UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`APOTEXINC., APOTEX CORP., APOTEX PHARMACEUTICALS HOLDINGS
`INC., AND APOTEX HOLDINGS,INC.,
`
`Petitioners,
`
`V.
`
`OSI PHARMACEUTICALS,INC.,
`
`Patent Owner.
`
`
`
`Case IPR2016-01284
`
`U.S. Patent No. 6,900,221
`
`
`
`DECLARATION OF KRISTOPHERA. BOUSHIE
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`APOTEX EX. 1054-001
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`APOTEX EX. 1054-001
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`IPR Trial No. 2016-01284
`Declaration of Kristopher A. Boushie
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`Il.
`
`IT.
`
`IV.
`
`QUALIFICATIONS.....cssscssessssssessecssssssssssssscssecsuessesessasssessuesasessessveasecsseesece 2
`
`PURPOSE GP THIS DECLARATIONcecwnnsssnsvussssveaiiicsnnn sttsiisicomeneneeeneeeneovem 4
`
`FACTS AND DATA CONSIDEREDIN FORMING MY OPINIONS......... 4
`
`SUMMARY OF CONCLUSIONS....scsssessssssssssssessesssesssecesesstesssesssesseessvessseen 5
`
`COMMERCIAL SUCCESS AS A SECONDARY
`CONSIDERATION OF NONOBVIOUSNESS .....sscsssesssesssesssesssesssecnseceseceeee 6
`
`VI.
`
`TARCEVA® oocccsssssssssssssccsssessssesssssessssecssssessusesstecessucssasesssessssesssecenssesssseeesseee 7
`
`PATENTS COVERING TARCEVA® .ou.ccsscccssssssssecssessecssessesasecsecarsesecssesseeee 7
`
`INDICATED USES OF TARCEVA” ssisianscsiseissssiisdicseseneeenrecerennerenenvenancnaa 8
`
`USES OF TARCEVA® COVERED BYTHE °221 PATENTveeesccssescsseesese: 11
`
`VIL.
`
`COMMERCIAL SUCCESS OF TARCEVA®..v..ccccsccssecssesssecssecssecsvessseessees 11
`
`COMMERCIAL SUCCESS OF TARCEVA® RELATED TO THE
`BR TRE PATTp cceen cae tenia siecndianes TARte epmeermreereorenarynemmmneonmanoonecam 11
`
`MR. REISENAUER DOES NOT ANALYZE COMMERCIAL
`SUCCESS ATTRIBUTABLE TO THE CHALLENGED CLAIMS
`Se FATE cerermenscemremes:ccss eal idee ai er tsia 12
`
`VU.
`
`foreReeLllLCTING rerseacans <xtsy eceianax wi el Litiststiepemmenearecrrerremere aeereamenaweneneneys 14
`
`IX.
`
`POSSIBLE SUPPLEMENTATION OF THIS REPORT.....cccccsccessscecseseeees i
`
`AVETUABILID TS TESTDP¥ sccscncssservincnasseitsins ceamvtielieicli WG iiaeneamemcers is
`
`1
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`IPR Trial No. 2016-01284
`Declaration of Kristopher A. Boushie
`
`I. Qualifications
`
`L.
`
`I am an Associate Director in the Washington, DC office of NERA
`
`Economic Consulting (“NERA”), where I am a memberofthe firm’s Intellectual
`
`Property Practice.
`
`I have over 30 years of experience in financial and litigation
`
`consulting, with an emphasis onforensic valuation issues, and over 25 years of
`
`experience focused onintellectual property matters. My expertise includes the
`
`analysis of historical and projected financial-related business records and
`
`preparation of economic damageestimatesin theareas ofintellectual property
`
`infringement, antitrust, distributorship terminations, contract disputes, andtort
`
`claims.
`
`2.
`
`Throughout myprofessional career, I have frequently analyzed
`
`businesssales andprofitability data in the context of valuing intellectual property.
`
`Most of my work involving patents has been in connection with patent
`
`infringement lawsuits. This work often resulted in expert opinions regarding
`
`damagesrelated to a party’s alleged patent infringement.
`
`I have also researched,
`
`written, and presented onintellectual property valuation and damages-related
`
`topics.
`
`a
`
`I am an editor and contributing author of Calculating and Proving
`
`Damages published by Law JournalPress. I am also a regular contributorto the
`
`Z
`APOTEX EX. 1054-003
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`IPR Trial No. 2016-01284
`Declaration of Kristopher A. Boushie
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`Financial Valuation and Litigation Expert journal and am onits Panel of Experts.
`
`I have prepared and presented a number of Continuing Legal Education and
`
`Continuing Professional Education seminars on a variety of topics related to the
`
`estimation of damages and valuation issues.
`
`~
`
`I am a memberof the AmericanInstitute of Certified Public
`
`Accountants; the Virginia Society of Certified Public Accountants (where I am a
`
`past chairmanofthe Litigation Services Committee); the National Association of
`
`Certified Valuators and Analysts (“NACVA,” where I am a memberof the Chapter
`
`Foundation Committee and immediate past Chair of the Executive Advisory
`
`Board); and the Association of Certified Fraud Examiners (“ACFE”). lama
`
`memberofthe Intellectual Property Owners Association, where I am a memberof
`
`the Trade Secret Committee.
`
`I am also an affiliate member of the American
`
`Intellectual Property Law Association and an associate memberof the American
`
`Bar Association, Intellectual Property Law Practice Section.
`
`=e
`
`I am a Certified Public Accountant, licensed in Virginia, Accredited in
`
`Business Valuation (through the American Institute of Certified Public
`
`Accountants, “AICPA”), and Certified in Financial Forensics (through the
`
`AICPA). Iam also a Certified Valuation Analyst (through NACVA)and a
`
`Certified Fraud Examiner (through ACFE).
`
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`6.|NERA is being compensated for my services in this matter at a rate of
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`IPR Trial No. 2016-01284
`Declaration of Kristopher A. Boushie
`
`$605 per hour and forthe services of consultants and researchersat their customary
`
`rates. Neither my nor NERA’s compensation in this matter is dependent on the
`
`outcomeofthis case or the substance of my opinions. A copy of my curriculum
`
`vitae is attached as Appendix A.
`
`II.
`
`Purposeof this Declaration
`
`Te
`
`I have been asked by counselfor Petitioners Apotex Inc., Apotex
`
`Corp., Apotex Pharmaceuticals Holdings Inc., and Apotex Holdings,Inc. to review
`
`the declaration of Mark L. Reisenauer and other materials, and to present my
`
`opinion on whetherthe sales of Tarceva" are related to claims 44-46 and 53 of
`
`U.S. Patent No. 6,900,221 B1 (the ’221 patent) and whetherthere is any evidence
`
`of commercial success attached to these challenged claims.
`
`Ill.
`
`Facts and Data Considered in Forming my Opinions
`
`8.
`
`Myopinions expressedin this declaration are based on my
`
`professionaltraining and experience, my review andanalysis of information
`
`producedbytheparties, and certain third-party information. This information
`
`includes, butis not limited to, the Declaration of Mr. Mark L. Reisenauer and
`
`accompanying exhibits, the July 13, 2017 deposition of Mr. Reisenauer andrelated
`
`exhibits, the decision regarding theinstitution of inter partes review in this matter,
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`4
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`IPR Trial No. 2016-01284
`Declaration of Kristopher A. Boushie
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`and case pleadings,legal briefs and exhibits from other related matters. A
`
`complete list of information considered in forming my opinionsis attached as
`
`Appendix B.
`
`IV.
`
`Summary of Conclusions
`
`9.
`
`In a prior district court litigation involving the ’221 patent, Patent
`
`OwnerOSI Pharmaceuticals, LLC (“OSI Pharmaceuticals”) submitted expert
`
`testimonythat all of Tarceva®’s commercial success wasrelated to the RE ’065
`
`patent. (Ex. 1055 at 951:25 —952:5.) OSI Pharmaceuticals now relies on
`
`testimony from oneofits own executives, Mr. Reisenauer,to assert that Tarceva®
`
`is commercially successful and that the sales of Tarceva® are attributable to claims
`
`44-46 and 53 of the ’221 patent. In my opinion, Mr. Reisenauerhasnot provided
`
`any evidence of Tarceva®’s commercial successthatis related to the challenged
`
`claims of the ’221 patent. (Ex. 1050 at 75:16 — 76:6.)
`
`10.
`
`It is my opinionthat, based on the information produced by OSI
`
`Pharmaceuticals, the declaration and testimony of Mr. Reisenauer, and additional
`
`third-party information,there is no evidence that Tarceva’’s sales are related
`
`specifically to, or driven by, the challenged claims of the ’221 patent. Thus, the
`
`question of whether Tarceva” is in fact a commercially successful productis
`
`irrelevant to the validity of the challenged claims.
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`Vv. Commercial Success as a Secondary Consideration of Nonobviousness
`
`11.
`
`IT understand that while evaluating the underlying merits of patents and
`
`the related prior art are the primary considerations in determining nonobviousness,
`
`commercial successis a relevant secondary consideration.'
`
`I also understand that
`
`the Patent Owner must “show both commercial success and that a nexusexists
`
`992
`betweenthat success and the merits of the claimed invention.”” More explicitly, I
`
`understand that the evidence presented must be “commensurate with the claim
`
`scope,”* and courts havecriticized patent holdersthat fail to provide a persuasive
`
`link between the claims at issue and purported commercial success.’ Thus,itis
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`myoverall understanding that any alleged commercial success must be derived
`
`from the specific claims at hand.°
`
`1 Graham v. John Deere Co. ofKansas City, 383 U.S. 1 (1966)
`
`2 Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 104 U.S.P.Q.2d 1785,
`1791 (Fed. Cir. 2012); see also Iron Grip Barbell Co. v. USA Sports Inc., 392 F.3d 1317 (Fed. Cir. 2004).
`
`3 In re Hiniker Co., 150 F.3d 1362 (Fed. Cir. 1998); In re Huai-Hung Kao, 639 F.3d 1057 (Fed. Cir. 2011).
`
`4 See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 73 U.S.P.Q.2d 1225, 1229-1230 (Fed.Cir. 2004)
`(citing Solder RemovalCo. v, USITC, 582 F.2d 628, 637 (CCPA 1978) (“Iron Grip has not made a showing of
`commercial success. Our cases make clear that a ‘nexus must beestablished between the merits of the claimed
`invention and evidence of commercial success before that evidence may becomerelevant to the issue of
`obviousness.”).)
`
`5 In re Hiniker Co., 150 F.3d 1362 (Fed. Cir. 1998)(citing Giles Sutherland Rich, Extent ofProtection and
`Interpretation ofClaims-American Perspectives, 21 Int’] Rev. Indus. Prop. & Copyright L. 497, 499 (1990), “The
`U.S.is strictly an examination country and the main purposeof the examination, to which every application is
`subjected,is to try to make sure that what each claim definesis patentable. To coin a phrase, the name ofthe gameis
`the claim.”); see also In re Bimeda Research & Dev. Ltd., 724 F.3d 1320 (Fed.Cir. 2013).
`
`6
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`12.
`
`I also understand that Courts havecriticized analysesthat rely solely
`
`on sales as a form of commercial success’ or where product sales were largely a
`
`7
`’
`byproduct of promotional and marketing efforts. Showing productsales aloneis
`
`not clear evidence of commercialsuccess.” Establishing commercial successis a
`
`two-part analysis. First, the Patent Owner mustestablish the overall success of the
`
`product in the marketplace. Second, the Patent Owner must show that the success
`
`in the market was driven by the challenged claimsofthe patent at issue.
`
`VI.
`
`Tarceva®
`
`A. Patents covering Tarceva®
`
`13.
`
`Patents for pharmaceutical compoundsandrelated uses are disclosed
`
`by patent holders in the FDA “Orange Book.” (See Ex. 1039 at 1-2.) A search on
`
`the FDA website showsthatthree patents are associated with the drug Tarceva®.
`
`(See id.) These patents are U.S. patent numbers 5,747,498 (reissued as RE41065,
`
`6 Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010) (holding “[e]ven with respect to the sleeve patents,
`Wyersrelies solely on Master Lock’s $20 million in sales of the accused product, and established no direct nexus to
`the sleeve feature.”).
`
`7 Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120 (Fed. Cir. 2000) (Finding “[t]he record
`further shows that B&W engagedin promotional offers for years after the Capri launch, andit indicates that many
`Capri smokersoriginally tried Capri as the result of a promotion and would discontinue smoking Capri without the
`promotions.”).
`
`8 See id (“[T]he district court found from the evidence before it that it was ‘impossible to distinguish market share
`resulting from thepatentattributes of the Capricigarette, from that which was achieved throughtargeted marketing
`and image development.””).
`
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`the “RE ’065 patent”), 6,900,221 (the “’221 patent”), and 7,087,613 (the “613
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`IPR Trial No. 2016-01284
`Declaration of Kristopher A. Boushie
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`patent”).
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`B. Indicated uses of Tarceva”
`
`14.
`
`Tarceva® is an oraltablet with erlotinib hydrochloride as its active
`
`ingredientthat is used to treat specific types of cancer and wasfirst approved in
`
`2004for use in the United States. (See generally Ex. 2026.) Tarceva® is presently
`
`indicated for the “treatment of patients with metastatic non-smallcell lung cancer
`
`(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19
`
`deletions or exon 21 (L858R)substitution mutations as detected by an FDA-
`
`approvedtest receivingfirst-line, maintenance, or secondorgreaterline treatment
`
`after progression following at least one prior chemotherapy regimen.” (Ex. 2030 at
`
`1.) Tarceva® is additionally indicated for the “first-line treatment of patients with
`
`locally advanced, unresectable or metastatic pancreatic cancer, in combination with
`
`gemcitabine.” (/d.) Tarceva® hasalso beensold forusein other, “off-label
`
`capacities” and can beprescribed subject to “physician discretion... in areas that
`
`[Tarceva™ is] not indicated”for use. (Ex. 1050 at 48:8 — 12.)
`
`15.
`
`understand that during Tarceva®’s period on the market, it has
`
`undergonevarious indication changes. On November 18, 2004, Tarceva" received
`
`its initial approval for “treatment of patients with locally advanced or metastatic
`
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`APOTEX EX. 1054-009
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`non small-cell lung cancerafter failure of at least one prior chemotherapy
`
`regimen.” (Ex. 2026 at 11.) In October 2005, a secondindicationforfirst-line
`
`treatmentof patients with locally advanced, unresectable or metastatic pancreatic
`
`cancer, in combination with gemcitabine, was approved for Tarceva®. (Ex. 2027 at
`
`18.) In April 2010, Tarceva®’s label was revised again to include an indication for
`
`maintenancetreatmentof patients with NSCLC “whosedisease has not progressed
`
`after four cycles of platinum-basedfirst-line chemotherapy.” (Ex. 2028at 1.)
`
`Uses were revised again in May 2013 to include anindicationforfirst-line
`
`treatment of patients with metastatic non-small cell lung cancer whose tumors have
`
`epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R)
`
`substitution mutations as detected by an FDA-approvedtest. (Ex. 2029 at 1.)
`
`16.
`
`Prior to recent changes in the FDA approvedindications and uses for
`
`Tarceva® in October 2016, Genentech and OSI Pharmaceuticals entered into a
`
`settlement agreement with the United States government, effective June 6, 2016,
`
`regarding a lawsuit underthe False Claims Act. (See generally Ex. 1045; Ex.
`
`1046.) The United States alleged that Genentech and OSI “made misleading
`
`representations to physicians andotherhealth care providers about Tarceva®’s
`
`effectiveness to treat certain NSCLC patients when there waslittle evidence to
`
`show that Tarceva” waseffective, unless the patients also had an EFGR mutation
`
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`or unless they had never smoked.” (Ex. 1045 at 2-3.) Aspart of the settlement,
`
`Genentech and OSI committed to pay United States’ governmentagenciesa total
`
`of $67 million dollars plus interest of 2.125% annually up through the date of
`
`payment. (Ex. 1045 at 4.)
`
`17.
`
`On October 18, 2016, the U.S. Food and Drug Administration
`
`(“FDA”) further revised Tarceva®’s label for treatment of NSCLC by limiting
`
`treatmentto patients with NSCLC tumorscontaining specific epidermal growth
`
`factor receptor, EGFR, mutations previously discussed in Tarceva®’s current label
`
`indications. (Ex. 2030 at 1.) The FDA emphasizesonits websitethatthis
`
`relabeling effort was based ontheresults of a trial which indicated that patient
`
`survival wasnodifferent for NSCLCpatients receiving erlotinib than for patients
`
`receiving a placebo whenthepatient lacked any EGFR mutations. (Ex. 1052 at 1;
`
`see also Ex. 1044 at 1.) I understand from Mr. Reisenauer’s representations, that
`
`roughly 10 to 20 percent of the NSCLC cancerpatient population actually has the
`
`relevant EGFR mutations that Tarceva" is effective at treating. (Ex. 1050 at
`
`72:1 - 73:1.) This would indicate that 80 to 90 percent of past NSCLC-related
`
`sales were not connectedto the challengedclaimsbut instead to an overly broad
`
`label for Tarceva®.
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`Declaration of Kristopher A. Boushie
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`C. Uses of Tarceva® covered by the ’221 Patent
`
`18.
`
`I understand that the subject matter at issue in the challenged claims
`
`of the ’221 patent relates to a method of treating NSCLC (as well as pediatric
`
`malignancies, cervical and other tumors caused or promoted by human papilloma
`
`virus, Barrett’s esophagus, and neoplastic cutaneous diseases) in a mammal by
`
`administering a therapeutically effective amount of erlotinib. It is my
`
`understanding that the challenged claimsof the ’221 patent do not cover any
`
`treatment for pancreatic cancer.
`
`VII. Commercial Success of Tarceva”
`
`A. Commercial Success of Tarceva’ related to the RE ’065 Patent
`
`19.
`
`Ina priorlitigation involving both the RE ’065 patent and the ’221
`
`patent, Dr. Robert Maness, with Charles River Associates, testified on the issue of
`
`commercial success on behalf of OSI Pharmaceuticals, Inc., Pfizer Inc. and
`
`Genetech, Inc. (Ex. 1055 at 947:1 —951:1.) Dr. Manesstestified that the
`
`commercial success wasrelated to the RE ’065 patent, stating, “[a]s I understand
`
`the patent, the patent covers the chemical. It’s the chemical that I understand
`
`generates the clinical properties that are then in demandin the marketplace and
`
`9 It is my understanding that erlotinib is represented by the chemical name N-(3-ethynylpheny)-6,7-bis(2-
`methoxyethoxy)-4-quinazolinamine, or pharmaceutically acceptable sales thereof in anhydrous or hydrate form”that
`is recited in the ’221, claims 44-46 and 53.
`
`11
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`have caused the productto sell. So in that sense, there’s a relationship between the
`
`patent and the commercial success.” (Id. at 951:25 — 952:5.)
`
`20. Oncross examination, Dr. Maness wasasked, “[y]ou’re not here to
`
`say that sales are caused by the [RE ’065] patent?” Dr. Manessresponds,“I
`
`believe I am, yes.” Dr. Maness’s rationale for his responseis that “you’ve got a
`
`patentin this case that coversthe active ingredient, and the active ingredient
`
`generates clinical properties, and doctors are making the choice based on those
`
`clinical properties. So in that sense,the clinical properties flow from the patent
`
`and therefore cause the sales.” (/d. at 978:7-16.)
`
`21. While both the RE ’065 patent and the ’221 patent wereat issue in the
`
`prior district court litigation, Dr. Manessattributed none of Tarceva®’s commercial
`
`success to the ’221 patent. Mr. Reisenauer is not even aware that the RE ’065
`
`patent claims the invention oferlotinib. (Ex. 1050 at 15:5-12.)
`
`B. Mr. Reisenauer Does Not Analyze Commercial Success
`Attributable to the Challenged Claimsof the ’221 Patent
`
`22.
`
`In his declaration, Mr. Reisenauer answers the question of whether he
`
`thinks Tarceva” has been a commercially successful product. Unfortunately, he
`
`answers the wrong question. Mr. Reisenauer never attempts to analyze the cause
`
`of Tarceva®’s success. Mr. Reisenauerfails to analyze Tarceva®’s success
`
`attributable to the ’221 patent, muchless any of the challenged claims. Mr.
`
`lz
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`Reisenaueris generally unfamiliar with the patents underlying Tarceva” and has
`
`not read the ’221 patent or claims being asserted. (Ex. 1050 at 25:21 — 26:16.)
`
`While hetestifies that the mechanism ofaction of a drug is something important to
`
`commercial success, he is unaware that the RE ’065 patent claims the invention of
`
`erlotinib. (Ex. 1050 at 74:8-14; 15:5-12.) Mr. Reisenauer’s admissionis
`
`significant because, as OSI Pharmaceuticals argued in thepriordistrict court
`
`litigation, the active ingredient(erlotinib) that is covered by the RE ’065 patent
`
`generatestheclinical properties that would accountfor all of Tarceva®’s sales
`
`(including NSCLC,pancreatic cancer, and other off-label uses notrecited in the
`
`challenged claims. Mr. Reisenauer’s ignoranceofthis fact and his inability to
`
`articulate the amountof sales that are attributable to the treatment of NSCLC make
`
`his opinions concerning commercial success unreliable.
`
`23.
`
`It is not surprising then that he also did not look at or apportion any
`
`amount of Tarceva®’s commercial success to the RE ’065 patent. (Ex. 1050 at
`
`73:11-17 and 75:16-21.) Even though Mr. Reisenauer was awarethatthe level of
`
`marketing and/or advertising was a contributing factor to commercial success, he
`
`did not look at these expendituresin relation to Tarceva® salesin his analysis of
`
`commercial success. (Ex. 1050 at 27:22 — 28:4; 29:14 — 30:9.) In fact, marketing
`
`and promotion may have hadthe mostsignificant impact on Tarceva" sales. The
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`FDA’s action in limiting the non-small cell lung cancerindications in the fall of
`
`2016 due to Tarceva*”’s lack ofeffectiveness in treating all but a small subset of
`
`patients could reduce Tarceva*’s patient population by about 80 to 90 percent.
`
`(Ex. 1050 at 62:11 — 65:17; .) This seemsto be strong support that, historically,
`
`the vast majority of Tarceva” sales were madenot becausethe drug waseffective,
`
`but because it was promoted(i.e., marketed and advertised) as being effective. In
`
`fact, as mentioned above, false claims regarding Tarceva®’s effectivenessled to a
`
`financial settlement with the U.S. government. Mr. Reisenauer madeno attemptat
`
`determining the sales of Tarceva” that were actually effective.
`
`24. Along with not analyzing the impacts of the ’221 patent, the RE ’065
`
`patent, marketing or advertising expenses, false claims, and limited actual
`
`effectiveness on commercial success, Mr. Reisenaueralso fails to consider the
`
`impact of the product’s overall level ofprofitability or return on investment. (Ex.
`
`1050 at 41:13 — 42:1; 30:14-18.)
`
`VII. Conclusions
`
`25. Mr. Reisenauer hasnot specifically considered the impact of the ’221
`
`patent and the challenged claims on the commercial success of Tarceva®. Further,
`
`he hasnot analyzed how muchofTarceva®’s commercial successis related to the
`
`RE ’065 patent and was unawareofprior experts whotestified on behalf of OSI
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`Pharmaceuticals, that all commercial success wasrelated to the RE ’065 patent
`
`and, by implication, not the ’221 patent.
`
`26. Despite knowing aboutthe substantial curtailment of indications for
`
`use by the FDA, Mr. Reisenauerfailed to subtract these sales from his analysis or
`
`appropriately attribute them to the false promotion of the product’s effectiveness.
`
`27.
`
`Insummary, Mr. Reisenauer has not met the burden ofestablishing
`
`(or even discussing) a nexus between the challenged claimsof the patent and the
`
`commercial success of Tarceva".
`
`IX.
`
`Possible Supplementation of this Report
`
`28.
`
`I reserve the right to supplementthis declaration in the future in
`
`consideration of new information that becomesavailable and to respond to
`
`additional arguments that the Patent Owner mayraise.
`
`X. Availability to Testify
`
`29.
`
`Insigning this declaration, I recognize that the declaration will be
`
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office. I also recognize that I may be
`
`subject to cross examination in the case and that cross examination will take place
`
`within the United States. If cross examination is required of me, I will appear for
`
`15
`APOTEX EX. 1054-016
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`APOTEX EX. 1054-016
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`

`

`IPR Trial No. 2016-01284
`Declaration of Kristopher A. Boushie
`
`cross examination within the United States during the timeallotted for cross
`
`examination.
`
`I declare under penalty of perjury that, to the extent of my knowledge and
`
`belief, the foregoing is true and correct.
`
`I further declare that all statements made
`
`herein of my own knowledgearetrue and thatall statements made on information
`
`and belief are believed to be true; and further that these statements were made with
`
`the understanding that knowing and willful false statements and the like so made
`
`are punishable by fine or imprisonment, or both, under section 1001 oftitle 18 of
`
`the United States Code.
`
`
`
`Date:feaky24,hospLilcabyehse24.cesta
`
`Kristopher A. Boushie
`
`16
`APOTEX EX. 1054-017
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`APOTEX EX. 1054-017
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`

`

`APPENDIX A
`APPENDIX A
`
`APOTEX EX. 1054-018
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`

`

`Appendix A
`
`Kristopher A. Boushie
`Associate Director
`
`Mr. Kristopher Boushie has over 35 years of experience in financial and litigation consulting, with an
`emphasis on forensic valuation issues, and over 25 years of experience focused on intellectual property
`matters. His expertise includes the analysis of historical and projected financial-related business records
`and preparation of damages estimates in the areas of intellectual property infringement, antitrust,
`distributorship terminations, contract disputes, and tort claims.
`
`Mr. Boushie consults with clients on intellectual property and business valuations, intellectual asset
`management, royalty auditing, and other financial and cost accounting-related issues in areas such as
`Federal Insecticide, Fungicide, and Rodenticide Act data compensation, cost assignment and allocation,
`ability to pay, and forensic accounting. He has been named as an expert in a number of cases and has
`testified in deposition, arbitration hearings, federal district court, and before the European Commission.
`
`Mr. Boushie has conducted economic analyses of a variety of industries, including wireless telecom
`technology, automated telephony systems, computer hardware and software, consumer products, avionics
`systems, medical products and equipment, automobile components, industrial ovens, pharmaceuticals,
`military defense systems, and radio controlled models.
`
`Mr. Boushie is a regular contributor to the Financial Valuation and Litigation Expert journal and is on its
`Panel of Experts. He is editor and contributing author of Calculating and Proving Damages published by
`Law Journal Press. Mr. Boushie has prepared and presented a number of Continuing Legal Education and
`Continuing Professional Education seminars on a variety of topics related to the estimation of damages and
`valuation issues. He also serves as a forensic accounting instructor at the FBI Academy in Quantico,
`Virginia.
`
`Mr. Boushie is a member of several professional organizations, including the American Institute of
`Certified Public Accountants (“AICPA”); the Virginia Society of Certified Public Accountants (“VSCPA,”
`where he is past chairman of the Litigation Services Committee); the National Association of Certified
`Valuators and Analysts (“NACVA,” where he is immediate past Chairman of the Executive Advisory
`Board, a past member of the Valuation Credentialing Board, a past President of the Vermont State Chapter,
`a past member of the Chapter Foundation Committee); and the Association of Certified Fraud Examiners
`(“ACFE”). Mr. Boushie is an associate member of the American Bar Association, Intellectual Property
`Law Practice Section. He is also a member of the Intellectual Property Owners Association (“IPO”) and an
`affiliate member of the American Intellectual Property Law Association (“AIPLA”) and is on the Trade
`Secret Committees for both organizations.
`
`Mr. Boushie is a Certified Public Accountant, licensed in Virginia. He is Accredited in Business Valuation
`(AICPA) and Certified in Financial Forensics (AICPA). He is also a Certified Valuation Analyst
`(NACVA) and a Certified Fraud Examiner (ACFE).
`
`Click here to enter text.
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` Page | 1
`
`APOTEX EX. 1054-019
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`

`

`Qualifications
`
`The George Washington University
`MAcc (Accountancy)
`
`Allegheny College
`B.S. Economics
`
` Certified Public Accountant
` Accredited in Business Valuation
` Certified in Financial Forensics
` Certified Valuation Analyst
` Certified Fraud Examiner
`
`Career Details
`2015-
`
`2013-2015
`
`2006-2013
`
`2004-2012
`
`1990-2006
`
`1988-1990
`
`1984-1988
`
`NERA Economic Consulting
`Associate Director
`
`Stout Risius Ross
`Managing Director
`Dispute Resolution Advisory & Forensic Services Group
`
`Quantus Consulting LLC
`President and LLC Managing Member
`
`Elected Town Auditor, Jericho, Vermont
`
`CapAnalysis Group LLC/Howrey LLP
`Senior Vice President, head of CapAnalysis’ Intellectual Property Practice
`
`Thompson Greenspon
`Staff Accountant
`
`NERA Economic Consulting
`Research Associate
`
`Page | 2
`
`APOTEX EX. 1054-020
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`

`

`Testimony
`
`Deposition testimony and the preparation of an expert report on the issue of inexorable flow of profits in a
`patent infringement matter on behalf of Bayer HealthCare Pharmaceuticals, Inc. in a declaratory judgment
`action brought Bayer against Biogen Idec MA Inc., in U.S. District Court, New Jersey.
`
`Testimony before the European Commission, Directorate General Competition, Case AT.40136-
`Capacitors, on behalf of Rubycon Holdings Co., Ltd., Rubycon Corporation and affiliated companies
`regarding ability to pay.
`
`Deposition testimony and the preparation of an expert report on a patent infringement matter on behalf of
`Tempur Sealy International, Inc. in an action brought by Select Comfort Corporation, U.S. District Court,
`Minnesota.
`
`Deposition testimony and the preparation of an expert report on a Lanham Act false advertising claim for
`damages on behalf of Tempur Sealy International, Inc. in an action brought by Select Comfort Corporation,
`U.S. District Court, Minnesota.
`
`Deposition testimony and the preparation of an expert report on patent infringement damages on behalf of
`Intema Limited in a declaratory judgment action brought by PerkinElmer, Inc. and NTD Laboratories, U.S.
`District Court, Massachusetts.
`
`Deposition testimony and the preparation of an expert report on patent infringement damages on behalf of
`Sandoz, Inc. and Eon Labs Manufacturing, Inc. in an action brought by Pfizer, Inc., et al. In Re Gabapentin
`Patent Litigation, U.S. District Court, District of New Jersey.
`
`Deposition testimony and the preparation of an expert report on patent infringement damages on behalf of
`Macy’s in an action brought by Ronald A. Katz Technology Licensing, L.P., U.S. District Court, Southern
`District of New York.
`
`Testimony before the American Arbitration Association regarding claimed study cost compensation and
`adjustments under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA). Mr. Boushie has testified
`in 11 FIFRA arbitrations. Arbitration hearings that have been publicly disclosed are:
`
`Syngenta Crop Protection v. Oxon Italia and SipCamAgro USA, re atrazine;
`
` Avecia, Inc. and Mareva Piscines et Filtrations, S.A., re baquacil ;
` Cheminova A/S and Griffin L.L.C., re malathion.
`Publications and Presentations
`
`“Valuing IP – Differences Between Licensing Support & Damages Analysis,” American Intellectual
`Property Law Association, Mid-Winter Institute, Ft. Lauderdale, FL, February 2, 2017.
`
`“Advanced Topics in IP Licensing and Valuation,” panel discussion at the American Intellectual Property
`Law Association, Mid-Winter Institute, Ft. Lauderdale, FL, February 2, 2017.
`
`“Best Practices in Business Valuation and Litigation Services,” panel discussion at the National
`Association of Certified Valuators and Analysts’ Financial Consultants’ SuperConference in Las Vegas,
`December 6, 2016.
`
`Page | 3
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`APOTEX EX. 1054-021
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`

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`“Where, When, and How to Value Intellectual Property” at the National Association of Certified Valuators
`and Analysts’ Financial Forensics and Expert Witness Conference in Chicago, November 15, 2016 and at
`the National Association of Certified Valuators and Analysts’ Financial Consultants’ SuperConference in
`Las Vegas, December 6, 2016.
`
`“Trade Secrets – Valuation, Misappropriation & Damages,” Intellectual Property Owners Association,
`Trade Secrets Committee, May 3, 2016
`
`“On Being a Credible Witness – from discovery through trial,” presentation to forensic accountants at the
`FBI Academy, Quantico, VA, April 21, 2016, with Martin Cunniff, Esq.
`
`Kristopher A. Boushie, Christopher H. Spadea, and Martin F. Cunniff, eds., Calculating and Proving
`Damages (New York: Law Journal Press, 2011, last supplemented April 2016). Coauthored chapters on
`Litigant Damage Expectations; Looking at D