Trials@uspto.gov
`571-272-7822
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` Paper: 38
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` Entered: March 31, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`
`SHIRE LLC,
`Patent Owner.
`
`
`Case IPR2015-02009
`Patent RE42,096 E
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-1
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
`
`
` Paper: 38
`
`
` Entered: March 31, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`
`SHIRE LLC,
`Patent Owner.
`
`
`Case IPR2015-02009
`Patent RE42,096 E
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-1
`
`
`
`IPR2015-02009
`Patent RE42,096 E
`
`
`I. INTRODUCTION
`Amerigen Pharmaceuticals Limited (“Petitioner”) filed a Petition
`(Paper 1, “Pet.”) on October 1, 2015, requesting an inter partes review of
`claims 1–3, 5, 8, 9, 11, 18–21, 23, and 25 of U.S. Patent No. RE42,096 E
`(Ex. 1001, “the ’096 patent”). Shire LLC (“Shire” or “Patent Owner”) filed
`a Preliminary Response (Paper 7, “Prelim. Resp.”) on January 19, 2016. On
`April 18, 2016, we instituted an inter partes review with respect to claims
`18–21, 23, and 25. Paper 8 (“Decision” or “Dec.”).
`Subsequent to institution, Patent Owner filed a Motion to Amend.1
`Paper 14. Petitioner filed an Opposition to the Motion to Amend (Paper 17),
`and Patent Owner filed a Reply to the Opposition to the Motion to Amend
`(Paper 21).
`The Board has jurisdiction under 35 U.S.C. § 6. This is a Final
`Written Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Patent Owner’s Motion to Amend is granted.
`
`A. Related Proceedings
`Petitioner informs us of the following related judicial matters: Shire
`
`LLC v. Amerigen Pharms. Ltd., 14-cv-6095 (D.N.J. Oct. 1, 2014); Shire LLC
`v. Corepharma LLC, 14-05694 (D.N.J. Sept. 12, 2014); Shire LLC v. Par
`Pharm. Inc., 15-cv-01454 (D.N.J. Feb. 26, 2015). Pet. 1. Patent Owner
`
`
`1 Shire did not file a Patent Owner’s Response.
`2
`
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`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-2
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`IPR2015-02009
`Patent RE42,096 E
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`identifies the same related matters in its Mandatory Notices under 37 C.F.R.
`§ 42.8(a)(2). Paper 6, 1.
`In addition, trial has been instituted against claims 18–25 of the ’096
`patent in Mylan Pharmaceuticals, Inc. v. Shire Laboratories, Inc., Case
`IPR2016-01033, slip. op. at 34 (PTAB Nov. 17, 2016) (Paper 8).
`
`B. The Asserted Grounds of Unpatentability
`We instituted trial on the following grounds. Dec. 38.
`
`
`
`References
`
`Basis
`
`Claims Challenged
`
`Mehta2
`Mehta and Adderall PDR3
`
`§ 102(e)
`§ 103(a)
`
`18–21 and 23
`18–21, 23, and 25
`
`II. ANALYSIS
`A. Patent Owner’s Motion to Amend and Proposed
`Substitute Claim 26
`
`Patent Owner “moves to amend U.S. Reissued Patent RE 42,096 . . .
`under 37 C.F.R. § 42.121, by cancelling all of the claims that have currently
`been instituted for trial and proposing one substitute claim.” Paper 14, 1.
`Specifically, Patent Owner requests cancellation of “instituted claims 18–21
`
`
`2 U.S. Patent No. 5,837,284, issued November 17, 1998, to Mehta et al.
`(“Mehta”) (Ex. 1003).
`3 PHYSICIANS’ DESK REFERENCE 331, 2209–11 (51st ed. 1997) (“Adderall
`PDR”) (Ex. 1004).
`
`3
`
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`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-3
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`IPR2015-02009
`Patent RE42,096 E
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`and 23, plus claims 22 and 24 (each of which depends from claim 18)” and
`proposes that “new claim 26 be substituted for claim 25.” Id. at 2; see also,
`Paper 21, 2. Instituted claim 25 and proposed substitute claim 26 are as
`follows:
`25. The pharmaceutical composition of any one of claims 2, 13
`or 18 to 20 wherein the pharmaceutically active amphetamine
`salt in (a) and (b) comprises mixed amphetamine salts.
`
`26. The pharmaceutical composition of any one of claims 2[[,]]
`or 13 or 18 to 20 wherein the pharmaceutically active
`amphetamine salt in (a) and (b) comprises mixed amphetamine
`salts.4
`
`Proposed substitute claim 26 is identical to multiple dependent claim
`25, except that dependencies from instituted claims 18–20 have been
`deleted. Id.
`According to 35 U.S.C. § 112(e), “[a] multiple dependent claim shall
`be construed to incorporate by reference all the limitations of the particular
`claim in relation to which it is being considered.” In other words, “a
`multiple dependent claim is considered in the same manner as a plurality of
`single dependent claims.” MPEP 608.01(n).
`In instituting an inter partes review of claims 18–21, 23, and 25, we
`differentiated between the limitations of claim 25 owing to its dependency
`from claim 2 (Dec. 29), and the limitations owing to its dependency from
`
`
`4 Paper 14, Appendix A, 7 (underlining indicates an addition; bracketing
`and strikethrough indicate deletions).
`
`4
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`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-4
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`IPR2015-02009
`Patent RE42,096 E
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`claims 18–20 (id. at 29, 30, 31, 35). We did not institute an inter partes
`review of claim 2 on any ground (id. at 29–34), and we further noted that
`claim 13 had not been challenged by Petitioner (id. at 29 n.9). Thus, claim
`25 is part of the trial only to the extent it depends from claims 18–20, and
`the practical effect of substituting proposed claim 26 (which depends from
`claim 2 or claim 13) for claim 25 would be to leave no instituted claim
`remaining in the trial.
`
`C. Petitioner’s Opposition to the Motion to Amend
`
`Petitioner argues that Patent Owner’s Motion to Amend should be
`
`denied with respect to entering substitute claim 26 “because Patent Owner
`has not demonstrated the patentability of claim 26 as required by Board
`precedent.” Paper 17, 2. Petitioner contends essentially that Patent Owner
`has not met its “burden of showing the substitute claim’s patentable
`distinction over not only the prior art asserted in the petition, but also all
`prior art of record in the initial patent prosecution, reissue proceeding, prior
`litigations and other prior art known to patent owner.” Id. at 4 (citing Idle
`Free Sys. v. Berstrom, Inc., Case IPR2012-00027, slip op. at 6, 7 (PTAB
`June 11, 2013) (Paper 26)).
`Petitioner’s argument is inapposite. Idle Free concerned, in relevant
`part, the burden on a patent owner “to show a patentable distinction over the
`prior art of record and also prior art known to the patent owner” in the
`instance where a feature is “added to each substitute claim, as compared to
`the challenged claim it replaces.” Idle Free at 7. As explained in Nike v.
`
`5
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`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-5
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`IPR2015-02009
`Patent RE42,096 E
`
`Adidas AG, 812 F.3d 1326, 1334 (Fed. Cir. 2016), “the patent owner carries
`an affirmative duty to justify why newly drafted claims . . . should be
`entered into the proceeding.” In this instance, however, multiple dependent
`substitute claim 26 merely has the effect of eliminating three claims
`dependent on instituted claims 18–20, and preserving two claims dependent
`from non-instituted claims 2 and 13. As Patent Owner aptly explains,
`“[e]ffectively, no claim is being amended, and claims are only being
`cancelled, because claims 18–24 are being removed, and proposed claim 26
`removes three multiple dependent claims (claim 25 as it depends from
`claims 18–20)” and “[n]o other changes to the claims are being made.”
`Paper 14, 2.
`With the cancellation of claims 18–25, and the entry of substitute
`claim 26, there would be no claim remaining subject to inter partes review
`in this proceeding. We agree with Patent Owner that “[t]here is no
`requirement for Shire to prove, after the Institution Decision, that original
`non-amended claims are patentable over all potential prior art, especially
`non-instituted claims.” Paper 21, 4.
`
`III. CONCLUSION
`For the foregoing reasons, Patent Owner’s Motion to Amend is
`granted in all respects.
`
`
`
`
`6
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`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-6
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`IPR2015-02009
`Patent RE42,096 E
`
`
`IV. ORDER
`For the reasons given, it is
`ORDERED that Patent Owner’s Motion to Amend is granted; and
`FURTHER ORDERED that because this is a Final Decision, parties
`to the proceeding seeking judicial review of the Decision must comply with
`the notice and service requirements of 37 C.F.R. § 90.2.
`
`
`
`
`
`7
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`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-7
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`IPR2015-02009
`Patent RE42,096 E
`
`PETITIONER:
`Erik B. Flom
`Marc R. Wezowski
`Husch Blackwell LLP
`
`erik.flom@huschblackwell.com
`marc.wezowski@huschblackwell.com
`
`PATENT OWNER:
`Joseph R. Robinson
`Robert Schaffer
`Dustin B. Weeks
`
`joseph.robinson@troutmansanders.com
`robert.schaffer@troutmansanders.com
`dustin.weeks@troutmansanders.com
`
`
`
`
`
`
`8
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`Polaris Innovations LTD Exhibit 2011
`Kingston v. Polaris, IPR2016-01622
`Page 2011-8
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`
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