HB Ad Slot
HB Mobile Ad Slot
Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc., IPR2014-01365: Granting Petitioner’s Request for Joinder
Wednesday, March 4, 2015

Takeaway: 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.

In its Decision, the Board granted Petitioner’s Motion for Joinder with respect to the asserted ground that claims 44 and 47 of the ’216 patent would have been obvious, and instituted inter partes review based on this ground. On the other hand, the Board denied the Motion for Joinder in all other respects, and found that no other ground was authorized for inter partes review.

Petitioner had requested inter partes review of claims 5, 16, 44, 46, 47, and 72-82 of the ’216 patent. Petitioner filed a Motion for Joinder on the same day as its Petition seeking joinder of this matter with IPR2014-00360, also relating to the ’216 patent, within one month after institution of trial in that proceeding. Petitioner had been served with a complaint asserting infringement of the ’216 patent more than one year before the filing of the Petition in this IPR2014-01365, meaning that institution based on the Petition in the instant IPR2014-01365 proceeding was barred “absent joinder of Petitioner in this proceeding as a party to IPR2014-00360.”

The Board characterized Petitioner’s filing of the Petition in the instant IPR2014-01365 proceeding at a point in time approximately one month after institution in the IPR2014-00360 proceeding, as “a second bite at the apple” for Petitioner (because it could give Petitioner the benefit of having seen the Board’s Institution Decision in the prior IPR2014-00360 proceeding involving the same parties and the same patent). Patent Owner opposed Petitioner’s Motion for Joinder, citing the Decision Denying a Motion for Joinder in Target Corp. v. Destination Maternity Corp., Case IPR2014-00508 (PTAB Sept. 25, 2014) by a different Board panel.

Despite the Target Decision, the Board panel in this IPR2014-01365 proceeding noted 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.” The Board next indicated that “[i]n 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, the Board then went on to state that “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.”

The Board then proceeded to note that the Petition in the instant IPR2014-01365 proceeding asserted the following grounds: (1) obviousness of claims 5, 16, 44, 46, and 47 in view of Oshlack and the Handbook of Dissolution Testing; (2) obviousness of claims 72-82 in view of Oshlack, the Handbook of Dissolution Testing, and the Handbook of Pharmaceutical Excipients; and (3) obviousness of claims 72-82 in view of Baichwal ’757, Penwest Statement, Baichwal ‘933, and Gordon. The Board noted the aforementioned ground (1) was “based on the same art, Oshlack and Handbook of Dissolution Testing, raised in a ground upon which [the Board had] instituted review of claims 1, 2, 6, 12-14, 17, 21-43, 45-51, and 54-71 of the same [’216] patent in IPR2014-00360,” and that grounds (2) and (3) “each challenge claims 72-82 based on new obviousness grounds, not raised in the Petition in IPR2014-00360,” and “citing . . . 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.”

As for ground (1), the Board was “not persuaded that Petitioner has shown that joinder is justified in relation to the ground challenging claims 5, 16, and 46.” According to the Board, “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.” The Board found that the “[c]hallenges to claims 44 and 47, however, stand on different footing.” As found by the Board, “[b]ecause 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, [the Board was] persuaded that 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.”

With respect to grounds (2) and (3), the Board took notice that each of these cites “at least one reference not raised in any ground in the earlier proceeding,” and concluded that such “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.” Thus, the Board did not agree that “no discernible prejudice” to Patent Owner would result if the Board granted the Joinder Motion with respect to grounds (2) and (3).

With further regard to grounds (2) and (3), the Board noted that “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.” Instead, according to the Board, “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.” Accordingly, the Board was not persuaded that Petitioner had demonstrated that joinder was justified with respect to new grounds (2) and (3) challenging claims 72–82.

In conclusion, the Board was “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” and “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.” The Board had not yet made a final determination as to the patentability of challenged claims 44 and 47, however.

Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc., IPR2014-01365
Paper 64: Decision Granting Petitioner’s Motion for Joinder In-Part, and Instituting Inter Partes Review
Patent 8,329,216 B2
Dated: February 4, 2015
Before: Toni R. Scheiner, Francisco C. Prats, and Jacqueline Wright Bonilla
Written by: Bonilla
Related Proceeding: IPR2014-00360

HB Ad Slot
HB Mobile Ad Slot
HB Ad Slot
HB Mobile Ad Slot
HB Ad Slot
HB Mobile Ad Slot
 

NLR Logo

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins

 

Sign Up for e-NewsBulletins