UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730
`_____________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNER REQUEST FOR
`REHEARING PURSUANT TO 37 C.F.R. § 42.71(d)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1 Case IPR2015-01818 has been joined with this proceeding.
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730
`_____________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNER REQUEST FOR
`REHEARING PURSUANT TO 37 C.F.R. § 42.71(d)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1 Case IPR2015-01818 has been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`Page
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED . Error!
`Bookmark not defined.
`LEGAL STANDARD .................................. Error! Bookmark not defined.
`
`PATENT OWNER HAS FAILED TO PROVE THAT THE BOARD
`OVERLOOKED OR MISAPPREHENDED ANY EVIDENCE THAT
`SHOULD MODIFY ITS FINAL CLAIM CONSTRUCTIONS .......... Error!
`Bookmark not defined.
`
`A.
`
`“the prescription requests containing information identifying
`patients” Error! Bookmark not defined.
`
`B.
`
`“the prescription requests containing information identifying . . . various
`credentials of the any and all medical doctors” ........... Error! Bookmark not
`defined.
`IV. CONCLUSION ............................................. Error! Bookmark not defined.
`
`i
`
`
`
`I.
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
`
`Pursuant to the Board’s e-mail authorization on September 6, 2016 (see
`
`Exhibit 1062), Petitioners Amneal Pharmaceuticals LLC and Par Pharmaceutical,
`
`Inc. (collectively, “Petitioners”) submit this opposition to Patent Owner’s Request
`
`for Rehearing Pursuant to 37 C.F.R. § 42.71(d) (Paper 69).
`
`Patent Owner’s Request does not provide a proper basis for rehearing, but
`
`instead merely reiterates Patent Owner’s rejected arguments and evidence to import
`
`certain limitations into the claims. The Board’s Final Decision (Paper 68) explicitly
`
`acknowledged and correctly refuted these arguments and evidence based on the
`
`governing intrinsic evidence, in holding claims 1–11 of U.S. Patent No. 7,668,730
`
`(“the ’730 patent”) unpatentable as obvious over the Advisory Committee Art (Exs.
`
`1003–1006) (the “ACA”). Patent Owner’s Request for Rehearing should therefore
`
`be denied.
`
`II.
`
`LEGAL STANDARD
`
`In a request for rehearing, the dissatisfied party “must specifically identify all
`
`matters the party believes the Board misapprehended or overlooked, and the place
`
`where each matter was previously addressed in a motion, an opposition, or a reply.”
`
`37 C.F.R. § 42.71(d). “The burden of showing a decision should be modified lies
`
`with the party challenging the decision.” Id.
`
`1
`
`
`
`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
`
`is not an opportunity
`
`to re-argue old
`
`arguments . . . .” Histologics, LLC v. CDX Diagnostics, Inc. et al., IPR2014-00779,
`
`slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9) (citing Office Patent Trial Practice
`
`Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012)). Yet that is precisely what
`
`Patent Owner’s Request seeks to do here. Patent Owner simply re-argues that
`
`exemplary embodiments of “information identifying the patient” and “various
`
`credentials” should limit the claims—arguments that the Board squarely addressed
`
`and rejected. And while Patent Owner highlights certain specification excerpts
`
`and/or expert testimony, the Board already considered and refuted that evidence in
`
`its Final Decision. The proper course for Patent Owner here “is to appeal, not to file
`
`a request for rehearing to re-argue issues that have already been decided.” SAP Am.,
`
`Inc. v. Versata Dev. Gr., Inc., CBM2012-00001, slip op. at 5 (PTAB Sept. 13, 2013)
`
`(Paper 81).
`
`A.
`
` “the prescription requests containing information identifying
`patients”
`
`Patent Owner first argues that the Board overlooked portions of the
`
`specification “separate and apart from Figure 9” and certain expert testimony on
`
`information “to identify the narcoleptic patient,” which Patent Owner uses to justify
`
`its limiting construction of “the prescription requests containing information
`
`2
`
`
`
`identifying patients.” (Request at 4–6 (citing Ex. 1001 at 4:20–22; Ex. 2046 at
`
`¶¶ 43–44; Ex. 2044 at 97:11–98:5, 99:18–100:10).) This is incorrect.
`
`To the contrary, the Final Decision’s claim construction analysis for this term
`
`begins by explicitly and repeatedly acknowledging Patent Owner’s arguments and
`
`evidence, including the exact specification excerpt and expert testimony of Dr.
`
`DiPiro and Dr. Valuck on which Patent Owner’s Request relies. (Final Decision
`
`at 18 (citing Ex. 2046 at ¶¶ 39–44; Ex. 1001 at 4:8–22; Ex. 2044 at 97:11–98:5,
`
`99:18–100:10); id. (citing Ex. 1001 at 4:20–22; Ex. 2044 at 97:11–23, 99:18–
`
`100:10).) The Board did not “overlook” this evidence and consider only Figure 9 of
`
`the specification, as Patent Owner suggests. (See Request at 3.) It simply disagreed
`
`with Patent Owner on what this evidence means for claim construction.
`
`Confirming that the final claim construction was not based solely on the
`
`rejection of Patent Owner’s arguments as to Figure 9, the Final Decision states that
`
`“nothing in the specification suggests that excluding one or more pieces of
`
`information in the list of a ‘patient’s name, social security number, date of birth, sex,
`
`and complete address information, including city, state, and zipcode,’ as proposed
`
`by Patent Owner, means that a prescription fails to contain ‘information identifying
`
`the patient,’ as recited in the claims.” (Final Decision at 19 (emphasis added).) The
`
`Board made clear that this controlling understanding of the specification refuted
`
`Patent Owner’s arguments and supporting evidence to import any such limitations
`
`3
`
`
`
`into the claim term. (Id. (“Thus, we construe ‘prescription requests [for GHB]
`
`containing information identifying patients’ to refer to information identifying a
`
`patient, which may include [Patent Owner’s specifically listed information], but is
`
`not limited to that information nor requires all of that information.”) (emphasis
`
`added).)
`
`It is for good reason that the Board refused to contradict the intrinsic evidence
`
`using the expert testimony Patent Owner now presents for a second time—such an
`
`approach would violate the basic laws of claim construction. Phillips v. AWH Corp.,
`
`415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (outside sources may not be “used
`
`to contradict claim meaning that is unambiguous in light of the intrinsic evidence”).
`
`Patent Owner’s argument also misinterprets Dr. Valuck’s testimony, which did not
`
`provide that the claimed patient information is limited to or requires every piece of
`
`information noted by Patent Owner, consistent with the Board’s final construction.
`
`(See Reply (Paper 46) at 16; Final Decision at 19.) In any event, while Patent Owner
`
`may disagree with the Board’s Final Decision, “mere disagreement with a decision
`
`is not the proper basis for rehearing.” SAP Am., Inc., CBM2012-00001, Paper 81
`
`at 8.
`
`B.
`
`“the prescription requests containing information identifying . . .
`various credentials of the any and all medical doctors”
`
`Patent Owner also mistakenly argues that the Board overlooked or
`
`misapprehended evidence as to the proper construction of “the prescription requests
`
`4
`
`
`
`containing information identifying . . . various credentials of the any and all medical
`
`doctors,” particularly as to certain expert testimony of Dr. Valuck and Dr. DiPiro
`
`that Patent Owner offered to support its proposed limitations. (Request at 6–8 (citing
`
`Ex. 1001 at 4:20–22; Ex. 2044 at 181:1–23; Ex. 2046 at ¶¶ 47, 49.).) This argument
`
`is no more compelling than the first, and fails to provide a basis for rehearing for the
`
`same reasons.
`
`Again, the Final Decision’s claim construction analysis here undoubtedly
`
`considered Patent Owner’s arguments and evidence including the expert testimony
`
`and specification excerpt it re-argues now. In fact, the Board acknowledged this
`
`evidence relied on by Patent Owner not once, but twice in its discussion. (Final
`
`Decision at 19–20 (citing Ex. 2046 at ¶¶ 45–49; Ex. 1001 at 4:8–14, 4:20–22;
`
`Ex. 2044 at 181:1–23); id. (citing Ex. 1001 at 4:8–14, 4:20–22; Ex. 2044 at 181:1–
`
`23; Ex. 2046 at ¶ 47.) The Board even quoted verbatim the specification excerpt
`
`with which Patent Owner’s Request leads its argument on the “various credentials”
`
`term here. (Final Decision at 20 (quoting Ex. 1001 at 4:18–20); Request at 6.) Patent
`
`Owner’s Request as to this term presents merely another re-argument, not an
`
`identification of any evidence the Board failed to examine.
`
`Patent Owner’s Request likewise fails to accept that the Final Decision
`
`rejected Patent Owner’s arguments for what they were—attempts to limit broad
`
`claim language using exemplary embodiments and extrinsic expert testimony. After
`
`5
`
`
`
`explicitly acknowledging all of Patent Owner’s evidence, the Board unambiguously
`
`explained that “we are not persuaded that the ‘various credentials’ necessarily
`
`include each and every piece of prescriber information described in [certain
`
`embodiments].” (Final Decision at 21.) The Board further confirmed its reliance on
`
`the intrinsic evidence to reject Patent Owner’s submissions in concluding that “[t]he
`
`specification does not suggest that failing to include on the prescription one or more
`
`pieces of information from the list . . . proposed by Patent Owner, means that a
`
`prescription fails to contain information regarding ‘various credentials,’ as recited in
`
`the claims.” (Id.)
`
`Thus, the Board obviously considered but rejected the positions and evidence
`
`Patent Owner reiterates now on the “various credentials” element, based on the clear
`
`implications of the intrinsic evidence. As with the previous term, this was the correct
`
`approach under the controlling law of claim construction, notwithstanding Patent
`
`Owner’s misreading of the extrinsic evidence. Phillips, 415 F.3d at 1324. At a
`
`minimum, Patent Owner’s mere disagreements with the Final Decision’s claim
`
`constructions are not a proper basis for rehearing.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Patent Owner’s Request for Rehearing should be
`
`denied.
`
`6
`
`
`
`Date: September 16, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`Respectfully submitted,
`
`Bradford C. Frese
`Registration No. 69,772
`
`Attorney for Petitioner Par
`Pharmaceutical, Inc.
`
`7
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`The undersigned hereby certifies that the above-captioned “PETITIONERS’
`
`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
`
`John V. Biernacki
`jvbiernacki@jonesday.com
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`the following parties via Electronic Mail:
`
`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.
`
`Date: September 16, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`Respectfully submitted,
`
`Bradford C. Frese
`Registration No. 69,772
`
`Attorney for Petitioner Par
`Pharmaceutical, Inc.
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