Paper No. 54
`Filed: May 27, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`COALITION FOR AFFORDABLE DRUGS VI LLC,
`
`PETITIONER,
`
`V.
`
`CELGENE CORPORATION,
`
`PATENT OWNER
`
`___________________
`
`Case No.: IPR2015-01103
`Patent No. 6,315,720
`___________________
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`Filed: May 27, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`COALITION FOR AFFORDABLE DRUGS VI LLC,
`
`PETITIONER,
`
`V.
`
`CELGENE CORPORATION,
`
`PATENT OWNER
`
`___________________
`
`Case No.: IPR2015-01103
`Patent No. 6,315,720
`___________________
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
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`I.
`II.
`
`III.
`
`IV.
`
`INTRODUCTION .......................................................................................... 1
`THE TESTIMONY OF CELGENE’S EXPERTS IS ENTITLED TO NO
`WEIGHT ........................................................................................................ 2
`CELGENE’S PROPOSED CLAIM CONSTRUCTION IS
`UNSUPPORTED ........................................................................................... 6
`THE CLAIMS OF THE ’720 PATENT ARE OBVIOUS IN VIEW OF
`THE COMBINATION OF THE GROUND 1 REFERENCES .................. 10
`A. Celgene’s Argument that the Only Motivation to Improve Upon the
`Prior Art Was Contained in Confidential Celgene Documents Is
`Artificial ....................................................................................................... 10
`B. The Disclosures of the Ground 1 References Render the Claims Obvious . 15
`1. Motivation to Combine Mitchell, Dishman, and Cunningham ................... 16
`2. Independent Claims 1 and 28 Are Obvious in View of the Combination
`of Mitchell, Dishman, and Cunningham ..................................................... 18
`3. Dependent Claims 5, 6, 10, and 17 Are Obvious in View of the
`Ground 1 References ................................................................................... 21
`
`
`
`i
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`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Alza Corp. v. Mylan Labs., Inc.,
`464 F.3d 1286 (Fed. Cir. 2006) ............................................................................ 19
`
`Custom Accessories, Inc. v. Jeffrey-Allan Indus.,
`807 F.2d 955 (Fed. Cir. 1986) ................................................................................ 6
`
`Daiichi Sankyo Co. v. Apotex, Inc.,
`501 F.3d 1254 (Fed. Cir. 2007) ..........................................................................7, 8
`
`Edmund Optics, Inc. v. Semrock, Inc.,
`IPR2014-00583, Paper No. 50 (PTAB Sep. 9, 2015) .......................................... 18
`
`InTouch Techs., Inc. v. VGo Communs., Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) ............................................................................ 20
`
`Martinez v. Porta,
`601 F. Supp. 2d 865 (N.D. Tex. 2009) ................................................................ 20
`
`NHK Seating of America, Inc. v. Lear Corp.,
`IPR2014-01079, Paper No. 30 (PTAB Jan. 12, 2016) ......................................... 11
`
`United States v. 319.88 Acres of Land,
`498 F. Supp. 763 (D. Nev. 1980) ......................................................................... 20
`
`ZTE Corp. v. ContentGuard Holdings, Inc.,
`No. IPR2013-00133, Paper 61 (PTAB July 1, 2014) .......................................... 12
`
`
`
`ii
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`
`
`
`
`
`
`Statutes and Regulations
`
`35 U.S.C. § 103 ........................................................................................................ 19
`
`37 C.F.R. § 42.6(e) ..................................................................................................... 1
`
`37 C.F.R. 42.100(b) ................................................................................................... 9
`
`37 CFR § 42.24(c)(1) ............................................................................................... 29
`
`37 CFR § 42.24(d) ................................................................................................... 29
`
`
`
`
`
`iii
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`
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`I.
`
`INTRODUCTION
`
`The Board instituted this IPR proceeding because Petitioner established a
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`reasonable likelihood in prevailing on its assertions that Claims 1–32 of U.S.
`
`Patent 6,315,720 (“’720 patent”) (Ex. 1001) are invalid as obvious. Patent Owner
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`Celgene Corporation’s (“Celgene”) Response (Paper No. 42; “POR”) has failed to
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`rebut Petitioner’s strong case of obviousness that the claims of the ’720 patent
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`(Ex. 1001) are obvious over Mitchell and Dishman in view of Cunningham and
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`further in view of Mundt, Mann, Vanchieri, Shinn, Linnarsson, Grönroos, Soyka,
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`Hamera, Kosten, and Menill (collectively, the “Ground 1 references”).
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`In their responses to the Petition, Celgene and its experts applied the wrong
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`analysis at every step. First, it is clear from the testimony of their experts that
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`Celgene failed to offer any testimony from an appropriate POSA—both experts
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`testified that the person of ordinary skill in the art (“POSA”) each used in their
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`analysis would be unable to design the claimed methods of the ’720 patent.
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`Second, Celgene and its experts applied the wrong standard for claim
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`construction, ignoring the plain disclosures of the specification in favor of
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`misconstruing arguments in the file history.
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`Third, Celgene proceeds through its obviousness analysis as if each prior art
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`reference must literally disclose each and every limitation of the claims—ignoring
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`the teachings, suggestions, and motivations in the art that render those claims
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`
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`1
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`
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`obvious in view of the knowledge of a proper POSA. In that context, Celgene’s
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`denials of the motivation of a POSA to combine the prior art references of
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`Ground 1—which it bases on the purported confidentiality of material that it (or
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`either of its experts) does not identify—are simply not credible.
`
`In view of Celgene’s flawed analyses, its arguments and evidence should be
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`rejected, and the Board should find that claims 1–32 of the ’720 patent are invalid
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`for obviousness.
`
`II. THE TESTIMONY OF CELGENE’S EXPERTS IS ENTITLED TO
`NO WEIGHT
`
`Celgene has submitted the testimony of multiple putative experts with
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`differing and conflicting perspectives regarding the qualifications of a POSA.
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`Through one of its experts, Celgene attempts to limit the obviousness inquiry by
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`narrowly construing the knowledge and experience of a POSA; through the other
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`expert, Celgene purports to adopt Petitioner’s proposed POSA. Celgene’s approach
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`is convoluted, unnecessary, and at odds with its own experts’ testimony.
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`As the Board has determined in this case, in agreement with Petitioner, a
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`POSA, as of October 2000, would typically have either a Pharm. D. or a BS in
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`pharmacy with approximately 5–10 years of related experience and a license to
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`practice as a registered pharmacist in any one or more of the United States. (Paper
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`No. 21 at 9; Ex. 1027 ¶ 16.) Critically, such a POSA would “have experience in
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`safeguards in dispensing medication.” (Ex. 2061 at 185:6–8.) In designing methods
`
`
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`2
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`
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`for safely dispensing medication, a POSA “may work as part of a multi-
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`disciplinary team and draw upon not only his or her own skills, but also work
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`collaboratively with other team members that have their own unique specialized
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`skillset, training, and knowledge base[.]” (Ex. 1027 ¶ 17.) It is well-settled that the
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`patent’s inventors need not necessarily be POSAs themselves. See Custom
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`Accessories, Inc. v. Jeffrey-Allan Indus., 807 F.2d 955, 962 (Fed. Cir. 1986) (“The
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`actual inventor’s skill is not determinative.”).
`
`One of Celgene’s experts, Dr. Lourdes M. Frau, opines that a POSA should
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`instead have “a bachelor’s degree and at least 2 years of experience in risk
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`management relating to pharmaceutical drug products, or a B.S. or M.S. in
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`pharmaceutical drug product risk management or a related field.” (Ex. 2059 ¶ 39.)
`
`As a threshold matter, it is unclear exactly what degree Dr. Frau has in mind, as
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`Dr. Frau was unable to identify any university in the United States that offers a
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`degree in pharmaceutical drug product risk management. (Ex. 1086 at 166:19–
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`167:12.) Dr. Frau further conceded that pharmacists, such as Petitioner’s POSA,
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`may have sufficient experience to be included within Dr. Frau’s definition of a
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`POSA. (Id. at 175:23–176:11 (“If the pharmac[ist] had met the criteria for my
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`POSA, they would[.]”); see also id. at 185:3–10.) Even more critically, however,
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`Dr. Frau testified that her own proposed POSA would not be able to design the
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`claimed methods of the ’720 patent. (Ex. 1086 at 168:5–11, 166:3–7, 306:4–10.)
`
`
`
`3
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`
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`As Celgene itself acknowledges (see POR at 15), the Federal Circuit has made
`
`clear that a POSA must be able to develop the claimed inventions. See Daiichi
`
`Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1257 (Fed. Cir. 2007) (POSA must be
`
`able to “develop[]” the claimed inventions). Dr. Frau’s proposed POSA fails as a
`
`matter of law.
`
`Celgene attempts a straw-man argument that Petitioner’s expert, Dr. Jeffrey
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`Fudin, “admitted that CFAD’s POSA would not have been capable of designing or
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`implementing the claimed systems of the ’720 Patent.” (POR at 14.) Celgene
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`misconstrues Dr. Fudin’s testimony. Critically, the ’720 patent claims methods—
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`not systems—for delivering a drug to a patient. (See Ex. 1001.) As Dr. Fudin
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`testified, a POSA should be a clinician with “experience in dispensing
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`medication.” (Ex. 2061 at 185:5–6.) Dr. Fudin’s proposed POSA would not be a
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`computer engineer or an administrator without clinical pharmacy experience. (See,
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`e.g., id. at 184:3–16, 185:2–22, 191:21–192:14.) Instead, Dr. Fudin testified that
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`his proposed POSA would be a clinician who “could” design successful methods
`
`for risk management in delivering medication by drawing upon the support of a
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`“multi-disciplinary team.” (Ex. 2061 at 190:15–18, 192:10–14; accord Ex. 1027
`
`¶ 17.) “Risk management,” Dr. Fudin emphasized, “is part and parcel of the
`
`
`
`4
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`
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`pharmacy profession. Period.” (Ex. 2061 at 191:10–15.)1
`
`Finally, Celgene also offers the testimony of Dr. Joseph T. DiPiro, a
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`pharmacist, who purports to “assume that Dr. Fudin’s definition of a POSA is
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`correct and to offer my opinions through the eyes of that POSA.” (Ex. 2060 ¶ 16.)
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`Dr. DiPiro concedes that “pharmacists use risk management techniques in their
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`practice on a day-to-day basis.” (Ex. 1085 at 95:17–96:1.) Indeed, Dr. DiPiro has
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`even advocated that “[p]harmacists can be assured of an important role in health
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`care as long as we are focused on [the] needs and unresolved problems” related to
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`“medications . . . [and] preventable adverse drug effects[.]” (Ex. 1065 at 2; see also
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`id. at 1 (noting “hospitals are partnering with community pharmacies to help keep
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`patients out of the hospital by managing their medications”).) Nevertheless, Dr.
`
`DiPiro asserts that “someone with Dr. Fudin’s POSA’s qualifications . . . would
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`certainly not have been able to design or implement [restricted distribution]
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`systems.” (Ex. 2060 ¶ 17.) Petitioner respectfully submits that Dr. DiPiro’s
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`testimony is nonsensical. On one hand, Dr. DiPiro claims to adopt Dr. Fudin’s
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`definition of a POSA; on the other hand, Dr. DiPiro claims such a POSA would in
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`fact not be a POSA for lack of ability to design or implement the ’720 patent’s
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`claimed inventions. See Daiichi, 501 F.3d at 1257 (POSA must be able to
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`1 Relatedly, Celgene’s expert’s critique of Dr. Fudin’s definition of a POSA applies
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`to her own proffered definition. (See Ex. 1091; Ex. 1086 at 185:12-187:8.)
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`5
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`“develop[]” the claimed inventions). The Board should disregard Dr. DiPiro’s
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`testimony, which contradicts itself and is contrary to Federal Circuit law.
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`
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`For all the foregoing reasons, the Board should adopt Petitioner’s
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`proposed definition of POSA. The Board should reject the testimony of Drs.
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`Frau2 and DiPiro3, which apply POSA perspectives that are contradictory
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`and insufficient as a matter of law.
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`III. CELGENE’S PROPOSED CLAIM CONSTRUCTION IS
`UNSUPPORTED
`
`Celgene acknowledges that the proper standard for claim construction in an
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`IPR is that claim terms are given their broadest reasonable interpretation in light of
`
`the specification. See 37 C.F.R. 42.100(b) Yet Celgene’s proposed construction for
`
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`2 The Board should also reject Dr. Frau’s testimony for the independent reason that
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`it is not credible on its face. As the videotaped testimony submitted as Exhibits
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`1087–1091 shows, Dr. Frau frequently paused for two to three minutes before
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`answering CFAD’s counsel’s questions. (See also Ex. 1086 at 75:22–77:2, 81:12–
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`83:5, 129:11–133:7, 152:12–154:21, 185:12–187:8.) Dr. Frau openly expressed
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`confusion about important aspects of her analysis, at one point testifying that her
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`“interpretation of prior art may not be accurate.” (Id. at 307:3–4.)
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`3 If the Board accepts Dr. Frau’s definition of POSA—which it should not—the
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`testimony of Dr. DiPiro would be irrelevant.
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`
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`6
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`
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`“prescription approval code” disregards the specification and seeks to limit the
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`claims to an unwarranted and unjustifiably narrow scope.
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`First, Celgene’s proposed definition for “prescription approval code” is a
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`“code representing that an affirmative risk assessment has been made based upon
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`risk-group assignment and the information collected from the patient, and that is
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`generated only upon a determination that the risk of a side effect occurring is
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`acceptable.” (POR at 21–22.) But this reading has no support in the patent. For
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`example, Celgene’s experts admit that the word “affirmative” does not appear
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`anywhere in the claims. (Ex. 1086 at 316:15–16; Ex. 1085 at 242:24–244:22.)
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`More importantly, the specification of the patent provides that:
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`This approval code is preferably not provided unless the prescriber,
`the pharmacy, the patient, the patient’s risk group and the patient’s
`informed consent have been properly registered in the storage
`medium. Additionally, depending upon the risk group assignment,
`generation of the prescription approval code may further require the
`registration in the storage medium of the additional set of
`information, including periodic surveys and the results of diagnostic
`tests, as have been defined as being relevant to the risk group
`assignment.
`(Ex. 1001 at 13:42–54 (emphasis added).) This disclosure makes it clear that the
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`only requirement for retrieval of the approval code is registration. Additional
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`information relating to the purported risk group assessment that Celgene references
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`7
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`
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`in its proposed construction may be required, but is not necessarily required. See
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`NHK Seating of America, Inc. v. Lear Corp., IPR2014-01079, Paper No. 30
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`(Jan. 12, 2016) (rejecting claim construction “argument because it improperly
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`attempted to incorporate limitations of preferred embodiments into the claims…”).
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`Dr. Frau’s analysis of this claim term is flawed and should be given no
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`weight. First, at her deposition, Dr. Frau appeared confused regarding what
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`standard should apply to claim construction in an IPR, testifying initially that the
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`standard for claim construction is not the broadest reasonable construction in view
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`of the specification:
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`Q. And do you agree with me, based on what you have in your
`declaration, that the broadest reasonable construction, as would
`be understood by a POSA in view of the specification, is the
`standard for claim construction?
`[Objection]
`
`
`
`A. No, I don’t agree. I don’t agree -- I don’t agree with -- I don’t
`agree with your interpretation of my interpretation.
`(Ex.1086 at 204:10–18.)
`
`Second, Dr. Frau’s claim construction opinions were based on the claims in
`
`view of the prosecution history and do not account for the clear statements of the
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`specification. She does not cite any portions of the specification of the patent in
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`support of her opinions. (Ex. 2059 ¶¶ 50–52.) Moreover, she appears to view the
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`specification as a “discussion” section and the claims as a “conclusion,” saying that
`8
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`
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`the claims “supercede[s] what was discussed before.” (Ex. 1086 at 201:22–24.)
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`That approach places little importance on the specification—which is consistent
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`with the fact that she ignores the disclosures in it that undermine her construction.
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`Similarly, Dr. DiPiro, who purports to offer the same construction, also fails to cite
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`to any portion of the patent aside from the claims. (Ex. 1085 at 242:24–244:22.)
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`Finally, Celgene’s arguments invoking the file history are also unsupported
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`by the cited portions of the record. Those portions reflect Applicants’ attempts to
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`distinguish the Boyer reference. (Ex. 1002 at 106.) But Boyer does not disclose an
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`approval code of any sort. (Id. at 107.) Rather it teaches the use of a barcode or
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`code to identify vials in a pharmacy setting. (See generally Ex. 1005.) Thus, the
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`focus of Applicant’s differentiation of its claims was the fact that Boyer did not
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`require any steps prior to the issuance of the code. (Ex. 1002 at 107.) To the extent
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`that Applicants’ arguments could be interpreted to limit the scope of their claims
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`further, such limits are contrary to the broadest reasonable interpretation in view of
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`the specification. Celgene’s attempt to override the clear disclosures of the
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`specification by arguing that the claim term “prescription approval code” should be
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`narrowly construed must fail under the relevant claim construction standard. See
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`ZTE Corp. v. ContentGuard Holdings, Inc., No. IPR2013-00133, Paper 61 at 21
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`(PTAB July 1, 2014) (rejecting claim construction that ignored disclosures in
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`specification).
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`9
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`
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`IV. THE CLAIMS OF THE ’720 PATENT ARE OBVIOUS IN VIEW OF
`THE COMBINATION OF THE GROUND 1 REFERENCES
`A. Celgene’s Argument that the Only Motivation to Improve Upon the
`Prior Art Was Contained in Confidential Celgene Documents Is
`Artificial
`
`Celgene argues that the S.T.E.P.S. program, which it claims practices U.S.
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`Patent No. 6,045,501 (the “’501 patent”), was “100% successful” by October of
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`2000, and that therefore “there was no problem to be solved” in the art. (POR at 6.)
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`But even assuming that there were no reported birth defects4 between the launch of
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`Celgene’s thalidomide product in July of 1998 and the filing date of the ’720
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`4 Approximately two years, in view of the human gestational period of nine
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`months, is a short amount of time in which to judge whether a pharmaceutical
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`product was successful by any measure. And, in fact, later research showed that the
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`S.T.E.P.S. program was not 100 percent successful in preventing fetal exposure,
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`which was the stated purpose of the invention of the ’501 patent. (See Ex. 1085 at
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`180:10–19; Ex. 2061 at 515:1–516:16; Ex. 1083 at 5 (“four confirmed fetal
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`exposures”).) At her deposition, Celgene’s expert Dr. Frau refused to answer the
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`question of whether the goal of S.T.E.P.S. was to prevent birth defects through
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`avoiding fetal exposure. (See Ex. 1089; Ex. 1086 at 129:11–133:7.) She also
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`admitted that her only evidence of this purported 100 percent success rate was the
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`declaration of a Celgene employee. (See Ex. 1090; Ex. 1086 at 152:12–154:21.)
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`10
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`patent, it does not follow that there was no motivation to improve upon the
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`S.T.E.P.S. program. Indeed, Celgene’s own public statements prior to the filing
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`date identify ways in which the claimed invention could be improved.
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`In an article entitled S.T.E.P.S.™: A Comprehensive Program for
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`Controlling and Monitoring Access to Thalidomide, inventor Bruce Williams and
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`other Celgene authors noted room for improvement: “Celgene is committed to
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`making the S.T.E.P.S.TM program succeed and will make any modifications to the
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`program that are necessary to ensure its effectiveness.” (Ex. 1011 at 329.) In
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`addition, Celgene inventor Mr. Williams recognized at a meeting of the FDA
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`Dermatologic and Ophthalmic Drugs Advisory Committee in 1997 (“FDA
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`Meeting”) that compliance issues with the S.T.E.P.S. program presented an
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`opportunity to enhance the program:
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`(Ex. 1012 at 119.) That these statements were made prior to or around the same
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`time S.T.E.P.S. was launched is of no consequence—Celgene does not dispute that
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`11
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`the program had been designed by the time of the FDA meeting, since much of the
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`presentation at the meeting related to the details of the program. (See generally id.)
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`Celgene and its experts claim that “Celgene conceived of Enhanced
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`S.T.E.P.S. based on confidential, nonpublic information.” (POR at 5.) But the POR
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`does not specify what this purported confidential information was, except to call it
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`“confidential feedback from Celgene’s vendors.” (See POR at 5–7.) Nor were
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`Celgene’s experts able to testify as to any confidential information that would have
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`prompted a POSA to explore improvements to S.T.E.P.S. in a manner distinct from
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`the actions such a POSA would take without the alleged confidential information.
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`While Celgene’s experts claim that Exhibit 2007 contains the confidential
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`information that supposedly motivated the inventors, they are unable to (1) identify
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`it, (2) explain how any of the information would not be known to participants of
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`the S.T.E.P.S. program, or (3) how it related to the methods of the ’720 patent. For
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`instance, Dr. Frau testified that the confidential information in Exhibit 2007 would
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`be in the “attachments,” but she admitted that she had only reviewed Attachment 7,
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`and was unable to point to any specific confidential information in that attachment:
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`Q. And what in these documents informed the inventors focused
`on implementing changes based on confidential information?
`A. All the information that they had submitted to the agency
`concerning Attachments 1 through 6 plus attachment 7.
`
`
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`12
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`
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`Q. Can you point me to specific information within those
`documents that they used?
`I don’t have those attachments.
`So you never reviewed those?
`I didn’t review the contents of those attachments, no.
`
`A.
`Q.
`A.
`…
`Q.
`
`So with respect to the attachment you do have, Attachment 7, is
`there anything in there that you say informed the inventors
`focusing on implementing changes?
`(Pause.)
`A.
`The only statement that is made here is Celgene has been
`working in the intervening months. So it tells me that they had
`been working and they knew more details from this attachment.
`But you can’t point me to anything more specific than that?
`Q.
`A. Not in the attachment.
` (Ex. 1086 at 325:2–327:19.)5
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`Similarly, Dr. DiPiro purported to identify the confidential information in
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`Exhibit 2007, but was unable to explain its relevance to the methods of the ’720
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`patent. For example:
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`5 Celgene’s expert Dr. Frau exhibited great confusion as to the parameters of a
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`motivation to combine in an obviousness analysis. (See Ex. 1087; Ex. 1088; Ex.
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`1086 at 75:22–77:2, 81:12–83:5.)
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`13
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`(Ex. 1085 at 215:15–219:11.) Celgene itself describes Ex. 2007 as a document in
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`which Celgene “explained the differences between S.T.E.P.S. and Enhanced
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`S.T.E.P.S.…to the FDA,” but fails to point to any examples of confidential
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`information that actually gave rise to those differences. (POR at 8–9.)
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`Celgene’s citations to the testimony of Dr. Fudin to argue that Dr.
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`14
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`Fudin “admitted…there was no motivation” to combine (POR at 19) are based on a
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`mischaracterization of that testimony. Rather, the portions of Dr. Fudin’s
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`deposition that Celgene relies upon lead to the opposite conclusion: that a POSA
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`would be motivated to make changes to S.T.E.P.S. based on other drugs in the
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`future to which the program might be applied. (Ex. 2061 at 590:15–592:9.)
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`Consequently, Celgene’s unsubstantiated argument and the conclusory statements
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`of its experts should not be credited. See, e.g., Edmund Optics, Inc. v. Semrock,
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`Inc., IPR2014-00583, Paper No. 50 (PTAB Sep. 9, 2015) (rejecting expert
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`testimony that “does little more than repeat…conclusory arguments of [counsel].”).
`
`B.
`
`The Disclosures of the Ground 1 References Render the Claims
`Obvious
`
`Celgene’s POR reads as if Ground 1 was based on an anticipation ground; it
`
`walks through each reference to purportedly point out that that “[e]ach reference
`
`fails to disclose several, if not all, elements of the ’720 patent claims...” (POR at
`
`24.) But not only are Celgene’s assertions inaccurate, Celgene ignores that this IPR
`
`was instituted because the Board found a reasonable likelihood of prevailing on the
`
`ground that the ’720 patent claims are “obvious over the combined teachings of the
`
`prior art.” (See Paper No. 22 at 23 (emphasis added).) Unlike the standard Celgene
`
`appears to apply, obviousness requires a showing that the “differences between the
`
`claimed invention and the prior art are such that the claimed invention as a whole
`
`would have been obvious…to a person having ordinary skill in the art…”
`
`
`
`15
`
`
`
`35 U.S.C. § 103. And, as explained in the Petition and herein, it is evident that
`
`those combined disclosures would have made the claims obvious to a POSA.
`
`1. Motivation to Combine Mitchell, Dishman, and Cunningham
`Celgene appears to have a separate argument with respect to the motivation
`
`of a POSA to combine Mitchell, Dishman, and Cunningham. Specifically, Celgene
`
`argues that Mitchell does not mention the Dishman reference; Dishman addresses a
`
`different patient population; and Cunningham relates to a different field altogether.
`
`But these arguments are erroneous for several reasons.
`
`First, Celgene’s implication that a prior art reference that comes after
`
`another prior art reference must mention the preceding reference (see POR at 25,
`
`55) is incorrect. Instead, the law is clear that a motivation to combine references
`
`may come from the knowledge of a person of ordinary skill in the art, and need not
`
`be explicit in the prior art. See Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286,
`
`1294 (Fed. Cir. 2006) (stating that motivation to combine the relevant prior art
`
`teachings does not have to be found explicitly in the prior art). Dr. Frau testified
`
`that she performed her analysis under the mistaken assumption that an explicit
`
`motivation must be disclosed in a reference. (See Ex. 1086 at 86:4–14 (asserting
`
`that “a POSA h[as] to be able to cite to a particular reference”).) Dr. Frau’s
`
`reliance on an incorrect legal assumption renders her testimony on this topic
`
`unreliable, and should be given no weight. See, e.g., InTouch Techs., Inc. v. VGo
`
`
`
`16
`
`
`
`Communs., Inc., 751 F.3d 1327, 1348 (Fed. Cir. 2014) (excluding expert testimony
`
`that “applied an incorrect legal standard”); United States v. 319.88 Acres of Land,
`
`498 F. Supp. 763, 766 (D. Nev. 1980) (“Where the opinion of an expert is based on
`
`erroneous assumptions of fact or law, the evidence is incompetent[.]”); Martinez v.
`
`Porta, 601 F. Supp. 2d 865, 866 (N.D. Tex. 2009) (“[Expert] opinion cannot be
`
`based on an erroneous legal premise.”).
`
`Second, Celgene’s experts admitted the relevance of the programs disclosed
`
`in Mitchell and Dishman. For example, Dr. DiPiro testified that “we noted in some
`
`of the literature where isotretinoin and clozapine systems were discussed by
`
`Celgene employees, that the results from these systems could guide an individual
`
`in either direction, as a way to do it or as a way not to do it. So in that sense they
`
`are relevant.” (Ex. 1085 at 326:23–327:5.) Dr. Frau similarly acknowledged that
`
`the clozapine program was a restricted distribution program (Ex. 1086 at 112:7–15,
`
`113:3–8), and thus it would be relevant to the art of her POSA.
`
`Third, Celgene’s smoke-and-mirrors attempt to minimize the relevance of
`
`Dishman because it purportedly focuses on “one hospital within the VA system” is
`
`similarly misplaced. Celgene offers no reason that the disclosures of Dishman—
`
`including the methods related to the screening of patients to determine eligibility
`
`for treatment (see Ex. 1027 ¶ 68; Ex. 1007 at 900)—could not be applied on a
`
`larger scale across multiple hospitals.
`
`
`
`17
`
`
`
`Finally, despite Celgene’s argument that Cunningham does not relate to the
`
`field of the invention, Celgene’s experts acknowledge that Cunningham discloses a
`
`“method for managing and tracking the distribution of pharmaceutical trial or
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`sample products;” that the invention “involv[ed] the participating prescribers,
`
`pharmacies, and patients;” and that the “process…inherently includes checks and
`
`balances…” (Ex. 1008 at 3:42–44; Ex. 1085 at 264:14–266:9; Ex. 1086 at 320:8–
`
`21.) In view of the plain language of Cunningham, then, it is evident that the
`
`reference is relevant to the field of pharmaceutical prescriptions as well as
`
`restricted drug distribution and would have been consulted by a POSA.
`
`2.
`
`Independent Claims 1 and 28 Are Obvious in View of the
`Combination of Mitchell, Dishman, and Cunningham
`The only aspect of claims 1 and 28 that Celgene contends is not identified in
`
`Mitchell is that it does not disclose the claimed prescription approval code, an
`
`argument that completely ignores its combination with the Cunningham reference,
`
`which—as explained below—explicitly discloses such a code. The remainder of
`
`Celgene’s arguments related to Mitchell address the dependent claims of the ’720
`
`patent. As a result, it is uncontested that Mitchell discloses the “desirability, when
`
`treating patients with drugs associated with adverse side effects to certain risk
`
`groups, of ‘defining a plurality of patient risk groups based upon a predefined set
`
`of risk parameters for said drug,’ ‘defining a set of information to be obtained from
`
`said patient, which information is probative of the risk that said adverse side effect
`
`
`
`18
`
`
`
`is likely to occur if said drug is taken by said patient,’ ‘in response to said
`
`information set, assigning said patient to at least one of said risk groups,’ and
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`‘based upon said information and said risk group assignment, determining whether
`
`the risk that said adverse side effect is likely to occur is acceptable.’” (Ex. 1027
`
`¶¶ 78–94, quoting Ex. 1001 at claim 1.)
`
`The only aspects of claims 1 and 28 that Celgene contends are not identified
`
`in Dishman is the claimed prescription approval code, again ignoring the
`
`combination of Dishman with the disclosure of Cunningham, described below. But
`
`that argument also ignores Dishman’s disclosure of a lockout system, which
`
`exemplifies approval of acceptable risk through a “registry [that] permits
`
`community and hospital pharmacies to dispense clozapine only upon the
`
`pharmacist’s verification that the WBC count is within acceptable limits. … [T]he
`
`lockout system prevents the filling of any clozapine prescription if the computer
`
`notices three consecutive drops in WBC count.” (Ex. 1007 at 899–900; see Ex.
`
`1027 ¶ 95.)
`
`The remainder of Celgene’s arguments related to Dishman address the
`
`dependent claims of the ’720 patent. As a result, it is uncontested that Dishman
`
`teaches “implement[ation] of a computerized registry for ‘delivering a drug to a
`
`patient in need of the drug, while avoiding the occurrence of an adverse side effect
`
`known or suspected of being caused by said drug’” followed by “entering the risk
`
`
`
`19
`
`
`
`group in said medium,” and finally “approval of acceptable risk” through a
`
`registry. (Ex. 1027 ¶¶ 88–95; see also Ex. 1007 at 899–900.)
`
`Finally, Celgene’s sole argument with respect to the disclosure of
`
`Cunningham as it relates to the independent claims is that the Cunningham
`
`approval code is not used in connection with side effects. (See POR at 30.) This
`
`contention rests on Celgene’s flawed claim construction proposal for the claimed
`
`prescription approval code which, as described above, should be rejected. The
`
`Cunningham approval code is analogous to the claimed code in the ’720 patent, as
`
`Cunningham describes:
`
`Prior to actually filling the pharmaceutical trial prescription, the
`participating pharmacy, like the prescriber, must establish
`authorization.
`…
`Assuming full validation, the central computing station issues a
`pharmacy approval code and the pharmacy records that approval code
`on the actual presented product trial media 18. … Once validation is
`established the pharmacy then dispenses pharmaceutical trial
`product.…
`(Ex. 1008 at 10:28–11:8, 17–23 (emphasis added).) This disclosure teaches a
`
`validation step associated with the code prior to the drug being dispensed, wh
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