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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`AMERIGEN PHARMACEUTICALS LIMITED,
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`Petitioner,
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`v.
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`SHIRE LLC,
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`Patent Owner.
`____________
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`Case IPR2015-02009
`Patent RE 42,096
`____________
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`PATENT OWNER’S MOTION TO AMEND
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-1
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`IPR2015-02009
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`PATENT OWNER’S MOTION TO AMEND
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`I. Statement of Relief Requested
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`Patent Owner Shire LLC moves to amend U.S. Reissued Patent RE 42,096
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`(Ex. 1001) under 37 C.F.R. §§ 42.121, by cancelling all of the claims that have
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`currently been instituted for trial and proposing one substitute claim for multiple-
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`dependent Claim 25, which removes its dependency from all instituted claims.
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`II. Motion to Amend
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`Petitioner Amerigen challenged claims 1-3, 5, 8, 9, 11, 18-21, 23, and 25 of
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`the ’096 patent. The Board instituted a trial for claims 18-21, 23, and 25. See
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`Decision on Institution (“Decision,” Paper 8), at 31 (claims 18-21 and 23); and at
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`36-38 (claims 18-21, 23 and 25). No trial was instituted for claims 1-17.
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`Claim 25 states:
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`25. The pharmaceutical composition of any one of claims 2,
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`13 or 18
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`to 20 wherein
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`the pharmaceutically active
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`amphetamine
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`salt
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`in
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`(a) and
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`(b) comprises mixed
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`amphetamine salts.
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`Claim 25 is a multiple dependent claim, and was instituted only as it depends from
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`claims 18-20, and not as it depends from claim 2 or claim 13. See Patent Owner’s
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`Request for Reconsideration, Paper 10 (pending; unopposed by Petitioner).
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`Page 2007-2
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`Patent Owner moves to amend the ’096 patent by cancelling instituted
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`claims 18-21 and 23, plus claims 22 and 24 (each of which depends from claim
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`18). Patent Owner also proposes new claim 26 be substituted for claim 25, and
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`claim 25 would then be cancelled. Substitute claim 26 is identical to cancelled
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`claim 25, with the exception that all dependencies from cancelled claims 18-20
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`have been removed. Thus, claim 26 is supported by the original claims and earlier
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`disclosures. Claim 26 depends only from non-instituted claims.
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`Effectively, no claim is being amended, and claims are only being cancelled,
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`because claims 18-24 are being removed, and proposed claim 26 removes three
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`multiple dependent claims (claim 25 as it depends from claims 18-20). No other
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`changes to the claims are being made.
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`Patent Owner’s Motion to Amend complies with the requirements of 37
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`C.F.R. § 1.121. Prior to filing this motion, Patent Owner conferred with the Board
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`by email on July 14, 2014. See 37 C.F.R. § 1.121(a). Patent Owner sought
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`guidance regarding this Motion to Amend, as well as regarding its intention to
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`request adverse judgment under 37 C.F.R. 42.73(b)(2), because the amendment
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`cancels all instituted claims. The Board advised that the motion to amend can be
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`submitted, while the request for adverse judgment is premature, because the Board
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`has not yet decided the pending requests for reconsideration. Petitioner sought
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`Kingston v. Polaris, IPR2016-01622
`Page 2007-3
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`reconsideration of the non-instituted claims. Patent Owner sought clarification that
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`multiple dependent claim 25 was instituted only as it depends from instituted
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`claims (18-20), and not from non-instituted claims (2 and 13). This Motion to
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`Amend corresponds to Patent Owner’s request for reconsideration.
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` This motion is timely. 37 C.F.R. § 1.121(a)(1); Paper 9, at 6. The proposed
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`amendment cancels all instituted claims and proposes one substitute claim that
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`cancels claim 25 as instituted, to the extent it depends from instituted claims. The
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`amendments respond to the grounds asserted for unpatentability (37 C.F.R. §
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`1.121(a)(2)(i)) and they do not enlarge the scope of the claims or introduce new
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`subject matter (37 C.F.R. § 1.121(a)(2)(i)).
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`The Motion to Amend also proposes a reasonable number of substitute
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`claims, i.e., one substitute Claim 26 to replace canceled Claim 25. 37 C.F.R.
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`§ 1.121(a)(3). Appendix A provides a complete claim listing clearly showing the
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`proposed amendments. 37 C.F.R. § 1.121(b).
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`Patent Owner respectfully requests that its Motion to Amend be granted.
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`Dated: July 18, 2016
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` Respectfully submitted,
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`/Joseph R. Robinson/
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`Joseph R. Robinson, PTO Reg. No. 33,448
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` Robert Schaffer, PTO Reg. No. 31,194
` Dustin B. Weeks, PTO Reg. No. 67,466
` Attorneys for Patent Owner
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`3
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`Kingston v. Polaris, IPR2016-01622
`Page 2007-4
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Motion to Amend has been served on attorneys for Petitioner, via
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`electronic mail on July 18, 2016, to the following addresses provided by Petitioner:
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`erik.flom@huschblackwell.com
`marc.wezowski@huschblackwell.com
`IPR2015-Amerigen1@huschblackwell.com
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`Dated: July 18, 2016
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` Respectfully submitted,
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`/Dustin B. Weeks/
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` Dustin B. Weeks, PTO Reg. No. 67,466
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-5
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`IN THE 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 RE 42,096
`____________
`
`
`PATENT OWNER’S MOTION TO AMEND
`APPENDIX A – CLAIM LISTING
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-6
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`Claim Listing Pursuant to 37 C.F.R. § 1.121(b)
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`1.
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`(Not Instituted) A pharmaceutical composition for delivery of one or
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`more pharmaceutically active amphetamine salts, comprising:
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`(a) one or more pharmaceutically active amphetamine salts covered with an
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`immediate release coating; and
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`(b) one or more pharmaceutically active amphetamine salts that are covered
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`with an enteric release coating that provides for delayed pulsed enteric release,
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`wherein said enteric release coating releases essentially all of said one or more
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`pharmaceutically active amphetamine salts coated with said enteric coating within
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`about 60 minutes after initiation of said delayed pulsed enteric release;
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`wherein the pharmaceutically active amphetamine salts in (a) and (b) comprise
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`mixed amphetamine salts.
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`2.
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`(Not Instituted) A pharmaceutical composition for delivery of one or
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`more pharmaceutically active amphetamine salts, comprising:
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`(a) one or more pharmaceutically active amphetamine salts covered with an
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`immediate release coating; and
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`(b) one or more pharmaceutically active amphetamine salts that are covered
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`with an enteric release coating that provides for delayed pulsed enteric release,
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`wherein said enteric release coating releases essentially all of said one or more
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`1
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-7
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`pharmaceutically active amphetamine salts coated with said enteric coating within
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`about 60 minutes after initiation of said delayed pulsed enteric release; wherein
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`said enteric release coating has a thickness of at least 25μ.
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`3.
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`(Not Instituted) The pharmaceutical composition of claim 1 wherein the
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`one or more pharmaceutically active amphetamine salts are coated onto a core.
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`4.
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`(Not Instituted) The pharmaceutical composition of claim 1 wherein the
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`one or more pharmaceutically active amphetamine salts are incorporated into a
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`core.
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`5.
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`(Not Instituted) A pharmaceutical composition for delivery of one or
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`more pharmaceutically active amphetamine salts, comprising:
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`(a) one or more pharmaceutically active amphetamine salts covered with an
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`immediate release coating; and
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`(b) one or more pharmaceutically active amphetamine salts that are covered
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`with an enteric release coating that provides for delayed pulsed enteric release,
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`wherein said enteric release coating releases essentially all of said one or more
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`pharmaceutically active amphetamine salts coated with said enteric coating within
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`about 60 minutes after initiation of said delayed pulsed enteric release; wherein the
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`one or more pharmaceutically active amphetamine salts covered with an immediate
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`2
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-8
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`release coating and the one or more pharmaceutically active amphetamine salts
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`covered with an enteric release coating are present on a single core.
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`6.
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`(Not Instituted) The pharmaceutical composition of claim 1 wherein the
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`one or more pharmaceutically active amphetamine salts covered with an immediate
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`release coating and the one or more pharmaceutically active amphetamine salts
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`covered with an enteric release coating are present on different cores.
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`7.
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`(Not Instituted) The composition of claim 1 wherein said enteric release
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`coating is a non-pH dependent enteric release coating.
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`8.
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`(Not Instituted) A pharmaceutical composition for delivery of at least one
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`amphetamine salt, comprising:
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`(a) at least one pharmaceutically active amphetamine salt covered with an
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`immediate release coating; and
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`(b) at least one pharmaceutically active amphetamine salt covered with an
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`enteric release coating, said component (a) providing for an immediate release of
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`amphetamine salt to provide a first blood level of amphetamine salt and component
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`(b) providing a delayed pulse enteric release of amphetamine salt that increases the
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`blood level of amphetamine salt to a second level that is greater than the first level
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`provided by component (a), wherein said enteric release coating releases
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`3
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-9
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`essentially all of said one or more pharmaceutically active amphetamine salts
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`coated with said enteric coating within about 60 minutes after initiation of said
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`delayed pulsed enteric release;
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`wherein the pharmaceutically active amphetamine salts comprise mixed
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`amphetamine salts in (a) and (b) comprise mixed amphetamine salts.
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`9.
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`(Not Instituted) The pharmaceutical composition of claim 8 wherein the
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`one or more pharmaceutically active amphetamine salts are coated onto a core.
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`10.
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`(Not Instituted) The pharmaceutical composition of claim 8 wherein the
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`one or more pharmaceutically active amphetamine salts are incorporated into a
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`core.
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`11.
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`(Not Instituted) A pharmaceutical composition for delivery of at least one
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`amphetamine salt, comprising:
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`(a) at least one pharmaceutically active amphetamine salt covered with an
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`immediate release coating; and
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`(b) at least one pharmaceutically active amphetamine salt covered with an
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`enteric release coating, said component (a) providing for an immediate release of
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`amphetamine salt to provide a first blood level of amphetamine salt and component
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`(b) providing a delayed pulse enteric release of amphetamine salt that increases the
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`4
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-10
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`blood level of amphetamine salt to a second level that is greater than the first level
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`provided by component (a), wherein said enteric release coating releases
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`essentially all of said one or more pharmaceutically active amphetamine salts
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`coated with said enteric coating within about 60 minutes after initiation of said
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`delayed pulsed enteric release; and wherein the one or more pharmaceutically
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`active amphetamine salts covered with an immediate release coating and the one or
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`more pharmaceutically active amphetamine salts covered with an enteric release
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`coating are present on a single core.
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`12.
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`(Not Instituted) The pharmaceutical composition of claim 8 wherein the
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`one or more pharmaceutically active amphetamine salts covered with an immediate
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`release coating and the one or more pharmaceutically active amphetamine salts
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`covered with an enteric release coating are present on different cores.
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`13.
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`(Not Instituted) A pharmaceutical composition for delivering one or more
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`pharmaceutically active amphetamine salts comprising:
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`(a) one or more pharmaceutically active amphetamine salts covered with an
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`immediate release coating;
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`(b) one or more pharmaceutically active amphetamine salts that are covered
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`with an enteric release coating that provides for delayed pulsed enteric release,
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`wherein said enteric release coating releases essentially all of said one or more
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`5
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-11
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`pharmaceutically active amphetamine salts coated with said enteric coating within
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`about 60 minutes after initiation of said delayed pulsed enteric release; and
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`(c) a protective layer over the enteric release coating.
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`14.
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`(Not Instituted) The pharmaceutical composition of claim 13 wherein the
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`one or more pharmaceutically active amphetamine salts are coated onto a core.
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`15.
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`(Not Instituted) The pharmaceutical composition of claim 13 wherein the
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`one or more pharmaceutically active amphetamine salts are incorporated into a
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`core.
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`16.
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`(Not Instituted) The pharmaceutical composition of claim 13 wherein the
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`one or more pharmaceutically active amphetamine salts covered with an immediate
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`release coating and the one or more pharmaceutically active amphetamine salts
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`covered with an enteric release coating are present on a single core.
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`17.
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`(Not Instituted) The pharmaceutical composition of claim 13 wherein the
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`one or more pharmaceutically active amphetamine salts covered with an immediate
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`release coating and the one or more pharmaceutically active amphetamine salts
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`covered with an enteric release coating are present on different cores.
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`18-21.
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`(Instituted/Canceled)
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`6
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`Polaris Innovations LTD Exhibit 2007
`Kingston v. Polaris, IPR2016-01622
`Page 2007-12
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`(Not Instituted/Canceled)
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`(Instituted/Canceled)
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`(Not Instituted/Canceled)
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`(Instituted with respect to dependency from Claims 18-20/Canceled)
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`(Substitute for Claim 25) The pharmaceutical composition of any one of
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`22.
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`23.
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`24.
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`25.
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`26.
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`claims 2[[,]] or 13 or 18 to 20 wherein the pharmaceutically active amphetamine
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`salt in (a) and (b) comprises mixed amphetamine salts.1
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`1 Underlines (additions) and brackets or strikethrough (deletions) show the
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`changes in Claim 26 from original Claim 25.
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`7
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`Kingston v. Polaris, IPR2016-01622
`Page 2007-13
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