Trials@uspto.gov
`571-272-7822
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` Paper No. 48
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` Entered: November 14, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`____________
`
`Case PGR2015-00011
`Patent 8,859,623 B1
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 328(a) and 37 C.F.R. § 42.73
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`571-272-7822
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` Paper No. 48
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` Entered: November 14, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`____________
`
`Case PGR2015-00011
`Patent 8,859,623 B1
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 328(a) and 37 C.F.R. § 42.73
`
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`PGR2015-00011
`Patent 8,859,623 B1
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`INTRODUCTION
`Altaire Pharmaceuticals, Inc. (“Petitioner”) filed a Petition for a post-
`grant review of claims 1–13 of U.S. Patent No. 8,859,623 B1 (“the ’623
`patent,” Ex. 1001). Paper 1 (“Pet.”). On November 16, 2015, the Board
`instituted trial to review patentability of the challenged claims. Paper 14
`(“Dec.”). Thereafter, Paragon Bioteck, Inc. (“Patent Owner”) filed a
`Response (Paper 20 (“PO Resp.”)), and Petitioner filed a Reply (Paper 35).
`Oral hearing was held on July 12, 2016. See Paper 47 (“Tr.”).
`The Board has jurisdiction under 35 U.S.C. § 6 and issues this final
`written decision pursuant to 35 U.S.C. § 328(a) and 37 C.F.R. § 42.73.
`For the reasons provided below, we determine that Petitioner has not
`met its burden of proving the unpatentability of claims 1–13 of the ’623
`patent by a preponderance of the evidence. See 35 U.S.C. § 326(e).
`The ’623 Patent
`The ’623 patent “is directed to methods and compositions of
`stabilizing phenylephrine formations.” Ex. 1001, Abstract. “Phenylephrine
`is a selective α1-adrenergic receptor agonist used primarily as a
`decongestant, as an agent to dilate the pupil, and to increase blood pressure.”
`Id. at 1:6–8. At the time of the ’623 patent invention, it was known that
`R-phenylephrine, but not S-phenylephrine, was useful to dilate the pupil. Id.
`at 6:21–30. According to the ’623 patent, “it is important that an eye drop
`containing Phenylephrine Hydrochloride used for dilation of the pupil
`contains predominantly the R-isomer in order to maintain maximum efficacy
`of the ophthalmic solution.” Id. at 6:30–33.
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`In addition, according to the ’623 patent, generally, commercially
`available phenylephrine hydrochloride ophthalmic solutions were stored at
`20 to 25 degree Celsius, with the container tightly closed. Id. at 2:60–65. A
`solution under such condition, however, often turns brown over time and
`cannot be used. Id. at 2:66–3:3. The ’623 patent states that it “provides the
`improvement to overcome such instability problem.” Id. at 3:4–5.
`Specifically, the ’623 patent provides “a composition comprising at
`least 95% R-phenylephrine hydrochloride and an aqueous buffer, wherein
`the composition substantially maintains an initial chiral purity of R-
`phenylephrine hydrochloride for at least 6 months stored between –10 to 10
`degree Celsius.” Id. at 1:16–21. It also discloses “methods of dilating the
`pupil comprising administering a composition comprising R-phenylephrine
`hydrochloride topically to a mammal, wherein the composition substantially
`maintains the initial chiral purity of R-phenylephrine hydrochloride for at
`least 6 months.” Id. at 1:38–42.
`Illustrative Claim
`Claims 1 is the sole independent claim. It reads:
`1.
`A method of using an ophthalmic composition for pupil
`dilation,
`the
`composition
`comprising R-phenylephrine
`hydrochloride having an initial chiral purity of at least 95% and
`an aqueous buffer, wherein the chiral purity of R-phenylephrine
`hydrochloride is at least 95% of the initial chiral purity after 6
`months, the method comprising:
`administering the composition into an eye of an individual in
`need thereof, wherein the composition is stored between –10 to
`10 degree Celsius prior to administration, and wherein the
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`composition comprises R-phenylephrine hydrochloride having a
`chiral purity of at least 95% when administered after storage.
`Reviewed Ground of Unpatentability
`The Board instituted trial to review whether claims 1–13 of the ’623
`patent are unpatentable as obvious over Altaire’s Product, i.e., the
`phenylephrine hydrochloride ophthalmic solution Lot # 11578 and Lot
`# 11581.1
`
`ANALYSIS
`Claim Construction
`In a post-grant review, we interpret a claim term in an unexpired
`patent according to its broadest reasonable construction in light of the
`specification of the patent in which it appears. 37 C.F.R. § 42.200(b); see
`also In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1281 (Fed. Cir. 2015)
`(concluding that “Congress implicitly adopted the broadest reasonable
`interpretation standard in enacting the AIA”), aff’d sub nom. Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard,
`and absent any special definitions, we assign claim terms their ordinary and
`customary meaning, as would be understood by one of ordinary skill in the
`
`
`1 Lot # 11578 is a 2.5% phenylephrine hydrochloride ophthalmic solution,
`manufactured in December 2011, and sold and distributed to an Altaire
`customer in October 2012. Ex. 1003 ¶¶ 4, 36; Ex. 1007. Lot # 11581 is a
`10% phenylephrine hydrochloride ophthalmic solution, manufactured in
`January 2012, and sold and distributed to another Altaire customer in
`October 2012. Ex. 1003 ¶¶ 5, 6, 36; Ex. 1009.
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`art at the time of the invention, in the context of the entire patent disclosure.
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`In its Response, Patent Owner states that it agrees with our
`determination in the Institution Decision that no terms require express
`construction. PO Resp. 14 (citing Dec. 9). Nonetheless, Patent Owner
`contends that “claim 1 requires storage after six months, between −10 to 10
`degrees Celsius, such that the chiral purity after said storage is at least 95%
`of the initial chiral purity.” Id. To the extent Patent Owner requests that we
`limit the method step by adding a six-months-cold-storage requirement, we
`reject this attempt.
`We find no basis to interpret the claims as requiring a step of cold
`storage of the composition for six months before administering to a patient.
`The only step of claim 1 recites that the composition is “stored between –10
`to 10 degree Celsius prior to administration.” Ex. 1001, 12:45–48. It does
`not specify how long the storage must be at that cold temperature. Patent
`Owner, however, relies on the preamble, which explicitly recites the chiral
`purity “is at least 95% of the initial chiral purity after 6 months.” Ex. 1001,
`12:42–44 (emphasis added). This language of the preamble is consistent
`with the prosecution history, in which the applicants argued, and the
`examiner agreed, that claim 1 was patentable because the chiral purity
`remained at least 95% of the initial chiral purity after cold storage for six
`months. See Ex. 1002, 110, 113, 167.
`Maintaining at least 95% of the initial chiral purity after six months,
`however, simply describes a property of the composition to be administered.
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`The characteristic, defined in the preamble, does not add a limitation on the
`duration of storage at cold temperatures recited in the “administering” step.
`This is especially so because the preamble requires that, after the six-month
`storage, the chiral purity is only at least 90.25% (i.e., “at least 95% of the
`initial chiral purity,” which is already defined in the preamble as “at least
`95%”). See id. at 12:41–44. In contrast, the step of claim 1 requires “a
`chiral purity of at least 95% when administered after storage.” Id. at 12:49–
`50. In other words, the step of claim 1 defines the chiral purity of the
`composition at the time of administration after cold storage for an
`unspecified time period, whereas the preamble defines chiral purity of the
`composition after six months in relation to the “initial” chiral purity. We,
`therefore, treat the preamble as a limitation only to the extent that it defines a
`property of the composition to be administered.2
`Thus, we reject Patent Owner’s interpretation that the administering
`step of claim 1 requires an active step of cold storage for six months.
`Instead, we determine that claim 1 is directed to a method of administering a
`composition—wherein the composition comprises R-phenylephrine
`hydrochloride that exhibits the property of having at least 95% of the initial
`chiral purity after six months—as long as the composition is stored in cold
`temperature before the administration, and is at least 95% R-phenylephrine
`hydrochloride when administered.
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`2 Neither party has argued that the preamble should be disregarded
`altogether in our analysis.
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`Witness Status of Assad Sawaya
`In support of its patentability challenge, Petitioner relies on a
`Declaration of Assad Sawaya, who is the President of Petitioner. Ex. 1003.
`Patent Owner argues that Petitioner’s witness, Mr. Sawaya, is a fact witness,
`and not an expert. PO Resp. 29. We agree with Patent Owner.
`In his declaration in support of the Petition, Mr. Sawaya testifies
`“based upon [his] personal knowledge of the facts stated [t]herein.”
`Ex. 1003 ¶ 1. Nowhere in that declaration does he explain his “knowledge,
`skill, experience, training, or education” that would provide the bases for his
`qualification as an expert. See Dec. 14 (quoting Fed. R. Evid. § 702). As
`such, we find it appropriate to consider Mr. Sawaya as a fact witness, rather
`than an expert, in this proceeding.
`This is so even though later, in its Reply, Petitioner argues that
`Mr. Sawaya qualifies as an expert witness. See Reply 2–3. As support,
`Petitioner submits another declaration by Mr. Sawaya, accompanied by his
`curriculum vitae, detailing his experience in the pharmaceutical industry.3
`See Ex. 1025. Petitioner fails to appreciate that the issue here is not whether
`Mr. Sawaya qualifies as an expert witness in the abstract; rather, it is
`whether Petitioner has properly qualified Mr. Sawaya as an expert witness
`with respect to the testimony he has provided in this proceeding. We
`determine Petitioner has not.
`
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`3 Substantively, the Reply Declaration of Mr. Sawaya does not include any
`testimony to support Petitioner’s patentability challenge.
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`A reply may only respond to arguments raised in the corresponding
`patent owner response. 37 C.F.R. § 42.23(b). As we previously explained,
`“respond,” in the context of this Rule, does not permit Petitioner to depart
`from the positions originally taken in the Petition and embark in a new
`direction with a new approach. Paper 38, 1. Here, Petitioner intends to
`revise the witness status of Mr. Sawaya from a lay person to an expert. This
`change would affect what subjects on which Mr. Sawaya may testify
`competently. For example, under Federal Rule of Evidence 602, a witness
`may testify only to a matter of which he has personal knowledge. In
`contrast, “[a]n expert may base an opinion on facts or data in the case that
`the expert has been made aware of or personally observed.” Fed. R. Evid.
`§ 703. As a result, while an expert may testify on certain topics, such as
`prior art teachings or the level of ordinary skill, a lay witness may not do so.
`Because retroactively qualifying Mr. Sawaya as an expert at the time of the
`Reply would impact our treatment of the testimony he provided in support of
`the Petition, and because Patent Owner did not have the opportunity to
`consider and respond to Mr. Sawaya’s prior testimony in that capacity, we
`decline to do so at this late stage.
`Our approach is consistent with those of federal courts, which
`generally do not consider new evidence presented at the end of a briefing
`schedule when the other party no longer has an opportunity to respond. See,
`e.g., Stamps.com Inc. v. Endicia, Inc., 437 F. App’x 897, 909 (Fed. Cir.
`2011) (holding that the district court acted within its discretion when it did
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`not consider supplementary declarations submitted for the first time in a
`reply brief because the other party did not have an opportunity to respond).
`In sum, we reject Petitioner’s belated attempt and decline to consider
`the new Sawaya declaration because it is improper reply evidence.
`Petitioner has failed to timely qualify Mr. Sawaya as an expert witness in
`this proceeding. Thus, we accord no weight to his opinion in that capacity.
`Obviousness over Altaire’s Product
`Petitioner argues that claims 1–13 of the ’623 patent are unpatentable
`as obvious over Altaire’s Product. Pet. 33–45.
`Petitioner relies on two lots of Altaire’s phenylephrine hydrochloride
`ophthalmic solution products: Lot # 11578 and Lot # 11581. Pet. 34. We
`explained in the Decision to Institute that Petitioner has shown that these
`products were “in public use, on sale, or otherwise available to the public”
`before November 14, 2013, the effective filing date of the challenged claims.
`See Dec. 10 (citing 35 U.S.C. § 102(a)(1)). Patent Owner does not dispute
`this finding. Having considered the complete record developed at trial, we
`see no reason to change our conclusion that Lot # 11578 and Lot # 11581
`qualify as prior art.
`Petitioner points out that Altaire’s Product contains R-phenylephrine
`hydrochloride and an aqueous buffer, as claim 1 requires. Pet. 38 (citing
`Ex. 1018, 1). The package insert directs the user to place one drop of the
`solution in each eye for pupil dilation, also as claim 1 requires. Id. at 37
`(citing Ex. 1018, 1), 39 (citing Ex. 1018, 2). Furthermore, the package insert
`instructs that the Altaire’s Product should be stored at 2–8 degree Celsius,
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`within the temperature range recited in claim 1. Id. at 40 (citing Ex. 1018,
`2). Patent Owner does not dispute Petitioner’s assertions regarding these
`limitations. Based on the full record developed at trial, we are persuaded
`that Altaire’s Product meets these limitations of claim 1.
`With regard to the chiral-purity limitations of claim 1, Petitioner
`refers to Exhibits 1012, 1016, and 1019.4 Id. at 35–39. Exhibits 1016 and
`1019 refer to data from certain High Performance Liquid Chromatography
`(HPLC) experiments. Exhibit 1012 refers to certain optical rotation data
`obtained using an optical polarimeter.
`HPLC Data (Exhibits 1016 and 1019)
`Petitioner argues that, in Exhibit 1016, the HPLC data showed no S-
`form of phenylephrine was detected in either Lot # 11578 or Lot # 11581
`after storage under room temperature for 37 months. Pet. 35–37. Petitioner
`also asserts that, in Exhibit 1019, the HPLC data showed no S-form of
`phenylephrine was detected in Lot # 11581 after cold storage for over six
`months. Id. at 37, 39. According to Petitioner, because the chiral purity of
`R-phenylephrine hydrochloride remained undiminished after over six
`months of storage under either cold or room temperature, the initial chiral
`purity must have been essentially 100%. Id. at 35–39. Thus, Petitioner
`concludes that Altaire’s Product meets the limitations of claim 1, requiring
`
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`4 Petitioner also refers to Exhibit 1017. See Pet. 24–26, 36. The results
`shown in that exhibit, however, are from a “fresh preparation of” sample,
`and not Lot # 11578 or Lot # 11581. Thus, we do not consider the data in
`Exhibit 1017 in rendering this Decision.
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`“an initial chiral purity of at least 95%” and the chiral purity to be “at least
`95% of the initial chiral purity after 6 months.” Id.
`In its Response, Patent Owner maintains that the USP standard HPLC
`does not reliably detect chiral impurity.5 PO Resp. 38–42. According to
`Patent Owner, because the USP standard HPLC method is incapable of
`separating R- and S- form of phenylephrine, Petitioner cannot use the
`method to show that Altaire’s Product meets the chiral-purity limitations of
`the challenged claims. Id. at 42–43.
`In its Reply, Petitioner does not address the USP standard HPLC
`method. Rather, it asserts that, instead of the “publicly available” USP
`standard HPLC method, Petitioner “relies on its proprietary HPLC
`procedure <TMQC-247> (ref.:Validation Report STU0346).” Reply 8.
`According to Petitioner, “Patent Owner did not conduct its own testing to
`show that Petitioner’s products do not meet the limitations of the challenged
`claims.” Reply 9. Petitioner argues that “because Patent Owner failed to
`provide affirmative test results to the contrary, it is more likely than not that
`Petitioner’s HPLC testing data is reliable and accurate.” Id. at 9–10.
`Petitioner is mistaken.
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`5 On this issue, at the institution stage, we were not persuaded by the record
`available then, wherein Patent Owner relied upon a declaration submitted
`during the prosecution (“the Witham Declaration”). Dec. 12. During trial,
`Patent Owner provides additional evidence to support its position. See
`Exs. 2021, 2040.
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`In a post-grant review, as in an inter partes review, the burden of
`persuasion is on the petitioner to prove unpatentability, and that burden
`never shifts to the patentee. See 35 U.S.C. § 326(e); Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). In
`addition, “[w]here, as here, the only question presented is whether due
`consideration of the four Graham factors renders a claim or claims obvious,
`no burden [of production] shifts from the patent challenger to the patentee.”
`In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1376 (Fed. Cir. 2016).
`Further, while we may institute a post-grant review if the petition
`demonstrates it is “more likely than not” that at least one challenged claim is
`unpatentable (see 35 U.S.C. § 324(a)), the petitioner must prove
`unpatentability by a preponderance of the evidence (see 35 U.S.C. § 326(e)).
`Thus, in this proceeding, our only inquiry is whether Petitioner has met its
`burden of proving obviousness by a preponderance of the evidence. And we
`conclude Petitioner has not done so.
`Petitioner contends that, in the Decision to Institute, we “relied on
`Patent Owner’s representations that Petitioner used the HPLC method
`published by the USP Guidelines.” Reply 8 n.3. In fact, however, we also
`relied on Petition’s representation that “Altaire’s HPLC method for chiral
`purity testing was validated pursuant to established United States
`Pharmacopeia guidelines (USP <1225> Validation of Compendial
`Procedures).” See Pet. 36 n.10. Petitioner argues that, notwithstanding
`footnote 10 in the Petition, the only HPLC methodology referred to therein
`is TMQC-247, Petitioner’s proprietary method. Tr. 10:23–11:13; see also
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`Reply 9 (arguing that the Validation of Compendial Procedures monograph
`“does not set forth a method of conducting HPLC testing, nor does it require
`a method to follow the USP published HPLC method to obtain validation”).
`According to Petitioner, Mr. Sawaya’s declaration confirmed the usage of
`the proprietary methodology. Tr. 11:21–23; Reply 8. We are not persuaded.
`The Petition refers to Altaire’s allegedly proprietary HPLC method
`TMQC-247 three times, none of which addresses the chiral purity of
`Altaire’s Product. See Pet. 20, 49–50, 61. Indeed, according to the Petition,
`“Altaire performed Chiral HPLC studies using its proprietary and validated
`HPLC procedure <TMQC-247> (ref.: Validation Report STU0346) to
`determine the impact of storage at room temperature upon” the “Akorn
`product.” Id. at 20. In addition, “Altaire tested five lots of the API
`manufactured by Syn-Tech – more than one year prior to the ’623 patent’s
`filing date – using Altaire’s HPLC method (Altaire test method TMQC-
`247).” Id. at 49–50; see also id. at 61 (the same). Mr. Sawaya’s testimony
`on this issue is substantially the same as these two statements. See Ex. 1003
`¶¶ 21, 47.
`In contrast, when discussing the HPLC method to determine the chiral
`purity of Altaire’s Product, Petitioner neither describes it as proprietary nor
`refers to it as TMQC-247. See, e.g., Pet. 35 (stating “HPLC analysis of lot
`# 11578 for chiral purity”), 36 (stating a freshly prepared lot was “analyzed
`by HPLC for chiral purity”). Thus, we cannot verify, based on the Petition
`and the accompanying evidence, that the HPLC data of Altaire’s Product
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`Petitioner relies on were generated using its allegedly proprietary HPLC
`method TMQC-247, and not the USP standard HPLC method.
`Moreover, even if we accept Petitioner’s assertion that it generated the
`data using its allegedly proprietary HPLC method TMQC-247, we still
`would not be persuaded to rule in Petitioner’s favor. This is because, as
`Patent Owner correctly points out, the tests and data submitted with the
`Petition do not meet the requirements of 37 C.F.R. § 42.65. See PO Resp.
`31–38.
`Our Rule requires that:
`If a party relies on a technical test or data from such a test, the
`party must provide an affidavit explaining:
`(1) Why the test or data is being used;
`(2) How the test was performed and the data was generated;
`(3) How the data is used to determine a value;
`(4) How the test is regarded in the relevant art; and
`(5) Any other information necessary for the Board to evaluate the
`test and data.
`37 C.F.R. § 42.65(b). Here, Petitioner relies on the HPLC data to show that
`Altaire’s Product meets the chiral-purity limitations of claim 1. The Sawaya
`Declaration (Ex. 1003)—the only declaration submitted with the Petition—
`however, fails to explain, among others, how the test was performed and
`how the data was generated.
`During the hearing, Petitioner argued that Exhibit 1020 provides all
`necessary HPLC information. Tr. 12:3–10. Exhibit 1020 shows the
`detection of S- and R- isomers in the drug substance used in manufacturing
`Altaire’s Product, i.e., the active ingredient from Syn-Tech. Pet. 50; Tr. 8:3–
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`14. The note of the exhibit reads: “S(+)-isomer concentration was
`determined by HPLC using a Chiralpak 4.6x250mm, 5m column at 270nm
`as per Altaire test method TMQC-247.” Ex. 1020. According to Petitioner,
`this note shows that “all of the information that was necessary for the HPLC
`methodology to be run or to be tested against was provided within the
`petition.” Tr. 12:8–10. We are not persuaded.
`Dr. Gojko Lalic, the expert witness for Patent Owner, testifies that in
`an HPLC test, “[t]he elution profile for a given sample is dependent on
`experimental conditions,” such as the “solid packing material in the column,
`mobile phase (solvent), flow rate, and temperature.” Ex. 2016 ¶ 26.
`Petitioner’s own documents (Exs. 1027, 1028)6 appear to confirm Dr. Lalic’s
`testimony. Indeed, the protocol for TMQC-247 is ten pages long, in contrast
`to the one-sentence note in Exhibit 1020. The protocol provides information
`about the standards and samples preparation as well as the procedures for
`running the test. For chromatographic parameters, the protocol lists not only
`the column and wavelength as shown in Exhibit 1020, but also includes the
`flow rate, column temperature, injection volume, and run time. Petitioner,
`however, did not submit the protocol until filing its Reply, when Patent
`Owner no longer has an opportunity to respond. Tr. 11:14–20. As a result,
`we do not consider Exhibits 1027 and 1028. See 77 Fed. Reg. 48612, 48620
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`6 We previously granted Petitioner’s Motion to seal Exhibits 1027 and 1028
`in their entirety. See Paper 46. In rendering this Decision, although we refer
`to the sealed exhibits, we do not rely on the substantive information therein.
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`(Aug. 14, 2012) (“Reply evidence . . . must be responsive and not merely
`new evidence that could have been presented earlier.”).
`Petitioner asserts that Patent Owner has waived its challenge of
`Petitioner’s evidence, including the HPLC data supporting the Petition,
`because Patent Owner failed to timely object pursuant to 37 C.F.R.
`§ 42.64(b)(1). Reply 4–5. According to Petitioner, had Patent Owner
`followed the rules, “Petitioner could have, if deemed necessary, served
`supplemental evidence or sought leave to file supplemental information to
`address Patent Owner’s concerns.” Id. at 5. We are not persuaded.
`First, Patent Owner’s contention regarding Petitioner’s HPLC data is
`directed to the sufficiency of the evidence, rather than its admissibility.7 As
`a result, the time limit provided for evidentiary objections in § 42.64(b)(1)
`does not apply. Second, as Petitioner recognizes, it could have sought leave
`to file supplemental information after we instituted trial. Filing
`supplemental information, however, does not depend on any objection from
`Patent Owner. See 37 C.F.R. § 42.123. Thus, we conclude that Patent
`Owner has not waived its challenge of the sufficiency of Petitioner’s
`evidence, including the HPLC data.
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`7 Patent Owner also asserts that Mr. Sawaya lacks personal knowledge in
`testifying on the HPLC and polarimetry tests that Petitioner relies on. PO
`Resp. 30–31. To the extent these arguments relate to the admissibility of
`Petitioner’s evidence, we do not consider Patent Owner’s assertions in
`rendering this Decision.
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`Petitioner also argues that Patent Owner is, and has been, in
`possession of the details of Petitioner’s test method TMQC-247. Reply 5.
`That might well be so; yet, it does not relieve Petitioner from meeting the
`requirements of § 42.65(b). After all, it is the Board, and not Patent Owner,
`who must evaluate the patentability of the challenged claims. In this post-
`grant review, an adversarial proceeding, while each party should conduct
`itself in a civil manner, Patent Owner has no duty to first bring to our
`attention, and then thoroughly address, evidence to support Petitioner’s case.
`Without the necessary information prescribed in § 42.65(b), we cannot
`determine whether the evidence Petitioner relies on is credible.
`In short, regarding the HPLC data, Petitioner does not point to any
`credible evidence accompanying the Petition that meets the requirements of
`§ 42.65(b). Thus, even if we accept Petitioner’s assertion that the HPLC
`data of Altaire’s Product were generated using its allegedly proprietary
`HPLC method TMQC-247, we give no weight to those data.
`Optical-Rotation Data (Exhibit 1012)
`Petitioner further relies on Exhibit 1012, which reports the optical-
`rotation data from an identification test by polarimetry. Ex. 1012, 3. Exhibit
`1012 uses “Phenylephrine Hydrochloride R (-) Sigma Aldrich lot P6126” as
`the control to determine if the phenylephrine hydrochloride in Altaire’s
`product is in R- or S- form. Id. Exhibit 1012 shows the specific rotation of
`Lot # 11578 is 101.5% of the control. Id. at 8–9. In other words, the chiral
`purity of Altaire’s product Lot # 11578 was over 100%. Pet. 10. Because
`the chiral purity of Lot # 11578 after cold storage for over six months was
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`essentially 100% of R-phenylephrine, Petitioner contends, the initial
`chirality of the product would have been essentially 100%. Id. at 36–39.
`Patent Owner counters that because of their variability, “optical
`rotation measurements are considered unsatisfactory as a tool for
`determining chiral purity.” PO Resp. 37 (citing Ex. 2016 ¶¶ 44, 45;
`Ex. 2022, 1073). According to Patent Owner, the optical-rotation method
`merely determines the purity of a test sample as relative to a control. Id. at
`44 (citing Ex. 2016 ¶ 42). Thus, Patent Owner argues, the optical-rotation
`study Petitioner relies on is “of no value because, rather than quantitating
`chiral purity, it merely compares the Lot #11578 sample to a control sample
`of unknown chiral purity.” Id. at 43 (citing Ex. 2016 ¶¶ 42, 43, 46, 47). We
`find Patent Owner’s argument more persuasive.
`First, as Patent Owner points out, the control sample used in Exhibit
`1012 does not appear to be analytical grade. See PO Resp. 45. Indeed,
`while Sigma Aldrich provides certain R-phenylephrine hydrochloride as
`“analytical standard,” Sigma-Aldrich P6126, the control sample Petitioner
`used, is merely labeled as “powder.” Ex. 2037, 1.
`Second, in Exhibit 1012, the control sample was assigned a purity
`factor of 1.00. Ex. 1012, 3. Petitioner does not, however, explain how the
`chiral purity of the control was determined. Instead, Petitioner points to the
`catalog page of Sigma-Aldrich P6126, evidence submitted by Patent Owner,
`which states that the purity is ≥99%. Reply 10 (citing Ex. 2019). We agree
`with Petitioner that there is no reason to doubt this representation by Sigma-
`Aldrich. See id. at 11. The same catalog page, however, qualifies this
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`representation as made “at the time of the quality release or subsequent
`retest date.” Ex. 2019. It further suggests that the recommended retest
`period is three years. Id. Petitioner does not point to any credible evidence
`to show the lot number of the phenylephrine hydrochloride P6126 it used as
`control, when the lot was manufactured, or how long after the manufacturing
`date Petitioner used it as the control. Indeed, for the optical-rotation data, as
`for the HPLC data, Petitioner has not provided any affidavit in compliance
`with 37 C.F.R. § 42.65(b). Thus, while P6126 was ≥99% pure R-
`phenylephrine hydrochloride at the time Sigma-Aldrich tested it, Petitioner
`has not sufficiently shown that the chiral purity remained the same at the
`time it was used as the control in the polarimetry test of Exhibit 1012.
`We acknowledge that Exhibit 1012 shows the specific rotation of
`25 mg/mL control solution is -46.3º. Ex. 1012, 6. According to Petitioner, a
`specific rotation within the -42º to -47.5º range indicates that the
`phenylephrine hydrochloride tested is in the R-form. Id. at 3. We also
`acknowledge that the USP Monograph reports the same range for a sample
`of 50 mg/mL of R-phenylephrine hydrochloride. Ex. 2020, 1. Nonetheless,
`Patent Owner has presented sufficient evidence to challenge the accuracy of
`estimating enantiomer purity based on the specific rotation. For example, it
`is recognized that:
`Values of [specific rotation] are affected by many variables,
`among which are wavelength,
`solvent, concentration,
`temperature, and presence of soluble impurities.
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`The cumulative effect of the above-mentioned variables on [the
`specific-rotation value] is potentially very large. A practical
`consequence is that precise reproduction of published rotation
`values, from laboratory to laboratory, or even from day to day in
`the same laboratory, is difficult to achieve.
`Ex. 2022, 1073.
`Lastly, the specific rotation of Altaire’s Product is over 100% of the
`control. Ex. 1012, 8. This further casts doubt into either the purity of the
`control, or the accuracy of the optical-rotation methodology. In sum, we are
`not persuaded that Petitioner’s optical-rotation data amount to a
`preponderance of the evidence to show that Altaire’s Product meets the
`chiral-purity limitations of the challenged claims.
`Real Party in Interest
`Patent Owner urges that we dismiss the Petition because Petitioner
`fails to identify additional real parties in interest with respect to the Petition.
`PO Resp. 14–28. Because we determine that Petitioner has not shown, by a
`preponderance of the evidence, the unpatentability of the challenged claims,
`we need not reach the real-party-in-interest
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