UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEALS BOARD
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`AMERIGEN PHARMACEUTICALS LIMITED,
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`Petitioner,
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`v.
`
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`SHIRE LLC,
`
`Patent Owner
`
`Case No.: IPR2015-02009
`Patent No.: Re 42,096
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`PETITIONER’S OPPOSITION TO MOTION TO AMEND
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-1
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`BEFORE THE PATENT TRIAL AND APPEALS BOARD
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`
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`
`Petitioner,
`
`v.
`
`
`SHIRE LLC,
`
`Patent Owner
`
`Case No.: IPR2015-02009
`Patent No.: Re 42,096
`
`PETITIONER’S OPPOSITION TO MOTION TO AMEND
`
`
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-1
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`The Board should deny Patent Owner’s Motion to Amend to add claim 26
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`because Patent Owner has not demonstrated the patentability of claim 26 as
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`required by Board precedent (as affirmed by the Federal Circuit), nor has Patent
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`Owner met its burden of production for the same.1 Further, Patent Owner did not
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`file its Motion to Amend by the deadline required by the Scheduling Order, and
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`should be denied for that reason as well.
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`Petitioner does not oppose Patent Owner’s proposed cancellation of
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`claims 18-25.
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`I.
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`The Motion To Amend Should Be Denied Because Patent Owner Has
`Not Made The Showings Of Patentability Required Under Masterimage
`And Idle Free.
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`Patent Owner asks the Board to enter a substitute claim without Patent
`
`Owner making the required showings of patentability under Masterimage 3D, Inc.
`
`v. RealD Inc., IPR2015-00040, Paper 42 (July 15, 2015). Masterimage makes clear
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`1 Patent Owner represented that Petitioner does not oppose Patent Owner’s request
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`for reconsideration. (Patent Owner’s Motion to Amend, Paper 14 at 1.) Petitioner
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`did not request an opportunity to file a response to the request, but does oppose
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`Patent Owner’s attempt to state that the multiple dependent claims are only
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`conditionally a part of this proceeding. Petitioner will brief such opposition if the
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`Board desires.
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`- 2 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-2
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`
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`that the standards of Idle Free Systems, Inc. v. Bergstrom, Inc., IPR2012-00027,
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`Paper 26 (P.T.A.B. June 11, 2013) still apply. Masterimage, at 2. Idle Free
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`requires that “in all circumstances” Patent Owner seeking an amendment will make
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`a showing of patentable distinction over the prior art. Idle Free, at 6. Patent Owner
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`did not even attempt to make the required showing of patentable distinction, and
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`for that reason alone the Motion to Amend should be denied. Indeed, Patent Owner
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`was required to make its argument for the validity of the substitute claim in its
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`Motion to Amend. Masterimage 3D, at 4. Patent Owner did not do so.
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`Patent Owner has not set forth any prima facie case of patentability for
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`Petitioner to rebut. Claim 25, the claim being replaced by claim 26, only adds to
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`claims 2 and 13 the requirement that mixed amphetamine salts be present. The
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`Board found that “mixed amphetamine salts” were disclosed by the prior art as the
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`term was construed by the Board. (Decision to Institute, Paper 8 at 29-30.) Patent
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`Owner argued for a different construction of “mixed amphetamine salts” which the
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`Board found unpersuasive. (Decision to Institute, Paper 8 at 11-14.) Given, at least,
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`the Board’s finding that it is obvious to substitute the mixed amphetamine salts of
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`the Adderall PDR for methylphenidate, under Idle Free it was incumbent on Patent
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`Owner to show patentable distinction over claims 2 and 13. Idle Free, at 7-8.
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`Under Idle Free, there are multiple requirements for a Patent Owner to
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`successfully bear the burden of proving patentable distinction for a substitute
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`- 3 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-3
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`
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`claim. First, Patent Owner could have argued the construction of the claim term of
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`claim 25 (“mixed amphetamine salts”) that would have lent patentable distinction
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`over claims 2 and 13 when it did not do so over claim 25. Idle Free, at 7. Patent
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`Owner has not offered any claim construction in its motion nor adopted that of the
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`Board. Patent Owner could have argued its favored interpretation of mixed
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`amphetamine salts, or that the term was not an obvious extension of claims 2 and
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`13. Instead, Patent Owner has not cited any support in the specification for the
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`claim term. (Patent Owner’s Motion to Amend, Paper 14.) Patent Owner has not
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`made even a conclusory statement by counsel (which itself would be facially
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`inadequate had it been made). See Idle Free, at 7-8.
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`The Patent Owner also bears the burden of showing the substitute claim’s
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`patentable distinction over the prior art. Idle Free, at 7. For those purposes, the
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`prior art includes not only the prior art asserted in the petition, but also all prior art
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`of record in the initial patent prosecution, reissue proceeding, prior litigations and
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`other prior art known to patent owner. Id. This patent has been the subject of
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`numerous litigations with invalidity arguments, including currently-pending
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`litigation against Petitioner. Said invalidity arguments undoubtedly have set forth
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`numerous items of prior art that bear on the validity claim 26. Patent Owner did
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`not present any of this evidence in its Motion to Amend. Indeed, the prior art
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`- 4 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-4
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`known to the Patent Owner is that prior art that falls under the duty of good faith
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`and candor of Rule 42.11. Masterimage, at 3.
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`Regarding prior art subject to the duty of candor, Patent Owner has not even
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`apprised the Board of the parallel proceeding before the Board containing such
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`prior art: Mylan Pharmaceuticals Inc. v. Shire Laboratories, Inc., IPR2016-01033,
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`Paper 2 (P.T.A.B. filed May 12, 2016)(challenging the same U.S. Reissue Patent
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`Re 42,096 as this proceeding). Claim 25 is challenged in that proceeding. (Mylan,
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`Paper 2 at 56-57.) Claims 2 and 13 are also challenged in that proceeding. (Mylan,
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`Paper 2 at 28-31, 44-47.) Indeed, the Mylan proceeding will receive an institution
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`decision no later than one month from now—November 18, 2016—and the
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`Board’s decision there will impact the issues being decided here. Again, Patent
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`Owner has not apprised the Board of any of this information in its Motion to
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`Amend. Given that the Mylan institution decision will significantly impact the
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`Board’s decision here, and Petitioner’s and Patent Owner’s Motions for
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`Reconsideration are still pending, it is Petitioner’s position that the Board’s
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`decisions on these Motions should be stayed until the Mylan institution decision is
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`rendered. Notably, Patent Owner’s argument for the propriety of its amendment to
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`add claim 26 also depends on a favorable finding of its Motion for Reconsideration
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`asking for “clarification that multiple dependent claim 25 was instituted only as it
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`- 5 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-5
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`depends from instituted claims (18-20), and not from non-instituted claims (2 and
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`13).” (Patent Owner’s Motion to Amend, Paper 14 at 2-3.)
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`By filing its corrected Motion to Amend on July 28, 2016, Patent Owner
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`seeks to sidestep the requirements of Idle Free, as clarified in Masterimage, that
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`Patent Owner show patentability of the claim over the prior art known to it. In
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`presenting its Motion to Amend, Patent Owner also has failed to meet its discovery
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`obligations under 37 C.F.R. § 42.51(b)(1)(iii) (“a party must serve relevant
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`information that is inconsistent with a position advanced by the party during the
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`proceeding concurrent with the filing of the documents or things that contains the
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`inconsistency”) to apprise Petitioner of material information inconsistent with its
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`position. Indeed, Patent Owner has not met, nor even attempted to meet, its burden
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`of production.
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`Patent Owner also attempts to sidestep its duty of candor and good faith
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`specific to motions to amend. Patent Owner appears to reason that if it is not
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`“amending” the claim, then it need not apply the prior art in that proceeding or
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`even report it to the other party.
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`Along with its failure to argue the patentability of substitute claim 26 in
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`view of the prior art made of record in this proceeding before the Board, there is
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`yet further prior art known to Patent Owner and not before the Board. Indeed, there
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`is extensive prior art of record in the initial prosecution and the reissue proceeding.
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`- 6 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-6
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`Additionally, Petitioner provided Patent Owner with invalidity contentions
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`in the parallel litigation which were not limited to the prior art of record in this
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`inter partes review. Patent Owner is aware of the arguments for invalidity of the
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`Re 42,096 claims from those contentions as well as from other proceedings where
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`the prior art and arguments were never put into the record of the reissue patent,
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`including, at least Shire LLC v. Amerigen Pharms. Ltd., 14-cv-6095 (D.N.J filed
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`October 1, 2014); Shire LLC v. Par Pharm., Inc., 15-cv-01454 (D.N.J. filed Feb.
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`26, 2015) and Shire LLC v. Corepharma, LLC, 14-05694 (D.N.J filed Sept. 12,
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`2014). (See Paper No. 16 at 2-3.) That the other parties are pursuing invalidity in
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`district court rather than the PTAB does not excuse Shire from its requirement to
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`prove the validity of the substitute claim.
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`Further, the obligation to show patentability over the prior art encompasses
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`all prior art known to the Patent Owner. That obligation is not limited to the
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`patents and printed publications to which a Petitioner is limited in its Petition. E.g.
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`Luv N’ Care, Ltd. v. Munchkin, Inc., IPR2015-00872, Paper 24 (P.T.A.B. Feb. 18,
`
`2016) (granting motion to compel third-party subpoena about the on-sale date of a
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`photographed product as prior art to oppose a motion to amend). Patent Owner also
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`fails to inform the Board that there is reason to believe that Adderall® XR has
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`essentially the same release profile as Focalin XR, the methylphenidate listed in
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`the Orange Book as being covered by the Mehta reference. (Orange Book Entry for
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`- 7 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-7
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`
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`Focalin XR, Exhibit 1081.) The facts about Focalin XR available to Petitioner
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`could not be asserted as prior art in the Petition, but may be used as prior art
`
`against substitute claim 26. Again, Patent Owner has not met its burden of
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`production in this regard.
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`There are also a multiplicity of issues under 35 U.S.C. § 112 that arise from
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`the comparison of Adderall® XR to Focalin XR. First, when the release period of
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`Adderall® XR does not match that of the patent as suggested by U.S. Patent
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`Publication No. 2006/0204575, Exhibit 1082 (showing Adderall® XR essentially
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`identical to a formulation having complete release on the order of 2 to 6 hours),
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`there is a question as to whether the best mode was disclosed, an issue that is
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`proper for new claims. 35 U.S.C. § 282(b)(3)(A). Second, it is not clear that the
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`claims are enabled given the properties of Adderall® XR. The records for the
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`testing that support the specification’s examples should be made of record before
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`the specification is taken as support for the claims. Also, it may be that under
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`various testing methods not included in the specification, Adderall® XR does or
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`does not have the claimed release period. Those variable testing results would
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`render the claim indefinite because the testing is not specified. Teva Pharms. USA,
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`Inc. v. Sandoz, Inc., 789 F.3d 1335, 1341-1345 (Fed. Cir. 2015) (multiple methods
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`of measuring average molecular weight render the term indefinite).
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`- 8 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-8
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`The Board plays an important role in adjudicating whether a new claim may
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`be added to a patent, especially during litigation. Unjustified patent claims cause
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`mischief and added burden for defendants and the courts. Indeed, Patent Owner is
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`presently asserting Re 42,096 against Petitioner and others in litigation. If the
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`Board allows the addition of claim 26 by Patent Owner, the Courts in those
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`litigations will be required to give claim 26 deference and presume that it is
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`independently valid over claims 2 and 13 (35 U.S.C. § 282(a) (“multiple dependent
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`claims shall be presumed valid even though dependent upon an invalid claim”).),
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`despite that claim never being reviewed by the Patent Office. That result will
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`improperly burden Petitioner with then having to prove the claim invalid under the
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`clear and convincing evidence standard. Microsoft Corp. v. i4i Ltd. P’ship, 564
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`U.S. 91, 95 (2011). This would be an inequitable result.
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`Rather, the patent system and federal courts that rely on this Board’s entry of
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`claims should be provided with a claim that the Board finds to be separately
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`patentable by at least a preponderance of the evidence, or in the alternative an
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`examination by a patent examiner in a reexamination or reissue proceeding. Patent
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`Owner has not respected the Board’s precedent that sets forth requirements
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`recognizing the importance of the entry of amended claims by the Board. As such,
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`Patent Owner’s attempt to add claim 26 without Patent Office examination should
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`be denied.
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`- 9 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-9
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`
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`II. The Motion To Amend Should Be Denied Because Patent Owner Has
`No Excuse For Failing To File Its Motion To Amend By The Ordered
`Deadline.
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`Under Rule 42.5(c), the Board may excuse a late action upon a showing of
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`good cause or a separate showing that consideration on the merits would be in the
`
`interests of justice. Patent Owner can meet neither standard, so Patent Owner’s
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`Motion to Amend should be denied.
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`A.
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`Patent Owner lacks good cause because it was warned of an error
`in its filing and did not actually verify the correctness of its filing.
`
`On July 18, Patent Owner filed a motion to amend without uploading any
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`documents. (Ex. 1083 (7/18/2016 Filing Courtesy Notice to Erik Flom); Ex. 1084
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`(7/28/2016 email from PTAB E2E Admin to Dustin Weeks).) Petitioner
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`immediately contacted Patent Owner to report a problem:
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`We just received a notice showing me as the filer for Shire’s (Patent
`Owner’s) motion to amend. It may be that PTAB E2E has a problem
`of some kind. We would appreciate it if you could confirm that the
`paper was properly filed, and that it is PTAB E2E that has misnamed
`me as the filing attorney.
`
`(Ex. 1085 (7/18/2016 email from Erik Flom to Dustin Weeks).)
`
`Patent Owner confirmed that the motion had been properly filed, stating: “I
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`confirm that the motion was properly filed (Joe Robinson was the filer) and the
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`system has misnamed you as the filing attorney.” (Ex. 1086 (7/18/2016 email from
`
`Dustin Weeks to Erik Flom).) Having received that confirmation from Patent
`
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`- 10 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-10
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`
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`Owner, Petitioner objects to Patent Owner’s Motion to Amend as filed on July 28,
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`2016, ten days after DUE DATE 1 (July 18, 2016).
`
`On July 28, 2016, Patent Owner contacted the Board stating: “but it has
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`recently come to Patent Owner’s attention that the PTABE2E system does not
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`currently show that the motion was filed.” (Ex. 1087 (7/28/2016 email from Dustin
`
`Weeks to PTAB).) The PTAB E2E Admin informed Patent Owner that “[it]
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`appears that you filed a motion, but did not upload any documents with it.”
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`(Ex. 1084 (7/28/2016 email from PTAB E2E Admin to Dustin Weeks); see also
`
`below excerpt from Ex. 1084 (arrows in original from PTAB E2E Admin).)
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`- 11 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-11
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`
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`Patent Owner then uploaded the document ten days late and separately
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`requested that the filing date be reset in an email to the PTAB E2E Administrator,
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`copied to the Board. (Ex. 1088 (7/29/2016 email from Dustin Weeks to PTAB E2E
`
`Admin).) Petitioner objected to any entry of a correction, especially one made by
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`the PTAB E2E Admin, and not the Board. (Ex. 1089 (7/29/2016 email from Erik
`
`Flom to Board).)
`
`When Patent Owner filed its motion to amend on July 28, 2016, it stated,
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`“[t]his motion is timely” and it backdated the filing to July 18, 2016 as if a motion
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`to reset the date had been granted. (Patent Owner’s Motion to Amend, Paper 15, at
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`3.) It did not cite the emails with the PTAB E2E Administrator as the reason for
`
`calling the motion “timely” but entirely omitted the circumstances of the late filing
`
`from the record. (Patent Owner’s Motion to Amend, Paper 15, at 3.)
`
`The Motion should thus be denied for the inexcusable late filing. If there had
`
`been a misunderstanding by Patent Owner of how PTAB E2E worked on July 18,
`
`2016, Petitioner’s email to Patent Owner should have resulted in a summary
`
`correction immediately, not a correction ten days after the event. Rather, Patent
`
`Owner assured Petitioner that the filing had been performed correctly. However, it
`
`appears that Patent Owner did not verify that the paper had actually been filed
`
`when they represented to Petitioner that they had filed their papers correctly. The
`
`excuse offered by Patent Owner for its failure to timely file is insufficient because
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`
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`- 12 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-12
`
`
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`Patent Owner was informed, and acknowledged, that the Board’s email about the
`
`filing was incorrect. Again, when Patent Owner filed the paper late, it improperly
`
`back-dated the paper to the date in the scheduling order. (Patent Owner’s Motion
`
`to Amend, Paper 15, at 3.)
`
`The Board regularly denies motions for failure to meet the dates of the rules
`
`or the scheduling order as set or as stipulated by the parties. Olympus America Inc.
`
`v. Perfect Surgical Techniques, Inc., 2015 WL 3622887, IPR2014-00241, Final
`
`Written Decision, Paper 51, at 24-27 (P.T.A.B. June 8, 2015) (motion to exclude
`
`filed after stipulated date denied for lateness); Google, Inc. v. PersonalWeb
`
`Technologies, LLC, 2014 WL 5585272, IPR2014-00980, Decision, Paper 10, at 4-
`
`5 (P.T.A.B. Oct. 30, 2014) (motion for joinder denied as untimely); The Scotts
`
`Company LLC v. Encap LLC, 2014 WL 2886290, IPR2013-00110, Final Written
`
`Decision, Paper 79, at 5 (P.T.A.B. June 24, 2014) (untimely declarations not
`
`considered); Apple Inc. v. Rensselaer Polytechnic Institute, 2014 WL 10920508,
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`IPR2014-00319, Decision, Paper 20, at 4 (P.T.A.B. Dec. 12, 2014) (denying
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`argument as untimely). The Board should deny this motion for the same reason.
`
`In another case, Dealersocket, Inc. v. Autoalert LLC, 2014 WL 4468531,
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`CBM2014-00147, Order, Paper 8, at 6-7 (P.T.A.B. Sept. 8, 2014), a panel of the
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`Board stated that prompt remedial action, explaining the inadvertent circumstance,
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`- 13 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-13
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`
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`requesting leave for the late filing, and working with opposing counsel are the
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`ordinary steps for correcting a late filing.
`
`Even if Patent Owner’s initial failure may have been inadvertent, the actions
`
`taken by Patent Owner when asked to investigate the filing are insufficient to meet
`
`the good cause standard. Indeed, Patent Owner, in a tardy acknowledgement of the
`
`problem, sought correction through emails rather than a motion. Still, three months
`
`after the initial due date, Patent Owner has not requested leave to file a motion to
`
`excuse the late filing. Additionally, prior to contacting the Board, Patent Owner did
`
`not confer with Petitioner, requiring Petitioner to respond to the email to the Board
`
`to protect its rights.
`
`The fact is that Patent Owner made no use of the same-day warning by
`
`Petitioner to correct its filing and has not asked the Board to excuse the late filing.
`
`The paper Patent Owner filed does not reflect the late filing, nor does it ask to
`
`excuse its tardiness. Patent Owner’s actions since the filing date do not constitute
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`good cause to be excused. Instead, its lack of action constitutes waiver of any
`
`argument to be excused under 37 C.F.R. § 42.5(c)(3).
`
`B.
`
`Excusing the late filing is not in the interests of justice because
`Patent Owner may yet amend the claims in a reexamination or
`reissue proceeding.
`
`Patent Owner may still pursue claim amendments of any scope by
`
`reexamination or reissue after this proceeding concludes. Idle Free Systems, Inc. v.
`
`
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`- 14 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-14
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`
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`Bergstrom, Inc., IPR2012-00027, Paper 26, at 6 (P.T.A.B. June 11, 2016). As was
`
`shown in Part I of this Opposition, Patent Owner has made only a perfunctory
`
`effort to support its claim substitution in this proceeding. If Patent Owner’s motion
`
`is denied, Patent Owner will not be deprived of any substantive right that it cannot
`
`pursue through ordinary examination channels. Also, Patent Owner’s inaction after
`
`the discovery of the problem with its filing constitutes waiver of arguments that it
`
`meets the interests of justice standard just as much as it does for the good cause
`
`standard.
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`
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`
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`Dated: October 18, 2016
`
`/Erik B. Flom/
`
`
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`- 15 -
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-15
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`CERTIFICATE OF SERVICE
`
`I certify that under 37 C.F.R. §42.6 a copy of the foregoing
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`
`AMEND and any exhibits identified were served upon the named individuals
`
`below on October 18, 2016 by email as provided by 37 C.F.R. § 42.6(e)(1) and the
`
`agreement of the parties:
`
`Dated: October 18, 2016
`
`
`
`
`
`Joseph R. Robinson
`joseph.robinson@troutmansanders.com
`
`Robert Schaffer
`robert.schaffer@troutmansanders.com
`
`Dustin B. Weeks, Reg. No. 67,466
`dustin.weeks@troutmansanders.com
`
`
`
`/Erik B. Flom/
`Erik B. Flom, Reg. No. 41,021
`Lead Counsel for Petitioner
`erik.flom@huschblackwell.com
`Marc R. Wezowski, Reg. No. 73,825
`Backup Counsel for Petitioner
`marc.wezowski@huschblackwell.com
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`
`
`
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`Polaris Innovations LTD Exhibit 2008
`Kingston v. Polaris, IPR2016-01622
`Page 2008-16
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`
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