Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
`
` Paper No. 10
`
` 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 IPR2017-01621
`Patent 9,358,240 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 Corporation 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. 10
`
` 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 IPR2017-01621
`Patent 9,358,240 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 Corporation is the assignee of
`record with respect to US Patent No. 9,399,507 B2. Prelim Resp. 1 n.1.
`
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`
` INTRODUCTION
`Watson Laboratories, Inc. (“Petitioner” or “Watson”) filed a Petition
`requesting an inter partes review of claims 1‒9 of U.S. Patent No. 9,358,240
`B2 (Ex. 1001, “the ’240 patent”). Paper 2 (“Pet.”). United Therapeutics
`Corp. (“Patent Owner” or “UTC”) filed a Preliminary Response to the
`Petition. 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 ‘240 patent: United Therapeutics Corp. v. Watson
`Laboratories, Inc. Case No. 15-cv-05723 (D.N.J.) and IPR2017-01622,
`which challenges the patentability of U.S. Patent No. 9,339,507 (“the ’507
`patent”). Id. The ’240 patent and the ’507 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.
`
`2
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`
`The ’240 Patent (Ex. 1001)
`B.
`The ’240 patent issued June 7, 2016, identifying Horst Olschewski,
`Robert Roscigno, Lewis J. Rubin, Thomas Schmehl, Werner Seeger, Carl
`Sterritt, and Robert Voswinckel as co-inventors. Ex. 1001. The patent
`discloses “methods and kits for therapeutic treatment . . . involving
`administering treprostinil using a metered dose inhaler and related kits.” Id.
`at 1:15–19.
`
`The ’240 patent teaches that pulmonary hypertension is “a condition
`associated with an elevation of pulmonary arterial pressure (PAP) over
`normal levels.” Id. at 2:6–8. “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 2:37–40. “Pulmonary hypertension may also
`ultimately result in a potentially fatal heart condition known as ‘cor
`pulmonale,’ or pulmonary heart disease.” Id. at 2:48–51. According to the
`’240 patent, “currently there is no treatment for pulmonary hypertension that
`can be administered using a compact inhalation device, such as a metered
`dose inhaler.” Id. at 2:53–55.
`
`The ’240 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 5:8–11. The ’240 patent further discloses that “such
`administering does not cause significant side effects.” Id. at 5:12–13.
`Challenged Claims
`C.
`Petitioner challenges claims 1‒9 of the ’240 patent. Claim 1, the only
`independent claim, is reproduced below:
`
`3
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`
`1.
`
`A method of treating pulmonary hypertension comprising:
`administering by inhalation to a human suffering from
`pulmonary hypertension a therapeutically effective single event
`dose of a formulation comprising 200 to 1000 μg/ml of
`treprostinil or a pharmaceutically acceptable salt thereof
`with a pulsed ultrasonic nebulizer that aerosolizes a fixed
`amount of treprostinil or a pharmaceutically effective salt
`thereof per pulse,
`said pulsed ultrasonic nebulizer comprising an opto-
`acoustical trigger which allows said human to synchronize each
`breath to each pulse,
`said therapeutically effective single dose event
`comprising from 15 μg to 90 μg treprostinil or a
`pharmaceutically acceptable salt thereof delivered in 1 to 18
`breaths.
`Ex. 1001, 18:2‒17.
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1‒9 of the ’240 patent
`on the following grounds (Pet. 6):
`References
`Voswinckel,2 Patton,3 and
`Ghofrani4
`
`Claims Challenged
`1‒9
`
`Basis
`§ 103(a)
`
`
`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 Patton et al., WO 93/00951, published Jan. 21, 1993 (Ex. 1012, “Patton”).
`4 Hossein Ardeschi Ghofrani, Robert Voswinckel, et al., Neue
`Therapieoptionen in der Behandlung der pulmonalarteriellen
`Hypertonie, 30(4) HERTZ 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).
`4
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`
`Basis
`§ 103(a)
`
`Claims Challenged
`1‒9
`
`References
`Voswinckel, Patton, and the
`OptiNeb User Manual5
`Voswinckel, 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
`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 ’240 patent in the United
`States District Court for the District of New Jersey on July 22, 2015.
`
`§ 103(a)
`
`1‒9
`
`
`5 Opti-Neb-ir® Operating Instructions, Model ON-100/2-2.4 MHz (2005)
`(Ex. 1006, “OptiNeb”). OptiNeb was originally published in German. Pet.
`17, 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
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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 ’240 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 ’240 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 ’240 patent
`on June 21, 2017.
`The issue before us is whether Petitioner was “served with a
`complaint” alleging infringement of the ’240 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
`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
`
`
`7 Patent Owner also sought to add the newly issued ’507 patent, which is at
`issue in IPR2017-01622.
`
`6
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`time-barred from seeking inter partes review of the ’240 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 Pharmaceuticals, LLC v. Endo Pharmaceuticals 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 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).
`
`7
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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 16–17. Patent
`Owner further notes that Petitioner sent a Paragraph IV Certification
`alleging invalidity of the ’240 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
`defendant,” Patent Owner requested leave to amend its pleading and make
`Petitioner a defendant with respect to ’240 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 ’240 patent
`
`8
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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. 8–9;
`Prelim. Resp. 7. 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
`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.
`
`9
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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
`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).
`
`
`8 These determinations would be the same if Patent Owner’s description of
`the person of ordinary skill in the art were applied.
`10
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`
`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
`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
`
`
`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.
`11
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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. 2005. Petitioner asserts that Ghofrani is a prior art printed publication
`under 35 U.S.C. § 102(a). Pet. 15. 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 authorship of the portions of the reference relied
`upon as prior art. Riverwood Int’l Corp. v. R.A. Jones &Co., Inc., 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
`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 ’240 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
`
`12
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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 ’240 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
`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 of Ghofrani, as would be
`
`13
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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. 1004. 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. 1004 and 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
`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 authorization for ‘Ventavis® – Iloprost,’ a medicinal product for
`
`
`10 Patent Owner has not asserted that fewer than all of the listed inventors
`contributed to any of the challenged claims.
`14
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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. 18. 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
`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.
`
`15
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`
`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. 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
`identified by Petitioner as the EU Community Register page for Ventavis
`(Ex. 1043). Dr. Donovan testifies that by using the “decision docs”
`
`16
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`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, ¶ 99.11
`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. 19–20.
`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
`1043 as recited in her Declaration). See, Ex. 1002, ¶ 99. Similarly, it
`appears that the Commission Decision she accessed was Exhibit 1042 (not
`Exhibit 1043 as recited in her Declaration). Id.
`17
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`
`Ex. 1002, ¶ 100. The image reproduced 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
`¶ 100.
`
`Id. 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
`
`18
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`for “Ventavis” does not pull up the Commission Decision when searching
`“final 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. at 31–32. We
`agree.
`
`19
`
`
`
`IPR2017-01621
`Patent 9,358,240 B2
`
`With respect to Petitioner’s first argument for public accessibility –
`
`that based on availability through the EU Community Register of Medicinal
`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. 18–21.
`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. Reply 22–25;
`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
`identified by Petitioner that would have suggested that the “08/09
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
