When Might a PTAB Rehearing Be Granted?

by | Feb 21, 2024 | PTAB News, Request for Reconsideration

By Sabrina Bellantoni and Matt Johnson –

Recently, the Patent Trial and Appeals Board (“PTAB”) granted a request for rehearing of a decision that denied an institution of inter partes review and then instituted a trial on all the challenged claims on all the grounds raised by the Petitioner regarding a patent for a cladribine regimen for treating multiple sclerosis.  TWi Pharmaceuticals, Inc. v. Merck Serono SA, IPR2023-00049, Paper 15 (December 20, 2023).

Twi Pharmaceuticals (the Petitioner) brought a request for a rehearing of the institution decision denying inter partes review challenging the claims 36, 38, 39, and 41-48 of Merk Serono’s (the Patent Owner) U.S. Patent No. 7,713,947 B2 (“the ‘947 patent”).  The basis for the institution was anticipation under 35 U.S.C. § 102(e) by US 7,888,328 B2, issued Feb. 15, 2011 (“Bodor”) and obviousness under 35 U.S.C. § 103(a) by Bodor and Rice et al., Cladribine and progressive MS: Clinical and MRI outcomes of a multicenter controlled trial, NEUROLOGY, 54(5):1145–1155 (2000) (“Rice”).

The party that requests the rehearing has the burden to show that the PTAB’s decision should be modified by “specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply.”  See 37 C.F.R. § 42.71(d).  Further, according to 37 C.F.R. § 42.71(c) the PTAB will review the decision based on an abuse of discretion that could arise from “an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors.”  Citing Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).

The claim at issue, independent claim 36 of the ‘947 patent, recites “[a] method of treating multiple sclerosis comprising the oral administration of a formulation comprising cladribine” following steps for an induction period of administering cladribine, a cladribine-free period, a maintenance period of administering cladribine, and a cladribine-free period.  The amount of cladribine administered in the induction period ranges from 1.7–3.5 mg/kg and the amount of cladribine administered in the maintenance period is about 1.7 mg/kg.

In the PTAB’s decision they found that Petitioner did not show that the dosage administered in Bodor’s maintenance period “would necessarily be” the same amount administered in the first round because Bodor required continuous clinical evaluations to determine if the dosage amounts of cladribine needed adjustment.  The PTAB found that this adjustment did not involve considerations based on the patient’s weight.  In the Petitioner’s request for rehearing, it argued that the PTAB overlooked or misapprehended the scope of the ‘947 patent claims because the challenged claims do not require but allow for the same dosage amount in the maintenance period.  Petitioner argued that the challenged claims required a total dosage amount of cladribine to reach the claimed amounts and that Bodor disclosed those amounts when cladribine is administered to a patient of average weight.

After reconsideration, the PTAB found Petitioner met its burden under 37 C.F.R. §§ 42.71(c) and (d) to support a reasonable likelihood of obviousness by Bodor either alone or with Rice.  The PTAB reasoned that although Bodor did not explicitly state that the same regimen would be used again after the cladribine free period, it would be reasonably inferred “from Bodor’s teachings in conjunction with the knowledge of the ordinary artisan that the cladribine dosing protocol in Bodor is repeated.”  Thus, Petitioner argued that the PTAB misinterpreted the claims because the ‘947 patent simply provided a different way of reciting the required total amount of cladribine administered throughout the treatment phase compared to the teachings of Bodor, but the challenged claims did overlap with Bodor’s method and dosage.  The PTAB agreed with the Petitioner’s argument.  The PTAB stated that the amount of cladribine administered to a patient in the ‘957 patent required the patient’s weight, and, in the petition, Petitioner relied solely on a patient of an acceptable average human weight.  With this, in the PTAB’s decision it found that the Petitioner’s reliance demonstrated a total dosage possible for only some patients.  However, at the rehearing, the PTAB concluded it erred by stating that the one example was insufficient and acknowledged, “where there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.”  Quoting Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004).

After making the conclusion that the PTAB erred in its decision, the PTAB analyzed the issue under 35 U.S.C. § 325(d).  This section provides that a director may reject a petition if “the same or substantially the same prior art or arguments previously were presented to the Office.”  The PTAB has created a two-part framework from Advanced Bionics, Paper 6 at 8.  The framework is “(1) [determining] whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, [determining] whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.”

The PTAB found that the first prong was satisfied because the Bodor disclosure and the Rice reference were both considered by the examiner during prosecution.  Under the second prong, the PTAB found that the Office erred in its evaluation of the cited reference and declined to exercise its discretion to deny institution.  The PTAB reasoned that the Office erred in allowing the broader claim 36 and that the claim was not properly examined during prosecution because the examiner misapprehended the scope of the claim.  As the PTAB cautioned “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”

Therefore, the PTAB concluded after reviewing all evidence and arguments that Petitioner demonstrated a reasonable likelihood of success in proving at a minimum one of the challenged claims of the ‘947 patent to be unpatentable and therefore, the PTAB instituted trial on all challenged claims on all grounds raised in the petition.  Note that at this stage the PTAB did not make any final determinations as to the patentability of the ‘947 patent.

Takeaway:

When the rate of rehearing grants is less than 10%, this decision demonstrates the essential criteria that the PTAB will look at when determining if it should rehear a decision.  The PTAB will look to 37 C.F.R. § 42.71(c) and (d) to determine whether its decision should be modified and whether there was an abuse of discretion.  If the PTAB finds that a petitioner met its burden under 37 C.F.R. §§ 42.71(c) and (d), the request for a rehearing will be granted.  Afterwards, the PTAB will look to 35 U.S.C. § 325(d) to see if it may reject the petition.  If the PTAB cannot find a reason to exercise their discretion, it will institute the trial.

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Matthew Johnson

Partner at Jones Day
Matt Johnson is one of the Firm's primary contacts on practice before the PTAB. Currently co-chairing the Firm's PTAB subpractice and involved in proceedings at the Board since the first day of their availability in September 2012, Matt regularly represents clients as both petitioners and patent owners at the Board. He further works as an advocate for clients in appeals from Board proceedings at the Federal Circuit.