Trials@uspto.gov
`571.272.7822
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` Paper No. 11
` Entered: July 18, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ROSELLINI SCIENTIFIC, LLC,
`Petitioner,
`
`v.
`
`GRÜNENTHAL GMBH,
`Patent Owner.
`____________
`
`Case IPR2016-00471
`Patent 7,994,364 B2
`____________
`
`
`Before TONI R. SCHEINER, ZHENYU YANG, and TINA E. HULSE,
`Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`

`

`IPR2016-00471
`Patent 7,994,364 B2
`
`
`INTRODUCTION
`
`Rosellini Scientific, LLC (“Petitioner”) filed a Petition requesting an
`inter partes review of claims 1–4 and 24–27 of U.S. Patent No. 7,994,364
`B2 (Ex. 1001, “the ’364 patent”). Paper 1 (“Pet.”). Grünenthal GmbH
`(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 9
`(“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 determine that Petitioner has not
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1–4 and 24–27 of the ’364 patent. Accordingly,
`we decline to institute an inter partes review of those claims.
`Related Proceedings
`A.
`The parties identify several district court proceedings as relating to the
`’364 patent. Pet. 2; Paper 7, 1–2.
`Patent Owner also identifies pending U.S. Patent Application
`No. 14/930,337, which claims benefit of priority to the application that
`issued as the ’364 patent. Paper 7, 1.
`The ’364 Patent
`B.
` The ’364 patent relates to solid crystalline forms of (−)-(1R,2R)-3-
`(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
`(“tapentadol HCl”) compounds, methods of producing the compounds, and
`related treatments. Ex. 1001, 1:21–24. The Specification states that
`tapentadol HCl can be produced in two different crystalline forms. Id. at
`
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`IPR2016-00471
`Patent 7,994,364 B2
`1:55–58. The present invention provides a new form (Form A) of the
`compound. Id. at 1:58–60. Form B was already known and obtained by the
`procedure described in Example 25 of U.S. Patent Nos. 6,248,737 and
`6,344,558, as well as EP 693 475 B1. Id. at 1:61–63. According to the
`Specification, the new Form A “is very stable at ambient conditions and
`therefore useful for producing a pharmaceutical composition.” Id. at 1:63–
`67.
`
`The crystalline Form A can be identified by X-ray powder diffraction
`(“XRPD”). The XRPD pattern of Form A is shown in Figure 1, which is
`reproduced below:
`
`
`
`
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`IPR2016-00471
`Patent 7,994,364 B2
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1–4 and 24–27 of the ’364 patent,
`of which claims 1, 25, and 27 are independent claims. Claim 1 is
`representative and is reproduced below:
`1. A crystalline Form A of (−)-(1R,2R)-3-(3-
`dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
`exhibiting at least X-ray lines (2-theta values) in a powder
`diffraction pattern when measured using CuKα radiation at
`15.1±0.2, 16.0±0.2, 18.9±0.2, 20.4±0.2, 22.5±0.2, 27.3±0.2,
`29.3±0.2 and 30.4±0.2
`Independent claim 25 recites a “solid pharmaceutical
`composition” comprising the crystalline Form A recited in claim 1,
`and independent claim 27 recites a “method of treating or inhibiting
`pain or urinary incontinence” comprising administering a
`pharmaceutically effective amount of the crystalline Form A recited in
`claim 1.
`
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–4 and 24–27 of the
`’364 patent on the following grounds:
`Reference
`Basis
`EP ’4751
`§ 102(b)
`
`Claim(s) challenged
`1–4 and 24–27
`
`Bartholomäus2
`
`§ 102(b)
`
`1–4 and 24–27
`
`
`1 EP 0 693 475 A1, issued Jan. 24, 1996 (Ex. 1007). In this Decision, we
`cite to Exhibit 1006, the certified English translation of EP ’475.
`2 Bartholomäus et al., WO 03/035053 A1, published May 1, 2003
`(Ex. 1010). In this Decision, we cite to Exhibit 1009, the certified English
`translation of Bartholomaus.
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`IPR2016-00471
`Patent 7,994,364 B2
`Petitioner also relies on the testimony of William E. Mayo, Ph.D. (Ex. 1012)
`and Ron Bihovsky, Ph.D. (Ex. 1014).
`ANALYSIS
`
`Person of Ordinary Skill in the Art
`A.
`Petitioner asserts that a person of ordinary skill in the art would have
`had a “Ph.D. in fields relevant to small molecule drug development, such as
`biochemistry, medicinal chemistry, organic chemistry, or the equivalent.”
`Pet. 17 (citing Ex. 1012 ¶ 26; Ex. 1014 ¶ 10). Patent Owner asserts a person
`of ordinary skill in the art would have had a bachelor’s degree in chemistry,
`chemical engineering, or related disciplines, and “either (i) at least three
`years of experience related to organic synthesis, API manufacturing and
`formulation, or detection and/or evaluation of solid state forms in the
`pharmaceutical industry; or (ii) an advanced degree in chemistry, chemical
`engineering, or related disciplines.” Prelim. Resp. 14. Patent Owner further
`asserts that an ordinary artisan would have had “working knowledge of the
`preparation, characterization, and analysis of solid state forms, including a
`working knowledge of crystallography.” Id.
`At this stage of the proceeding, we note that any difference in the
`levels of ordinary skill in the art asserted by the parties would not impact our
`Decision. We further note that the prior art itself demonstrates the level of
`skill in the art at the time of the invention. See Okajima v. Bourdeau, 261
`F.3d 1350, 1355 (Fed. Cir. 2001) (holding the absence of specific findings
`on “level of skill in the art does not give rise to reversible error ‘where the
`prior art itself reflects an appropriate level and a need for testimony is not
`shown’”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755
`F.2d 158, 163 (Fed. Cir. 1985)).
`
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`IPR2016-00471
`Patent 7,994,364 B2
`
`Claim Construction
`B.
`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 *14
`(U.S. June 20, 2016). 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 parties both assert that, for purposes of this proceeding, the claim
`terms should be given their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art and consistent with the
`disclosure. Pet. 13; Prelim. Resp. 15. We determine that it is unnecessary to
`expressly construe any claim terms for purposes of this Decision. See
`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
`the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999)).
`Anticipation by EP ’475
`C.
`Petitioner asserts that claims 1–4 and 24–27 are anticipated by
`EP ’475. Pet. 17–50. Patent Owner opposes Petitioner’s assertion. Prelim.
`Resp. 18–45. Based on the current record, we determine that Petitioner has
`not established a reasonable likelihood that it would prevail in showing
`claims 1–4 and 24–27 are anticipated by EP ’475.
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`IPR2016-00471
`Patent 7,994,364 B2
`
`EP ’475 (Ex. 1006)
`1.
`EP ’475 relates to 1-phenyl-3-dimethylaminopropane compounds, a
`method of preparing them, and their use as pharmaceutical active
`ingredients. Ex. 1006, 2. Example 25 of EP ’475 discloses the synthesis of
`tapentadol HCl.3 Id. at 33. In particular, Example 25 states: “Enantiomer
`(-21) was obtained in 45% yield under the conditions cited in Example 24
`starting from (-1), which was prepared as in Example 2.” Id. That is,
`Example 25 discloses a three-step process (as described in Example 24) for
`preparing tapentadol HCl, starting with the compound (–)-(2S,3S)-1-
`dimethylamino-3-(3-methoxyphenyl)-2-methylpentan-3-ol, hydrochloride (-
`1), as prepared in Example 2. Id. at 11 (Example 2), 29–32 (Example 24).
`Analysis
`2.
`Petitioner asserts that EP ’475 anticipates claims 1–4 and 24–27. The
`parties agree that EP ’475 discloses the synthesis of tapentadol HCl in
`Example 25. See Pet. 18 (“EP 475 discloses the synthesis of tapentadol HCl
`in Example 25.”); Prelim. Resp. 15 (“The EP ’475 patent is the first
`disclosure of tapentadol hydrochloride and describes the synthesis of this
`compound.”). The parties also agree that EP ’475 does not describe the
`crystalline form of the tapentadol HCl compound produced according to
`Example 25. See Pet. 22 (“EP 475 does not itself characterize the crystalline
`nature of the tapentadol HCl product produced according to Example 25.”);
`
`
`3 Although EP ’475 states that the compound of Example 25 is (−)-(1R,2S)-
`3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride, the
`’364 patent states that this is incorrect and that it discloses (−)-(1R,2R)-3-(3-
`dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride. Ex. 1001,
`1:46–54 (“As proven by [XRPD] the 1R,2R configuration as shown in the
`drawing of the structure in example 25 is correct although the configuration
`is reported as (–)-(1R,2S). . . .”).
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`IPR2016-00471
`Patent 7,994,364 B2
`Prelim. Resp. 15 (“[EP ’475] does not . . . describe any polymorphic form of
`tapentadol hydrochloride.”). The parties disagree, however, regarding
`whether EP ’475 inherently discloses Form A, as recited in the challenged
`claims of the ’364 patent.
`Petitioner asserts that Dr. Mayo obtained a research sample of
`tapentadol HCl and performed XRPD on the sample to determine that the
`sample consisted entirely of Form A. Pet. 23 (citing Ex. 1012 ¶¶ 61–69).
`Dr. Mayo then provided the research sample to Dr. Bihovsky, who purported
`to have followed the procedure of Example 25 in EP ’475 to generate the
`tapentadol free base and precipitate crystalline Form B of tapentadol HCl.
`Id. (citing Ex. 1014 ¶¶ 19–43). Because Dr. Bihovsky and Dr. Mayo
`observed the production of some amount of Form A every time they
`attempted to generate Form B, Petitioner argues that Example 25 inherently
`discloses the synthesis of Form A, according to the challenged claims. Id. at
`24–35.
`Patent Owner responds, arguing that Dr. Bihovsky did not faithfully
`reproduce Example 25. Prelim. Resp. 35–44. For example, Patent Owner
`asserts that by starting with commercially available Form A of tapentadol
`HCl rather than reproducing the multi-step procedure mandated by
`Example 25, Dr. Bihovsky has failed to reproduce Example 25. Id. at 35–
`40.
`
`After considering the Petition and Preliminary Response, we agree
`with Patent Owner that Petitioner has not offered sufficient evidence to
`establish a reasonable likelihood of proving inherent anticipation. “To
`establish inherency, the extrinsic evidence ‘must make clear that the missing
`descriptive matter is necessarily present in the thing described in the
`reference.’” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). Inherency
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`Patent 7,994,364 B2
`is not “established by probabilities or possibilities. The mere fact that a
`certain thing may result from a given set of circumstances is not sufficient.”
`Id. (quotation omitted).
`Here, we are not persuaded that Petitioner has shown that
`Example 25—as described in the EP ’475—necessarily and inevitably
`produces Form A of tapentadol HCl. We agree with Patent Owner that
`Petitioner’s declarants, Dr. Bihovsky and Dr. Mayo, deviated from the
`protocol described in Example 25 of EP ’475 by starting with the
`commercially available, pure Form A of tapentadol HCl rather than
`preparing the tapentadol free base according to Example 25 (via the steps of
`Example 24). Specifically, Dr. Bihovsky states that to form the free base of
`tapentadol described in step 3 of Example 24, he performed the following
`steps:
`
`I mixed tapentadol hydrochloride Form A (300 mg) with freshly
`prepared saturated aqueous sodium bicarbonate (4.5 mL) then
`extracted this mixture three times with 3 mL of dichloromethane.
`I dried the combined dichloromethane extracts over sodium
`sulfate, filtered, and evaporated the solvent in vacuo to give the
`free base of tapentadol (252 mg, 98% yield) as a colorless oil
`which crystallized after storage at 5 ºC. These crystals melted at
`86–88 ºC.
`
`Ex. 1014 ¶ 30.
`In contrast, to form the tapentadol free base, Example 25 (via
`Example 24) of EP ’475 states:
`4.3 g (15 mmol) of ([-23]) from step 2 were added to 100
`ml of concentrated hydrobromic acid. The mixture was then
`heated under reflux for two hours. After cooling to room
`temperature, the reaction mixture was concentrated under the
`vacuum from a water pump. The residue was treated with
`concentrated sodium hydrogen carbonate solution until an
`alkaline reaction was obtained. After extracting twice with 50 ml
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`IPR2016-00471
`Patent 7,994,364 B2
`dichloromethane in each case, the combined organic phases were
`dried over sodium sulfate.
`
`Ex. 1006, 32.
`Thus, on its face, we note several differences between the method
`performed by Dr. Bihovsky and the method of Example 25. First, whereas
`Dr. Bihovsky started with pure tapentadol HCl Form A obtained from a
`commercial source, step 3 of Example 25 starts with compound (-23)
`(i.e., (–) (2R,3S)-[3-3-methoxyphenyl)-2-methylphentyl]-dimethylamine,
`hydrochloride), which is “from step 2.” Id. at 31–32. Step 2 incorporates
`the compound produced in step 1, which uses the compound (-1), which was
`prepared as in Example 2. Id. at 29–32. Thus, EP ’475 sets forth step-by-
`step instructions for preparing the starting material of step 3, none of which
`Dr. Bihovsky followed because he simply started with the desired end-
`product—the commercially available, pure Form A of tapentadol HCl.
`Second, because their starting materials differ, the steps of the
`methods differ. For example, to form the tapentadol free base, step 3 of
`Example 25 adds concentrated hydrobromic acid to compound (-23), heats
`the mixture under reflux for two hours, cools the mixture to room
`temperature, and concentrates the mixture under the vacuum from a water
`pump. Id. at 32. Dr. Bihovsky did not perform any of these steps, instead
`simply mixing pure tapentadol HCl Form A with “freshly prepared saturated
`aqueous sodium bicarbonate” and then “extract[ing] this mixture three times
`with 3 mL of dichloromethane.” Ex. 1014 ¶ 30.
`Moreover, although both Dr. Bihovsky and Example 25 mix the
`solution with saturated aqueous sodium bicarbonate, Dr. Bihovsky states that
`he extracted the mixture three times with dichloromethane. Ex. 1014 ¶ 30.
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`IPR2016-00471
`Patent 7,994,364 B2
`Example 25, however, states it “extract[s] twice” with dichloromethane.
`Ex. 1006, 32.
`Because Petitioner’s declarant did not follow each of the steps of
`Example 25 of EP ’475 (including the preceding steps required to perform
`Example 25), we find that Petitioner has not shown sufficiently that those
`steps would necessarily and inevitably yield Form A of tapentadol HCl.
`Petitioner and Dr. Bihovsky fail to explain why they deviated from the
`protocol disclosed in Example 25 or why that deviation would have had no
`impact on the synthesized compound as compared to the compound of
`Example 25. At best, Dr. Bihovsky states that “the only step in the synthesis
`that will impart a polymorphic form to tapentadol HCl is the latter half of the
`3rd Step of Example 24, wherein the free base of tapentadol (generated in
`situ) is taken up (dissolved) in 2-butanone and treated with
`trimethylchlorosilane (TCMI) and water.” Ex. 1014 ¶ 31. He continues,
`stating, “The preceding steps will not influence or determine the
`polymorphic form of tapentadol HCl because the free base of tapentadol is
`completely dissolved in 2-butanone and therefore has no crystalline form
`since it is in solution.” Id.
`We are not persuaded. Dr. Bihovsky provides no objective evidence
`or support for his opinion that only the latter half of step 3 of Example 25
`matters for crystalline form, regardless of how the free base of tapentadol is
`synthesized. On this record, Dr. Bihovsky’s opinion is therefore of little
`probative value. See 37 C.F.R. § 42.65(a) (stating opinion testimony that
`does not disclose underlying facts or data “is entitled to little or no weight”);
`see also Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281,
`294 (Fed. Cir. 1985) (stating a lack of objective support for expert opinion
`“may render the testimony of little probative value in a validity
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`IPR2016-00471
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`determination”). Had Petitioner, for example, provided some objective
`evidence that the process employed by Dr. Bihovsky results in the same
`product as the process described in Example 25 of EP ’475, our decision
`may have been different. On this record, however, Petitioner has not shown
`that the results of Dr. Bihovsky’s studies are necessarily the same as the
`results that would be obtained if an ordinary artisan followed the steps of
`Example 25.
`In light of the differences between the steps conducted by
`Dr. Bihovsky and the steps recited in Example 25 of EP ’475, we find that
`Petitioner has not offered sufficient evidence to show that Example 25 of
`EP ’475 necessarily and inevitably produces a compound that includes
`Form A of tapentadol HCl. Without such evidence, we determine that
`Petitioner has failed to establish a reasonable likelihood that it would prevail
`in showing EP ’475 anticipates claims 1–4 and 24–27.
`Anticipation by Bartholomäus
`D.
`Petitioner asserts that claims 1–4 and 24–27 are anticipated by
`Bartholomäus. Pet. 50–59. Patent Owner opposes Petitioner’s assertion.
`Prelim. Resp. 45–53. Based on the current record, we determine that
`Petitioner has not established a reasonable likelihood that it would prevail in
`showing claims 1–4 and 24–27 are anticipated by Bartholomäus.
`Bartholomäus (Ex. 1009)
`1.
` Bartholomäus relates to a pharmaceutical that provides delayed
`release of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol, which “is
`known from [EP ’475].” Ex. 1009, 3. Example 1 of Bartholomäus describes
`the synthesis of matrix tablets with the following composition per tablet:
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`Patent 7,994,364 B2
`
`
`
`Id. at 18. Example 1 then states that all of the components were weighed in
`and screened, mixed in a container mixer, and “pressed on a Korsch EK0
`press into tablets having a diameter of 10 mm, a radius curvature of 8 mm,
`and a mean tablet weight of 310 mg.” Id.
`Analysis
`2.
`Petitioner argues that Bartholomäus inherently anticipates claims 1–4
`and 24–27. Specifically, Petitioner asserts that Bartholomäus discloses that
`the active ingredient is produced according to EP ’475, which Patent Owner
`has asserted produces Form B of tapentadol HCl. Pet. 51–52. Petitioner
`then notes that, during prosecution of the ’364 patent’s European counterpart
`application, the European patent applicant “admitted that ‘[t]he crystalline
`form B disclosed in D1 [EP 475] has the disadvantage under the influence
`of pressure (which occurs e.g. in the manufacturing process for the drug
`tablet) polymorph B (crystalling form of D1 [EP 475]) is transformed in a
`mixture of the crystalline forms A and B.’” Pet. 52 (citing Ex. 1004, 1).
`Petitioner asserts that this is consistent with the knowledge of an ordinary
`artisan at the time that pressure, such as that caused by tableting, could cause
`polymorphic interconversions. Id. (citing Ex. 1012 ¶ 76). Thus, Petitioner
`concludes that Bartholomäus inherently discloses Form A of tapentadol HCl
`because Bartholomäus discloses forming matrix tablets by subjecting the
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`IPR2016-00471
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`Form B polymorph to the high pressures of a Korsch EK0 press, which
`Patent Owner admits would transform into Form A. Id. at 52–53.
`We are not persuaded. Petitioner offers no objective evidence to
`support its argument that pressure from a Korsch EK0 press during the
`process of forming tablets would necessarily and inevitably cause Form B to
`transform into Form A. Instead, Petitioner relies on a statement taken out of
`context from the prosecution of the European counterpart application. The
`European applicant states that the experiment demonstrating the conversion
`of Form B to Form A occurred for “all form B batches exposed to pressure
`of 2 tons within only 60 seconds.” Ex. 1004, 1–2. Nothing in Bartholomäus
`suggests that the preparation of tablets should include exposing the
`composition to a pressure of 2 tons for 60 seconds.
`Moreover, Petitioner offers no objective evidence that an ordinary
`artisan forming tablets of delayed release tapentadol HCl with a Korsch EK0
`press would read Bartholomäus and apply 2 tons of pressure to the
`composition for 60 seconds. At best, Petitioner and its declarant argue that a
`person of ordinary skill in the art “would have understood that the Korsch
`EK0 eccentric press is capable of achieving compression forces of up to
`30 kN, which is more than 3 tons (approx. 6,700 lb).” Pet. 53 (first
`emphasis added); Ex. 1012 ¶ 78. Petitioner then asserts that Bartholomäus
`“would have enabled a POSA following the procedure of Example 1 to
`i) prepare a matrix composition comprising Form B of tapentadol HCl, and
`ii) expose the composition to pressures of 6,000 lb or more in a Korsch EK0
`press to form a tablet.” Pet. 53 (citing Ex. 1012 ¶ 79). As alleged support,
`Dr. Bihovsky states that a person of ordinary skill in the art “would have
`understood that pressure, such as that caused by tableting, could cause
`polymorphic interconversions.” Ex. 1012 ¶ 76 (emphasis added).
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`But whether a person of ordinary skill in the art could have followed
`the procedure of Example 1 to use pressures of 6,000 lb or more to form a
`tablet is not the question. Nor is the question whether an ordinary artisan
`would have known that pressure could cause polymorphic interconversions.
`Inherency must be established by more than probabilities or possibilities,
`and the mere fact that polymorphic interconversion may result from a given
`set of circumstances is not sufficient. See In re Robertson, 169 F.3d at 743.
`After considering the Petition and Preliminary Response, we find that
`Petitioner has not offered sufficient evidence to show that Example 1 of
`Bartholomäus necessarily and inevitably produces Form A of tapentadol.
`Thus, we determine that Petitioner has failed to establish a reasonable
`likelihood that claims 1–4 and 24–27 are anticipated by Bartholomäus.
`Patent Owner’s Remaining Arguments
`E.
`Patent Owner asserts that we should deny the Petition because it fails
`to name all the real parties-in-interest. Prelim. Resp. 53–55. In particular,
`Patent Owner argues that the Petition fails to identify the Coalition for
`Affordable Drugs VI LLC (“CFAD VI”) as a party, despite the fact that
`CFAD VI is listed as the Petitioner on the face of the declarations of
`Drs. Bihovsky and Mayo. Id. (citing Exs. 1012, 1014).
`Patent Owner also argues that Petitioner is “seeking to short circuit
`the Hatch-Waxman process.” Id. at 56. Specifically, Patent Owner notes
`that Congress established the Abbreviated New Drug Application
`(“ANDA”) process where generic companies can challenge the validity of a
`patent in a Hatch-Waxman litigation. Id. at 55–56. If the ANDA filers are
`successful in the litigation, the first-filer generics receive 180 days of
`regulatory exclusivity, ensuring that no other generic products will be
`approved during that period. Here, Patent Owner asserts that by filing its
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`Petition, Petitioner may deprive the companies who have complied with the
`Hatch-Waxman ANDA procedures from obtaining the 180-day exclusivity
`period if their court challenges are successful. Id. at 56. Accordingly,
`Patent Owner contends that the filing of the Petition is an improper use of
`the inter partes review system.
`We have considered Patent Owner’s remaining arguments, but, in
`light of our findings above, we determine that it is unnecessary to reach
`these issues in this Decision.
`CONCLUSION
`
`We conclude that Petitioner has not established a reasonable
`likelihood of prevailing on its assertions that claims 1–4 and 24–27 of the
`’364 patent are unpatentable over the cited references.
`ORDER
`
`In consideration of the foregoing, it is hereby:
`ORDERED that Petitioner’s request for an inter partes review of
`claims 1–4 and 24–27 of the ’364 patent is denied.
`
`
`
`
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`IPR2016-00471
`Patent 7,994,364 B2
`
`PETITIONER:
`
`Sarah Spires
`Parvathi Kota
`SKIERMONT DERBY LLP
`
`364Rosellini@skiermontderby.com
`
`
`PATENT OWNER:
`
`Anthony C. Tridico
`Amanda K. Murphy
`Kristi McIntyre
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`
`anthony.tridico@finnegan.com
`amanda.murphy@finnegan.com
`GrunenthalGmbHIPRs@finnegan.com
`
`
`17
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`