Trials@uspto.gov
`Tel. 571-272-7822
`
`
`
`
`
`Paper 17
`Entered: April 21, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BOEHRINGER INGELHEIM INTERNATIONAL GMBH,
`Patent Owner.
`_____________
`
`Case IPR2016-01566
`Patent 9,173,859 B2
`______________
`
`
`
`
`Before TONI R. SCHEINER, BRIAN P.MURPHY, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`

`

`I.
`
`II.
`
`IPR2016-01566
`Patent 9,173,859 B2
`
`INTRODUCTION
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition for an inter partes
`review of claims 1–22 of U.S. Patent No. 9,173,859 B2 (“the ’859 patent,”
`Ex. 1001). Paper 2 (“Pet.”). We denied the Petition. Paper 15 (“Dec.”).
`Petitioner filed a request for rehearing of the Decision. Paper 16 (“Reh’g Req.”).
`For the following reasons, we deny Petitioner’s request.
`STANDARD OF REVIEW
`When rehearing a decision on institution, the Board reviews the decision for
`an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when
`a “decision was based on an erroneous conclusion of law or clearly erroneous
`factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese
`Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).
`The request must identify, specifically, all matters the party believes the Board
`misapprehended or overlooked. 37 C.F.R. § 42.71(d).
`III. DISCUSSION
`In our Decision denying the Petition, we declined to institute inter partes
`review of (1) claims 14 and 20 as anticipated by the ’510 publication, (2) claims 1–
`22 as obvious over the combination of the ’510 publication and Glucophage®
`Label, and (3) claims 1–22 as obvious over the combination of the ’510 publication
`and Ahrén, Hughes, and/or Brazg. Dec. 5–16. In its rehearing request, Petitioner
`only seeks redress on the third ground. Reh’g Req. 1 n.1.
`According to Petitioner, we erred because we applied an “incorrect legal
`standard for obviousness.” Reh’g Req. 1. Relying on Galderma Labs., L.P. v.
`Tolmar, Inc., 737 F.3d 731 (Fed. Cir. 2013), Petitioner contends that the
`challenged claims “are presumed obvious because the claimed linagliptin dosages
`and dosage ranges fall squarely within the prior art range disclosed in the ’510
`
`
`
`2
`
`

`

`IPR2016-01566
`Patent 9,173,859 B2
`
`Publication (Ex. 1003), and Patent Owner did not meet its burden to overcome this
`presumption.” Id. We are not persuaded.
`As a preliminary matter, we note that Petitioner did not argue in the Petition,
`as it argues now in its request for rehearing, that we should apply a legal
`presumption of obviousness. In fact, the Petition did not cite Galderma, or
`numerous other opinions of the Federal Circuit, district courts, and the Board,
`which Petitioner now relies on in its request for rehearing. The Board could not
`have misapprehended or overlooked an argument that was not made and case law
`that was not cited in the Petition.
`In addition, we reiterate, as we stated in our Decision denying institution, in
`an inter parte review, Petitioner has the ultimate burden of persuasion to prove
`unpatentability. Dec. 8 (citing 35 U.S.C. § 316(e); Dynamic Drinkware, LLC v.
`Nat’l Graphics, Inc., 800 F.3d 1375, 1378–79 (Fed. Cir. 2015)). According to
`Petitioner, Galderma holds “Patent Owner has burden of overcoming obviousness
`presumption ‘where there is a range disclosed in the prior art, and the claimed
`invention falls within that range.’” Req. Reh’g 1 (quoting Galderma, 737 F.3d at
`737–38). To the extent Petitioner argues for a presumption of obviousness that
`shifts the burden of persuasion to Patent Owner, such an argument is misplaced.
`See In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016)
`(stating that the “burden-shifting framework does not apply in the adjudicatory
`context of an IPR”).
`In its request for rehearing, Petitioner relies heavily on Galderma and other
`newly cited cases to support its argument that we “should have presumed that the
`Challenged Claims are obvious, as a matter of law, because the ’510 Publication’s
`preferred dosage range encompasses the claimed linagliptin dosages.” Req. Reh’g
`3 (emphasis added). According to Petitioner, the Board “has routinely applied”
`
`
`
`3
`
`

`

`IPR2016-01566
`Patent 9,173,859 B2
`
`such a presumption “in finding claimed inventions prima facie obvious, even
`where the prior art range—when compared to the claim limitation at issue—is
`relatively much broader than the ’510 Publication’s range as compared to the
`claimed linagliptin dosages.” Id. at 9. We decline to apply such a legal
`presumption in an analytical vacuum.
`In Galderma, the claim recited a “topically applicable pharmaceutical
`composition comprising 0.3% by weight of [adapalene] . . . effective for the
`treatment of acne.” Galderma, 737 F.3d at 734. The prior art Shroot patents
`taught topical adapalene compositions for treating acne “in a preferred range of
`0.01%–1%,” including exemplary formulations containing 0.001%, 0.1%, and 1%.
`Id. at 735–36. In addition, the Shroot patents were listed in the FDA’s Orange
`Book for “prior art Differin® 0.1% Gel as well as Differin® Gel, 0.3%.” Id. at
`735. Furthermore, other prior art references taught the use of 0.3% adapalene in an
`animal model for treating acne and taught the use of 0.3% adapalene for other skin
`conditions “without intolerable irritability.” Id. It was under these circumstances
`that the court framed the issue as “whether there was motivation to select the
`claimed 0.3% adapalene composition in the disclosed range.” Id. at 737–38.
`In contrast, here, Petitioner relies solely on the teachings of the ’510
`publication—a preferred dose of 1 to 100 mg administered “1 to 4 times a day”—
`to arrive at the claimed dosage of 2.5 mg or 5 mg. The Petition simply does not
`
`
`
`4
`
`

`

`IPR2016-01566
`Patent 9,173,859 B2
`
`provide the same type of evidence and context as those in Galderma, sufficient for
`us to apply the requested presumption.1
`Also in its request for rehearing, Petitioner asserts
`In fact, in the Companion IPR, this Board found, on the same evidence
`presented in this case, that Petitioner sufficiently established that the
`POSA would have been motivated to substitute the preferred linagliptin
`oral doses disclosed in the ’510 Publication—“1 mg to 100 mg, in each
`case 1 to 4 times a day”—for the DPP-IV inhibitors in the prior art
`metformin combination therapies of Ahrén (Ex. 1005), Hughes
`(Ex. 1006), and Brazg (Ex. 1007). (See IPR2016-01563, Paper 16 at
`20–21).
`Req. Reh’g 2. Petitioner’s representation is inaccurate.
`In IPR2016-01563, we indeed instituted an inter partes review, but only
`with respect to claims 1 and 10 of U.S. Patent No. 8,673,927. Mylan Pharms. Inc.
`v. Boehringer Ingelheim Int’l GMBH, Case IPR2016-01563, slip op. 1 (PTAB Feb.
`3, 2017) (Paper 16). That is because those claims recite “a pharmaceutically
`effective oral amount” or “a therapeutically effective oral dose” of linagliptin, and
`not any specific dose or dose range. Id. at 21. Petitioner fails to acknowledge that,
`for the same reason as we denied the Petition in this proceeding, we denied the
`petition in IPR2016-01563 with respect to the rest of the challenged claims,
`because each of those claims recites a particular dosage or dosage range for
`linagliptin. Id. at 22.
`
`
`1 As explained in our Decision, Petitioner’s argument regarding linagliptin dose is
`either conclusive or speculative. Dec. 16 (citing Pet. 36 (“The ’510 Publication
`discloses the combination of metformin and the recited oral doses of a DPP-IV
`Inhibitor (linagliptin).”); id. at 41 (“As described in Table 1 above in Ground 1, the
`’510 Publication discloses linagliptin dosages of 2.5mg and 5mg.”); id. at 38
`(“Linagliptin’s purported higher potency would have potentially allowed for
`smaller doses of DPP-IV inhibitor to be administered to the patient.”) (emphases
`added)).
`
`
`
`5
`
`

`

`IPR2016-01566
`Patent 9,173,859 B2
`
`In sum, in the Petition, Petitioner did not establish a reasonable likelihood
`that it would prevail in showing the combination of the ’510 publication and
`Ahrén, Hughes, and/or Brazg would have rendered the subject matter of the
`challenged claims obvious. On rehearing, we see no error in our findings of fact or
`conclusions of law. Thus, we conclude that Petitioner has not demonstrated that
`we abused our discretion in denying institution of the challenged claims.
`IV. ORDER
`Accordingly, it is
`ORDERED that Petitioner’s request for rehearing is denied.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`

`

`IPR2016-01566
`Patent 9,173,859 B2
`
`PETITIONER:
`Thomas Parker
`thomas.parker@alston.com
`
`Chris McArdle
`chris.mcardle@alston.com
`
`Ellen Cheong
`ellen.cheong@alston.com
`
`Charles Naggar
`charles.naggar@alston.com
`
`
`PATENT OWNER:
`Leora Ben-Ami
`leora.benami@kirkland.com
`
`Eugene Goryunov
`egoryunov@kirkland.com
`
`Mira Mulvaney
`mira.mulvaney@kirkland.com
`
`Jeanna Wacker
`Jeanna.wacker@kirkland.com
`
`
`
`
`
`
`
`
`7
`
`