`for the Federal Circuit
`______________________
`
`CELGENE CORPORATION,
`Appellant
`
`v.
`
`LAURA A. PETER, DEPUTY UNDER SECRETARY
`OF COMMERCE FOR INTELLECTUAL PROPERTY
`AND DEPUTY DIRECTOR OF THE UNITED
`STATES PATENT AND TRADEMARK OFFICE,
`Intervenor
`______________________
`
`2018-1167, 2018-1168, 2018-1169
`______________________
`
`Appeals from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in Nos. IPR2015-
`01096, IPR2015-01102, IPR2015-01103.
`--------------------------------------------------
`
`CELGENE CORPORATION,
`Appellant
`
`v.
`
`LAURA A. PETER, DEPUTY UNDER SECRETARY
`OF COMMERCE FOR INTELLECTUAL PROPERTY
`AND DEPUTY DIRECTOR OF THE UNITED
`STATES PATENT AND TRADEMARK OFFICE,
`Intervenor
`______________________
`
`
`
`
`2
`
`CELGENE CORPORATION v. PETER
`
`2018-1171
`______________________
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2015-
`01092.
`
`______________________
`
`Decided: July 30, 2019
`______________________
`
`GREGORY A. CASTANIAS, Jones Day, Washington, DC,
`argued for appellant. Also represented by JIHONG LOU,
`JENNIFER LORAINE SWIZE; GASPER LAROSA, New York, NY;
`ANTHONY INSOGNA, San Diego, CA; FRANK CHARLES
`CALVOSA, F. DOMINIC CERRITO, ANDREW CHALSON, Quinn
`Emanuel Urquhart & Sullivan, LLP, New York, NY.
`
` AMY J. NELSON, Office of the Solicitor, United States
`Patent and Trademark Office, Alexandria, VA, argued for
`intervenor.
` Also represented by MEREDITH HOPE
`SCHOENFELD, THOMAS W. KRAUSE.
` Also argued by
`KATHERINE TWOMEY ALLEN, Appellate Staff, Civil Division,
`United States Department of Justice, Washington, DC.
`Also represented by MARK R. FREEMAN, SCOTT R.
`MCINTOSH, JOSEPH H. HUNT.
`______________________
`
`
`
`Before PROST, Chief Judge, BRYSON and REYNA,
`Circuit Judges.
`
`PROST, Chief Judge.
`The Coalition for Affordable Drugs VI LLC (“CFAD”)
`filed a petition for inter partes review (“IPR”) challenging
`the validity of all of the claims of U.S. Patent No. 6,045,501
`(“the ’501 patent”) and three petitions for IPR challenging
`the validity of all of the claims of U.S. Patent No. 6,315,720
`(“the ’720 patent”). The Patent Trial and Appeal Board
`
`
`
`CELGENE CORPORATION v. PETER
`
`3
`
`(“Board”) determined that all of the claims of the ’501
`patent and claims 1–9 and 11–32 of the ’720 patent were
`obvious. Celgene Corporation (“Celgene”) appeals the
`Board’s decisions.
`For the reasons explained below, we affirm the Board’s
`decisions finding the appealed claims obvious. We also
`hold that the retroactive application of IPR proceedings to
`pre-AIA patents is not an unconstitutional taking under
`the Fifth Amendment.
`
`I
`A
`A teratogen is an agent known to disturb the
`development of an embryo or fetus. Teratogenic drugs can
`cause birth defects or other abnormalities following fetal
`exposure during pregnancy. One example of a teratogenic
`drug is thalidomide. Thalidomide, first synthesized in
`1957, was originally marketed for use as a sedative in
`many countries, not including the United States. See ’501
`patent col. 1 ll. 19–22. Following reports of serious birth
`defects, thalidomide was withdrawn from all markets by
`1962. Id. at col. 1 ll. 22–24. Despite these teratogenic
`effects, thalidomide has proven to be effective in treating
`other conditions. See id. at col. 1 ll. 24–35. The ’501 patent
`and the ’720 patent are generally directed to methods for
`safely distributing teratogenic or other potentially
`hazardous drugs while avoiding exposure to a fetus to
`avoid adverse side effects of the drug.
`B
`In order to obtain FDA approval to sell and distribute
`thalidomide, Celgene developed a system to safely
`distribute thalidomide to patients, which it called the
`System for Thalidomide Education and Prescription Safety
`(“Original S.T.E.P.S.”). Appeal No. 18-1171, Appellant’s
`Br. 8–9. According to Celgene, the ’501 patent is directed
`to its Original S.T.E.P.S. program. See id. at 10.
`
`
`
`4
`
`CELGENE CORPORATION v. PETER
`
`Celgene’s ’501 patent relates to “methods for delivering
`a drug to a patient while preventing the exposure of a
`foetus or other contraindicated individual to the drug.”
`’501 patent at Abstract. Claim 1 is representative and
`states:
`1. A method for delivering a teratogenic drug to
`patients in need of the drug while avoiding the
`delivery of said drug to a foetus comprising:
`a. registering in a computer readable storage
`medium prescribers who are qualified to
`prescribe said drug;
`b. registering in said medium pharmacies to fill
`prescriptions for said drug;
`c. registering said patients in said medium,
`including information concerning the ability of
`female patients to become pregnant and the
`ability of male patients to impregnate females;
`d. retrieving from said medium information
`identifying a subpopulation of said female
`patients who are capable of becoming pregnant
`and male patients who are capable of
`impregnating females;
`e. providing to the subpopulation, counseling
`information concerning the risks attendant to
`fetal exposure to said drug;
`f. determining whether patients comprising
`said subpopulation are pregnant; and
`g. in response to a determination of non-
`pregnancy for said patients, authorizing said
`registered pharmacies to fill prescriptions from
`said registered prescribers for said non-
`pregnant registered patients.
`
`
`
`CELGENE CORPORATION v. PETER
`
`5
`
`Id. at claim 1. Claim 2 recites “[t]he method of claim 1
`wherein said drug is thalidomide.” The remaining claims
`depend from claim 1 and are not limited to thalidomide.
`CFAD filed a petition for IPR challenging all ten claims
`of the ’501 patent. The Board instituted review of claims
`1–10 on a single ground—obviousness based on Powell,1
`Mitchell,2 and Dishman.3 Coalition for Affordable Drugs
`VI LLC v. Celgene Corp., No. IPR2015-01092, Paper 20
`(P.T.A.B. Oct. 27, 2015).
`In its final written decision, the Board held that CFAD
`had shown by a preponderance of the evidence that claims
`1–10 of the ’501 patent are unpatentable as obvious over
`the combination of Powell, Mitchell, and Dishman.
`Coalition for Affordable Drugs VI LLC v. Celgene Corp., No.
`IPR2015-01092, Paper 73, at 33 (P.T.A.B. Oct. 26, 2016)
`(“’501 Final Written Decision”).
` The Board denied
`Celgene’s request for rehearing.
`C
`In the interim, Celgene “overhaul[ed]” its Original
`S.T.E.P.S. program to create what it called an “Enhanced
`S.T.E.P.S.” program. Appeal No. 18-1167, Appellant’s Br.
`
`
`1 R.J. Powell & J.M.M. Gardner-Medwin, Guideline
`for the Clinical Use and Dispensing of Thalidomide, 70
`Postgrad Med. J. 901–904 (1994) (Appeal No. 18-1171, J.A.
`324–25).
`2 Allen A. Mitchell et al., A Pregnancy-Prevention
`Program in Women of Childbearing Age Receiving
`Isotretinoin, 333:2 New Eng. J. Med. 101–06 (July 13, 1995)
`(Appeal No. 18-1171, J.A. 328–33).
`3 Benjamin R. Dishman et al., Pharmacists’ Role in
`Clozapine Therapy at a Veterans Affairs Medical Center, 51
`Am. J. Hosp. Pharm. 899–901 (Apr. 1, 1994) (Appeal No.
`18-1171, J.A. 334–36).
`
`
`
`6
`
`CELGENE CORPORATION v. PETER
`
`8–9. According to Celgene, the ’720 patent is directed to its
`Enhanced S.T.E.P.S. program. See id. at 10.
`Celgene’s ’720 patent relates to “[i]mproved methods
`for delivering to a patient in need of the drug, while
`avoiding the occurrence of an adverse side effect known or
`suspected of being caused by the drug.” ’720 patent at
`Abstract. Claim 1, written in Jepson format, states:
`1. In a method 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, wherein said method is of the
`type in which prescriptions for said drug are filled
`only after a computer readable storage medium has
`been consulted to assure that the prescriber is
`registered in said medium and qualified to
`prescribe said drug, that the pharmacy
`is
`registered in said medium and qualified to fill the
`prescription for said drug, and the patient is
`registered in said medium and approved to receive
`said drug, the improvement comprising:
`a. defining a plurality of patient risk groups
`based upon a predefined set of risk parameters
`for said drug;
`b. 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;
`c. in response to said information set, assigning
`said patient to at least one of said risk groups
`and entering said risk group assignment in
`said medium;
`d. based upon said information and said risk
`group assignment, determining whether the
`
`
`
`CELGENE CORPORATION v. PETER
`
`7
`
`risk that said adverse side effect is likely to
`occur is acceptable; and
`e. upon a determination that said risk is
`acceptable, generating a prescription approval
`code to be retrieved by said pharmacy before
`said prescription is filled.
`CFAD filed three petitions for IPR, each challenging all
`32 claims of the ’720 patent. The Board instituted review
`of claims 1–32 in all three cases. In the first IPR, the Board
`instituted review based on obviousness over the Thalomid
`Package Insert,4 Cunningham,5 Zeldis,6 and other prior
`art. Coalition for Affordable Drugs VI, LLC v. Celgene
`Corp., No. IPR2015-01096, Paper 21 (P.T.A.B. Oct. 27,
`2015). In the second IPR, the Board instituted review
`based on obviousness over Powell and Dishman, in view of
`Cunningham, and further in view of Mann7 and other prior
`art. Coalition for Affordable Drugs VI, LLC v. Celgene
`Corp., No. IPR2015-01102, Paper 21 (P.T.A.B. Oct. 27,
`2015). In the third IPR, the Board instituted review based
`on obviousness over the same references as the second IPR
`but using Mitchell instead of Powell as the base reference.
`
`
`4 ThalomidTM
`(Thalidomide) Capsules Revised
`Package Insert (July 15, 1998) (Appeal No. 18-1167, J.A.
`411–32).
`5 U.S. Patent No. 5,832,449 (Appeal No. 18-1167,
`J.A. 440–62).
`6
`Jerome B. Zeldis et al., S.T.E.P.S.TM: A
`Comprehensive Program for Controlling and Monitoring
`Access to Thalidomide, Clinical Therapeutics® 21:2, 319–
`30 (1999) (Appeal No. 18-1167, J.A. 491–502).
`7 Thaddeus Mann & Cecelia Lutwak-Mann, Passage
`of Chemicals into Human and Animal Semen: Mechanisms
`and Significance, 11:1 CRC Critical Reviews in Toxicology
`1, 1–14 (1982) (Appeal No. 18-1167, J.A. 8237–52).
`
`
`
`8
`
`CELGENE CORPORATION v. PETER
`
`Coalition for Affordable Drugs VI, LLC v. Celgene Corp.,
`No. IPR2015-01103, Paper 22 (P.T.A.B. Oct. 27, 2015).
`In each of its final written decisions, the Board held
`that CFAD had shown by a preponderance of the evidence
`that claims 1–32 of the ’720 patent were unpatentable as
`obvious over the
`instituted ground.
` Coalition for
`Affordable Drugs VI, LLC v. Celgene Corp., No. IPR2015-
`01096, Paper 73 (P.T.A.B. Oct. 26, 2016) (“-01096 Final
`Written Decision”); Coalition for Affordable Drugs VI, LLC
`v. Celgene Corp., No. IPR2015-01102, Paper 75 (P.T.A.B.
`Oct. 26, 2016) (“-01102 Final Written Decision”); Coalition
`for Affordable Drugs VI, LLC v. Celgene Corp., No.
`IPR2015-01103, Paper 76 (P.T.A.B. Oct. 26, 2016) (“-01103
`Final Written Decision”). Following Celgene’s request for
`rehearing, the Board modified its final written decisions to
`uphold the patentability of claim 10 because CFAD failed
`to prove that claim obvious by a preponderance of the
`evidence.
`
`D
` We
`four IPRs.
`Celgene timely appealed all
`consolidated the appeals from the three IPRs on the ’720
`patent (Appeal Nos. 18-1167, 18-1168, 18-1169) and
`designated the appeal from the IPR on the ’501 patent
`(Appeal No. 18-1171) as a companion case. CFAD did not
`participate in these appeals. The Director of the United
`States Patent and Trademark Office (“PTO”) intervened
`pursuant to 35 U.S.C. § 143.
`We have jurisdiction over these appeals pursuant to
`28 U.S.C. § 1295(a)(4)(A).
`
`II
`On appeal, Celgene argues that the Board erred in
`finding all claims of the ’501 patent and claims 1–9 and 11–
`32 of the ’720 patent obvious. Celgene also argues that the
`retroactive application of IPRs to patents filed before
`September 16, 2012, when the relevant provisions of the
`
`
`
`CELGENE CORPORATION v. PETER
`
`9
`
`Leahy-Smith America Invents Act went into effect (“pre-
`AIA patents”), is an unconstitutional taking. We begin by
`addressing the merits of these appeals. Then, because we
`affirm the Board’s obviousness determinations, we turn to
`the constitutional challenge.
`A
`1
`Obviousness is a question of law based on underlying
`factual determinations. Belden Inc. v. Berk-Tek LLC, 805
`F.3d 1064, 1073 (Fed. Cir. 2015). We review the Board’s
`ultimate obviousness determination de novo and
`underlying factual findings for substantial evidence.
`Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016). Substantial evidence is “more than a mere
`scintilla” and means “‘such relevant evidence as a
`reasonable mind might accept as adequate to support a
`conclusion.’” Biestek v. Berryhill, 139 S. Ct. 1148, 1154
`(2019) (quoting Consol. Edison Co. v. NLRB, 305 U.S. 197,
`229 (1938)).
`We review the Board’s determination of the broadest
`reasonable interpretation of the claim language de novo.
`Straight Path IP Grp., Inc. v. Sipnet EU S.R.O., 806 F.3d
`1356, 1360 (Fed. Cir. 2015).8
`
`
`8 We note that the PTO has since changed the claim
`construction standard used in IPR proceedings. See 37
`C.F.R. § 42.100(b); Changes to the Claim Construction
`Standard for Interpreting Claims in Trial Proceedings
`Before the Patent Trial and Appeal Board, 83 Fed. Reg.
`51,340 (Oct. 11, 2018) (to be codified at 37 C.F.R. pt. 42).
`The new standard applies only to petitions filed on or after
`November 13, 2018, and therefore does not impact these
`cases. In these IPRs, the claims were to be construed using
`the broadest reasonable interpretation in light of the
`
`
`
`10
`
`CELGENE CORPORATION v. PETER
`
`2
`We begin with the ’501 patent. Celgene seeks reversal,
`or at
`least vacatur and remand, of the Board’s
`determination that CFAD established by a preponderance
`of the evidence that claims 1–10 would have been obvious
`over the combination of Powell, Mitchell, and Dishman.
`The Board relied on Powell’s teachings of the clinical use
`and dispensing of thalidomide; Mitchell’s description of a
`pregnancy-prevention program
`for women users of
`Accutane, another teratogenic drug; and Dishman’s
`disclosure of a registry for pharmacies, prescribers, and
`users of clozapine, an anti-psychotic drug with serious
`potential side effects. ’501 Final Written Decision at 13.
`The Board determined that a person of ordinary skill in the
`art would have been motivated to combine Powell,
`Mitchell, and Dishman “to address the problem of limiting
`thalidomide access to patients likely to suffer serious
`adverse side effects, including birth defects in a developing
`fetus.” Id. at 24.
`On appeal, Celgene challenges three aspects of the
`Board’s obviousness determination: (1) its finding that the
`prior art satisfies the “computer readable storage medium,”
`limitation, which rises and falls with a claim construction
`argument; (2) its finding that it would have been obvious
`to counsel male patients about the risks of teratogenic
`drugs; and (3) its findings on secondary considerations. We
`address each in turn.
`
`a
`Before the Board, Celgene argued that the term
`“computer readable storage medium” in claim 1 requires a
`centralized computer readable storage medium, namely “a
`centralized database
`that
`includes all registration
`
`specification. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct.
`2131, 2146 (2016).
`
`
`
`CELGENE CORPORATION v. PETER
`
`11
`
`prescribers,
`claimed
`the
`regarding
`information
`pharmacies, and patients.” ’501 Final Written Decision at
`9–10.
` The Board considered Celgene’s proffered
`construction and rejected its argument that the computer
`readable storage medium of claim 1 must be centralized.
`Id. at 10–11. First, the Board noted that the term
`“centralized” does not appear in claim 1. Id. at 10. In
`addition, the Board found that the specification does not
`require that all registration information be centralized in
`one database. Id. (“‘The computer readable storage
`medium in which the pharmacies are registered may be the
`same as, or different from the computer readable storage
`medium in which the prescribers are registered.’” (quoting
`’501 patent col. 4 ll. 54–57)). Finally, the Board considered
`and rejected Celgene’s prosecution history and extrinsic
`evidence arguments. See id. at 10–11.
`On appeal, Celgene again argues that the claims
`require a centralized computer readable storage medium.
`Appeal No. 18-1171, Appellant’s Br. 31–36. According to
`Celgene, the claims’ use of the term “said medium”
`referring back to “a computer readable storage medium”
`indicates that it must be a single, centralized computer
`readable storage medium. Id. at 32. But, as the PTO
`points out, the use of “a” or “an” in an open-ended
`“comprising” claim connotes “one or more.” Appeal No. 18-
`1171, Intervenor’s Br. 26–27; Baldwin Graphic Sys., Inc. v.
`Siebert, Inc., 512 F.3d 1338, 1342 (Fed. Cir. 2008). And
`“[t]he subsequent use of definite articles ‘the’ or ‘said’ in a
`claim to refer back to the same claim term does not change
`the general plural rule, but simply reinvokes that non-
`singular meaning.” Baldwin, 512 F.3d at 1342. Exceptions
`to the general rule that “a” or “an” means more than one
`arise only when “the language of the claims themselves, the
`specification, or the prosecution history necessitate a
`departure from the rule.” See id. at 1342–43.
`Neither the claims themselves, the specification, nor
`the prosecution history necessitate such a departure.
`
`
`
`12
`
`CELGENE CORPORATION v. PETER
`
`See ’501 Final Written Decision at 10–11. The claims recite
`“a computer readable storage medium” and do not specify
`that it is centralized. The specification does not require
`that the computer readable storage medium be centralized.
`In fact, the specification envisions that there may be
`multiple, distinct computer readable storage media, i.e.,
`separate media for prescribers, pharmacies, and patients.
`See ’501 patent at col. 4 ll. 54–57, col. 10 ll. 13–17.
`Further, we are not persuaded by Celgene’s argument
`that the prosecution history disclaimed a non-centralized
`computer readable storage medium. See Appeal No. 18-
`1171, Appellant’s Br. 33–34. We agree with the PTO that
`the better reading of the prosecution history is that
`Celgene distinguished the claimed invention from the prior
`art on the basis that the invention uses a computer
`readable storage medium while the prior art used the
`Internet. See Appeal No. 18-1171, Intervenor’s Br. 31–33.
`Finally, because the intrinsic evidence does not require
`a centralized computer readable storage medium, the
`Board was correct to not allow the extrinsic evidence,
`including expert testimony, to “trump the persuasive
`intrinsic evidence in this case.” ’501 Final Written Decision
`at 10. Under the broadest reasonable interpretation, the
`Board was therefore correct in determining that claim 1
`was not limited to a centralized computer readable storage
`medium.
`Based on the Board’s finding that the computer
`readable storage medium recited in claim 1 need not be
`centralized,
`the Board
`found
`that Dishman’s
`“computerized
`lockout system” satisfied
`the claim
`limitation. Id. at 18–20. Celgene concedes that Dishman
`teaches a decentralized storage medium and does not
`dispute that Dishman satisfies this limitation under the
`Board’s construction. See Appeal No. 18-1171, Appellant’s
`Br. 37. Because Celgene’s challenge relies entirely on its
`
`
`
`CELGENE CORPORATION v. PETER
`
`13
`
`proposed claim construction and we affirm the Board’s
`construction, Celgene’s challenge must fail.9
`For these reasons, Celgene’s arguments on the
`“computer readable storage medium”
`limitation are
`unpersuasive and are not grounds for reversal or vacatur
`and remand.
`
`b
`Claim 1 of the ’501 patent requires providing “male
`patients who are capable of impregnating females” with
`“counseling information concerning the risks attendant to
`fetal exposure to said drug.” Celgene argues that
`counseling male patients about the risks of fetal exposure
`to the drug upon or after fertilization would not have been
`obvious. Appeal No. 18-1171, Appellant’s Br. 25–31.
`In finding this limitation obvious, the Board relied on
`CFAD’s expert Dr. Jeffrey Fudin’s opinion that at the time
`of the alleged invention, “the sperm of male patients could
`be damaged by teratogenic drugs and consequently result
`in birth defects, if the male was to impregnate a female.”
`’501 Final Written Decision at 15–16. For support, Dr.
`Fudin relied on the Mann study, which showed that
`thalidomide had negative effects on the sperm of male
`rabbits and the fetuses resulting from mating with female
`rabbits. See id. at 15–17.
`The Board evaluated Dr. Fudin’s opinion and the
`supporting Mann study and credited his testimony that a
`person of ordinary skill in the art would have “understood
`
`
`9 Even under Celgene’s claim construction, the
`Board determined that its ultimate determination on
`obviousness would not change. ’501 Final Written Decision
`at 11, 20. Specifically, the Board held, in the alternative,
`that using a centralized database would have been obvious.
`See id. at 20.
`
`
`
`14
`
`CELGENE CORPORATION v. PETER
`
`the necessity of counseling males, capable of impregnating
`females, about the risks that attend fetal exposure to a
`teratogenic drug.” Id. at 16–17. The Board acknowledged
`that Powell stated that “[n]o effects on male sperm are
`recognized,” but found that statement alone insufficient to
`defeat Dr. Fudin’s testimony that an ordinarily skilled
`artisan would have recognized that sperm of male patients
`treated with teratogenic drugs could lead to birth defects
`in fetuses. Id. at 17.
`On appeal, Celgene primarily disputes the Board’s
`reading of Powell, specifically the statement that “[n]o
`effects on male sperm are recognized.” See Appeal No. 18-
`1171, Appellant’s Br. 26–29. The Board found that, when
`read in context, this statement in Powell refers to the
`contraceptive effects thalidomide has on male sperm, not
`the teratogenic effects thalidomide has on male sperm. See
`’501 Final Written Decision at 17. Celgene argues that
`“[n]o reasonable fact finder could possibly read” this
`sentence in Powell “as referring to the contraceptive effects
`of thalidomide.” Appeal No. 18-1171, Appellant’s Br. 27.
`But, the Board’s decision on this limitation relied on Dr.
`Fudin’s opinion, supported by Mann, as described above.
`Celgene’s main challenge to Dr. Fudin’s opinion and his
`reliance on Mann was that the Mann study was conducted
`on male rabbits rather than human men. Appeal No. 18-
`1171, Appellant’s Br. 30–31, Reply Br. 7–8. The Board
`considered and rejected this argument. See ’501 Final
`Written Decision at 17 (noting that Celgene previously
`admitted that studies related to rabbit sperm were
`relevant to evaluating the effects of thalidomide on human
`sperm).
` Substantial evidence supports the Board’s
`ultimate determination, based on Dr. Fudin’s opinion as
`supported by Mann, that it would have been obvious in
`light of the prior art to counsel male patients about the
`risks of fetal exposure to the drug.
`
`
`
`CELGENE CORPORATION v. PETER
`
`15
`
`c
`Finally, Celgene challenges the Board’s determination
`that Celgene’s evidence of objective indicia of non-
`obviousness was unpersuasive. The Board considered and
`weighed Celgene’s evidence of long-felt but unmet need,
`industry praise, and unexpected results. Substantial
`evidence supports the Board’s conclusions on each of these
`secondary considerations and its conclusion that they do
`not outweigh the showing of obviousness.
`The Board found that Celgene failed to establish a
`long-felt but unsolved need because it did not show that the
`prior art methods of controlling the distribution of
`hazardous drugs—including Mitchell and Dishman—were
`insufficient to meet any need to control distribution of
`thalidomide. ’501 Final Written Decision at 28. The Board
`acknowledged Celgene’s evidence of industry praise and
`gave it weight. See id. The Board also considered Celgene’s
`evidence of unexpected results but ultimately gave it “little
`weight” because the Board was not persuaded that the
`results obtained by combining the features of the prior art
`drug distribution programs to control distribution of
`thalidomide would have been truly unexpected. See id. at
`28–29. The Board concluded that the evidence of secondary
`considerations did not outweigh the strong showing of
`obviousness. See id. at 29.
`On appeal, Celgene challenges the Board’s findings on
`unexpected results and long-felt need. Appeal No. 18-1171,
`Appellant’s Br. 38–41, Reply Br. 16–23. On unexpected
`results, Celgene faults the Board’s decision to give its
`evidence “little weight” and argues that it should have been
`given “significant, if not dispositive weight.” Appeal No.
`18-1171, Appellant’s Br. 39–40. However, substantial
`evidence supports the Board’s assessment and weighing of
`this evidence, and we decline to reweigh the evidence on
`appeal. See In re NTP, Inc., 654 F.3d 1279, 1292 (Fed. Cir.
`2011) (“This court does not reweigh evidence on appeal, but
`
`
`
`16
`
`CELGENE CORPORATION v. PETER
`
`rather determines whether substantial evidence supports
`the Board’s fact findings.”); Regents of the Univ. of Cal. v.
`Broad Inst., Inc., 903 F.3d 1286, 1294 (Fed. Cir. 2018) (“We
`do not reweigh the evidence. It is not our role to ask
`whether substantial evidence supports fact-findings not
`made by the Board, but instead whether such evidence
`supports the findings that were in fact made.”).
`On long-felt need, Celgene identifies what it contends
`is an “inconsisten[cy]” between the Board’s determination
`in this IPR on the ’501 patent and the IPRs on the ’720
`patent. Appeal No. 18-1171, Reply Br. 22–23. In this case,
`the Board found no long-felt but unmet need for a better
`system to distribute potentially hazardous drugs like
`thalidomide in part because existing systems were
`available and adequate. ’501 Final Written Decision at 28.
`As explained below, in the IPRs on the ’720 patent, the
`Board found that there was a motivation to improve
`existing distribution systems for potentially hazardous
`drugs because of the severity of the possible adverse effects.
`See, e.g., -01096 Final Written Decision at 22–23.
`Contrary to Celgene’s assertion, this tension is not
`irreconcilable. The fact that there is no long-felt, unmet
`need does not necessarily mean that there is no motivation
`to improve a system. See Spectrum Pharm., Inc. v. Sandoz
`Inc., 802 F.3d 1326, 1336 (Fed. Cir. 2015) (upholding
`district court’s finding that “despite the motivation . . .
`there was not a long-felt but unmet need”). In fact, Celgene
`stated that it was “committed to making the S.T.E.P.S.
`program succeed and will make any modifications to the
`program that are necessary to ensure its effectiveness.”
`See Appeal No. 18-1167, J.A. 501. Especially in this
`context involving safety, we see no conflict between finding
`a motivation to improve the safety of existing systems even
`though the existing systems were mostly successful. We
`conclude that substantial evidence supports the Board’s
`assessment of Celgene’s evidence of long-felt, unresolved
`need.
`
`
`
`CELGENE CORPORATION v. PETER
`
`17
`
`Finally, we see no error in the Board’s ultimate
`determination of obviousness. Before concluding that the
`claims would have been obvious, the Board weighed the
`“strong showing of obviousness” against the “appropriate
`weight” given to evidence of industry praise and the “little
`weight” given to evidence of unexpected results. ’501 Final
`Written Decision at 28–29.
`We therefore affirm the Board’s holding that claims 1–
`10 of the ’501 patent are unpatentable as obvious over the
`asserted prior art.
`
`3
`Turning to the ’720 patent, Celgene seeks reversal, or
`at least vacatur and remand, of the Board’s determinations
`that CFAD established by a preponderance of the evidence
`that claims 1–9 and 11–32 would have been obvious over
`the prior art. The Board’s analysis relevant to this appeal
`was nearly identical across all three proceedings. See -
`01096 Final Written Decision at 15–26; -01102 Final
`Written Decision at 16–27; -01103 Final Written Decision
`at 16–27; see also Appeal No. 18-1167, Appellant’s Br. 27,
`Intervenor’s Br. 26.
`On motivation, the Board determined that a person of
`ordinary skill in the art would have been motivated to
`improve the existing distribution methods of potentially
`hazardous drugs because “where significant safety risks
`exist with a drug, one would continuously search for safer
`ways to control the distribution of the drug.” -01096 Final
`Written Decision at 22–23; -01102 Final Written Decision
`at 24–25; -01103 Final Written Decision at 24–25.
`The Board construed the claim term “prescription
`approval
`code” and adopted Celgene’s proposed
`construction: “[A] code representing that an affirmative
`risk assessment has been made based upon risk-group
`assignment and the information collected from the patient,
`and that is generated only upon a determination that the
`
`
`
`18
`
`CELGENE CORPORATION v. PETER
`
`risk of a side effect occurring is acceptable.” -01096 Final
`Written Decision at 12–13; -01102 Final Written Decision
`at 13; -01103 Final Written Decision at 13.
`The Board then considered whether the prior art
`taught the
`following disputed
`limitation: “upon a
`determination that said risk is acceptable, generating a
`prescription approval code to be retrieved by said
`pharmacy before said prescription is filled.” The Board
`determined that it would have been obvious to a person of
`ordinary skill in the art because they would have
`appreciated that Cunningham’s approval code, used to
`track and manage trial pharmaceutical products, could
`likewise be used by prescribers and pharmacies to track
`and manage prescription pharmaceutical products. -01096
`Final Written Decision at 24; -01102 Final Written Decision
`at 26; -01103 Final Written Decision at 26. The Board
`concluded that:
`We further hold that the claimed improvement
`recited in the challenged claims represents a
`combination of known prior art elements
`(identifying patient risk groups, collecting patient
`information relating to the risk, determining
`whether the risk is acceptable, and controlling
`dispensation of the drug using both a prescription
`and an approval code) for their known purpose
`(control distribution of drug) to achieve a
`predictable result (avoid giving patients drugs that
`have an unacceptable risk of side effects).
`-01096 Final Written Decision at 24–25; -01102 Final
`Written Decision at 26; -01103 Final Written Decision at 26.
`On appeal, Celgene challenges two aspects of the
`Board’s obviousness determination: (1) its finding that
`there was a motivation to improve the existing distribution
`methods of potentially hazardous drugs; and (2) its finding
`that a person of skill in the art would have been motivated
`to develop the claimed invention. We address each below.
`
`
`
`CELGENE CORPORATION v. PETER
`
`19
`
`a
`Celgene first argues that there was no motivation to
`improve the existing method for avoiding birth defects from
`exposure to thalidomide (the Original S.T.E.P.S. program)
`because it was working so well that there had been no
`reports of birth defects or even potential fetal exposure to
`thalidomide using that system. Appeal No. 18-1167,
`Appellant’s Br. 32–33, 35–37. Celgene contends that
`because there were no problems with the Original
`S.T.E.P.S. program, a person skilled in the art would not
`have been motivated to improve it. See id. Celgene
`essentially argues that there was no motivation because,
`“[i]f it ain’t broke, don’t fix it.” Id. at 33.
`The Board consider