`Trials@uspto.gov
`571-272-7822 Entered: February 4, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`ENDO PHARMACEUTICALS INC.,
`Patent Owner.
`____________
`
`Case IPR2014-01365
`Patent 8,329,216 B2
`____________
`
`
`
`
`Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`
`BONILLA, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Petitioner’s Motion for Joinder In-Part,
`and Instituting Inter Partes Review
`37 C.F.R. §§ 42.108, 42.122
`
`
`
`
`
`
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`IPR2014-01365
`Patent 8,329,216 B2
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`I.
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`INTRODUCTION
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`Amneal Pharmaceuticals, LLC, (“Petitioner”) filed a Petition requesting
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`inter partes review of claims 5, 16, 44, 46, 47, and 72–82 of U.S. Patent No.
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`8,329,216 (“the ’216 patent”). Paper 2 (“Pet.,” “current Petition,” or “Second
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`Petition”). On the same day, Petitioner also filed a Motion for Joinder, requesting
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`joinder of the Petition with a related and instituted proceeding, IPR2014-00360.
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`Paper 3 (“Joinder Motion”), 1–2. Petitioner filed its Joinder Motion within one
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`month after institution of a trial in IPR2014-00360, as required by 37 C.F.R.
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`§ 42.122(b). Endo Pharmaceuticals Inc. (“Patent Owner”) filed an Opposition to
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`Petitioner’s Motion for Joinder (Paper 8, “Opp. to Joinder”), and Petitioner filed a
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`Reply to Opposition to Motion for Joinder (Paper 10, “Reply to Opp. to Joinder”).
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`Thereafter, Patent Owner filed a Preliminary Response (Paper 12, “Prelim.
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`Resp.”). We have jurisdiction under 35 U.S.C. § 314.
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`For the reasons that follow, we grant Petitioner’s Motion for Joinder in
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`relation to a ground in the current Petition regarding claims 44 and 47, but not in
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`relation to any grounds regarding claims 5, 16, 46, and 72–82. In addition, we are
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`persuaded that Petitioner has demonstrated that there is a reasonable likelihood that
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`it would prevail with respect to claims 44 and 47 of the ’216 patent, and we grant
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`the Petition as to those claims.
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`II.
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`BACKGROUND REGARDING JOINDER
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`The statutory provision governing joinder of inter partes review proceedings
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`is 35 U.S.C. § 315(c), which reads as follows:
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`(c) JOINDER.—If the Director institutes an inter partes review, the
`Director, in his or her discretion, may join as a party to that inter
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`2
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`IPR2014-01365
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`partes review any person who properly files a petition under section
`311 that the Director, after receiving a preliminary response under
`section 313 or the expiration of the time for filing such a response,
`determines warrants the institution of an inter partes review under
`section 314.
`
`Section 315(b) of the statute normally bars institution of inter partes review
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`when the petition is filed more than one year after the petitioner (or petitioner’s
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`real party in interest or privy) is served with a complaint alleging infringement of
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`the patent. 35 U.S.C. § 315(b); 37 C.F.R. § 42.101(b). That one-year time bar,
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`however, does not apply to a request for joinder. 35 U.S.C. § 315(b) (final
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`sentence); 37 C.F.R. § 42.122(b). This is an important consideration here because
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`Petitioner was served with a complaint asserting infringement of the ʼ216 patent
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`more than one year before filing the Petition in this proceeding.1 Thus, absent
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`joinder of Petitioner in this proceeding as a party to IPR2014-00360, institution
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`based on the current Petition is barred.
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`Joinder may be authorized when warranted, but the decision to grant joinder
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`is discretionary. 35 U.S.C. § 315(c); 37 C.F.R. § 42.122(b). When exercising that
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`discretion, the Board is mindful that patent trial regulations, including the rules for
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`joinder, must be construed to secure the just, speedy, and inexpensive resolution of
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`every proceeding. 37 C.F.R. § 42.1(b).2
`
`
`
`1 Petitioner was served with a complaint alleging infringement of the ’216 patent
`on January 17, 2013, triggering a § 315(b) bar date of January 17, 2014. IPR2014-
`00360, Paper 15, 6, 9–10. Petitioner filed its Petition in the instant proceeding on
`August 22, 2014.
`2 35 U.S.C. § 316(b) (“In prescribing regulations under this section, the Director
`3
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`III. ANALYSIS ON JOINDER
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`Petitioner filed its Second Petition approximately one month after institution
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`in IPR2014-00360. Thus, this case represents a “second bite at the apple” for
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`Petitioner, who has received the benefit of seeing our Institution Decision in the
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`prior case involving the same parties and patent. See IPR2014-00360, Paper 16
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`(“Institution Decision,” dated July 25, 2014). This “second bite at the apple”
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`situation is particularly noteworthy in view of the § 315(b) bar at issue here.
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`We observe that in its Opposition to Petitioner’s Motion for Joinder, Patent
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`Owner points us to a Decision Denying a Motion for Joinder by a different Board
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`panel in Target Corp. v. Destination Maternity Corp., Case IPR2014-00508
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`(PTAB Sept. 25, 2014) (Paper 18) (“Target Decision”). Opp. to Joinder 5–10. We
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`are aware of the Target Decision, and respect our colleagues’ well-reasoned
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`position in the majority opinion in that case. We also recognize, however, as
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`evident from Target Decision itself, that reasonable minds can differ on an
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`interpretation of 35 U.S.C. § 315 as it relates to joining a party to an earlier
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`proceeding in which the party is already a participant.3
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`
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`shall consider the effect of any such regulation on the economy, the integrity of the
`patent system, the efficient administration of the Office, and the ability of the
`Office to timely complete proceedings instituted under this chapter.”).
`3 See Target Corp. v. Destination Maternity Corp., Case IPR2014-00508 (PTAB
`Sept. 25, 2014) (Paper 18); see also, e.g., Ariosa Diagnostics v. Isis Innovation
`Ltd., Case IPR2012-00022, slip op. at 18–22 (PTAB Sept. 2, 2014) (Paper 166);
`Ariosa Diagnostics v. Isis Innovation Ltd., Case IPR2013-00250 (PTAB Sept. 3,
`2013) (Paper 25) (designated Paper 24). In Target, a Motion for Rehearing of the
`Decision Denying Petitioner’s Motion of Joinder is currently pending. Target,
`Case IPR2014-00508 (Papers 18–25).
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`4
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`In view of the reasonable difference of opinion, as well as the existence of
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`other Board cases allowing joinder of Petitions filed by a same party, we interpret
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`§ 315(c) as granting us discretion to allow joinder under the circumstances of this
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`case. That said, when a § 315(b) bar would apply absent joinder, we hesitate to
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`allow a petitioner a second bite one month after institution in a first case, at the
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`expense of scheduling constraints for everyone, as well as additional costs (and
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`potential prejudice) to Patent Owner, absent a good reason for doing so.
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`In this proceeding, in relation to the current Petition, Petitioner moves for
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`joinder with IPR2014-00360. Joinder Motion 1–2. We instituted a trial in
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`IPR2014-00360 on July 25, 2014, and denied a Request for Rehearing of our
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`Institution Decision on September 16, 2014; Patent Owner subsequently filed a
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`Response and Contingent Motion to Amend on October 27, 2014. IPR2014-
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`00360, Institution Decision, Papers 21, 29, 31, 32.
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`The current Petition raises three grounds in relation to challenged claims 5,
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`16, 44, 46, 47, and 72–82 of the ’216 patent, as indicated below.
`
`
`References
`1 Oshlack (Ex. 1007)4 and Handbook of Dissolution
`Testing (“the Handbook”) (Ex. 1008)5
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`Challenged Claims
`
`5, 16, 44, 46, and 47
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`
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`4 Oshlack et al., U.S. Patent No. 5,958,452, “Extruded Orally Administrable
`Opioid Formulations,” filed Apr. 10, 1997, issued Sept. 28, 1999.
`5 Hanson, HANDBOOK OF DISSOLUTION TESTING, v–xii, 1–13, 26–53, 69–91, 111–
`123 (2d ed. 1991).
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`5
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`References
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`2 Oshlack, Handbook of Dissolution Testing, and
`Handbook of Pharmaceutical Excipients (Ex. 1019)6
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`3 Baichwal ’757 (Ex. 1031),7 Penwest Statement (Ex.
`1009),8 Baichwal ’933 (Ex. 1032),9 and Gordon (Ex.
`1011)10
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`Pet. 7.
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`Challenged Claims
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`72–82
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`72–82
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`The first ground in the current Petition challenges claims 5, 16, 44, 46, and
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`47 based on the same art, Oshlack and Handbook of Dissolution Testing, raised in
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`a ground upon which we instituted review of claims 1, 2, 6, 12–14, 17, 21–43, 45–
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`51, and 54–71 of the same patent in IPR2014-00360. IPR2014-00360, Paper 16,
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`22. The other two grounds each challenge claims 72–82 based on new
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`obviousness grounds, not raised in the Petition in IPR2014-00360, citing, inter
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`alia, three prior art references not at issue in the earlier proceeding, i.e., Handbook
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`of Pharmaceutical Excipients in Ground 2, and Baichwal ’757 and Baichwal ’933
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`
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`6 HANDBOOK OF PHARMACEUTICAL EXCIPIENTS, 252–255, 599–601 (3rd ed.,
`Kibbe) (2000).
`7 Baichwal et al., U.S. Patent No. 5,135,757, “Compressible Sustained Release
`Solid Dosage Forms,” filed Jan. 16, 1991, issued Aug. 4, 1992.
`8 Penwest Pharms. Co., Registration Statement under The Securities Act of 1933
`(Form S-1) (Dec. 17, 1997).
`9 Baichwal et al., U.S. Patent No. 5,662,933, “Controlled Release Formulation
`(Albuterol),” filed Nov. 3, 1993, issued Sept. 2, 1997.
`10 Gordon et al., Opioid Equianalgesic Calculations, 2(2) J. PALLIATIVE MED.
`209–218 (1999).
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`6
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`IPR2014-01365
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`in Ground 3. Pet. 7; IPR2014-00360, Paper 1, 7. In our Institution Decision and
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`Decision on Rehearing in IPR2014-00360, we denied grounds challenging claims
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`72–82 based on different combinations of references. Institution Decision 2, 14–
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`22; Paper 21, 3–6.
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`A. Ground 1 challenging claims 5, 16, 44, 46, and 47
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`The Board determines whether to grant joinder on a case-by-case basis,
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`taking into account the particular facts of each case. In this regard, we are mindful
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`of a public interest in securing “the just, speedy, and inexpensive resolution of
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`every proceeding.” 37 C.F.R. § 42.1(b).
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`In Ground 1, the current Petition challenges claims 5, 16, and 44 of ’216
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`patent for the first time. Regarding claims 46 and 47, as noted by Petitioner,
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`“[d]ue to an unintentional inconsistency in claim numbering in the First Petition,
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`trial was instituted for claims 46 and 47 without Petitioner’s specific analysis of
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`these claims in the First Petition.” Joinder Motion 7; see also Opp. to Joinder 14
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`(stating that “due to Amneal’s error in identifying claims 46 and 47 in its petition
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`headings, the Board inadvertently instituted review of these claims”). Thus, while
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`the Petition in IPR2014-00360 lists claims 46 and 47 (among others) in headings in
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`relation to certain grounds, the analysis in the Petition in that case does not address
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`these two claims. IPR2014-00360, Paper 1.
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`In relation to claims 5, 16, and 46, Petitioner’s Motion for Joinder does not
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`articulate why it did not challenge claims 5 or 16, or articulate reasoning in relation
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`to claim 46, in its Petition in IRP2014-00360. Instead, Petitioner contends that its
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`current challenge to claims 5, 16, 44, 46, and 47 involves the same art at issue in an
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`instituted ground, and the claims “all depend from independent claims on which
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`7
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`trial was instituted in Case IPR2014-00360,” and “have similar limitations.”
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`Joinder Motion 7–8.
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`Patent Owner states it never has asserted infringement of claims 5, 16 and 46
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`against Petitioner in a district court case, and Petitioner does not suggest otherwise.
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`Opp. to Joinder 12–13; Joinder Motion 4; Reply to Opp. to Joinder 4. Thus, it is
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`not clear why Petitioner challenges those claims now. Opp. to Joinder 12. Patent
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`Owner contends that Petitioner does so “to artificially create overlapping issues in
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`both proceedings.” Id. at 12–13. Patent Owner further contends that Petitioner
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`“will not be prejudiced if joinder is denied given that it has no real interest in the
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`patentability of these claims,” while “prejudice to Patent Owner from extending
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`the schedule in IPR2014-00360 to address these claims governs against joinder.”
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`Id. at 13.
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`Based on the contentions of both parties here, and considering the particular
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`facts of this case, we are not persuaded that Petitioner has shown that joinder is
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`justified in relation to the ground challenging claims 5, 16, and 46. Petitioner has
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`not articulated persuasive reasoning as to why this panel and Patent Owner should
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`take the time and resources to address claims not at issue in a related district court
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`case, when Petitioner could have challenged those claims, and provided analysis,
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`in its original Petition or another petition filed before the relevant § 315(b) bar
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`date.
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`Challenges to claims 44 and 47, however, stand on different footing. In its
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`Joinder Motion, Petitioner points out that Patent Owner asserted infringement of
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`claims 44 and 47 of the ’216 patent for the first time against Petitioner in a related
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`district court case, Endo Pharms. Inc. v. Amneal Pharms., C.A. No. 12-CIV-8115
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`8
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`(S.D.N.Y.), on February 5, 2014. Joinder Motion 4, 7. Thus, Patent Owner
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`asserted these two claims in a district court case after Petitioner filed its Petition in
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`IPR2014-00360 on January 16, 2014, and after the § 315(b) bar date passed for
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`Petitioner on January 17, 2014. Patent Owner concedes these facts, but contends
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`that Petitioner was on notice of the infringement contentions “a mere three weeks
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`after it filed its petition in IPR2014-00360 on January 16, 2014,” but “waited more
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`than seven months before filing its Second Petition to challenge these claims.”
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`Opp. to Joinder 13 (emphasis in original). Arguing against joinder, Patent Owner
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`also contends that “[a]ny purported prejudice to Amneal—which would be the
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`result of Amneal’s own delay—is mitigated by the fact that Amneal can challenge
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`the validity of these claims in the underlying litigation.” Id.
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`Regarding the alleged delay by Petitioner, we point out that we could not
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`have instituted a second inter parties review proceeding based on a Petition filed
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`after January 17, 2014, in view of the bar date under § 315(b), absent granting
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`joinder under § 315(c). Nor could we grant joinder in the absence of another
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`instituted case to join, which did not occur in IPR2014-00360 until we instituted a
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`trial in that case on July 25, 2014. As required under 37 C.F.R. § 42.122(b),
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`Petitioner filed its Joinder Motion within one month after institution of a trial on
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`that date.
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`Thus, in relation to claims 44 and 47, we are less concerned about a “delay”
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`by Petitioner, or gain by Petitioner of a “second bite at the apple,” than potential
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`prejudice to Patent Owner, which also does not cause us great concern. Because
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`Patent Owner asserted claims 44 and 47 for the first time after Petitioner filed its
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`first Petition, and after the § 315(b) bar date passed, we are persuaded that
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`9
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`Petitioner has shown that joinder is justified in relation to the ground in the current
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`Petition challenging claims 44 and 47 as obvious over Oshlack and the Handbook
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`of Dissolution Testing.
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`B. Grounds 2 and 3 challenging claims 72–82
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`The current Petition also raises two new grounds challenging claims 72–82,
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`each citing a least one reference not raised in any ground in the earlier proceeding.
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`Pet. 7, IPR2014-00360, Paper 1, 7. Those new grounds would require Patent
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`Owner to address, for the first time, new arguments in relation to new evidence,
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`potentially implicating the need for additional declarations, witness depositions, as
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`well as a non-trivial supplemental response by Patent Owner in IPR2014-00360.
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`Opp. to Joinder 11–12. Thus, we do not agree that there is “no discernible
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`prejudice” to Patent Owner if we grant the Joinder Motion in relation to those
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`grounds. See Microsoft Corp. v. Proxyconn, Inc., Case IPR2013-00109, slip op. at
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`4 (PTAB Feb. 25, 2013) (Paper 15) (concluding there was “no discernible
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`prejudice to either party” in granting joinder); Toyota Motor Corp. v. American
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`Vehicular Sci. LLC, Case IPR2015-00261, slip op. at 6 (PTAB Jan. 29, 2015)
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`(Paper 10).
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`In addition, as also noted by Patent Owner, Petitioner articulates no reason
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`why it did not raise those two grounds in its earlier Petition, or in any petition filed
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`before the § 315(b) bar date. Opp. to Joinder 11–12. Rather, it appears that
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`Petitioner attempts additional bites at the apple, after raising multiple grounds
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`challenging the same claims in the earlier proceeding, and after obtaining
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`Decisions from this panel on institution and regarding a Request for Rehearing in
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`relation to those grounds and claims. IPR2014-00360, Paper 1, 7; Papers 16, 21.
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`10
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`Under the circumstances, we are not persuaded that Petitioner has shown
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`that joinder is justified in relation to the two new grounds challenging claims 72–
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`82.
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`IV. ANALYSIS OF PETITION REGARDING CLAIMS 44 AND 47
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`For the reasons discussed above, we are persuaded that joinder is justified in
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`relation to the ground in the current Petition that claims 44 and 47 would have been
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`obvious over Oshlack and the Handbook of Dissolution Testing. Pet. 7–24.
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`Under 35 U.S.C. § 314(a), an inter partes review may not be instituted
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`“unless . . . there is a reasonable likelihood that the petitioner would prevail with
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`respect to at least 1 of the claims challenged in the petition.” Upon consideration
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`of the current Petition and Preliminary Response, and for the reasons explained
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`below, we determine that Petitioner has shown that there is a reasonable likelihood
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`that it would prevail with respect to claims 44 and 47 of the ’216 patent.
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`Our previous Institution Decision provides a summary of related
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`proceedings, the ’216 patent, as well as the Oshlack and Handbook of Dissolution
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`Testing references. IPR2014-00360, Institution Decision, 2–5, 14–16. Claims 44
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`and 47 of the ’216 patent both depend from claim 43, which depends from
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`independent claim 38. Ex. 1001, 29:49–30:45. In our Institution Decision, we
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`determined that Petitioner had shown a reasonable likelihood that it would prevail
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`with respect to claims 38 and 43, among other claims. IPR2014-00360, Institution
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`Decision, 16–20.
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`Here, we likewise determine that Petitioner has shown in the current Petition
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`that there is a reasonable likelihood that it would prevail in showing that the
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`limitations of independent claim 38 and dependent claim 43, which are required in
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`11
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`each of challenged claims 44 and 47, are taught or suggested in Oshlack in view of
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`the Handbook of Dissolution Testing. Pet. 8–24. For example, Petitioner makes a
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`threshold showing that Oshlack discloses controlled release oxymorphone
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`formulations, as well as testing of those formulations using in vitro dissolution
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`methods. Pet. 8 (citing Ex. 1007, 6:23–25, 7:35–39, 26:39–43). Relying on a
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`Declaration by Dr. Anthony Palmieri, Petitioner also makes a threshold showing
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`that an ordinary artisan “would have looked to the teachings of the Handbook, a
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`main general reference in the field of dissolution testing, for further specifics on
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`the dissolution tests provided in Oshlack.” Pet. 8 (citing Ex. 1003 ¶ 53), 10–11
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`(citing Ex.1008, 35, ¶ 5).
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`In addition, Petitioner makes a threshold showing that Oshlack discloses “a
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`controlled release oxymorphone composition comprising the excipient HPMC,” as
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`well as “in vitro dissolution profiles that overlap with the profiles recited by the
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`claims of the ’216 patent.” Pet. 9–11 (citing Ex. 1007, 1:10–12, 4:34–43, 5:25–32;
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`7:35–56, 8:62–65, 9:16–23, 9:46–52, 26:34–47). Petitioner further makes a
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`threshold showing that the opioid concentration ranges in Oshlack overlap and are
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`similar to the dosage limitations recited in independent claim 38. Pet. 14–15. In
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`addition, Petitioner addresses the “Four and Ten Hour Dissolution Limitations,”
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`“Food Effect Limitations,” and “Method of Treating Pain,” as recited in claim 38.
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`Pet. 18–21.
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`Dependent claim 44 recites that the method of claim 43, and therefore, claim
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`38, further comprises a hydrophilic material that “is selected from the group
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`consisting of a gum, a cellulose ether, an acrylic resin, a protein-derived material,
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`and mixtures thereof.” Ex. 1001, 30:30–33 (emphasis added). Claim 47 recites
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`12
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`that the method of claim 43, and therefore, claim 38, further comprises hydrophilic
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`material that “is selected from the group consisting of hydroxyethyl cellulose,
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`hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethylcellulose,
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`and mixtures thereof.” Id. at 30:41–45 (emphasis added).
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`Petitioner makes a threshold showing that Oshlack discloses that its
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`“hydrophobic fusible carrier may comprise . . . hydrophobic and hydrophilic
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`polymers having hydrocarbon backbones.” Pet. 11–12 (citing Ex. 1007, 9:16–23).
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`Petitioner also points to where Oshlack describes that, in certain embodiments,
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`“the hydrophobic material is selected from materials such as
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`hydroxyalkylcelluloses such as hydroxypropylmethylcellulose [HPMC].” Pet.
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`12 (citing Ex. 1007, 8:62–65).
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`Relying on the Declaration by Dr. Palmieri, Petitioner makes a threshold
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`showing that HPMC, as disclosed in Oshlack, “meets the hydrophilic material
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`limitation” of claims 44 and 47. Pet. 13 (citing Ex. 1003 ¶ 59). In addition to the
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`above-mentioned teachings in Oshlack, Petitioner points out that the ’216 patent
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`itself “defines HPMC as a hydrophilic material that forms a gel upon exposure to
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`gastrointestinal fluid [], notwithstanding that Oshlack refers to HPMC as a
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`hydrophobic agent.” Pet. 14 (citing Ex. 1001, 6:49-59; Ex.1007, 8:52–65).
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`Petitioner also makes a threshold showing that “Oshlack teaches that HPMC is a
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`hydroxyalkyl cellulose, a type of cellulose ether.” Pet. 14 (citing Ex. 1007, 8:62–
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`65; Ex. 1003).
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`Petitioner further makes a threshold showing, again relying on Dr.
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`Palmieri’s Declaration, that an ordinary artisan would have had reason to combine
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`the disclosures of Oshlack and the Handbook, and would have had a reasonable
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`expectation of success in doing so. Pet. 12–13 (citing Ex. 1003 ¶ 53), 21–24
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`(citing Ex. 1003 ¶¶ 77–83). For example, Petitioner makes a threshold showing
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`that an ordinary artisan would have had a reasonable expectation of success in
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`obtaining the dissolution profiles required in claims 38, 43, 44, and 47 “from the
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`controlled release formulations and dissolution profiles taught by Oshlack, as the
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`Handbook shows that results provided by the Paddle apparatus at 100 rpm and the
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`Basket apparatus at 50 rpm are roughly equivalent.” Pet. 20–21 (citing Ex. 1008,
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`35, ¶ 5; Ex. 1003 ¶ 77).
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`In its Preliminary Response, Patent Owner does not address the merits of
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`Petitioner’s contentions regarding Oshlack and the Handbook. Rather, Patent
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`Owner contends that we should deny the Petition in relation to Ground 1 because it
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`raises the same prior art, and the same or substantially the same arguments, as
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`raised in IPR2014-00360, and Petitioner provides “no justification” as to why it did
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`not challenge those claims earlier. Prelim. Resp. 11–15. As discussed above,
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`however, Petitioner provides a justification as to why it challenges claims 44 and
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`47 in the current Petition, and not in the Petition in IPR2014-00360. Because
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`Patent Owner asserted infringement of claims 44 and 47 in a district court case for
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`the first time after Petitioner filed its first Petition and after the § 315(b) bar date
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`passed, we are persuaded that Petitioner provides an adequate justification for
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`considering its contentions in the current Petition in relation to those claims.
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`In view of contentions and cited evidence in the current Petition and
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`Preliminary Response, as well as our rationale for instituting a trial in IPR2014-
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`00360 in relation to claims 38 and 43, we are persuaded that Petitioner has
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`demonstrated that there is a reasonable likelihood that it would prevail on the
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`14
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`ground that claims 44 and 47 would have been obvious over Oshlack and the
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`Handbook of Dissolution Testing.
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`V. CONCLUSION
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`For the foregoing reasons, we are persuaded that joinder with IPR2014-
`
`00360 is justified in relation to the ground in the current Petition regarding claims
`
`44 and 47, but not in relation to any grounds regarding claims 5, 16, 46, and 72–82.
`
`We also are persuaded that Petitioner has demonstrated that there is a reasonable
`
`likelihood that it would prevail on the ground that claims 44 and 47 of the ’216
`
`patent would have been obvious over Oshlack and the Handbook. We have not
`
`made a final determination on the patentability of the challenged claims.
`
`VI. CHANGES TO SCHEDULING ORDER
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`The Scheduling Order entered in IPR2014-00360 (Paper 17), along with any
`
`agreed-upon stipulations by the parties to that Scheduling Order in relation to DUE
`
`DATES 1 and 2, shall govern the schedule of the joined proceedings with the
`
`following exceptions.
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`The due date, now designated DUE DATE 1A, for Patent Owner to file a
`
`supplemental response to the instituted ground in the current Petition, as well as a
`
`supplemental motion to amend claims 44 and 47 of the ’216 patent, in this
`
`proceeding is February 25, 2015. Patent Owner’s supplemental response shall only
`
`address Petitioner’s obviousness challenge of claims 44 and 47 of the ’216 patent
`
`as presented in the Petition in IPR2014-01365, and is limited to 7 pages. Patent
`
`Owner’s supplemental motion to amend claims, if Patent Owner chooses to file
`
`one, is limited to 5 pages.
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`15
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`IPR2014-01365
`Patent 8,329,216 B2
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`The due date, now designated DUE DATE 2A, for Petitioner to file a
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`supplemental reply to Patent Owner’s supplemental response, as well as a
`
`supplemental opposition to Patent Owner’s supplemental motion to amend, in this
`
`proceeding is March 18, 2015. The supplemental reply and the supplemental
`
`opposition are each limited to 5 pages.
`
`In the “supplemental” papers due on DUE DATES 1A and 2A, either party
`
`may incorporate by reference portions of the original paper it supplements (e.g.,
`
`Patent Owner’s supplemental response due on DUE DATE 1A may refer to, and
`
`incorporate by reference, portions of Patent Owner’s Response in IPR2014-00360),
`
`but may not incorporate by reference any other paper. The parties may stipulate to
`
`a different date for DUE DATES 1A and 2A (earlier or later, but no later than
`
`DUE DATE 4, as designated below).
`
`Patent Owner’s reply to petitioner’s oppositions to motions to amend, due on
`
`DUE DATE 3, is Patent Owner’s opportunity to respond to both Petitioner’s
`
`original Opposition to Patent Owner’s Contingent Motion to Amend (IPR2014-
`
`00360, Paper 51) and Petitioner’s supplemental opposition to Patent Owner’s
`
`supplemental motion to amend (due on DUE DATE 2A), assuming one is filed.
`
`Patent Owner’s reply to petitioner’s oppositions to motions to amend is limited to 7
`
`pages if Petitioner files a supplemental opposition to Patent Owner’s supplemental
`
`motion to amend, but otherwise is limited to 5 pages.
`
`In addition to DUE DATES 1A and 2A, revised DUE DATES 3–7 shall
`
`apply as designed below.
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`16
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`IPR2014-01365
`Patent 8,329,216 B2
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`DUE DATE 1A .................................................................. February 25, 2015
`
`Patent Owner’s supplemental response to Petition in IPR2014-01365
`Patent Owner’s supplemental motion to amend claims 44 and 47
`
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`DUE DATE 2A ...................................................................... March 18, 2015
`
`Petitioner’s supplemental reply to supplemental response
`Petitioner’s supplemental opposition to supplemental motion to amend
`
`DUE DATE 3 ....................................................................... February 4, 2015
` April 8, 2015
`
`Patent Owner’s reply to petitioner’s oppositions to motions to amend
`
`DUE DATE 4 ..................................................................... February 25, 2015
` April 22, 2015
`
`Motion for observation regarding cross-examination of reply witness
`Motion to exclude evidence
`Request for oral argument
`
`DUE DATE 5 ......................................................................... March 11, 2015
` May 6, 2015
`
`Response to observation
`Opposition to motion to exclude
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`DUE DATE 6 ......................................................................... March 18, 2015
` May 12, 2015
`
`Reply to opposition to motion to exclude
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`DUE DATE 7 ............................................................................. April 2, 2015
` May 19, 2015
`
`Oral argument (if requested)
`
`
`17
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`IPR2014-01365
`Patent 8,329,216 B2
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`VII. ORDER
`
`For the reasons given, it is
`
`ORDERED that Petitioner’s Motion for Joinder is granted with
`
`respect to the alleged ground, under 35 U.S.C. § 103, that claims 44 and 47 of the
`
`’216 patent would have been obvious over Oshlack and the Handbook of
`
`Dissolution Testing;
`
`FURTHER ORDERED that Petitioner’s Motion for Joinder is denied
`
`in all other respects;
`
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`
`partes review is hereby instituted with respect to the alleged ground, under
`
`35 U.S.C. § 103, that claims 44 and 47 of the ’216 patent would have been obvious
`
`over Oshlack and the Handbook of Dissolution Testing;
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`FURTHER ORDERED that no other ground in the current Petition is
`
`authorized for inter partes review;
`
`FURTHER ORDERED that this proceeding is joined with IPR2014-
`
`00360;
`
`FURTHER ORDERED that changes to the Scheduling Order, as
`
`designated above, apply to the joined case, and DUE DATES 1A and 2A, and
`
`revised DUE DATES 3–7 are set accordingly;
`
`FURTHER ORDERED that that IPR2013-01365 is instituted, joined,
`
`and terminated under 37 C.F.R. § 42.72 and all further filings should be made in
`
`IPR2014-00360;
`
`FURTHER ORDERED that the case caption in IPR2014-00360 shall
`
`be changed to reflect the joinder with this proceeding in accordance with the
`
`18
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`IPR2014-01365
`Patent 8,329,216 B2
`
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`attached example;
`
`FURTHER ORDERED that because an initial conference call was
`
`already held on August 22, 2014, in IPR2014-00360, with which the current
`
`proceeding is joined, an initial conference call in the current proceeding is not
`
`necessary. If the parties feel an additional initial conference call with the Board is
`
`necessary, they should contact the Board to arrange such a call; and
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`FURTHER ORDERED that a copy of this Decision be entered into
`
`the file of IPR2014-00360.
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`19
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`IPR2014-01365
`Patent 8,329,216 B2
`
`
`For PETITIONER:
`
`Eldora Ellison
`Eellison-PTAB@skgf.com
`
`Dennies Varughese
`Dvarughe-PTAB@skgf.com
`
`
`
`For PATENT OWNER:
`
`
`Joseph Mahoney
`jmahoney@mayerbrown.com
`
`Erick Palmer
`ejpalmer@mayerbrown.com
`
`
`
`
`
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`20
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`ENDO PHARMACEUTICALS INC.,
`Patent Owner.
`____________
`
`Case IPR2014-003601
`Patent 8,329,216 B2
`____________
`
`