Amneal Pharmaceuticals, LLCv.Jazz Pharmaceuticals, Inc.

Patent Trial and Appeal Board

Jan 13, 2015

13595757 (P.T.A.B. Jan. 13, 2015)

Trials@uspto.gov Paper 11
Tel: 571-272-7822 Entered: January 13, 2015 

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
PAR PHARMACEUTICAL, INC., ROXANE LABORATORIES, INC. and
AMNEAL PHARMACEUTICALS, LLC,
Petitioners,
v.
JAZZ PHARMACEUTICALS, INC.,
Patent Owner.
_____________

Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)1

______________
Before LORA M. GREEN, BRIAN P. MURPHY, and JON B.
TORNQUIST, Administrative Patent Judges.

MURPHY, Administrative Patent Judge.

DECISION
Denying Institution of Covered Business Method Patent Review
37 C.F.R. § 42.208

1 This Decision addresses the same jurisdictional issue raised in all four
cases. The patents at issue in CBM2014-00149, CBM2014-00150,
CBM2014-00151, and CBM2014-00153 are all related, and the
jurisdictional arguments by Petitioners and Patent Owner are largely the
same in each case. Therefore, we issue one Decision to be entered in each
case.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
2

I. INTRODUCTION
Par Pharmaceutical, Inc. (“Par”), Roxane Laboratories, Inc.
(“Roxane”), and Amneal Pharmaceuticals, LLC (“Amneal”)(together,
“Petitioner”) filed several Petitions, including a Petition requesting covered
business method patent review of claims 1–11 (all claims) of U.S. Patent No.
7,668,730 B2 (Ex. 1001, “the ’730 patent”),2 pursuant to 35 U.S.C. § 321
and § 18 of the Leahy-Smith America Invents Act (Pub. L. No. 112-29, 125
Stat. 284 (2011)) (“AIA”). Paper 1 (“Pet.”). Jazz Pharmaceuticals, Inc.
(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 10
(“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 324, which
provides that a covered business method (“CBM”) patent review may not be
instituted unless information presented in the Petition “would demonstrate
that it is more likely than not that at least 1 of the claims challenged in the
petition is unpatentable.”
Petitioner challenges claims 1–11 of the ’730 patent as unpatentable
under 35 U.S.C. §§ 101, 102(b), and 103(a). Pet. 29–30. Based on the
information presented in the Petition and Preliminary Response, we
determine Petitioner has not demonstrated that the ’730 patent is a “covered
business method patent” pursuant to the statutory definition in § 18(d)(1) of
the AIA. Therefore, for the reasons given below, we deny the Petition.

2 For clarity and expediency, we treat CBM2014-00151 as representative of
all four cases and note that Par and Roxane filed the Petition in CBM2014-
00151. All citations are to CBM2014-00151 unless otherwise noted.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
3

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 and Par Pharmaceutical, Inc., 2:13-cv-391
(consolidated with 2:13-cv-7884) (D.N.J.); and Jazz Pharmaceuticals, Inc. v.
Ranbaxy Laboratories Ltd., et al., 2:14-cv-4467 (D.N.J.). Pet. 78–79; Paper
8, 2–3.
The parties identify the following as petitions for covered business
method review of patents related to the ’730 patent: Amneal
Pharmaceuticals, LLC et al. v. Jazz Pharmaceuticals, Inc., CBM2014-00149
(filed June 24, 2014) (US 7,895,059 B2); Amneal Pharmaceuticals, LLC et
al. v. Jazz Pharmaceuticals, Inc., CBM2014-00150 (filed July 7, 2014) (US
8,457,988 B1); and Amneal Pharmaceuticals, LLC et al. v. Jazz
Pharmaceuticals, Inc., CBM2014-00153 (filed July 9, 2014) (US 8,589,182
B1). Pet. 78–79; Paper 8, 3.
Patent Owner identifies the following pending U.S. patent
applications claiming priority benefit from US Patent Application No.
10/322,348—the application from which the ’730 patent issued: US Patent
Application No. 14/196,603, filed March 4, 2014; US Patent Application
No. 14/219,904, filed March 19, 2014; and US Patent Application No.
14/219,941, filed March 19, 2014. Paper 8, 3.
B. The ’730 Patent
The ’730 patent, titled “Sensitive Drug Distribution System and
Method,” issued February 23, 2010 from an application filed December 17,
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
4

2002. Ex. 1001.3 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:

3 US 7,895,059 B2 (“the ’059 patent”) issued from a continuation
application of US 10/322,348 (“the ’348 application”), which issued as the
’730 patent. CBM2014-00149 Ex. 1001, 1:6–8. US 8,457,988 B1 (“the
’988 patent”) and US 8,589,182 B1 (“the ’182 patent”) issued from a series
of divisional and/or continuation applications of the ’348 application.
CBM2014-00150 Ex. 1001, 1:6–13; CBM2014-00153 Ex. 1001, 1:6–13.
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Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
7

program (CHIP) for Xyrem®.”4 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).
C. 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

4 Xyrem is the brand name for gamma hydroxy butyrate, 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.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
8

the any and all doctors to determine the eligibility of the
doctors to prescribe the prescription drug;

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.

II. ANALYSIS
A. AIA § 18
Section 18 of the AIA governs the transitional program for “covered
business method patent” reviews. AIA § 18(a)(1)(B) limits such reviews to
a person, or the person’s real party in interest or privy, who has been sued
for infringement or charged with infringement of the patent at issue. As
indicated above, the parties both represent that Petitioner has been sued for
infringement of the ’730 patent. Pet. 78; Paper 8, 2–3.
Section 18(a)(1)(E) states that a transitional proceeding may be
instituted only for a “covered business method patent,” which is “a patent
that claims a method or corresponding apparatus for performing data
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
9

processing or other operations used in the practice, administration, or
management of a financial product or service, except that the term does not
include patents for technological inventions.” AIA § 18(d)(1) (emphasis
added). The Office considered the legislative intent and history behind the
AIA's definition of “covered business method patent” when it promulgated
rules for CBM patent review. See 37 C.F.R. § 42.301(a) (definition of CBM
patent); see also 77 Fed. Reg. 48,734, 48,735 (Aug. 14, 2012 Final
Rule)(Response to Comment 1: “[T]he legislative history explains that the
definition of covered business method patent was drafted to encompass
patents ‘claiming activities that are financial in nature, incidental to a
financial activity or complementary to a financial activity.’ 157 Cong. Rec.
S5432 (daily ed. Sept. 8, 2011) (statement of Senator Schumer).” (emphasis
added)).
Petitioner bears the burden of demonstrating that the ’730 patent
claims a method “used in the practice, administration, or management of a
financial product or service.” AIA § 18(d)(1); 37 C.F.R. § 42.304(a). In
making this determination, our focus is firmly on the claims. See 77 Fed.
Reg. at 48,736 (Aug. 14, 2012 Final Rule)(Response to Comment 4: “[T]he
definition . . . is based on what the patent claims.”); see also Int’l Sec. Exch.,
LLC v. Chicago Bd. Options Exch., Case CBM2013-00050, slip op. 9
(PTAB Mar. 4, 2014 (Paper 16)) (“For purposes of determining whether a
patent is eligible for a covered business method patent review, the focus is
on the claims.”). A patent needs only one claim directed to a covered
business method to be eligible for review. Id. For the reasons explained
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
10

below, we conclude Petitioner has not demonstrated that the ’730 patent is a
“covered business method patent” under AIA § 18(d)(1).
B. Financial Product or Service
1. The ’730 Patent Claims
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 requires
entering the physician, patient, and prescription information into an
“exclusive computer database,” then tracks all prescriptions and utilizes 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.

Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
11

2. Analysis of whether a patent claim satisfies the statutory
“financial product or service” requirement
a. Petitioner’s arguments
Petitioner argues that at least claim 1 of the ’730 patent is CBM-
eligible because the claimed method “would be used in commerce,” i.e., the
claimed method of distributing a prescription drug “is financial in nature;
and it is also incidental and complementary to financial activities.” Pet. 12.
Petitioner emphasizes the ’730 patent’s description of the steps for verifying
insurance coverage or a patient’s ability to pay for the prescription (“In one
embodiment, cash payers are also identified” (Ex. 1001, 6:39–40)), pursuant
to the intake reimbursement workflow process described above. Pet. 13–14
(citing Ex. 1001, 6:33–7:65). Petitioner further argues that, because the
claims recite “receiving all prescription requests,” “checking the credentials
of any and all doctors,” and “mailing” or “providing” 6 the prescription drug
to the patient, the claimed method comprises “running the very business of a
mail order pharmacy that direct ships to consumers.” Pet. 14. Petitioner
relies on the Declaration testimony of Dr. Robert J. Valuck as evidence that
filling a prescription necessarily involves checking a patient’s insurance
coverage or ability to pay, which “ultimately relate[s] to the financial
transaction of providing a prescription drug.” Ex. 1007 ¶¶ 47–48.
b. The language of the patent claims
The patent claims recite a method for controlling access to a
prescription drug to guard against “potential abuse” or “diversion;” they do

5 The intake reimbursement steps of Figure 4B, described in the cited
passage, are functionally the same as in Figure 2A reproduced above.
6 Claims 7, 8, and 11 recite “providing” the prescription drug to the patient.
Ex. 1001, 10:7, 10:42, 12:39.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
12

not recite a financial product or service. The issue in dispute is whether the
claim language recites method steps used in the practice, administration, or
management of a “financial” 7 product or service. Petitioner does not
analyze the claim language, in detail and in context, to explain how the
claim language recites method steps involving the movement of money or
extension of credit in exchange for a product or service, e.g., the sale of a
prescription drug. Pet. 12–15. Petitioner’s argument that the ’730 patent
claims a “financial product or service” is conclusory and not supported by
persuasive evidence or analysis.
The claim limitations quoted by Petitioner, “distributing a prescription
drug,” 8 “receiving all prescription requests,” “checking the credentials of
any and all doctors,” “mailing” or “providing” the prescription drug to a
“patient” (Pet. 12, 14), when considered in the context of the claim as a
whole, do not recite or require an activity involving the movement of money
or extension of credit in connection with the sale of a prescription drug.
Prelim. Resp. 20–21. The claims also do not recite a product or service
particular to or characteristic of financial institutions such as banks,
insurance companies, and investment houses. For example, the claim

7 “Finance” is “the way in which money is used and handled; . . . 2: the
system that includes the circulation of money, the granting of credit, the
making of investments, and the provision of banking facilities.” Finance
Definition, MERRIAM-WEBSTER, , available at http://www.merriam-
webster.com/dictionary/finance (last visited December 16, 2014). Ex. 3001.
8 The preamble phrase “distributing a prescription drug” is not a substantive
claim limitation because it is not “necessary to give life, meaning, and
vitality” to the claims. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d
1298, 1305 (Fed. Cir. 1999)(citations omitted). All steps necessary to
execute the method are recited in the body of the claim.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
13

language does not recite or require (i) the sale of a prescription drug, (ii)
processing of payments, benefits, or insurance claims related to the sale of a
prescription drug, (iii) a method of insuring a patient or determining the cost
of insurance, (iv) a method of determining the cost of prescription benefits,
(v) a method of facilitating payment of health care benefits, or (vi) the
extension of credit for the purchase of a prescription drug. Id. at 21. We
agree with Patent Owner that the activities recited in the claim language, in
the context of the claim as a whole, constitute checks (“checking”) and
controls (“confirming”) on “shipping,” “mailing,” or “providing” a
prescription drug to an authorized “patient” to prevent “potential abuse” and
“evaluate potential diversion patterns.” Id.
Therefore, for the reasons given above, we are unpersuaded by
Petitioner’s argument that the ’730 patent claims recite method steps “used
in the practice, administration, or management of a financial product or
service.”
c. The written description of the ’730 patent
The claim limitations of the ’730 patent cited by Petitioner also do
not recite or require the act of verifying a patient’s insurance coverage or
ability to pay for the prescription drug. Petitioner and Dr. Valuck do not
explain, in detail with specific analysis of the claim language, why the
claimed method steps recite or require verifying insurance coverage or a
patient’s ability to pay as described in Figures 2A, 4B, or 5 of the patent.
Pet. 13–14 (citing Ex. 1007 ¶¶ 47–48); Prelim. Resp. 25–27. Petitioner and
Dr. Valuck also do not explain why any of the claimed method steps should
be considered “financial” when considered in the context of the claim
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Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
15

Pet. 51. Petitioner’s diagram, above, omits all reference to method steps for
verifying insurance coverage or a patient’s ability to pay in Figures 2A
(steps 226–238), 4B (steps 448–452, 458–466), and 5, even though other
flow diagram steps from Figures 2A and 4B are represented in Petitioner’s
claim 1 diagram. The omission is telling. In short, the claimed method steps
do not recite or require verifying insurance coverage or a patient’s ability to
pay for a prescription drug product. Prelim. Resp. 26–27 (citing, e.g., TIP
Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1373 (Fed.
Cir. 2008)(“Our precedent is replete with examples of subject matter that is
included in the specification, but is not claimed.”)(citations omitted)).
We also agree with Patent Owner that in the three CBM decisions
cited by Petitioner (Pet. 13, n.3, 4), the Board relied on the written
description of the respective patents to support the “financial product or
service” requirement because the claim limitations recited method steps used
in the embodiments described in the relied-upon portions of the
specifications. Prelim. Resp. 24–25 (citing CRS Advanced Tech., Inc. v.
Frontline Tech., Inc., Case CBM2012-00005, slip. op. 8 (PTAB January 23,
2013(Paper 17))(claimed method for substitute teller fulfillment system used
in embodiment for retail banking system); Google Inc. v. Inventor Holdings,
Case CBM2014-00002, slip op. 8–9 (PTAB April 1, 2014 (Paper
16))(claimed method of facilitating exchange of identities between two
anonymous parties used in embodiment for matching employment
candidates with employer); Google Inc. v. Inventor Holdings, CBM2014-
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
16

00003, slip op. 8–9 (PTAB April 1, 2014(Paper 12))(same, id.)).9 Petitioner
has not made a comparable or persuasive argument based on a close analysis
of the claim language, considered in context as a whole, in view of the
embodiments described in the ’730 patent. Therefore, we find the cited
authority inapposite to the facts of the present case.
For the reasons given above, we are unpersuaded by Petitioner’s
argument that the written description of method steps for verifying insurance
coverage or a patient’s ability to pay are recited or required by the ’730
patent claims.
d. Petitioner’s “used in commerce” argument
We agree with Patent Owner that Petitioner improperly attempts to
expand CBM review to cover a claimed business method because it is “used
in commerce.” Pet. 12–14; Prelim. Resp. 10–12. Petitioner’s argument is
not supported by the plain language of the statute or the legislative history.
Pet. 11–12; Prelim. Resp. 11 (citing Conn. Nat’l Bank v. Germain, 503 U.S.
249, 253–54 (1992) (“[I]n interpreting a statute a court should always turn
first to one, cardinal canon before all others . . . courts must presume that a

9 In CBM2014-00149 (Pet. 12–13), CBM2014-00150 (Pet. 12) and
CBM2014-00153 (Pet. 15–16), Petitioner also cites Liberty Mutual
Insurance Co. v. Progressive Casualty Insurance Co., Case CBM2012-
00002 (PTAB Jan. 23, 2014) and Gilllman v. Stoneeagle Servs., Inc., Case
CBM2013-00047, slip op. at 8 (PTAB Feb. 18, 2014)(Paper 11) in further
support of the argument that the written description of verifying insurance
coverage or a patient’s ability to pay is claimed in the ’059, ’988, and ’182
patents. Liberty Mutual involved a claimed method for determining the cost
of automobile insurance, and Gillman involved a claimed method for
adjudicating a health insurance claim and processing payment for that claim.
Id. Both cases are factually distinguishable from the present cases for the
reasons given in sections 2.b. and 2.c. of this Decision.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
17

legislature says in a statute what it means and means in a statute what it says
there.”). Petitioner does not provide a cogent argument or rationale for why
the statutory phrase “financial product or service” should be interpreted to
include a method for controlling access to a prescription drug that may be
used in commerce. Pet. 11–14. Contrary to Petitioner’s argument, Congress
did not say in the statute that a business method patent “used in commerce”
or covering “core activities” of running a business is eligible for CBM
review. AIA § 18(d)(1); Prelim. Resp. 11–12, 17–18. To the contrary, the
language of the statute excludes such a business method from CBM review
unless a petitioner demonstrates that the method is “used in the practice,
administration, or management of a financial product or service.” AIA §
18(d)(1). Petitioner does not persuasively address the language of the statute
or provide persuasive evidence or analysis from which we might conclude
that the claimed method recites steps used in the practice, administration, or
management of a financial product or service.
The legislative history, taken in context as a whole, also does not
support Petitioner’s argument. As Patent Owner emphasizes, when an
adjudicator considers legislative intent “the Supreme Court has cautioned
that the adjudicator must consider the legislative intent as a whole—not just
‘isolated fragments’ of congressional comments.” Prelim. Resp. 13 (citing
New England Power Co. v. New Hampshire, 455 U.S. 331, 342 (1982)
(“Reliance on such isolated fragments of legislative history in divining the
intent of Congress is an exercise fraught with hazards . . . .”); Offshore
Logistics, Inc. v. Tallentire, 477 U.S. 207, 220–21 (1986) (statements in the
legislative history must be read in light of the statutory language and
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
18

legislative history as a whole)). With such caution in mind, we observe that
members of Congress expressed varying views concerning the scope of a
“covered business method patent” during the debate leading up to passage of
the AIA on September 16, 2011. Prelim. Resp. 13–16.
Those views are exemplified on the one hand by Senator Schumer, co-
sponsor of the transitional program for CBM patent review, who stated that
“Any business that sells or purchases goods or services ‘practices’ or
‘administers’ a financial service by conducting such transactions . . . .” 157
Cong. Rec. S5432 (daily ed. Sept. 8, 2011). On the other hand, Senator
Leahy, co-sponsor of the AIA, expressed a more limited view and stated that
the program was intended to cover “only those business method patents
intended to be used in the practice, administration, or management of
financial services or products, and not to technologies common in business
environments across sectors and that have no particular relation to the
financial services sector.” Id. at S5441. Senator Kyl, co-sponsor with
Senator Schumer of AIA Section 18, entered into the record the Senate
Manager’s Amendment, which described a covered business method patent
as “limited to data processing relating to just a financial product or service
(rather than also to an enterprise10).” Id. at S1367 (daily ed. Mar. 8, 2011).
The ’730 patent’s claimed method for controlling access to a
prescription drug does not recite method steps involving the movement of

10 An “enterprise” is distinguished from the more limited “financial product
or service” in the USPTO’s Manual of Classification, Class 705, which
defines an enterprise as, inter alia, a “conventional business organization.”
Prelim. Resp. 15; see
http://www.uspto.gov/web/offices/ac/ido/oeip/taf/def/705.htm.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
19

money or extension of credit in connection with the sale of a prescription
drug. The claims are more limited and define a decidedly different activity –
controlling access to a prescription drug to guard against potential abuse or
diversion. The claimed method, moreover, has no particular relation to the
financial services industry and does not relate to just a financial product or
service rather than to an enterprise, i.e., a conventional business
organization. Therefore, in the absence of clear and compelling evidence of
legislative intent to include any business method “used in commerce” within
the definition of a “covered business method patent” pursuant to AIA §
18(d)(1), we are unpersuaded by Petitioner’s argument.
e. Petitioner’s Class 705 argument
Petitioner relies on the classification of the ’730 patent in Class 705,
subclass 2, which includes “billing systems based on entered medical codes,”
in support of the argument that “[b]illing systems encompassed within the
’730 patent are activities that are financial in nature, incidental . . . or
complementary to a financial activity.” Pet. 14–15. Petitioner also relies on
the citation of prior art billing systems by the Examiner during examination
of the ’730 application as further support for this argument. Id. at 15.
Petitioner argues that, although not dispositive, the classification of the ’730
patent in Class 705 and citation of art regarding prescription drug payment
arrangements is persuasive evidence that the ’730 method claims satisfy the
statutory “financial product or service” requirement. Id. at 14–15.
Petitioner does not explain, however, how the claim language of the
’730 patent recites method steps used in medical code billing systems or
prior art payment systems. Id. As indicated by Patent Owner, the ’730
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
20

patent claims do not recite method steps used in billing systems, and the
patent does not even describe billing systems. Prelim. Resp. 29. In sum, in
the absence of a more detailed analysis and explanation of how the claim
language and prior art recite method steps used in billing systems, we are not
persuaded that mere classification in Class 705 supports the inference that
the patent claims satisfy the “financial product or service” requirement of
AIA § 18(d)(1).
3. Conclusion
For the reasons given above, based on the present record and
particular facts of this case, Petitioner has not demonstrated that at least one
claim of the ’730 patent recites or requires method steps “used in the
practice, administration, or management of a financial product or service” as
defined in Section 18(d)(1) of the AIA.
C. Additional arguments of Petitioner regarding whether the ’059,
’988, and ’182 patents claim a method step “used in the practice,
administration, or management of a financial product or service”

1. The ’059 patent claim 8 (CBM2014-00149)
Petitioner argues that “claim 8 [of the ’059 patent] is clearly CBM-
eligible, because it expressly covers incidental activities related to a financial
product or service—verifying insurance coverage and patient payment.”
Pet. 12.11 Claim 8 does not recite a method step for “verifying” a patient’s
insurance coverage or payment for the prescription drug. Ex. 1001, 9:56–67.
Claim 8 depends from claim 7, which depends from independent claim 6
that recites a “computerized method of distributing a prescription drug under

11 All citations in this subsection are to the papers and exhibits in CBM2014-
00149.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
21

control of an exclusive central pharmacy” to guard against “potential abuse”
or unauthorized “diversion” of the prescription drug. Id. at 9:13–14. Claim
8 recites additional controls on providing access to the prescription drug
when the drug is dispensed to the patient by “another pharmacy,” i.e., a
pharmacy other than the exclusive central pharmacy. Id. at 9:56–67. Those
additional controls include: “contacting the patient’s insurance company,
questioning early refill requests by the patient, flagging repeat instances of
lost, stolen, destroyed or spilled prescriptions, flagging that the patient paid
cash for the prescription drug, flagging early requests to refill the
prescription drug, and limiting the prescription to a supply of limited
duration.” Id. at 9:61–67.
Although Petitioner highlights “contacting the patient’s insurance
company” and “flagging that the patient paid cash,” they do not attempt to
explain how the claim language, when read in context as a whole, recites or
requires verifying insurance coverage or patient payment. To the contrary,
when read in context, the method steps of claim 8 highlighted by Petitioner
recite controls on access to the prescription drug to guard against “potential
abuse” or “diversion,” not to verify insurance or payment for the drug.
Prelim. Resp. 22–23. The ’730 patent defines the problem: “Some patients
. . . will obtain prescriptions from multiple doctors, and have them filled at
different pharmacies. Still further, an unscrupulous physician may actually
write multiple prescriptions for a patient, or multiple patients, who use cash
to pay for the drugs.” Id. at 24 (citing Ex. 1001, 1:30–34). The claimed
method solves the problem by monitoring the database for potentially
abusive prescription patterns, including the steps of flagging cash payments
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
22

and contacting a patient’s insurance company. Id. at 25 (citing Ex. 1001,
1:45–49).
In sum, the inventors could have claimed the steps of verifying
insurance coverage or patient payment, but they did not. Petitioner does not
provide a persuasive analysis for why we should find otherwise. Petitioner’s
argument that claim 8 recites method steps used in the practice,
administration, or management of a financial product or service, rather than
steps used to control access to a prescription drug to guard against potential
abuse or diversion, is contrary to the plain meaning of claim 8. Therefore,
we decline to accept Petitioner’s argument with respect to claim 8 of the
’059 patent.
2. The ’988 patent claims (CBM2014-00150)
The preambles to the independent claims in the ’988 patent, such as in
claim 1, recite a “method of treatment of a narcoleptic patient with a
prescription drug while controlling potential misuse, abuse or diversion of
said prescription drug.” Ex. 1001, 8:38–40.12 The body of the claim recites
very similar method steps as in the ’730 patent for controlling access to a
sensitive prescription drug. Id. at 8:41–9:13. Petitioners Amneal and Par
cite the PTAB decision in Saleforce.com in support of their argument that
“the claimed methods [of the ’988 patent] have particular application
involving ancillary activities related to a financial product or service.” Pet.
11 (citing Salesforce.com v. VirtualAgility, Case CBM2013-00024, slip op.
at 11 (PTAB Nov. 19, 2013 (Paper 16))). As Patent Owner correctly notes,

12 All citations in this subsection are to the papers and exhibits in CBM2014-
00150.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
23

Petitioners Amneal and Par do not explain their citation to the
Salesforce.com decision or otherwise offer any analysis of the case in
support thereof. Prelim. Resp. 23. Therefore, we are unpersuaded by their
citation to the Salesforce.com case.
3. The ’182 patent claims (CBM2014-00153)
The independent claim preambles in the ’182 patent, such as in claim
1, recite a “method of treatment of a narcoleptic patient with a prescription
drug that has a potential for misuse, abuse or diversion, wherein the
prescription drug is sold or distributed by a company that obtained approval
for distribution of the prescription drug.” Ex. 1001, 8:38–42.13 The body of
the claim then recites very similar method steps as in the ’730 patent for
controlling access to a sensitive prescription drug. Id. at 8:43–9:6.
Petitioners Amneal and Par argue that the preamble “wherein” clause,
describing the drug as one “sold or distributed by a company that obtained
approval” for its distribution, has particular application in the practice,
administration, or management of a financial product or service. Pet. 12–13.
Petitioners Amneal and Par, however, do not provide supporting evidence,
explanation, or analysis for this argument. Id. The preamble “wherein”
clause is little more than a contextual description of a company approved by
the Food and Drug Administration (“FDA”) to sell or distribute the drug; a
company not approved by the FDA is not authorized to sell the drug or
perform the claimed method steps. Prelim. Resp. 24. In short, the
descriptive “wherein” clause is not a method step used in the practice,

13 All citations in this subsection are to the papers and exhibits in CBM2014-
00153.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
24

administration, or management of a financial product or service, including
sale of a prescription drug. Therefore, we are unpersuaded by that
argument.14

III. CONCLUSION
For the reasons given above, based on the present record and
particular facts of these cases, we are not persuaded that the information
presented in the Petition establishes that any claim in the ’730, ’059, ’988,
and ’182 patents qualifies as a covered business method patent under Section
18 of the AIA. Petitioner, therefore, has failed to satisfy the jurisdictional
requirements of Section 18.

IV. ORDER
Accordingly, it is ORDERED that the Petition is denied.

14 Amneal and Par further argue that, because a method step recited in
dependent claims 3, 10, and 21 (“wherein a pharmacy enters data into the
single computer database”) is “to be performed by a pharmacy – which itself
is a business,” the claims are related to the practice, administration, or
management of a financial product or service. Pet. 13. That argument is
part and parcel of the “used in commerce” argument addressed in subsection
2.d., above.
Case CBM2014-00149 (Patent 7,895,059 B2)
Case CBM2014-00150 (Patent 8,457,988 B1)
Case CBM2014-00151 (Patent 7,668,730 B2)
Case CBM2014-00153 (Patent 8,589,182 B1)
25

FOR PETITIONERS:
Dennies Varughese, Lead Counsel
Deborah Sterling, Backup Counsel
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
dvarughe-PTAB@skgf.com
dsterlin-PTAB@skgf.com

FOR PATENT OWNER:
F. Dominic Cerrito, Lead Counsel
QUINN EMANUEL URQUHART & SULLIVAN, LLP
nickcerrito@quinnemanuel.com

John V. Biernacki, Backup Counsel
JONES DAY
jvbiernacki@jonesday.com

kis