Trials@uspto.gov
`571.272.7822
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`
`
`
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` Paper No. 9
`
` Entered: January 11, 2018
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WATSON LABORATORIES, INC.
`Petitioner,
`v.
`UNITED THERAPEUTICS, CORP.1
`Patent Owner.
`____________
`
`Case IPR2017-01622
`Patent 9,339,507 B2
`____________
`
`
`Before LORA M. GREEN, ERICA A. FRANKLIN, and DAVID COTTA,
`Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`1 Further to Patent Owner’s request, we have changed the case caption in
`order to reflect that United Therapeutics Corp. is the assignee of record with
`respect to US Patent No. 9,399,507 B2. Prelim Resp. 1, n. 1.
`
`
`
`571.272.7822
`
`
`
`
`
`
` Paper No. 9
`
` Entered: January 11, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WATSON LABORATORIES, INC.
`Petitioner,
`v.
`UNITED THERAPEUTICS, CORP.1
`Patent Owner.
`____________
`
`Case IPR2017-01622
`Patent 9,339,507 B2
`____________
`
`
`Before LORA M. GREEN, ERICA A. FRANKLIN, and DAVID COTTA,
`Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`1 Further to Patent Owner’s request, we have changed the case caption in
`order to reflect that United Therapeutics Corp. is the assignee of record with
`respect to US Patent No. 9,399,507 B2. Prelim Resp. 1, n. 1.
`
`
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`IPR2017-01622
`Patent 9,339,507 B2
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`
` INTRODUCTION
`Watson Laboratories, Inc. (“Petitioner” or “Watson”) filed a Petition
`requesting an inter partes review of claims 1‒9 of U.S. Patent No. 9,339,507
`B2 (Ex. 1001, “the ’507 patent”). Paper 2 (“Pet.”). United Therapeutics
`Corp. (“Patent Owner” or “UTC”) filed a Preliminary Response to the
`Petition opposing institution. Paper 5 (Prelim. Resp.).
`Institution of an inter partes review is authorized by statute only when
`“the information presented in the petition . . . and any response . . . shows
`that there is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.” 35 U.S.C.
`§ 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition, the
`Preliminary Response, and the cited evidence, we conclude that Petitioner
`has satisfied the burden under 35 U.S.C. § 314(a) to show that there is a
`reasonable likelihood that it would prevail with respect to at least one of the
`challenged claims.
`
`Related Proceedings
`A.
`Petitioner and Patent Owner identify the following proceedings as
`relating to the ’507 patent: United Therapeutics Corp. v. Watson
`Laboratories, Inc., Case No. 15-cv-05723 (D.N.J.) and IPR2017-01621,
`which challenges the patentability of U.S. Patent No. 9,358,240 (“the ’240
`patent”). Pet. 4; Paper 3, 2. The ’507 patent and the ’240 patent share a
`common parent and provisional application. Id. Patent Owner also
`identifies US Patent Application No. 15/011,999, a pending continuation
`application with common priority to the ’240 and ’507 patents, as related to
`this proceeding. Paper 3, 2.
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`2
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`Patent 9,339,507 B2
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`
`The ’507 Patent (Ex. 1001)
`B.
`The ’507 patent issued May 17, 2016, identifying Horst Olschewski,
`Robert Roscigno, Lewis J. Rubin, Thomas Schmehl, Werner Seeger, Carl
`Sterritt, and Robert Voswinckel as co-inventors. Ex. 1001 (45), (75). The
`’507 patent discloses “methods and kits for therapeutic treatment . . .
`involving administering treprostinil using a metered dose inhaler and related
`kits.” Id. at 1:16–19.
`
`The ’507 patent teaches that pulmonary hypertension is “a condition
`associated with an elevation of pulmonary arterial pressure (PAP) over
`normal levels.” Id. at 2:7–9. “Pulmonary hypertension has been implicated
`in several life-threatening clinical conditions, such as adult respiratory
`distress syndrome (‘ARDS’) and persistent pulmonary hypertension of the
`newborn (‘PPHN’).” Id. at 2:39–42. “Pulmonary hypertension may also
`ultimately result in a potentially fatal heart condition known as ‘cor
`pulmonale,’ or pulmonary heart disease.” Id. at 2:50–53. According to the
`’507 patent, “[c]urrently, there is no treatment for pulmonary hypertension
`that can be administered using a compact inhalation device, such as a
`metered dose inhaler.” Id. at 2:55–57.
`
`The ’507 patent discloses that “[t]he inventors discovered that a
`therapeutically effective dose of treprostinil can be administered in a few
`single inhalations using a compact inhalation device, such as a metered dose
`inhaler.” Id. at 5:4–7. The ’507 patent further discloses that “such
`administering does not cause significant side effects.” Id. at 5:9–10.
`Challenged Claims
`C.
`Petitioner challenges claims 1‒9 of the ’507 patent. Claim 1, the only
`independent claim, is reproduced below:
`
`3
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`Patent 9,339,507 B2
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`
`1.
`
`A kit for treating pulmonary hypertension comprising:
`(i)
`a formulation comprising 200 to 1000 μg/ml
`treprostinil or a pharmaceutically acceptable salt thereof;
`(ii) a pulsed ultrasonic nebulizer comprising an opto-
`acoustical trigger, configured to
`(a)
`aerosolize a fixed amount of treprostinil per
`pulse, and
`therapeutically
`inhalation a
`(b) deliver by
`effective single event dose of said formulation,
`said single event dose comprising 15 μg to 90 μg treprostinil or
`a pharmaceutically acceptable salt thereof delivered in 1 to 18
`breaths; and
`(iii) instructions for using the pulsed ultrasonic nebulizer
`with the formulation to treat a patient with pulmonary
`hypertension by delivering 15 μg to 90 μg treprostinil or a
`pharmaceutically acceptable salt thereof in 1 to 18 breaths to
`the patient in the single event dose.
`Ex. 1001, 18:12‒28.
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1‒9 of the ’507 patent
`on the following grounds (Pet. 6):
`
`4
`
`
`
`§ 103(a)
`
`§ 103(a)
`
`1‒9
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`1‒9
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`Patent 9,339,507 B2
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`Basis
`§ 103(a)
`
`Claims Challenged
`1‒9
`
`References
`Voswinckel,2 Chaudry,3
`Patton, and Ghofrani4
`Voswinckel, Chaudry, Patton,
`and the OptiNeb User Manual5
`Voswinckel, Chaudry,
`Ghofrani, and the EU
`Community Register6
`
`Petitioner submits the Declaration of Dr. Maureen D. Donovan
`(Ex. 1002), the Declaration of Dr. Scott Bennett (Ex. 1013), two Affidavits
`of Christopher Butler (Ex. 1014 and 1015), and the Declaration of
`Dr. DeForest McDuff (Ex. 1055) in support of institution of inter partes
`review. Patent Owner submits the Declaration of Dr. Richard Dalby (Ex.
`2001), the Declaration of Dr. Werner Seeger (Ex. 2020), the Declaration of
`Dr. Hossein A. Ghofrani (Ex. 2026), the Declaration of Dr. Frank
`
`
`2 Robert Voswinckel, et al. Inhaled Treprostinil Sodium (TRE) for the
`Treatment of Pulmonary Hypertension, Abstract #1414, CIRCULATION, 110,
`17, SUPPLEMENT (OCT. 2004): III-295 (Ex. 1003, “Voswinckel”).
`3 Chaudry, US Patent Publication No. 2004/0265238 A1 issued Dec. 30,
`2004 (Ex. 1004, “Chaudry”).
`4 Hossein Ardeschir Ghofrani et al., Neue Therapieoptionen in der
`Behandlung der pulmonalarteriellen Hypertonie, 30 (4) HERZ 296–302
`(2005) (Ex. 1005, “Ghofrani”). Ghofrani was originally published in
`German. All citations herein are to the English translation of Ghofrani
`provided by Petitioner (Ex. 1005).
`5 OptiNeb-ir Operating Instructions, Model ON-100/2-2.4 MHz (2005) (Ex.
`1006, “OptiNeb”). OptiNeb was originally published in German. Pet. 18, n.
`6. All citations herein are to the English translation of OptiNeb provided by
`the Petitioner (Ex. 1006).
`6 Annexes to Commission Decision C(2005)3436 of 05 September
`2005, http://ec.europa.eu/health/documents/communityregister/
`2005/2005090510259/anx_10259_en.pdf (Annex III–Ventavis Labelling and
`Package Leaflet) (Ex. 1009, “EU Community Register” or “Annex III”).
`5
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`Reichenberger (Ex. 2027), and the Declaration of Dr. Friedrich Grimminger
`(Ex. 2028) to support their arguments in opposition to institution.
` ANALYSIS
`35 U.S.C. § 315(b)
`A.
`We first consider arguments raised in Patent Owner’s Preliminary
`Response challenging whether Petitioner timely filed the Petition. Prelim.
`Resp. 13–20. Patent Owner initially filed a complaint against Petitioner
`alleging infringement of patents other than the ’507 patent in the United
`States District Court for the District of New Jersey on July 22, 2015.
`Ex. 2009, 3. On June 17, 2016, Patent Owner served Petitioner with a
`Motion for Leave to Amend that complaint to assert infringement of the
`newly issued ’507 patent.7 Id. at 4, 11; Ex. 2010. The Motion for Leave to
`Amend attached, as Exhibit A, a copy of a Patent Owner’s proposed First
`Amended Complaint and Jury Demand, which added the ’507 patent to
`Patent Owner’s allegations of infringement in the original complaint.
`Ex. 2009, 15. Petitioner did not oppose Patent Owner’s motion. Id. at 4.
`On June 21, 2016, the District Court granted the motion and Patent Owner
`filed the Amended Complaint. Ex. 2011; Pet. 5; Prelim. Resp. 14.
`Petitioner filed the Petition requesting inter partes review of the ’507 patent
`on June 21, 2017. Paper 4.
`The issue before us is whether Petitioner was “served with a
`complaint” alleging infringement of the ’507 patent prior to June 21, 2016,
`which would bar institution of inter partes review under 35 U.S.C. § 315(b).
`More specifically, the issue is whether service of the “First Amended
`
`
`7 Patent Owner also sought to add the newly issued ’240 patent, which is at
`issue in IPR2017-01621.
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`6
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`Patent 9,339,507 B2
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`Complaint and Jury Demand” as an exhibit attached to Patent Owner’s
`Motion for Leave to Amend constituted service of a “complaint,” thereby
`triggering the one-year time bar under § 315(b).
`The relevant portion of § 315(b) provides:
`(b) PATENT OWNER’S ACTION.--An inter partes
`review may not be instituted if the petition requesting the
`proceeding is filed more than 1 year after the date on which the
`petitioner, real party in interest, or privy of the petitioner is
`served with a complaint alleging infringement of the patent.
`35 U.S.C. § 315(b).
`Patent Owner urges us to deny the Petition, arguing that Petitioner is
`time-barred from seeking inter partes review of the ’507 patent under
`§ 315(b) because Petitioner was served with a complaint on June 17, 2016,
`i.e., more than one year before the June 21, 2017 filing date of the Petitions
`in this proceeding. Prelim. Resp. 13–20.
`
`The Board has previously addressed the issue of when an amended
`complaint is considered to be served in TRW Automotive US LLC v. Magna
`Electronics, Inc., IPR2014-00293, Paper 18 (June 27, 2014) (informative)
`and in Amneal Pharms., LLC v. Endo Pharms. Inc., IPR2014-00360 Paper
`15, (June 27, 2014). In both cases, leave of court was required in order for
`the patent owners to amend their complaints to include additional newly
`issued patents. In both cases, the Board concluded that serving an amended
`complaint as an attachment to a motion seeking leave from the District Court
`to amend the patent owners’ complaints did not constitute service of the
`amended complaint under 35 U.S.C. § 315(b). The rationale, as articulated
`in TRW, was that the patent owner had “requested, but had not obtained yet,
`permission to file a Second Amended Complaint” and, thus, “[a]t the point
`of filing the Motion for Leave to file its Second Amended Complaint, the
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`attachment to the Motion for Leave was merely a proposed complaint, and
`Petitioner was not yet a defendant in a lawsuit with respect to the [patent at
`issue].” TRW, IPR2014-00293, Paper 18 at 10; see also Amneal, IPR2014-
`00360 Paper 15 at 7–8. The Board further reasoned: “We do not believe
`that Congress intended to have the [one-year] time period start before a
`petitioner is officially a defendant in a lawsuit.” TRW, IPR2014-00293,
`Paper 18 at 10 (citing Motorola Mobility LLC v. Arnouse, IPR2013-00010,
`Paper 20, 5 (Jan. 30, 2013)).
`
`Patent Owner argues that this case is distinguishable over TRW
`because Petitioner “conceded its status as a defendant.” Prelim. Resp. 15.
`Patent Owner notes that the parties agreed upon a “proposed schedule to
`account for the inclusion of the new patents in the Civil Action while
`maintaining the original trial schedule” and that Petitioner informed Patent
`Owner that it did not oppose the Motion for Leave. Id. at 16. Patent Owner
`further notes that Petitioner sent a Paragraph IV Certification alleging
`invalidity of the ’507 patent (which constitutes an act of infringement). Id.
`at 18. Finally, Patent Owner argues that the magistrate judge ruling on the
`Motion for Leave to Amend has a 100% allowance rate and there was, thus,
`“no doubt Petitioner was a defendant as to those patents.” Id.
`The distinctions advanced by Patent Owner do not compel a different
`result than was reached in TRW and Amneal. Here, as in TRW and Amneal,
`Patent Owner did not have the authority to amend its complaint until granted
`permission by the District Court. It is undisputed in this case that Patent
`Owner sought leave from the District Court to file an amended complaint
`and that such leave was not granted until June 21, 2016. Ex. 2009;
`Ex. 2011. Thus, regardless of whether Petitioner “conceded its status as a
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`defendant,” Patent Owner requested leave to amend its pleading and make
`Petitioner a defendant with respect to the ’507 patent, which left the matter
`in the Court’s hands to decide. The attachment to the Motion for Leave was
`thus merely a proposed complaint, not an actual “complaint” within the
`meaning of § 315(b).
`In view of the record before us at this time, we conclude Petitioner
`was not “served with a complaint” alleging infringement of the ’507 patent
`for the purposes of § 315(b) until June 21, 2016 and, therefore, that 35
`U.S.C. § 315(b) does not bar institution of this Petition.
`Person of Ordinary Skill in the Art
`B.
`Factual indicators of the level of ordinary skill in the art include “the
`various prior art approaches employed, the types of problems encountered in
`the art, the rapidity with which innovations are made, the sophistication of
`the technology involved, and the educational background of those actively
`working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct.
`Cl. 1975); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011
`(Fed. Cir. 1983) (quoting with approval Jacobson Bros.).
`Petitioner and Patent Owner offer different descriptions of the person
`of ordinary skill in the art, but appear generally to agree that the person of
`ordinary skill would have had a post-graduate degree in a field related to
`drug development and at least two years of practical experience. Pet. 9;
`Prelim. Resp. 8. Petitioner formulates its definition as “a person having . . .
`a Ph.D. degree in pharmaceutical science or a related discipline like
`chemistry or medicinal chemistry, as well as at least two years of practical
`experience in the development of potential drug candidates, specifically in
`the delivery of drug by inhalation.” Pet. 8–9. Patent Owner formulates its
`
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`definition as “a person with a post-graduate degree in medicine or drug
`development (such as the pharmaceutical sciences) with at least two years of
`experience in the investigation or treatment of pulmonary hypertension.”
`Prelim. Resp. 8.
`Petitioner’s description of the level of ordinary skill in the art is
`supported by the current record. In addition, both parties’ experts applied
`Petitioner’s definition of the person of ordinary skill in the art. See Prelim.
`Resp. 8 (noting that Patent Owner’s expert, Dr. Richard Dalby, applied the
`Petitioner’s definition of the person of ordinary skill in the art).
`Accordingly, for purposes of this Decision, we adopt Petitioner’s
`description.
`Moreover, we have reviewed Dr. Donovan’s credentials (Ex. 1002
`¶¶ 5–9) and, at this stage in the proceeding, we consider Dr. Donovan to be
`qualified to provide an opinion on the level of skill and the knowledge of a
`person of ordinary skill in the art at the time of the invention. Additionally,
`we have reviewed Dr. Dalby’s credentials (Ex. 2022) and, at this stage in the
`proceeding, we consider Dr. Dalby to be qualified to provide an opinion on
`the level of skill and the knowledge of a person of ordinary skill in the art at
`the time of the invention. 8
`Claim Construction
`C.
`We interpret claims of an unexpired patent 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 Cuozzo Speed Techs., LLC
`v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under the broadest reasonable
`
`
`8 These determinations would be the same if Patent Owner’s description of
`the person of ordinary skill in the art were applied.
`10
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`construction standard, claim terms are generally 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 Patent Owner offers constructions for several claim terms
`(Prelim. Resp. 9–13), at this stage of the proceeding, we determine that no
`explicit construction of any claim term is necessary to determine whether to
`institute a trial in this case. See Nidec Motor Corp. v. Zhongshan Broad
`Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need
`only construe terms ‘that are in controversy, and only 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))); 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’”).
`Availability of Ghofrani and the EU Community Register as Prior Art
`D.
`Printed Publications
`Patent Owner argues that Ghofrani and the EU Community Register
`do not qualify as prior art printed publications.9 For the reasons explained
`below, we determine that Petitioner has made a sufficient threshold showing
`
`
`9 Patent Owner also argues that Petitioner has not established that OptiNeb
`qualifies as a prior art printed publication. We do not address this argument
`because, even assuming OptiNeb qualifies as a printed publication, we
`determine that Petitioner has not shown a reasonable likelihood of prevailing
`on Ground 2, as explained below in section II. F.
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`that Ghofrani qualifies as a prior art printed publication for purposes of
`institution. To be clear, we have not yet made a determination that
`Petitioner has established by a preponderance of the evidence that Ghofrani
`is a prior art printed publication. Rather, at this preliminary stage, resolving
`factual disputes involving a genuine issue of material fact in favor of
`Petitioner, we have determined only that Petitioner’s evidence is sufficient
`for institution. For the reasons explained below, we determine that the
`Petitioner has not provided sufficient threshold evidence demonstrating that
`the EU Community Register qualifies as a prior art printed publication.
`Availability of Ghofrani
`i.
`Ghofrani is a journal article published in the June 2005 issue of Herz.
`Ex. 1005. Petitioner asserts that Ghofrani is a prior art printed publication
`under 35 U.S.C. § 102(a). Pet. 16. Patent Owner contends that Ghofrani
`does not qualify as prior art because it is not the work of “another.” Prelim.
`Resp. 21–24.
`In order to determine whether Ghofrani qualifies as prior art under
`35 U.S.C. § 102(a), we must consider whether Ghofrani is the work of
`another. In re Katz, 687 F.2d 450, 454 (CCPA 1982) (“[A] printed
`publication cannot stand as a reference under § 102(a) unless it is describing
`the work of another.”) “A [reference] is [considered] ‘to another’ when the
`‘inventive entities’ are different.” In re Fong, 378 F.2d 977, 980 (CCPA
`1967). The determination of whether the disclosure in a reference is the
`work of another focuses on the authorship of the portions of the reference
`relied upon as prior art. Riverwood Int’l Corp. v. R.A. Jones & Co., 324
`F.3d 1346, 1356 (Fed. Cir. 2003) (“What is significant is not merely the
`differences in the listed inventors, but whether the portions of the reference
`
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`relied on as prior art, and the subject matter of the claims in question,
`represent the work of a common inventive entity.”).
`
`Here, Ghofrani lists as authors two persons identified on the face of
`the ’507 patent as inventors (Robert Voswinckel and Werner Seeger) as well
`as three non-inventors (Hossein Ardeschir Ghofrani, Frank Reichenberger,
`and Friedrich Grimminger). Exs. 1001 & 1005. Patent Owner asserts that
`the “non-inventor co-authors made specific and limited contributions to the
`reference, none of which were pertinent to the section (Ex. 1005, 298) relied
`upon by Petitioner.” Prelim. Resp. 22. To support this assertion, Patent
`Owner provides the Declaration of Dr. Seeger, who quotes the passage of
`Ghofrani relied upon by Petitioner and then states:
`The information in this excerpt was compiled and composed by
`Dr. Voswinckel and myself. The idea to perform the
`underlying work described in this section originated with Dr.
`Voswinckel and myself, in view of our work with the other
`inventors listed on the ’240 patent. The other authors listed in
`the Ghofrani article – Drs. Ghofrani, Reichenberger and
`Grimminger – did not contribute to this excerpt or the
`underlying work.
`Ex. 2020 ¶ 7. In addition, Patent Owner provides Declarations from Drs.
`Ghofrani, Reichenberger and Grimminger that describe their contributions to
`the Ghofrani article and, consistent with the Seeger Declaration, disclaim
`having made any contribution to the excerpted passage of Ghofrani relied
`upon by Petitioner. Ex. 2026 ¶¶ 4–6; Ex. 2027 ¶¶ 4–6; Ex. 2028 ¶¶ 4–6.
`
`The declarations from the Ghofrani authors leave some ambiguity as
`to whether and to what extent the five persons who were listed as inventors
`of the ’507 patent, but who were not listed as authors of Ghofrani,
`contributed to the relevant portion of Ghofrani. The contribution of these
`five non-author inventors is discussed in one sentence in Dr. Seeger’s
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`declaration. Dr. Seeger states that the idea to perform the work described in
`the relevant portion of Ghofrani “originated with Dr. Voswinckel and
`myself, in view of our work with the other inventors listed on the ’240
`patent.” Ex. 2020 ¶ 7. It is not clear whether this means that the five non-
`author inventors contributed to the relevant portion Ghofrani, as would be
`necessary to establish that Ghofrani is not the work of another.10 See In re
`Land, 368 F.2d 866, 881 (CCPA 1966) (holding that individual applications
`to Land and to Rogers were prior art with respect to joint application to Land
`and Rogers). This ambiguity creates a genuine issue of material fact.
`In addition, the non-inventor Ghofrani authors are identified as
`authors of Voswinckel, a reference with subject matter limited to inhaled
`treprostinil. Ex. 1003. Voswinckel references a 17 patient study that
`appears to be the same as the 17 patent study discussed in the relevant
`portions of Ghofrani. Compare Ex. 1003 with Ex. 1005. The narrow focus
`of Voswinckel and the potential that Voswinckel involved the same study as
`disclosed in Ghofrani, create a genuine issue of material fact as to the
`contribution of these non-inventors to Voswinckel and, by extension, to the
`relevant portions of Ghofrani.
`At this stage of this proceeding, we are required to resolve any
`genuine issue of material fact in the light most favorable to Petitioner.
`37 C.F.R. § 42.108(c). For purposes of the present decision only, we must
`resolve the disputed factual issues regarding whether Ghofrani constitutes
`the work of another in Petitioner’s favor. Accordingly, for purposes of
`
`
`10 Patent Owner has not asserted that fewer than all of the listed inventors
`contributed to any of the challenged claims.
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`institution, we find that Petitioner has provided a sufficient basis on which to
`conclude that Ghofrani was the work of another.
`Availability of the EU Community Register
`ii.
`The EU Community Register appears to be the third annex to a
`decision of the Commission of the European Communities “amending the
`marketing authori[z]ation for ‘Ventavis® – Iloprost,’ a medicinal product
`for human use, granted by Decision C(2003)3348” (“the Commission
`Decision”). Ex. 1042; Ex. 1009 (Annexes to the Decision). The
`Commission Decision is marked “NOT FOR PUBLICATION,” (Ex. 1042,
`1) and the penultimate page of Annex III states: “This leaflet was last
`approved on {date}.” Ex. 1009, 29. Petitioner asserts that the EU
`Community Register is a prior art printed publication under 35 U.S.C.
`§ 102(a). Pet. 19. Patent Owner contends that the Petitioner has not
`established public accessibility for the EU Community Register. Prelim.
`Resp. 29–33.
`“In order to qualify as a printed publication within the meaning of
`§ 102, a reference ‘must have been sufficiently accessible to the public
`interested in the art.’” In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009).
`“A reference is considered publicly accessible if it was ‘disseminated or
`otherwise made available to the extent that persons interested and ordinarily
`skilled in the subject matter or art exercising reasonable diligence, can locate
`it.’” Id. “The decision whether a particular reference is a printed
`publication ‘must be approached on a case-by-case basis.’” In re Cronyn,
`890 F.2d 1158, 1161 (Fed. Cir. 1989) (quoting In re Hall, 781 F.2d 897, 899
`(Fed. Cir. 1986)).
`Petitioner, relying on the testimony of Dr. Donovan, asserts that a
`person of ordinary skill in the art would have been aware that Ventavis like
`
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`treprostinil, is a stable postcyclin analogue and would have “investigated the
`capabilities of the nebulizers used to deliver Ventavis®” including by
`accessing “regulatory filings in United States and Europe.” Pet. 19.
`Petitioner then offers two alternate arguments for why Annex III to the
`Commission Decision was publically available.
`First, Petitioner contends that Annex III to the Commission Decision
`was available to the public through the EU Community Register of
`Medicinal Products. Pet. 19–20. The Community Register page for
`Ventavis is reproduced in relevant part below.
`
`Ex. 1043, 1–4 (annotation added). The above table is a portion of a three-
`page table entitle “EU Commission procedures” reproduced from a webpage
`
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`identified by Petitioner as the EU Community Register page for Ventavis.
`Ex. 1043; Ex. 1002¶ 105. Dr. Donovan testifies that by using the “decision
`docs” dropdown for the encircled entry she was able to access the
`Commission Decision and by using the “annex” dropdown, she was able to
`access the Annexes to that decision. Ex. 1002 ¶ 105.11
`Second, Petitioner argues that the Commission Decision and its
`
`Annexes were “available to the public through the European Commission’s
`Register of Commission Documents (‘European Register’), which provides
`public access to the documents of the European Parliament, the Council and
`the Commission pursuant to Regulation (EC) No 1049/2001.” Pet. 20.
`Dr. Donovan testifies that she used the “Document search” feature on the
`webpage (reproduced below) for the Register of Commission documents.
`
`
`
`
`
`
`
`
`
`
`11 Dr. Donovan references the Exhibits she accessed by name and by Exhibit
`number; however, the names do not match the exhibit numbers. For
`purposes of this decision, we assume that this was a typographical error and
`that the Annexes Dr. Donovan accessed were Exhibit 1009 (not Exhibit
`1042 as recited in her Declaration). See Ex. 1002 ¶ 105. Similarly, it
`appears that the Commission Decision she accessed was Exhibit 1042 (not
`Exhibit 1044 as recited in her Declaration). Id.
`17
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`Ex. 1002 ¶ 106. The image above is the webpage that Dr. Donovan testified
`was reached at http://ec.europa.eu/health/documents/community-register/.
`Id.; Ex. 1051. By using “Document search” feature on the above webpage
`and searching using the keyword “Ventavis” she reached a page (reproduced
`below) including a “Document request” link. Ex. 1002 ¶ 106.
`
`The above image is a reproduction of Exhibit 1053, the web page that Dr.
`Donovan testified was reached by searching the Community Register for the
`keyword “Ventavis.” Id. Dr. Donovan explains that keyword searching for
`“Ventavis” does not pull up the Commission Decision when searching “final
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`versions only,” which she suggests means the “Commission Decision was
`not a final version” and explains “why it includes the notation ‘Not for
`Publication’ on its face.” Id.
`
`Patent Owner argues that Petitioner has not sufficiently demonstrated
`public accessibility of Annex III. Prelim. Resp. 29–33. We agree.
`Annex III is identified as a “Labeling and Package Leaflet” for the
`drug Ventavis. As an initial matter, Petitioner does not contend, and does
`not provide evidence supporting, that Annex III was ever actually included
`as product literature with the drug Ventavis. Given that Annex III was
`appended to a Commission Decision marked “Not for Publication,” includes
`an empty place holder for the date on which “this leaflet was last approved,”
`and cannot be retrieved when searching for “final versions only,” we do not
`consider Annex III to be representative of an actual product label
`disseminated for Ventavis. Accordingly we do not consider whether actual
`dissemination of Annex III as a product label for Ventavis is sufficient to
`establish public accessibility. Rather, we consider the public accessibility of
`Annex III only as an annex to a non-final regulatory document.
`Regarding public accessibility of the non-final regulatory document,
`Patent Owner argues that Petitioner has not established that the Commission
`Decision “was indexed at the critical time period in a manner allowing it to
`be retrieved at a time that would make it prior art.” Prelim. Resp. 31. Patent
`Owner thus asserts that the “various exhibits referenced by Dr. Donovan
`nowhere show that the same retrieval user interface has always been in place
`dating back to the earlier time alleged by Petitioner.” Id. We agree.
`
`With respect to Petitioner’s first argument for public accessibility –
`that based on availability through the EU Community Register of Medicinal
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`Products (Ex. 1043) – Petitioner provides no evidence that the webpage it
`relies upon as providing access to Annex III existed during the critical time
`period. See Pet. 19–21.
`In addition, to the extent the webpage did exist during the critical time
`period, it would have provided little guidance to direct the skilled artisan to
`the subject matter of interest – nebulizer capabilities. Although the evidence
`indicates that Dr. Donovan was, at some unspecified point in time, able to
`access Annex III through the EU Community Register of Medicinal
`Products, Petitioner does not provide persuasive evidence indicating that
`“persons interested and ordinarily skilled in the subject matter or art
`exercising reasonable diligence” could have located it. Pet. 19–21; see SRI
`Int’l, Inc. v. Internet Security Sys., Inc., 511 F.3d 1186, 1194, 1196–97 (Fed.
`Cir. 2008). In this regard, the facts here are similar to those in In re Cronyn,
`in which the Federal Circuit found that theses documents indexed
`alphabetically by author name were not publicly accessible because “the
`only research aid [in finding the theses] was the student’s name, which, of
`course, bears no relationship to the subject of the student’s thesis” and, thus,
`they were not “cataloged or indexed in a meaningful way” so as to be
`accessible to the public. 890 F.2d at 1161. Here, the only information
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