`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`
`
`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICAL,
`INC., and WOCKHARDT BIO AG,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case IPR2015-005471
`Patent: 7,765,107
`_____________________
`
`
`PETITIONERS RESPONSE TO PATENT OWNER REQUEST FOR
`REHEARING PURSUANT TO 37 C.F.R. § 42.71(d)
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`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
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`1 Case IPR2015-01820 has been joined with this proceeding.
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED ........... 1
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`LEGAL STANDARD ..................................................................................... 1
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`I.
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`II.
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`PATENT OWNER HAS FAILED TO PROVE THAT THE BOARD
`III.
`OVERLOOKED OR MISAPPREHENDED ANY EVIDENCE THAT SHOULD
`MODIFY ITS FINAL CLAIM CONSTRUCTIONS. ............................................... 2
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`“wherein said [prescription] request data contain information identifying
`A.
`the patient” .............................................................................................................. 2
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`“wherein said [prescription] request data contain information
`B.
`identifying . . . credentials of the medical doctor” ................................................. 4
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`IV. CONCLUSION ................................................................................................ 6
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`i
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`I.
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`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
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`Pursuant to the Board’s e-mail authorization on September 6, 2016 (see
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`Exhibit 1062), Petitioners Amneal Pharmaceuticals LLC and Par Pharmaceutical,
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`Inc. (collectively, “Petitioners”) submit this opposition to Patent Owner’s Request
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`for Rehearing Pursuant to 37 C.F.R. § 42.71(d) (Paper 71).
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`Patent Owner’s Request does not provide a proper basis for rehearing, but
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`instead merely reiterates Patent Owner’s rejected arguments and evidence to import
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`certain limitations into the claims. The Board’s Final Decision (Paper 70) explicitly
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`acknowledged and correctly refuted these arguments and evidence based on the
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`governing intrinsic evidence, in holding claims 1–6 of U.S. Patent No. 7,765,107
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`(“the ’107 patent”) unpatentable as obvious over the Advisory Committee Art (Exs.
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`1003–1006) (the “ACA”). Patent Owner’s Request for Rehearing should therefore
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`be denied.
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`II. LEGAL STANDARD
`In a request for rehearing, the dissatisfied party “must specifically identify all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, an opposition, or a reply.”
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`37 C.F.R. § 42.71(d). “The burden of showing a decision should be modified lies
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`with the party challenging the decision.” Id.
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`
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`1
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`
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`III. PATENT OWNER HAS FAILED TO PROVE THAT THE BOARD
`OVERLOOKED OR MISAPPREHENDED ANY EVIDENCE THAT
`SHOULD MODIFY ITS FINAL CLAIM CONSTRUCTIONS.
`
`“A Request for Rehearing
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`is not an opportunity
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`to re-argue old
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`arguments . . . .” Histologics, LLC v. CDX Diagnostics, Inc. et al., IPR2014-00779,
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`slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9) (citing Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012)). Yet that is precisely what
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`Patent Owner’s Request seeks to do here. Patent Owner simply re-argues that
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`exemplary embodiments of “information identifying the patient” and “credentials of
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`the medical doctor” should limit the claims—arguments that the Board squarely
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`addressed and rejected. And while Patent Owner highlights certain specification
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`excerpts and/or expert testimony, the Board already considered and refuted that
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`evidence in its Final Decision. (Id.) The proper course for Patent Owner here “is to
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`appeal, not to file a request for rehearing to re-argue issues that have already been
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`decided.” SAP Am., Inc. v. Versata Dev. Grp., Inc., CBM2012-00001, slip op. at 5
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`(PTAB Sept. 13, 2013) (Paper 81).
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`A.
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` “wherein said [prescription] request data contain information
`identifying the patient”
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`Patent Owner first argues that the Board overlooked portions of the
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`specification “separate and apart from Figure 9” and certain expert testimony on
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`information “to identify the narcoleptic patient,” which Patent Owner uses to justify
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`its limiting construction of “wherein said [prescription] request data contain
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`2
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`
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`information identifying the patient.” (Request at 4–5 (citing Ex. 1001 at 4:26–28;
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`Ex. 2046 at ¶¶ 43–44; Ex. 2044 at 97:11–98:5, 99:18–100:10).) This is incorrect.
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`To the contrary, the Final Decision’s claim construction analysis for this term
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`begins by explicitly and repeatedly acknowledging Patent Owner’s arguments and
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`evidence, including the exact specification excerpt and expert testimony of Dr.
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`DiPiro and Dr. Valuck on which Patent Owner’s Request relies. (Final Decision
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`at 18 (citing Ex. 2046 at ¶¶ 39–44; Ex. 1001 at 4:14–28; Ex. 2044 at 97:11–98:5,
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`99:18–100:10); id. at 19 (citing Ex. 1001 at 4:26–28; Ex. 2044 at 97:11–23, 99:18–
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`100:10).) The Board did not “overlook” this evidence and consider only Figure 9 of
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`the specification, as Patent Owner suggests. (See Request at 3.) It simply disagreed
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`with Patent Owner on what this evidence means for claim construction.
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`Confirming that the final claim construction was not based solely on the
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`rejection of Patent Owner’s arguments as to Figure 9, the Final Decision states that
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`“nothing in the specification suggests that excluding one or more pieces of
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`information in the list of a ‘patient’s name, social security number, date of birth, sex,
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`and complete address information, including city, state, and zipcode,’ as proposed
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`by Patent Owner, means that a prescription fails to contain ‘information identifying
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`the patient,’ as recited in the claims.” (Final Decision at 19 (emphasis added).) The
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`Board made clear that this controlling understanding of the specification refuted
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`Patent Owner’s arguments and supporting evidence to import any such limitations
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`3
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`into the claim term. (Id. (“Thus, we construe prescription ‘request data contain
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`information identifying the patient’ to refer to information identifying a patient,
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`which may include [Patent Owner’s specifically listed information], but is not
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`limited to that information nor requires all of that information.”) (emphasis added).)
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`It is for good reason that the Board refused to contradict the intrinsic evidence
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`using the expert testimony Patent Owner now presents for a second time—such an
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`approach would violate the basic laws of claim construction. Phillips v. AWH Corp.,
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`415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (outside sources may not be “used
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`to contradict claim meaning that is unambiguous in light of the intrinsic evidence”).
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`Patent Owner’s argument also misinterprets Dr. Valuck’s testimony, which did not
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`provide that the claimed patient information is limited to or requires every piece of
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`information noted by Patent Owner, consistent with the Board’s final construction.
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`(See Reply (Paper 50) at 16–17; Final Decision at 19.) In any event, while Patent
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`Owner may disagree with the Board’s Final Decision, “mere disagreement with a
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`decision is not the proper basis for rehearing.” SAP America, Inc., CBM2012-
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`00001, Paper 81 at 8.
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`B.
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`“wherein said [prescription] request data contain information
`identifying . . . credentials of the medical doctor”
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`Patent Owner also mistakenly argues that the Board overlooked or
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`misapprehended evidence as to the proper construction of “wherein said
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`[prescription] request data contain information identifying . . . credentials of the
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`4
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`
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`medical doctor,” particularly as to certain expert testimony of Dr. Valuck and Dr.
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`DiPiro that Patent Owner offered to support its proposed limitations. (Request at 6–
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`8 (citing Ex. 1001 at 4:24–26; Ex. 2044 at 181:1–23; Ex. 2046 at ¶¶ 47, 49.).) This
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`argument is no more compelling than the first, and fails to provide a basis for
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`rehearing for the same reasons.
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`Again, the Final Decision’s claim construction analysis here undoubtedly
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`considered Patent Owner’s arguments and evidence including the expert testimony
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`and specification excerpt it re-argues now. In fact, the Board acknowledged this
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`evidence relied on by Patent Owner not once, but twice in its discussion. (Final
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`Decision at 20 (citing Ex. 2046 at ¶¶ 45–49; Ex. 1001 at 4:14–26; Ex. 2044 at 181:1–
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`23); id. (citing Ex. 1001 at 4:14–26; Ex. 2044 at 181:1–23; Ex. 2046 at ¶ 47.) The
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`Board even quoted verbatim the specification excerpt with which Patent Owner’s
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`Request leads its argument on the “credentials of the medical doctor” term here.
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`(Final Decision at 20 (quoting Ex. 1001 at 4:24–26); Request at 6.) Patent Owner’s
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`Request as to this term presents merely another re-argument, not an identification of
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`any evidence the Board failed to examine.
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`Patent Owner’s Request likewise fails to accept that the Final Decision
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`rejected Patent Owner’s arguments for what they were—attempts to limit broad
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`claim language using exemplary embodiments and extrinsic expert testimony. After
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`explicitly acknowledging all of Patent Owner’s evidence, the Board unambiguously
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`5
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`
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`explained that “we are not persuaded that the recited ‘credentials’ necessarily
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`include each and every piece of prescriber information described in [certain
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`embodiments].” (Final Decision at 21.) The Board further confirmed its reliance on
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`the intrinsic evidence to reject Patent Owner’s submissions in concluding that “[t]he
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`specification does not suggest that failing to include on the prescription one or more
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`pieces of information from the list . . . proposed by Patent Owner, means that a
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`prescription fails to contain information regarding ‘credentials,’ as recited in the
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`claims.” (Id.)
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`Thus, the Board obviously considered but rejected the positions and evidence
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`Patent Owner reiterates now on the “credentials of the medical doctor” element,
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`based on the clear implications of the intrinsic evidence. As with the previous term,
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`this was the correct approach under the controlling law of claim construction,
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`notwithstanding Patent Owner’s misreading of the extrinsic evidence. Phillips, 415
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`F.3d at 1324. At a minimum, Patent Owner’s mere disagreements with the Final
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`Decision’s claim constructions are not a proper basis for rehearing.
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`IV. CONCLUSION
`For the foregoing reasons, Patent Owner’s Request for Rehearing should be
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`denied.
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`6
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`Dated: September 16, 2016
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`Respectfully Submitted,
`MADDOX EDWARDS, PLLC
`
`
`
`
`Matthew C. Ruedy
`Registration No. 64,823
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`Attorney for Petitioners
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`7
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`
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`The undersigned hereby certifies that the above-captioned “PETITIONER
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`RESPONSE TO PATENT OWNER REQUEST FOR REHEARING PURSUANT
`
`TO 37 C.F.R. § 42.71(d)” was served in its entirety on September 16, 2016, upon
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`the following parties via Express Mail:
`
`John V. Biernacki
`jvbiernacki@jonesday.com
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`
`F. Dominic Cerrito
`nickcerrito@quinnemanuel.com
`Eric C. Stops
`ericstops@quinnemanuel.com
`Evangeline Shih
`evangelineshih@quinnemanuel.com
`Frank Calvosa
`frankcalvosa@quinnemanuel.com
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`Counsel for Patent Owner Jazz Pharmaceuticals, Inc.
`
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`Respectfully Submitted,
`MADDOX EDWARDS, PLLC
`
`
`
`
`
`Matthew C. Ruedy
`Registration No. 64,823
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`Attorney for Petitioners
`
`1
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`Dated: September 16, 2016