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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
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`BEFORE THE PATENT TRIAL AND APPEALS BOARD
`________________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
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`v.
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`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`________________
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`
`Case IPR 2014-00325
`Patent 8,475,832
`_________________
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`DECLARATION OF CHRISTINE SIEGWARTH MEYER, PH. D. IN
`SUPPORT OF PETITIONER’S REPLY
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`Date: January 30, 2015
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`NERA Economic Consulting
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`Table of Contents
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`I.
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`INTRODUCTION ........................................................................................... 1
`A. Professional Qualifications and Expertise ....................................................... 1
`B. Retention and Assignment ............................................................................... 2
`C. Compensation .................................................................................................. 2
`D. Sources Relied Upon ....................................................................................... 3
`E. Summary of Opinions ...................................................................................... 3
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`II.
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`BACKGROUND ............................................................................................. 4
`A. The Patent at Issue ........................................................................................... 4
`B. The Product at Issue......................................................................................... 5
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`III. Legal Background ............................................................................................ 8
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`IV. RB Failed to Show the Commercial Success of Suboxone® Film ............... 10
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`V.
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`RB Failed to Demonstrate a Nexus Between the Alleged Commercial
`Success of Suboxone® Film and the Challenged Claims ............................. 13
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`I.
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`INTRODUCTION
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`A.
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`Professional Qualifications and Expertise
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`1.
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`I am an economist and Senior Vice President at National Economic
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`Research Associates, Inc. (“NERA”). NERA is a firm of consulting economists
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`that was founded in 1961 and that provides research and analysis in economics,
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`including analysis in the areas of competition, regulation, and finance. I joined the
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`firm in 2000 and have worked since then mainly in the areas of the economics of
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`intellectual property, antitrust analysis, and the evaluation of commercial damages.
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`I have testified in U.S. District Court, the Federal Court of Canada, the Supreme
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`Court of the State of New York, and the High Court of Justice in England as an
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`expert witness.
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`2.
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`Since joining NERA, I have analyzed economic issues in a wide
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`variety of cases including analyses of commercial success, irreparable harm and
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`damages in patent cases. I have been retained to analyze commercial success on
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`behalf of brand and generic pharmaceutical companies in both District Court and
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`Patent Trial and Appeals Board (“PTAB”) proceedings.
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`3.
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`I received my bachelor’s degree with a concentration in economics
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`from the United States Military Academy at West Point and my Ph.D. in
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`economics from the Massachusetts Institute of Technology. I taught economics
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`and statistics at Bentley College and Colgate University. A complete list of my
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`prior testimony and publications can be found in my curriculum vitae, Exhibit
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`1032.
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`B. Retention and Assignment
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`4.
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`I have been retained by the counsel for BioDelivery Sciences
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`International, Inc. (“BDSI” or “Petitioner”), McCarter & English, LLP, to provide
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`an economic opinion regarding whether Suboxone® film is a commercial success,
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`and whether RB Pharmaceuticals Limited (“RB”) has proven a nexus between any
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`such commercial success and the subject matter claimed in claims 15-19 of U.S.
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`Patent No. 8,475,832 (the “challenged claims”).
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`5.
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`Specifically, I have been asked by counsel for BDSI to assess the
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`claims made by RB in its “Patent Owner’s Corrected Response” submitted to this
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`Board on November 7, 2014 concerning Suboxone® film’s alleged commercial
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`success and whether there is a nexus between such alleged success and the subject
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`matter claimed in the challenged claims. This report summarizes my opinions.
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`C. Compensation
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`6.
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`NERA is being compensated for the time I spend on this assignment
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`at my customary hourly rate of $595. Professional staff members employed by
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`NERA and working under my direction on this matter have hourly billing rates that
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`range from $295 to $495. No part of my or NERA’s compensation is dependent
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`upon the outcome of this review or the nature of the opinions that I express.
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`D.
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`Sources Relied Upon
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`7.
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`In preparing this declaration, I (or economists working under my
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`direction) have reviewed pleadings, documents, exhibits and data submitted to the
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`Board by the parties in this Inter Partes Review, as well as information and data
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`from publicly available sources. A complete list of the information that has been
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`relied on in preparing this declaration can be found in Exhibit 1032.
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`E.
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`Summary of Opinions
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`8. Based on the information available to me and my analysis to date, it is
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`my opinion that:
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` RB has not demonstrated the commercial success of Suboxone® film,
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`and
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` RB has failed to show a nexus between any alleged commercial success
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`of Suboxone® film and the subject matter claimed in the challenged
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`claims.
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`II. BACKGROUND
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`A. The Patent at Issue
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`9.
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`I understand that the only challenged independent claim, claim 15,
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`recites:
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`An orally dissolving film formulation comprising buprenorphine and
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`naloxone, wherein said formulation provides an in vivo plasma profile
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`having a Cmax1 of between about 0.624 ng/ml and about 5.638 ng/ml
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`for buprenorphine and an in vivo plasma profile having a Cmax of
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`between about 41.04 pg/ml to about 323.75 pg/ml for naloxone.2
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`I further understand that the remaining challenged claims recite the film
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`formulation of claim 15 that provides mean AUC3 ranges for buprenorphine (claim
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`16), mean AUC ranges for naloxone (claim 17), and milligram amounts of
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`1 I understand that the ‘832 patent defines “Cmax” as “the mean maximum
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`plasma concentration after administration of the composition to a human
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`subject.” Ex. 1001 at 3:9-11.
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`2 Exhibit 1001, claim 15 at 24:56-61.
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`3 I understand that the ‘832 patent defines “AUC” as “the mean area under the
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`plasma concentration-time curve value after administration of the compositions
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`formed herein.” Exhibit 1001 at 3:11-14.
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`buprenorphine and naloxone (claims 18 and 19, respectively). Furthermore, it is
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`my understanding that the combination of buprenorphine and naloxone in
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`sublingual tablet form was used to treat individuals addicted to narcotics prior to
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`the filing of the application for the ’832 patent on August 7, 2009.4
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`B.
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`The Product at Issue
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`10. RB produces a buprenorphine/naloxone combination product for the
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`treatment of opiate dependence under the brand name Suboxone®.5 I understand
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`that RB first obtained approval from the U.S. Food and Drug Administration
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`(“FDA”) for its Suboxone® sublingual tablet product, which was developed under
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`a cooperative agreement between RB and the National Institute on Drug Abuse, in
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`October 2002.6 I also understand that Suboxone® sublingual tablets were
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`protected under Orphan Drug Status until October 2009, when the product lost
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`4 See Exhibit 1001, col. 1 (“Background Information”); Exhibit 2007.
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`5 Exhibit 1003, 2012 Reckitt Benckiser Group Annual Report, p. 11.
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`6 Exhibit 1040, RB Press Release, US FDA Marketing Approval For Reckitt
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`Benckiser’s Subutex® & Suboxone®, October 9, 2002, available at
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`https://www.rb.com/documentdownload.axd?documentresourceid=8.
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`exclusivity under its Orphan Drug Status.7 The FDA Office of Orphan Products
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`Development provides incentives for pharmaceutical companies to develop
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`products for rare diseases.8 One such incentive is the designation of a drug as an
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`Orphan Drug, which grants exclusivity to the manufacturer of the designated
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`Orphan Drug for seven years.9
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`11. According to the FDA National Drug Code Directory, generic
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`formulations for buprenorphine and naloxone sublingual tablets were approved
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`7 Exhibit 1003, 2012 Reckitt Benckiser Group Annual Report, p. 11.
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`8 Exhibit 1041, “Developing Products for Rare Diseases & Conditions,” available
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`at
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`http://www.fda.gov/forindustry/DevelopingProduCTsforrareDiseasesConditions
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`/default.htm.
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`9 Exhibit 1042, “Frequently Asked Questions on Patents and Exclusivity,”
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`available at
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`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm.
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`starting in February 2013.10 Four different pharmaceutical companies currently
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`manufacture generic buprenorphine and naloxone sublingual tablets in the U.S. 11
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`12. On August 31, 2010, RB obtained approval from the FDA to
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`manufacture and sell Suboxone® in film form.12 The company voluntarily
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`withdrew its Suboxone® sublingual tablet product in March 2013, even though it
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`earned a higher margin on the Suboxone® sublingual tablets than on its
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`Suboxone® sublingual film at that time.13 At its launch, Suboxone® film was
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`priced lower than Suboxone® sublingual tablets.14 I understand that the
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`Suboxone® sublingual tablet and the Suboxone® sublingual film contain the same
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`10 Exhibit 1043, “National Drug Code Directory,” at 4-5available at
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`http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm (Type: Active
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`Ingredient; Name: buprenorphine).
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`11 Id.
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`12 Exhibit 1003, 2012 Reckitt Benckiser Group Annual Report, pp. 11.
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`13 Exhibit 1044, 2013 Reckitt Benckiser Group Annual Report, p. 14.
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`14 Exhibit 1003, 2012 Reckitt Benckiser Group Annual Report, pp. 11.
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`active ingredients in the same proportion and the two products are indicated for the
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`same medical condition.15
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`III. Legal Background
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`13. I have been informed and understand that the following legal principles
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`apply in a commercial success analysis:
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` To show nonobviousness of a patent based on “commercial success,”
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`the patent owner must show (1) that commercial success actually
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`occurred, and (2) that there is a nexus--i.e., a causal relationship--
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`between that success and the merits of the claimed invention. It is not
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`sufficient that a product merely be within the scope of a claim.
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` Evidence of commercial success is only significant if there is a nexus
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`between a claimed feature and the commercial success.
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` The patent holder has the burden of showing that the commercial
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`success derives from a feature recited in the claims. The patent holder
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`must offer proof that the sales were a direct result of the unique
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`characteristics of the claimed invention, as opposed to other economic
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`15 Exhibit 2007; Exhibit 2038.
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`and commercial factors unrelated to the quality of the patented subject
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`matter.
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` Objective evidence that results from something that is not both
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`claimed and novel lacks a nexus to the merits of the claimed
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`invention.
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` A patent holder must identify specific features in the claims at issue
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`that form the basis for its commercial success argument in order to
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`establish the required nexus.
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` If commercial success is due to an element in the prior art, no nexus
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`exists. Similarly, where the alleged commercial success is due to
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`business activities or the patent holder’s pre-existing dominance in the
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`market, rather than to the claimed features, the patent holder has not
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`established nexus.
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` Where blocking patents prevent market entry, the inference from
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`evidence of commercial success is weak. Likewise, where market
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`entry of competitors is precluded by an exclusive statutory right in
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`conjunction with an FDA program, the inference of commercial
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`success will be found to be weak.
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` Where a product is covered by more than one patent, there is no
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`presumption of nexus between the challenged patent and the product.
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` The mere fact that generic pharmaceutical companies seek approval to
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`market a generic version of a drug, without more evidence, is not
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`proof of commercial success that speaks to the non-obviousness of
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`patent claims.
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`IV. RB Failed to Show the Commercial Success of Suboxone® Film
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`14. Based on my prior experience, as a matter of course, I would normally
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`expect that the party which alleges that its products achieved commercial success
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`provide at least the following to establish commercial success: the patent owner’s
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`current and historical sales/prescription data, the patent owner’s current and
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`historical market share data, pricing data, and an expert opinion regarding the
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`definition of the relevant market, the size of the relevant market, and why that
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`market is the market relevant to the patent claims.
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`15. Here, RB does not present any such evidence. Instead, RB cites (1) a
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`BDSI press release, (2) a BDSI SEC filing, and (3) quotations from a presentation
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`by Al Medwar16, a BDSI executive, and by Mark Sirgo, the CEO of BDSI. 17 RB
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`16 I understand that Mr. Medwar is neither an attorney nor an economist.
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`cites quotations from Mr. Medwar and another BDSI executive as alleged “praise
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`from others.”18 As explained below at Paragraphs 21 and 26, it is my opinion that
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`those quotations are consistent with RB’s product conversion campaign, rather
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`than concerning the subject matter of the challenged claims.
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`16. RB does not explain why it relies on BDSI statements rather than
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`presenting its own verifiable sales, prescription, and market share data. The
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`absence of raw data precludes detailed analysis of sales and market share data.
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`Similarly, RB does not explain why it only presents sales figures for 2013.19 The
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`evidence indicates that 2013 was a highly unusual year: as explained below at
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`Paragraph 27, I understand that in March 2013, RB voluntarily withdrew its
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`competing Suboxone® tablets; a withdrawal the FDA subsequently determined
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`was not based on safety or efficacy concerns.20 Given this, in my opinion, RB’s
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`decision only to reference data from 2013 to support its claim of commercial
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`success of the challenged claims is questionable at best.
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`17 See Paper 25, Patent Owner’s Corrected Response (“P.O.C.R.”), pp. 54-57.
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`18 P.O.C.R., pp. 55-57.
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`19 P.O.C.R., p. 55.
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`20 Exhibit 1045, Fed. Reg. 2013-13446, Jun. 6, 2013.
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`17. Further, none of these quotations are taken from a discussion of the
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`‘832 patent or a discussion of the market that is relevant for an analysis of the
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`alleged commercial success of the ‘832 patent or the challenged claims.
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`18.
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`In addition, in its cited quotations, RB references at least two different
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`markets, but has not identified either market as the relevant market for the ‘832
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`patent or the challenged claims.21 Similarly, RB has not offered any explanation as
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`to why either market is the relevant market for a commercial success analysis. RB
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`has not explained why other markets, such as the market for products used for the
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`treatment of opiate dependence, are not relevant to this analysis. Furthermore, the
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`figures cited by RB are inconsistent with RB’s own public statements about the
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`share of its Suboxone® film’s relevant market: for example, in its own press
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`21 P.O.C.R., p. 55, quoting a BDSI SEC statement (“The total market for
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`buprenorphine containing products for opioid dependence…”); P.O.C.R., p. 55,
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`quoting Mr. Medwar (“…market for buprenorphine/naloxone products…”).
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`releases, RB touts its share of the “buprenorphine market.”22 RB has offered no
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`opinion or argument regarding the relevant market to which I can respond.
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`19.
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`In conclusion, in my opinion, RB has failed to provide the evidence
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`and analyses necessary to substantiate its assertion that Suboxone® film was a
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`commercial success. Because RB fails to provide the necessary data and analysis,
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`in my opinion, the conclusion by RB’s attorneys that Suboxone® film was a
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`commercial success is unfounded.
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`V. RB Failed to Demonstrate a Nexus Between the Alleged Commercial
`Success of Suboxone® Film and the Challenged Claims
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`20. Assuming that Suboxone® film was indeed a commercial success –
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`and I have not seen the evidence to conclude that it was – RB also fails to show
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`that the supposed commercial success of the product was attributable to the
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`claimed subject matter of the challenged claims. I discuss below why the evidence
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`cited by RB does not (or does not sufficiently) support the nexus between the
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`assumed commercial success of Suboxone® film and the challenged claims.
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`22 Exhibit 1046, RB Press Release, “Proposed Demerger of the RB
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`Pharmaceuticals business,” at 2-3, November 17, 2014, available at
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`https://www.rb.com/proposed-demerger-of-the-rb-pharmaceuticals-business.
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`21. As explained below, in my opinion, the evidence indicates that the
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`alleged commercial success of Suboxone® film, if any, is likely due to a product
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`conversion campaign. Here, I believe some background would be helpful.
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`Branded pharmaceutical companies, anticipating the loss of exclusivity, may
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`engage in product life cycle management strategies such as reformulating existing
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`branded pharmaceutical products that would require approval from the FDA
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`(which would result in three years of FDA regulatory market exclusivity) and then
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`converting users of the original drug to the reformulated product.23 This practice,
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`also known as “product switching,” “product conversion,” “product hopping,” or
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`“line extension,” is often used to delay generic entry for a branded product. This
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`23 Exhibit 1047, Paul Ragusa and Dennis Bissonnette, Product Improvements and
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`Life Cycle Management – Antitrust Pitfalls, New Jersey Intellectual Property
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`Law Association, p. 1, available at
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`http://www.njipla.org/Resources/Documents/event_proceedings/2012-12-05-
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`26th-Annual-Pharmaceutical-
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`Chemical/NJIPLA%20Presentation%20on%20Product%20Switching---
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`Final%20Paper%20NY02%20760911%201-2.pdf; Exhibit 1048, Jessie Cheng,
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`An Antitrust Analysis of Product Hopping in the Pharmaceutical Industry,
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`COLUM. L. REV., Issue 6, October 2008, p. 1472.
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`works because pharmaceutical substitution laws only permit an “AB-rated” generic
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`substitute for a branded product, thus the generic product is often only deemed
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`“AB-rated” to the original branded product. As such, a prescription for the
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`reformulated branded product cannot be substituted by the generic formulation of
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`the original branded product. By shifting consumers from the original product to
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`the reformulated product, through marketing efforts or discontinuation of the
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`original formulation, branded pharmaceutical companies can avoid generic
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`competition for its reformulated product.24
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`22. A paper published in Antitrust states the following:
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`24 See Exhibit 1047, Paul Ragusa and Dennis Bissonnette, Product Improvements
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`and Life Cycle Management – Antitrust Pitfalls, Presentation by the New Jersey
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`Intellectual Property Law Association, p. 1, available at
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`http://www.njipla.org/Resources/Documents/event_proceedings/2012-12-05-
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`26th-Annual-Pharmaceutical-
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`Chemical/NJIPLA%20Presentation%20on%20Product%20Switching---
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`Final%20Paper%20NY02%20760911%201-2.pdf; Exhibit 1048, Jessie Cheng,
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`An Antitrust Analysis of Product Hopping in the Pharmaceutical Industry,
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`COLUM. L. REV., Issue 6, October 2008, p. 1472.
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`[Product hopping] can have the effect of destroying demand for the
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`generic and thus impeding an effective product launch. The branded
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`manufacturer’s move to a new drug formulation … serves to reset the
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`product market, putting the generic essentially back to square one in
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`its efforts to deliver FDA-approved equivalents to the marketplace.25
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`23. RB does not provide any evidence of a nexus – i.e., a causal
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`relationship – between the challenged claims and the alleged commercial success
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`of Suboxone® tablets. Instead, RB states that “Suboxone® sublingual films … are
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`covered by the challenged claims of the ‘832 patent.”26 As explained above at
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`Paragraph 13, I understand that it is not sufficient that a product merely be covered
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`by the challenged claims. In the past, RB has claimed that Suboxone® film is
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`covered by patents other than the ‘832 patent, including patents listed by RB in the
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`FDA Orange Book.27 RB has offered no explanation regarding how much of the
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`25 Exhibit 1049, M. Sean Royall, Ashely E. Johnson, and Jason C. McKenney,
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`Antitrust Scrutiny of Pharmaceutical “Product Hopping,” ANTITRUST, Vol. 28,
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`No. 1, Fall 2013, p. 71.
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`26 P.O.C.R., p. 53.
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`27 Exhibit 2050, Orange Book: Approved Drug Products with Therapeutic
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`Equivalence Evaluations.
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`alleged commercial success of Suboxone® film is attributable to these other
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`patents that allegedly cover Suboxone® film.
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`24. Further, RB fails to consider important market factors that may have
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`contributed to the alleged commercial success of Suboxone® film. In fact, RB
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`cites the following quotes from Exhibits 2048 and 2045 as evidence of commercial
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`success itself and that subject matter claimed in the challenged claims was
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`responsible for the alleged commercial success of Suboxone® film:
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`…“I think the other thing is [RB] did an outstanding job of converting
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`people from their sublingual table[t] to their sublingual film and it
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`convinced physicians that is just better overall than tablets”… “The
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`actions taken by [RB] as well as patient preference for a film
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`formulation of Suboxone® resulted in significant conversion of the
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`Suboxone® market to the branded film formulation…28
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`At most, these two quotes show that the BDSI executives believed that RB
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`engaged in efforts to convert patients and physicians to the film from the tablet. As
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`explained at Paragraph 27 below, RB voluntarily withdrew its Suboxone® tablets
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`28 P.O.C.R., p. 56. I note that RB misquoted the original source. Exhibit 2048
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`actually states “they convinced physicians that is just better overall than tablets.”
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`See, Exhibit 2048, p. 4.
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`citing alleged pediatric safety concerns, but the FDA subsequently found the
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`tablets were withdrawn for reasons other than safety or efficacy.
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`25. From the quotes cited by RB, it is unclear how much—if any—
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`commercial success of Suboxone® film was attributable to the patented features
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`and how much was attributable to the promotional efforts by RB. RB fails to
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`address how business events, such as promotional and marketing efforts, the
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`expiration of Suboxone® sublingual tablet’s Orphan Drug status, RB’s voluntary
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`withdrawal of the Suboxone® sublingual tablet, exit or entry of other comparable
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`generic drugs, and changes in demand for drugs for the treatment of opioid
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`dependence contributed to the claimed commercial success of Suboxone® film.
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`26. After having reviewed the documents submitted to the Board in this
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`matter as well as publicly available annual reports filed by RB, it is my opinion
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`that there is evidence that is consistent with RB engaging in product hopping. For
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`example, RB’s 2010 annual report states the following:
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`As a result of the loss of exclusivity in the US, up to 80% of the
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`revenues and profits of the Suboxone tablet business might be lost in
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`the year following the launch of generic competitors, with the
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`possibility of further erosion thereafter. To mitigate this potential
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`impact, [RB] introduced Suboxone sublingual film in September 2010
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`… As [RB] is rapidly converting Suboxone tablets to the sublingual
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`film, there is a short-term dilutive impact on net revenue and
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`operating profit: however, this conversion much better protects the
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`medium and long-term earnings stream from the Suboxone franchise
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`in the US. Hence, in the event of generic competition to the tablet, the
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`Group expects that the Suboxone sublingual film will help to mitigate
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`the impact thereof.29
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`First, RB admits that the introduction of Suboxone® sublingual film would
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`mitigate loss of revenue from potential generic entry of generic Suboxone® tablets.
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`Second, RB admits to engaging in efforts to “rapidly” convert users of Suboxone®
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`tablets to film formulation after its loss of exclusivity on Suboxone® tablets in the
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`U.S. and the launch of generic competitors. Finally, RB shows that it is willing to
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`suffer a negative short-term impact on net revenue by converting patients from the
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`tablet, which has a higher price and earns a higher margin, to the film formulation
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`because this effort would be beneficial in the long-term.30 RB has made similar
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`statements on the motivation behind the development of Suboxone® film and the
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`29 Exhibit 1050, 2010 Reckitt Benckiser Group Annual Report, pp. 8.
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`30 Exhibit 1003, 2012 Reckitt Benckiser Group Annual Report, p. 11; Exhibit
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`1044, 2013 Reckitt Benckiser Group Annual Report, p. 14.
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`efforts to convert patients from the tablet formulation to the film formulation in its
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`publicly filed annual reports for the years 2011 through 2013.31
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`27. Furthermore, the timing of the introduction of Suboxone® sublingual
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`film and the timing of the discontinuation of Suboxone® sublingual tablet is
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`consistent with that of a company engaging in product hopping. I note that RB
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`launched its Suboxone® film product in September 2010, less than a year after its
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`Suboxone® sublingual tablet lost its exclusivity in the U.S. provided by its Orphan
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`Drug Status.32 Additionally, RB discontinued its Suboxone® sublingual tablet
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`product in March 2013 coinciding with the approval of the generic formulations of
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`Suboxone® sublingual tablets by the FDA approximately a month earlier, in
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`February 2013.33 At the time, RB stated publicly that it discontinued the tablets
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`31 Exhibit 1051, 2011 Reckitt Benckiser Group Annual Report, p. 11; Exhibit
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`1003, 2012 Reckitt Benckiser Group Annual Report, p. 11; Exhibit 1044, 2013
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`Reckitt Benckiser Group Annual Report, p. 14.
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`32 Exhibit 1050, 2010 Reckitt Benckiser Group Annual report, p. 8.
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`33 Exhibit 1044, 2013 Reckitt Benckiser Group Annual Report, p. 14; Exhibit
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`1043, National Drug Code Directory,” available at
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`for “pediatric exposure” concerns.34 However, the FDA subsequently found
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`Suboxone® tablets were “Not Withdrawn From Sale for Reasons of Safety or
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`Effectiveness.”35
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`28.
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`In addition, RB does not address the impact of the price difference
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`between Suboxone® film and Suboxone® tablets on the sales of Suboxone®
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`film.36 Similarly, RB does not address the impact of the dominance of Suboxone®
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`tablets in the market, if any, on the sales of the Suboxone® film. As explained
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`above at Paragraph 13, I understand that if commercial success is attributable to
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`http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm (Type: Active
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`Ingredient; Name: buprenorphine).
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`34 Exhibit 1052, Lachman Consultant Services, Inc. Citizen Petition, September
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`27, 2012 (Docket No. FDA–2012–P–1034); see also Exhibit 1053 RB Press
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`Release, Further US RB Pharmaceuticals Announcement, September 25, 2012,
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`available at
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`http://www.rb.com/site/rkbr/templates/mediainvestorsgeneral2.aspx?pageid=133
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`2&cc=GB.
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`35 Exhibit 1045, Fed. Reg. 2013-13446, Jun. 6, 2013.
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`36 Ex. 1003, 2012 Reckitt Benckiser Group Annual Report, p. 11.
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`the patent holder’s preexisting dominance in the market, rather than the subject
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`matter of the patent claims, there is no nexus with the patent claims.
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`29. Given the regulatory framework in the pharmaceutical industry and
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`the pattern of RB’s market activities at the time of launching its Suboxone® film
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`product, RB’s assertion—that the commercial success of its Suboxone® film is due
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`to the subject matter claimed in the challenged claims, rather than to business
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`activities or elements present in the prior sublingual tablet formulation—is
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`unsubstantiated.37 Instead, RB’s actions described above are consistent with
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`practices of product hopping and, as such, sales of the film product are likely to
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`have been driven by factors other than the subject matter claimed in the challenged
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`claims.
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`30. Finally, RB fails to consider other features of Suboxone® film that
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`were in the prior art and may have contributed to the alleged commercial success
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`of the product. For example, RB does not take into account the contribution of
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`buprenorphine and naloxone combination, the active ingredients in the product, to
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`the alleged commercial success of Suboxone® film. I understand that both forms
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`37 P.O.C.R., pp. 56-57.
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`of Suboxone®, tablets and film, contain buprenorphine and naloxone.38 RB does
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`not address whether and how much of alleged commercial success of Suboxone®
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`film is attributable to the combination of the active ingredients or other features
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`known in the prior art, rather than to something novel in the challenged claims.
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`This is particularly relevant as RB voluntarily discontinued its Suboxone® tablets
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`about a month after FDA approved its generic formulations.39 Similarly, I
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`understand that RB is not arguing that it invented films, in general. Without an
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`evaluation of important features that existed in the prior art and that may have
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`contributed to the success of Suboxone® film, RB cannot demonstrate a nexus
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`between any commercial success and the inventions claimed in the challenged
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`claims.
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`38 Exhibit 2007; Exhibit 2038.
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`39 Exhibit 1044, 2013 Reckitt Benckiser Group Annual Report, p. 14; Exhibit 1043,
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`“National Drug Code Directory,” available at
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`http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm (Type: Active
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`Ingredie
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