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`Filed: June 22, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`KASHIV PHARMA, LLC,
`Petitioner,
`v.
`
`PURDUE PHARMA L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS L.P.,
`Patent Owners.
`____________________
`Case IPR2018-00625
`U.S. Patent No. 9,492,392
`_____________________
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`PATENT OWNER PRELIMINARY RESPONSE
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`IPR2018-00625
`U.S. Patent 9,492,392
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`TABLE OF CONTENTS
`TABLE OF AUTHORITIES .................................................................................. iii
`TABLE OF ABBREVIATIONS ………………………………………………….v
`LIST OF EXHIBITS ................................................................................................vi
`I.
`INTRODUCTION .......................................................................................... 1
`II.
`BACKGROUND ............................................................................................ 3
`A. OxyContin® .......................................................................................... 3
`B.
`The ’392 Patent and Prosecution History ............................................. 4
`C.
`Pending Litigations............................................................................... 6
`D.
`The Impax Merger ................................................................................ 7
`PERSON OF ORDINARY SKILL IN THE ART (“POSA”) ........................ 8
`III.
`IV. CLAIM CONSTRUCTION ........................................................................... 8
`A.
`“Compression Shaped” And “Compression” ....................................... 9
`B.
`“Curing” ............................................................................................. 10
`C.
`“Optionally” ....................................................................................... 11
`D.
`“Total Combined Weight Of Said High And Low Molecular
`Weight PEO” ...................................................................................... 11
`“Selected From The Group Consisting Of 4,000,0000;
`7,000,000; And A Combination Thereof” .......................................... 12
`Product-By-Process Limitations ........................................................ 13
`F.
`THE PETITION SHOULD BE DENIED BECAUSE PETITIONER
`HAS NOT IDENTIFIED AMNEAL AS A REAL PARTY-IN-
`INTEREST ................................................................................................... 16
`A.
`Legal Standards Governing Real-Parties-In-Interest ......................... 16
`1.
`Factors relevant to determining who is a real-party-in-
`interest ...................................................................................... 17
`35 U.S.C. § 315(b) Time Bar ................................................... 18
`2.
`Amneal Is A Real-Party-In-Interest ................................................... 19
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`V.
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`E.
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`B.
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`IPR2018—00625
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`US. Patent 9,492,392
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`3.
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`Amneal and Kashiv were represented by the same
`counsel in prior IPRs, and are currently represented by
`the same counsel in a litigation involving the ’392 patent ...... 25
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`4.
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`Kashiv equates itself with Amneal in its Petition .................... 27
`
`C.
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`The Petition Should Be Time-Barred Under 35 U.S.C. § 315(b) ...... 28
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`VI.
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`THE PETITION SHOULD BE DENIED BECAUSE PETITIONER’S
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`ASSERTED PRIOR ART AND ARGUMENTS HAVE ALREADY
`
`BEEN REJEC TED BY THE EXAMINER .................................................. 29
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`A.
`
`The Examiner Determined That Purdue’s Density Testing
`Results Were Unexpected .................................................................. 31
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`1.
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`2.
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`3.
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`4.
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`A POSA would have expected curing to increase the
`density ...................................................................................... 32
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`Purdue’s data establishes an unexpected density decrease ...... 34
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`Decreased density provides superior results ............................ 40
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`Decreased density is not a latent property ............................... 42
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`B.
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`The Petition Presents Substantially The Same Prior Art Or
`Arguments Previously Considered By The Office ............................ 43
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`1.
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`2.
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`3.
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`Ground 1 Presents Substantially The Same Prior Art Or
`Arguments Previously Considered By The Office .................. 44
`
`Ground 2 Presents Substantially The Same Prior Art Or
`Arguments Previously Considered By The Office .................. 47
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`Ground 3 Presents Substantially The Same Prior Art Or
`Arguments Previously Considered By The Office .................. 49
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`VII. CONCLUSION ............................................................................................. 5 1
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`_ii_
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`TABLE OF AUTHORITIES
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`IPR2018-00625
`U.S. Patent 9,492,392
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`Page
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`CASES
`
`Apotex Inc. et al. v. Osi Pharms, Inc.,
`IPR2016-01284, Paper 8 (P.T.A.B. Jan. 9, 2017) .............................................. 30
`
`Atlanta Gas Light Co. v. Bennet Regulatory Guards, Inc.,
`IPR2013-00453, Paper 88 (P.T.A.B. Jan. 6, 2015) .....................................passim
`
`Becton, Dickinson and Company v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (P.T.A.B. Dec. 15, 2017) ........................................... 30
`
`Cisco Systems, Inc. v. C-Cation Tech., LLC,
`IPR2014-00454, Paper 12 (P.T.A.B. Aug. 29, 2014) ......................................... 39
`
`Harmonic Inc. v. Avid Tech, Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) .......................................................................... 29
`
`In re Baxter Travenol, Labs.,
`952 F.2d 389392 (Fed. Cir. 1991) ...................................................................... 43
`
`In re Garnero,
`412 F.2d 276 (CCPA 1979) ................................................................................ 14
`
`Johnson Health v. ICON Health and Fitness,
`IPR2014-01242, Paper 16 (P.T.A.B. Feb. 11, 2015) .......................................... 27
`
`Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp.,
`831 F.3d 1350 (Fed. Cir. 2016) .......................................................................... 13
`
`Petroleum Geo-Services, Inc. v. WesternGeco, L.L.C.,
`IPR2014-00689, Paper 22 (P.T.A.B. Aug. 12, 2014) ......................................... 18
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................ 9
`
`
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`-iii-
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`

`

`IPR2018-00625
`U.S. Patent 9,492,392
`
`Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC,
`17-cv-00210-RGA (D. Del. Mar. 1, 2017) ..................................................... 6, 26
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`Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC,
`C.A. No. 15-1152-RGA (D. Del. Dec. 15, 2015) ......................................... 19, 22
`
`Purdue Pharma L.P. v. Kashiv,
`17-cv-210, D.I. 86 (D. Del. Mar. 23, 2018) ........................................................ 26
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`Unified Patents Inc. v. John L. Berman,
`IPR2016-01571, Paper 10 (P.T.A.B. Dec. 14, 2016) ......................................... 50
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`Zoll Lifecor Corp. v. Electronics N. Am. Corp. et al.,
`IPR2013-00609, Paper 15 (P.T.A.B. Mar. 20, 2014) ..................................passim
`
`STATUTES
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`35 U.S.C. 315(d) ........................................................................................................ 2
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`35 U.S.C. § 312(a)(2) ............................................................................................... 16
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`35 U.S.C. § 315(b) ......................................................................................... 1, 18, 28
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`35 U.S.C. § 325(d) ....................................................................................... 29, 43, 49
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`OTHER AUTHORITIES
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`37 C.F.R. 42.100(b) ................................................................................................... 8
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`37 C.F.R. § 42.6(a)(3) .............................................................................................. 39
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`77 Fed. Reg. 48,759 (Aug. 14, 2012)........................................................... 17-18, 21
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`77 Fed. Reg. 48,760 (Aug. 14, 2012)....................................................................... 25
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`-iv-
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`IPR2018-00625
`U.S. Patent 9,492,392
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`TABLE OF ABBREVIATIONS
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`BRC
`Pet.
`PO
`POSA
`PTO
`Pet. Opp.
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`Broadest Reasonable Construction
`IPR2018-00625 Petition for Inter Partes Review
`Patent Owner
`Person of Ordinary Skill in the Art
`United States Patent and Trademark Office
`Petitioner’s Opposition to Patent Owner’s Motion to Compel
`Additional Discovery
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`Description
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`EX
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`LIST OF EXHIBITS
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`2011
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`2015 Amneal Alliance webpage, http://aecompaniesllc.com/
`2016 Confidential Transcript of June 7, 2018 PTAB Conference Call – Parties
`and Board Only
`2017 Redacted Transcript of June 7, 2018 PTAB Conference Call
`2018 Expert Declaration of Stephen Byrn, Ph.D. – Parties and Board Only
`2019 Claim Construction Order in Purdue Pharma L.P. et al., v. Amneal
`Pharmaceuticals, 17-cv-210 (RGA) D. Del.
`2020 Department of Justice, Information Bulletin: OxyContin Diversion
`and Abuse (Jan. 2001)
`2021 OxyContin®, Physicians’ Desk Reference 2569-74 (53rd ed. 1999)
`2022 Dictionary of Pharmacy (2004)
`2023 OxyContin® Quality Overall Summary – Parties and Board Only
`2024 FDA News Release, FDA requests removal of Opana ER for risks related
`to abuse (June 8, 2017), available at
`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562
`401.htm
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`IPR2018-00625
`U.S. Patent 9,492,392
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`Impax SEC Filing
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`IPR2018-00625
`U.S. Patent 9,492,392
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`2025 OxyContin® Supplemental Approval Letter – Parties and Board Only
`2026 Statistical Analysis of Stephen Byrn on Table 13.6 of the ’393 patent
`2027 Statistical Analysis of Stephen Byrn on Mannion Declaration (Ex. 1036)
`2028 Statistical Analysis of Stephen Byrn on Table 14.6 of the ’393 patent
`2029 Redacted Expert Declaration of Stephen Byrn, Ph.D.
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`-vii-
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`I.
`
`INTRODUCTION
`Patent Owner Purdue Pharma L.P., The P.F. Laboratories, Inc., and Purdue
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`Pharmaceuticals L.P. (collectively, “Purdue” or “PO”) submit this Patent Owner
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`Preliminary Response to the petition for inter partes review (“IPR”) filed by
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`Kashiv Pharma, LLC (“Kashiv” or “Petitioner”) seeking to invalidate Purdue’s
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`U.S. Patent No. 9,492,392 (“the ’392 patent”). In a nearly identical petition,
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`Petitioner also seeks IPR of one additional patent owned by Purdue that is related
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`to the ’392 patent: U.S. Pat. No. 9,492,393 (“the ’393 patent”).
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`As a threshold issue, Petitioner has failed to name all real-parties-in-interest
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`in its petition for inter partes review, namely, its affiliate Amneal Pharmaceuticals,
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`LLC (“Amneal”). Amneal is currently a defendant and counterclaimant in a series
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`of patent infringement actions relating to Amneal’s Abbreviated New Drug
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`Application (“ANDA”) seeking approval to market a generic version of Purdue’s
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`OxyContin® products (“OxyContin®”). The patents at issue include the ’392 and
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`’393 patents, which were asserted against Amneal in a Complaint served on March
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`2, 2017. Kashiv brought this petition for inter partes review on February 28,
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`2018—just two days prior to the 35 U.S.C. § 315(b) statutory deadline for Amneal
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`to file a petition.
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`Amneal—who recently merged with Impax Laboratories, Inc.—and Kashiv
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`U.S. Patent 9,492,392
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` Thus, Amneal should have been named as a real-party-in-interest.
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`Because Amneal has not been named, and Purdue served Amneal with a Complaint
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`for patent infringement in the District Court of Delaware more than one year ago,
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`any corrected (or new) petition properly identifying Amneal should be dismissed
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`as time barred under 35 U.S.C. 315(d).
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`Further, institution should be denied because all of the prior art cited in
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`Kashiv’s petition was before the Examiner during prosecution, and Petitioner
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`raises substantially the same arguments that were already traversed during
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`prosecution. Here, Petitioner argues that the asserted claims are rendered obvious
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`by three different combinations of prior art—each combination containing four
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`references: (1) Bartholomaus (Ex. 1024) in view of McGinity (Ex. 1025), Oshlack
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`2 (Ex. 1026), and Oshlack 1 (Ex. 1016); (2) Wright (Ex. 1017) in view of Royce
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`(Ex. 1027), Moroni (Ex. 1028), and Shao (Ex. 1029); or (3) Oshlack 1 (Ex. 1016)
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`in view of Bartholomaus (Ex. 1024), McGinity (Ex. 1025), and Oshlack 2 (Ex.
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`1026). As Petitioner admits, all of that art was before the Examiner during
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`prosecution of the ’392 and ’393 patents. As discussed in the Notices of
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`Allowance, that prior art does not teach with sufficient specificity the combination
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`
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`-2-
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`IPR2018-00625
`U.S. Patent 9,492,392
`of components claimed, and Purdue demonstrated unexpected results. Thus, the
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`Examiner has already reviewed and rejected substantially the same arguments
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`raised in the petition.
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`For these reasons and for the reasons set forth below, Purdue respectfully
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`requests that the Board deny institution of Kashiv’s petition.
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`II. BACKGROUND
`A. OxyContin®
`Original OxyContin®, which was a groundbreaking treatment for patients
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`suffering chronic pain, was approved and launched in the United States in 1995
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`and 1996, respectively. Original OxyContin®’s medical success is attributed to its
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`unique extended-release profile providing for twelve hours of therapeutic relief,
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`allowing for optimum treatment of chronic pain. (Ex. 2018 ¶ 28; Ex. 1019 ¶ 13).
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`But many of the features that made it so effective, including its strength, duration,
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`and known dosage, also made it attractive to abusers. (Ex. 2018 ¶ 29).
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`Unfortunately, by at least 2001 it became evident that OxyContin® was, in fact,
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`widely abused. (Ex. 2018 ¶ 28; Ex. 1019 ¶ 13).
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`Seeking an instant and powerful “high,” abusers would crush the 12-hour
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`tablet, reducing it to an immediate-release fine powder, and then either snort it or,
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`after adding water and drawing it into a syringe, inject it. (Ex. 2018 ¶ 30; Ex. 2020
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`at 3). The consequences of that abuse included addiction, overdose, and death.
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`IPR2018-00625
`U.S. Patent 9,492,392
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`(Ex. 2018 ¶ 30; Ex. 2021 at 2571-73).
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`In response to this abuse, Purdue undertook a lengthy and costly research
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`program which eventually resulted in a reformulated OxyContin® that uses
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`patented technologies to deter abuse without sacrificing original OxyContin®’s
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`intended benefits. OxyContin® now incorporates, as one of its abuse-deterring
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`mechanisms, gelling to impede snorting and injecting of any powder resulting from
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`crushed tablets, but without disrupting the extended-release profile for a 12-hour
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`therapeutic effect. (Ex. 2018 ¶ 31; Ex. 1003 at 30-31).
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`The ’392 Patent and Prosecution History
`B.
`The ’392 patent issued on November 15, 2016 to William H. McKenna,
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`Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang. It is listed in
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`the Orange Book as covering OxyContin®. The ’392 patent is directed to tamper
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`resistant dosage forms and processes of manufacture, uses, and methods thereof.
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`The ’392 patent and its patent family were the first to disclose tamper resistant
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`formulations, which display reduced density of the final dosage forms as compared
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`to before curing (or to prior-art manufacturing methods), manufactured by a
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`process comprising compression shaping followed by air curing without
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`compression.
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`Each and every piece of prior art that Petitioner relies upon in its Petition
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`was before the Examiner during prosecution, and the main references,
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`-4-
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`IPR2018-00625
`U.S. Patent 9,492,392
`Bartholomaus and Wright, were substantively addressed. As acknowledged by the
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`Examiner in the Notice of Allowance (Ex. 1040), the prior art does not render
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`Purdue’s invention obvious. Moreover, Purdue’s invention provides an
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`unexpected decrease in the density of the tablets. In particular, the Examiner
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`stated,
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`[n]ot only does the prior art not teach with sufficient
`specificity this combination of components but also
`Applicant has demonstrated unexpected results
`concerning density decreasing changes that are a result of
`the curing process that has been addressed in the
`Affidavit filed on 12/11/2015 [Ex. 1035].
`(Ex. 1040 at 4).
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`Based on a thorough review of the scientific literature in the field (i.e., Mai
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`(Ex. 1041), Al Khatib (Ex. 1042), and Mpofu (Ex. 1043)), the Examiner
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`determined that “there is an expectation in the art to increase the density of the
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`polymer matrix upon heat curing,” not decrease it. (Ex. 1040 at 4) (emphasis
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`added). The Examiner found that in contrast to what a POSA would expect based
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`on the scientific literature, “Applicant has surprisingly demonstrated a decrease in
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`density which does not appear to be a predictable or expected result.” Based on
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`“the amendment to specific ingredients and amounts as well as a showing of
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`unexpected results,” the instant claims were deemed allowable. (Id.).
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`-5-
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`IPR2018-00625
`U.S. Patent 9,492,392
`The unexpected decrease in density leads to greater tablet porosity. In turn,
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`the tablets will gel more quickly, decreasing the potential for abuse. (Ex. 2018 ¶
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`52).1 The decrease in density therefore contributes to the increased abuse
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`deterrence of the invention of the ’392 patent.
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`Pending Litigations
`C.
`On January 16, 2017, Amneal served Purdue with a Notice of Paragraph IV
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`Certification of, inter alia, the ’392 and ’393 patents. In that notice, Amneal
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`alleged that the claims of those patents are invalid as obvious. Purdue brought a
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`series of now consolidated patent infringement actions against Amneal in the
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`United States District Court for the District of Delaware relating to that
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`Certification and to Amneal’s ANDA No. 203235 seeking approval to market a
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`generic version of OxyContin®. The ’392 and ’393 patents are asserted in a civil
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`action captioned Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 17-
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`cv-00210-RGA (D. Del. Mar. 1, 2017). The Complaint in that case was served on
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`
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`1 Ex. 2018 is the confidential Declaration of Dr. Stephen Byrn, Ph.D in
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`Support of Patent Owners’ Preliminary Response to Petition for Inter Partes Review.
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`Ex. 2029 is the public, redacted version of that Declaration. Paragraph numbering
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`is identical in both Declarations.
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`-6-
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`IPR2018-00625
`U.S. Patent 9,492,392
`March 2, 2017, thus triggering the one year deadline of March 2, 2018 to file a
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`petition for inter partes review. 2
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`Amneal previously challenged two of Purdue’s other patents listed in the
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`Orange Book as covering OxyContin® in IPR2016-01027, IPR2016-1028,
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`IPR2016-01412 and IPR2016-01413. In those proceedings, both Amneal, as
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`Petitioner, and Kashiv were named as real-parties-in-interest.
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`D. The Impax Merger
` On October 17, 2017, Amneal announced that it entered into a “Business
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`Combination Agreement” with Impax Laboratories, Inc. (“the Impax Merger”).
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`Closing of that merger in May 2018 divested Amneal of its right to challenge
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`Purdue’s patents.
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`2 Amneal’s continued prosecution of the District Court actions, including
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`challenging the patents at issue in these proceedings, removes any doubt that Amneal
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`is a real-party-in-interest that Kashiv should have named in this proceeding.
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`-7-
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`IPR2018-00625
`U.S. Patent 9,492,392
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`III. PERSON OF ORDINARY SKILL IN THE ART (“POSA”)
`For purposes of this proceeding, a POSA in the art of abuse-deterring patents
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`as of August 25, 2006 had a degree in one or more fields of medicine, chemical
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`engineering, chemistry, pharmaceutical science, polymer chemistry,
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`pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or
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`pharmacology and/or a number of years of industry training or experience in one or
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`more of those fields, particularly with controlled-release formulations. (Ex. 2018
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`¶¶ 37-40). Purdue submits that even under Petitioner’s definition of a POSA3, the
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`claim constructions and patentability analysis set forth herein would remain the
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`same.
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`IV. CLAIM CONSTRUCTION
`37 C.F.R. 42.100(b) states that claims must be given their broadest
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`reasonable construction in light of the specification (“BRC standard”). On May 8,
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`3 Petitioner admitted that this definition “is based on Petitioner’s position
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`articulated in the co-pending litigation.” (Pet. 19). Kashiv, however, has not set
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`forth any opinions regarding the definition of a POSA in the litigation—Amneal has.
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`Thus, for the purpose of this IPR proceeding, Kashiv has equated itself to Amneal.
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`-8-
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`IPR2018-00625
`U.S. Patent 9,492,392
`2018, the USPTO proposed rulemaking that would change the standard for
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`construing claims from BRC to the standard set forth in Phillips v. AWH Corp.,
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`415 F.3d 1303 (Fed. Cir. 2005). In anticipation that the rule-change will apply to
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`these proceedings, Petitioner construes the claims based on the standard set forth in
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`Phillips. Accordingly, Purdue construes the claim terms as they would by POSAs
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`at the filing date, in light of the intrinsic evidence, i.e., the claim language,
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`specification, and prosecution history. Phillips, 415 F.3d at 1313-14. The
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`constructions are consistent with the ordinary and customary meaning of the terms,
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`unless they have been given a special definition in the specification. Id. at 1316.
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`Even if the Board were to apply the BRC standard, there are no broader reasonable
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`constructions than those set forth herein by Purdue in view of the intrinsic
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`evidence.
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`Kashiv has construed the claim terms under the BRC standard, which is
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`improper under the USPTO proposed rulemaking guidelines, particularly because
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`Kashiv’s proposed BRC may capture prior art that would otherwise be excluded
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`under the Phillips standard. For that reason alone, this Petition should be denied.
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`“Compression Shaped” And “Compression”
`A.
`The terms “compression shaped” and “compression” should be given their
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`plain and ordinary meaning and do not require construction. (Ex. 2018 ¶ 41).
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`Purdue does not agree with Petitioner’s contention that “compression shaped” and
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`IPR20 l 8—00625
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`US. Patent 9,492,392
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`“compression” should be construed to include “any compaction step.” (Pet. 19-
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`20). Petitioner hasn’t explained how compaction is different than compression or
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`provides any additional meaning. (Ex. 2018 1] 41). The plain and ordinary
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`meaning of “compression” and “compression shaped” in light of the specification
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`is a technique that compresses material to form tablets, and requires no additional
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`construction-
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`B.
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`“Curing”
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`Petitioner’s Construction
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`Patent Owner’s Construction
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`“heating to an elevated temperature
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`“heating the compression shaped
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`temperature or melting pointfor a few
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`high molecular weight PE0 present in
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`that is at least as high as the softening matrix, without compression, until the
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`minutes.” (Pet. 20).
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`the matrix has at least partially
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`softened or melted.”
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`The claim language of the ’392 Patent supports Purdue’s construction. The
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`claims require “at least a first compression shaped and then air cured matrix,
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`wherein said curing is without compression
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`(Ex. 1001, e.g. claim 1). Thus,
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`according to the plain language of the claim, an “air cured” matrix is one cured
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`“without compression.” (Ex. 2018 1] 43). Petitioner’s definition does not take into
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`account the fact that curing must be “without compression.”
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`According to the specification, “it is believed that the curing at a temperature
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`-10-
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`IPR2018-00625
`U.S. Patent 9,492,392
`that is at least as high as the softening temperature of the high molecular weight
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`polyethylene oxide causes the polyethylene oxide particles to at least adhere to
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`each other or even to fuse.” (Ex. 1001 at 17:62-66). And Petitioner acknowledges
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`that the specification defines the “curing temperature” as being “at least the
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`softening temperature” of the PEO (id. at 3:10-15, 17:10-14) and “curing” as being
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`heated to a point where the PEO “at least partially melts” (id. at 17:28-30).
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`In light of the claim language and specification, a POSA would understand
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`the term “curing” and “air cured” to mean “heating the compression shaped matrix,
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`without compression, until the high molecular weight PEO present in the matrix
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`has at least partially softened or melted.” (Id. at 17:28-30, 17:42-45, 17:56-66,
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`22:47-50, 54-59; (Ex. 2018 ¶ 44)).
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`Petitioner’s proposed construction adds the phrase “for a few minutes.”
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`(Pet. 20). That phrase is redundant, however, since the claims specify the amount
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`of the time for curing. (Ex. 2018 ¶ 45).
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` “Optionally”
`C.
`Purdue contends that no construction is necessary for the term “optionally”
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`and it should be given its plain and ordinary meaning.
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`D.
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`“Total Combined Weight Of Said High And Low Molecular
`Weight PEO”
`Purdue contends that no construction is necessary for the term “total
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`combined weight of said high and low molecular weight PEO” and it should be
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`22-23).
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`7,000,000 daltons, or a combination
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`thereofbased on rheological
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`given its plain and ordinary meaning.
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`IPR2018—00625
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`US. Patent 9,492,392
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`E.
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`“Selected From The Group Consisting Of 4,000,0000; 7,000,000;
`And A Combination ThereoP’
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`Petitioner’s Construction
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`“the approximate molecular weight of
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`the PEO material used can be about
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`4,000,000, about 7,000,000, or any
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`molecular weight in between.” (Pet.
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`Patent Owner’s Construction
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`“one or a combination ofpolyethylene
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`oxides having an overall weight
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`average molecular weight of
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`approximately 4,000, 000 daltons,
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` measurements.”
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`The claims of the ’392 Patent require a “cured shaped pharmaceutical tablet
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`comprising” “polyethylene oxide having, based on rheological measurements, an
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`approximate molecular weight selectedfrom the group consisting of4,000,000,
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`7,000,000, and a combination thereof.” This term should be construed in
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`accordance with the construction adopted by the district court: “one or a
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`combination of polyethylene oxides having an overall weight average molecular
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`weight of approximately 4,000,000 daltons, 7,000,000 daltons, or a combination
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`thereof based on rheological measurements.” (Ex. 2020; (Ex. 2018 111] 46-47)).
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`The claim language limits the “high molecular weight” PEO to specific
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`molecular weights defined by the recited Markush group, i.e., “an approximate
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`IPR2018-00625
`U.S. Patent 9,492,392
`molecular weight selected from the group consisting of 4,000,000, 7,000,000, and
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`a combination thereof.” The words “consisting of” define the group and create “a
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`very strong presumption that that claim element is ‘closed’ and therefore ‘excludes
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`any elements, steps, or ingredients not specified in the claim.’” Multilayer Stretch
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`Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir.
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`2016) (quoting AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1245 (Fed.
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`Cir. 2001)). Thus, the “at least one high molecular weight” PEO component can
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`be made up of (1) a PEO ingredient (which may be comprised of one or more PEO
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`grades) having a molecular weight of either 4,000,000 or 7,000,000, or (2) “a
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`combination thereof,” that is, a combination of a PEO ingredient having a
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`molecular weight of 4,000,000 and a PEO ingredient having a molecular weight of
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`7,000,000. (Ex. 2018 ¶¶ 48-49).
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`Petitioner’s proposed construction, that “the approximate molecular weight
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`of the PEO material used can be about 4,000,000, about 7,000,000, or any
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`molecular weight in between,” ignores the plain language of the Markush group in
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`an attempt to capture PEO ingredients with molecular weights between 4,000,000
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`and 7,000,000. That construction should be rejected, however, as inconsistent with
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`the claim language itself and the basic tenets of claim construction.
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`Product-By-Process Limitations
`F.
`Petitioner argues that certain terms “should not be considered limitations for
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`IPR2018-00625
`U.S. Patent 9,492,392
`purposes of validity or patentability” because “the nature of these recitations
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`strongly suggest that these are product-by-process limitations” and “do not connote
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`a required structure.” (Pet. 23). Petitioner is incorrect. The process steps recited
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`in the claims, in particular the curing process and density limitations, impart
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`structure to the claimed products. (Ex. 2018 ¶ 52).
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`A process step in a product-by-process claim must be considered in an
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`anticipation or obviousness analysis if the process imparts distinctive structural
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`characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279
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`(CCPA 1979). The invention’s curing elements provide such structure to the
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`claimed tablet and must be considered.
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`First, as stated in the specification: “it is believed that the curing at a
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`temperature that is at least as high as the softening temperature of the high
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`molecular polyethylene oxide causes the polyethylene oxide particles to at least
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`adhere to each other or even to fuse.” (E.g., Ex. 1001, 17:62-66). A POSA would
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`understand that these curing conditions impart increased hardness and crush
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`resistance due to the structural change in the PEO particles. (Ex. 2018 ¶ 52).
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`Second, a POSA would understand that the claimed curing without
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`simultaneous compression imparts a decrease in density, which corresponds to
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`greater tablet porosity, leading to faster tablet gelling and increased potential to
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`reduce intravenous abuse. (Id.). The decrease in density therefore contributes to
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`IPR2018-00625
`U.S. Patent 9,492,392
`the increased abuse deterrence of the invention of the ’392 patent. (Id. at ¶ 53).
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`And the shaping followed by curing results in the decreased density and therefore
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`impacts the structure of the claimed products for this additional reason. (Ex. 2018
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`¶ 54).
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`Petitioner argues that, during prosecution, the Examiner rejected the claims
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`as being product-by-process claims. (Pet. 23). However, the claims were
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`ultimately allowed due in part to the relationship between the claimed air curing
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`without compression and the structural change that it imparts (i.e., decreased
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`density). (Ex. 1040 at 4 (“Applicant has demonstrated unexpected results
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`concerning density decreasing changes that are a result of the curing process”)
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`(emphasis added)). Therefore, it must be considered a limitation for the purpose of
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`determining the validity of the claims.
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` In contrast, Opana
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`ER® was manufactured using hot-melt extrusion (i.e., simultaneous heat and
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`pressure). (Ex. 2018 ¶52; Ex. 2024 at 1). The FDA granted OxyContin abuse-
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`IPR2018-00625
`U.S. Patent 9,492,392
`deterrent labeling recognizing its reduced potential for intravenous abuse.
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`The FDA, however, refused to grant Opana ER®
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`such labeling, and Opana ER®’s tendency to be abused via injection led the FDA
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`to request that it be withdrawn from the market. (Ex. 2018 ¶ 52; Ex. 2024 at 1-3).
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`V. THE PETITION SHOULD BE DENIED BECAUSE PETITIONER
`HAS NOT IDENTIFIED AMNEAL AS A REAL PARTY-IN-
`INTEREST
`A. Legal Standards Governing Real-Parties-In-Interest
`“A petition for inter partes review ‘may be considered only if – …the
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`petition identifies all real parties in interest.” 35 U.S.C. § 312(a)(2) (emphasis
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`added). The statutory requirement that a petition for inter partes review identify
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`all real parties in interest defines a “threshold issue.” Atlanta Gas Light Co. v.
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`Bennet Regulatory Guards, Inc., IPR2013-00453, Paper 88 at 7 (P.T.A.B. Jan. 6,
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`2015). And when “a patent owner provides sufficient rebuttal evidence that
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`reasonably brings into question the accuracy of a petitioner’s identification of the
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`real parties in interest, the burden remains with the petitioner to establish that it has
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`complied with the statutory requirement to identify all of the real parties in
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`interes