Filed: February 10, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`and
`
`DR. REDDY’S LABORATORIES, INC.,
`
`Petitioner1
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY.
`Patent Owners
`____________________________
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`____________________________
`
`PATENT OWNERS’ MOTION TO TERMINATE
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-00894, has been joined
`as a Petitioner to this proceeding
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`and
`
`DR. REDDY’S LABORATORIES, INC.,
`
`Petitioner1
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY.
`Patent Owners
`____________________________
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`____________________________
`
`PATENT OWNERS’ MOTION TO TERMINATE
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-00894, has been joined
`as a Petitioner to this proceeding
`
`
`
`TABLE OF CONTENTS
`
`
`Page
`Background ..................................................................................................... 1
`I.
`The Board Has Authority to Terminate These Proceedings ........................... 4
`II.
`III. Petitioners Cannot Meet their Burden of Showing that the Claims Are
`Unpatentable ................................................................................................... 4
`IV. Proceeding Would be a Waste of the Board’s Resources .............................. 8
`
`
`
`
`
`
`-i-
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`
`Page
`
`Cases
`Blackberry Corp. v. MobileMedia Ideas, LLC,
`IPR2013-00036, Paper 65 (P.T.A.B. Mar. 7, 2014) ......................................... 4, 5
`Comtech Mobile Datacom Corp. v. Vehicle IP, LLC,
`Case IPR2018-00531, Paper 9 (P.T.A.B. July 20, 2018) ................................. 8, 9
`Enzo Biochem, Inc. v. Applera Corp.,
`599 F.3d 1325 (Fed. Cir. 2010) ............................................................................ 5
`Facebook, Inc. v. EveryMD.com LLC,
`Case IPR2017-02027, Paper 24 (P.T.A.B. Oct. 9, 2018) ..................................... 4
`Medtronic, Inc. v. Robert Bosch Healthcare Sys., Inc.,
`839 F.3d 1382 (Fed. Cir. 2016) ............................................................................ 4
`Microsoft Corp. v. IpLearn-Focus, LLC,
`IPR2015-00097, Paper 11 (P.T.A.B. Mar. 26, 2015) ................................... 5, 6, 7
`In re Steele,
`305 F.2d 859 (C.C.P.A. 1962) .............................................................................. 5
`United Carbon Co. v. Binney & Smith Co.,
`317 U.S. 228 (1942) .............................................................................................. 5
`Other Authorities
`37 C.F.R.
`§ 42.71(a) .......................................................................................................... 1, 4
`§ 42.72 ............................................................................................................... 1, 4
`
`
`
`
`
`
`
`-ii-
`
`
`
`
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`Pursuant to the Board’s Order dated January 25, 2019 (IPR2017-01995, Paper
`
`No. 60), Patent Owners, Horizon Pharma USA, Inc. and Nuvo Pharmaceuticals
`
`(Ireland) Designated Activity Company, submit this Motion to Terminate the Inter
`
`Partes Review of U.S. Patent No. 9,220,698 (“the ’698 patent”). Corresponding
`
`motions will be filed concurrently in co-pending Case Nos. IPR2018-00272 and
`
`IPR2018-01341 involving U.S. Patent No. 9,393,208 (“the ’208 patent”).
`
`The Board should dismiss the Petition pursuant to 37 C.F.R. § 42.71(a) and
`
`terminate this inter partes review pursuant to 37 C.F.R. § 42.72 for two reasons.
`
`First, Petitioners cannot meet their burden of demonstrating by a preponderance of
`
`the evidence that the challenged claims are unpatentable because the district court
`
`has found that under Petitioners’ own construction, the claims are indefinite.
`
`Second, because of the late stage of the district court litigation and pending appeal
`
`to the Federal Circuit, proceeding with this inter partes review would not be an
`
`effective use of the Board’s resources.
`
`I.
`
`Background
`The claims of the ’698 patent require administering AM and PM unit dose
`
`forms that provide 500 mg of naproxen and 20 mg of esomeprazole and that
`
`“target” particular pharmacokinetic (PK) and pharmacodynamic (PD) profiles for
`
`naproxen and esomeprazole. Ex. 1001 at 52:25-38 (claim 1).
`
`- 1 -
`
`
`
`The parties began litigating the ’698 patent in February 2016 and the ’208
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`
`
`patent in December 2016 in the District of New Jersey. In November 2017, the
`
`district court issued its Markman Order construing the claims of the ’698 and ’208
`
`patents. Ex. 2073. The court adopted Petitioners’ proposed construction of the
`
`term “target” as used in claim 1 of both patents to mean “set as a goal.” Id. at 11.
`
`Fact discovery closed in December 2017 and expert discovery closed in July 2018.
`
`On August 10, 2018, Petitioners moved for summary judgment that the
`
`claims of the ’698 and ’208 patents are invalid as indefinite. Ex. 2074. Petitioners
`
`argued that under the court’s construction of “target,” the claims of both patents
`
`are indefinite because “[n]othing in the claims, the specification, or the prosecution
`
`history allows those skilled in the art to discern with any reasonable certainty
`
`where the boundaries of the asserted claims lie.” Id. at 2. According to
`
`Petitioners, the claims are merely aspirational and “provide no discernable standard
`
`for how far a particular formulation administered to any given patient or group of
`
`patients can stray from the stated goals and still infringe the claims.” Id. at 10.
`
`Petitioners also argued that the claims are indefinite because they do not specify
`
`“who or what must ‘target’” the PK and PD profiles in the claims. Id. at 16-18.
`
`The district court granted Petitioner’s motion because it found the claims of
`
`the ’698 and ’208 patents to be “incomprehensible.” Ex. 2075 at 10. The district
`
`- 2 -
`
`
`
`
`court explained that because it construed “target” as “set as a goal,” “it is not
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`possible to discern what the target clauses are telling you to do or not do.” Id.
`
`According to the court, “[i]t is not possible to comprehend what these phrases
`
`mean, because pills cannot be said to set goals.” Id. at 8. The court went on to
`
`state that, even if it interpreted the claims as requiring that a physician set the
`
`goals, the claims are neither “comprehensible nor cognizable” because “it simply
`
`cannot be that the question of infringement of a method patent turns on the mental
`
`state of the accused infringer, or of a pill that does not have one.” Id. at 10-11. On
`
`January 22, 2019, the court entered final judgment that “all claims of the ’698 and
`
`’208 patents are invalid for indefiniteness.” Exs. 2076 and 2077.
`
`On August 24, 2017, Petitioner Mylan filed the petition that led to this inter
`
`partes review. Petitioner DRL was later joined in this review. Petitioners
`
`identified only a single term for construction: the term “target” as used in claim 1.
`
`Petitioners contend that “target” should be construed to mean “with the goal of
`
`obtaining.” Paper 2 at 16. According to Petitioners, “the patent drafters wrote the
`
`claims so that the recited PK values need only be ‘targeted,’ not necessarily
`
`achieved.” Id. at 18. Petitioners relied on the same prior art and arguments
`
`presented during the district court litigation.
`
`- 3 -
`
`
`
`In its institution decision, the Board adopted Petitioners’ proposed
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`
`
`construction of “target,” but for grammatical reasons altered it to read, “have or set
`
`the goal of obtaining.” Paper 18, at 11-12.
`
`II. The Board Has Authority to Terminate These Proceedings
`“[T]he Board has inherent authority to reconsider its decisions.” Medtronic,
`
`Inc. v. Robert Bosch Healthcare Sys., Inc., 839 F.3d 1382, 1386 (Fed. Cir. 2016).
`
`A decision to reconsider institution and terminate inter partes review is final and
`
`non-appealable. Id. at 1384-85. The Board has found that applicable regulations
`
`grant the Board “broad authority” to dismiss petitions and terminate trial.
`
`Facebook, Inc. v. EveryMD.com LLC, Case IPR2017-02027, Paper 24 at 4-6
`
`(P.T.A.B. Oct. 9, 2018) (dismissing petition and terminating trial where patent at
`
`issue was found to be invalid under 35 U.S.C. § 101 in other proceedings).
`
`Specifically, applicable regulations grant the Board authority to “dismiss any
`
`petition” and “terminate a trial . . . where appropriate . . . .” 37 C.F.R. §§ 42.71(a),
`
`42.72.
`
`III. Petitioners Cannot Meet their Burden of Showing that the Claims Are
`Unpatentable
`Where the claims at issue have been found to be indefinite, it is
`
`inappropriate for the Board to consider prior art challenges in an inter partes
`
`review. For example, in Blackberry Corp. v. MobileMedia Ideas, LLC, the Board
`
`- 4 -
`
`
`
`
`terminated the proceedings after oral argument because the claims at issue were
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`indefinite. IPR2013-00036, Paper 65 (Order, Termination of Proceeding) at 7-8
`
`(P.T.A.B. Mar. 7, 2014). The Board stated that “[w]ithout ascertaining the proper
`
`claim scope, we cannot conduct a necessary factual inquiry for determining
`
`obviousness—ascertaining differences between the claimed subject matter and the
`
`prior art.” Id. at 20. In addition, the Board has declined to institute review for
`
`similar reasons. See, e.g., Microsoft Corp. v. IpLearn-Focus, LLC, IPR2015-
`
`00097, Paper 11 (Decision) at 13-14 (P.T.A.B. Mar. 26, 2015) (“As claim 1 fails to
`
`indicate the scope of the claimed invention, we do not attempt to apply claim 1 to
`
`the asserted prior art.”).
`
`The Board’s decisions to terminate trial where claims have been found
`
`indefinite is proper because “the claims must be reasonably clearcut to enable
`
`courts to determine whether novelty and invention are genuine.” United Carbon
`
`Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942). Indeed, “a claim cannot be
`
`both indefinite and anticipated.” Enzo Biochem, Inc. v. Applera Corp., 599 F.3d
`
`1325, 1332 (Fed. Cir. 2010); see also In re Steele, 305 F.2d 859, 862-63 (C.C.P.A.
`
`1962) (holding that where a claim’s meaning is indefinite under 35 U.S.C. § 112,
`
`¶ 2, any rejection based on prior art is improperly based on speculation).
`
`- 5 -
`
`
`
`Petitioners cannot meet their burden of demonstrating by a preponderance of
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`
`
`the evidence that the challenged claims are unpatentable because they rely on a
`
`construction, which has been accepted in this proceeding, that both they and the
`
`district court found to be indefinite. See Microsoft Corp., IPR2015-00097, Paper
`
`11 at 13-14 (determining that Petitioner has not shown a reasonable likelihood that
`
`it would prevail where claims were indefinite). As explained above, the district
`
`court accepted Petitioner’s argument and found that “target,” should be construed
`
`as “set as a goal.” Under that construction, the court held that the claims were
`
`indefinite because “target” did not specify how closely one must match the claimed
`
`parameters to target them, it introduced a subjective element into the claims, and it
`
`did not specify who or what must set the goal. Ex. 2075 at 8-11.
`
`Under the court’s construction of “target,” Petitioners cannot meet their
`
`burden of showing that the relevant limitations are disclosed by the prior art.
`
`Although Petitioners employ a construction that they and the district court contend
`
`is indefinite, they make no effort to explain how the prior art addresses the
`
`ambiguities they claim are inherent in their construction.
`
`Instead, the Petition compounds the confusion. For example, after laying
`
`out their proposed construction, Petitioners make no argument that the prior art
`
`discloses a “goal” of any sort in either of the first two grounds. Paper 2 at 34-48.
`
`- 6 -
`
`
`
`
`Instead, Petitioner argues that, although the claimed PK and PD parameters were
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`not disclosed in the cited art, they were “inherent.” Id. at 36-39. But Petitioners
`
`do not explain how the dosage forms of the prior art could “set as a goal of
`
`obtaining” the PK and PD parameters that were simply unknown in the art.
`
`Further, Petitioners contend that “Grounds 1 and 2 of this Petition do not depend
`
`on the Board adopting Petitioner’s proposed construction of ‘target.’” Id. at 36 n.8.
`
`Thus, it is unclear what construction of “target” Petitioners contend should be
`
`compared against the prior art in Grounds 1 and 2 or even if Petitioners considered
`
`the “target” limitation at all. If Petitioners contend that different constructions of
`
`“target” apply to Grounds 1 and 2 than to Ground 3, this also favors termination of
`
`the proceedings. See, e.g., Microsoft Corp., IPR2015-00097, Paper 11 at 7-10, 13-
`
`14 (declining to institute where Petitioner proposed alternative constructions for a
`
`claim term).
`
`For Ground 3, Petitioners argue that “[t]he skilled artisan must therefore
`
`have the goal of obtaining the recited PK and PD elements.” Paper 2 at 48. But
`
`Petitioners’ definition of a skilled artisan includes both a medical doctor, who
`
`would treat patients, and a pharmacologist or pharmacokineticist, who would not.
`
`Id. at 7-8. And Petitioners do not explain which of the individuals within its
`
`definition would be responsible for setting a goal. Nor do Petitioners explain how
`
`- 7 -
`
`
`
`
`their interpretation of the claims as requiring that a skilled artisan set a goal are
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`consistent with the claim’s requirement that “the AM and PM unit dose forms” and
`
`not an artisan “target” the specified PK and PD profiles.
`
`Because Petitioners rely on a construction of “target” that has been found
`
`indefinite, and because Petitioners do not apply a consistent interpretation of the
`
`term in its petition, they cannot meet their burden of demonstrating that the
`
`challenged claims are unpatentable. Accordingly, this inter partes review should
`
`be terminated.
`
`IV. Proceeding Would be a Waste of the Board’s Resources
`Although Patent Owners do not concede that the claims of the ’698 and ’208
`
`patents are indefinite, proceeding with this inter partes review would not be an
`
`efficient use of the Board’s resources. This is because an appeal of the district
`
`court’s judgment of indefiniteness will focus on the construction of the term
`
`“target” and the scope of the PK and PD elements of the claims, which are
`
`precisely the issues that are dispositive in this review.2
`
`The Board was presented with a similar situation in Comtech Mobile
`
`Datacom Corp. v. Vehicle IP, LLC, Case IPR2018-00531, Paper 9 (P.T.A.B. July
`
`
`2 A notice of appeal is due by February 21, 2019. Should Patent Owners decline to
`appeal the district court’s judgment, proceeding with trial would also not be
`efficient because the issues raised in the petition would be moot.
`
`- 8 -
`
`
`
`
`20, 2018). There the Board determined that inter partes review would not be an
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`efficient use of the Board’s resources because the district court had already
`
`construed a potentially dispositive claim term and entered judgment of non-
`
`infringement, which was on appeal. The Board found the situation to “strongly
`
`warrant against institution of inter partes review because the construction of [the
`
`disputed term] is both pending on appeal before the Federal Circuit and potentially
`
`dispositive in this case.” Id. at 12. As in Comtech Mobile, should trial proceed,
`
`the Board “would be deciding a disputed legal issue that is already currently before
`
`our reviewing court for resolution.” Id. In such circumstance the Board has found
`
`that trial “would not be an efficient use of the Board’s resources.” Id. Indeed, the
`
`very act of proceeding with this review conflicts with and in fact undermines the
`
`district court’s determination regarding the definiteness of the claims at issue.
`
`Other factors also weigh in favor of terminating these proceedings. The art
`
`and arguments presented by Petitioners here are the same as those in the district
`
`court litigation. The parties have completed fact and expert discovery and the
`
`cases are ready for trial. Should the appeals court reverse the finding of
`
`indefiniteness, then Petitioners would be able to assert the anticipation and
`
`obviousness challenges at issue here at the district court, but with the Federal
`
`Circuit’s guidance as to the scope of the claims.
`
`- 9 -
`
`
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`Further, this and the co-pending IPRs are at a relatively early stage.
`
`Petitioners have not filed a reply in this proceeding; Patent Owners have not filed a
`
`response in IPR2018-00272, and an institution decision has not been made in the
`
`IPR2018-01341. Oral Argument will not occur until mid-June 2019. Thus,
`
`termination of these proceedings would save considerable resources while not
`
`depriving Petitioners of the ability to make their anticipation and obviousness
`
`arguments at the district court should it be necessary following an appeal.
`
`DATED: February 10, 2019
`
`Respectfully submitted,
`
`By: /Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Ave., N.W. Suite 700
`Washington, DC 20004-2400
`Tel: (202) 842-7800
`Fax: (202) 842-7899
`tblinka@cooley.com
`
`USPTO Reg. No. 44,541
`
`- 10 -
`
`
`
`Case No. IPR2017-01995
`Patent No. 9,220,698
`
`CERTIFICATE OF SERVICE UNDER 37 C.F.R. § 42.6(e)
`
`I, Thomas A. Blinka, hereby certify that on this 8th day of February 2019,
`
`the foregoing PATENT OWNERS’ MOTION TO TERMINATE was served
`
`electronically via email on the following:
`
`Brandon M. White
`Emily J. Greb
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`egreb@perkinscoie.com
`EsoNaproxen@perkinscoie.com
`
`Alan Pollack
`Stuart D. Sender
`Louis Weinstein
`BUDD LARNER PC
`apollack@buddlarner.com
`ssender@buddlarner.com
`lweinstein@buddlarner.com
`
`Date: February 8, 2019
`
`BY:
`
`/Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
`
`- 11 -
`
`
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
