Paper 13
`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
`
`
`
`
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`I.
`
`INTRODUCTION
`
`Amneal Pharmaceuticals, LLC, (“Petitioner”) filed a Petition requesting
`
`inter partes review of claims 5, 16, 44, 46, 47, and 72–82 of U.S. Patent No.
`
`8,329,216 (“the ’216 patent”). Paper 2 (“Pet.,” “current Petition,” or “Second
`
`Petition”). On the same day, Petitioner also filed a Motion for Joinder, requesting
`
`joinder of the Petition with a related and instituted proceeding, IPR2014-00360.
`
`Paper 3 (“Joinder Motion”), 1–2. Petitioner filed its Joinder Motion within one
`
`month after institution of a trial in IPR2014-00360, as required by 37 C.F.R.
`
`§ 42.122(b). Endo Pharmaceuticals Inc. (“Patent Owner”) filed an Opposition to
`
`Petitioner’s Motion for Joinder (Paper 8, “Opp. to Joinder”), and Petitioner filed a
`
`Reply to Opposition to Motion for Joinder (Paper 10, “Reply to Opp. to Joinder”).
`
`Thereafter, Patent Owner filed a Preliminary Response (Paper 12, “Prelim.
`
`Resp.”). We have jurisdiction under 35 U.S.C. § 314.
`
`For the reasons that follow, we grant Petitioner’s Motion for Joinder in
`
`relation to a 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. In addition, we are
`
`persuaded that Petitioner has demonstrated that there is a reasonable likelihood that
`
`it would prevail with respect to claims 44 and 47 of the ’216 patent, and we grant
`
`the Petition as to those claims.
`
`II.
`
`BACKGROUND REGARDING JOINDER
`
`The statutory provision governing joinder of inter partes review proceedings
`
`is 35 U.S.C. § 315(c), which reads as follows:
`
`(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
`
`2
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`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
`
`when the petition is filed more than one year after the petitioner (or petitioner’s
`
`real party in interest or privy) is served with a complaint alleging infringement of
`
`the patent. 35 U.S.C. § 315(b); 37 C.F.R. § 42.101(b). That one-year time bar,
`
`however, does not apply to a request for joinder. 35 U.S.C. § 315(b) (final
`
`sentence); 37 C.F.R. § 42.122(b). This is an important consideration here because
`
`Petitioner was served with a complaint asserting infringement of the ʼ216 patent
`
`more than one year before filing the Petition in this proceeding.1 Thus, absent
`
`joinder of Petitioner in this proceeding as a party to IPR2014-00360, institution
`
`based on the current Petition is barred.
`
`Joinder may be authorized when warranted, but the decision to grant joinder
`
`is discretionary. 35 U.S.C. § 315(c); 37 C.F.R. § 42.122(b). When exercising that
`
`discretion, the Board is mindful that patent trial regulations, including the rules for
`
`joinder, must be construed to secure the just, speedy, and inexpensive resolution of
`
`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
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`III. ANALYSIS ON JOINDER
`
`Petitioner filed its Second Petition approximately one month after institution
`
`in IPR2014-00360. Thus, this case represents a “second bite at the apple” for
`
`Petitioner, who has received the benefit of seeing our Institution Decision in the
`
`prior case involving the same parties and patent. See IPR2014-00360, Paper 16
`
`(“Institution Decision,” dated July 25, 2014). This “second bite at the apple”
`
`situation is particularly noteworthy in view of the § 315(b) bar at issue here.
`
`We observe that in its Opposition to Petitioner’s Motion for Joinder, Patent
`
`Owner points us to a Decision Denying a Motion for Joinder by a different Board
`
`panel in Target Corp. v. Destination Maternity Corp., Case IPR2014-00508
`
`(PTAB Sept. 25, 2014) (Paper 18) (“Target Decision”). Opp. to Joinder 5–10. We
`
`are aware of the Target Decision, and respect our colleagues’ well-reasoned
`
`position in the majority opinion in that case. We also recognize, however, as
`
`evident from Target Decision itself, that reasonable minds can differ on an
`
`interpretation of 35 U.S.C. § 315 as it relates to joining a party to an earlier
`
`proceeding in which the party is already a participant.3
`
`
`
`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).
`
`4
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`In view of the reasonable difference of opinion, as well as the existence of
`
`other Board cases allowing joinder of Petitions filed by a same party, we interpret
`
`§ 315(c) as granting us discretion to allow joinder under the circumstances of this
`
`case. That said, when a § 315(b) bar would apply absent joinder, we hesitate to
`
`allow a petitioner a second bite one month after institution in a first case, at the
`
`expense of scheduling constraints for everyone, as well as additional costs (and
`
`potential prejudice) to Patent Owner, absent a good reason for doing so.
`
`In this proceeding, in relation to the current Petition, Petitioner moves for
`
`joinder with IPR2014-00360. Joinder Motion 1–2. We instituted a trial in
`
`IPR2014-00360 on July 25, 2014, and denied a Request for Rehearing of our
`
`Institution Decision on September 16, 2014; Patent Owner subsequently filed a
`
`Response and Contingent Motion to Amend on October 27, 2014. IPR2014-
`
`00360, Institution Decision, Papers 21, 29, 31, 32.
`
`The current Petition raises three grounds in relation to challenged claims 5,
`
`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
`
`Challenged Claims
`
`5, 16, 44, 46, and 47
`
`
`
`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).
`
`5
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`
`
`References
`
`2 Oshlack, Handbook of Dissolution Testing, and
`Handbook of Pharmaceutical Excipients (Ex. 1019)6
`
`3 Baichwal ’757 (Ex. 1031),7 Penwest Statement (Ex.
`1009),8 Baichwal ’933 (Ex. 1032),9 and Gordon (Ex.
`1011)10
`
`Pet. 7.
`
`Challenged Claims
`
`72–82
`
`72–82
`
`The first ground in the current Petition challenges claims 5, 16, 44, 46, and
`
`47 based on the same art, Oshlack and Handbook of Dissolution Testing, raised in
`
`a ground upon which we instituted review of claims 1, 2, 6, 12–14, 17, 21–43, 45–
`
`51, and 54–71 of the same patent in IPR2014-00360. IPR2014-00360, Paper 16,
`
`22. The other two grounds each challenge claims 72–82 based on new
`
`obviousness grounds, not raised in the Petition in IPR2014-00360, citing, inter
`
`alia, three prior art references not at issue in the earlier proceeding, i.e., Handbook
`
`of Pharmaceutical Excipients in Ground 2, and Baichwal ’757 and Baichwal ’933
`
`
`
`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).
`
`6
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`in Ground 3. Pet. 7; IPR2014-00360, Paper 1, 7. In our Institution Decision and
`
`Decision on Rehearing in IPR2014-00360, we denied grounds challenging claims
`
`72–82 based on different combinations of references. Institution Decision 2, 14–
`
`22; Paper 21, 3–6.
`
`A. Ground 1 challenging claims 5, 16, 44, 46, and 47
`
`The Board determines whether to grant joinder on a case-by-case basis,
`
`taking into account the particular facts of each case. In this regard, we are mindful
`
`of a public interest in securing “the just, speedy, and inexpensive resolution of
`
`every proceeding.” 37 C.F.R. § 42.1(b).
`
`In Ground 1, the current Petition challenges claims 5, 16, and 44 of ’216
`
`patent for the first time. Regarding claims 46 and 47, as noted by Petitioner,
`
`“[d]ue to an unintentional inconsistency in claim numbering in the First Petition,
`
`trial was instituted for claims 46 and 47 without Petitioner’s specific analysis of
`
`these claims in the First Petition.” Joinder Motion 7; see also Opp. to Joinder 14
`
`(stating that “due to Amneal’s error in identifying claims 46 and 47 in its petition
`
`headings, the Board inadvertently instituted review of these claims”). Thus, while
`
`the Petition in IPR2014-00360 lists claims 46 and 47 (among others) in headings in
`
`relation to certain grounds, the analysis in the Petition in that case does not address
`
`these two claims. IPR2014-00360, Paper 1.
`
`In relation to claims 5, 16, and 46, Petitioner’s Motion for Joinder does not
`
`articulate why it did not challenge claims 5 or 16, or articulate reasoning in relation
`
`to claim 46, in its Petition in IRP2014-00360. Instead, Petitioner contends that its
`
`current challenge to claims 5, 16, 44, 46, and 47 involves the same art at issue in an
`
`instituted ground, and the claims “all depend from independent claims on which
`
`7
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`trial was instituted in Case IPR2014-00360,” and “have similar limitations.”
`
`Joinder Motion 7–8.
`
`Patent Owner states it never has asserted infringement of claims 5, 16 and 46
`
`against Petitioner in a district court case, and Petitioner does not suggest otherwise.
`
`Opp. to Joinder 12–13; Joinder Motion 4; Reply to Opp. to Joinder 4. Thus, it is
`
`not clear why Petitioner challenges those claims now. Opp. to Joinder 12. Patent
`
`Owner contends that Petitioner does so “to artificially create overlapping issues in
`
`both proceedings.” Id. at 12–13. Patent Owner further contends that Petitioner
`
`“will not be prejudiced if joinder is denied given that it has no real interest in the
`
`patentability of these claims,” while “prejudice to Patent Owner from extending
`
`the schedule in IPR2014-00360 to address these claims governs against joinder.”
`
`Id. at 13.
`
`Based on the contentions of both parties here, and considering the particular
`
`facts of this case, we are not persuaded that Petitioner has shown that joinder is
`
`justified in relation to the ground challenging claims 5, 16, and 46. Petitioner has
`
`not articulated persuasive reasoning as to why this panel and Patent Owner should
`
`take the time and resources to address claims not at issue in a related district court
`
`case, when Petitioner could have challenged those claims, and provided analysis,
`
`in its original Petition or another petition filed before the relevant § 315(b) bar
`
`date.
`
`Challenges to claims 44 and 47, however, stand on different footing. In its
`
`Joinder Motion, Petitioner points out that Patent Owner asserted infringement of
`
`claims 44 and 47 of the ’216 patent for the first time against Petitioner in a related
`
`district court case, Endo Pharms. Inc. v. Amneal Pharms., C.A. No. 12-CIV-8115
`
`8
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`(S.D.N.Y.), on February 5, 2014. Joinder Motion 4, 7. Thus, Patent Owner
`
`asserted these two claims in a district court case after Petitioner filed its Petition in
`
`IPR2014-00360 on January 16, 2014, and after the § 315(b) bar date passed for
`
`Petitioner on January 17, 2014. Patent Owner concedes these facts, but contends
`
`that Petitioner was on notice of the infringement contentions “a mere three weeks
`
`after it filed its petition in IPR2014-00360 on January 16, 2014,” but “waited more
`
`than seven months before filing its Second Petition to challenge these claims.”
`
`Opp. to Joinder 13 (emphasis in original). Arguing against joinder, Patent Owner
`
`also contends that “[a]ny purported prejudice to Amneal—which would be the
`
`result of Amneal’s own delay—is mitigated by the fact that Amneal can challenge
`
`the validity of these claims in the underlying litigation.” Id.
`
`Regarding the alleged delay by Petitioner, we point out that we could not
`
`have instituted a second inter parties review proceeding based on a Petition filed
`
`after January 17, 2014, in view of the bar date under § 315(b), absent granting
`
`joinder under § 315(c). Nor could we grant joinder in the absence of another
`
`instituted case to join, which did not occur in IPR2014-00360 until we instituted a
`
`trial in that case on July 25, 2014. As required under 37 C.F.R. § 42.122(b),
`
`Petitioner filed its Joinder Motion within one month after institution of a trial on
`
`that date.
`
`Thus, in relation to claims 44 and 47, we are less concerned about a “delay”
`
`by Petitioner, or gain by Petitioner of a “second bite at the apple,” than potential
`
`prejudice to Patent Owner, which also does not cause us great concern. Because
`
`Patent Owner asserted claims 44 and 47 for the first time after Petitioner filed its
`
`first Petition, and after the § 315(b) bar date passed, we are persuaded that
`
`9
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`Petitioner has shown that joinder is justified in relation to the ground in the current
`
`Petition challenging claims 44 and 47 as obvious over Oshlack and the Handbook
`
`of Dissolution Testing.
`
`B. Grounds 2 and 3 challenging claims 72–82
`
`The current Petition also raises two new grounds challenging claims 72–82,
`
`each citing a least one reference not raised in any ground in the earlier proceeding.
`
`Pet. 7, IPR2014-00360, Paper 1, 7. Those new grounds would require Patent
`
`Owner to address, for the first time, new arguments in relation to new evidence,
`
`potentially implicating the need for additional declarations, witness depositions, as
`
`well as a non-trivial supplemental response by Patent Owner in IPR2014-00360.
`
`Opp. to Joinder 11–12. Thus, we do not agree that there is “no discernible
`
`prejudice” to Patent Owner if we grant the Joinder Motion in relation to those
`
`grounds. See Microsoft Corp. v. Proxyconn, Inc., Case IPR2013-00109, slip op. at
`
`4 (PTAB Feb. 25, 2013) (Paper 15) (concluding there was “no discernible
`
`prejudice to either party” in granting joinder); Toyota Motor Corp. v. American
`
`Vehicular Sci. LLC, Case IPR2015-00261, slip op. at 6 (PTAB Jan. 29, 2015)
`
`(Paper 10).
`
`In addition, as also noted by Patent Owner, Petitioner articulates no reason
`
`why it did not raise those two grounds in its earlier Petition, or in any petition filed
`
`before the § 315(b) bar date. Opp. to Joinder 11–12. Rather, it appears that
`
`Petitioner attempts additional bites at the apple, after raising multiple grounds
`
`challenging the same claims in the earlier proceeding, and after obtaining
`
`Decisions from this panel on institution and regarding a Request for Rehearing in
`
`relation to those grounds and claims. IPR2014-00360, Paper 1, 7; Papers 16, 21.
`
`10
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`Under the circumstances, we are not persuaded that Petitioner has shown
`
`that joinder is justified in relation to the two new grounds challenging claims 72–
`
`82.
`
`IV. ANALYSIS OF PETITION REGARDING CLAIMS 44 AND 47
`
`For the reasons discussed above, we are persuaded that joinder is justified in
`
`relation to the ground in the current Petition that claims 44 and 47 would have been
`
`obvious over Oshlack and the Handbook of Dissolution Testing. Pet. 7–24.
`
`Under 35 U.S.C. § 314(a), an inter partes review may not be instituted
`
`“unless . . . there is a reasonable likelihood that the petitioner would prevail with
`
`respect to at least 1 of the claims challenged in the petition.” Upon consideration
`
`of the current Petition and Preliminary Response, and for the reasons explained
`
`below, we determine that Petitioner has shown that there is a reasonable likelihood
`
`that it would prevail with respect to claims 44 and 47 of the ’216 patent.
`
`Our previous Institution Decision provides a summary of related
`
`proceedings, the ’216 patent, as well as the Oshlack and Handbook of Dissolution
`
`Testing references. IPR2014-00360, Institution Decision, 2–5, 14–16. Claims 44
`
`and 47 of the ’216 patent both depend from claim 43, which depends from
`
`independent claim 38. Ex. 1001, 29:49–30:45. In our Institution Decision, we
`
`determined that Petitioner had shown a reasonable likelihood that it would prevail
`
`with respect to claims 38 and 43, among other claims. IPR2014-00360, Institution
`
`Decision, 16–20.
`
`Here, we likewise determine that Petitioner has shown in the current Petition
`
`that there is a reasonable likelihood that it would prevail in showing that the
`
`limitations of independent claim 38 and dependent claim 43, which are required in
`
`11
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`each of challenged claims 44 and 47, are taught or suggested in Oshlack in view of
`
`the Handbook of Dissolution Testing. Pet. 8–24. For example, Petitioner makes a
`
`threshold showing that Oshlack discloses controlled release oxymorphone
`
`formulations, as well as testing of those formulations using in vitro dissolution
`
`methods. Pet. 8 (citing Ex. 1007, 6:23–25, 7:35–39, 26:39–43). Relying on a
`
`Declaration by Dr. Anthony Palmieri, Petitioner also makes a threshold showing
`
`that an ordinary artisan “would have looked to the teachings of the Handbook, a
`
`main general reference in the field of dissolution testing, for further specifics on
`
`the dissolution tests provided in Oshlack.” Pet. 8 (citing Ex. 1003 ¶ 53), 10–11
`
`(citing Ex.1008, 35, ¶ 5).
`
`In addition, Petitioner makes a threshold showing that Oshlack discloses “a
`
`controlled release oxymorphone composition comprising the excipient HPMC,” as
`
`well as “in vitro dissolution profiles that overlap with the profiles recited by the
`
`claims of the ’216 patent.” Pet. 9–11 (citing Ex. 1007, 1:10–12, 4:34–43, 5:25–32;
`
`7:35–56, 8:62–65, 9:16–23, 9:46–52, 26:34–47). Petitioner further makes a
`
`threshold showing that the opioid concentration ranges in Oshlack overlap and are
`
`similar to the dosage limitations recited in independent claim 38. Pet. 14–15. In
`
`addition, Petitioner addresses the “Four and Ten Hour Dissolution Limitations,”
`
`“Food Effect Limitations,” and “Method of Treating Pain,” as recited in claim 38.
`
`Pet. 18–21.
`
`Dependent claim 44 recites that the method of claim 43, and therefore, claim
`
`38, further comprises a hydrophilic material that “is selected from the group
`
`consisting of a gum, a cellulose ether, an acrylic resin, a protein-derived material,
`
`and mixtures thereof.” Ex. 1001, 30:30–33 (emphasis added). Claim 47 recites
`
`12
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`that the method of claim 43, and therefore, claim 38, further comprises hydrophilic
`
`material that “is selected from the group consisting of hydroxyethyl cellulose,
`
`hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethylcellulose,
`
`and mixtures thereof.” Id. at 30:41–45 (emphasis added).
`
`Petitioner makes a threshold showing that Oshlack discloses that its
`
`“hydrophobic fusible carrier may comprise . . . hydrophobic and hydrophilic
`
`polymers having hydrocarbon backbones.” Pet. 11–12 (citing Ex. 1007, 9:16–23).
`
`Petitioner also points to where Oshlack describes that, in certain embodiments,
`
`“the hydrophobic material is selected from materials such as
`
`hydroxyalkylcelluloses such as hydroxypropylmethylcellulose [HPMC].” Pet.
`
`12 (citing Ex. 1007, 8:62–65).
`
`Relying on the Declaration by Dr. Palmieri, Petitioner makes a threshold
`
`showing that HPMC, as disclosed in Oshlack, “meets the hydrophilic material
`
`limitation” of claims 44 and 47. Pet. 13 (citing Ex. 1003 ¶ 59). In addition to the
`
`above-mentioned teachings in Oshlack, Petitioner points out that the ’216 patent
`
`itself “defines HPMC as a hydrophilic material that forms a gel upon exposure to
`
`gastrointestinal fluid [], notwithstanding that Oshlack refers to HPMC as a
`
`hydrophobic agent.” Pet. 14 (citing Ex. 1001, 6:49-59; Ex.1007, 8:52–65).
`
`Petitioner also makes a threshold showing that “Oshlack teaches that HPMC is a
`
`hydroxyalkyl cellulose, a type of cellulose ether.” Pet. 14 (citing Ex. 1007, 8:62–
`
`65; Ex. 1003).
`
`Petitioner further makes a threshold showing, again relying on Dr.
`
`Palmieri’s Declaration, that an ordinary artisan would have had reason to combine
`
`the disclosures of Oshlack and the Handbook, and would have had a reasonable
`
`13
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`expectation of success in doing so. Pet. 12–13 (citing Ex. 1003 ¶ 53), 21–24
`
`(citing Ex. 1003 ¶¶ 77–83). For example, Petitioner makes a threshold showing
`
`that an ordinary artisan would have had a reasonable expectation of success in
`
`obtaining the dissolution profiles required in claims 38, 43, 44, and 47 “from the
`
`controlled release formulations and dissolution profiles taught by Oshlack, as the
`
`Handbook shows that results provided by the Paddle apparatus at 100 rpm and the
`
`Basket apparatus at 50 rpm are roughly equivalent.” Pet. 20–21 (citing Ex. 1008,
`
`35, ¶ 5; Ex. 1003 ¶ 77).
`
`In its Preliminary Response, Patent Owner does not address the merits of
`
`Petitioner’s contentions regarding Oshlack and the Handbook. Rather, Patent
`
`Owner contends that we should deny the Petition in relation to Ground 1 because it
`
`raises the same prior art, and the same or substantially the same arguments, as
`
`raised in IPR2014-00360, and Petitioner provides “no justification” as to why it did
`
`not challenge those claims earlier. Prelim. Resp. 11–15. As discussed above,
`
`however, Petitioner provides a justification as to why it challenges claims 44 and
`
`47 in the current Petition, and not in the Petition in IPR2014-00360. Because
`
`Patent Owner asserted infringement of claims 44 and 47 in a district court case for
`
`the first time after Petitioner filed its first Petition and after the § 315(b) bar date
`
`passed, we are persuaded that Petitioner provides an adequate justification for
`
`considering its contentions in the current Petition in relation to those claims.
`
`In view of contentions and cited evidence in the current Petition and
`
`Preliminary Response, as well as our rationale for instituting a trial in IPR2014-
`
`00360 in relation to claims 38 and 43, we are persuaded that Petitioner has
`
`demonstrated that there is a reasonable likelihood that it would prevail on the
`
`14
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`ground that claims 44 and 47 would have been obvious over Oshlack and the
`
`Handbook of Dissolution Testing.
`
`V. CONCLUSION
`
`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
`
`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.
`
`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.
`
`15
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`The due date, now designated DUE DATE 2A, for Petitioner to file a
`
`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.
`
`16
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`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
`
`
`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
`
`DUE DATE 6 ......................................................................... March 18, 2015
` May 12, 2015
`
`Reply to opposition to motion to exclude
`
`DUE DATE 7 ............................................................................. April 2, 2015
` May 19, 2015
`
`Oral argument (if requested)
`
`
`17
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`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;
`
`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
`
`

`

`IPR2014-01365
`Patent 8,329,216 B2
`
`
`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
`
`FURTHER ORDERED that a copy of this Decision be entered into
`
`the file of IPR2014-00360.
`
`19
`
`

`

`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
`
`
`
`
`
`
`20
`
`

`

`
`
`
`
`
`
`
`
`
`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
`____________
`
`