Trials@uspto.gov
`Tel: 571-272-7822
`
`
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`
`
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`Paper 24
`Entered: October 20, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`NISSAN CHEMICAL INDUSTRIES, LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01069
`Patent 5,856,336
`____________
`
`
`
`Before JACQUELINE WRIGHT BONILLA, SHERIDAN K. SNEDDEN,
`and TINA E. HULSE, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`Tel: 571-272-7822
`
`
`
`
`
`
`Paper 24
`Entered: October 20, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`NISSAN CHEMICAL INDUSTRIES, LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01069
`Patent 5,856,336
`____________
`
`
`
`Before JACQUELINE WRIGHT BONILLA, SHERIDAN K. SNEDDEN,
`and TINA E. HULSE, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`IPR2015-01069
`Patent 5,856,336
`
`
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition to institute
`
`an inter partes review of claims 1 and 2 (Paper 2; “Pet.”) of U.S. Patent No.
`
`5,856,336 B2 (Ex. 1001; “the ’336 patent”). Nissan Chemical Industries,
`
`Ltd. (“Patent Owner”) filed a Patent Owner Preliminary Response. Paper 7
`
`(“Prelim. Resp.”).
`
`Upon consideration of the Petition and Patent Owner Preliminary
`
`Response, we conclude that Petitioner has not established that there is a
`
`reasonable likelihood that it will prevail with respect to at least one of the
`
`challenged claims. For the reasons that follow, we do not institute an inter
`
`partes review.
`
`A. Related Proceedings
`
`The parties inform us of the following related litigation between them
`
`involving the ’336 patent: Kowa Company, Ltd. v. Mylan, Inc., 1:14-cv-
`
`02647 (S.D.N.Y. Apr. 14, 2014). Pet. 1; Paper 5.
`
`B. The ’336 patent (Ex. 1001)
`
`The ’336 patent discloses mevalonolactone derivatives having a
`
`quinoline ring and their use as a pharmaceutical for reducing hyperlipidemia,
`
`hyperlipoproteinemia or atherosclerosis. Ex. 1001, 1:635.
`
`
`
`2
`
`
`
`IPR2015-01069
`Patent 5,856,336
`
`
`C. Challenged Claims
`
`Challenged claims 1 and 2 are reproduced below:
`
`1. A compound of the formula,
`
`
`
`
`Z= —CH(OH)—CH2—CH(OH) —CH2—COO. ½Ca.
`
`2. A method for reducing hyperlipidemia, hyperlipoproteinemia
`or atherosclerosis, which comprises administering an effective
`amount of the compound of formula A as defined in claim 1.
`
`D. Asserted Grounds of Unpatentability
`
`Petitioner challenges claims 1 and 2 of the ’336 patent on the
`
`following grounds. Pet. 1660.
`
`Reference[s]
`
`Basis
`
`Claims Challenged
`
`Kathawala,1 Kathawala Abstract, 2
`Hoefle,3 Roth,4 Anderson,5 Wareing,6
`Hansch,7 Suh,8 Berge,9 and Gould10
`
`§ 103
`
`1 and 2
`
`
`
`1 U.S. Patent No. 4,739,073, issued Apr. 19, 1988. Ex. 1010.
`2 Faizulla G. Kathawala, et al., XU 62-320, An HMG-CoA Reductase
`Inhibitor, More Potent Than Compactin, Abstract for American Chemical
`Society library, July 29, 1987 (hereinafter “Kathawala Abstract”). Ex. 1009.
`3 U.S. Patent No. 4,647,576, issued Mar. 3, 1987. Ex. 1016.
`4 U.S. Patent No. 4,681,893, issued July 21, 1987. Ex. 1019.
`5 U.S. Patent No. 4,751,235, issued June 14, 1988. Ex. 1020.
`6 U.S. Patent No. 4,613,610, issued Sept. 23, 1986. Ex. 1018.
`3
`
`
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`
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`IPR2015-01069
`Patent 5,856,336
`
`
`Reference[s]
`
`Kathawala, Kathawala Abstract, Hoefle,
`Roth, Anderson, Wareing, Hansch, Suh,
`Berge, Gould, Engstrom Abstract,11
`Tobert,12 Lee,13 and Picard14
`
`Picard
`
`
`
`Basis
`
`Claims Challenged
`
`§103
`
`1 and 2
`
`§ 102
`
`1 and 2
`
`Petitioner relies also on the Declaration of Roger Frank Newton,
`
`Ph.D. (Ex. 1008) and the Declaration of Dr. David Gortler (Ex. 1015) in
`
`support of the proposed grounds of unpatentability.
`
`
`
`7 Corwin Hansch et al., “Aromatic” Substituent Constants for Structure-
`Activity Correlations, 16 J. MED. CHEM. 1207–1216 (1973) (hereinafter
`“Hansch”). Ex. 1024.
`8 John T. Suh et al., Angiotensin-Converting Enzyme Inhibitors New Orally
`Active Antihypertensive (Mercaptoalkanoyl)- and
`[(Acylthio)alkanoyl]glycine Derivatives, 28 J. MED. CHEM. 57–60 (1985)
`(hereinafter “Suh”). Ex. 1029.
`9 Stephen M. Berge et al., Pharmaceutical Salts, 66 J. PHARM. SCI. 1–19
`(1977) (hereinafter “Berge”). Ex. 1027.
`10 Philip L. Gould, Salt Selection for Basic Drugs, 33 INT. J. PHARM. 201–
`217 (1986). Ex. 1028.
`11 R. G. Engstrom et al., Hypolipoproteinemic Effects of a Potent HMG-CoA
`Reductase Inhibitor, IX International Symposium on Drugs Affecting Lipid
`Metabolism, Florence (Italy), Oct. 22-25, 1986 (hereinafter “Engstrom”).
`Ex. 1011.
`12 Jonathan A. Tobert, New Developments in Lipid-Lowering Therapy: The
`Role of Inhibitors of Hydroxymethylglutaryl-Coenzyme A Reductase, 76
`CIRCULATION 534–538 (1987). Ex. 1012.
`13 Ta-Jyh Lee, Synthesis, SARs and Therapeutic Potential of HMG-CoA
`Reductase Inhibitors, 8 TRENDS PHARMACOL. SCI. 442–446 (1987).
`Ex. 1013.
`14 U.S. Patent No. 4,761,419, issued Aug. 2, 1988. Ex. 1021.
`4
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`
`
`
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`IPR2015-01069
`Patent 5,856,336
`
`
`II. ANALYSIS
`
`A. Claim Interpretation
`
`We interpret claims using the “broadest reasonable construction in
`
`light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`
`§ 42.100(b); see also Office Patent Trial Practice Guide, 77 Fed. Reg.
`
`48,756, 48,766 (Aug. 14, 2012); In re Cuozzo Speed Techs., LLC, 793 F.3d
`
`1268, 1278–79 (Fed. Cir. 2015) (“Congress implicitly approved the broadest
`
`reasonable interpretation standard in enacting the AIA,”15 and “the standard
`
`was properly adopted by PTO regulation.”). Under the broadest reasonable
`
`construction standard, claim terms are given their ordinary and customary
`
`meaning, as would be understood by one of ordinary skill in the art at the
`
`time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`
`(Fed. Cir. 2007). “Absent claim language carrying a narrow meaning, the
`
`PTO should only limit the claim based on the specification . . . when [it]
`
`expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320,
`
`1325 (Fed. Cir. 2004). “Although an inventor is indeed free to define the
`
`specific terms used to describe his or her invention, this must be done with
`
`reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d
`
`1475, 1480 (Fed. Cir. 1994).
`
`We determine that explicit construction of any specific claim term is
`
`not necessary to determine whether to institute a trial in this case. See, e.g.,
`
`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
`
`(“[C]laim terms need only be construed ‘to the extent necessary to resolve
`
`
`
`15 The Leahy-Smith America Invents Act, Pub. L. No. 11229, 125 Stat.
`284 (2011) (“AIA”).
`
`5
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`IPR2015-01069
`Patent 5,856,336
`
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`the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`
`200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`B. Petitioner’s Asserted Obviousness Grounds
`
`We generally follow a two-part inquiry to determine whether a new
`
`chemical compound would have been obvious over particular prior art
`
`compounds. Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1291–93
`
`(Fed. Cir. 2012). First, we determine “whether a chemist of ordinary skill
`
`would have selected the asserted prior art compounds as lead compounds, or
`
`starting points, for further development efforts.” Id. at 1291. Second, we
`
`analyze whether there was a reason to modify a lead compound to make the
`
`claimed compound with a reasonable expectation of success. Id. at 1292.
`
`Establishing that a chemical compound would have been obvious over a
`
`structurally similar compound requires “a showing that the prior art would
`
`have suggested making the specific molecular modifications necessary to
`
`achieve the claimed invention.” Takeda Chem. Indus., Ltd. v. Alphapharm
`
`Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (internal quotations
`
`omitted).
`
`In the instant case, Petitioner contends that Kathawala discloses
`
`fluvastatin, which would have been a lead compound as it was known to
`
`possess “excellent in vitro activity and demonstrated relatively high activity
`
`for in vivo cholesterol biosynthesis inhibition.” Pet. 7. Petitioner argues that
`
`a “[person of ordinary skill in the art] would have considered the logical
`
`structural avenues available to further optimize [fluvastatin]” in order to
`
`achieve the compound encompassed by the claims of the ’336 patent,
`
`referred to in the Petition as pitavastatin. Id. at 89. Such “optimization”
`
`
`
`6
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`
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`IPR2015-01069
`Patent 5,856,336
`
`
`would require, inter alia, adding a single carbon to the indole ring of the
`
`fluvastatin core to arrive at the quinoline ring structure of pitavastatin,
`
`relocating the isopropyl group on the nitrogen of the indole ring of the
`
`fluvastatin core to a carbon on the 2 position of the quinoline ring, and
`
`modifying the isopropyl group to a cyclopropyl group. Id. 810; 2843.
`
`Petitioner contends that such modifications would have been routine to a
`
`person of ordinary skill in the art. Id.
`
`We are not convinced that the steps needed to go from fluvastatin
`
`ultimately to pitavastatin constituted routine optimization. The process of
`
`modifying fluvastatin to pitavastatin would have required a number of
`
`chemical alterations, each having a number of possible combinations.
`
`Rather, we find that the process of modifying fluvastatin to pitavastatin
`
`would have required significant guesswork and variation of a number of
`
`parameters to achieve the end result. Prelim. Resp. 2646. For example, if
`
`we focus on the modification of the isopropyl group to a cyclopropyl group
`
`alone, the prior art does not clearly direct a person of ordinary skill in the art
`
`to a cyclopropyl group, let alone the placement of a cyclopropyl group at the
`
`2 position of a quinoline ring. As provided in the Petition,
`
`Kathawala [] compounds of Formula I include compounds in
`which one of Ro and R is a substituted phenyl (such as 4-
`fluorophenyl), and the other is primary or secondary C1-6alkyl not
`containing an asymmetric carbon atom, C3-6 cycloalkyl, or
`phenyl(CH2)m.
`
`Pet. 37 (emphasis in original). Petitioner contends that the C3-6 cycloalkyl
`
`group contains a small number of compounds including cyclopropyl. Id.
`
`(citing Ex. 1008 ¶¶ 111112). Kathawala formula I, however, describes a
`
`genus of compounds that are distinct from pitavastatin, and we find no
`
`7
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`
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`IPR2015-01069
`Patent 5,856,336
`
`
`teaching in Kathawala directing us specifically to the use of cyclopropyl.
`
`Nonetheless, relying on Roth, for example, Petitioner contends that one of
`
`ordinary skill in the art “would have been motivated to try modifications at
`
`the 2 position with substituents similar to isopropyl” because Roth
`
`“disclosed the substitution of a trifluoromethyl group for isopropyl at the 2
`
`position.” Id. at 36 (citing Roth Table 1; Ex. 1008 ¶¶ 86–99). Petitioner
`
`then contends that, as “there were a finite number of compounds that had
`
`similar size and chemistry to isopropyl, cyclopropyl would have been
`
`obvious to try.” Id. at 43.
`
`Such information does not make a persuasive case that knowledge in
`
`the prior art was specific enough to identify the specific compound of the
`
`claims. See Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1089 (Fed.
`
`Cir. 2008) (upholding the district court’s finding of non-obviousness where
`
`there were a “wide range of possible outcomes” and a “relative
`
`unlikelihood” that the desired results would be obtained); cf. Pfizer, Inc. v.
`
`Apotex, Inc., 480 F.3d 1348, 1367 (Fed. Cir. 2007) (“[T]he prior art provided
`
`not only the means of creating acid addition salts but also predicted the
`
`results, which Pfizer merely had to verify through routine testing.”). Rather,
`
`we conclude that the information set forth in the Petition offers an
`
`impermissible “obvious to try” situation, where the prior art provides only
`
`general guidance with regard to a line of experimentation to pursue. See
`
`Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 997 (Fed.
`
`Cir. 2009) (“[P]atents are not barred just because it was obvious ‘to explore
`
`a new technology or general approach that seemed to be a promising field of
`
`experimentation, where the prior art gave only general guidance as to the
`
`particular form of the claimed invention or how to achieve it.’”) (quoting
`
`
`
`8
`
`
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`IPR2015-01069
`Patent 5,856,336
`
`
`In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)).
`
`In view of the above, we are not persuaded that there is a reasonable
`
`likelihood that Petitioner would prevail at trial with respect to at least one
`
`claim of the ’336 patent on either of their obviousness challenges.
`
`C. Petitioner’s Asserted Anticipation Ground
`
`Petitioner asserts that “the genus disclosed in [Picard] clearly includes
`
`pitavastatin calcium.” Pet. 58 (citing Ex. 1021, 2:93:1, 9:6168; Ex. 1008
`
`¶ 168). Patent Owner contends that Picard discloses a genus of thousands of
`
`compounds based on a quinoline core. Prelim. Resp. 56, (citing Ex. 1021,
`
`2:103:2, 17:6720:15).
`
`We agree with Patent Owner. The Petition fails to explain adequately
`
`why the genus of Picard meets the test for a genus-to-species anticipation.
`
`See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006)
`
`(“It is well established that the disclosure of a genus in the prior art is not
`
`necessarily a disclosure of every species that is a member of that genus.”).
`
`For example, Petitioner has not established a “pattern of preferences” in
`
`Picard that points to the pitavastatin calcium species of the claims. See
`
`Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006)
`
`(requiring the genus disclosure to disclose a “pattern of preferences” that
`
`reads onto the species claim in order for anticipation to be found).
`
`Accordingly, we are not persuaded that there is a reasonable likelihood that
`
`Petitioner would prevail at trial with respect to at least one claim of the ’336
`
`patent, based on anticipation of claims 1 and 2 by Picard.
`
`
`
`9
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`
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`IPR2015-01069
`Patent 5,856,336
`
`
`III. CONCLUSION
`
`The Petition does not persuade us that there is a reasonable likelihood
`
`that at least one of the challenged claims is unpatentable based on the
`
`asserted grounds. We deny the petition for inter partes review and decline
`
`to institute trial on any of the asserted grounds as to any of the challenged
`
`claims.
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby ORDERED that the
`
`petition is denied as to all challenged claims and no trial is instituted.
`
`
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`10
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`
`
`IPR2015-01069
`Patent 5,856,336
`
`
`
`
`PETITIONER:
`
`Jitendra Malik
`ALSTON & BIRD LLP
`Jitty.Malik@alston.com
`
`Deanne M. Mazzochi
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`dmazzochi@rmmslegal.com
`
`
`PATENT OWNER:
`
`David G. Conlin
`Kathleen B. Carr
`MINTZ, LEVIN, COHN FERRIS, GLOVSKY & POPEO P.C.
`DGConlin@mintz.com
`KBCarr@mintz.com
`
`
`
`
`11
`
`
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