Trials@uspto.gov
`571-272-7822
`
`Paper 24
`Date: August 1, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`
`IPR2022-01104
`Patent 9,919,024 B2
`
`
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, CYNTHIA M. HARDMAN, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request on Rehearing of Decision on Institution
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`

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`IPR2022-01104
`Patent 9,919,024 B2
`
`
`I.
`
`INTRODUCTION
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`Mylan Pharmaceuticals, Inc. (“Petitioner”) requests rehearing of the
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`Board’s Decision (Paper 15) (“Decision” or “Dec.”) denying institution of
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`inter partes review of claims 1–16 of U.S. Patent No. 9,919,024 B2 (“the
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`’024 patent,” Ex. 1001). (Paper 17) (“Request for Rehearing” or “Req.
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`Reh’g.”).1
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`In our Decision, we declined to institute inter partes review of the
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`challenged claims as obvious because the Petition did not sufficiently show
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`that a person of ordinary skill in the art would have been motivated to use
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`“an inert low moisture carrier,” as recited in independent claims 1 and 3.
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`Dec. 14. Petitioner seeks reconsideration of our Decision because it argues
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`that we misapprehended the controlling obviousness standard, overlooked
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`evidence supporting obviousness, shifted the agency’s position, and imposed
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`an impossible burden. Req. Reh’g. 1, 14–15.
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`For the reasons that follow, Petitioner’s Request for Rehearing is
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`denied.
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`II.
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`LEGAL STANDARD
`
`Pursuant to 37 C.F.R. § 42.71(d):
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` A
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` party dissatisfied with a decision may file a single request for
`rehearing without prior authorization from the Board. The
`burden of showing a decision should be modified lies with the
`party challenging the decision. The request must specifically
`identify all matters the party believes the Board misapprehended
`
`
`1 Petitioner has also filed Requests for Rehearing in related cases IPR2022-
`01102 (Patent 9,610,321), IPR2022-01103 (Patent 9,616,027), and IPR2022-
`01105 (Patent 9,925,231). Citations are to the record in IPR2022-01102,
`which is representative.
`
`2
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`

`

`IPR2022-01104
`Patent 9,919,024 B2
`
`
`or overlooked, and the place where each matter was previously
`addressed in a motion, an opposition, or a reply.
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`When reconsidering a decision on institution, we review the decision for an
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`abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists
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`where a “decision [i]s based on an erroneous conclusion of law or clearly
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`erroneous factual findings, or . . . a clear error of judgment.” PPG Indus.
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`Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir.
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`1988).
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`A rehearing request is not an opportunity for the requesting party to
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`reargue its case or merely to express disagreement with the underlying
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`decision. Nor is it an opportunity for the moving party to present new
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`arguments that were not in its original submissions.
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`III. ANALYSIS
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`A.
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`Petitioner’s Request for Additional Briefing
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`To begin, Petitioner contends that it was not given the ability to
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`provide additional briefing to address its concerns regarding Patent Owner’s
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`arguments on the merits of the asserted obviousness grounds. Req. Reh’g.
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`14. Petitioner explains that it alerted the Board of Patent Owner’s
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`“improperly heightened obviousness standard,” but the Board denied
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`Petitioner the opportunity to provide additional briefing on this issue. Id.
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`Petitioner argues that as a result, the Decision imposed an “unlawfully
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`heightened burden,” “improper standard,” and “impossible burden.” Id. at 1,
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`6, 14–15.
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`We first note that our procedure does not provide Petitioner a right to
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`reply to Patent Owner’s Preliminary Response. Patent Trial and Appeal
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`3
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`IPR2022-01104
`Patent 9,919,024 B2
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`Board Consolidated Trial Practice Guide November 20192, 51 (“The
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`decision concerning whether the petitioner will be afforded a reply and the
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`appropriate scope of such a reply rests with the panel deciding the
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`proceeding to take into account the specific facts of the particular case.”).
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`Petitioner is afforded a request for rehearing in order to identify all matters it
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`believes the Board misapprehended or overlooked. In that regard, Petitioner
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`has now entered its Request for Rehearing identifying those matters it
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`believes we misapprehended or overlooked, including its contention that we
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`applied an improper obviousness standard, namely, a standard requiring
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`specific motivation. Id. More specifically, Petitioner contends we
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`1) misapprehended the law and the record in dismissing Dr. Buckton’s
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`testimony as “conclusory” and the Lai reference as “equivocal”;
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`2) overlooked general teachings in the cited prior art regarding the moisture
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`sensitivity of peptides; 3) misapprehended law rejecting any requirement for
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`a specific teaching in the prior art that plecanatide is especially sensitive to
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`water; and 4) overlooked Patent Owner’s arguments from the Preliminary
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`Response supporting Petitioner’s position that a low moisture formulation is
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`an expected improvement. Req. Reh’g. 7, 15.
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`Petitioner’s concerns are addressed below.
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`B. Dr. Buckton’s Testimony
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`In its Petition, Petitioner’s alleged rationale for combining the cited
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`prior art is that
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`[persons of ordinary skill in the art] had good reason to use a low-
`moisture [microcrystalline cellulose (“MCC”)] carrier (e.g.,
`Mihranyan’s Avicel PH112) to reduce plecanatide’s moisture
`
`
`2 Available at https://www.uspto.gov/sites/default/files/documents/
`tpgnov.pdf.
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`4
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`IPR2022-01104
`Patent 9,919,024 B2
`
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`exposure from tablet excipients because peptides generally are
`subject to moisture-based degradation during storage. EX1002,
`¶¶522, 143-144, 146-147; EX1016, 489; see also [Pet. at] §VI.A;
`EX1006, 731 (“moisture is one of the most important
`environmental factors that can affect solid-state stability”).
`
`Pet. 27. Dr. Buckton’s testimony relied on by Petitioner states as follows:
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`Moreover, . . . [persons of ordinary skill in the art]
`understood that peptides, in particular, were generally subject to
`degradation from moisture during storage. See, e.g., EX1016
`(Lai), 489; see also EX1029 (Aulton), 9. Thus, a [person of
`ordinary skill in the art] would have had reason to combine a low-
`moisture carrier with a peptide when preparing an oral-dosage
`formulation. More specifically, a [person of ordinary skill in the
`art] had good reason to evaluate commercially available grades
`of microcrystalline cellulose,
`taught more generally by
`Remington, that had low-moisture contents, to formulate the
`plecanatide peptide taught by Shailubhai.
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`Ex. 1002 ¶¶ 104, 144.
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`At page 17 of the Petition, Petitioner relies on Dr. Buckton’s
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`testimony for the premise that “[persons of ordinary skill in the art]
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`recognized low-moisture MCC as a preferred inert carrier for direct-
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`compression tableting of peptides.” That testimony provides as follows:
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`One main source of potential degradation for pharmaceutical
`formulations is the presence of moisture. See EX1029 (Aulton),
`9. In particular, it was well known that peptides in particular are
`generally subject to degradation from moisture during storage.
`See, e.g., EX1016 (Lai), 489.
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`Ex. 1002 ¶ 104.
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`In our Decision, we addressed Dr. Buckton’s testimony and the
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`information of record supporting the proposition that peptides are sensitive
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`to degradation from moisture during storage. Dec. 14–18. As we explained
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`in our Decision,
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`5
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`IPR2022-01104
`Patent 9,919,024 B2
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`Petitioner and Dr. Buckton generically cite Lai’s first page (page
`489), but fail to articulate any specific reason why a skilled
`artisan would have been motivated to use a low-moisture MCC
`carrier in a peptide formulation (let alone in the claimed
`plecanatide formulation). At most, Lai page 489 is equivocal
`about the impact of moisture on peptides, stating only that,
`among other factors, moisture “may impact the chemical stability
`of proteins and peptides in the solid-state.” Id. (emphasis added).
`Neither Petitioner nor Dr. Buckton adequately explains how this
`teaching (or any other teaching in Lai) would have informed a
`person of ordinary skill in the art that peptides were moisture-
`sensitive, thereby motivating use of a low-moisture MCC carrier.
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`Dec. 15–16. Our Decision also recognized multiple examples from
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`Petitioner’s references that show that moisture affects stability of all drugs,
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`not just peptides. Id. at 16–18. For example, we recognized that Remington
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`teaches that the “presence or absence of moisture is one of the most
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`important environmental factors that can affect solid-state stability.”
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`Dec. 15; Ex. 1006, 731. We also recognized Aulton’s teaching that drug
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`substances decompose as a result of multiple factors including moisture.
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`Dec. 15–16; Ex. 1029, 9.
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`The evidence of record, however, also distinguishes between ordinary
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`MCC and low-moisture MCC. For example, the Mihranyan reference
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`explains that “[f]or moisture sensitive drugs, low moisture grades of MCC
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`are available.” Ex. 1007, 433. Petitioner’s Doelker reference states that
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`“Avicel PH-112 is indicated for moisture-sensitive drugs.” Ex. 1010, 660.
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`Thus, we explained that “[d]espite this global concern with moisture, the
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`record does not suggest the use of low-moisture MCC in every tablet
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`formulation, but rather only for moisture-sensitive drugs,” i.e., drugs with a
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`particular sensitivity to moisture such that specialized excipients might be
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`required. Dec. 16. For this reason, we determined that Petitioner’s evidence
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`6
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`IPR2022-01104
`Patent 9,919,024 B2
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`suggesting that moisture is a general concern for all types of drugs, including
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`peptides, does not sufficiently show that it would have been obvious to
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`formulate plecanatide with low-moisture MCC. Id. Thus, we did not
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`overlook this evidence, nor has Petitioner shown that we misapprehended it.
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`We also did not overlook Dr. Buckton’s opinion based on “his
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`uncontested personal experience in the art when stating what a [person of
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`ordinary skill in the art] would have known.” Req. Reh’g. 8. We stated that
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`Dr. Buckton’s testimony lacks sufficient explanation and is not persuasive to
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`support Petitioner’s burden for institution. Dec. 18 (citing 37 C.F.R.
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`§ 42.65(a) (“Expert testimony that does not disclose the underlying facts or
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`data on which the opinion is based is entitled to little or no weight.”);
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`Verlander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (noting that
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`Board has discretion to accord little weight to expert’s “broad conclusory
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`statements that it determined were unsupported by corroborating
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`references”)).
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`C. Moisture Sensitivity of Peptides
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`
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`Petitioner contends that it “established a basic logical syllogism:
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`peptides generally are moisture-sensitive, plecanatide is a peptide, thus a
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`[person of ordinary skill in the art] would expect plecanatide to be moisture-
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`sensitive.” Req. Reh’g. 10. Petitioner turns to Patent Owner’s arguments
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`regarding Lai and contends that, “[w]hile Lai notes a few specific low-
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`moisture problems for specific (non-plecanatide) peptides, the only general
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`problem it identifies is Maillard reactions (in foods).” Id. at 11 (citing
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`Ex. 1016, 491–92). In Petitioner’s view, Patent Owner did not properly
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`assert “the conditions for a Maillard reaction are present in the claimed
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`formulation or, if present, are actually a problem.” Id.
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`7
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`IPR2022-01104
`Patent 9,919,024 B2
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`We find this argument unpersuasive. As discussed in our Decision,
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`Petitioner does not sufficiently demonstrate that a skilled artisan would have
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`understood plecanatide, or even peptide drugs generally, to be a moisture-
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`sensitive material such that they would have been motivated to formulate it
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`with a low-moisture MCC carrier. Dec. 15–16, 17. Petitioner has not
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`presented any evidence that we may have overlooked or misapprehended in
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`order to address that specific point.
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`Petitioner also suggests that we overlooked the Office’s “prior
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`finding” that Lai teaches that peptides are moisture-sensitive. Req. Reh’g. 2,
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`9. Petitioner, however, did not make this point in its Petition, and thus we
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`could not have overlooked it.3
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`D. Obviousness and Motivation to Combine
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`Petitioner addresses the obviousness standard by stating that “where
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`the relevant structure (here, peptides) is the same, motivation exists to apply
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`the teaching (reduce moisture), and the burden of production shifts to the
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`patentee to show this facially obvious modification is wrong.” Req.
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`Reh’g. 12 (citing KSR Int’l v. Teleflex, 550 U.S. 398, 418 (2007) (“As our
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`precedents make clear, however, the analysis need not seek out precise
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`teachings directed to the specific subject matter of the challenged claim, for
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`3 Moreover, the “finding” Petitioner refers to appears to be the Examiner’s
`general observation, during prosecution of an application to which the
`’321 patent claims priority, that “[t]he stability of peptide drugs was known
`to be sensitive to temperature, moisture and excipients taught by Lai.”
`Ex. 1022, 4139. Contrary to Petitioner’s suggestion, this observation is not
`at odds with our Decision. See Dec. 15 (noting that Lai “teaches that
`moisture content is one of several factors (along with temperature,
`excipients, and the physical state of the formulation) that influences
`chemical reactions affecting peptides in the solid state”).
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`8
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`IPR2022-01104
`Patent 9,919,024 B2
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`a court can take account of the inferences and creative steps that a person of
`
`ordinary skill in the art would employ.”); id. at 416 (“combination of
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`familiar elements according to known methods is likely to be obvious when
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`it does no more than yield predictable results”)).
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`For the same reasons as discussed above and cited in our Decision,
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`Petitioner has not sufficiently demonstrated a general motivation to
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`combine. Petitioner relies on the same evidence as cited above to support its
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`contention. While we recognize that precise teachings are unnecessary to
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`show motivation to combine, as explained above, Petitioner has not
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`articulated a sufficient rationale for using a low-moisture MCC with
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`plecanatide.
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`E. Expected Improvements
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`Lastly, Petitioner contends that “improved stability is exactly what a
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`[person of ordinary skill in the art] would expect with a low-moisture carrier
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`for most peptides.” Req. Reh’g. 15 (citation omitted). Further, Petitioner
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`contends that it “explained at length why this result was not unexpectedly
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`good, but rather an expected improvement.” Id. (citing Pet. 3, 63–69).
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`Petitioner’s contentions noted above relate to preemptive arguments
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`and information set forth in the Petition concerning evidence of unexpected
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`results asserted by Patent Owner to overcome obviousness rejections during
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`the prosecution of the ’024 patent. See Pet. 60–65. We did not overlook or
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`misapprehend these arguments. We determined that “Petitioner does not
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`sufficiently demonstrate for purposes of institution that a skilled artisan
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`would have understood plecanatide to be a moisture-sensitive material such
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`that they would have been motivated to formulate it with a low-moisture
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`MCC carrier.” Dec. 17. Consequently, a detailed review of Petitioner’s
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`9
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`IPR2022-01104
`Patent 9,919,024 B2
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`preemptive arguments related to Patent Owner’s evidence of unexpected
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`results was unnecessary for the purpose of deciding whether to institute inter
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`partes review. See, e.g., Mylan Pharms. Inc. v. Research Corp. Techs., Inc.,
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`914 F.3d 1366, 1376 (Fed. Cir. 2019) (“Because we agree with the Board
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`that Appellants failed to establish a motivation to modify compound 3I, we
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`need not reach Appellants’ arguments regarding objective indicia.”).
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`IV. CONCLUSION
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`On rehearing, we see no error in our findings of fact or conclusions of
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`law. For the reasons given, Petitioner has not demonstrated that we abused
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`our discretion in denying institution of an inter partes review of claims 1–16
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`of the ’024 patent.
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`Accordingly, it is
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`V. ORDER
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`ORDERED that Petitioner’s Request for Rehearing is denied.
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`
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`10
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`IPR2022-01104
`Patent 9,919,024 B2
`
`FOR PETITIONER:
`
`Jad Mills
`Richard Torczon
`Nicole Stafford
`Dennis Gregory
`WILSON SONSINI GOODRICH & ROSATI
`jmills@wsgr.com
`rtorczon@wsgr.com
`nstafford@wsgr.com
`dgregory@wsgr.com
`
`
`FOR PATENT OWNER:
`
`Justin J. Hasford
`Bryan C. Diner
`Joshua Goldberg
`Caitlin O'Connell
`Kyu Yun Kim
`FINNEGAN, HENSDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`justin.hasford@finnegan.com
`bryan.diner@finnegan.com
`joshua.goldberg@finnegan.com
`caitlin.o'connell@finnegan.com
`kyuyun.kim@finnegan.com
`
`
`
`11
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`