Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 14
`
` Entered: July 1, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LOWER DRUG PRICES FOR CONSUMERS, LLC,
`Petitioner,
`
`v.
`
`FOREST LABORATORIES HOLDINGS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2016-00379
`Patent 6,545,040 B1
`____________
`
`
`Before MICHAEL P. TIERNEY, LORA M. GREEN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 14
`
` Entered: July 1, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LOWER DRUG PRICES FOR CONSUMERS, LLC,
`Petitioner,
`
`v.
`
`FOREST LABORATORIES HOLDINGS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2016-00379
`Patent 6,545,040 B1
`____________
`
`
`Before MICHAEL P. TIERNEY, LORA M. GREEN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`
`
`INTRODUCTION
`
`Lower Drug Prices for Consumers, LLC (“Petitioner”) filed a
`Corrected Petition requesting an inter partes review of claims 1–6 of U.S.
`Patent No. 6,545,040 B1 (Ex. 1001, “the ’040 patent”). Paper 6 (“Pet.”).
`Forest Laboratories Holdings Limited (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 12 (“Prelim. Resp.”).
`We have jurisdiction under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
`the Petition and Preliminary Response, we conclude that the Petition
`presents substantially the same art and arguments as those previously
`presented to the Office, and, therefore, exercise our discretion under 35
`U.S.C. § 325(d) to deny the Petition.
`Related Proceedings
`A.
`The parties identify several district court proceedings as relating to the
`’040 patent, all of which are now closed. Pet. 59; Paper 5, 1.
`Patent Owner also states the ’040 patent was the subject of ex parte
`reexamination proceeding 90/008,356, which is concluded. Paper 5, 2.
`The ’040 Patent
`B.
`The ’040 patent relates to a certain class of isomers of 2,2ꞌ-
`iminobisethanol derivatives having β-adrenergic blocking properties that
`potentiate the activity of blood pressure reducing agents. Ex. 1001, 1:13–17.
`The class of compounds is represented by formula (I):
`
`2
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`
`
`or the pharmaceutically acceptable acid addition salts thereof. Id. at 1:21–
`37.
`
`According to the ’040 patent, the most preferred compound is
`[2R,αS,2ꞌS, αꞌS]-α, αꞌ-[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-
`benzopyran-2-methanol] or a pharmaceutically acceptable acid addition salt
`thereof. Id. at 1:60–63. The Specification states that the compounds of
`formula (I) potentiate the activity of blood pressure reducing agents and, in
`particular, potentiate the reduction of blood pressure and heart rate. Id. at
`4:6–9. The Specification also provides examples of such blood pressure
`reducing agents, including the SRRR-isomers of the compounds of formula
`(I). Id. at 4:51–55.
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1–6 of the ’040 patent. Claims 1
`and 2 are the only independent claims and are reproduced below:
`1. A composition consisting of the compound [2R,αS,2ꞌS,
`αꞌS]-α, αꞌ-[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-
`benzopyran-2-methanol] having the formula:
`
`
`or a pharmaceutically acceptable acid addition salt thereof.
`
`
`3
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`2. A pharmaceutical composition consisting of a
`pharmaceutically acceptable carrier and, as active ingredients:
`(a) the blood pressure reducing compound [2S,αR,2ꞌR, αꞌR]-
`α, αꞌ-[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-
`benzopyran-2-methanol] having the formula:
`
`
`or a pharmaceutically acceptable acid addition salt thereof;
`and
`(b) the compound [2R,αS,2ꞌS, αꞌS]-α, αꞌ-
`[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-
`benzopyran-2-methanol] having the formula:
`
`
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–6 of the ’040 patent
`on the following grounds:
`References
`Van Lommen1 in view of
`Handbook of Chromatography2
`Van Lommen and Handbook of
`Chromatography in view of
`Okamoto3
`
`1 Van Lommen et al., US 4,654,362, issued Mar. 31, 1987 (Ex. 1004).
`2 HANDBOOK OF CHROMATOGRAPHY, Vol. II (Gunter Zweig, Ph.D. & Joseph
`Sherma, Ph.D. eds. 1972) (Ex. 1005).
`3 Okamoto et al., Optical Resolution of β-Blockers by HPLC on Cellulose
`Triphenylcarbamate Derivatives, CHEMISTRY LETTERS 1237–40 (1986)
`(Ex. 1006).
`
`Claim(s) challenged
`2–6
`
`1
`
`Basis
`§ 103
`
`§ 103
`
`4
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`References
`Van Lommen and Handbook of
`Chromatography in view of
`Armstrong4
`
`Basis
`§ 103
`
`Claim(s) challenged
`1
`
`Petitioner also relies on the testimony of Ronald W. Millard, Ph.D.
`(Ex. 1052) and Daniel W. Armstrong, Ph.D. (Ex. 1050).
`ANALYSIS
`
`Claim Construction
`A.
`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. 37 C.F.R. § 100(b);
`Cuozzo Speed Techs., LLC v. Lee, No. 15–446, 2016 WL 3369425, at *12
`(U.S. June 20, 2016) (upholding the use of the broadest reasonable
`interpretation standard). 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). Any special definitions for claim terms must be set forth with
`reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`The claims recite a composition “consisting of” the claimed
`compound. The parties agree that the transitional phrase “consisting of” is a
`term of art in patent law that “closes” the claim and excludes other elements,
`steps, or ingredients not specified in the claim. Pet. 29–30; Prelim. Resp. 23.
`
`
`4 Armstrong et al., Separation of Drug Stereoisomers by the Formation of β-
`Cyclodextrin Inclusion Complexes, 232 SCIENCE 1132–35 (1986)
`(Ex. 1007).
`
`5
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`The use of “consisting of” does not exclude the presence of ordinary and
`expected impurities or additional components or steps that are unrelated to
`the invention. Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349,
`1360 (Fed. Cir. 2006). Accordingly, we determine that the term “consisting
`of” does not exclude the presence of ordinary expected impurities or the
`presence of additional components that are unrelated to the invention.
`35 U.S.C. § 325(d)
`B.
`Under 35 U.S.C. § 325(d), the Board has discretion to reject a petition
`for inter partes review because “the same or substantially the same prior art
`or arguments previously were presented to the Office.” Id. Under the facts
`and circumstances of this proceeding, we exercise our discretion to deny the
`Petition under § 325(d).
`Prosecution History of the ’040 Patent
`1.
`During prosecution, the Examiner repeatedly rejected the pending
`claims on several grounds, including as obvious over Van Lommen.
`Ex. 1002, 73–75 (Office Action mailed Nov. 10, 1992), 88–90 (Office
`Action mailed May 14, 1993), 114–16 (Final Office Action mailed Feb. 15,
`1994). The rejected claims mirror the issued claims of the ’040 patent,
`except the rejected claims used the transitional phrase “consisting essentially
`of” rather than the narrower phrase “consisting of,” as recited in the patented
`claims. Compare id. at 158–60 (claims 21, 22, 24–26), with Ex. 1001,
`11:22–12:35 (claims); see also Prelim. Resp. 9 (comparing side-by-side the
`rejected claims with the ’040 patent claims).
`According to the examiner, Van Lommen teaches the claims’
`designated compounds, “includ[ing] all position isomers inherent in the
`claimed compound.” See, e.g., Ex. 1002, 114. The examiner then stated that
`“a skilled artisan would have known that various isomers would exhibit
`
`6
`
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`IPR2016-00379
`Patent 6,545,040 B1
`biological activity at various levels.” Id. “Absent information to the
`contrary, the skilled artisan would have seen optical isomer separation as a
`routine procedure leading to the compounds claimed herein.” Id.
`In response to the rejections, the applicants offered a declaration from
`the inventor, Dr. Raymond M. Xhonneux, supporting their unexpected
`results argument. Id. at 41–45. Dr. Xhonneux described the results of a
`study published in the EUROPEAN JOURNAL OF PHARMACOLOGY regarding
`the potentiating activity of RSSS-nebivolol with SRRR-nebivolol. Id.
`(referring to Ex. 10435). Dr. Xhonneux concluded that the results of the
`study indicate that “the (RSSS)-compound potentiates the antihypertensive
`effects of the (SRRR)-compound, but not the bradycardiac [e]ffects of the
`(SRRR)-compound.” Id. at 44.
`The examiner, however, was not persuaded by the applicants’
`evidence of unexpected results. See, e.g., id. at 114–16. The examiner
`stated that “[a]ny information proffered to demonstrate unexpected benefits
`residing in any isomer must be compared to the natural racemic mixture.”
`Id. at 114. The examiner also stated that the differences in biological
`activity between the different isomers is a difference in degree, and not
`patentably distinct differences in kind. Id. at 116.
`The applicants appealed the rejection to our predecessor, the Board of
`Patent Appeals and Interferences. Id. at 137–57. In its decision, the panel
`reversed the examiner’s rejection of the pending claims. The panel
`recognized that Van Lommen discloses “compound 84,” a mixture of four of
`
`
`5 Xhonneux et al., The l-Enantiomer of Nebivolol Potentiates the Blood
`Pressure Lowering Effect of the d-Enantiomer, 181 EUR. J. OF PHARM. 261–
`65 (1990) (Ex. 1043).
`
`7
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`the ten possible isomers of nebivolol, and that Van Lommen states that
`“[p]ure stereochemically isomeric forms of the compounds . . . may be
`obtained by the application of art-known procedures.” Id. at 198–99. The
`panel also acknowledged the examiner’s argument that Van Lommen
`teaches the claimed compound and that a skilled artisan would have seen
`optical isomer separation as a routine procedure leading to the compounds
`claimed. Id. at 199.
`For purposes of the appeal, the panel “accept[ed], without deciding,
`that the examiner has established a prima facie case of obviousness against
`claims 21, 22, and 24–26.” Id. The panel then considered the Xhonneux
`declaration, finding that it “presents evidence supporting a conclusion that
`the RSSS stereoisomer, unlike its enantiomer, SRRR, ‘only minimally
`affects blood pressure when administered alone’ but significantly
`‘potentiates the antihypertensive effects of the (SRRR)-compound, but not
`the bradycardiac affects [sic] of the (SRRR)-compound.’” Id. at 200. The
`panel also found that the examiner “does not propose any reason why a
`person having ordinary skill in the art would have expected the RSSS
`stereoisomer to have such properties. Nor does the examiner contend that
`the potentiating property, described in the declaration, is insignificant.” Id.
`Accordingly, the panel reversed the rejection under § 103 “on the strength of
`appellants’ rebuttal evidence establishing that the claimed subject matter
`possesses unexpectedly superior results.” Id.
`On remand, the applicants canceled the pending claims and added
`new, narrower claims using the phrase “consisting of” instead of “consisting
`essentially of.” Id. at 210–12. The applicants also submitted the declaration
`of Alain Gilbert Dupont, who provided further evidence, including several
`journal articles, regarding the unexpected properties of the RSSS isomer. Id.
`
`8
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`at 214–16; 219–30 (Dupont Decl.). The examiner subsequently allowed the
`amended claims. Id. at 248.
`
` Analysis
`2.
`Patent Owner asserts that we should exercise our discretion to deny
`the Petition under § 325(d) because Petitioner’s obviousness challenge is
`based on (i) the same primary reference addressed during prosecution,
`including by the Board in an appeal; and (ii) the same arguments regarding
`that primary reference and how it allegedly would have been modified.
`Prelim. Resp. 56–60. Upon reviewing the Petition, Preliminary Response,
`and the prosecution history of the ’040 patent, we agree.
`During prosecution, the examiner rejected the claims as obvious over
`Van Lommen. Here, Petitioner also relies primarily on Van Lommen to
`argue the claims are obvious. We, therefore, find that substantially the same
`prior art was previously presented to the Office.
`We also find that substantially the same arguments were previously
`presented to the Office, including to the Board. Petitioner argues that a
`person of ordinary skill in the art would have selected Compound 84 of Van
`Lommen as a base compound for investigation and would have been
`motivated to stereochemically separate the stereoisomers of Compound 84
`using the chromatography techniques disclosed in the secondary prior art
`references. Pet. 33. As Patent Owner notes, however, the examiner
`repeatedly stated that “the skilled artisan would have seen optical isomer
`separation as a routine procedure leading to the compounds claimed herein.”
`Prelim. Resp. 57 (citing Ex. 1002, 48, 73, 88, 113). Thus, Petitioner asserts
`substantially the same argument that the examiner asserted during
`prosecution.
`
`9
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`Petitioner also argues that the prosecution is “devoid of any discussion
`as to whether a POSITA would have selected Compound 84 of [Van
`Lommen] as a base compound for investigation, or whether a POSITA
`would have been motivated and able to stereochemically separate
`Compound 84 to create the claimed purified enantiomers using
`chromatography.” Pet. 57. We disagree. The Board specifically referred to
`compound 84 in its decision, noting that it was acknowledged in the brief
`and at oral argument that compound 84 is an unresolved mixture of four of
`the ten isomers of nebivolol. Ex. 1002, 198–99. Regardless, the panel
`assumed the examiner established a prima facie case of obviousness and
`found the evidence of unexpected results was sufficient to rebut the prima
`facie case. Id. at 199–200.
`Petitioner also asserts that the evidence of unexpected results should
`be disregarded because the declarations discuss laboratory testing that
`occurred after the priority date of the ’040 patent. Pet. 55. We are not
`persuaded because the law permits consideration of evidence of unexpected
`results even if it was obtained after the patent’s filing or issue date. See
`Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d
`1291, 1307 (Fed. Cir. 2011).
`Petitioner further argues that Patent Owner did not present evidence
`with a sufficient nexus to the claims. Pet. 55–56. In particular, Petitioner
`asserts that Patent Owner did not submit evidence that the claimed
`compounds showed unexpected properties or results as compared to the
`prior art base compound (Compound 84). Id. at 56. The examiner made a
`similar argument in the Examiner’s Answer to the Board, stating “[a]ny
`information proffered to demonstrate unexpected benefits residing in any
`isomer must be compared to the natural racemic mixture.” Ex. 1002, 169.
`
`10
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`The Board, however, was not persuaded by the examiner’s argument,
`concluding the applicants’ evidence of unexpected results sufficient, and
`implicitly finding a sufficient nexus between the evidence and the claimed
`invention. See In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“For
`objective evidence of secondary considerations to be accorded substantial
`weight, its proponent must establish a nexus between the evidence and the
`merits of the claimed invention.”) (quoting Wyers v. Master Lock Co., 616
`F.3d 1231, 1246 (Fed. Cir. 2010)).
`Finally, Petitioner argues that it has submitted “ample evidence” that
`the compounds of claims 1 and 2 would be the intended and expected result
`of combining the asserted references, and that claims 3–6 would not be an
`unexpected result of the suggested combination. Pet. 56 (citing Ex. 1050
`¶¶ 50, 56, 66, 73, 74, 81, 93, 106; Ex. 1052 ¶¶ 60–68, 93, 100). But
`Petitioner’s cited evidence relates to how a person of ordinary skill in the art
`would have considered separating and studying the stereoisomers of
`compound 84 to be ordinary and routine. See, e.g., Ex. 1050 ¶ 73 (“A
`POSITA at the time would have had an expectation that this stereochemical
`resolution could be easily achieved using known and commercially available
`techniques, without undue experimentation.”); Ex. 1052 ¶ 93 (“[I]t is my
`opinion that a POSITA at the time of the ’040 Patent’s priority date, would
`have been motivated to carry out standard new-drug investigation on each of
`the purified stereochemical forms in order to determine the effectiveness of
`each stereochemical form, to determine whether the drug could be
`administered as a racemic mixture or whether a purified enantiomer was
`required, to determine the interactions between stereoisomers if administered
`together, and to determine the effective amounts of each compound
`necessary for treatment of hypertension.”). The Board, however, assumed
`
`11
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`
`IPR2016-00379
`Patent 6,545,040 B1
`this to be true in its prior decision by accepting, without deciding, that the
`examiner established a prima facie case of obviousness. Ex. 1002, 199.
`Nevertheless, the Board still found the unexpected results evidence
`presented by the applicants to be sufficient.
`Finally, although the prior panel expressly set forth the deficiencies in
`the examiner’s position with respect to the evidence of unexpected results,
`the Petition is silent as to those deficiencies. In particular, Petitioner has not
`offered sufficient evidence to show why an ordinary artisan “would have
`expected the RSSS stereoisomer to have such [potentiating] properties” or to
`show “that the potentiating property, described in the declaration, is
`insignificant.” See Ex. 1002, 200. Because Petitioner has not addressed
`these issues, we are not inclined to reconsider the Board’s prior decision.
`Accordingly, under the facts and circumstances of this case, we find that
`readjudicating substantially the same prior art and arguments as those
`presented during prosecution would not be an efficient use of Board
`resources.
`
`CONCLUSION
`
`We find that the same prior art and substantially the same arguments
`were presented to the Office previously. We, therefore, exercise our
`discretion and deny the Petition under 35 U.S.C. § 325(d).
`ORDER
`
`In consideration of the foregoing, it is hereby:
`ORDERED that Petitioner’s request for an inter partes review of
`claims 1–6 of the ’040 patent is denied.
`.
`
`
`
`
`12
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`
`PETITIONER:
`Barry Bumgardner
`barry@nelbum.com
`Brent Bumgardner
`brent@nelbum.com
`
`PATENT OWNER:
`Jeffrey Kushan
`IPRNotices@sidley.com
`
`
`13
`
`
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