Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`Paper 13
`
`Entered: October 16, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FRESENIUS KABI USA, LLC and
`FRESENIUS KABI SWISSBIOSIM GmbH,
`Petitioners,
`
`v.
`
`AMGEN, INC. and AMGEN MANUFACTURING, LIMITED,
`Patent Owner.
`____________
`
`Case IPR2019-00971
`Patent 9,856,287 B2
`____________
`
`
`Before ZHENYU YANG, J. JOHN LEE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`LEE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`Paper 13
`
`Entered: October 16, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FRESENIUS KABI USA, LLC and
`FRESENIUS KABI SWISSBIOSIM GmbH,
`Petitioners,
`
`v.
`
`AMGEN, INC. and AMGEN MANUFACTURING, LIMITED,
`Patent Owner.
`____________
`
`Case IPR2019-00971
`Patent 9,856,287 B2
`____________
`
`
`Before ZHENYU YANG, J. JOHN LEE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`LEE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`
`INTRODUCTION
`
`Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH
`
`(collectively, “Fresenius”) filed a Petition (Paper 3, “Pet.”) requesting an
`
`inter partes review of claims 1, 4–6, 8–10, 12, 14–16, 19–21, 23–26, 29, and
`
`30 (“the challenged claims”) of U.S. Patent No. 9,856,287 B2 (Ex. 1001,
`
`“the ’287 Patent”). Amgen Inc. and Amgen Manufacturing, Limited
`
`(collectively, “Amgen”)1 timely filed a Preliminary Response (Paper 8,
`
`“Prelim. Resp.”). Fresenius filed an authorized Reply to the Preliminary
`
`Response (Paper 11, “Reply”), and Amgen filed an authorized Sur-Reply
`
`(Paper 12, “Sur-Reply”).
`
`Upon consideration of the Petition and the Preliminary Response, and
`
`in light of Board precedent, we conclude that the Petition should be denied
`
`under the discretion provided to the Director in 35 U.S.C. § 314(a).
`
`A.
`
`Related Cases
`
`The parties identify the following matters as related to the ’287 Patent
`
`and, thus, the present case:
`
`Amgen Inc. v. Adello Biologics LLC, No. 2:18-cv-03347 (D.N.J.)
`
`Amgen Inc. v. Apotex Inc., No. 19-cv-61828 (S.D. Fla.)
`
`Adello Biologics LLC v. Amgen Inc., Case PGR2019-00001 (PTAB)
`
`Pet. 4; Paper 6, 1. The parties also note that U.S. Patent No. 8,952,138 and
`
`U.S. Patent Application Nos. 14/793,590, 14/611,037, and 15/889,559 are
`
`related or may be affected by the present case.
`
`
`
`1 Amgen notes that Amgen Inc. is the owner of the ’287 Patent whereas
`Amgen Manufacturing, Limited is an exclusive licensee. Prelim. Resp. 1 n.2.
`
`2
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`B.
`
`Background of the ’287 Patent
`
`The ’287 Patent relates to a method of refolding proteins expressed in
`
`non-mammalian cells. Ex. 1001, 2:62–3:4. Such refolding is necessary in
`
`some non-mammalian expression systems, such as bacteria, “because of the
`
`inability of a bacterial host cell to fold recombinant proteins properly at high
`
`levels of expression.” Id. at 1:25–32. As a result, the improperly-folded
`
`proteins are insoluble and precipitate out of solution to form inclusion
`
`bodies. Id. According to the ’287 Patent, prior art refolding techniques did
`
`not demonstrate refolding of larger, more complex protein molecules at high
`
`concentrations, i.e., 2.0g/L or higher, at a scale suitable for industrial
`
`applications. Id. at 2:8–32.
`
`C. Challenged Claims
`
`Fresenius challenges claims 1, 4–6, 8–10, 12, 14–16, 19–21, 23–26,
`
`29, and 30. Claims 1, 10, 16, and 26 are the independent claims. Claim 1 is
`
`illustrative and is reproduced below:
`
`A method or refolding proteins expressed in a non-
`1.
`mammalian expression system, the method comprising:
`
`contacting the proteins with a preparation that supports the
`renaturation of at least one of the proteins to a biologically active
`form, to form a refold mixture, the preparation comprising:
`
`at least one ingredient selected from the group consisting
`of a denaturant, an aggregation suppressor and a protein
`stabilizer;
`
`an amount of oxidant; and
`
`an amount of reductant;
`
`3
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`
`wherein the amounts of the oxidant and the reductant are
`related through a thiol-pair ratio and a thiol-pair buffer
`strength,
`
`wherein the thiol-pair ratio is in the range of 0.001-100;
`and
`
`wherein the thiol-pair buffer strength maintains the
`solubility of the preparation; and
`
`incubating the refold mixture so that at least about 25% of
`the proteins are properly refolded.
`
`Ex. 1001, 18:21–41.
`
`D.
`
`Asserted Grounds of Unpatentability and Asserted Prior Art
`
`Fresenius challenges the patentability of claims 1, 4–6, 8–10, 12, 14–
`
`16, 19–21, 23–26, 29, and 30 of the ’287 Patent on the following grounds
`
`(Pet. 23):
`
`Claim(s) Challenged
`1, 4, 8–10, 12, 14–16, 19,
`23–26, 29, 30
`16, 19–21, 23–26, 29, 30 102(a)(1)
`
`102(a)(1)
`
`35 U.S.C. §
`
`Reference(s)/Basis
`Vallejo2
`
`Ruddon3
`
`
`
`2 Eur. Patent App. No. EP 1449848 A1, published Aug. 25, 2004 (Ex. 1031,
`“Vallejo”).
`
`3 PCT Int’l App. Pub. No. WO 95/32216, published Nov. 30, 1995
`(Ex. 1025, “Ruddon”).
`
`4
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`
`Claim(s) Challenged
`1, 4–6, 8–10, 12, 14–16,
`19–21, 23–26, 29, 30
`
`35 U.S.C. §
`
`103
`
`8, 9, 14, 15, 23–25, 30
`
`103
`
`Reference(s)/Basis
`Ruddon, Clark 1998,4
`Schafer5/Gilbert 19956
`Ruddon, Clark 1998, Vallejo,
`Schafer/Gilbert 1995
`
`
`
`In addition, Fresenius relies on the Declaration of Paul A. Dalby, Ph.D.
`
`(Ex. 1002) in support of the asserted grounds of unpatentability.
`
`ANALYSIS
`
`Discretionary Denial of Petition Under § 314(a)
`
`Amgen argues that institution of an inter partes review should be
`
`denied under 35 U.S.C. § 314(a) and the Board’s precedents in General
`
`Plastic Industrial Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357,
`
`
`
`4 Eliana De Bernardez Clark et al., Oxidative Renaturation of Hen Egg-
`White Lysozome, BIOTECH. PROGRESS, Jan./Feb. 1998, at 47–54 (Ex. 1007,
`“Clark 1998”).
`
`5 Freya Q. Schafer & Garry R. Buettner, Redox Environment of the Cell as
`Viewed Through the Redox State of the Glutathione Disulfide/Glutathione
`Couple, 30 FREE RADICAL BIOL. & MED. 1191–1212 (Ex. 1027, “Schafer”).
`
`6 Hiram F. Gilbert, Thiol/Disulfide Exchange Equilibria and Disulfide Bond
`Stability, in 251 METHODS IN ENZYMOLOGY 8 (Lester Packer ed., 1995)
`(Ex. 1014, “Gilbert 1995”). The Petition initially indicates its reliance on
`Gilbert 1995 (called “Gilbert” in the Petition). See Pet. 48 n.9. As Amgen
`points out (Prelim. Resp. 53–54), however, the Petition also cites repeatedly
`to “Gilbert 1990,” a different reference albeit by the same author. See, e.g.,
`Pet. 53. Although we do not reach the merits of Fresenius’ challenges, we
`note that 37 C.F.R. § 42.104(b)(5) requires a petition for inter partes review
`to provide a clear statement of, inter alia, “[t]he exhibit number of the
`supporting evidence relied upon to support the challenge and the relevance
`of the evidence to the challenge raised.”
`
`5
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`Paper 19 (PTAB Sep. 6, 2017) (precedential as to Section II.B.4.i), and
`
`Valve Corporation v. Electronic Scripting Products, Inc., Case IPR2019-
`
`00062, Paper 11, at 9 (PTAB Apr. 2, 2019) (precedential). Prelim. Resp.
`
`23–31. Although Fresenius only briefly addressed this issue in the Petition
`
`(Pet. 3), the Reply was authorized specifically to address it, including “any
`
`relevant legal authority.” See Paper 10, 1; Reply 3–5. The Reply, however,
`
`does not cite General Plastic, and it mentions Valve only in passing without
`
`addressing it in detail.
`
`Institution of an inter partes review may be denied as a matter of
`
`discretion. See 35 U.S.C. § 314(a); Cuozzo Speed Techs., LLC v. Lee, 136 S.
`
`Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is a
`
`matter committed to the Patent Office’s discretion.”). In General Plastic,
`
`the Board set forth seven “non-exhaustive” factors considered when
`
`assessing whether to exercise the discretion to deny institution. Gen.
`
`Plastic, Paper 19, at 16. We address each factor below.
`
`Factor 1: Previous Filed Petitions Against the Same Claims
`
`Under General Plastic, we first assess “whether the same petitioner
`
`previously filed a petition directed to the same claims of the same patent.”
`
`Id. In Valve, the Board expanded the scope of this factor, holding that “our
`
`application of the General Plastic factors is not limited solely to instances
`
`when multiple petitions are filed by the same petitioner.” Valve, Paper 11,
`
`at 9. When, as here, “different petitioners challenge the same patent, we
`
`consider any relationship between those petitioners.” Id. (emphasis added).
`
`In Valve, the two petitioners at issue had filed separate petitions that
`
`each challenged the same claims of the same patent. Id. at 10. Further, both
`
`petitioners were co-defendants in litigation in which both were accused of
`
`6
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`
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`IPR2019-00971
`Patent 9,856,287 B2
`
`infringing that patent, and the infringement allegations involved technology
`
`that one petitioner had licensed from the other petitioner. Id. Consequently,
`
`the panel in Valve held that “[t]he complete overlap in the challenged claims
`
`and the significant relationship between [the petitioners] favor denying
`
`institution.” Id.
`
`Here, the Petition here and the petition filed by Adello Biologics LLC
`
`(“Adello”) in PGR2019-00001 also have complete overlap in the challenged
`
`claims—the earlier-filed Adello petition challenged each of the claims of the
`
`’287 Patent now challenged in the present Petition. See Adello Biologics
`
`LLC v. Amgen Inc., Case PGR2019-00001, Paper 13, at 2 (PTAB Apr. 19,
`
`2019). Unlike the petitioners in Valve, Adello and Fresenius are not co-
`
`defendants, and there is no evidence indicating any business relationship
`
`between them. Fresenius admits, however, that its counsel attended the
`
`deposition of Adello’s expert in PGR2019-00001. Reply 3. Moreover,
`
`Fresenius represents that “[Fresenius] and Adello are willing to coordinate
`
`this IPR with the instituted PGR . . . to facilitate joint consideration by the
`
`Board.” Id. Thus, by its own admission, Fresenius clearly is seeking to
`
`coordinate its challenges in the present case with Adello’s challenges in
`
`PGR2019-00001. On the whole, based on the precedent in Valve that
`
`requires we consider “any relationship” between the petitioners, we
`
`determine that these facts indicate the first General Plastic factor weighs in
`
`favor of denying institution.
`
`Factor 2: Knowledge of the Prior Art
`
`We next evaluate “whether at the time of filing of the first petition the
`
`petitioner knew of the prior art asserted in the second petition or should have
`
`known of it.” Gen. Plastic, Paper 19, at 16. The concern in General Plastic
`
`7
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`was whether the petitioner, in filing a second petition, relied on prior art that
`
`it should have asserted in the first petition because it knew, or should have
`
`known, about that prior art when filing the first petition. See id. at 20–21.
`
`The scope of this factor also was expanded in Valve, where the panel
`
`found that the second petitioner “knew or should have known” of certain
`
`prior art asserted in its petition around the time the first petition was filed
`
`because “it was one of the two references relied upon” by the first petitioner.
`
`Valve, Paper 11, at 11. In other words, although the second petitioner did
`
`not file the first petition, its knowledge of the prior art asserted in that first
`
`petition at about the time it was filed weighed in favor of denial of the
`
`second petition based on the same art. See id.
`
`Amgen argues that, similar to Valve, the present Petition relies on
`
`prior art also relied on in the earlier-filed petition in PGR2019-00001,
`
`specifically Vallejo and Ruddon. Prelim. Resp. 25–26; see Adello, Paper 13,
`
`at 8–9. Fresenius does not offer any argument distinguishing Valve with
`
`respect to this factor, nor does it dispute that it knew or should have known
`
`of Vallejo and Ruddon at about the time Adello filed the petition in
`
`PGR2019-00001. We are persuaded that the pertinent facts here are similar
`
`to those in Valve, and, thus, determine that the second General Plastic factor
`
`weighs against institution under the Board’s precedents.
`
`Factor 3: Availability of Information from Earlier Proceeding
`
`Next, we consider “whether at the time of filing of the second petition
`
`the petitioner already received the patent owner’s preliminary response to
`
`the first petition or received the Board’s decision on whether to institute
`
`review in the first petition.” Gen. Plastic, Paper 19, at 16. This factor is
`
`“directed to Petitioner’s potential benefit from receiving and having the
`
`8
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`opportunity to study Patent Owner’s Preliminary Response . . . prior to its
`
`filing of follow-on petitions.” Id. at 17.
`
`The present Petition was filed on April 14, 2019. See Paper 4, 1.
`
`Thus, Fresenius did not have available our institution decision in PGR2019-
`
`00001, which was issued on April 19, 2019. Amgen’s preliminary response
`
`in PGR2019-00001, however, was filed on January 23, 2019. See Adello,
`
`Paper 8. Thus, it was available at the time Fresenius filed the present
`
`Petition. Further, a significant portion of the arguments and contentions in
`
`the present Petition are similar to those in Adello’s petition in PGR2019-
`
`00001, such as those relating to alleged anticipation by Vallejo, which
`
`supports Amgen’s position that Fresenius benefited from Adello’s petition
`
`and, thus, likely Amgen’s preliminary response as well. See Prelim. Resp.
`
`26–27; see also id. at 14–18 (arguing that the Petition’s arguments are
`
`substantially the same as those in Adello’s petition in PGR2019-00001). We
`
`conclude that this factor also weighs against institution.
`
`Factors 4 & 5: Delay in Filing Petition
`
`We next examine “the length of time that elapsed between the time
`
`the petitioner learned of the prior art asserted in the second petition and the
`
`filing of the second petition” (factor 4), and “whether the petitioner provides
`
`adequate explanation for the time elapsed between the filings of multiple
`
`petitions directed to the same claims of the same patent” (factor 5). Gen.
`
`Plastic, Paper 19, at 16. In Valve, these factors were held to weigh against
`
`institution because the second petitioner knew or should have known about
`
`the prior art ultimately asserted in the second petition when the first petition
`
`was filed, but waited five months before filing the second petition. See
`
`Valve, Paper 11, at 14. The second petitioner’s interests aligned with those
`
`9
`
`
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`IPR2019-00971
`Patent 9,856,287 B2
`
`of the first petitioner, and the second petitioner “could have filed its Petition
`
`at or around the same time” as the first petition. Id.
`
`As discussed above, Fresenius “knew or should have known” about
`
`the prior art asserted in its Petition, particularly Vallejo and Ruddon, under
`
`the analysis in Valve. The Petition was filed on April 14, 2019, which was
`
`nearly three months after Amgen’s preliminary response was filed in
`
`PGR2019-00001, and over six months after Adello filed its petition on
`
`October 1, 2018. See Paper 4, 1; Adello, Paper 8; Adello, Paper 6, 1.
`
`Although it is unclear to what extent Fresenius’ and Adello’s interests
`
`coincide, the presence of Fresenius’ counsel at the deposition of Adello’s
`
`expert in PGR2019-00001 appears to indicate they intersect. See Reply 3.
`
`Further, Fresenius explains the timing of its Petition by noting that it
`
`was “not engaged in litigation over the ’287 Patent and had no reason to
`
`assess invalidity positions any earlier.” Reply 4. The panel in Valve
`
`rejected a similar explanation; the petitioner there indicated that an
`
`intervening change in law had created a need to file a petition to preserve its
`
`ability to do so, whereas it had no intention of filing any petitions under the
`
`previous law once it had been dismissed voluntarily from the infringement
`
`litigation (i.e., it was not engaged in litigation with the patent owner). Valve,
`
`Paper 11, at 13–14. Based on the precedent in Valve, we conclude that the
`
`fourth and fifth General Plastic factors weigh against institution.
`
`Factors 6 & 7: Board Resources and Statutory Deadlines
`
`Finally, we consider “the finite resources of the Board” (factor 6), and
`
`“the requirement under 35 U.S.C. § 316(a)(11) to issue a final determination
`
`not later than 1 year after the date on which the Director notices institution
`
`of review” (factor 7). Gen. Plastic, Paper 19, at 16. “The sixth and seventh
`
`10
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`factors are efficiency considerations.” Valve, Paper 11, at 15. “In general,
`
`having multiple petitions challenging the same patent, especially when not
`
`filed at or around the same time as in this case, is inefficient and tends to
`
`waste resources.” Id. Similar to Valve, the present Petition was filed over
`
`six months after Adello’s petition, and the resulting post-grant review was
`
`instituted less than a week after the present Petition was filed.
`
`Although Fresenius expresses its willingness to “coordinate this IPR
`
`with the instituted PGR, including by expediting [Fresenius’] briefing and
`
`discovery” and that consideration of the present Petition in coordination with
`
`Adello’s post-grant review would be more efficient (Reply 3–5), Fresenius
`
`fails to distinguish this case from the facts of Valve. Moreover, the post-
`
`grant review in PGR2019-00001 was instituted approximately six months
`
`ago and Amgen’s patent owner response has already been filed. See Adello,
`
`Paper 19. Thus, coordination with the present case, even if instituted, would
`
`be impractical. While Fresenius may be correct that defending two
`
`challenges against the ’237 Patent, in and of itself, is not unduly burdensome
`
`for Amgen, the sixth and seventh General Plastic factors concern the burden
`
`on the Board. Thus, we conclude that these factors weigh against institution.
`
`CONCLUSION
`
`For the foregoing reasons, based on Board precedents and the
`
`information presented in the parties’ briefing, we determine that all of the
`
`General Plastic factors weigh against institution. As a result, we conclude
`
`11
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`that exercising the discretion provided in 35 U.S.C. § 314(a) is warranted to
`
`deny institution of an inter partes review.7
`
`ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that the Petition is denied and no trial is instituted.
`
`
`
`
`
`7 Consequently, we do not reach the merits of Fresenius’ challenges, nor do
`we reach the issue of whether the Petition should be denied under 35 U.S.C.
`§ 325(d) or 35 U.S.C. § 311(c)(2).
`
`12
`
`
`
`IPR2019-00971
`Patent 9,856,287 B2
`
`PETITIONER:
`
`Huiya Wu
`hwu@goodwinlaw.com
`
`Linnea Cipriano
`lcipriano@goodwinlaw.com
`
`
`
`
`PATENT OWNER:
`
`J. Steven Baughman
`sbaughman@paulweiss.com
`
`Megan Raymond
`mraymond@paulweiss.com
`
`
`
`
`
`
`
`13
`
`
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