Paper 17 Tel: Entered: October 15, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE

Transcription

1 Paper 17 Tel: Entered: October 15, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD COALITION FOR AFFORDABLE DRUGS III LLC, Petitioner, v. JAZZ PHARMACEUTICALS, INC., Patent Owner. Case IPR Patent No. 7,895,059 B2 Before JACQUELINE WRIGHT BONILLA, SUSAN L. C. MITCHELL, and BRIAN P. MURPHY, Administrative Patent Judges. MITCHELL, Administrative Patent Judge. DECISION Denying Institution of Inter Partes Review 37 C.F.R

2 A. Background I. INTRODUCTION Coalition for Affordable Drugs III LLC ( Petitioner ) filed a Petition requesting an inter partes review of claims 1 16 (all claims) of U.S. Patent No. 7,895,059 B2 (Ex. 1001, the 059 patent ). Paper 1 ( Petition or Pet. ). Jazz Pharmaceuticals, Inc. ( Patent Owner ) filed a Preliminary Response to the Petition. Paper 11 ( Prelim. Resp. ). 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. For the reasons that follow, we do not institute an inter partes review. B. Related Proceedings The parties identify the following as related district court proceedings regarding the 059 patent: Jazz Pharms, Inc. v. Par Pharm., Inc., 2:13-cv (D.N.J. Dec. 27, 2013); Jazz Pharms, Inc. v. Amneal Pharms., LLC, 2:13-cv (consolidated) (D.N.J. Jan. 18, 2013); Jazz Pharms, Inc. v. Roxane Labs., Inc., 2:10-cv (consolidated) (D.N.J. Nov. 22, 2010); Jazz Pharms., Inc. v. Ranbaxy Labs. Ltd., 2:14-cv-4467 (D.N.J. July 15, 2014); Jazz Pharms., Inc. v. Watson Labs., Inc., 2:14-cv-7757 (D.N.J). Pet. 3 4; Paper 7, 1 2. As noted by Patent Owner (Paper 7), different petitioners previously filed Petitions for a covered business method review (CBM ) and an inter partes review (IPR ) that challenged the claims of the 059 patent. The Board declined to institute review in CBM , but instituted review of claims 1 16 of the 059 patent in IPR on 2

3 July 28, Par Pharma, Inc. v. Jazz Pharms., Inc., Case IPR (PTAB July 28, 2015) (Paper 19) ( Dec. ). C. The 059 Patent The 059 patent, titled Sensitive Drug Distribution System and Method, 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. Ex. 1001, Abstract, 1: 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: Figures 2A, 2B, and 2C comprise flow charts representing an initial prescription order entry process for a sensitive drug. Id. at 4: 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 31, Fig. 2A (steps ). 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: Steps , of Figure 2A are reproduced below: 3

4 Figure 2A, above, depicts steps for verifying insurance coverage or ability to pay. Id. at 2:28 30, 4: The pharmacy workflow includes verification of the prescribing physician s credentials. Id. at 5:15 31, Fig. 2B (steps ). 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 5:31 6:4. Figure 2C, a flowchart describing a method for sensitive drug distribution, is reproduced below. Id. at 2:

5 Figure 2C, above, depicts 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 5

6 program (CHIP) for Xyrem. 1 Id. at 4: 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 6:37 41, Fig. 4B (step 436). C. Illustrative Claims The 059 patent contains six independent claims (1, 6, 9, 12, 13, 14) and ten dependent claims (2 5, 7, 8, 10, 11, 15, 16), of which claim 1 is illustrative and reproduced below: 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; 1 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: Xyrem is a sensitive prescription drug prone to potential abuse or diversion. Id. 6

7 confirming with a patient that educational material has been received and/or read prior to shipping the prescription drug; checking the exclusive computer database for potential abuse of the prescription drug; mailing or sending by courier 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. Ex. 1001, 8:37 9:3 (emphases added). Dependent claims 7, 10, and 15, which depend from independent claims 6, 9, and 14, respectively (which are similar to claim 1), recite that providing the prescription drug to the patient comprises the central pharmacy authorizing the prescription drug to be dispensed to the patient by another pharmacy. See, e.g., id. at 9:52 54 (claim 6). Dependent claims 8, 11, and 16 of the 059 patent recite certain controls, such as confirming with the patient that the educational material has been received and/or read by the patient, confirming receipt of the prescription drug by the patient. See, e.g., id. at 9:56 66 (claim 8). D. Prior Art Relied Upon Petitioner challenges the patentability of claims 1 16 on the basis of the following prior art references: Lilly US 2004/ A1 Sept. 9, 2004 (Ex. 1002) FDA Peripheral & Central Nervous System Drugs (Ex. 1003) Advisory Committee, Transcript and Slides ( DAC Transcript ) Camarda US 6,587,829 B1 July 1, 2003 (Ex. 1004) 7

8 FDA Peripheral & Central Nervous System (Ex. 1005) Drugs Advisory Committee, Briefing Information, Division of Neuropharmacological Drug Products Preliminary Clinical Safety Review of NDA ( CSR ) E. The Asserted Grounds of Unpatentability Petitioner contends that the challenged claims are unpatentable based on the following grounds (Pet ): References Basis Claims challenged Lilly, DAC Transcript, and Camarda 103(a) 1 6, 9, and Lilly, DAC Transcript, Camarda, and CSR 103(a) 7 8, 10 11, and II. ANALYSIS A. Real Parties-in-Interest Patent Owner contends that Petitioner fails to identify individuals or entities who have invested in the Hayman funds allegedly responsible for filing the Petition. Prelim. Resp. 46. Patent Owner asserts that the unnamed investors are RPI not only because they fund the Petition, but also because [the Petitioner] is merely a proxy for the unnamed investors who... stand to gain or lose financially from the Petition. Id. at Patent Owner points to where our Trial Practice Guide states: [A]t a general level, the real party-in-interest is the party that desires review of the patent. Id. at 47 (quoting Zoll Life Corp. v. Philips Elecs. N.A. Corp., IPR , 2014 WL , at *5 (PTAB Mar. 20, 2014)); see Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012) ( Trial Practice 8

9 Guide ) (emphasis added)). We consider multiple factors, however, when assessing whether a party is a RPI who desires review. As stated in our Trial Practice Guide, the RPI inquiry is a highly fact dependent question there is no bright line test. 77 Fed. Reg. at 48,759. Although rarely will one fact, standing alone, be determinative of the inquiry (id. at 48,760), [a] common consideration is whether the non-party exercised or could have exercised control over a party s participation in a proceeding. Id. at 48,759 (citations omitted); Reflectix, Inc. v. Promethean Insulation Tech. LLC, Case IPR , slip op. at 12 (PTAB April 24, 2015) (Paper 18). Along those lines, the RPI requirement exists to ensure that a non-party is not litigating through a proxy. Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., Case IPR , slip op. at 12 (PTAB Feb. 20, 2015) (Paper 13). Thus, when assessing RPI, we inquire into the relationship between a party and a proceeding, and consider the degree of control the nonparty could exert over the inter partes review, not the petitioner. Id. at 11. Additional 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. Trial Practice Guide, 77 Fed. Reg. at 48,760. A party does not become a RPI merely through association with another party in an endeavor unrelated to the AIA 2 proceeding. Id. 2 The Leahy-Smith America Invents Act, Pub. L. No , 125 Stat. 284 (2011) ( AIA ). 9

10 The record before us does not persuade us sufficiently that any individual or entity who has invested in the listed RPIs has or could have exerted control over the filing of the Petition in this case. Likewise, insufficient evidence exists as to whether any unnamed investor funded or otherwise paid for expenses associated with the Petition, or if an unnamed investor in its own capacity (or via its legal counsel) controlled or participated in the filing of the Petition here. See Prelim. Resp. 48 (providing only generalized statements from Hayman investment materials stating investors will generally bear costs of the investments, including outside professional fees and expenses, including those of attorneys, and litigation expenses ). This record presents little to no information as to how any unnamed investor relates to, or could have participated in, this proceeding in particular. Based on the particular facts of this case, in view of the evidence before us on the present record, we are not persuaded that Patent Owner has provided sufficient evidence to show that Petitioner s disclosure of real parties-in-interest is inadequate in relation to individuals or entities who have invested in the listed real parties-in-interest. B. Alleged Abuse of Process Patent Owner asserts that we should exercise our discretion under 35 U.S.C. 314(a) and 315(b) to deny the Petition because it is presented for an improper purpose contrary to the purpose of the AIA. Prelim. Resp Patent Owner asserts that Petitioner is a non-practicing entity who is abusing and misusing the IPR process to initiate their investment strategy aimed at affecting stock prices of targeted innovator pharmaceutical companies. Id. at 11; Paper 15, 2. 10

11 The purpose of the AIA, however, was not limited to providing only a less costly alternative to litigation. Rather, the AIA sought to establish a more efficient and streamlined patent system that improved patent quality, while at the same time, limiting unnecessary and counterproductive litigation costs. The AIA was designed to encourage the filing of meritorious patentability challenges, 3 by any person who is not the patent owner, in an effort to improve patent quality. H.R. Rep. No , pt. 1, at 85 (2011); see 35 U.S.C Accordingly, consistent with the proposition that Article III standing is not a requirement to appear before this administrative agency, we hold that Congress did not limit inter partes reviews to parties having a specific competitive interest in the technology covered by the patents. See Sierra Club v. E.P.A., 292 F.3d 895, 899 (D.C. Cir. 2002) (stating that an administrative agency is not subject to Article III of the Constitution of the United States, so a petitioner would have no need to establish standing to participate in proceedings before the agency); see also Consumer Watchdog v. Wis. Alumni Res. Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014) (citing Sierra Club). Patent Owner s assertion that that the profit motive behind the filing of this Petition is an improper purpose is equally unavailing. Prelim. Resp. 11, Paper 15, 2. Profit is at the heart of seeking patent protection in almost all inter partes reviews. As such, an economic motive for challenging a patent claim alone does not raise abuse of process issues. We take no position on the merits of short-selling as an investment strategy other than it is legal and regulated. 3 In its Preliminary Response, Patent Owner does not allege that Petitioner filed a non-meritorious patentability challenge. Prelim. Resp

12 For the above reasons, we decline to exercise our discretion to deny the Petition because of any alleged abuse or misuse of the inter partes review process. C. Public Accessibility of the DAC Transcript and the CSR The priority date of the 059 patent is December 17, Ex Petitioner asserts that the DAC Transcript and the CSR are printed publications that qualify as 102(b) prior art because the DAC Transcript was published no later than July 13, 2001, and the CSR was published no later than June 5, Pet Patent Owner counters that Petitioner s evidence of public availability of the two documents does not show public availability of the DAC Transcript at all, and the webpage offered by Petitioner in support of the public availability of the CSR was first archived by the Wayback Machine November 21, 2011, well after the priority date of the 059 patent. Prelim. Resp Because we find that Petitioner has not shown that the DAC Transcript was publicly available and Petitioner relies on this reference for both grounds presented, we need not determine the public accessibility of the CSR. Under 35 U.S.C. 311(b), a petitioner in an inter partes review may challenge only the claims of a patent based on prior art consisting of patents or printed publications. 35 U.S.C. 311(b). Here, Petitioner has the ultimate burden of persuasion in a review, if instituted, to prove unpatentability by a preponderance of the evidence. Dynamic Drinkware, LLC v. Nat l Graphics, Inc., No , 2015 WL , at *4 12

13 (Fed. Cir. Sept. 4, 2015). 4 Petitioner also has the initial burden of production to establish that there is prior art that renders the claims unpatentable. Id. To satisfy this initial burden, we often have required Petitioner to come forward with sufficient evidence to make a threshold showing, at the institution stage, that the reference relied upon is available prior art. See, e.g., Coalition For Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR , slip op. at 3 5 (PTAB Aug. 24, 2015) (Paper 15); Symantec Corp. v. Trs. of Columbia Univ., IPR , slip op. at 5 9 (PTAB June 17, 2015); Temporal Power, Ltd. v. Beacon Power, LLC, IPR , slip op. at 8 11 (PTAB Apr. 27, 2015) (Paper 10); Dell, Inc. v. Selene Comm n Techs., LLC, IPR , slip op. at (PTAB Feb. 26, 2015) (Paper 23). 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, 1312 (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 4 In Dynamic Drinkware, the Petitioner relied on a prior art patent to challenge the claims of the involved patent WL , at *2. Based on the earlier filing date of the prior art patent, Petitioner satisfied its initial burden of production by arguing that the prior art patent anticipated the asserted claims under 35 U.S.C. 102(e)(2). Id. at *7. In contrast, here, Petitioner does not rely on a filing date recorded on the face of a patent. 13

14 reasonable diligence, can locate it. Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (quoting In re Wyer, 655 F.2d 221, 226 (CCPA 1981)). With these principles in mind, we consider the parties arguments below. Petitioner relies on the Federal Register notice announcing the FDA s Advisory Committee meeting on Xyrem for its statement that the transcript and slides of the FDA Peripheral & Central Nervous System Drugs Advisory Committee meeting is generally posted about 3 weeks after the meeting. Pet. 24 (quoting Ex. 1015). Petitioner concludes that [b]ased on the stated timeline, the DAC Transcript thus was publicly accessible to a POSA [, i.e., a person of ordinary skill in the art,] exercising reasonable diligence as of June 27, Id. Petitioner also points to another webpage to support that the DAC Transcript was available no later than July 13, 2001, (id. at 25 (citing Ex. 1016)), which Petitioner asserts is supported by the Wayback Machine (id. (citing Ex. 1017)). Patent Owner asserts that the DAC Transcript is not a linked document on Petitioner s Exhibit 1017, and that [b]y scouring the web pages that are linked to that archived web page, only the CSR not the DAC transcript can be found as an indirectly-lined web page. Prelim. Resp. 14. Patent Owner concludes that [b]ecause at least one reference in the combination of references relied on by [Petitioner] in both Grounds 1 and 2 is not prior art, the Petition should be denied. Id. at 15. We agree. The DAC Transcript (Ex. 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 ). The Advisory Committee Meeting was 14

15 convened to discuss Xyrem, with the main focus of the deliberations... on risk management issues. Ex. 1003, 5:23 6:3. A Federal Register Notice dated May 14, 2001, provided public notice of the Advisory Committee Meeting. Ex 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). This statement, by itself, however, is not sufficient under the circumstances to show that the DAC Transcript actually was made available to the extent that interested, ordinarily skilled persons, exercising reasonable diligence, could have located it as of June 27, 2001, three weeks after the date of the Advisory Committee meeting. Petitioner s reliance on Exhibit 1016 is equally unavailing. The face of Exhibit 1016 allegedly shows 2001 meeting documents organized by a Center within the Food and Drug Administration ( FDA ). Under the Center for Drug Evaluation and Research (CDER), a link to the Peripheral and Central Nervous System Drugs Advisory Committee states (Updated 07/13/01), but there is no indication as to which documents are associated with the July 13, 2001 update, if any. Ex Therefore, we do not agree with Petitioner that Exhibit 1016 shows that the DAC Transcript was available no later than July 13, 2001, nor do we agree that the Wayback Machine archived page confirms this availability date for the DAC Transcript. As Patent Owner notes, the DAC Transcript does not appear to be one of the linked documents on the Wayback Machine archived page. See Ex. 1017, 5. In fact, the columns titled Transcript PDF ID (size in kb) and Transcript Text ID (size in kb) next to the June 6 th date for the 15

16 Advisory Committee meeting are empty. Id. We agree with Patent Owner that Ex indicates that the DAC Transcript was not publicly available as of the Wayback Machine archive date. Prelim. Resp. 16. We, therefore, determine that Petitioner has not satisfied its initial burden of coming forward with sufficient evidence to make a threshold showing that the DAC Transcript is a prior art printed publication. Because Petitioner relies on this reference for both asserted grounds to challenge the patentability of the claims, we also determine that Petitioner has failed to establish a reasonable likelihood that it would prevail in asserting that claims 1 through 16 of the 059 patent are unpatentable. Furthermore, even if Petitioner were able to establish that both the DAC Transcript and the CSR were prior art, Petitioner s substantive challenge to claims 1 16 of the 059 patent also fails, for the reasons discussed below. D. Claim Construction exclusive central pharmacy and exclusive computer database In an inter partes review, claim terms in an unexpired patent are given their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R (b); see also In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1279 (Fed. Cir. 2015) ( Congress implicitly approved the broadest reasonable interpretation standard in enacting the AIA, and the standard was properly adopted by PTO regulation. ). Significantly, claims are not interpreted in a vacuum but are part of, and read in light of, the specification. United States v. Adams, 383 U.S. 39, 49 (1966) ( [I]t is fundamental that claims are to be construed in the light of the specifications and both are to be read with a view to ascertaining the invention.... ). Claim terms are given their ordinary and 16

17 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). An inventor may rebut that presumption by providing a definition of the term in the specification with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In the absence of such a definition, limitations are not to be read from the specification into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Petitioner generally relies on the ordinary meaning of the claim terms, but offers an explicit construction of exclusive central pharmacy and exclusive computer database. Pet Petitioner relies on the prosecution history and the specification of the 059 patent to support its assertion that the broadest reasonable interpretation of the term exclusive means single or sole. Id. The claim language is consistent with Petitioner s proposed claim constructions. The claims recite receiving, only into an exclusive central computer system, all prescriptions in an effort to control distribution of a prescription drug and guard against potential abuse and unauthorized diversion. Ex. 1001, 8:40 50, 9:1 3 (emphasis added). The 059 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., 789 F.3d 1292, 1298 (Fed. Cir. 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. ). 17

18 Thus, we construe exclusive central pharmacy to mean single or sole pharmacy, and we construe exclusive computer database to mean single or sole computer database. E. Obviousness of Claims 1 6, 9, and of the 059 Patent over Lilly in View of the DAC Transcript and Camarda Petitioner contends that claims 1 6, 9, and of the 059 patent would have been obvious over Lilly in view of the DAC Transcript and Camarda. Pet 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, wherein the pharmacies may be affiliated or unaffiliated. Ex. 1002, 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. 39. Camarda discloses a system for improving patient compliance with prescriptions by converting prescription information into electronic form as records for each patient, and running a regression analysis on these patient records to create a model of likelihood of prescription compliance in general by the patient. Ex. 1004, Abs. If the regression analysis shows that a patient may not be compliant, intervention may be used to encourage compliance. Id. 18

19 The DAC Transcript discloses a closed distribution system where Xyrem is manufactured at a single manufacturing facility and is distributed from a single national specialty pharmacy. Ex. 1003, 177:24 178:6, 527 (slide depicting Xyrem Closed Distribution System ), 528 (slide describing single specialty pharmacy as single location for controls and records), 539 (slide describing benefits of central data repository). Therefore, the DAC Transcript teaches that the product is distributed from a central location with all the controls and all the records in one place. Id. at 178:8 11. The DAC Transcript describes that a shipment of Xyrem is sent by a system that allows real-time tracking of the shipment and will be returned to the specialty pharmacy after one delivery reattempt if the patient or the designee is not available for receipt of the shipment at the agreed upon time with the specialty pharmacy. Id. 182:17 183:6, 536. Petitioner glosses over the differences between the DAC Transcript and Lilly or Camarda, and does not address the specific language of the steps in the independent claims, in context, to explain why it would have been obvious for one of ordinary skill to combine the prior art references in the manner recited. See Pet As argued by Patent Owner, Lilly discloses the use of a plurality of pharmacies that may be affiliated or unaffiliated with one another, rather than the use of an an exclusive computer database associated with the exclusive central pharmacy to receive, process, and dispense prescriptions. Prelim. Resp. 24 (citing Ex. 1002, Abstract). Petitioner relies on Dr. Fudin 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 teachings of Lilly with the teachings in the DAC 19

20 Transcript and Camarda to arrive at the claimed invention. Ex , cited in Pet. 27. Specifically, Petitioner asserts: A POSA at the time of the alleged invention of the 059 Patent would have been motivated to combine the teachings of Lilly, the DAC Transcript and Camarda to arrive at a method for reducing the abuse of drug products such [as] Xyrem and thus improve the healthcare system while reducing healthcare costs. It was well-known to a POSA that it was desirable to reduce spiraling costs structure, mitigate health risks, provide more efficient billing, eliminate redundancy, and improve informational flow. It would be desirable to provide a healthcare utility that can assist substantially in reducing these misused and abused prescriptions. Pet. 27 (citing Ex , Ex , 35) (quoting Ex. 1002, 9, 12, respectively). Patent Owner asserts Petitioner does not offer reasons why a POSA would cobble together disclosures from the[se] disparate references that are not related to the same endeavor. Prelim. Resp. 22, 24. Patent Owner states that Petitioner ignores that the DAC Transcript is the only reference in Ground 1 that refers to a sensitive prescription drug like GHB, or the need to control access to GHB to minimize its potential abuse, misuse, and diversion. Neither Camarda nor Lilly are directed to a centralized system of controlling access to a drug substance like GHB, which has a unique history of being misused to harm innocent third parties.... Neither Camarda nor Lilly is directed to the safe, secure, and comprehensive controlled access to pharmaceuticals with the potential to harm patients and third parties, and a POSA would not look to these references for guidance in addressing any such need. Pet We agree with Patent Owner. Petitioner does not provide adequate reasoning based on rational underpinnings to persuade us, in the absence of hindsight, that one of 20

21 ordinary skill would have modified the Lilly system to incorporate the DAC Transcript and Camarda to achieve, for example, 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 required by the claims of the 059 patent. 5 For the reasons given above, we are not persuaded Petitioner has shown a reasonable likelihood of prevailing in its assertion of unpatentability of claims 1 16 of the 059 patent. Accordingly, it is III. ORDER ORDERED that the Petition is denied as to all challenged claims of the 059 patent. 5 We need not address Petitioner s second ground as it applies only to dependent claims. 21

22 PETITIONER: Daniel W. McDonald Jeffrey D. Blake Thomas J. Leach MERCHANT & GOULD P.C. PATENT OWNER: Francis Dominic Cerrito QUINN EMANUEL URQUHART & SULLIVAN, LLP John V. Biernacki JONES DAY 22