UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR
`PHARMACEUTICAL, INC.,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-01903
`Patent 8,731,963
`_____________________
`
`PETITIONERS’ REPLY TO PATENT OWNER’S RESPONSE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR
`PHARMACEUTICAL, INC.,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-01903
`Patent 8,731,963
`_____________________
`
`PETITIONERS’ REPLY TO PATENT OWNER’S RESPONSE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ............................................................................................1
`I.
`BACKGROUND ..............................................................................................3
`II.
`III. ARGUMENT ....................................................................................................4
`A.
`Jazz concedes that the ACA (Exs. 1003-1006) was publicly
`accessible prior to the critical date ......................................................... 4
`Claim Construction................................................................................. 4
`1.
`The Board has already determined that Jazz’s proposed
`narrowing of “periodic reports” has no basis ...............................5
`The ACA in view of Korfhage renders the challenged claims
`obvious ................................................................................................... 8
`1.
`The Board has already found motivation to combine the
`ACA and Korfhage ......................................................................8
`Claim 27 is likewise obvious because the ACA teaches
`generating periodic reports
`to
`identify current or
`anticipated patterns of abuse ..................................................... 10
`IV. CONCLUSION .............................................................................................. 11
`
`B.
`
`C.
`
`2.
`
`-i-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................................1, 3, 4
`
`Statutes
`
`35 U.S.C. § 102(b) ...........................................................................................................................4
`
`-ii-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`TABLE OF ABBREVIATIONS
`
`ACA = “Advisory Committee Art”— i.e., Exs. 1003–1006.
`
`FDA = “U.S. Food and Drug Administration”
`
`IPR = “inter partes review proceeding”
`
`POSA = “person of ordinary skill in the art at the time of the alleged invention”
`
`-iii-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`I.
`
`INTRODUCTION
`
`U.S. Patent No. 8,731,963 (“the ’963 patent”) is directed to restricted drug
`
`distribution systems, which relate to Patent Owner’s Xyrem (sodium oxybate) drug
`
`product. The Board has already reviewed six other such restricted drug
`
`distribution patents held by Patent Owner in related IPRs 2015-00545, -546, -547,
`
`-548, -551, and -554 (the “related IPRs”), and the Board held that the claims at
`
`issue in those IPRs were obvious.1 Patent Owner advances the same arguments
`
`here in its effort to preserve claims 24, 26 and 27 (the “challenged claims”) of the
`
`’963 patent. For the same reasons as in the related IPRs, the challenged claims are
`
`obvious.
`
`1 Par Pharmaceutical, Inc., et al. v. Jazz Pharmaceuticals, Inc., IPR2015-00548,
`
`Paper 69, at 59 (P.T.A.B July 27, 2016); Par Pharmaceutical, Inc., et al. v. Jazz
`
`Pharmaceuticals, Inc., IPR2015-00546, Paper 70, at 52 (P.T.A.B July 27, 2016);
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc., IPR2015-
`
`00545, Paper 69, at 47–48 (P.T.A.B July 27, 2016); Par Pharmaceutical, Inc., et
`
`al. v. Jazz Pharmaceuticals, Inc., IPR2015-00551, Paper 70, at 61 (P.T.A.B July
`
`27, 2016); Par Pharmaceutical, Inc., et al. v. Jazz Pharmaceuticals, Inc., IPR2015-
`
`00554, Paper 68, at 61 (P.T.A.B July 27, 2016); Par Pharmaceutical, Inc., el al. v.
`
`Jazz Pharmaceuticals, Inc., IPR2015-00547, Paper 70, at 53 (P.T.A.B July 27,
`
`2016).
`
`-1-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`The Board has already held that the ACA was publically accessible prior to
`
`the critical date.2 Additionally, the Board has already rejected Patent Owner’s
`
`proposed narrowing of the claims through claim construction.3 Finally, the Board
`
`has already held that the ACA in view of Korfhage (Ex. 1037) renders obvious
`
`claims 2 and 10 of U.S. Patent No. 8,457,988 (“the ‘988 patent”), directed to
`
`materially same subject matter as the challenged claims.4 Since there are neither
`
`material differences between claims 2 and 10 of the ‘988 patent and the challenged
`
`2 See, e.g., Par Pharmaceutical, Inc., et al. v. Jazz Pharmaceuticals, Inc., IPR2015-
`
`00551, Paper 70, at 28, 35(P.T.A.B July 27, 2016). For ease of reference,
`
`Petitioner will refer primarily to IPR2015-00551 in light of the similarity between
`
`the claims at issue in that IPR and the challenged claims of the ’963 patent.
`
`Despite Petitioners’ citations to IPR2015-00551, many of the issues discussed
`
`herein are present in one or more of the related IPRs.
`
`3 Final Written Decision, IPR2015-00551, Paper 70, at 14-18.
`
`4 Id. at 56-59.
`
`-2-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`claims, nor Patent Owner’s already-rejected arguments in support of them, the
`
`Board should cancel each of the challenged claims.5
`
`II.
`
`BACKGROUND
`
`In Final Written Decisions dated July 27, 2016, the Board held that claims 1-
`
`16 of U.S. Patent No. 7,895,059, claims 1, 3-9, and 11-15 of the ’988 Patent,
`
`claims 1-11 of U.S. Patent No. 7,668,730, claims 1-26 of U.S. Patent No.
`
`8,589,182, claims 1-8 of U.S. Patent No. 7,765,106, and claims 1-6 of U.S. Patent
`
`No. 7,765,107 were invalid as obvious over the ACA.6 In addition, the Board held
`
`5 On July 28, 2016, Petitioners asked Patent Owner to voluntarily cancel the
`
`challenged claims to conserve the parties’ and judicial resources. Patent Owner
`
`refused to do so.
`
`6 Par Pharmaceutical, Inc., et al. v. Jazz Pharmaceuticals, Inc., IPR2015-00548,
`
`Paper 69, at 59 (P.T.A.B July 27, 2016); Par Pharmaceutical, Inc., et al. v. Jazz
`
`Pharmaceuticals, Inc., IPR2015-00546, Paper 70, at 52 (P.T.A.B July 27, 2016);
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc., IPR2015-
`
`00545, Paper 69, at 47–48 (P.T.A.B July 27, 2016); Par Pharmaceutical, Inc., et
`
`al. v. Jazz Pharmaceuticals, Inc., IPR2015-00551, Paper 70, at 61 (P.T.A.B July
`
`27, 2016); Par Pharmaceutical, Inc., et al. v. Jazz Pharmaceuticals, Inc., IPR2015-
`
`00554, Paper 68, at 61 (P.T.A.B July 27, 2016); Par Pharmaceutical, Inc., el al. v.
`
`-3-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`that claims 2 and 10 of the ‘988 patent were invalid as obvious over the ACA in
`
`view of Korfhage.7 There are no material differences between the issues in the
`
`related IPRs and the issues in the present IPR.
`
`III. ARGUMENT
`
`A.
`
`Jazz concedes that the ACA (Exs. 1003-1006) was publicly
`accessible prior to the critical date
`
`In the related IPRs, the Board held that the ACA was publicly available and
`
`qualifies as prior art under 35 U.S.C. § 102(b).8 Patent Owner has presented no
`
`new arguments in the Patent Owner Response, and indeed requested that this
`
`Board apply the decision that it reached in the related IPRs here. Thus, there is no
`
`longer a dispute as to public availability of the ACA.
`
`B.
`
`Claim Construction
`
`Claim terms in an IPR are given their broadest reasonable interpretation in
`
`light of the patent specification.9 Patent Owner and its experts ignore this standard
`
`Jazz Pharmaceuticals, Inc., IPR2015-00547, Paper 70, at 53 (P.T.A.B July 27,
`
`2016).
`
`7 Final Written Decision, IPR2015-00551, Paper 70, at 56-59.
`
`8 Id. at 38.
`
`9 37 C.F.R. § 42.100(b) (2012); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`
`2142 (2016).
`
`-4-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`by proposing an overly restrictive construction of the “periodic reports” term. The
`
`Board has already held that this is improper.
`
`1.
`
`The Board has already determined that Jazz’s proposed
`narrowing of “periodic reports” has no basis
`
`Patent Owner seeks to unreasonably narrow claim 27. In particular, Patent
`
`Owner asserts that the term “periodic reports” should be construed to mean reports
`
`generated “at regular frequencies or intervals, as opposed to intermittently or upon
`
`request.”10 Patent Owner seeks the same improper construction of the “periodic
`
`reports” term here as it sought in the related IPRs.11 Indeed, Patent Owner’s claim
`
`construction argument on pages 4-6 of its Patent Owner Response is a practically
`
`verbatim copy of its arguments in the related IPRs.12 The Board has already
`
`rejected this construction.13
`
`As it argued in the related IPRs, Patent Owner continues to assert here that
`
`the risk diversion reports disclosed in Figure 4B of the ‘963 patent are an
`
`10 Patent Owner Response, Paper 14, at 4.
`
`11 Compare Patent Owner Response, Paper 14, at 4-6, with Patent Owner
`
`Response, IPR2015-00551, Paper 40, at 24-27.
`
`12 Id.
`
`13 Final Written Decision, IPR2015-00551, Paper 70, at 14-18.
`
`-5-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`“unclaimed embodiment.”14 As Petitioners noted in the related IPRs, Patent
`
`Owner’s argument directly contradicts the prosecution history.15 In an Appeal
`
`Brief in the prosecution history of related great-grandparent U.S. Patent No.
`
`7,668,730 (“the ’730 patent”), the applicants cited Figure 4B and corresponding
`
`disclosure in the specification as support for the “periodic reports” claim term.16
`
`The Board cited to this disclosure in its Final Written Decision in IPR2015-00551,
`
`in support of its holding.17
`
`Here, Patent Owner does not present any argument that the ’963 patent
`
`specification or prosecution history somehow changes this result. Nor could it,
`
`since the specification of the ’963 patent is the same as the specification of the
`
`’730 patent.18 Indeed, in the ’963 patent prosecution history, the applicants again
`
`cited, inter alia, the specification disclosure describing Figure 4B as support for
`
`several claims (including what became claim 27), and made no citation to Figures
`
`14 Patent Owner Response, Paper 14, at 8 n.3.
`
`15 Petitioners’ Reply to Patent Owner Response, IPR2015-00551, Paper 47, at 14.
`
`16 Ex. 1041 at 6 (citing Ex. 1042 at page 9, lines 12-19 and Figure 4, 436).
`
`17 Final Written Decision, IPR2015-00551, Paper 70, at 17.
`
`18 Compare Ex. 1001, with Ex. 1001, IPR2015-00551.
`
`-6-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`13A-C or its corresponding disclosure in the specification.19 Thus, the ’963 patent
`
`prosecution history further supports Petitioners’ argument.
`
`Ignoring this conflicting intrinsic evidence, Patent Owner instead relies
`
`exclusively on extrinsic evidence in the form of Dr. Bergeron’s testimony. Patent
`
`Owner dismisses the ’730 patent prosecution history evidence because the ’730
`
`patent applicants did not cite element 434 of Figure 4B, which Patent Owner
`
`asserts is “the only portion of Figure 4B that discloses any type of report.”20 But
`
`even disregarding the applicants’ further citations to Figure 4B in the ’963 patent
`
`prosecution history, Dr. Bergeron admitted that the only citations in the ’730 patent
`
`prosecution history about generating reports are in conjunction with evaluating
`
`potential abuse due to early refill requests, i.e., the subject of Figure 4B.21 Patent
`
`19 Ex. 1043 at 2313 (citing, inter alia, page 10, lines 10-18 of the specification).
`
`20 Patent Owner Response, Paper 14, at 7. Counsel for Patent Owner
`
`unsuccessfully presented the same argument at Oral Hearing in the related IPRs.
`
`Oral Hearing Transcript, IPR2015-00551, Paper 69, at 58; see also id. at 98.
`
`21 Ex. 2012 at 353:6-355:10. There is no support for Patent Owner’s statement that
`
`the claim limitation in the ’730 patent prosecution history has an “evaluation step.”
`
`See Patent Owner Response, Paper 14, at 7. Rather, the claim element is
`
`“generating periodic reports via the exclusive computer database to evaluate
`
`-7-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`Owner’s myopic interpretation of the ’730 patent prosecution history should be
`
`rejected.
`
`C.
`
`The ACA in view of Korfhage renders the challenged claims
`obvious
`
`In the related IPRs, the Board has already rejected the same arguments that
`
`Patent Owner makes here in its Patent Owner Response. Because there are no new
`
`issues raised here, the Board should cancel each of the challenged claims.
`
`1.
`
`The Board has already found motivation to combine the
`ACA and Korfhage
`
`In its Final Written Decision in IPR2015-00551, the Board held that the
`
`ACA in view of Korfhage renders obvious claims 2 and 10 of the ’988 patent.22
`
`Those claims are directed to materially same subject matter as the challenged
`
`claims. For example, claim 2 of the ’988 patent recites:
`
`The method of claim 1, wherein one or more of the exclusive
`central pharmacy and the exclusive central database are
`distributed over multiple computers, and wherein a query
`operates over all data in all the distributed databases relating to
`
`potential diversion patterns.” Ex. 2011 at 8; Ex. 1002 at 14-26, 31-55, 2305-2319.
`
`The use of the adverb “to” indicates that any evaluation of potential diversion
`
`patterns is based on the periodic reports generated—else there would be nothing
`
`upon which to conduct an evaluation.
`
`22 Final Written Decision, IPR2015-00551, Paper 70, at 59.
`
`-8-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`the prescriptions, the doctors, and the narcoleptic patients.23
`
`Similarly, claim 26 of the ’963 patent recites:
`
`The system of claim 24, where the central computer database is
`distributed among multiple computers, and where the one or
`more database queries operate over all data relating to said
`prescription fields, prescriber fields, and patient fields for the
`prescription drug.24
`
`In addition to there being no material differences between claims 2 and 10 of
`
`the ’988 patent and the challenged claims, there are no material differences
`
`between Patent Owner’s arguments in their defense. Indeed, Patent Owner’s
`
`argument on pages 9-14 of its Patent Owner Response is a practically verbatim
`
`copy of its rejected arguments in IPR2015-00551.25 The Board addressed each of
`
`these arguments in its Final Written Decision.26 Specifically, the Board found that a
`
`POSA would have been motivated to modify the ACA “to include multiple
`
`computers in a distributed database system for reasons of cost, efficiency, and the
`
`anticipated volume of prescription-related information to be received, entered, and
`
`23 IPR2015-00551, Ex. 1001 at claim 2.
`
`24 Ex. 1001 at claim 26.
`
`25 Compare Patent Owner Response, Paper 14, at 9-14, with Patent Owner
`
`Response, IPR2015-00551, Paper 40, at 56-60.
`
`26 Final Written Decision, IPR2015-00551, Paper 70, at 57-58.
`
`-9-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`queried.”27 The Board also held that there was no requirement that Korfhage
`
`specifically relate to drug distribution, pharmacy practice, or drug abuse, misuse or
`
`diversion.28 Finally, the Board noted that there was no teaching away from the use
`
`of distributed database systems.29
`
`Since there are neither material differences between claims 2 and 10 of the
`
`’988 patent and the challenged claims, nor Patent Owner’s already-rejected
`
`arguments in support of them, the Board should cancel each of the challenged
`
`claims.
`
`2.
`
`Claim 27 is likewise obvious because the ACA teaches
`generating periodic reports to identify current or
`anticipated patterns of abuse
`
`As in the related IPRs, Patent Owner’s argument that the ACA does not
`
`disclose generating “periodic reports” to identify current or anticipated patterns of
`
`abuse necessarily relies on the Board adopting Patent Owner’s narrow
`
`construction, which the Board has already rejected.30 Again, Patent Owner’s
`
`27 Id. at 58.
`
`28 Id. at 59.
`
`29 Id.
`
`30 Final Written Decision, IPR2015-00551, Paper 70, at 14-18.
`
`-10-
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Petitioners’ Reply to Patent Owner’s Response
`
`argument here mirrors the rejected arguments it made in the related IPRs.31 The
`
`Board addressed each of these arguments in its Final Written Decision.32
`
`Specifically, the Board found that the ACA at least suggests generating periodic
`
`reports to evaluate potential diversion patterns, and therefore this limitation is
`
`rendered obvious by the ACA.33 The same logic applies here, as the “periodic
`
`reports” limitation in claim 27 is not materially different than the “periodic
`
`reports” limitation in the related IPRs.
`
`Therefore, Patent Owner has not rebutted Petitioners’ showing that the
`
`claimed “periodic reports” would have been obvious based on the ACA.
`
`IV. CONCLUSION
`
`For the reasons above, Par and Amneal request that the Board cancel all
`
`challenged claims of the ’963 patent.
`
`31 Compare Patent Owner Response, Paper 14, at 15-20, with Patent Owner
`
`Response, IPR2015-00551, Paper 40, at 40-46.
`
`32 Final Written Decision, IPR2015-00551, Paper 70, at 46.
`
`33 Id. at 47-48.
`
`-11-
`
`
`
`IPR20I 5-01 903—~Patent N0. 8, 731,963
`
`Petitioners’ Reply to Patent Owner ’s Response
`
`Date: August 5, 2016
`
`Respectfully Submitted,
`
`ARENT FOX LLP
`
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`a ' e Carlan
`Registration No. 42,387
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`_12_
`
`
`
`IPR2015-01903—Patent No. 8, 731,963
`Word Count Certification
`
`WORD COUNT CERTIFICATION 137 C.F.R. § 42.24gdn
`
`I, Janine Carlan, hereby certify that his paper complies with the type-
`
`Volume limitation of 37 C.F.R. § 42.24. The paper contains 2,171 words,
`
`excluding the parts of the paper exempted by § 42.24(a).
`
`This paper also complies with the typeface requirements of 37 C.F.R. §
`
`42.6(a)(ii) and the type style requirements of § 42.6(a)(iii)&(iV).
`
`Date: August 5, 2016
`
`ARENT FOX LLP
`
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`Respectfully Su
`
`' ted,
`
`
`
`Janine Carlan
`Registration No. 42,387
`Attorneyfor Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`IPR2015-01903—Patent No. 8,731,963
`Certification of Service
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Reply to Patent Owner’s Response” was served in its entirety on August 5, 2016,
`
`upon the following parties via Electronic Mail:
`
`F. Dominic Cerrito
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`NickCerrito@quinnemanuel.com
`
`John V. Biernacki
`Jones Day
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`JVBiernacki@JonesDay.Com
`
`Date: August 5, 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.
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
