UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`AFFORDABLE DRUGS V LLC,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`____________________________________________
`
`Case: IPR2015-01993
`U.S. Patent No. 8,399,514
`____________________________________________
`
`BIOGEN’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`AFFORDABLE DRUGS V LLC,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`____________________________________________
`
`Case: IPR2015-01993
`U.S. Patent No. 8,399,514
`____________________________________________
`
`BIOGEN’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`Case No. IPR2015-01993
`Patent 8,399,514
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`The Board Should Deny This Petition Under 35 U.S.C. § 325(d) .................. 3
`
`A.
`
`This Second Petition Raises the Same or Substantially the Same
`Prior Art and Arguments as the First Petition ....................................... 5
`
`B. No Circumstances Justify a Repetitive Challenge to the ’514
`Patent ................................................................................................... 15
`
`III. The Petition Does Not Establish a Likelihood That Any Claim Is
`Unpatentable .................................................................................................. 19
`
`A.
`
`The Petition Does Not Establish That One of Ordinary Skill
`Would Have Selected a Dose of About 480 mg/day of DMF or
`Have Reasonably Expected From the Asserted Prior Art That
`Such Dose Would Be Therapeutically Effective or Useful ................ 20
`
`1.
`
`2.
`
`3.
`
`ICH Guideline E4 Would Have Provided No Reason to
`Select a Dose of About 480 mg/day ......................................... 21
`
`Gastrointestinal Side Effects Would Have Provided No
`Reason to Select a Dose of About 480 mg/day ........................ 22
`
`The Petition Fails to Establish Any Reasonable
`Expectation That a Dose of About 480 mg/day of DMF
`Would Be Therapeutically Effective or Useful ........................ 25
`
`4.
`
`The Cited Cases Are Distinguishable ....................................... 28
`
`B.
`
`The Petition Fails to Rebut the Record Evidence of Unexpected
`Results ................................................................................................. 30
`
`IV. Conclusion ..................................................................................................... 38
`
`
`
`
`
`i
`
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`Case No. IPR2015-01993
`Patent 8,399,514
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`Amgen Inc. v. F. Hoffmann-La Roche Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009) .......................................................................... 25
`
`BioGatekeeper, Inc. v. Kyoto Univ.,
`IPR2014-01286, Paper 12 (PTAB Feb. 11, 2015) .............................................. 27
`
`BioMarin Pharm. Inc. v. Genzyme Therapeutic Prods. Ltd.,
`IPR2013-00537, Paper 79 (PTAB Feb. 23, 2015) .............................................. 28
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) .................................................................... 25, 27
`
`Butamax Advanced Biofuels, LLC v. Gevo, Inc.,
`IPR2014-00581, Paper 8 (PTAB Oct. 14, 2014) .................................................. 4
`
`Coal. for Affordable Drugs V LLC v. Biogen MA Inc.,
`IPR2015-01136, Paper 23 (PTAB Sept. 2, 2015) ................................................. 5
`
`Conopco, Inc. v. Procter & Gamble Co., IPR2014-00506, Paper 25
`(PTAB Dec. 10, 2014) .......................................................................................... 3
`
`Conopco, Inc. v. Procter & Gamble Co.,
`IPR2014-00628, Paper 21 (PTAB Oct. 20, 2014) .......................................... 5, 15
`
`Creative Compounds, LLC v. Starmark Labs.,
`651 F.3d 1303 (Fed. Cir. 2011) .................................................................... 18, 37
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) .......................................................................... 27
`
`HTC Corp. v. NFC Tech., LLC,
`IPR2015-00384, Paper 11 (PTAB July 6, 2015) .................................................. 4
`
`ii
`
`
`
`Hybritech Inc. v. Monoclonal Antibodies, Inc.,
`802 F.2d 1367 (Fed. Cir. 1986) .......................................................................... 36
`
`Case No. IPR2015-01993
`Patent 8,399,514
`
`
`Johnston v. IVAC Corp.,
`885 F.2d 1574 (Fed. Cir. 1989) .................................................................... 18, 37
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00529, Paper 8 (PTAB Sept. 23, 2014) ............................................... 26
`
`Knoll Pharm. Co. v. Teva Pharm. USA, Inc.,
`367 F.3d 1381 (Fed. Cir. 2004) .......................................................................... 35
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 25
`
`Medtronic, Inc. v. Nuvasive, Inc.,
`IPR2014-00487, Paper 8 (PTAB Sept. 11, 2014) ............................................... 18
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .......................................................................... 25
`
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012) .......................................................................... 29
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 25
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 30
`
`Samsung Elecs. Co. v. Rembrandt Wireless Techs., LP,
`IPR2015-00114, Paper 14 (PTAB Jan. 28, 2015) ................................................ 4
`
`In re Soni,
`54 F.3d 746 (Fed. Cir. 1995) .................................................................. 18, 36, 38
`
`TRW Auto. US LLC v. Magna Elecs., Inc.,
`IPR2014-00258, Paper 18 (PTAB Aug. 27, 2014) ............................................. 27
`
`Unilever, Inc. v. Procter & Gamble Co.,
`IPR2014-00506, Paper 17 (PTAB July 7, 2014) ........................13, 14, 15, 16, 19
`
`iii
`
`
`
`ZTE Corp. v. ContentGuard Holdings Inc.,
`IPR2013-00454, Paper 12 (PTAB Sept. 25, 2013) ............................................. 15
`
`Case No. IPR2015-01993
`Patent 8,399,514
`
`
`Federal Statutes
`
`35 U.S.C. § 102 .................................................................................................... 3, 16
`
`35 U.S.C. § 103 ................................................................................................ 1, 5, 20
`
`35 U.S.C. § 314(a) ..................................................................................................... 4
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`Regulations
`
`37 C.F.R. § 1.132 ..................................................................................................... 31
`
`37 C.F.R. § 42.1(b) .................................................................................................... 4
`
`37 C.F.R. § 42.104 ..................................................................................................... 8
`
`37 C.F.R. § 42.107 ..................................................................................................... 1
`
`Other Authorities
`
`H.R. REP. NO. 112-98, pt. 1, at 48 (2011) ............................................................ 4, 15
`
`MPEP § 2107.03 ...................................................................................................... 30
`
`
`
`
`
`iv
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`Case No. IPR2015-01993
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`
`
`TABLE OF ABBREVIATIONS
`
`Definition
`
`dimethyl fumarate
`
`monomethyl fumarate
`
`multiple sclerosis
`
`
`
`
`
`v
`
`Abbreviation
`
`DMF
`
`MMF
`
`MS
`
`
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`Case No. IPR2015-01993
`Patent 8,399,514
`
`I.
`
`Introduction
`
`Patent Owner Biogen MA Inc. respectfully submits this preliminary
`
`response under 37 C.F.R. § 42.107 to Petitioner’s second petition for inter partes
`
`review of U.S. Patent No. 8,399,514. The Board denied institution of the first
`
`petition on September 2, 2015, concluding that Petitioner had failed to establish a
`
`likelihood of success as to any challenged claim. The Board also denied
`
`Petitioner’s request for rehearing on October 23, 2015.
`
`Less than a month after the Board declined to institute an IPR against
`
`Biogen’s ’514 patent, Petitioner repackaged its arguments and filed the present
`
`petition against the same patent. Institution of an IPR, however, is discretionary;
`
`and, in exercising its discretion, the Board may reject a new petition that presents
`
`the same or substantially the same prior art or arguments as an earlier petition. 35
`
`U.S.C. § 325(d). This provision applies here because the second petition:
`
` was filed by the same Petitioner (Coalition for Affordable Drugs V LLC);
`
` challenges the same claims (claims 1-20 of the ’514 patent);
`
` relies on the same statutory basis (35 U.S.C. § 103);
`
` asserts the same alleged effective filing date for the ’514 patent (February 7,
`
`2008);
`
` relies on the same overview of the ’514 patent;
`
`1
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`
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`Case No. IPR2015-01993
`Patent 8,399,514
` relies on the same two claim-construction positions and recites, but does not
`
`apply, the definition of a third claim term (“therapeutically effective
`
`amount”) set forth in the specification;
`
` relies on the same prior art (ClinicalTrials NCT00168701; ICH Guideline
`
`E4; Begleiter) and substantially the same additional prior art (Kappos 2006;
`
`Joshi; Joshi 2002);
`
` advances the same contention that it would have been obvious to treat MS
`
`by orally administering about 480 mg/day of DMF as claimed because one
`
`of ordinary skill allegedly would have modified the design of the Phase II
`
`clinical study of BG00012 (DMF) based on concerns about DMF’s
`
`gastrointestinal side effects and the instructions on dose-ranging studies
`
`provided in ICH Guideline E4;
`
` relies on a substantially similar declaration from the same technical expert
`
`(Steven E. Linberg, Ph.D.); and
`
` again fails to rebut the claimed invention’s unexpected results established
`
`during prosecution.
`
`Petitioner provides no legitimate justification for the second petition. For
`
`example, the interference decision cited by Petitioner concerning the priority date
`
`of the ’514 patent is irrelevant because Petitioner asserted the same alleged
`
`2
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`February 7, 2008 effective filing date in both petitions. Thus, under its own theory,
`
`Petitioner could have argued in the first petition that Kappos 2006 is § 102(b) prior
`
`art, but chose not to do so. Indeed, every prior-art reference and argument in the
`
`second petition was fully available to Petitioner at the time it filed the first petition.
`
`Thus, because the second petition presents the same or substantially the same prior
`
`art and arguments as the first petition, the Board should decline to institute an IPR.
`
`If the Board considers the merits, it should conclude that the petition does
`
`not establish a reasonable likelihood that any claim is unpatentable. The petition,
`
`for example, fails to prove that one of ordinary skill would have selected a dose of
`
`about 480 mg/day of DMF as claimed or, based on the prior art asserted, would
`
`have reasonably expected that such dose would be therapeutically effective or
`
`useful. The petition also does not rebut the record evidence of unexpected results,
`
`further demonstrating that Petitioner is unlikely to prove that any of claims 1-20 of
`
`the ’514 patent are unpatentable for obviousness.
`
`II. The Board Should Deny This Petition Under 35 U.S.C. § 325(d)
`A petitioner is not entitled to unlimited patent challenges. The Board may
`
`decline to institute an IPR when a petition raises the same or substantially the same
`
`prior art or arguments as previously presented. 35 U.S.C. § 325(d). Section 325(d)
`
`empowers the Board to prevent petitioners from repeatedly challenging patents.
`
`Conopco, Inc. v. Procter & Gamble Co., IPR2014-00506, Paper 25 at 3-4 (PTAB
`
`3
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`Case No. IPR2015-01993
`Patent 8,399,514
`Dec. 10, 2014) (Informative Opinion) (holding that the Board’s authority to deny
`
`institution of follow-on petitions is grounded in § 325(d) and stating that institution
`
`is nevertheless discretionary, not mandatory, under § 314(a)); see H.R. REP. NO.
`
`112-98, pt. 1, at 48 (2011).
`
`Serial challenges undermine the goals of these proceedings by using IPRs as
`
`a tool for harassment rather than as an effective alternative to litigation and by
`
`forcing patent owners to divert resources away from research and development.
`
`H.R. REP. NO. 112-98, pt. 1, at 48 (2011); Butamax Advanced Biofuels, LLC v.
`
`Gevo, Inc., IPR2014-00581, Paper 8 at 12-13 (PTAB Oct. 14, 2014). This policy
`
`concern is particularly relevant as to this Petitioner, which markets no product and
`
`is not using IPRs as an alternative to litigation. (See Ex. 2001 (discussing objective
`
`of taking long or short stock positions in the pharmaceutical sector).) Serial
`
`challenges also prevent the Board from achieving the just, speedy, and inexpensive
`
`resolution of every proceeding. See 37 C.F.R. § 42.1(b); HTC Corp. v. NFC Tech.,
`
`LLC, IPR2015-00384, Paper 11 at 11-12 (PTAB July 6, 2015) (denying institution
`
`under § 325(d) and explaining that institution on the same or substantially the same
`
`prior art or arguments would not ensure the just, speedy, and inexpensive
`
`resolution of every proceeding); Samsung Elecs. Co. v. Rembrandt Wireless
`
`Techs., LP, IPR2015-00114, Paper 14 at 7 (PTAB Jan. 28, 2015) (“Permitting
`
`4
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`Case No. IPR2015-01993
`Patent 8,399,514
`second chances in cases like this one ties up the Board’s limited resources; we
`
`must be mindful not only of this proceeding, but of ‘every proceeding.’”).
`
`This follow-on petition is substantially the same as the first petition. It
`
`challenges the same patent claims (claims 1-20 of the ’514 patent) as the first
`
`petition, relies on the same statutory basis (35 U.S.C. § 103), and uses prior art that
`
`was fully available at the time of the first petition. (Pet. at 1, 7-8; Ex. 2002 at 1, 6-
`
`7.) It also identifies the same Petitioner (Coalition for Affordable Drugs V LLC)
`
`and same eleven real parties-in-interest as the first petition. (Pet. at 1-2; Ex. 2002
`
`at 1-3.) Therefore, Petitioner and the real parties-in-interest already had a full and
`
`fair opportunity to present their best challenges to the ’514 patent. See Conopco,
`
`Inc. v. Procter & Gamble Co., IPR2014-00628, Paper 21 at 11-12 (PTAB Oct. 20,
`
`2014).
`
`A. This Second Petition Raises the Same or Substantially the Same
`Prior Art and Arguments as the First Petition
`
`Critically, as detailed below, this petition challenges the ’514 patent claims
`
`by relying on the same or substantially the same prior art and obviousness
`
`arguments as the first petition. The Board, however, has already fully considered
`
`“all arguments presented by Petitioner” in the first petition and held that “none
`
`justify instituting an inter partes review.” See Coal. for Affordable Drugs V LLC v.
`
`Biogen MA Inc., IPR2015-01136, Paper 23 at 16 (PTAB Sept. 2, 2015). Petitioner
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`5
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`Case No. IPR2015-01993
`Patent 8,399,514
`should not be afforded an opportunity to reassert the same deficient obviousness
`
`contentions.
`
`Like the first petition, this petition asserts that the ’514 patent is only entitled
`
`to a February 7, 2008 priority date and is not entitled to the benefit of U.S.
`
`Provisional Application No. 60/888,921, filed February 8, 2007. (Pet. at 14; Ex.
`
`2002 at 10-11.) The same prior art was therefore available to Petitioner in both
`
`proceedings. (See infra Section II.B.)
`
`Both petitions provide the same overview of the ’514 patent. (Pet. at 14-16;
`
`Ex. 2002 at 11-13.) They both also state that the field of the ’514 patent is treating
`
`a disease with an orally administered drug. (Pet. at 16; Ex. 2002 at 13.)
`
`Both petitions provide substantially the same definition of a person of
`
`ordinary skill in the art, asserting that such person most likely would have had an
`
`advanced degree, such as a Ph.D. in one of the life sciences, M.D., a D.O., or a
`
`Pharm.D. (Pet. at 16-17; Ex. 2002 at 13-14.) The first petition further stated that
`
`such person would have had “some experience with clinical trials” whereas the
`
`second petition states that such person would have had “some experience with
`
`clinical trial designs for dose selection.” (Pet. at 17; Ex. 2002 at 14.) But Petitioner
`
`never explains or relies on this modified language, which therefore does not
`
`diminish the otherwise identical definitions.
`
`6
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`Case No. IPR2015-01993
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`Both petitions also include the same proposed constructions for the claim
`
`terms “excipients” and “consisting essentially of.” (Pet. at 17-18; Ex. 2002 at 14-
`
`15.)
`
`Both petitions also advance substantially the same arguments regarding
`
`claim 1’s requirement for a dosage of DMF of about 480 mg/day. Neither petition
`
`cites any prior art disclosing a dosage of 480 mg/day of DMF. (See Pet. at 26-30;
`
`Ex. 2002 at 20-22.) The first petition discussed Kappos 2006 in its summary of the
`
`prosecution history, but chose not to expressly rely on this reference. (Ex. 2002 at
`
`7-10.) Instead, the first petition relied on the “clinical trial design” of the Phase II
`
`study disclosed in Kappos 2005 and ClinicalTrials NCT00168701, including the
`
`proposed doses of BG00012 (DMF) of 120 mg/day, 360 mg/day, and 720 mg/day.
`
`(Ex. 2002 at 20-22.) The second petition relies principally on the same Phase II
`
`“clinical trial design” disclosed in Kappos 2006 and ClinicalTrials NCT00168701,
`
`with the same three doses. (Pet. at 27-29.)
`
`Kappos 2006 (unlike Kappos 2005) discloses the results of the Phase II
`
`study, but the second petition never attempts to tie those results to any theory of
`
`obviousness of the claimed dose of about 480 mg/day of DMF, MMF, or a
`
`combination thereof. (See, e.g., Pet. at 27-29.) Instead, both petitions similarly
`
`assert that one of ordinary skill would have had reason to modify the design of the
`
`Phase II study in view of ICH Guideline E4 “as part of a group of dosing studies.”
`
`7
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`Case No. IPR2015-01993
`Patent 8,399,514
`(Id. at 29; Ex. 2002 at 22.) The petitions thus present the same theory of
`
`obviousness regarding the claimed dosage of about 480 mg/day, notwithstanding
`
`the additional disclosure of the Phase II study results in Kappos 2006.
`
`The second petition adds a definition of “therapeutically effective amount,”
`
`which the first petition omitted. (Pet. at 18; Ex. 2002 at 14-15.) This proposed
`
`definition matches the definition provided in the ’514 patent specification, and it is
`
`also the same definition proposed in Biogen’s preliminary response to the first
`
`petition. (Ex. 1001 at 5:52-59; Ex. 2003 at 6-7.) The inclusion of this undisputed
`
`definition in the second petition is irrelevant, however, because Petitioner does not
`
`advance any new argument based on it. 37 C.F.R. § 42.104(b)(3), (4) (petition
`
`must identify how a claim is to be construed and how the construed claim is
`
`unpatentable). For example, the second petition does not argue or prove that
`
`Kappos 2006 (or any other prior art) would have suggested to one of ordinary skill
`
`that a dose of about 480 mg/day of DMF would be therapeutically effective (impart
`
`the specified biological effects) in treating MS as claimed. (See, e.g., Pet. at 26-29;
`
`see also infra Section III.A.)
`
`Both petitions also rely on the statement in ClinicalTrials NCT00168701
`
`that dose reduction would be allowed for subjects who were unable to tolerate
`
`DMF. (Pet. at 27; Ex. 2002 at 20.) The first petition relied on Kappos 2005 and
`
`ClinicalTrials NCT00168701 to argue that doses in multiples of 120 mg and 240
`
`8
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`Case No. IPR2015-01993
`Patent 8,399,514
`mg were available. (Ex. 2002 at 21.) The second petition relies on Kappos 2006
`
`and ClinicalTrials NCT00168701 to make substantially the same argument that
`
`single dosage forms were available in 120 mg and 240 mg units. (Pet. at 27-29.)
`
`(Both petitions also incorrectly assume that 240 mg units were available. (See infra
`
`Section III.A.2.))
`
`Both petitions also make the same argument concerning an alleged gap in
`
`the Phase II study’s doses. Citing Kappos 2005, the first petition asserted that the
`
`study “did not test doses between 360 mg/day and 720 mg/day.” (Ex. 2002 at 21.)
`
`The second petition similarly argues that the study “did not disclose doses between
`
`360 mg/day and 720 mg/day,” citing Kappos 2006 (which describes the same study
`
`as Kappos 2005). (Pet. at 28.)
`
`Both petitions also rely heavily on the same portions of ICH Guideline E4 to
`
`support their obviousness arguments. Quoting several passages from the guideline,
`
`the first petition argued that the guideline would have instructed one of ordinary
`
`skill as follows regarding assessment of dose-response:
`
` “Assessment of dose-response should be an integral component of drug
`
`development with studies designed to assess dose-response an inherent part
`
`of establishing the safety and effectiveness of the drug. If development of
`
`dose-response information is built into the development process it can
`
`usually be accomplished with no loss of time and minimal extra effort
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`Case No. IPR2015-01993
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`compared to development plans that ignore dose-response.” (Ex. 2002 at 20
`
`(quoting Ex. 1004 at 7).)
`
` “It is all too common to discover, at the end of a parallel dose-response
`
`study, that all doses were too high (on the plateau of the dose-response
`
`curve), or that doses did not go high enough.” (Ex. 2002 at 20-21 (quoting
`
`Ex. 1004 at 10).)
`
` Dosing studies are performed as a standard procedure in drug development
`
`in order to “allow study of the proper dose range” in Phase III. (Ex. 2002 at
`
`21 (quoting Ex. 1004 at 10 (without citation)).)
`
` The purpose of ICH Guideline E4 is to provide instructions to help identify
`
`“an appropriate starting dose, the best way to adjust dosage to the needs of a
`
`particular patient, and a dose beyond which increases would be unlikely to
`
`provide added benefit or would produce unacceptable side effects.” (Ex.
`
`2002 at 22 (quoting Ex. 1004 at 5).)
`
`The second petition relies on the same quotes from ICH Guideline E4. (Pet.
`
`at 27-29.) In fact, the petitions are word-for-word identical when discussing the
`
`guideline. (Compare Pet. at 27-29 (paragraph starting with “Dr. Linberg attests
`
`. . .”), with Ex. 2002 at 20-21 (paragraph also starting “Dr. Linberg attests . . .”).)
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`Case No. IPR2015-01993
`Patent 8,399,514
`Dr. Linberg’s expert declarations also contain identical discussions of ICH
`
`Guideline E4. (See, e.g., Ex. 1005 at ¶ 32; Ex. 2004 at ¶ 33.)
`
`Both petitions also argue (with identical language) that “side effects are
`
`always a concern in drug development, as they were for DMF.” (Pet. at 29; Ex.
`
`2002 at 21.) Further, both petitions rely heavily on a substantially similar
`
`declaration from the same technical expert, Dr. Linberg. (Compare Ex. 1005, with
`
`Ex. 2004.)
`
`Based on the same underlying factual assertions regarding the Phase II
`
`study’s design and the fact that it did not test doses between 360 mg/day and 720
`
`mg/day, concerns about DMF’s potential gastrointestinal side effects, and the
`
`purported availability of doses in 120 mg and 240 mg units, both petitions advance
`
`the same proposed obviousness conclusion: that one of ordinary skill allegedly
`
`would have been motivated to administer BG00012 (DMF) at 480 mg/day (as well
`
`as at 600 mg/day) as a standard process of drug development. (Pet. at 27-29; Ex.
`
`2002 at 20-21.)
`
`Ground 1 of each petition concludes that, “[i]n sum,” one of ordinary skill
`
`“would have been motivated to conduct routine experiments at a range of doses,
`
`including 480 mg/day, by orally administering that dose” to subjects in need of
`
`treatment for MS. (Pet. at 30; Ex. 2002 at 22.)
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`Case No. IPR2015-01993
`Patent 8,399,514
`Although Ground 1 of the second petition raises a new prior-art reference
`
`(Joshi), its reliance on this reference is repetitive and cumulative to its reliance on
`
`ClinicalTrials NCT00168701 and Kappos 2006 (and Kappos 2005). The second
`
`petition, for example, cites ClinicalTrials NCT00168701 as disclosing DMF’s
`
`potential gastrointestinal side effects, but then cites Joshi as also disclosing the
`
`same potential gastrointestinal side effects. (Pet. at 28-29.) Similarly, the second
`
`petition cites Kappos 2006 as showing the oral administration of BG00012, but
`
`then cites Joshi as also disclosing oral preparations. (Id. at 30.) Highlighting the
`
`cumulative nature of Joshi, Petitioner repeatedly introduces it with the phrase
`
`“Joshi also teaches . . .” or “Joshi also discloses . . . .” (See, e.g., id. at 25, 26, 28,
`
`30, 37, 39-40, 43, 47, 49, 50, 52.) Thus, the second petition’s addition of Joshi in
`
`this cumulative manner does not meaningfully distinguish the two petitions.
`
`Further, the second petition also substitutes Joshi for other references that
`
`the first petition cited for the same point. The first petition, for example, relied on
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`the Nieboer reference for the excipient claim element. (Ex. 2002 at 19-20 (citing
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`Ex. 1019A, Nieboer).) The second petition, on the other hand, asserts that Joshi
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`suggests combining DMF with excipients. (Pet. at 26.) Similarly, the first petition
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`relied on the Werdenberg paper (coauthored by Joshi) for its disclosure that
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`monomethyl fumarate (MMF) is a metabolite of DMF. (Ex. 2002 at 19, 28 (citing
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`Ex. 1016A, Werdenberg).) The second petition, for no explained reason, relies on
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`Patent 8,399,514
`Joshi and Joshi 2002 for their similar disclosure that MMF (also known as methyl
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`hydrogen fumarate) is a metabolite of DMF. (Pet. at 54-55.) In each case, the
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`change in cited reference does not alter Petitioner’s argument as to these claim
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`limitations. In fact, the arguments are identical: that DMF may be mixed with
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`excipients and that MMF is a metabolite of DMF. The second petition’s citation of
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`Joshi and Joshi 2002 therefore adds nothing to the first petition’s obviousness
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`contentions.
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`Nor does Petitioner state that it was unaware of Joshi or Joshi 2002 at the
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`time of the first petition. See Unilever, Inc. v. Procter & Gamble Co., IPR2014-
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`00506, Paper 17 at 6 (PTAB July 7, 2014) (Informative Opinion) (“Unilever . . .
`
`presents no argument or evidence that the seven newly cited references were not
`
`known or available to it at the time of filing of the 505 Petition.”). Indeed, every
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`prior-art reference and argument in the second petition was fully available to
`
`Petitioner at the time it filed the first petition. Petitioner’s strategic decision to
`
`exclude certain references or arguments from its unsuccessful first petition does
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`not justify a second petition.
`
`The second petition states its obviousness challenge to dependent claim 7 as
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`a separate “Ground 2.” (Pet. at 54-56.) But, as explained, the newly cited Joshi and
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`Joshi 2002 references in “Ground 2” do not substantively change the first petition’s
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`argument that MMF was a known metabolite of DMF.
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`13
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`Case No. IPR2015-01993
`Patent 8,399,514
`Similarly, the second petition states its challenge to dependent claims 17-19
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`as a separate “Ground 3.” (Pet. at 56-59.) Yet both petitions assert that the subject
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`matter of these claims would have been obvious based on the same prior art
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`(Begleiter) and same arguments concerning the purported inherent relationship
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`between treatment with DMF and NQO1 activity. (Id. at 56-58; Ex. 2002 at 44-
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`45.) The first petition, for example, argued that “Begleiter . . . teaches that NQO1
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`activity increases after either in vitro or in vivo treatment with DMF.” (Ex. 2002 at
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`44.) The second petition repeats this statement verbatim. (Pet. at 57.) Dr. Linberg’s
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`analysis in both petitions also relies on Begleiter. (Ex. 1005 at ¶ 76; Ex. 2004 at
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`¶ 84.) In the second petition, Petitioner names Begleiter in the proposed ground of
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`unpatentability rather than simply relying on it within the proposed ground. But
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`this is a difference without meaning. Both petitions rely on Begleiter to advance
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`the same argument regarding the expression level of NQO1 after treatment with
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`DMF. (Pet. at 56-58; Ex. 2002 at 44-45.) Both petitions also cite the same
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`inherency case law. (Pet. at 56; Ex. 2002 at 43.)
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`Accordingly, because the second petition raises the same or substantially the
`
`same prior art and arguments as the first petition, the Board should exercise its
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`discretion to deny the second, follow-on petition under 35 U.S.C. § 325(d). See
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`Unilever, IPR2014-00506, Paper 17 at 5-8.
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`Case No. IPR2015-01993
`Patent 8,399,514
`B. No Circumstances Justify a Repetitive Challenge to the ’514
`Patent
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`Petitioner fails to justify why the Board should permit a repetitive challenge
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`to the ’514 patent. The Board’s practice is to prevent petitioners from using failed
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`institution attempts as “how-to guide(s)” in preparing later challenges. See ZTE
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`Corp. v. ContentGuard Holdings Inc., IPR2013-00454, Paper 12 at 5-6 (PTAB
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`Sept. 25, 2013) (Informative Opinion). These “second chances” unreasonably
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`burden the patent owner and the Office when the petitioner has already had an
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`opportunity to present its best case. See H.R. REP. NO. 112-98, pt. 1, at 48 (2011);
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`Conopco, IPR2014-00628, Paper 21 at 11.
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`In Unilever, IPR2014-00506, Paper 17 at 8, for example, the Board
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`determined that Unilever’s petition was substantially similar to a previous petition.
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`Where the petitions differed, the Board was persuaded that Unilever was “armed
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`with the Board’s guidance” and had tailored the second petition to correct the flaws
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`of the first. Id. The Board also stated that Unilever had presented no considerations
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`tipping the balance in favor of review. Id. It therefore denied the request for inter
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`partes review under § 325(d). Id.
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`This case is analogous. Less than a month after the Board denied Petitioner’s
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`first petition against the ’514 patent, Petitioner repackaged the same or
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`substantially the same arguments and prior art in this second petition. But to the
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`15
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`Patent 8,399,514
`extent Petitioner raises any new prior art or arguments, it has done so in attempt to
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`cure the first petition’s deficiencies. As in Unilever, Petitioner’s use of the Board’s
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`earlier decision as a roadmap in this manner does not justify permitting a repetitive
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`challenge to the ’514 patent. IPR2014-00506, Paper 17 at 8.
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`Anticipating that the Board may deny this follow-on petition under § 325(d),
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`Petitioner raises three purported justifications for the new petition:
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`First, Petitioner asserts that in interference proceedings involving the ’514
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`patent, priority was accorded only to February 7, 2008, not to the February 8, 2007
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`filing date of the U.S. provisional application. (Pet. at 20.) Petitioner argues that
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`this priority ruling changed its ability to rely on the Kappos 2006 reference as
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`§ 102(b) prior art (which Biogen could not antedate); and that Kappos 2006, unlike
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`Kappos 2005, provides the results of the Phase II study showing that DMF is
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`effective in treating MS. (Id. at 20-21.)
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`This argument is unavailing. The first petition asserted the same February 7,
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`2008 effective filing date as the second petition (and the interference decision).
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`(Ex. 2002 at 10-11.) Consequently, under Petitioner’s own theory, Kappos 2006
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`was available as § 102(b) prior art in the first petition. Moreover, even if a different
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`effective filing date applied, Kappos 2006 was still available as § 102(a) prior art.
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`Petitioner acknowledges this fact. (Pet. at 20.) Petitioner was admittedly aware of
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`16
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`Case No. IPR2015-01993
`Patent 8,399,514
`Kappos 2006, yet chose not to rely on it in the first petition. That unsuccessful
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`strategic decision does not justify a second petition.
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`Further, although Kappos 2006 (unlike Kappos 2005) summarized the
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`results of the Phase II study of BG00012 (DMF), the second petition continues to
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`rely principally on the “clinical trial design” of the Phase II study, not the results of
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`the study, exactly as in the first petition. (See supra Section II.A; compare Pet. at
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`26-30, with Ex. 2002 at 20-22.) Indeed, the second petition only mentions the
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`study results in passing without any analysis. (See Pet. at 27.
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