Trials@uspto.gov
`571-272-7822
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` Paper 8
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` Entered: April 4, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`3M COMPANY,
`Patent Owner.
`____________
`
`Case IPR2015-02002
`Patent 6,743,413 B1
`____________
`
`
`
`Before LORA M. GREEN, RAMA G. ELLURU, and
`ELIZABETH A. LAVIER, Administrative Patent Judges.
`
`LAVIER, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`

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`IPR2015-02002
`Patent 6,743,413 B1
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`I.
`INTRODUCTION
`Petitioner, Mylan Pharmaceuticals Inc. (“Mylan”), filed a Petition
`requesting an inter partes review of claims 1–24 of U.S. Patent No.
`6,743,413 B1 (“the ’413 patent”; Ex. 1001). Paper 2 (“Pet.”). Patent
`Owner, 3M Company (“3M”), filed a Preliminary Response (Paper 7
`(“Prelim. Resp.”)), indicating 3M filed a statutory disclaimer of claims 1–13,
`20, and 21. Prelim. Resp. 1 (citing Ex. 2007). We have jurisdiction under
`35 U.S.C. § 314, which provides that an inter partes review may not be
`instituted unless the information presented in the petition “shows that there
`is a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`For the reasons set forth below, on this record we find that Mylan has
`established a reasonable likelihood of prevailing with respect to at least one
`of the remaining challenged claims of the ’413 patent. Accordingly, we
`institute an inter partes review of claims 14–19 and 22–24 of the ’413
`patent.1
`
`A. The ’413 Patent
`The ’413 patent is titled “Suspension Aerosol Formulations.” Ex.
`1001, at [54]. The Specification states: “[t]he term ‘suspension aerosol
`formulation’ as used herein refers to a formulation in which the drug is in
`particulate form and is substantially insoluble in the propellant.” Id. at 3:26–
`
`
`1 We do not institute review of the disclaimed claims. See 37 C.F.R.
`§ 42.107(e).
`
`2
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`28. One of the disclosed propellants is 1,1,1,2-tetrafluoroethane, also known
`as “hydrofluorocarbon 134a” or “HFC 134a.” Id. at 1:29–30. The ’413
`patent explains that HFC 134a is an ozone-friendlier alternative to
`chlorofluorocarbon (CFC) propellants. Id. at 1:29–34.
`
`B. Illustrative Claim
`The non-disclaimed claims are all method of treatment claims.
`Claims 14, 17, and 22 are independent. Claim 14 is illustrative of the
`challenged claims and is reproduced below:
`14. A method of treating a mammal having a condition
`capable of treatment by inhalation, comprising the step of:
`
`administering by inhalation a formulation suitable for
`aerosol administration, wherein
`the formulation consists
`essentially of:
`
`(i) particulate drug; and
`
`(ii) 1,1,1,2-tetrafluoroethane as propellant,
`
`wherein the formulation is substantially free of surfactant.
`
`Ex. 1001, 16:66–17:7.
`
`C. Asserted Grounds of Unpatentability
`Mylan asserts the following grounds of unpatentability as to the non-
`disclaimed claims:
`
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`Challenged Claims
`
`14–19, 22–243
`
`14–19, 22–246
`
`15, 18, 237
`
`16, 19, 249
`
`Basis2
`§ 102(a)
`or (b)4
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`Reference(s)
`
`’011 publication5
`
`’011 publication
`’011 publication and ’051
`patent8
`’011 publication and
`Weir10
`
`
`2 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112–29, took effect on March 16, 2013. Because the application
`from which the ’413 patent issued was filed before that date, our citations to
`Title 35 are to its pre-AIA version.
`3 See Pet. 10–27.
`4 Mylan asserts that the ’011 publication qualifies as prior art under
`35 U.S.C. § 102(b) because the earliest priority date to which the ’413 patent
`is entitled is May 4, 1992. See Pet. 10; see also id. at 2–5. In the alternative,
`if the ’413 patent is entitled to an earlier filing date (of December 18, 1991),
`Mylan asserts the ’011 publication nonetheless qualifies as prior art under
`§ 102(a). See id. at 2, 10. 3M does not contest the priority date issue at this
`stage of the proceeding. As the ’011 publication is available as prior art in
`either case, we need not reach this issue at this time.
`5 PCT International Publication WO 91/04011, published Apr. 4, 1991 (Ex.
`1007).
`6 See Pet. 28–41.
`7 See id. at 39–41.
`8 Hunt et al., U.S. Patent No. 4,866,051, issued Sept. 12, 1989 (Ex. 1009).
`9 See Pet. 39–41.
`10 Weir et al., Corticosteroid Trials in Non-Asthmatic Chronic Airflow
`Obstruction: A Comparison of Oral Prednisolone and Inhaled
`Beclomethasone Dipropionate, 45 THORAX 112–17 (1990) (Ex. 1010).
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`IPR2015-02002
`Patent 6,743,413 B1
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`Challenged Claims
`14, 20–2211
`
`Basis2
`§ 102(b)12
`
`Reference(s)
`’333 publication13
`
`14–19, 22–2414
`
`§ 103(a)
`
`’333 publication
`
`15, 18, 2315
`
`§ 103(a)
`
`’333 publication and ’051
`patent
`
`§ 103(a)
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`16, 19, 2416
`
`In support of its contentions, Mylan relies on the Declaration of Dr.
`Hugh Smyth (Smyth Declaration) (Ex. 1006).17
`
`’333 publication and Weir
`
`
`11 See Pet. 41–50.
`12 Mylan asserts that the ’333 publication qualifies as prior art under
`§ 102(b) regardless of the priority date issue noted above. Pet. 41–42.
`13 PCT International Publication WO 90/07333, published July 12, 1990 (Ex.
`1011).
`14 See Pet. 50–58.
`15 See id. at 57–58.
`16 See id.
`17 3M asserts that Dr. Smyth’s testimony should be given little or no weight
`because Dr. Smyth “had not even finished college” at the time of the
`invention and thus was not a person of ordinary skill in the art at the relevant
`time. Prelim. Resp. 31. 3M cites no authority for the proposition that an
`expert must have been a person of ordinary skill in the art at the time of the
`invention, and we are not persuaded that Dr. Smyth’s age relative to the ’413
`patent is dispositive of his qualifications. See Fed. R. Evidence 702 (stating
`that an expert witness may be qualified by “knowledge, skill, experience,
`training, or education”).
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`II.
`CLAIM CONSTRUCTION
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`of the specification of the patent in which they appear. See In re Cuozzo
`Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed. Cir. 2015), cert. granted
`sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016);
`37 C.F.R. § 42.100(b). Under that standard, and absent any special
`definitions, we give claim terms their ordinary and customary meaning, as
`would be understood by one of ordinary skill in the art at the time of the
`invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). The level of ordinary skill in the art is reflected by the prior art of
`record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`Mylan states that no terms require specific construction (Pet. 7), but
`we agree with 3M (Prelim. Resp. 11–14) that three phrases benefit from
`express constructions at this time. Our constructions are not final.
`
`A. “formulation consisting essentially of particulate drug”
`Each of independent claims 14, 17, and 22 recites some variation of
`the phrase “formulation consisting essentially of particulate drug.” See
`generally Ex. 1001, 16:66–18:20. 3M asserts that the broadest reasonable
`interpretation of this term is that “it refers to suspension formulations in
`which drug particles are dispersed, rather than dissolved, in the propellant.”
`Prelim. Resp. 11–12. For support, 3M points to the express definition of
`“suspension aerosol formulation” in the ’413 patent noted above, i.e., “a
`formulation in which the drug is in particulate form and is substantially
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`insoluble in the propellant.” Id.; Ex. 1001, 3:26–28. On this record, we
`agree with 3M that this definition from the ’413 patent informs the type of
`formulation encompassed by the claims. Accordingly, we construe
`“formulation consisting essentially of particulate drug” to include
`formulations in which the particulate drug is substantially insoluble in the
`propellant, and to exclude formulations in which the drug is substantially
`soluble in the propellant.
`
`B. “stabilizing amount of surfactant”
`Claims 17 and 22 both recite that the formulation either lacks
`surfactant altogether,18 or contains “less than a stabilizing amount of
`surfactant.” Ex. 1001, 17:24–25, 18:25–26. The ’413 patent offers little
`guidance as to the meaning of “stabilizing amount.” Indeed, from our
`review, this term appears only once outside the claims:
`The formulations of the invention that consist essentially
`of drug and a propellant contain drug and propellant in relative
`amounts such
`that a
`formulation suitable
`for aerosol
`administration is obtained without the need for additional
`components. Such formulations preferably contain less than an
`effective stabilizing amount of surfactant and more preferably
`are substantially free of surfactant and other components.
`
`Id. at 3:33–40 (emphasis added). 3M proffers statements from other
`sources, including cited prior art, to conclude that “[t]he ordinary meaning of
`the term ‘stabilizing amount’ is an amount of surfactant that improves a
`
`18 In this regard, claim 17 recites “no surfactant,” while claim 22 recites
`“free of surfactant.” Ex. 1001, 17:24–25, 18:25–26.
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`measure of stability relative to a formulation that lacks surfactant
`altogether.” Prelim. Resp. 13. We agree with 3M that this ordinary meaning
`of the claim language captures the usage in the ’413 patent cited above. For
`purposes of this Decision, we need not seek numeric bounds of the scope of
`“stabilizing amount” to appreciate its functional contours. See Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (observing
`that claim terms need be construed “only to the extent necessary to resolve
`the controversy”). Thus, we construe “stabilizing amount of surfactant” to
`mean “an amount of surfactant that improves a measure of stability relative
`to a formulation that lacks surfactant altogether.”
`
`C. “substantially free of surfactant”
`Claim 14 recites that “the formulation is substantially free of
`surfactant.” Ex. 1001, 17:6–7. 3M reasons that “the amount of surfactant in
`a formulation that is ‘substantially free of surfactant’ necessarily must be
`less than ‘an effective stabilizing amount of surfactant.’” Prelim. Resp. 14
`(citing Ex. 1001, 3:33–40). We agree that “substantially free” is less than
`“an effective stabilizing amount” of surfactant, as this relationship is implied
`by how these terms are used in the Specification:
`The formulations of the invention that consist essentially of drug
`and a propellant contain drug and propellant in relative amounts
`such that a formulation suitable for aerosol administration is
`obtained without the need for additional components. Such
`formulations preferably contain less than an effective stabilizing
`amount of surfactant and more preferably are substantially free
`of surfactant and other components.
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`Ex. 1001, 3:33–40 (emphasis added). As with our discussion above
`regarding “stabilizing amount,” we need not explore the numerical contours
`of “substantially free,” except that as to the lower end, we note that it
`encompasses no surfactant.
`
`III. ANALYSIS
`Mylan’s asserted grounds of unpatentability fall into two groups: (1)
`those grounds relying in whole or in part on the ’011 publication, and (2)
`those grounds relying in whole or in part on the ’333 publication. Because
`Mylan addresses claims 1–24 in its Petition, some of the arguments it
`presents for claims 14–19 and 22–24 refer back to the now-disclaimed
`claims. Accordingly, some of our analysis likewise refers to arguments
`made most thoroughly by Mylan in regard to disclaimed claims.
`
`A. Challenges Based on the ’011 Publication
`
`1. The ’011 Publication
`The ’011 publication, entitled “Medicinal Aerosol Formulations,”
`particularly describes substantially CFC-free formulations for pulmonary,
`nasal, buccal, or topical administration. Ex. 1007, at [54], 1:2–6. The ’011
`publication notes the widespread use of pressurized inhalers to deliver
`bronchodilator drugs and steroids to asthmatic patients, as well as more
`recent use of inhalers with other drugs, for uses beyond “treatment of a
`bronchial malady.” Id. at 1:7–17. The ’011 publication notes that “[f]or
`best results, the concentration of the surface-active agent is kept at a
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`minimum as it may tend to increase the droplet size and the tendency for
`particle agglomeration.” Id. at 7:36–37.
`Example 1 of the ’011 publication reports results from tests of eight
`aerosol formulations, each comprising a drug, a surfactant, and HFC 134a.19
`See id. at 12:13–24, 14 (Table). As a control, each formulation, without the
`surfactant, was prepared according to the same procedure as the test
`formulations. See id. at 12:15–17. To compare each test formulation with
`its respective control formulation, Example 1 provides the “Drug Deposition
`Potential,” calculated by dividing the average weight of drug deposits from
`the test formulation by the average weight of drug deposits from the control
`formulation. Id. at 13:17–20. The ’011 publication explains that “[a] value
`of less than 1.0 for the drug deposition potential indicates an improvement
`due to the pre-coating of the micronised drug particles with the surfactant.”
`Id. at 22–24. The table from Example 1 is reproduced below:
`
`
`19 The ’011 publication refers to 1,1,1,2-tetrafluoroethane simply as
`“Propellant 134a.” Ex. 1007, 2:6–7. For consistency, we use “HFC 134a,”
`unless directly quoting a source.
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`The table from Example 1 of the ’011 publication presents the drug
`deposition potential calculations for each of eight test formulations.
`
`2. Anticipation – ’011 Publication
`“Anticipation requires the presence in a single prior art disclosure of
`all elements of a claimed invention arranged as in the claim.” SynQor, Inc.
`v. Artesyn Techs., Inc., 709 F.3d 1365, 1375 (Fed. Cir. 2013) (quoting
`Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)).
`Nonetheless, “a reference can anticipate a claim even if it ‘d[oes] not
`expressly spell out’ all the limitations arranged or combined as in the claim,
`if a person of skill in the art, reading the reference, would ‘at once envisage’
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`the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll
`Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (quoting In re
`Petering, 301 F.2d 676, 681 (CCPA 1962)); see also In re Preda, 401 F.2d
`825, 826 (CCPA 1968) (noting that “in considering the disclosure of a
`reference, it is proper to take into account not only specific teachings of the
`reference but also the inferences which one skilled in the art would
`reasonably be expected to draw therefrom”). Unlike obviousness, “teaching
`away” is not part of the anticipation analysis. See Celeritas Techs., Ltd. v.
`Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998) (“A reference is
`no less anticipatory if, after disclosing the invention, the reference then
`disparages it.”).
`
`a. Independent Claims (14, 17, 22)
`As shown in the table reproduced above from Example 1 of the ’011
`publication, Formulations 7 and 8 showed drug deposition potentials of 0.92
`and 0.85, respectively. Ex. 1007, 14. Mylan argues that these values, being
`only slightly less than 1, indicate that Formulations 7 and 8 did not perform
`much better than their surfactant-free controls.20 See Pet. 14; see also
`28–29. Thus, according to Mylan, “the inclusion of the surfactant in these
`formulations resulted in minor, if any, changes between the control
`
`
`20 Mylan argues “these values are likely not statistically different.” Pet. 14
`(citing Ex. 1006 ¶¶ 41–42). Whether the differences are minor or non-
`existent, Mylan’s point is the same: “the Salbutamol B.P. and Salbutamol
`Sulphate B.P. ‘control’ formulations were almost as successful, if not as
`successful, as the surfactant-containing formulations.” Id.
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`formulations and the surfactant formulations.” Id. at 14. At this stage of the
`proceeding, we are persuaded by Mylan’s interpretation of the data for
`Formulations 7 and 8 in Example 1 of the ’011 publication. The controls for
`Formulations 7 and 8 each consists essentially of a drug and HFC 134a as a
`propellant, and contains no surfactant, as recited in the formulations used in
`the methods of claims 17 and 22. And because a formulation containing no
`surfactant falls within the category of “substantially free of surfactant,” the
`formulation used in the method of claim 14 is satisfied as well.21, 22
`
`
`21 Mylan expressly argues unpatentability over the control formulations for
`independent claims 17 and 22, but not for independent claim 14. Compare
`Pet. 22–25 (claims 17, 22 (referring back to analysis for claims 1 and 6)),
`with id. at 21. As our construction of “substantially free of surfactant”
`includes no surfactant, the surfactant-free controls of Formulations 7 and 8
`of the ’011 publication necessarily satisfy that limitation of claim 14.
`Accordingly, we consider Mylan’s arguments based on the controls for
`Formulations 7 and 8 of the ’011 publication as applicable to claim 14 and
`its dependents as well. The asserted ground of unpatentability is still the
`same for claim 14; only the rationale has changed. Cf. Cuozzo, 793 F.3d at
`1275 (declining mandamus review, inter alia, because “[i]t is not clear that
`IPR is strictly limited to the grounds asserted in the petition”).
`22 For claim 14, Mylan also argues that Formulation 1 (i.e., the test, not the
`control) is “substantially free of surfactant” because it only contains 0.001%
`w/v surfactant. See Pet. 21; see also id. at 18–19. As 3M points out,
`however, the drug deposition potential of 0.64 calculated for Formulation 1
`indicates that even the small amount of surfactant (0.001% w/v) was
`sufficient to stabilize that formulation. See Prelim. Resp. 20–21. Therefore,
`Formulation 1 is not “substantially free of surfactant” under our construction
`of the term. Accordingly, we do not consider further Mylan’s arguments
`premised on the test formulation for Formulation 1, as to any of the claims.
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`3M does not appear to dispute that the control formulations from
`Example 1 of the ’011 publication satisfy the formulation-based limitations
`of the challenged method claims, acknowledging that “[d]etermining the
`Drug Deposition Potential requires the preparation of surfactant-free
`formulations as control formulations.” Prelim. Resp. 16 (discussing Ex.
`1007, 12–14). Further, 3M does not appear to dispute Mylan’s arguments,
`which we find persuasive on this record (see Pet. 22–25), that Example 1 of
`the ’011 publication also discloses the other recited features of the
`formulations administered in claims 17 and 22, such as the redispersibility
`recited in claim 17 or the plurality of doses, per se, of claim 22.
`Rather, 3M argues that the ’011 publication “does not teach treating a
`mammal with any of the surfactant-free control formulations. In fact, the
`opposite is true: by designating a formulation as a control, the [’011
`publication] instructs persons of ordinary skill not to use the surfactant-free
`formulations to treat mammals.” Prelim. Resp. 16; see also id. at 18. 3M’s
`point is well taken with respect to those formulations from Example 1 in
`which the addition of surfactant materially improved the formulation (as
`indicated by a low drug deposition potential), as the logical inference would
`be to use the surfactant-containing formulations for treatment. But 3M’s
`argument loses its force with respect to the higher-performing controls for
`Formulations 7 and 8. The designation of these surfactant-free formulations
`as “controls” does not undermine their performance, nor, by extension, their
`suitability for therapeutic use. Thus, in view of the ’011 publication’s
`teaching that surfactants should be kept to a minimum, and given the
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`performance of the surfactant free “control” preparations for Formulations 7
`and 8, on this record, we find that an ordinary artisan would at once
`understand, see Kennametal, 780 F.3d at 1381, that the surfactant-free
`Formulations 7 and 8 of Example are suitable for therapeutic use, in light of
`the ’011 publication’s general teaching of using inhalers for drug delivery.
`3M also relies on a statement in the ’011 publication calling the
`surfactant-free formulations “unsatisfactory preparations.” Id. at 16 (quoting
`Ex. 1007, 16:43). This argument is unavailing, because that statement was
`made in the specific context of the formulations tested in Example 3, in
`which HFC 134a was mixed with perfluoropentane (as an
`adjuvant/propellant). See Ex. 1007, 16:9–45. The Example 3 formulations
`are not the same as those from Example 1, which do not contain
`perfluoropentane.
`Accordingly, we conclude that Mylan has shown a reasonable
`likelihood of prevailing at trial in demonstrating the unpatentability of
`claims 14, 17, and 22 as anticipated by the ’011 publication.
`
`b. Dependent Claims (15, 16, 18, 19, 23, 24)
`The dependent claims further specify that the conditions capable of
`treatment are asthma (claims 15, 18, 23) or chronic obstructive pulmonary
`disease (COPD) (claims 16, 19, 24). As noted above, the ’011 publication
`specifically discusses use of inhaled drugs to treat asthma, and further states
`that inhalers can be used to treat other types of maladies, bronchial or
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`otherwise.23 See Ex. 1007, 1:7–17. At this stage of the proceedings, we are
`persuaded that the ’011 publication teaches treating asthma or COPD such
`that Mylan is reasonably likely to prevail at trial in demonstrating the
`unpatentability of claims 15, 16, 18, 19, 23, and 24 as anticipated by the
`’011 publication.
`
`3. Obviousness – ’011 Publication
`A claim is unpatentable for obviousness if, to one of ordinary skill in
`the pertinent art, “the differences between the subject matter sought to be
`patented and the prior art are such that the subject matter as a whole would
`have been obvious at the time the invention was made.” 35 U.S.C. § 103(a)
`(2006); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406–07 (2007).
`While “prior art references that anticipate a claim will usually render that
`claim obvious,” anticipation and obviousness are different inquiries.
`Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir.
`2008). As is relevant here, for example, whether a reference “teaches away”
`from the claimed invention is a “significant factor” for obviousness. In re
`Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
`
`
`23 Mylan also avers that “[b]eclomethasone dipropionate, in aerosol form, is
`used for the treatment of both asthma and COPD.” Pet. 27 (citing Ex. 1006
`¶¶ 79–80). Beclomethasone dipropionate is the drug used in Formulation 1
`of Example 1 of the ’011 publication. As discussed herein, however, we
`conclude that the amount of surfactant present in Formulation 1, while small,
`is nonetheless sufficient to exclude it from the scope of the challenged
`claims. Mylan does not appear to assert in its Petition that the surfactant-
`free control of Formulation 1 is sufficiently effective for therapeutic use.
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`3M argues that the ’011 publication teaches away from using
`surfactant-free formulations, by using them only as controls and by declaring
`them “unsatisfactory” for administration. See Prelim. Resp. 22–26 (citing
`’011 publication, 16:42–45). But, as explained above, the “unsatisfactory
`preparation” statement appears in the context of the formulations of
`Example 3, which contain perfluoropentane as a propellant in addition to
`HFC 134a. Moreover, the ’011 publication specifically teaches that best
`results are achieved when the concentration of the surface-active agent is
`kept at a minimum. Ex. 1007, 7:36–37.
`3M also maintains that despite the “alleged lack of statistical
`difference between certain surfactant-free control and surfactant-containing
`formulations,” one of ordinary skill in the art would nonetheless been
`dissuaded by these differences from administering a surfactant-free control
`because “the ’011 PCT application relied on the difference in performance
`between the two types of formulations, further emphasizing the need for a
`surfactant,” to support patentability. Prelim. Resp. 25. On this record, we
`do not find this reasoning persuasive. As discussed above, the surfactant-
`free controls for Formulations 7 and 8 of Example 1 performed as well or
`almost as well as the test formulations. The slight improvement (if any) to
`be had from adding the surfactant would not have discouraged one of
`ordinary skill in the art from using the surfactant-free formulations. See
`Gurley, 27 F.3d at 553 (“A known or obvious composition does not become
`patentable simply because it has been described as somewhat inferior to
`some other product for the same use.”). Similarly, 3M’s argument
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`
`notwithstanding (see Prelim. Resp. 30–32), the motivation to use the
`surfactant-free controls of Formulations 7 and 8 for treatment would have
`been a matter of interpreting the data from Example 1, not hindsight.
`For these reasons and those described in conjunction with our
`anticipation analysis, we conclude that Mylan has shown a reasonable
`likelihood of prevailing at trial in demonstrating the unpatentability of
`claims 14–19 and 22–24 as obvious over the ’011 publication.
`
`4. Obviousness – ’011 Publication and Either ’051 Patent or Weir
`As discussed above with respect to anticipation, dependent claims 15,
`18, and 23 specify treatment of asthma, and claims 26, 19, and 24 specify
`treatment of COPD. In addition to asserting that these claims are anticipated
`by, and obvious over, the ’011 publication, Mylan cites these additional
`references for the propositions that beclomethasone dipropionate (the drug
`used in Formulation 1 of Example 1 of the ’011 publication) was known for
`the treatment of asthma (’011 publication) and COPD (Weir) via inhalation.
`As discussed above in footnote 22, Formulation 1 of Example 1 of the
`’011 publication falls outside the scope of “substantially free of surfactant,”
`so Mylan cannot rely on it as a basis for arguing that the claims are obvious.
`As to the surfactant-free control for Formulation 1 (i.e., beclomethasone
`dipropionate and HFC 134a, with no surfactant), Mylan does not appear to
`argue that the drug deposition potential for Formulation 1 (i.e., 0.64) is high
`enough to indicate that the surfactant-free control performed well enough
`against the test formulation to consider it for therapeutic use. Because of
`this missing link in the argument, further references to support the use of
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`beclomethasone dipropionate for the treatment of asthma or COPD are of no
`help to Mylan.
`Accordingly, we decline to institute review of claims 15, 18, and 23 as
`obvious over the ’011 publication and the ’051 patent, or of claims 16, 19,
`and 24 over the ’011 publication and Weir.
`
`B. Challenges Based on the ’333 Publication
`
`1. The ’333 Publication
`The ’333 publication describes aerosol formulations of fentanyl (or its
`derivatives), either dissolved or dispersed in propellant, for administration
`by inhalation. Ex. 1011, at [57], 2. In addition, the ’333 publication states
`that the formulation “optionally” includes a cosolvent, and “may
`additionally comprise” surfactant(s).24 Id. at 2. HFC 134a is listed as
`among the “wide range of propellants” that can be used. Id. at 3. Among
`other similarities, the ’333 publication shares a co-inventor with the ’011
`publication, as well as some of its introductory disclosure. Compare Ex.
`1007, at [75], with Ex. 1011, at [75]; compare Ex. 1007, 1:7–17, with Ex.
`1011, 1.
`
`2. Anticipation – ’333 Publication
`Mylan directs us to no specific formulation in the ’333 publication
`including HFC 134a but lacking (or being “substantially free of”) surfactant.
`
`
`24 The ’333 publication uses the term “surface active agents” rather than
`“surfactants.” The terms are analogous. See, e.g., Ex. 1011, 4.
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`The statement Mylan cites indicating the optionality of surfactants (see Pet.
`43 (citing Ex. 1011, 2; Ex. 1006 ¶ 84)) does not provide the “disclosure of
`all elements of a claimed invention arranged as in the claim,” SynQor, 709
`F.3d at 1375, required for anticipation. See In re Arkley, 455 F.2d 586, 587–
`88 (CCPA 1972) (“[P]icking and choosing may be entirely proper in the
`making of a 103, obviousness rejection . . . but it has no place in the making
`of a 102, anticipation rejection.”). Accordingly, we decline to institute
`review of any of the challenged claims based on anticipation over the ’333
`publication.
`
`3. Obviousness – ’333 Publication
`In contrast to anticipation, “picking and choosing” can be appropriate
`for an obviousness challenge. Stated differently, the fact that the prior art
`“discloses a multitude of effective combinations does not render any
`particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs.,
`Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
`
`a. Independent Claims (14, 17, 22)
`Mylan argues that the ’333 publication, in indicating the optionality of
`both cosolvent and surfactant, teaches that “the only materials that the
`formulation must contain are the fentanyl derivative and the propellant.”
`Pet. 43 (citing Ex. 1011, 2; Ex. 1006 ¶ 84). Thus, Mylan argues that “[t]he
`base limitations of every claim—i.e., making an aerosol formulation using a
`particulate drug, using 1,1,1,2-tetrafluoroethane as a propellant, and having a
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`surfactant-free . . . formulation—would have been obvious in light of the
`’333 publication.”25,26 Id. at 50–51 (citing Ex. 1006 ¶ 190).
`Mylan further argues that the effective amounts/doses, such as those
`recited in claims 17 and 22, would have been obvious given the ’333
`publication’s teaching of the drug’s “specific activity.” Pet. 53 (citing Ex.
`1011, 7; Ex. 1006 ¶ 200). For the dispersibility/flocculation element of
`claim 17, Mylan notes the ’333 publication’s emphasis on keeping the
`aerosol formulation in solution (Pet. 54 (citing Ex. 1011, 6)) and asserts that
`controlling for dispersibility and flocculation would have been a matter of
`“routine experimentation,” by controlling particle size, for example, as
`
`25 As with its challenges based on the ’011 publication, Mylan does not
`expressly argue claim 14 based on surfactant-free formulations in the ’333
`publication. See Pet. 47–48 (anticipation), 50–51 (obviousness). Again, as
`our construction of “substantially free of surfactant” includes no surfactant,
`we consider Mylan’s surfactant-free arguments made in regard to claims 17
`and 21 as applicable to claim 14 and its dependents as well.
`26 Mylan also challenges the patentability of the claims based on
`formulations in the ’333 publication including small amounts of surfactant
`such as 0.001% that Mylan argues would be considered “substantially free
`of surfactant.” See Pet. 50–51; see also id. at 47. This argument fails for
`essentially the same reasons as described above with regard