Roxane Laboratories, Inc.v.Jazz Pharmaceuticals, Inc.Download PDFPatent Trial and Appeal BoardFeb 9, 201510979665 (P.T.A.B. Feb. 9, 2015) Copy Citation Trials@uspto.gov Paper 16 Tel: 571-272-7822 Entered: February 9, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ ROXANE LABORATORIES, INC. and PAR PHARMACEUTICAL, INC., Petitioners, v. JAZZ PHARMACEUTICALS, INC., Patent Owner. _____________ Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 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 both cases. The patents at issue in CBM2014-00161 and CBM2014-00175 are 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. See Par Pharm., Inc. v. Jazz Pharms., Inc., Case CBM2014- 00149/150/151/153, slip op. (PTAB Jan. 13, 2015) (Paper 12). Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 2 I. INTRODUCTION Roxane Laboratories, Inc. (“Roxane”), and Par Pharmaceutical, Inc. (“Par”) (together, “Petitioner”) filed a Petition requesting covered business method (“CBM”) patent review of claims 1–8 (all claims) of US Patent No. 7,765,106 B2 (Ex. 1001, “the ’106 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 6 (“Pet.”). Jazz Pharmaceuticals, Inc. (“Patent Owner”) filed a Preliminary Response to the Petition. Paper 13 (“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 324, which provides that a post-grant patent review, such as a 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 1–8 of the ’106 patent as unpatentable under 35 U.S.C. §§ 101, 102(b), and 103(a). Pet. 34–35. Based on the information presented in the Petition and Preliminary Response, we determine Petitioner has not demonstrated that the ’106 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 CBM2014-00161 as representative of both cases. All citations are to CBM2014-00161 unless otherwise noted. In CBM2014-00175, Petitioner challenges claims 1–6 of US Patent No. 7,765,107 B2 (“the ’107 patent”), which claims a “computerized method to control abuse of a prescription drug” followed by a series of control steps, including “determining . . . current and anticipated patterns of potential prescription abuse . . . from periodic reports generated only by the central database based on prescription request data . . . .” CBM2014-00175, Ex. 1001, 8:36–9:25 (claim 1). Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 3 A. Related Proceedings The parties identify the following as related district court proceedings regarding the ’106 patent: Jazz Pharms., Inc. v. Roxane Labs., Inc., 2:10-cv- 6108 (D.N.J.); Jazz Pharms., Inc. v. Amneal Pharms., LLC, 2:13-cv-391 (consolidated with 2:13-cv-7884) (D.N.J.); and Jazz Pharms., Inc. v. Ranbaxy Labs. Ltd., 2:14-cv-4467 (D.N.J.). Pet. 79; Paper 11, 2–3. The parties identify the following as petitions for covered business method review of patents related to the ’106 patent: Amneal Pharms., LLC v. Jazz Pharms., Inc., Case CBM2014-00149 (filed June 24, 2014) (US 7,895,059 B2); Amneal Pharms., LLC v. Jazz Pharms., Inc., Case CBM2014-00150 (filed July 7, 2014) (US 8,457,988 B1); Par Pharm., Inc. v. Jazz Pharms., Inc., Case CBM2014-00151 (filed July 9, 2014)(US 7,668,730 B2), and Amneal Pharms., LLC v. Jazz Pharms., Inc., Case CBM2014-00153 (filed July 9, 2014) (US 8,589,182 B1). Pet. 79; Paper 11, 3. Patent Owner identifies the following pending US patent applications claiming priority benefit from US Patent Application No. 10/322,348, from which the ’106 patent also claims priority benefit: 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 11, 3. B. The ’106 Patent The ’106 patent, titled “Sensitive Drug Distribution System and Method,” issued July 27, 2010 from an application filed November 2, 2004. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 4 Ex. 1001. 3 The ’106 patent is directed to a method for treating a patient with a sensitive prescription drug and controlling access to the sensitive prescription drug, which is prone to potential abuse, misuse, or diversion, by utilizing a central pharmacy and database to track all prescriptions for the sensitive drug. Id. at Abstract, 1:44–46. Information regarding all physicians authorized to prescribe the drug and all patients receiving the drug is maintained in the database. Id. at 1:46–48. Abuses are identified by monitoring the database for prescription patterns by physicians and prescriptions obtained by patients. Id. at Abstract, 1:48–50. Figures 2A, 2B, and 2C comprise flow charts representing “an initial prescription order entry process for a sensitive drug . . . .” Id. at 4:13–14. 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 4:13–39, 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 4:51–55. Steps 226–230 and 234–238 of Figure 2A are reproduced below: 3 The ’107 patent issued from a divisional application of US 10/322,348 (“the ’348 application”). CBM2014-00175, Ex. 1001, 1:6–9. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 5 Figure 2A depicts steps for verifying insurance coverage or ability to pay. Id. at 2:28–30, 4:51–67. The “pharmacy” workflow includes verifying prescribing physicians’ credentials. Id. at 5:7–19, Fig. 2B (steps 274–280). Filling the prescription includes confirming the patient has read sensitive drug educational materials, confirming the patient’s receipt of the sensitive drug, and daily cycle counting and inventory reconciliation. Id. at 5:31–6:4. Figure 2C steps 240, 242, 246, and 258–266 are reproduced below. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 6 . . . Figure 2C 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 infusion Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 7 program (CHIP) for Xyrem®.” 4 Id. at 4:37–39. 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 6:39–41, Fig. 4B (step 436). C. Illustrative Claim The ’106 patent contains multiple independent claims (1, 3, 5, and 7) and several dependent claims, of which claim 1 is illustrative and reproduced below: The invention claimed is: 1. A therapeutic method for treating a patient with a prescription drug that is effective for therapeutic purposes, but is also a drug that has potential to be abused, misused, or diverted, comprising: receiving, only into an exclusive central computer system, all prescriptions for any and all patients being prescribed the prescription drug and from any and all doctors allowed to prescribe the prescription drug, the prescriptions containing information identifying the patient, the prescription drug, and various credentials of the medical doctor who is prescribing the prescription drug; requiring entering of the information into an exclusive computer database associated with the exclusive central computer system for analysis of potential abuse, misuse, or diversion of the prescription drug, such that all prescriptions for the prescription drug are processed for authorization only using the exclusive central computer system and the exclusive computer database; 4 Xyrem is the brand name for gamma hydroxy butyrate, indicated for the treatment of cataplexy (excessive daytime sleepiness) in narcoleptic patients. Ex. 1001, 3:20–26. Xyrem is a sensitive prescription drug prone to potential abuse or diversion. Id. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 8 controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug by determining current and anticipated patterns of potential prescription abuse, misuse, or diversion of said prescription drug from periodic reports generated by the exclusive central computer system and the exclusive computer database based on prescription data from a medical doctor, wherein said prescription data contain information identifying the patient, the drug prescribed, and credentials of the doctor; and selecting multiple controls for distribution using said exclusive central computer system, the controls selected from the group consisting of communicating prescriptions from a physician to the exclusive central computer system; identifying the physician's name, license, and DEA (Drug Enforcement Agency) registration information; verifying the prescription; obtaining patient information; verifying the physician is eligible to prescribe the prescription drug by consulting the National Technical Information Services to determine whether the physician has an active DEA number and to check on whether any actions are pending against the physician; providing comprehensive printed materials to the physician; contacting the patient's insurance company if any; verifying patient registry information; providing comprehensive education information to the patient; verifying the patient has received and/or reviewed the educational materials; verifying the home address of the patient; shipping via US postal service or a commercial shipping service; receiving the name of an at least year old designee to receive the drug; confirming receipt of an initial shipment of the drug to the patient; returning the drug to a pharmacy after two attempts to deliver; launching an investigation when a shipment is lost; shipping to another pharmacy for delivery; requiring manufacture Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 9 at a single location; authorizing release of inventory in a controlled manner; questioning early refills; flagging repeat instances of lost, stolen, destroyed, or spilled prescriptions; limiting the prescription to a one month supply; requiring rewriting of the prescription periodically; and making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions; authorizing the filling, using the exclusive central computer system, of a prescription for the prescription drug that has been subjected to said multiple controls and has been approved for shipment to the patient; noting, based on one or more of the analysis of the potential abuse, misuse, or diversion of the prescription drug and the periodic reports, that there is a potential for abuse, misuse, or diversion by the patient to whom the prescription drug is prescribed; and delivering the prescription drug to the patient in order to treat the patient with the prescription drug. II. ANALYSIS A. Covered Business Method Review Section 18 of the AIA governs the transitional program for “covered business method patent” reviews. Section 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 ’106 patent. Pet. 79; Paper 8, 2. Section 18(a)(1)(E) states that a transitional proceeding may be instituted only for a “covered business method patent,” which is “a patent Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 10 that claims a method or corresponding apparatus for performing data 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 Transitional Program for Covered Business Method Patents — Definitions of Covered Business Method Patent and Technological Invention, 77 Fed. Reg. 48,734, 48,735 (Aug. 14, 2012) (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 Sen. Schumer).” (emphasis added)). Petitioner bears the burden of demonstrating that the ’106 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 (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 below, we conclude Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 11 Petitioner has not demonstrated that the ’106 patent is a “covered business method patent” under AIA § 18(d)(1). B. Financial Product or Service 1. The ’106 patent claims Claim 1 of the ’106 patent claims a method of treating a patient and “controlling the distribution of said prescription drug using the exclusive central computer system that tracks all prescriptions of said prescription drug and analyzes for the potential abuse, misuse, or diversion of the prescription drug.” Ex. 1001, 8:54–58. The claimed method requires entering the physician, patient, and prescription information into an “exclusive computer database,” which then tracks all prescriptions and utilizes a series of checks and controls to prevent “potential abuse.” Id. at 8:47–9:32. The series of checks and controls are claimed as a Markush group of approximately 25 control steps, but Petitioner emphasizes the following controls for purposes of establishing the statutory “financial product or service” requirement: “contacting the patient’s insurance company,” “shipping via US postal service or a commercial shipping service,” “requiring manufacture at a single location,” “authorizing release of inventory in a controlled manner,” and “checking . . . for cash payments.” Pet. 16 (citing Ex. 1001, 8:67–9:32 (emphasis omitted)). 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 treating a patient and controlling access to the prescription drug used for treatment to guard against potential abuse, misuse, or unauthorized diversion. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 12 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 ’106 patent is CBM- eligible because the claimed method “is used in commerce,” i.e., the claimed method steps recite “incidental activities related to a financial product or service – verifying insurance coverage and patient payment.” Pet. 16. Petitioner further argues that, because the claims recite “receiving . . . all prescriptions,” “identifying the physician’s name, license, and DEA (Drug Enforcement Agency) registration information,” “contacting the patient’s insurance company if any,” and “confirming receipt of an initial shipment of the drug to the patient,” 5 the claimed method comprises “the core activities of running the business of an exclusive (single) mail order pharmacy that direct ships to patients.” Pet. 18. 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.” Id. (citing Ex. 1007 ¶¶ 45–46). b. The language of the patent claims The patent claims recite a method for treating a patient and controlling access to the prescription drug used for treatment to guard against “potential abuse, misuse, or diversion” of the prescription drug; they do 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 5 Claims 1, 3, 5, and 7 recite the quoted limitations. Ex. 1001, 8:36–14:8. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 13 management of a “financial” 6 product or service. Petitioner does not analyze the claim language, in detail or 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. 16–19. Petitioner’s argument that the ’106 patent claims a “financial product or service” is conclusory and not supported by persuasive evidence or analysis. The claim limitations quoted by Petitioner, particularly “contacting the patient’s insurance company,” “shipping via . . . a commercial shipping service,” and “checking . . . for cash payments” (Pet. 16), 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. 21. As noted by Patent Owner, Petitioner’s argument implies the control steps in claim 1 are equivalent to “verifying” insurance coverage or a patient’s ability to pay for the prescription drug, but such verification steps are not recited or required by the actual claim language. Id. at 22–23. Petitioner also quotes the phrases “contacting the patient’s insurance company” and “checking for cash payments” out of context. Id. at 23–24. Petitioner omits, for example, that checking for cash payments is claimed in the context of “making the database available to the DEA for checking for abuse, misuse, or diversion patterns in the data, for cash payments, and for inappropriate questions.” Id. 6 “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 February 9, 2015). Ex. 3001. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 14 at 24 (emphasis added). The language omitted by Petitioner makes very clear that the claimed control step recites a step in the process of preventing abuse, misuse, or diversion of the prescription drug, not verifying payment by a patient. Id. at 24–25. 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 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. Prelim. Resp. 20–21. 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 (“verifying” information or “confirming receipt” of the drug) on “delivering” a prescription drug to an authorized “patient” to treat the patient and prevent “the potential abuse, misuse, or diversion of the prescription drug.” Therefore, for the reasons given above, we are unpersuaded by Petitioner’s argument that the ’106 patent claims recite method steps “used in the practice, administration, or management of a financial product or service.” c. The written description of the ’106 patent The claim limitations of the ’106 patent cited by Petitioner also do not recite or require the act of verifying a patient’s insurance coverage or ability Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 15 to pay for the prescription drug. Petitioner and Dr. Valuck do not explain, in detail or 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. 17–18 (citing Ex. 1007 ¶¶ 45–46); 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 language as a whole. Their reasoning is circular—“[t]hese claimed steps are all financially related activities that are performed daily by pharmacies because they are required to provide prescription drugs to consumers and are part of the purchase process” (Ex. 1007 ¶ 45)—and unpersuasive. We agree with Patent Owner; the act of verifying a patient’s insurance coverage or ability to pay is not a claimed method step in the ’106 patent. Prelim. Resp. 26–27. In the context of the claims as a whole, the reference to “contacting the patient’s insurance company” is one of many controls for checking the patient’s information and identity. Prelim. Resp. 26. The claimed step of “checking . . . for cash payments” also is a control for preventing a patient from having multiple prescriptions filled by multiple pharmacies using cash payments. Id. Making the database available for the DEA to check for cash payments furthers this initiative. Id. The ’106 patent makes clear that the other elements Petitioner cites (“shipping via US postal service or a commercial shipping service;” “requiring manufacture at a single location;” and “authorizing release of inventory in a controlled manner”) are also controls to prevent “the potential abuse, misuse, or diversion of the prescription drug.” Id. The quoted claim limitations do not recite or require Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 16 a method step “used in the practice, administration, or management of a financial product or service.” We also agree with Patent Owner that in the three CBM decisions cited by Petitioner (Pet. 17, 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. 30–31 (citing CRS Advanced Tech., Inc. v. Frontline Tech., Inc., Case CBM2012-00005, slip. op. 8 (PTAB Jan. 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 Apr. 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, Case CBM2014-00003, slip op. 8–9 (PTAB Apr. 1, 2014) (Paper 12) (same). 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 ’106 patent. Therefore, we find the cited authority inapposite to the facts of the present case. For the reasons given above, we are not persuaded 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 ’106 patent claims. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 17 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. 16–17; Prelim. Resp. 11–12. Petitioner’s argument is not supported by the plain language of the statute or the legislative history. Prelim. Resp. 11–12 (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 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. 16–19. 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 7 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 address persuasively the language of the statute or provide persuasive evidence or analysis from which we might 7 Petitioner argues that certain method steps recited in claims 1, 3, 5, and 7 directed to “receiving” all prescriptions, “identifying” the prescribing physician, “contacting” the insurance carrier, and “confirming receipt” of the drug, comprise the “core activities of running the business of an exclusive (single) mail order pharmacy that direct ships to patients.” Pet. 18. That argument is part and parcel of Petitioner’s “used in commerce” argument. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 18 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 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. See Prelim. Resp. 14–17. Those views are exemplified on the one hand by Senator Schumer, co- sponsor of the transitional program for CBM patent review, who stated, “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 Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 19 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 enterprise 8 ).” Id. at S1367 (daily ed. Mar. 8, 2011). The ’106 patent’s claimed method for treating a patient and controlling access to a prescription drug does not recite method steps involving the movement of 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, misuse, 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 ’106 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 8 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. 16; see http://www.uspto.gov/web/offices/ac/ido/oeip/taf/def/705.htm. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 20 within the ’106 patent are activities that are financial in nature, incidental . . . or complementary to a financial activity.” Pet. 18–19. Petitioner also relies on the citation of prior art billing systems by the Examiner during examination of the ’106 patent as further support for this argument. Id. at 19. Petitioner argues that, although not dispositive, the classification of the ’106 patent in Class 705 and citation of art regarding prescription drug payment arrangements is persuasive evidence that the ’106 patent method claims satisfy the statutory “financial product or service” requirement. Id. at 18–19. Petitioner does not explain, however, how the claim language of the ’106 patent recites method steps used in medical code billing systems or prior art payment systems. Id. As indicated by Patent Owner, the ’106 patent claims do not recite method steps used in billing systems, and the patent does not even describe billing systems. Prelim. Resp. 35. In sum, in the absence of a more detailed analysis and explanation of how the claim language and prior art indicate that the claims 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 ’106 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. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 21 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 Petitions establishes that any claim in the ’106 and ’107 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 Petitions are denied. Case CBM2014-00161 (Patent 7,765,106 B2) Case CBM2014-00175 (Patent 7,765,107 B2) 22 FOR PETITIONERS: Alan B. Clement, Lead Counsel Peter N. Fill, Backup Counsel LOCKE LORD LLP aclement@lockelord.com pfill@lockelord.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 Copy with citationCopy as parenthetical citation