IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ALMIRALL, LLC.,
`Patent Owner.
`
`U.S. Patent No. 9,517,219 to Warner et al.
`Issue Date: December 13, 2016
`Title: Topical dapsone and dapsone/adapalene compositions and methods for use
`thereof
`Inter Partes Review No.: IPR2019-01095
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`141770677v2
`
`
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ALMIRALL, LLC.,
`Patent Owner.
`
`U.S. Patent No. 9,517,219 to Warner et al.
`Issue Date: December 13, 2016
`Title: Topical dapsone and dapsone/adapalene compositions and methods for use
`thereof
`Inter Partes Review No.: IPR2019-01095
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`141770677v2
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`Contents
`
`INTRODUCTION .................................................................................................................. 1
`
`III.
`
`INSTITUTION SHOULD NOT BE DENIED BASED ON §314(A).................................... 2
`
`IV. The General Plastic Factors Do Not Support Denial of Institution Under §314(A). ............. 3
`
`A. General Plastic Factor 1 ..................................................................................................... 4
`B. General Plastic Factors 2-5 ................................................................................................ 5
`C. General Plastic Factors 6-7 ................................................................................................. 7
`V. CONCLUSION ....................................................................................................................... 8
`
`141770677v2
`
`i
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abiomed, Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02134, Paper 7 (P.T.A.B. Apr. 16, 2018) ...................................................................6
`
`Amneal Pharmaceuticals LLC et al v. Almirall, LLC et al.,
`IPR2019-00207, Paper 13 (P.T.A.B. Nov. 6, 2018) ..................................................................1
`
`General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017) ........................................................ passim
`
`Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GMBH,
`IPR2018-01680, Paper 22 (P.T.A.B. Apr. 3, 2019) ...............................................................2, 3
`
`Sawai USA, Inc. v. Biogen MA, Inc.,
`IPR2019-00789, Paper 17 (P.T.A.B. Sept. 12, 2019) ...................................................... passim
`
`Valve Corp. v. Electronic Scripting Prods., Inc.,
`IPR2019-00062, -00063, -00084, Paper 11 (P.T.A.B. Apr. 2, 2019) ........................................5
`
`Statutes
`
`35 U.S.C. § 314(a) .......................................................................................................................1, 2
`
`35 U.S.C. § 316(a)(11) .....................................................................................................................4
`
`Regulations
`
`37 C.F.R. § 42.22 .............................................................................................................................6
`
`37 C.F.R. § 42.122(b) ......................................................................................................................6
`
`141770677v2
`
`ii
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`II.
`
`INTRODUCTION
`Mylan Pharmaceuticals Inc. (“Mylan” or “Petitioner”) filed a “me-too” or
`
`“copycat” petition seeking joinder with Amneal Pharmaceuticals LLC et al v.
`
`Almirall, LLC et al., IPR2019-00207, filed November 6, 2018 and instituted May
`
`10, 2019 (“the Amneal IPR”). See IPR2019-00207, Paper 13. There is no dispute
`
`that Mylan’s Petition is a “me-too” or “copycat” petition. In fact, Almirall, LLC
`
`(“Almirall” or “Patent Owner”) freely admits that Mylan’s Petition is a “me-too”
`
`Petition. Prelim. Resp. at 10 (“Mylan’s petition, copying Amneal’s petition word-
`
`for-word”); id. (“identical petition”); id. at 1 (“The Petitioner challenges the same
`
`claims of the same patent previously challenged by Amneal . . . in IPR2019-00207,
`
`asserting the same prior art references.”). Moreover, Patent Owner filed no
`
`Opposition against Mylan’s Motion for Joinder.
`
`In its Preliminary Patent Owner Response and without citing any credible
`
`authority, Patent Owner argues that 35 U.S.C. § 314(a) and its related PTAB case
`
`law preventing a Patent Owner from being exposed to serial petitions should
`
`somehow apply to a “me-too” joinder petition. The PTAB recently rejected this very
`
`argument explaining that “there is no abuse of process where . . . a different
`
`petitioner files a ‘me-too’ or ‘copycat’” petition in conjunction with a timely motion
`
`to join an inter partes review based upon the (essentially) copied petition filed by
`
`141770677v2
`
`1
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`different petitioner.” Sawai USA, Inc. v. Biogen MA, Inc., IPR2019-00789, Paper 17
`
`at 10 (P.T.A.B. Sept. 12, 2019).
`
`III.
`
`INSTITUTION SHOULD NOT BE DENIED BASED ON §314(A)
`When deciding to exercise its discretion under §314(a) and the General
`
`Plastic factors, the Board typically does so in the case of “follow-on” petitions that
`
`“abuse [the] review process by repeated attacks on patents.” General Plastic
`
`Industrial Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 17
`
`(P.T.A.B. Sept. 6, 2017) (precedential); Mylan Pharmaceuticals Inc. v. Sanofi-
`
`Aventis Deutschland GMBH, IPR2018-01680, Paper 22 at 17 (P.T.A.B. Apr. 3,
`
`2019) (“the General Plastic factors were articulated in the context of follow-on
`
`petitions.”).
`
`The instant petition is not a follow-on petition; it is a “me-too” or “copycat”
`
`petition filed concurrently with a Motion for Joinder with the Amneal IPR. Mylan’s
`
`Petition: (1) is identical in substance to the Amneal IPR; (2) challenges the same
`
`claims of the ’219 patent on the same grounds, (3) relies on substantively the same
`
`expert testimony, and (4) has no impact on the Amneal IPR schedule. See generally,
`
`IPR2019-01095, Paper 1; IPR2019-00789 at 11 (“[The joinder] Petition does not
`
`present any substantive ground or matter not already at issue”). And as stated in its
`
`Motion for Joinder, Mylan has also requested to serve as an understudy to Amneal.
`
`See IPR2019-01095, Paper 2.
`
`141770677v2
`
`2
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Patent Owner does not dispute any of these facts. Prelim. Resp. at 10
`
`(“Mylan’s petition, copying Amneal’s petition word-for-word”); id. (“identical
`
`petition”). As stated in Sawai USA, Inc. —a case that is exactly on point—under
`
`these circumstances, filing a “me-too” petition “effectively obviates any concerns of
`
`serial harassment and unnecessary expenditure of resources that the General Plastic
`
`factors and the Trial Practice Guide July 2019 Update are meant to address.” Sawai,
`
`IPR2019-00789 at 11.
`
`IV. The General Plastic Factors Do Not Support Denial of Institution Under
`§314(A).
`As mentioned above, General Plastic Industrial Co., Ltd. v. Canon Kabushiki
`
`Kaisha, cited by Patent Owner, addresses follow-on, serial petition situations where
`
`the PTAB has determined that the repeated nature of the filings constitutes an abuse
`
`of the Patent Owner. IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017); Mylan
`
`Pharmaceuticals Inc., IPR2018-01680 at 17. The instant petition is not a follow-on
`
`petition, but a joinder petition.
`
`In General Plastic, the Board set out seven nonexclusive factors to be weighed
`
`in deciding whether to exercise its denial discretion. These factors are:
`
`1. whether the same petitioner previously filed a petition directed to the
`same claims of the same patent;
`2. whether at the time of filing of the first petition the petitioner knew of
`the prior art asserted in the second petition or should have known of it;
`
`141770677v2
`
`3
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`4.
`
`3. whether at the time of filing of the second petition the petitioner already
`received the patent owner’s preliminary response to the first petition or
`received the Board’s decision on whether to institute review in the first
`petition;
`the length of time that elapsed between the time the petitioner learned
`of the prior art asserted in the second petition and the filing of the
`second petition;
`5. whether the petitioner provides adequate explanation for the time
`elapsed between the filings of multiple petitions directed to the same
`claims of the same patent;
`the finite resources of the Board; and
`the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the Director
`notices institution of review.
`General Plastic, IPR2016-01357, Paper 19 at 15-16.
`
`6.
`7.
`
`The Patent Owner’s own arguments provide support for why the General
`
`Plastic factors are not satisfied here. It is undisputed that the Petition is directed to
`
`the same claims of the same patent as the Amneal IPR and does not raise any
`
`substantively different grounds or matters. See generally IPR2019-01095, Paper 2.
`
`Mylan is willing to participate as a “silent understudy” in the Amneal IPR and as
`
`such, institution and joinder should have no impact on the schedule.
`
`General Plastic Factor 1
`A.
`Patent Owner focuses its General Plastic Factor 1 analysis on a supposed
`
`“relationship between Petitioner Mylan and Amneal.” Prelim. Resp. at 5. Patent
`
`141770677v2
`
`4
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Owner incorrectly applies Valve Corp. v. Electronic Scripting Prods., Inc., in
`
`support of its assertion that Mylan is similarly situated to Amneal. IPR2019-00062,
`
`-00063, -00084, Paper 11 at 9 (P.T.A.B. Apr. 2, 2019). In Valve Corp., among other
`
`things, Valve Corp. and HTC were co-defendants in district court litigation.
`
`IPR2019-00062, Paper 11 at 9-10 (“Valve represented that ‘HTC’s VIVE devices
`
`incorporate certain Valve technologies . . . .’ and ‘Valve employees did provide HTC
`
`with technical assistance during development of the accused VIVE devices.’”).
`
`Mylan and Amneal do not have any relationship with each other—they are
`
`independent companies, each filing a separate ANDA with the FDA for separate
`
`products. Prelim. Resp. at 6 (“Here, although Mylan and Amneal are not co-
`
`defendants in a district court case regarding the ʼ219 patent . . . ”). They provide no
`
`assistance to each other. Cf. Valve Corp., IPR2019-00062, Paper 11 at 9-10 (“Valve
`
`represented that ‘HTC’s VIVE devices incorporate certain Valve technologies . . . .’
`
`and ‘Valve employees did provide HTC with technical assistance during
`
`development of the accused VIVE devices.’”). Mylan and Amneal are, in fact,
`
`industry competitors. Patent Owner cannot allege otherwise. Moreover, Mylan and
`
`Amneal are not co-defendants in district court litigation involving the ’219 patent.
`
`Accordingly, General Plastic Factor 1 does not weigh in favor of denying institution.
`
`B.
`
`General Plastic Factors 2-5
`
`141770677v2
`
`5
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`General Plastic Factors 2-5 focus on the similarity between the Amneal IPR
`
`and the “me-too” Mylan IPR, and the timing of Mylan’s IPR filing. Prelim. Resp.
`
`at 7-9. As the PTAB explained in the context of joinder, the concerns raised by
`
`General Plastic Factors 2-5 are abated:
`
`By its very nature, such a “me-too” or “copycat” petition
`necessarily relies on substantially the same prior art and
`arguments previously considered by the Office, and is
`timely, even though such a petition is filed after our
`institution decision in the earlier proceeding. See 37 C.F.R.
`§ 42.122(b) (“Any request for joinder must be filed, as a
`motion under § 42.22, no later than one month after the
`institution date of any inter partes review for which joinder
`is requested.”). Patent Owner’s arguments directed to the
`other earlier filed petitions lose force when we consider that
`we have already instituted trial in the Mylan IPR, Patent
`Owner has filed its Response in the Mylan IPR addressing
`the same patentability challenges, and the case is actively
`proceeding to a Final Written Decision.
`Sawai, Paper 17 at 10.
`
`For its part, Patent Owner cites to Abiomed, Inc. v. Maquet Cardiovascular,
`
`LLC where the Board denied institution based on the abuse created by serially filed
`
`petitions. IPR2017-02134, Paper 7 at 8 (P.T.A.B. Apr. 16, 2018) (“[T]his Petition is
`
`the last of twenty petitions to be addressed by the Board, filed by Petitioner against
`
`six related patents held by Patent Owner . . . . [and] [w]e declined to institute inter
`
`141770677v2
`
`6
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`partes review in each of the previous nineteen cases.”) (emphasis added). The
`
`instant petition is a “me-too” or “copycat” joinder petition and any arguments “in
`
`favor of discretionary denial do not persuade us that there is abuse of process where,
`
`as here, a different petitioner files a ‘me-too’ or ‘copycat’ petition in conjunction
`
`with a timely motion to join an inter partes review based upon the (essentially)
`
`copied petition filed by different petitioner.” Sawai USA Inc., IPR2019-00789, Paper
`
`17 at 10. Under these circumstances, institution of the instant IPR will “not result
`
`in undue prejudice to Patent Owner.” Id. at 12. Accordingly, General Plastic Factors
`
`2-5 do not weigh in favor of denying institution.
`
`General Plastic Factors 6-7
`C.
`General Plastic Factors 6-7 focus on the finite resources of the Board and the
`
`related timing requirement for the Board to issue its Final Written Decision. Given
`
`Mylan will adhere to all applicable deadlines set in the Scheduling Order for the
`
`Amneal IPR and has asked to participate as a silent understudy, there is “little, if
`
`any, waste of Board resources in allowing Petitioner to join an ongoing inter partes
`
`review proceeding.” Sawai USA, Inc., IPR2019-00789, Paper 17 at 11. Accordingly,
`
`General Plastic Factors 6-7 do not weigh in favor of denying institution.
`
`141770677v2
`
`7
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`V.
`
`CONCLUSION
`Petitioner respectfully requests that the Board institute the Petition.
`
`RESPECTFULLY SUBMITTED,
`
`Katten Muchin Rosenman LLP
`
`Date: October 14, 2019
`
`/ Jitendra Malik /
`
`Jitendra Malik (Reg. No. 55823)
`
`Lead Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`141770677v2
`
`8
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
`
`certifies that on October 14, 2019, a complete copy of the foregoing Petitioner’s
`
`Reply to Patent Owner’s Preliminary Response was served via email to the Patent
`
`Owner’s counsel at:
`
`jtrainor@fenwick.com
`
`ehagan@fenwick.com
`
`jbush@fenwick.com
`
`Respectfully submitted,
`Katten Muchin Rosenman LLP
`By: /Jitendra Malik/
`
`141770677v2
`
`
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
