Obviousness of Claims 2, 3 10, and 11 of the ’988 Patent
Independent claims 1 and 9 of the ’988 patent recite a “method of
treatment of a narcoleptic patient with a prescription drug while controlling
potential misuse, abuse or diversion of said prescription drug.” ’551 Pet. Ex.
1001, 8:38–40, 9:40–42. The body of the claims, however, does not recite a
step for treating a narcoleptic patient. Id. at 8:41–9:13, 9:43–10:28. The
limitations recited in the independent claims of the ’988 patent, otherwise,
are very similar to the limitations recited in the independent claims of the
’730 patent. Many of the dependent claims in the ’988 patent also recite
method steps very similar to those recited in the ’730 patent claims. Id. at
24
For the same reasons, we reach the same conclusion with respect to
Ground 2 of the ’551 Petition challenging claims 1–15 of the ’988 patent.
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9:14–36, 10:29–53. Therefore, we address only the dependent claims of the
’988 patent requiring separate discussion.
1. Asserted Obviousness of Dependent Claims 3 and 11 over the
ACA
Claims 3 and 11 depend from claims 1 and 9, respectively, and further
recite “the exclusive central pharmacy authorizing the company’s
prescription drug to be dispensed to the narcoleptic patient by another
pharmacy.” Id. at 9:21–23, 10:37–39. Petitioner asserts claims 3 and 11
would have been obvious over the ACA. ’551 Pet. 17–19. As noted by
Petitioner, the ACA expressly discloses a situation where the prescription
drug “may be shipped by [the central pharmacy] to another pharmacy for
patient pick-up.” Id. at 34 (citing Ex. 1004, 110; Ex. 1007 ¶ 98). The ACA
further discloses that the sponsor “has a mechanism for verifying the second
pharmacy’s ability to protect against diversion of GHB before shipping the
drug there.” Id. Patent Owner does not comment on Petitioner’s evidence.
’551 Prelim. Resp.
On the present record, the evidence cited by Petitioner is sufficient to
establish that the ACA discloses the “other pharmacy” limitation recited in
claims 3 and 11 of the ’988 patent. Therefore, for the reasons given in
Section II.E., above, we are persuaded Petitioner has shown a reasonable
likelihood of prevailing in its assertion of unpatentability of the ’988 patent
claims 3 and 11 as obvious over the ACA.
2. Asserted Obviousness of Claims 2 and 10 over the ACA in view
of Elsayed, over the ACA in view of Korfhage, and over TAS,
Elsayed, Honigfeld, and Lilly in view of Korfhage
Claims 2 and 10 depend from claims 1 and 9, respectively, and further
recite “one or more of the exclusive central pharmacy and the exclusive
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central database are distributed over multiple computers, and wherein a
query operates over all data in all the distributed databases relating to the
prescriptions, the doctors, and the narcoleptic patients.” Petitioner asserts
claims 2 and 10 would have been obvious over the ACA in view of Elsayed
(Ground 3), over the ACA in view of Korfhage (Ground 4), and over TAS,
Elsayed, Honigfeld, and Lilly in view of Korfhage (Ground 5). ’551 Pet.
51–54. Patent Owner opposes. ’551 Prelim. Resp. 53–54. We address each
ground in turn.
Regarding Ground 3 (the ACA and Elsayed), Petitioner argues that
Elsayed discloses that pharmacies may fill prescriptions using multiple
computer readable storage media, which may be the same as, or different
from, the storage medium in which prescribers are registered. ’551 Pet. 48
(citing Ex. 1035, 4:50–57, 5:56–64, 8:26–32; Ex. 1007 ¶ 141), 51, 52.
Petitioner’s characterization of Elsayed’s disclosure again confuses the
different types of systems disclosed in Elsayed and the ACA or TAS, as
explained above in Section II.F.2. Petitioner’s citations to Dr. Valuck’s
Declaration regarding Ground 3 do not address or cure the stated deficiency
of the asserted combination. Id. at 52 (citing Ex. 1007 ¶¶ 155, 156). The
same line of reasoning applies to Ground 5 (TAS, Elsayed, Honigfeld, and
Lilly in view of Korfhage). Id. at 54 (citing Ex. 1007 ¶ 158). Therefore, we
are not persuaded Petitioner has shown a reasonable likelihood of prevailing
in its assertion of unpatentability of claims 2 and 10 as obvious over the
ACA and Elsayed or TAS, Elsayed, Honigfeld, and Lilly in view of
Korfhage.
Regarding Ground 4 (the ACA and Korfhage), Petitioner explains that
Korfhage discloses a database that can be distributed over multiple
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computers to accommodate “[c]ost, efficiency, and the [sheer] number of
documents.” Id. at 53 (citing Ex. 1037, 276 [294], Ex. 1007 ¶ 57).
Korfhage also suggests that a single query can operate over the distributed
database computers to accommodate user preference “to view the system as
accessing a single logical database in response to a query, even when the
system must consult multiple physical databases.” Id. Petitioner argues
that, because the ACA teaches a central database that may be queried to
minimize prescription drug abuse, it would have been obvious to modify the
ACA to incorporate the distributed database system of Korfhage to
accommodate cost, efficiency, the number of prescription requests, and
associated data. Id.
Patent Owner argues that Petitioner has not provided a sufficient of
motivation to combine the references. ’551 Prelim. Resp. 54. Patent Owner
asserts, in particular, that Petitioner’s argument and Dr. Valuck’s
Declaration testimony in support of a motivation to combine are conclusory.
We disagree.
Petitioner has provided sufficient evidence, on the present record, that
one of ordinary skill would have been motivated by Korfhage to modify the
ACA system to include multiple computers for reasons of cost, efficiency,
and the anticipated volume of prescription-related information to be
received, entered, and queried. ’551 Pet. 53 (citing Ex. 1007 ¶ 57; Ex. 1037,
294). Petitioner’s evidence, on the present record, indicates that such a
modification would have been a predictable use of a known distributed data
system according to its established function. Id. Patent Owner does not cite
evidence to the contrary. Therefore, on the present record, we are persuaded
Petitioner has shown a reasonable likelihood of prevailing in its assertion of
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unpatentability of claims 2 and 10 as obvious over the ACA in view of
Korfhage.
III. CONCLUSION
Petitioner has demonstrated a reasonable likelihood of prevailing with
respect to the claims challenged in this Petition, based on certain grounds
asserted and discussed above. At this stage of the proceeding, the Board has
not made a final determination as to the patentability of any challenged
claims.
IV. ORDER
Accordingly, it is
ORDERED that pursuant to 35 U.S.C. § 314, inter partes review is
instituted as to claims 1–11 of the ’730 patent and claims 1–15 of the ’988
patent on the following grounds of unpatentability:
Claims 1–11 of the ’730 patent as obvious over the Advisory
Committee Art pursuant to 35 U.S.C. § 103;
Claims 1, 3–9, 11–15 of the ’988 patent as obvious over the Advisory
Committee Art pursuant to 35 U.S.C. § 103; and
Claims 2 and 10 of the ’988 patent as obvious over the Advisory
Committee Art in view of Korfhage pursuant to 35 U.S.C. § 103.
FURTHER ORDERED that inter partes review is commenced on the
entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
§ 42.4, notice is hereby given of the institution of a trial; and
FURTHER ORDERED that the trial is limited to the grounds of
unpatentability listed above, and no other grounds of unpatentability are
authorized for inter partes review.
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For PETITIONER:
Aziz Burgy
Bradford C. Frese
ARENT FOX LLP
For PATENT OWNER:
Francis Cerrito
QUINN EMANUEL URQUHART & SULLIVAN, LLP
John Biernacki
JONES DAY