Paper No. 51
`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.: IPR2015-01096
`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.: IPR2015-01096
`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 .......................................................................................... 3
`THE TESTIMONY OF CELGENE’S EXPERTS IS ENTITLED TO NO
`WEIGHT ........................................................................................................ 4
`CELGENE’S PROPOSED CLAIM CONSTRUCTION IS
`UNSUPPORTED ........................................................................................... 8
`THE CLAIMS OF THE ’720 PATENT ARE OBVIOUS IN VIEW OF
`THE COMBINATION OF THE GROUND 2 REFERENCES .................. 12
`A. Celgene’s Argument that the Only Motivation to Improve Upon the
`Prior Art Was Contained in Confidential Celgene Documents Is
`Artificial ....................................................................................................... 12
`B. The Disclosures of the Ground 2 References Render the Claims
`Obvious ......................................................................................................... 18
`1. Motivation to Combine Thalomid PI and Cunningham ............................. 18
`2. Independent Claims 1 and 28 Are Obvious In View of the Combination
`of Thalomid PI and Cunningham ................................................................ 19
`3. Dependent Claims 5, 6, 10, and 17 Are Obvious In View of the
`Ground 2 References ................................................................................... 22
`a. Claims 5 and 6 ..................................................................................... 22
`b. Claim 10 ............................................................................................... 25
`c. Claim 17 ............................................................................................... 26
`
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`1
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`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Custom Accessories, Inc. v. Jeffrey-Allan Indus.,
`807 F.2d 955 (Fed. Cir. 1986) ................................................................................ 5
`
`Daiichi Sankyo Co. v. Apotex, Inc.,
`501 F.3d 1254 (Fed. Cir. 2007) ..........................................................................6, 7
`
`Edmund Optics, Inc. v. Semrock, Inc.,
`IPR2014-00583, Paper No. 50 (PTAB Sep. 9, 2015) .......................................... 17
`
`NHK Seating of America, Inc. v. Lear Corp.,
`IPR2014-01079, Paper No. 30 (PTAB Jan. 12, 2016) ......................................... 10
`
`ZTE Corp. v. ContentGuard Holdings, Inc.,
`No. IPR2013-00133, Paper 61 (PTAB July 1, 2014) .......................................... 12
`
`Statutes and Regulations
`
`35 U.S.C. § 103 ........................................................................................................ 18
`
`37 C.F.R. § 42.100(b) ................................................................................................ 9
`
`37 C.F.R. § 42.6(e) ..................................................................................................... 1
`
`37 C.F.R. § 42.24(c)(1) ............................................................................................ 29
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`37 C.F.R. § 42.24(d) ................................................................................................ 29
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`
`
`2
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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.
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`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. 40; “POR”) has failed to
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`rebut Petitioner’s strong case of obviousness that the claims of the ’720 patent (Ex.
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`1001) are obvious over Thalomid PI and in view of Cunningham and further in
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`view of Keravich, Zeldis, and Mundt (collectively, the “Ground 2 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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`obvious in view of the knowledge of a POSA. In that context, Celgene’s denials of
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`3
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`
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`the motivation of a POSA to combine the prior art references of Ground 2, which it
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`bases on the purported confidentiality of material that it (or either of its experts)
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`does not identify, are simply not credible.
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`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.
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`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 person of
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`ordinary skill in the art (a “POSA”). Through one of its experts, Celgene attempts
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`to limit the obviousness inquiry by narrowly construing the knowledge and
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`experience of a POSA; through the other expert, Celgene purports to adopt
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`Petitioner’s proposed POSA. Celgene’s approach is convoluted, unnecessary, and
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`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. 1021 ¶ 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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`4
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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. 1021 ¶ 16.) 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.”).
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`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.)
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`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. 1075 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. 1075 at 168:5–11, 166:3–7, 306:4–10.)
`
`
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`5
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`
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`As Celgene itself acknowledges (see POR at 15–16), the Federal Circuit has made
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`clear that a POSA must be able to develop the claimed inventions. See Daiichi
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`Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1257 (Fed. Cir. 2007) (POSA must be
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`able to “develop[]” the claimed inventions). Dr. Frau’s proposed POSA fails as a
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`matter of law.
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`Celgene attempts a straw-man argument by asserting that Petitioner’s expert,
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`Dr. Jeffrey Fudin, “admitted that CFAD’s POSA would not have been capable of
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`designing or implementing the claimed systems of the ’720 patent.” (POR at 15.)
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`Celgene misconstrues Dr. Fudin’s testimony. Critically, the ’720 patent claims
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`methods—not systems—for delivering a drug to a patient. See Ex. 1001. As Dr.
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`Fudin 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
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`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. 1021 ¶
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`17.) “Risk management,” Dr. Fudin emphasized, “is part and parcel of the
`
`
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`6
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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. 1074 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. 1073 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.
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`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. 1081; Ex. 1075 at 185:12–187:8.)
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`7
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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
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`the specification. See 37 C.F.R. § 42.100(b). Yet Celgene’s proposed construction
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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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`1077–1081 shows, Dr. Frau frequently paused for two to three minutes before
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`answering CFAD’s counsel’s questions. (See also Ex. 1075 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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`8
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`
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`for “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. 1075 at 316:15–16; Ex. 1074 at 242:24–244:22.)
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`More importantly, the specification of the patent provides that:
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`In certain embodiments of the invention, the methods may require that
`the registered pharmacy consult the computer readable medium to
`retrieve a prescription approval code before dispensing the drug to the
`patient. 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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`9
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`
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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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`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 (PTAB
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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.
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`(Ex. 1075 at 204:10–18.)
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`Second, Dr. Frau’s claim construction opinions were based on the claims in
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`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 of portions of the specification of the patent in
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`10
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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
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`the claims “supercedes what was discussed before.” (Ex. 1075 at 201:22–24.) That
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`approach places little importance on the specification—which is consistent with
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`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. 1074 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; see also Ex. 1005.) Rather it teaches the use
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`of a barcode or code to identify vials in a pharmacy setting. (See generally Ex.
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`1005.) Thus, the focus of Applicant’s differentiation of its claims was the fact that
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`Boyer did not require any steps prior to the issuance of the code. (Ex. 1002 at 107.)
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`To the extent that Applicants’ arguments could be interpreted to limit the scope of
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`their claims further, such limits are contrary to the broadest reasonable
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`interpretation in view of the specification. Celgene’s attempt to override the clear
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`disclosures of the specification by arguing that the claim term “prescription
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`approval code” should be narrowly construed must fail under the relevant claim
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`construction standard. See ZTE Corp. v. ContentGuard Holdings, Inc., No.
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`11
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`
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`IPR2013-00133, Paper 61 at 21 (PTAB July 1, 2014) (rejecting claim construction
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`that ignored disclosures in specification).
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`IV. THE CLAIMS OF THE ’720 PATENT ARE OBVIOUS IN VIEW OF
`THE COMBINATION OF THE GROUND 2 REFERENCES
`A. Celgene’s Argument that the Only Motivation to Improve Upon the
`Prior Art Was Contained in Confidential Celgene Documents Is
`Artificial
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`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 4,
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`6.) But even assuming that there were no reported birth defects4 between the
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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. 1074 at
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`180:10–19; Ex. 2061 at 515:1–516:16; Ex. 1072 at 5 (“four confirmed fetal
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`exposures”); Ex. 1001 at claim 1.) At her deposition, Dr. Frau refused to answer
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`the 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. 1079; Ex. 1075 at 129:11-133:7.) She also
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`12
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`launch of Celgene’s thalidomide product in July of 1998 and the filing date of the
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`’720 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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`For example, in an article entitled S.T.E.P.S.™: A Comprehensive Program
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`for Controlling and Monitoring Access to Thalidomide, inventor Bruce Williams
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`and 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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`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. 1080; Ex. 1075 at 152:12–154:21.)
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`13
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`(Ex. 1076 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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`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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`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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`14
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`the S.T.E.P.S. program, or (3) testify as to how it related to the methods of the ’720
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`patent. For instance, Dr. Frau testified that the confidential information in Exhibit
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`2007 would be in the “attachments,” but she admitted that she had only reviewed
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`Attachment 7, and was unable to point to any specific confidential information in
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`that attachment:
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`A.
`Q.
`A.
`…
`Q.
`
`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.
`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.
`
`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.
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`15
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` (Ex. 1075 at 323:24–327:19.)5
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`Similarly, Dr. DiPiro purported to identify 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. 1077; Ex. 1078; Ex.
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`1075 at 75:22–77:2, 81:12–83:5.)
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`16
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`(Ex. 1074 at 215:15–219:11.) Celgene itself describes Exhibit 2007 as a document
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`in 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. Fudin
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`“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].”).
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`17
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`B.
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`The Disclosures of the Ground 2 References Render the Claims
`Obvious
`
`Celgene’s POR reads as if Ground 2 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. 21 at 21 (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…” 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 Thalomid PI and Cunningham
`Celgene separately denies the motivation of a POSA to combine Thalomid
`
`PI and Cunningham. In particular, it argues that the Thalomid PI (undeniably
`
`relevant) and Cunningham “are directed to disparate fields.” (POR at 54.)
`
`However, 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
`
`
`
`18
`
`
`
`sample products;” that the invention “involv[ed] the participating prescribers,
`
`pharmacies, and patients;” and that the “process…inherently includes checks and
`
`balances…” (Ex. 1009 at col. 2:46–59, 3:39–43; Ex. 1074 at 264:14–266:9; Ex.
`
`1075 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 code.
`
`2.
`
`Independent Claims 1 and 28 Are Obvious In View of the
`Combination of Thalomid PI and Cunningham
`The only aspect of claims 1 and 28 that Celgene contends is not identified in
`
`Thalomid PI 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. Further, as the
`
`Board noted, “Petitioner states that one skilled in the art, following the teachings of
`
`Thalomid PI and seeking to avoid treating pregnant women with thalidomide,
`
`would have implemented the methods disclosed in Cunningham to limit
`
`dispensation of a drug associated with adverse effects to certain risk groups. (Paper
`
`No. 21 at 16 –17 (emphasis added).)
`
`The remainder of Celgene’s arguments related to Thalomid PI address the
`
`dependent claims of the ’720 patent. As a result, it is uncontested that Thalomid PI
`
`discloses the “desirability, when treating patients with drugs associated with
`
`adverse side effects to certain risk groups, of ‘defining a plurality of patient risk
`
`
`
`19
`
`
`
`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 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 ‘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. 1021 ¶¶ 78–86 (quoting Ex. 1001 at claim 1.)
`
`Celgene’s sole argument with respect to the disclosure of Cunningham as it
`
`relates to the independent claims is that the approval code of Cunningham is not
`
`used in connection with side effects. (See POR at 30.) This contention rests on
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`Celgene’s flawed claim construction proposal for the claimed prescription approval
`
`code which, as described above, should be rejected. The approval code of
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`Cunningham 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
`
`
`
`20
`
`
`
`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, which
`
`suggests the element of claim 1(e) of the ’720 patent. Celgene’s experts
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`acknowledged the authorization and validation teachings in Cunningham:
`
`Q.
`
`A.
`
`So the record is clear, my question is you agree that Claim 13
`mentions a pharmacy approval code on the presented product
`trial card as a part of the validation procedure; right?
`It states -- those are the words on this page, yes.
`
`(Ex. 1075 at 319:15–20.) Similarly:
`
`Q.
`
`Looking further down column 10 around line 28, in
`Cunningham it says, "Prior to actually filling the
`pharmaceutical trial prescription, the participating pharmacy,
`like the prescriber, must establish authorization."
`Do you see that?
`
`I do.
`A.
`Q. And the next paragraph in the same column says, "However,
`before the pharmacy can fill the prescriptive trial product of any
`presented product trial media, the product trial media must be
`subjected to a validation procedure."
`Do you see that?
`I do.
`
`
`A.
`
`
`
`21
`
`
`
`(Ex. 1074 at 268:3–18.) Therefore, the independent claims of the ’720 patent are
`
`obvious in view of the Ground 2 references.
`
`3.
`
`Dependent Claims 5, 6, 10, and 17 Are Obvious In View of the
`Ground 2 References
`
`The only dependent claims addressed in Celgene’s POR are claims 5, 6, 10,
`
`and 17. Celgene asserts that the Ground 2 prior art does not disclose elements of
`
`these claims, but in doing so, ignores the teachings and suggestions of the art.
`
`Instead, as with the independent claims, it walks through each reference and points
`
`to purported lacking disclosures while ignoring the prior art teachings in
`
`combination.
`
`Claims 5 and 6
`
`a.
`For claims 5 and 6, which require verification of informed consent at the
`
`time of patient registration, the Board credited Dr. Fudin’s testimony that Thalomid
`
`PI discloses this claim limitation:
`
`Dr. Fudin testifies that one of ordinary skill in the art would have
`reason to have the prescriber verify both risk group assignment and
`informed consent at the time of computer entry and informed consent
`at the time of computer entry to eliminate error and delay. … Based
`upon the evidence of record, we credit Dr. Fudin’s testimony and hold
`that one skilled in the art would have had a reason to enter the
`informed consent and risk assignment into a computer database at the
`same time.
`
`
`
`22
`
`
`
`(Paper No. 21 at 19–20.) The Thalomid PI explicitly supports this finding. Among
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`the forms included in the reference for physicians to complete is this statement and
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`signature block:
`
`
`
`(Ex. 1006 at 21.)
`
`While Celgene offers no new arguments on this issue, and therefore fails to
`
`contradict this finding, it relies on the materials of the S.T.E.P.S.TM program,
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`Keravich, and Zeldis to assert that the original program contemplated that the
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`pharmacist, not the prescriber, verifies the informed consent. (See POR at 42–44.)
`
`However, Celgene mischaracterizes those documents. For example, Celgene says
`
`that Exhibit 2065 shows a registration form in which a pharmacist must verify the
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`patient’s consent form. But in fact, that form does not specify who is verifying the
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`consent—it has blanks for information from both the physician and the pharmacist,
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`and there is no signature line at all:
`
`
`
`23
`
`
`
`(Ex. 2065.) Further, Celgene disregards statements throughou
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